Adult Immunization Toolkit For Rural Health Clinics

Transcripción

1 Adult Immunization Toolkit For Rural Health Clinics Prepared By: Health Consulting Strategies, Inc. May 25, 2013 P.O. Box 420 Grand Ledge, Michigan Phone Fax

2 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Adult Immunization Toolkit Table of Contents 00a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: TABLE OF CONTENTS 1. GETTING STARTED Page No. a. Vaccination Definition/Purpose 6 b. Getting Your Practice Immunization Ready (Overview) 8 c. Vaccine Coordinator Job Description 10 d. I-CARE Fact Sheet HOW TO DEVELOP YOUR STAFF a. Staff Training 14 b. Skills Checklist for Immunizations 16 c. Illinois RHC Immunization Competency Exam 18 d. Illinois RHC Immunization Competency Exam Answer Key 20 e. Illinois Immunization Resource Scavenger Hunt 22 f. Illinois Immunization Resource Scavenger Hunt Answer Key 24 g. Illinois RHC Vaccine Documentation Checklist 26 h. Vaccine Acronyms & Abbreviations VACCINE STORAGE AND MAINTENANCE a. RHC Vaccine Unit Equipment & Maintenance, Temperature 29 Monitoring & Storage Practices Policy b. Vaccines Thermometer Requirements & Types 34 c. Temperature Logs for Refrigerator/ Vaccine Storage Troubleshooting 36 Record d. Temperature Logs for Freezer/Vaccine Storage Troubleshooting 40 Record e. Don t Be Guilty of These Errors in Vaccine Storage & Handling 44 f. DO NOT UNPLUG signs for refrigerator/freezer outlet 45 g. DO NOT UNPLUG sign for circuit breaker associated with vaccine 46 storage equipment h. Vaccine Handling Tips 47 i. Emergency Response Worksheet 48 j. Illinois Vaccine Management Plan 49 k. Checklist for Safe Vaccine Storage and Handling VACCINE HANDLING a. Vaccine Wastage/Expiration/and Transfer Policy 56 b. Vaccine Loss & Replacement Protocol c. Illinois VFC Pediatric Vaccine Order, Inventory & Accountability 63 Form 1

3 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Adult Immunization Toolkit Table of Contents 00a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: d. Vaccine Waste Packing List for Excise Tax Credit and Disposal Form 65 e. Vaccine Transfer Form Illinois Department of Public Health 67 f. Transporting Refrigerated Vaccine Guidelines VACCINE ORDERING AND ACCOUNTABILITY a. Vaccine Receiving, Ordering, Accountability & Borrowing Policy 70 b. Illinois VFC Pediatric Vaccine Order, Inventory and Accountability 74 Form c. Illinois VFC Vaccine Borrowing Report 76 d. Illinois VFC Immunization Program/Vaccine Loss & Replacement 77 Policy 6. ADULT VACCINE SCREENING a. Summary of Recommendations for Adult Immunization (Age 19 & 84 above) b. Recommended Immunizations for Adults Chart 88 c. Immunization & Pregnancy Chart for the Adult Before, During, and 90 After Pregnancy d. Guide to Contraindications to Adult Vaccination 91 e. It s Federal Law! 92 f. VIS (Vaccine Information Statements) i. Influenza Inactivated (English/Spanish) 94 ii. Influenza Active (English/Spanish) 98 iii. Td or Tdap (English/Spanish) 102 iv. DTaP (English/Spanish) 106 v. Chickenpox (English/Spanish) 110 vi. HPV Cervarix (English/Spanish) 114 vii. HPV Gardasil (English/Spanish) 118 viii. Shingles (English/Spanish) 122 ix. MMR (English/Spanish) 126 x. Pneumococcal (English/Spanish) 130 xi. Meningococcal (English/Spanish) 134 xii. Hepatitis A General Information 138 xiii. Hepatitis A Screening Questionnaire 140 xiv. Hepatitis A (English/Spanish) 141 xv. Hepatitis B Screening Questionnaire 145 xvi. Hepatitis B (English/Spanish) 146 g. Viral Hepatitis information for Gay/Bisexual Men 150 h. Current dates of VIS s as of February 27,

4 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Adult Immunization Toolkit Table of Contents 00a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 3 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: i. Screening Checklist for Contraindications to Vaccines for Adults 153 (English/Spanish) j. HALO Screening Tool 157 k. Vaccine Assessment for Adult Patients with HIV 158 l. Vaccine Assessment for Adult Patients with Hepatitis C 159 m. Vaccine Assessment for Adult Patients with Diabetes 160 n. Vaccine Assessment for Adult Patients with Bleeding Disorders 161 o. Vaccine Administration Record 162 p. Illinois Adult Immunization Declination Form 166 q. Illinois Medical and Religious Exemptions ADULT VACCINE ADMINISTRATION a. Adult Vaccine Administration Policy 171 b. Standing Orders for Adult Vaccines i. Influenza 176 ii. Pneumococcal 177 iii. Zoster 178 iv. Varicella 179 v. MMR 180 vi. Tdap/Td 181 vii. Meningococcal 182 viii. HPV 183 ix. Hepatitis A 184 x. Hepatitis B 185 c. Shop IAC: Adult Immunization Record Cards Order Form 186 d. Vaccine Brand Tip Sheet 188 e. Vaccines With Diluents: How to Use Them 190 f. How to Administer IM & SQ Vaccine Injections to Adults 191 g. Administering Vaccines to Adults: Dose, Route, Site, and Needle Size 192 h. Anatomic Sites for Immunization 193 i. OSHA Guidelines for sharps disposal 194 j. After Receiving Vaccines Patient Instruction Template 196 k. Conditions Commonly Misperceived as Contraindications to Vaccines MEDICAL MANAGEMENT OF VACCINE REACTION IN ADULTS a. Medical Management of Vaccine Reaction in Adults Policy 202 b. Vaccinations for Adults with Diabetes 206 c. Vaccinations for Adults with HIV Infection 207 d. Vaccinations for Adults with Hepatitis C 209 3

5 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Adult Immunization Toolkit Table of Contents 00a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 4 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: e. VAERS (Vaccine Adverse Event Reporting System) FORM and 209 Instructions f. VAERS Reportable Events Table INFLUENZE VACCINATION PROGRAM a. Influenza Implementation Timeline Policy 215 b. Standing Orders for Administering Influenza Vaccine to Adults 217 c. Healthcare Personnel Vaccination Recommendations 218 d. Influenza Inactivated VIS (Vaccine Information Statement) (English 219 & Spanish) e. Influenza Consent/Declination (English/Spanish) 223 f. Medical Management of Vaccine Reactions in Adult Patients COMMUNITY OUTREACH a. Obstacles in a Vaccine Program 230 b. Suggestions to Improve Your Immunization Services 231 c. Adult Immunization Guidelines Brochure 233 d. You re Never Too Old to Get Immunized! (English/Spanish) 235 e. Supply List for Community Outreach Clinic 237 f. Free CDC Advertising Posters 238 g. CDC Success of Vaccine Strategies i. Computerized Record Reminder Report 239 ii. Performance Feedback Chart 240 iii. Mail Reminder & Telephone Script 241 iv. Immunization Clinic Poster 243 v. Adult Immunization Card 244 vi. Instructions for Conducting a Baseline Assessment in a Non- 246 Computerized Setting h. Flu Campaign Ideas MISCELLANEOUS a. Sample Vaccine Policy Statement 252 b. Vaccines Work! CDC Statistics 253 c. Personal Prevention Record 254 d. Contact Numbers for Vaccine Vendors RESOURCES a. Illinois Adult Immunization Toolkit Resources 257 b. General Immunization Information Resource Websites 263 4

6 Section 1 GETTING STARTED Section 1 5

7 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Vaccination Definition & Purpose 1a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: A vaccination, also called an inoculation/immunization is a preparation containing weakened or dead microbes of the kind that causes a disease; administered to stimulate the immune system to produce antibodies against the disease. These vaccinations are given by intramuscular or subcutaneous injection or in some cases by an intranasal method. This toolkit was developed as a resource guide for medical providers and their staff who wishes to provide adult immunizations in their practices. The document covers the important information necessary to plan, implement, and maintain an adult immunization program for your practice. See important links to resources below. 1. The Vaccine and Immunizations Website of the Centers for Disease Control and Prevention (CDC) at and the Pink Book produced by the CDC provide comprehensive information about vaccine-preventable diseases and the latest recommendations/guidelines concerning immunization services. The CDC s Pink Book may be downloaded or viewed at : Appendix A of the Pink Book may be downloaded at You may also contact the CDC directly for information on immunization via the CDC-INFO Contact Center 24 hours/7 days a week: (800) or (800) CD- INFO. 2. The Advisory Committee on Immunization Practices (ACIP) is an authorized group of experts that develops recommendations for the CDC on how to use vaccines to control diseases in the U.S. It covers ages, numbers of doses, intervals, precautions and contraindications. ACIP revises its report General Recommendations on Immunization, every 3 to 5 years. Most recently revised in January 2011, the report is a great source of vaccination information available at: 6

8 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Vaccination Definition & Purpose 1a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: 3. The Immunization Action Coalition s (IAC) website developed with the CDC compiles the guidelines and recommendations established by the CDC into practical charts/materials, updated continually, to be referred to by health practitioners in their day-to-day practice. Clinic Resources: Publications: 7

9 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Getting Your Practice Immunization Ready 1b APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: Get Support and Cooperation from Staff 1. Frontline staff, both medical and clerical, will be the most heavily affected by this increased volume. 2. Involve your entire team. Don t limit this group to clerical, nursing, and clinical. Ask management, finance, and insurance authorization personnel to help develop an immunization plan that will work for your office. For example, you may want to consider in advance if all adult patients will be offered vaccines or only a select group of high-risk patients. Will vaccines be available every day the clinic is open or only during designated hours? Look for Community Resources 1. If you are part of a large medical facility, you may want to contact those practices who routinely give immunizations such as other family practices, OB/GYN offices, and ICAAP (Illinois Chapter American Academy of Pediatrics) 2. Consult with your local or state health department. Assign a Vaccine Coordinator and Backup Vaccine Coordinator 1. Responsibilities include: Ø Developing or following protocol for routine vaccine management and for managing vaccine emergencies when there is equipment failure, power outages, natural disasters, or patients who have an adverse reaction to a vaccine. Ø Assure staff s competence with vaccine protocols. Develop a Workflow and Workspace 1. Consider where you will store vaccines and supplies, and where you will draw up or mix vaccines. Ø Space for refrigerator units. Ø Space for storing supplies such as needles, alcohol wipes, trays, band aids, etc. Ø Physical work surface for preparing vaccines. 2. Consider where vaccines will be administered. Ø In the exam room? In a different area of the clinic? Ø Place for patients to sit during and after vaccination. Ø Adequate lighting, a designated clean work surface, a sink for hand washing, access to supplies, sharps containers, and telephone. Ø Space for informational forms, questionnaires, patient record card, and the required Vaccine Information Statements. These can be found in Section 4 of the Illinois RHC Adult Vaccination Binder. 8

10 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Getting Your Practice Immunization Ready 1b APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: Purchase the Appropriate Vaccine Storage Equipment 1. The Advisory Committee on Immunization Practices (ACIP) maintains that stand-alone refrigerators and freezers are the most effective at maintaining the precise temperatures required for vaccine storage. Ø If you plan to store only a limited quantity of vaccine, a combination refrigerator-freezer unit may also be used, as long as the refrigerator and freezer compartments have separate external doors. Ø No dormitory- style units should be used. Ø The CDC s Refrigerator Buying Guide is located on the Vaccine Storage and Handling Recommendation page: Ø Refrigerators and freezers used for vaccine storage must be able to maintain the recommended storage temperatures. Ø Vaccines licensed for refrigerator storage should be stored at: 35 F to 46 F (2 to 8 C). Ø Vaccines licensed for freezer storage should be stored at: 5 or -15 C (excluding MMRV, which should be kept at -58 F to -5 F or -50 C to -15 C). Ø Refrigerators and freezers should be large enough to hold the year s largest inventory. Ø They should also be dedicated to the storage of vaccines and pharmaceuticals only (not food or drinks). Ø Aside from contamination issues, frequent opening and closing of refrigerator doors should be avoided to help maintain constant temperatures. Ø All refrigerators and freezers used for vaccine storage should be consistently monitored to ensure maintenance of recommended temperatures. 9

11 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Employment Job Description: Vaccine Coordinator 1c APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: SUMMARY: The Vaccine Coordinator will be responsible for the overall vaccine management of the rural health clinic. This includes managing emergencies when there is equipment failure, power outages, natural disasters, adverse reaction to a vaccine, and assuring the competency of the clinic s vaccinators. This individual should have 24-hour access to the building where the refrigerator/freezer storing vaccines is located. He/she should be familiar with the clinic s floor plan, location of light switches, flashlight, generator (if applicable), and any other pertinent information to deal with a power outage or other vaccine emergency, and implementation of the emergency response plan if necessary. QUALIFICATIONS: Registered Nurse, Licensed Practical Nurse licensed to practice in the state of Illinois or a certified Medical Assistant. Working knowledge of the I-CARE immunization tracking system and all aspects of the vaccine program is required. Must hold a current Basic Cardiac Life Support (BCLS) certification. ESSENTIAL JOB FUNCTIONS: 1.0 Develop emergency protocols for routine vaccine administration. 1.1 Management of vaccines during equipment failure, power outages, and natural disasters, including proper transfer of vaccines to an alternate location if necessary. 1.2 Establish protocol for identifying and treating adverse reactions in patients receiving vaccines. Guidelines are found in the Medical Management of Vaccine Reactions in Adults policy, p of the IAI Toolkit 1.3 Develop training for staff vaccinators. Assure competency by demonstrated use of I- CARE, p.30 and completion of annual vaccine protocol review, using the tools listed in, p. 4-5 of the Illinois Adult Immunization Toolkit Binder (IAI Toolkit). 1.4 Develop/mentor the back- up vaccine coordinator and/or designee to assume duties when the vaccine coordinator is not available. 2.0 Order and maintain an inventory of vaccines, syringes, and other required supplies for administering vaccines. 2.1 Coordinate with your local health department for VFC s (Vaccine for Children) and your hospital or other vendor to establish a vaccine ordering schedule. 10

12 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Employment Job Description: Vaccine Coordinator 1c APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: 3.0 Oversee the proper receipt and storage of vaccines shipments, using the guidelines in the Vaccine Receiving, Ordering, Accountability and Borrowing Policy, p and Vaccine Waste Expired Vaccine and Transfer Policy, p of the IAI Toolkit. 4.0 Monitor the refrigerator(s) and freezer (s) temperatures including recording referencing the Vaccine Unit Equipment & Maintenance, Temperature Monitoring & Storage Practices policy, p of the IAI Toolkit. 5.0 Ensure compliance with recordkeeping; and overall evaluation of the vaccination program. See the Adult Vaccine Administration policy, p of the IAI Toolkit. Physical Demands: Duties may include light to moderate exertion of manual effort in transporting materials and equipment; lifting bending, pushing, and/or pulling loads up to twenty-five (25) pounds. Accident/Health Hazards: The tasks performed on the job may produce exposure to blood borne pathogens, vaccines, and needle sticks. Working Conditions: The work is carried out in a clean, well-lighted environment with possibility of a mild to serious reaction in patients receiving a vaccine. 11

13 Policy Number: 1d 12

14 Section 2 HOW TO DEVELOP YOUR STAFF Section 2 13

15 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Staff Training 2a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: Policy: The materials in this toolkit will be helpful but should not be a substitute for LIVE instruction. A. Training 1. Use well-trained individuals to help train your new vaccinators. 2. Your local health department may also provide training or can refer you to other sources if necessary. 3. Updated in 2010, the California Department of Public Health, the DVD Immunization Techniques: Best Practices with Infants, Children, and Adults, focuses on the skills and techniques necessary for vaccine administration and may be ordered at 4. The e-learning website for California s VFC program, under the California Department of Public Health, provides free training, education, and tools that immunization providers need to develop immunization skills, order and store vaccines, and manage inventory Immunization courses offered in several formats are also made freely available on the CDC website at 6. Appendix D of the CDC s Pink Book provides a great deal of reference materials on vaccine administration at 7. Immunization webcasts and seminars are provided free at: 8. Nursing Initiative Promoting Immunization Training, is located at This program is made possible by the University of Oklahoma s College of Nursing and the CDC and is a free web-based curriculum, available until June 30, The Halo Screening Tool Health condition, Age, Lifestyle, and Occupation can help make an initial decision about vaccinating your patient. See attached example and at: The Skills Check List for Immunizations is attached and at: 14

16 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Staff Training 2a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: 11. Illinois RHC Immunization Competency Exam and Answer Key are included in this toolkit. 12. Illinois Immunization Resources Scavenger Hunt and Answer Key are included in this toolkit. 13. Illinois RHC Vaccine Documentation Checklist is included in this toolkit. B. Organize Immunization References, Questionnaires, Vaccine Information Statements, and other related paperwork. 1. It is important that all required forms and documents are organized and copies kept in convenient locations for either the patient of the provider. Examples of these can be found in Sections 7, 8, and 10 of your toolkit binder. C. Develop Standing Orders 1. Physicians may write standing orders for an authorized staff person to identify whether a patient should receive a vaccine and, if so, to administer the vaccine. 2. According to Subpart C, Section of the Illinois Joint Committee on Administrative Rules, Administrative Code, the delegation in bullet one is permissible Vaccine Standing Orders for every vaccine are found on the IAC website at Examples of all adult vaccine standing orders are attached. D. Immunization Registry 1. All staff should be trained on the I-CARE (Illinois Comprehensive Automated Immunization Registry Exchange). See attached information sheet. For general questions related to I-CARE, go to dph.icare@illinois.gov. For password assistance, go to dph.servicedesk@illinois.gov. 15

17 IMM-694B (9/01) Skills Checklist for Immunization The DVD Immunization Techniques: Best Practices with Infants, Children, and Adults ensures that staff administer vaccines correctly. Order online at The Skills Checklist is is a self-assessment tool tool for for health care care staff staff who who administer immuniza- immunizations. To complete To complete it, review it, review the the competency areas areas below below and and the the clinical clinical skills, skills, techniques tech- to vide several immunizations patients and to score several in the patients Supervisor and score Review in the columns. Supervisor If improvement Review columns. is needed, If score portunity themselves to score in advance. themselves Next in observe advance. their Next, performance observe their as they performance provide immunizations as they pro- and niques, procedures and procedures outlined outlined for each for of them. each of Score them. yourself Score yourself in the Self-Assessment in the Self-Assessment column. If meet improvement with them is to needed, develop meet a Plan with of Action them to (over) develop that will a Plan help of them Action achieve (p. 2) the that level will of competence them achieve you expect; the level circle of desired competence actions you or write expect; in circle others. desired In 30 actions days, observe or write their in others. perfor- help you column. check If Need you check to Improve Need you to Improve, indicate further you indicate study, further practice study, or change practice, is needed. or change When is you needed. check When Meets you or Exceeds check Meets you indicate or Exceeds, you believe you indicate you are you performing believe at you the are expected performing at the expected level of competence, or higher. them level mance again. When all competency areas meet expectations, file the Skills Checklist in their of competence, or higher. personnel The DVD folder. Immunization At the end of Techniques: the probationary Best Practices period and with annually Infants, thereafter, Children, observe and Adults again ensures and that complete staff administer the Skills Checklist. vaccines correctly. Order online at Supervisors: Use the Skills Checklist to to clarify responsibilities and and expectations for for staff staff who administer who administer vaccines. vaccines. When When you use you it for use performance it performance reviews, reviews, give staff give the opportunity staff the op-to Self-Assessment Competency Clinical Skills,Techniques, and Procedures Need to Improve Meets or Exceeds Need to Improve Supervisor Review Meets or Plan of Action* Exceeds A. Patient/Parent Education 1. Welcomes patient/family, establishes rapport, and answers any questions. 2. Explains what vaccines will be given and which type(s) of injection will be done. 3. Accommodates language or literacy barriers and special needs of patient/parents to help make them feel comfortable and informed about the procedure. 4. Verifies patient/parents received the Vaccine Information Statements for indicated vaccines and had time to read them and ask questions. 5. Screens for contraindications. (MA: score NA not applicable if this is MD function.) B. Medical Protocols 6. Reviews comfort measures and after care instructions with patient/parents, inviting questions. 1. Identifies the location of the medical protocols (i.e. immunization protocol, emergency protocol, reference material). 2. Identifies the location of the epinephrine, its administration technique, and clinical situations where its use would be indicated. 3. Maintains up-to-date CPR certification. C. Vaccine Handling 4. Understands the need to report any needlestick injury and to maintain a sharps injury log. 1. Checks vial expiration date. Double-checks vial label and contents prior to drawing up. 2. Maintains aseptic technique throughout. 3. Selects the correct needle size. for 1"-1IM 1 /2" and for SC. IM (DTaP, Td, Hib, HepA, HepB, Pneumo Conj., Flu); 5 /8" for SC (MMR, Var); IPV and Pneumo Poly depends on route to be used. 4. Shakes vaccine vial and/or reconstitutes and mixes using the diluent supplied. Inverts vial and draws up correct dose of vaccine. Rechecks vial label. 5. Labels each filled syringe or uses labeled tray to keep them identified. Adapted from California Department of Public Health Immunization Branch 6. Demonstrates knowledge of proper vaccine handling, e.g. protects MMR from light, logs refrigerator temperature. Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) Item #P7010 (8/11) page 1 of 2

18 Self-Assessment Supervisor Review Competency Clinical Skills,Techniques, and Procedures Need to Improve Meets or Exceeds Need to Improve Meets or Exceeds Plan of Action* D. Administering Immunizations 1. Rechecks the physician s order or instructions against prepared syringes. 2. Washes hands and if office policy puts on disposable gloves. 3. Demonstrates knowledge of the appropriate route for each vaccine. (IM for DTaP, Td, Hib, HepA, HepB, Pneumo Conj, Flu; SC for MMR, Var; Either SC or IM for IPV and Pneumo Poly). 4. Positions patient and/or restrains the child with parent s help; locates anatomic landmarks specific for IM or SC 5. Preps the site with an alcohol wipe using a circular motion from the center to a 2" to 3" circle. Allows alcohol to dry. 6. Controls the limb with the non-dominant hand; holds the needle an inch from the skin and inserts it quickly at the appropriate angle (45º for SC or 90º for IM). 7. Injects vaccine using steady pressure; withdraws needle at angle of insertion. 8. Applies gentle pressure to injection site for several seconds with a dry cotton ball. 9. Properly disposes of needle and syringe in sharps container. Properly disposes of live vaccine vial. 10.Encourages comfort measures before, during and after the procedure. E. Records Procedures 1. Fully documents each immunization in patient s chart: date, lot number, manufacturer, site, VIS date, name/initials. 2. If applicable, demonstrates ability to use IZ registry or computer to call up patient record, assess what is due today, and update computer immunization history. 3. Asks for and updates patient s record of immunizations and reminds them to bring it to each visit. Plan of Action: Circle desired next steps and write in the agreed deadline and date for the follow-up performance review. a. Watch video on immunization techniques. b. Review office protocols. c. Review manuals, textbooks, wall charts or other guides. d. Review package inserts. e. Review vaccine handling guidelines or video. f. Observe other staff with patients. g. Practice injections. h. Read Vaccine Information Statements. i. Be mentored by someone who has these skills. j. Role play with other staff interactions with parents and patients, including age-appropriate comfort measures. k. Attend a skills training or other courses or training. l. Attend health care customer satisfaction or cultural competency training. m. Renew CPR certification. Other: Employee Signature Date Plan of Action Deadline Supervisor Signature Date Date of Next Performance Review California Department of Health Services Immunization Branch 2151 Berkeley Way Berkeley, CA IMM-694B (9/01) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) Item #P7010 (8/11) page 2 of 2 17

19 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois RHC Immunization Competency Exam 2c APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: Name: Date: Question True False 1. All patients will have their immunization records reviewed at each office visit? 2. What action will you take if an adult patient tells you they had a tetanus shot one year ago at the local Emergency Department? 3. What do the terms minimum age and minimum interval mean when discussing vaccine dosing? 4. The following are questions about the VIS (Vaccine Information Statements) sheets and screening. Mark the correct True/False answer. True False a. It is acceptable for the nurse and/or Medical Assistant to give the patient the VIS sheet when she/he brings the shots in the room. b. It is federally mandated that the VIS sheet that you give the patient is the most current version of that vaccine information. c. Screening questionnaires done prior to vaccination helps to find contraindications or precautions to administering certain vaccines. d. It is acceptable to wait until after the shots are given to discuss any positive responses on the screening questionnaire with the provider. 5. Providers are responsible for reviewing which vaccines are due at the time of the patient visit. 6. During a nurse visit, if the provider ordered the first dose of Hep B, the RN or qualified clinic staff member can order subsequent doses. 7. Patients do not need to be observed for any length of time after receiving a vaccine (s). 8. It is acceptable to allow an adult patient to stand during vaccine administration. 9. The first initial, last name, and title are required of the vaccinator on the patient vaccine record. 18

20 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois RHC Immunization Competency Exam 2c APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: EXAM (continued): Question True False 10. The first initial, last name, and title are required of the vaccinator on the patient vaccine record. 19

21 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Illinois RHC Immunization Competency Exam Answer Key POLICY NUMBER: 2d APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: ANSWER KEY Question True False 1. All patients will have their immunization records reviewed at each TRUE office visit? 2. What action will you take if an adult patient tells you they had a tetanus shot one year ago at the local Emergency Department? Call the Emergency Department and/or Health Information Services of the local hospital (a release of information may be needed). Check in the I-CARE system. 3. What do the terms minimum age and minimum interval mean when discussing vaccine dosing? Minimum age is the earliest age that a dose of vaccine can be given. Minimum interval is the earliest time between doses that you can give a valid dose of vaccine. 4. The following are questions about the VIS (Vaccine Information Statements) sheets and screening. Mark the correct True/False answer. True False a. It is acceptable for the nurse and/or Medical Assistant to give the FALSE patient the VIS sheet when she/he brings the shots in the room. b. It is federally mandated that the VIS sheet that you give the patient TRUE is the most current version of that vaccine information. c. Screening questionnaires done prior to vaccination helps to find TRUE contraindications or precautions to administering certain vaccines. d. It is acceptable to wait until after the shots are given to discuss any FALSE positive responses on the screening questionnaire with the provider. 5. Providers are responsible for reviewing which vaccines are due at the TRUE time of the patient visit. 6. During a nurse visit, if the provider ordered the first dose of Hep B, the TRUE RN or qualified clinic staff member can order subsequent doses. 7. Patients do not need to be observed for any length of time after FALSE receiving a vaccine (s). All syringes must be labeled. 8. It is acceptable to allow an adult patient to stand during vaccine FALSE administration. All patients receiving vaccines should be observed for at least 15 minutes after wards. 9. The first initial, last name, and title are required of the vaccinator on the FALSE patient vaccine record. 20

22 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Illinois RHC Immunization Competency Exam Answer Key POLICY NUMBER: 2d APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: All adult patients are seated during vaccine administration, in case of fainting/reaction. 10. The first initial, last name, and title are required of the vaccinator on the patient vaccine record. TRUE 21

23 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois Immunization Resource Scavenger Hunt 2e APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: ILLINOIS IMMUNIZATION RESOURCE SCAVENGER HUNT Using the CDC Pink Book ( provide the answers to the following questions: Chapter: General Recommendations. 1. What does the CDC say about giving multiple routine vaccines at the same Page 11 visit? 2. What action should you take if 2 LIVE vaccines are accidently given closer than 4 weeks apart? Page What might happen if you decrease the interval between doses of a multi-dose vaccine? Page What should you do if a vaccine is given 5 days earlier than the minimum interval or minimum age for that vaccine? Page What are the 3 general categories that vaccine adverse reactions fall into? Page Which reactions are most common? Least common? Page What are 3 common local reaction symptoms following vaccination? Page 15 22

24 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois Immunization Resource Scavenger Hunt 2e APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: 8. How can we minimize the risk of severe allergic reactions to vaccines? Page What does VAERS stand for? Page What kinds of events should be reported to VAERS? Page What is a contraindication to a vaccine? Page What are some typical symptoms of a person having an allergic reaction to vaccine? Page In general, which type of vaccines should not be administered to pregnant women? Page What might happen to someone who is immunocompromised who received a dose of LIVE vaccine. Page Why do we hold vaccines from persons with moderate-severe illness? Page 23 23

25 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT Illinois Immunization Resource Scavenger Hunt POLICY NUMBER: TITLE: Answer Key 2f APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: ILLINOIS IMMUNIZATION RESOURCE SCAVENGER HUNT ANSWER KEY Using the CDC Pink Book ( provide the answers to the following questions: Chapter: General Recommendations. 1. What does the CDC say about giving multiple routine vaccines at the same Page 11 visit? Acceptable. 2. What action should you take if 2 LIVE vaccines are accidently given closer Page 12 than 4 weeks apart? Repeat the second vaccine given in 4 weeks. 3. What might happen if you decrease the interval between doses of a multi-dose vaccine? It may interfere with antibody response and protection. 4. What should you do if a vaccine is given 5 days earlier than the minimum interval or minimum age for that vaccine? The dose is not valid: repeat the doses at the appropriate age. If it is the interval that is incorrect, generally the repeat dose is spaced after the invalid dose by an interval at least equal to the minimum spacing for that vaccine as shown on Table What are the 3 general categories that vaccine adverse reactions fall into? Local, systemic, allergic. 6. Which reactions are most common? Least common? Most common is local. Least common is allergic. 7. What are 3 common local reaction symptoms following vaccination? 1. Pain 2. Swelling 3. Redness at the site of injection 8. How can we minimize the risk of severe allergic reactions to vaccines? By screening prior to giving vaccines. 9. What does VAERS stand for? Vaccine Adverse Event Reporting System 10. What kinds of events should be reported to VAERS? Any clinically significant event that occurs after vaccine administration. Page 12 Page 13 Page 15 Page 15 Page 15 Page 16 Page 16 Page 16 24

26 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT Illinois Immunization Resource Scavenger Hunt POLICY NUMBER: TITLE: Answer Key 2f APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: ANSWER KEY (continued): 11. What is a contraindication to a vaccine? Any condition in a recipient that greatly increases the chances of a serious adverse reaction. 12. What are some typical symptoms of a person having an allergic reaction to vaccine? Generalized hives, swelling of mouth, throat, difficulty breathing, wheezing, hypotension, shock. 13. In general, which type of vaccines should not be administered to pregnant women? LIVE vaccines MMR, MMRV, Varivax (Varicella), LAIV (Live attenuated influenza vaccine). 14. What might happen to someone who is immunocompromised who received a dose of LIVE vaccine. They could have a fata reaction due to uncontrolled replication of the vaccine virus. 15. Why do we hold vaccines from persons with moderate-severe illness? An adverse reaction such as fever may make medical management of the illness complicated. Page 16 Page 18 Page 19 Page 20 Page 23 25

27 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois RHC Vaccine Documentation Checklist 2g APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 1 SIGNATURE OF APPROVAL: TITLE SIGNER: The following list indicates information that is either required by law or by the Illinois Comprehensive Automated Immunization Registry Exchange (I-CARE) to be documented in the patient s chart when giving vaccines. o Name of vaccine (i.e. pneumococcal, tetanus) o Type/brand of vaccine (i.e. Tdap, Pentacel) o Vaccine lot number o Vaccine manufacturer o Vaccine expiration date o Date VIS (Vaccine Information Statement) given to patient o Edition date of VIS o Consent obtained o Date vaccine was administered o Site and route o Screening for contraindications and precautions (additional documentation for positive answers required including evidence of discussion with provider prior to administration. o Signature of vaccinator (first initial, last name, and title) 26

28 Vaccine Acronyms & Abbreviations Vaccine names are often abbreviated. Here are some common ones. California Immunization Registry (CAIR) codes may differ for certain vaccines. Use this chart as a reference.* CDC Abbreviation CAIR Code Vaccine Brand Name BCG BCG Bacillus Calmette-Guérin (Tuberculosis) DT DT Diphtheria & Tetanus DTaP DTaP Diphtheria, Tetanus & Acellular Pertussis DTaP-HepB-IPV DTaPHBIP Diphtheria, Tetanus & Acellular Pertussis, Hepatitis B, Polio DTaP-IPV DTaP-IPV Diphtheria, Tetanus & Acellular Pertussis, Inactivated Polio HepA HAV Hepatitis A Virus HepB HBV, HBV2dose Hepatitis B Virus HepA-HepB HAV-HBV Hepatitis A and Hepatitis B Hib-HepB HIB-HBV Hepatitis B and Haemophilus infl uenzae type b Hib HIB Haemophilus infl uenzae type b Hib HIBPEDVX Haemophilus infl uenzae type b DTaP-IPV/Hib DTaPIPHi Diphtheria, Tetanus & Acellular Pertussis, Haemophilus infl uenzae type b, Polio HPV2 HPV Human papillomavirus (bivalent) HPV4 HPV Human papillomavirus (quadravelent) IPV IPV Inactivated Polio LAIV FLU-LAIV Live, Attenuated Infl uenza (nasal spray) MMR MMR Measles, Mumps & Rubella MMRV MMR-VZV Measles, Mumps, Rubella & Varicella MCV4 MCV4 Meningococcal Conjugate MPSV4 MENING Meningococcal Polysaccharide PCV7 PNUcon Pneumococcal Conjugate, 7-valent PCV13 PCV13 Pneumococcal Conjugate, 13-valent PPSV23 PNUps Pneumococcal Polysaccharide, 23-valent RV5 Rotaviru Rotavirus RV1 Rotarix Rotavirus Td Td Tetanus & Reduced Diphtheria Tdap Tdap Tetanus, Reduced Diphtheria & Acellular Pertussis TIV FLU Trivalent (inactivated) Infl uenza TT TT Tetanus Toxoid VAR VZV Varicella ZOS Zoster Varicella Zoster Virus (Shingles) DAPTACEL, Infanrix, Tripedia Pediarix Kinrix Havrix, VAQTA ENGERIX B, RECOMBIVAX Twinrix,Twinrix Junior COMVAX ACTHIB, Hiberix PedvaxHIB Pentacel Cervarix Gardasil IPOL FluMist MMR-II ProQuad Menactra, Menveo Menomune Prevnar (discontinued in 2011) Prevnar13 Pneumovax RotaTeq Rotarix DECAVAC ADACEL, BOOSTRIX Afl uria, Fluarix, FluLaval, Fluvirin, Fluzone, Agrifl u, Fluzone High-Dose, Fluzone Intradermal VARIVAX Zostavax Note: You can find the most recent version of CDC s list at * Disclaimer: Abbreviations may vary across medical practices. California Department of Public Health, Immunization Branch 27 IMM-895 (2/12)

29 VACCINE STORAGE AND MAINTENANCE Section 3 Section 3 28

30 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: RHC Vaccine Unit Equipment and Maintenance; Temperature Monitoring and Storage Practices POLICY NUMBER: 3a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: Purpose: To provide a guideline for the protection and maintenance of the office s vaccine supply. NOTE: The responsibilities listed in this policy are those of the primary vaccine coordinator, back up vaccine coordinator and/or designee. Policy: A. Vaccine Unit Equipment and Maintenance 1. The Rural Health office will ensure that it has the appropriate equipment to store vaccine and maintain proper conditions. Two types of storage units are acceptable. A refrigerator that has a separate freezer compartment with a separate exterior door, or Stand-alone refrigerators and freezers. See Attachment. 2. Any refrigerator/freezer used for vaccine storage must be able to maintain the required vaccine storage temperatures year round, are large enough to hold the years largest inventory, be dedicated only to the storage of vaccines, and have a certified calibrated thermometer inside each storage compartment. The unit must be placed in a wellventilated room with sufficient space (at least 4 inches) around the sides and top for air circulation, be away from direct sunlight, and accessible only to clinic staff. 3. Dorm-style refrigerators are not capable of long-term or permanent storage of vaccines because they do not maintain proper temperatures and pose a high risk of freezing vaccine. 4. As of January 1, 2010, dorm-style refrigerators are only acceptable for short-term storage of select vaccines under the following very limited conditions. The purpose of using these units is for temporary storage when it is not reasonable for the staff administering the vaccine to go to the main storage unit to obtain vaccine for each patient. The unit is never used for storing Varicella-containing vaccines. Only small amounts of vaccine can be maintained in these units. The amount of vaccine stored in the unit should never exceed the amount used by the practice in one day. The vaccine is returned to main the main storage unit at the end of each business day and the vaccine is never stored in these units overnight or during periods of time when the practice is not open for business. 29

31 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: RHC Vaccine Unit Equipment and Maintenance; Temperature Monitoring and Storage Practices POLICY NUMBER: 3a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): 5. Refrigerator temperatures must be between 35 F to 46 F (2 C to 8 C). Ideally, the temperature should be maintained around 40 F (5 C). Freezer temperature must be less than 5 F (-15 C). 6. Make sure the refrigerator/freezer is plugged into an outlet in a protected area where it cannot be disconnected accidently. The use of a safety-lock plug or an outlet cover is strongly recommended to reduce the chance of the nit becoming inadvertently unplugged. Label the refrigerator, electrical outlets, and circuit breaker on the power circuit with information that clearly identifies the perishable nature of the vaccines and the immediate steps to be taken in case of interruption of power. Place DO NOT UNPLUG signs by the electrical outlet for the refrigerator and freezer and the circuit breaker panel to ensure that the power is not turned off. Instruct maintenance and/or cleaning personnel bot to unplug the refrigerator/freezer or switch off the circuit breaker. If the power needs to be shutoff for any reason, the primary and/or backup vaccine coordinator needs to be contacted immediately to ensure that the vaccine inside of the refrigerator and/or freezer can be safeguarded. 7. Regular maintenance is required to ensure proper operation, to maintain required temperatures, and to extend the useful life of the appliance. Maintenance of the refrigeration unit and freezer include: Cleaning the unit once per month to discourage bacterial and fungal growth. Periodically vacuuming the dust from exterior coils. Periodically checking to make sure the seals are intact. Checking the inside walls of the freezer compartment weekly for accumulation of frost defrost if necessary. Keeping a logbook to indicated date (s) of routine maintenance tasks, dates of any repairs or servicing, and the name of the person and/or company performing each of these tasks. B. Vaccine Storage Unit Temperature Monitoring 1. The recommended method to ensure that the refrigerator or freezer is maintaining the proper temperature for vaccine storage is to check and record the temperature at least twice a day at opening and closing of the office. The clinic will adhere to the following guidance: 30

32 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: RHC Vaccine Unit Equipment and Maintenance; Temperature Monitoring and Storage Practices POLICY NUMBER: 3a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 3 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): 2. Each refrigerator and freezer must have a calibrated working thermometer certified in accordance with the National Institute of Standards and Technology (NIST) or the American society for Testing and Materials (ATSM) placed in a central area inside each storage compartment. See Attachment. 3. Date the certified thermometers were last calibrated and/or purchased: Refrigerator #1 Freezer #1 Refrigerator #2 Freezer #2 Each thermometer should include a manufacturer s certificate indicating that is has undergone calibration against a reference standard from an appropriate agency such as the National Institute of Standards and Technology (NIST) or a laboratory recognized by NIST. Keep a copy of the manufacturer s certificate of the certified thermometers in your files for programmatic review. Place the thermometer in the center of the unit away from coils, walls, floor and fan in order to obtain a true temperature reading. The thermometer must be visually checked and recorded twice a day; once in the morning and again near the end of the business day, ensuring the refrigerator temperature is between 35 F and 46 F (2 C and 8 C), and the freezer temperature is 5 F or lower (-15 C or lower). See Attachment. The temperature should be recorded on a temperature log (see attachments) and maintained in an ongoing file of temperature logs for a period of three years. Post a temperature log sheet on the vaccine storage unit door or nearby in a readily accessible area. Take immediate action to correct improper vaccine storage conditions, including inappropriate exposure to storage temperatures outside the recommended range. In the event vaccine has been stored outside the recommended temperature range or the refrigerator/freezer is not working properly, document actions taken. See Section 5 for the Vaccine Waste, Expired Vaccine, and Transfer Procedures Policy. Emergency Response Worksheet attached. C. Vaccine Storage Practices 31

33 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: RHC Vaccine Unit Equipment and Maintenance; Temperature Monitoring and Storage Practices POLICY NUMBER: 3a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 4 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): 1. To ensure that vaccines are kept at the correct temperatures, designated staff will follow the following practices: Store extra ice packs/and or gel packs along the walls, back, and door of the freezer compartment. This helps keep a steady temperature during the automatic defrosting cycles and provides additional reserves of cold in the event of a power failure. Store a large water bottle or jugs against the inside walls and door of the refrigerator. This helps maintain a stable cold temperature in the event of a power outage or if the door is opened frequently. Never store food, beverages, or specimens in the same unit as vaccines. This interferes with proper temperature control and may contaminate vaccines. Frequently opening the refrigerator/freezer door can lead to temperature variations, which could affect vaccine efficacy. Store vaccines that require refrigeration in the middle of the refrigerator compartment away from the coils, walls, floor, and cold air vent. Do not store them in the doors, airtight containers, or near the floor of the refrigerator in the vegetable bins. Clinics may want to consider Removing vegetable bins so that staff does not place vaccines inside them. Keep vaccines in their original packaging with the lids in place until ready for administration and stacked in rows with vaccine of the same type. Bins, baskets, or some other type of uncovered containers with slotted sides or openings can be used to store the vaccines. There should be space between the vaccine stacks or containers. These measures will help avoid confusion between vaccines, provides for circulation of air around and through vaccine stacks for even cooling, and protects vaccines from unnecessary light exposure. Store diluents as directed in manufacturer s product information. Store refrigerated diluents with corresponding vaccine (these diluents may contain vaccine antigen). Store vaccines that require Freezer storage in the middle of the freezer compartment away from the walls, coils and peripheral areas. Space and/or stack vaccines to allow for cold air to freely circulate around the vaccines. Do not overstock the unit because this will impede cold air circulation and can result in temperature fluctuations that may expose the vaccines to inappropriate temperatures. 32

34 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: RHC Vaccine Unit Equipment and Maintenance; Temperature Monitoring and Storage Practices POLICY NUMBER: 3a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 5 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): Develop and maintain complete, accurate and separate records for both Vaccines for Children (VFC) and private purchased vaccines. Label VFC vaccines and keep separate from the private vaccine supply. Rotate vaccine stock and diluents on a regular basis by placing vaccines with shorter expiration dates in front of those with longer expiration dates; check expiration dates of the vaccines weekly for short-dated vaccines and diluents. Keep vaccines organized. Place open vials of vaccine in a tray so that they are readily identifiable. Indicate on the label of each multi-dose vial, the date and time it was reconstituted or first opened. Refer to the package insert for expiration date. Open only one vial or box of a particular vaccine at a time to control vaccine usage and allow for easier inventory control. Store vaccine products that have similar packaging in different locations to avoid confusion and medication errors. Post a sign on the refrigerator door showing which vaccines should be stored in the refrigerator and which should be stored in the freezer. See Vaccine Handling Tips, attached. D. Attachments: Vaccines Thermometer Requirements and Guide Sample Temperature Logs Refrigerator and Freezer/Vaccine Troubleshooting Template Don t Be Guilty of These Errors in Vaccine Storage and Handling Do Not Unplug Signs for Refrigerator/Freezer Outlet & Circuit Breaker Vaccine Handling Tips Emergency Response Worksheet Illinois Vaccine Management Plan Checklist for Safe Vaccine Storage and Handling 33

35 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Vaccine Thermometer Requirements and Types POLICY NUMBER: 3b APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: VACCINES THERMOMETER REQUIREMENTS & GUIDE All Vaccines for Children (VFC) providers are required to use certified calibrated thermometers in all refrigerators and freezers used for storage of VFC vaccines. The following requirements and guide apply to all vaccine storage. Correct vaccine storage should be a high priority to ensure that vaccines are effective when they are administered to patients and to prevent unnecessary loss of expensive vaccines. To ensure temperatures are correct, accurate thermometers must be used. Thermometer Requirements Use a calibrated thermometer with current Certificate of Traceability and Calibration in each refrigerator and freezer compartment. A Certificate of Traceability and Calibration guarantees that the thermometer s accuracy has been measured against a National Institute of Standards and Technology (NIST) or other internationally recognized standards agency. The National Institute of Standards and Technology (NIST) is an agency of the U.S. Department of Commerce. Use the calibrated thermometer to read and record refrigerator and freezer temperatures at least twice each workday in the morning and at the end of the workday. Keep the current certificate of calibration on file with the temperature logs for a period of at least three years. Follow the manufacturer s recommendations for calibration of the thermometers. Thermometer Recommendations It is strongly recommended that continuous reading thermometers be used. They provide valuable information when there is a problem with a vaccine storage unit. The continuous recording of temperatures allows the user to determine when and how long the refrigerator and/or freezer temperatures were too hot or too cold for vaccines. Ask your vendor if the thermometer comes with a certificate of calibration. Have a back-up thermometer with a current certificate of calibration for each refrigerator and freezer. It is inevitable that manual temperature monitoring may not be accomplished when a provider s office is closed, however, in that case, the electronic monitoring system can provide back-up for assurance that storage temperatures remain within the manufacturer s recommended ranges and that corrective action can be taken quickly if they go out of range. Providers should determine how they are to be notified in the event of an emergency (i.e. a power outage) during hours when the facility is not open. 34

36 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Vaccine Thermometer Requirements and Types POLICY NUMBER: 3b APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 2 SIGNATURE OF APPROVAL: TITLE SIGNER: GUIDE (continued): Vaccine Storage and Handling, Section 5, pg.67. What is a Certificate of Calibration? A certificate of calibration guarantees that the thermometer is accurate as measured against a National Institute of Standards and Technology (NIST) or American society for Testing and Materials standard. When you buy a thermometer, the certificate will ensure the accuracy of the thermometer for a certain period of time. After that time, the thermometer will need to be recalibrated. Some vendors charge for a certificate of calibration and most charge for recalibration. What is Recalibration? Recalibration refers to testing and adjustment of the instrument to maintain accuracy after purchase. Most manufacturers recommend recalibration every one to two years. All instruments lose accuracy over time due to normal usage and the environmental conditions to which they are exposed. Periodic NIST certified calibrations maintain the accuracy of your instrument throughout its life. NOTE: In some cases it is more effective to buy a new thermometer rather than pay for recalibration. Vaccine Thermometer Examples Dickson Co. Model VFC70 for refrigerator or freezer. Cost $260. Records temperature on paper, usually a circular graph. You must change the graph paper at the appropriate intervals. SensoScientific, Inc. This unit is wireless monitoring which provides reports and an alarm notification system. The is an automated and continuous 24/7 temperature monitoring and logging system to maintain the correct temperature of your refrigerator and freezer. You will receive immediate alerts via , pager, or cell phone text even while the office is closed if temperatures are out of limits. No price was listed. Digital Data Logger Records temperatures in the unit s memory. You must download the data to a computer or other device to view or print past data. Model VFC 6000 LCD (About $79). Model VFC 5000 TC has LCD display and remote sensor (About $100). 35

37 F º Temperature Log for Refrigerator Fahrenheit Completing this temperature log: Check the temperature in the refrigerator compartment of your vaccine storage unit at least twice each working day. Place an X in the box that corresponds with the temperature, the time of the temperature reading, and your initials. Once the month has ended, save each month s completed form for 3 years, unless state or local jurisdictions require a longer time period. If the recorded temperature is warmer than 46ºF or colder than 35ºF: this represents an unacceptable temperature range. You must take action! Month/Year: Days 1 15 Take Action! If temperature is too warm (above 46 o F) or too cold (below 35 o F): 1. Store the vaccine under proper conditions as quickly as possible. 2. Temporarily mark exposed vaccine do not use until you have verified whether or not the vaccine may be used. 3. Call the immunization program at your state or local health department and/or the vaccine manufacturer to determine whether the potency of the vaccine(s) has been affected: ( ). 4. Document the action taken on the reverse side of this log. Staff Initials Day of Month Room Temp. Exact Time am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm *Write any unacceptable temps (above 46 o F or below 35 o F) on these lines. Then take action! Danger! Temperatures above 46ºF are too warm! Write any unacceptable temperature on the lines above* and call your state or local health department immediately! Acceptable Temperatures 46ºF 45ºF 44ºF 43ºF 42ºF 41ºF 40ºF 39ºF 38ºF 37ºF 36ºF 35ºF Danger! Temperatures above 5 o F are too warm! Write any unacceptable temperature on the lines above* and call your VFC Rep immediately! Danger! Temperatures below 35ºF are too cold! Write any unacceptable temperature on the lines above* and call your state or local health department immediately! Adapted with appreciation from California Department of Public Health Technical content reviewed by the Centers for Disease Control and Prevention, August Distributed by the Immunization Action Coalition (651) admin@immunize.org See back for Vaccine Storage Troubleshooting Record Item #P3037F (8/11) 36

38 Vaccine Storage Troubleshooting Record Date Time Storage Unit Temp Room Temp Problem Action Taken Results Staff Initials 37

39 F º Temperature Log for Refrigerator Fahrenheit Completing this temperature log: Check the temperature in the freezer compartment of your vaccine storage unit at least twice each working day. Place an X in the box that corresponds with the temperature, the time of the temperature reading, and your initials. Once the month has ended, save each month s completed form for 3 years, unless state or local jurisdictions require a longer time period. If the recorded temperature is warmer than 46ºF or colder than 35ºF: this represents an unacceptable temperature range. You must take action! Month/Year: Days Take Action! If temperature is too warm (above 46 o F) or too cold (below 35 o F): 1. Store the vaccine under proper conditions as quickly as possible. 2. Temporarily mark exposed vaccine do not use until you have verified whether or not the vaccine may be used. 3. Call the immunization program at your state or local health department and/or the vaccine manufacturer to determine whether the potency of the vaccine(s) has been affected: ( ). 4. Document the action taken on the reverse side of this log. Staff Initials Day of Month Room Temp. Exact Time am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm *Write any unacceptable temps (above 46 o F or below 35 o F) on these lines. Then take action! Danger! Temperatures above 46ºF are too warm! Write any unacceptable temperature on the lines above* and call your state or local health department immediately! Acceptable Temperatures 46ºF 45ºF 44ºF 43ºF 42ºF 41ºF 40ºF 39ºF 38ºF 37ºF 36ºF 35ºF Danger! Temperatures below 35ºF are too cold! Write any unacceptable temperature on the lines above* and call your state or local health department immediately! Adapted with appreciation from California Department of Public Health Technical content reviewed by the Centers for Disease Control and Prevention, August Distributed by the Immunization Action Coalition (651) admin@immunize.org See back for Vaccine Storage Troubleshooting Record Item #P3037F (8/11) 38

40 Vaccine Storage Troubleshooting Record Date Time Storage Unit Temp Room Temp Problem Action Taken Results Staff Initials 39

41 F º Temperature Log for Freezer Fahrenheit Completing this temperature log: Check the temperature in the freezer compartment of your vaccine storage unit at least twice each working day. Place an X in the box that corresponds with the temperature, the time of the temperature reading, and your initials. Once the month has ended, save each month s completed form for 3 years, unless state or local jurisdictions require a longer time period. If the recorded temperature is warmer than 5º: this represents an unacceptable temperature range. You must take action! Month/Year: Days 1 15 Take Action! If temperature is too warm (above 5 o F): 1. Store the vaccine under proper conditions as quickly as possible. 2. Temporarily mark exposed vaccine do not use until you have verified whether or not the vaccine may be used. 3. Call the immunization program at your state or local health department and/or the vaccine manufacturer to determine whether the potency of the vaccine(s) has been affected: ( ). 4. Document the action taken on the reverse side of this log. Staff Initials Day of Month Room Temp. Exact Time am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm *Write any unacceptable temps (above 5 o F) on these lines. Then take action! Danger! Temperatures above 5ºF are too warm! Write any unacceptable temperature on the lines above* and call your state or local health department immediately! Acceptable Temperatures 5ºF 4ºF 3ºF 2ºF 1ºF 0ºF -1ºF -2ºF -3ºF -4ºF -5ºF to -30ºF and colder Danger! Temperatures above 5 o F are too warm! Write any unacceptable temperature on the lines above* and call your VFC Rep immediately! Some frozen vaccines must not be stored colder than -58 o F. Check the Prescribing Information on the vaccine manufacturer s website for specific storage temperature instructions. Technical content reviewed by the Centers for Disease Control and Prevention, August Distributed by the Immunization Action Coalition (651) admin@immunize.org See back for Vaccine Storage Troubleshooting Record Adapted with appreciation from California Department of Public Health Item #P3038F (8/11) 40

42 Vaccine Storage Troubleshooting Record Date Time Storage Unit Temp Room Temp Problem Action Taken Results Staff Initials 41

43 F º Temperature Log for Freezer Fahrenheit Completing this temperature log: Check the temperature in the freezer compartment of your vaccine storage unit at least twice each working day. Place an X in the box that corresponds with the temperature, the time of the temperature reading, and your initials. Once the month has ended, save each month s completed form for 3 years, unless state or local jurisdictions require a longer time period. If the recorded temperature is warmer than 5º: this represents an unacceptable temperature range. You must take action! Month/Year: Days Take Action! If temperature is too warm (above 5 o F): 1. Store the vaccine under proper conditions as quickly as possible. 2. Temporarily mark exposed vaccine do not use until you have verified whether or not the vaccine may be used. 3. Call the immunization program at your state or local health department and/or the vaccine manufacturer to determine whether the potency of the vaccine(s) has been affected: ( ). 4. Document the action taken on the reverse side of this log. Staff Initials Day of Month Room Temp. Exact Time am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm *Write any unacceptable temps (above 5 o F) on these lines. Then take action! Danger! Temperatures above 5ºF are too warm! Write any unacceptable temperature on the lines above* and call your state or local health department immediately! Acceptable Temperatures 5ºF 4ºF 3ºF 2ºF 1ºF 0ºF -1ºF -2ºF -3ºF -4ºF -5ºF to -30ºF and colder Danger! Temperatures above 5 o F are too warm! Write any unacceptable temperature on the lines above* and call your VFC Rep immediately! Some frozen vaccines must not be stored colder than -58 o F. Check the Prescribing Information on the vaccine manufacturer s website for specific storage temperature instructions. Technical content reviewed by the Centers for Disease Control and Prevention, August Distributed by the Immunization Action Coalition (651) admin@immunize.org See back for Vaccine Storage Troubleshooting Record Adapted with appreciation from California Department of Public Health Item #P3038F (8/11) 42

44 Vaccine Storage Troubleshooting Record Date Time Storage Unit Temp Room Temp Problem Action Taken Results Staff Initials 43

45 Don t Be Guilty of These Errors in Vaccine Storage and Handling The following are frequently reported errors in vaccine storage and handling. Some of these errors are much more serious than others, but none of them should occur. Be sure your clinic or practice is not making errors such as these. Error #1: Designating only one person, rather than at least two, to be responsible for storage and handling of vaccines Since vaccines are both expensive and fragile, everyone in the office should know the basics of vaccine handling, including what to do when a shipment arrives and what to do in the event of an equipment failure or power outage. It s very important to train at least one back-up person in all aspects of proper storage and handling of vaccines. The back-up and primary persons should be equally familiar with all aspects of vaccine storage and handling, including knowing how to handle vaccines when they arrive, how to properly record refrigerator and freezer temperatures, and should be prepared to lead the response to an equipment problem or power outage. Error #2: Refrigerating vaccine in a manner that could jeopardize its quality The temperature in the vegetable bins, on the floor, next to the walls, in the door, and near the cold air outlet from the freezer may differ significantly from the temperature in the body of the refrigerator: do not store your vaccines or place thermometers in these locations. Always store vaccines in their original packaging in the body of the refrigerator away from these locations, and place your thermometer with the vaccines. Place vaccine packages in such a way that air can circulate around the compartment. Never overpack a refrigerator compartment. Error #3: Storing food and drinks in the vaccine refrigerator Frequent opening of the refrigerator door to retrieve food items can adversely affect the internal temperature of the unit and damage vaccines. Error #4: Inadvertently leaving the refrigerator or freezer door open or having inadequate seals Remind staff to close the unit doors tightly each time they open them. Also, check the seals on the doors on a regular schedule, and if there is any indication the door seal may be cracked or not sealing properly, have it replaced. Replacing a seal is much less costly than replacing a box of pneumococcal conjugate or varicella vaccine. Error #5: Storing vaccine in a dorm-style refrigerator All vaccines should be stored in a refrigerator and/or freezer unit that is designed specifically for the storage of biologics or, alternatively, in a separate free-standing unit. A dorm-style combination refrigerator-freezer unit with just one exterior door has been shown to be unacceptable no matter where the vaccine was placed inside the unit. Small stand-alone refrigerator or freezer units are best for short-term storage needs. Error #6: Recording temperatures only once per day Temperatures fluctuate throughout the day. Temperatures in the refrigertor and freezer should be checked at the beginning and end of the day to determine if the unit is getting too cold or too warm. Ideally, you should have continuous thermometers that record temperatures all day and all night; those with alarms can alert you when temperatures go out of range. A less expensive alternative is to purchase maximum/minimum thermometers. Only thermometers with a Current Certificate of Traceability and Calibration* should be used for vaccine storage. It s also a good idea to record the room temperature on your temperature log in case there is a problem with the storage unit. This information may *A calibrated thermometer with a Certificate of Traceability and Calibration with calibration measurements traceable to a testing laboratory accredited by the International Organization of Standardization, to the Standards of the National Institute of Standards and Technology, or to another internationally recognized standards agency. be helpful to the vaccine manufacturer and/or state immunization program in determining whether your vaccine is still usable. Error #7: Recording temperatures for only the refrigerator or freezer, rather than both It is essential to monitor and record temperatures in all refrigerators and freezers used to store vaccine. At all times you should have calibrated thermometers in the refrigerators as well as the freezers. Assure that your storage temperature monitoring is accurate by purchasing thermometers that have a Certificate of Traceability and Calibration* and recalibrate them according to the manufacturer s instructions. Your state immunization program may be able to provide more information on calibrated thermometers. Error #8: Documenting out-of-range temperatures on vaccine temperature logs but not taking action Documenting temperatures is not enough. Acting on the information is essential! So, what should you do? Notify your supervisor whenever you have an out-of-range temperature. Sometimes the solution is as simple as shutting a door left ajar or re-checking a freezer temperature that is slightly elevated as it goes through a normal, brief defrost cycle. Check the condition of the unit for problems. Are the seals on the door tight? Is there excessive lint or dust on the coils? After you have made any adjustment, document the date, time, temperature, the nature of the problem, the action you took, and the results of your action. Recheck the temperature every two hours. Call maintenance or a repair person if the temperature is still out of range. If the solution is not quick and easy, you will need to safeguard your vaccines by moving them to another storage unit that is functioning at the proper temperature. Label the affected vaccines Do not use and contact your state immunization program or vaccine manufacturer to find out if the affected vaccine is still usable. Be sure to notify your state s VFC Program Coordinator if VFC vaccine was involved. Error #9: Discarding temperature logs at the end of every month It s important that you keep your temperature logs for at least three years. As your refrigerator or freezer ages, you can track recurring problems. If out-ofrange temperatures have been documented, you can determine how long and how often this has been happening and take appropriate action. It s also a great way to demonstrate why you need a new refrigerator or freezer. Error #10: Discarding multi-dose vials 30 days after they are opened Don t discard your multi-dose vials of vaccines prematurely. Almost all multidose vaccine vials contain a preservative and can be used until the expiration date on the vial unless there is actual contamination or the vials are not stored under appropriate temperatures. However, you must discard multi-dose vials of reconstituted vaccine (e.g., meningococcal polysaccharide, yellow fever) if they are not used within a defined period after reconstitution. Refer to the vaccine package inserts for detailed information. Error #11: Not having emergency plans for a power outage or natural disaster Every clinic should have a written Emergency Response Plan that identifies a refrigerator and freezer in another location (ideally, a storage unit with a back-up generator) in which to store vaccine in the event of a power outage or natural disaster. Consider arranging in advance for a local hospital or similar facility to be your back-up location if you should need it. Be sure back-up location staff understand vaccine storage and will allow you to supervise placement and verify storage temperatures so vaccine is not damaged. Technical content reviewed by the Centers for Disease Control and Prevention, April Item #P3036 (4/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

46 Credit: IAC thanks the Indiana State Department of Health. Item #P2090 (3/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

47 Credit: IAC thanks the Indiana State Department of Health. Item #P2091 (3/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

48 Vaccine Handling Tips Outdated or improperly stored vaccines won t protect patients! Freezer Refrigerator MMR* MMRV Varicella Zoster Maintain refrigerator temperature between 35 and 46 F (2 and 8 C) DTaP, Tdap, Td, DT Hib Hepatitis A Hepatitis B Human papillomavirus Influenza (TIV/LAIV) Polio (IPV) MMR* Meningococcal (MCV4 & MPSV4) Pneumococcal (PPSV & PCV13) Rotavirus Maintain freezer temperature between -58 and 5 F (-50 and -15 C) Manage vaccine inventories. Inventory your vaccine supplies at least monthly and before placing an order. Expired vaccine must never be used and is money wasted! Always use the vaccine with the soonest expiration date first. Move vaccine with the soonest expiration date to the front of the storage unit and mark it to be used first. Keep vaccine vials in their original boxes. Store vaccine appropriately. Place vaccines in refrigerator or freezer immediately upon receiving shipment. Keep vaccine vials in their original packaging. Place vaccine in clearly labeled wire baskets or other open containers with a 2 3" separation between baskets and from wall of unit. Separate vaccines that have been supplied from your state s Vaccines for Children program from vaccines that are privately purchased. Do not store vaccines in the door or on the floor of the unit. Stabilize temperatures. Store ice packs in the freezer and large jugs of water in the refrigerator along with the vaccines. This will help maintain a stable, cold temperature in case of a power failure or if the refrigerator or freezer doors are opened frequently or left open. Frequent opening of either the refrigerator or freezer door can lead to temperature variations inside, which could affect vaccine efficacy. For this reason you should not store food or beverages in the refrigerator or freezer. Safeguard the electrical supply to the refrigerator. Make sure the refrigerator and freezer are plugged into outlets in a protected area where they cannot be disconnected accidentally. Label the refrigerator, freezer, electrical outlets, fuses, and circuit breakers on the power circuit with information that clearly identifies the perishable nature of vaccines and the immediate steps to be taken in case of interruption of power. If your building has auxiliary power, use the outlet supplied by that system. *MMR may be stored in either the freezer or the refrigerator. Refer to package insert for specific instructions on the storage of each vaccine. If you have questions about the condition of the vaccine upon arrival, you should immediately place the vaccine in recommended storage, mark it do not use, and then call your state health department or the vaccine manufacturer(s) to determine whether the potency of the vaccine(s) has been affected. For other questions, call the immunization program at your state or local health department. Record your health department s phone number here: Technical content reviewed by the Centers for Disease Control and Prevention, December Item #P3048 (12/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

49 Follow these procedures: 1. Close the door tightly and/or plug in the refrigerator/freezer. 2. Ensure the vaccine is kept at appropriate temperatures. Make sure the refrigerator/freezer is working properly or move the vaccines to a unit that is. Do not discard the affected vaccines. Mark the vaccines so that the potentially compromised vaccines can be easily identified. 3. Notify the local or state health department or call the manufacturer (see manufacturers phone numbers below). 4. Record action taken. Emergency Response Worksheet What to do in case of a power failure or another event that results in vaccine storage outside of the recommended temperature range Record this information*: 1. Temperature of refrigerator: current max. min. 2. Temperature of freezer: current max. min. 3. Air temperature of room where refrigerator is located: 4. Estimated amount of time the unit s temperature was outside normal range: refrigerator freezer 5. Vaccines in the refrigerator/freezer during the event (use the table below) * Using a recording thermometer is the most effective method of tracking the refrigerator and freezer temperatures over time. Visually checking thermometers twice a day is an effective method to identify inconsistent or fluctuating temperatures in a refrigerator and freezer. Vaccines Stored in Refrigerator Vaccine, manufacturer, and lot # Expiration date # of doses # of affected vials Action taken Vaccines Stored in Freezer Vaccine, manufacturer, and lot # Expiration date # of doses # of affected vials Action taken Other Conditions 1. Prior to this event, was the vaccine exposed to temperatures outside the recommended range? Y N 2. Were water bottles in the refrigerator and ice packs in the freezer at the time of this event? Y N 3. Other: Manufacturers Crucell Vaccines Inc. (800) CSL Biotherapies, Inc. (888) GlaxoSmithKline (888) MedImmune, Inc. (877) Merck & Co., Inc. (800) Novartis Vaccines (800) Pfizer Inc. (800) sanofi pasteur (800) Other Resources Local health department phone number State health department phone number Adapted by the Immunization Action Coalition, courtesy of the Michigan Department of Community Health Technical content reviewed by the Centers for Disease Control and Prevention, October Item #P3051 (10/10) 48 Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

50 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois Vaccine Management Plan 3j APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: These guidelines should be posted near your storage unit or where they can be easily accessed in case of an emergency. All office staff, including maintenance, cleaning, and security staff, should know the standard procedure to follow, and where/how the individual vaccines are to be stored. Routine Vaccine Storage/Handling Plan Personnel responsible for routine vaccine storage and security (update as staff changes): PRIMARY VACCINE COORDINATOR: BACKUP VACCINE COORDINATOR: Vaccine ordering will be done on the following basis (choose one): Monthly Every other month Quarterly As needed Maintain proper temperature for storage of vaccine: Refrigerator F 2-8 C Freezer +5 F or colder -15 C or colder Use certified, calibrated thermometers to monitor temperatures and record twice daily (beginning and end of clinic/office day) for each unit containing state-supplied vaccine. Contact IDPH for replacement thermometers when calibration is due. Immediately take action if temperatures are out of range. On the temperature log, document what was done to ensure vaccine viability as well as action taken to establish and maintain proper temperatures. Keep temperature logs on file for at least three years. Procedure for receiving vaccine shipments: VACCINE IS RECEIVED BY: Vaccine shipments are immediately unpacked, enclosed temperature monitors are checked, 49

51 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois Vaccine Management Plan 3j APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: and the enclosed invoice/shipping information is compared to the actual shipment to verify lot numbers and expiration dates. Immediately move vaccine to proper cold storage unit. Label VFC and state-supplied vaccines and store separately from private stock. Monthly inventory counts are conducted on the day of the month. Store and rotate vaccines according to expiration dates, and use vaccines with the shortest expiration dates first. If vaccines are within 90 days of expiration and will not be used, arrange for provider-toprovider transfers. Fill out a Vaccine Transfer Form and fax to the IDPH. Vaccine that is transferred must be kept at acceptable temperatures at all times during transport. The following actions are done to ensure the safety of the vaccine supply: o o o o o Dorm-style refrigerators or combination units with a single external door are not used for vaccine storage. Check the unit doors to ensure they seal properly, are closed and, if possible, locked. DO NOT UNPLUG signs are placed next to electrical outlets and circuit breaker. Safety outlet covers or plug covers are placed where possible. Maintenance and janitorial personnel are advised not to unplug refrigerator/freezer units. If VFC vaccine is expired, wasted or spoiled: complete the Non-Viable Vaccine Return and Wastage form. Procedures for wasting/returning state-supplied vaccine are detailed on wastage form. Emergency Vaccine Relocation Plan Personnel responsible for emergency vaccine storage and security (update as staff changes): PRIMARY EMERGENCY CONTACT: BACKUP EMERGENCY CONTACT: 50

52 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois Vaccine Management Plan 3j APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 3 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: How will designated personnel be contacted in vaccine storage emergency? (ie: phone, alarm, etc) These people have 24-hour access to storage units storing vaccines: NAME TITLE CONTACT Steps to follow for proper storage and handling of vaccines to protect them from becoming spoiled (how to pack and move vaccines): Designated alternative storage units or facilities (back-up refrigerator, fire dept., hospital, other provider): ALTERNATE CONTACT PERSON ADDRESS & TELEPHONE Procedures that the designated personnel should follow to access alternative units or facilities: 1. 51

53 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Illinois Vaccine Management Plan 3j APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 4 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: Designate a refrigerator/freezer repair company to contact for equipment problems. COMPANY NAME: CONTACT INFORMATION: Record the following information on each refrigerator/freezer unit: BRAND MODEL # SERIAL # NOTE: IDPH staff will ask for a copy of your clinic s vaccine storage & handling plan, including relocation policy, during on-site visits. This plan must be reviewed at least annually and updated as staff and procedures change. 52

54 Checklist for Safe Vaccine Storage and Handling Here are the most important things you can do to safeguard your vaccine supply. Are you doing them all? Review this list to see where you might make improvements in your vaccine management practices. Fill in each box with either YES or NO. Establish Storage and Handling Policies YES YES YES YES NO NO NO NO 1. We have designated a primary vaccine coordinator and at least one back-up coordinator to be in charge of vaccine storage and handling at our facility. 2. Both the primary and back-up vaccine coordinator(s) have completely reviewed either CDC's online vaccine storage and handling guidance or equivalent training materials offered by our state health department's immunization program. 3. We have detailed, up-to-date, written policies for general vaccine management, including policies for routine activities and an emergency vaccine-retrieval-and-storage plan for power outages and other problems. Our policies are based on CDC's vaccine storage and handling guidance and/or on instruction from our state or local health department's immunization program. 4. We review these policies with all staff annually and with new staff, including temporary staff, when they are hired. Log In New Vaccine Shipments YES YES YES YES YES NO NO 5. We maintain a vaccine inventory log that we use to document the following: a. Vaccine name and number of doses received b. Date we received the vaccine c. Condition of vaccine when we received it d. Vaccine manufacturer and lot number e. Vaccine expiration date Use Proper Storage Equipment YES YES YES NO NO NO NO NO NO 6. We store vaccines in refrigerator and freezer units designed specifically for storing biologics, including vaccines. Alternatively, we keep frozen and refrigerated vaccines in separate, free-standing freezer and refrigerator units. At a minimum, we use a household-style unit with a separate exterior door for the freezer and separate thermostats for the freezer and refrigerator. We do NOT use a dormitory-style unit (a small combination freezer-refrigerator unit with a freezer compartment inside the refrigerator). 7. We use only calibrated thermometers with a Certificate of Traceability and Calibration* that are recalibrated as recommended by the manufacturer. 8. We have planned back-up storage unit(s) in the event of a power failure or other unforeseen event. We perform regular maintenance to assure optimal functioning. Ensure Optimal Operation of Storage Units YES YES NO NO 9. We have a "Do Not Unplug" sign next to the electrical outlets for the refrigerator and freezer and a "Do Not Stop Power" warning label by the circuit breaker for the electrical outlets. Both include emergency contact information. 10. We keep the storage unit clean, dusting the coils and cleaning beneath it every 3 6 months. Maintain Correct Temperatures YES NO 11. We always keep at least one accurate calibrated thermometer (+/-1ºC [+/-2ºF]) with the vaccines in the refrigerator; YES NO ideally, we have a continuous-temperature logger and/or temperature-sensitive alarm system. 12. We maintain the refrigerator temperature at 35 46ºF (2 8ºC), and we aim for 40ºF (5ºC). *Certificate of Traceability and Calibration with calibration measurements traceable to a testing laboratory accredited by the International Organization of Standardization, to the standards of the National Institute of Standards and Technology, or to another internationally recognized standards agency. Technical content reviewed by the Centers for Disease Control and Prevention, July (Maintain Correct Temperatures continued on page 2) Item #P3035 (7/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

55 Checklist for Safe Vaccine Storage and Handling (continued) (page 2 of 2) (Maintain Correct Temperatures continued from page 1) YES YES YES YES NO NO NO NO 13. We keep extra containers of water in the refrigerator (e.g., in the door, on the floor of the unit where the vegetable bins were located) to help maintain cool temperatures. 14. We always keep at least one accurate calibrated thermometer (+/-1ºC [+/-2ºF]) with vaccines in the freezer. 15. We maintain the average temperature in the freezer at +5ºF (-15ºC), preferably colder but no colder than -58ºF (-50ºC). 16. We keep ice packs or ice-filled containers in the freezer to help maintain cold temperatures. Store Vaccines Correctly YES YES YES YES YES YES YES 17. We post signs on the doors of the refrigerator and freezer that indicate which vaccines should be stored in the refrigerator and which in the freezer. 18. We do NOT store any food or drink in any vaccine storage unit. 19. We store vaccines in the middle of the refrigerator or freezer (never in the doors), with room for air to circulate. 20. We have removed all vegetable and deli bins from the storage unit. 21. If we are using a combination refrigerator-freezer unit, we do not store vaccines in front of the cold air outlet that leads from the freezer to the refrigerator (often near the top shelf). 22. We check vaccine expiration dates and rotate our supply of each type of vaccine so that we use the vaccines that will expire soonest. 23. We store vaccines in their original packaging in clearly labeled uncovered containers with slotted sides that allow air to circulate. Maintain Daily Temperature Logs YES YES YES YES YES YES YES NO NO NO NO NO NO NO 24. On days when our practice is open, we document refrigerator and freezer temperatures on the daily log twice a day first thing in the morning and right before our facility closes. 25. We consistently record temperatures on the log in either Fahrenheit or Celsius. We NEVER mix in any way how we record our temperatures. For example, if the log prompts us to insert an "x" by the temperature that's preprinted on the log, we do not attempt to write in the actual temperature. 26. The logs show whom to call if the temperature in the storage unit goes out of range. 27. When we change the thermostat setting, we document it in the daily log sheet's note section. 28. If out-of-range temperatures occur in the unit, we document in the daily log sheet's note section who responded and when. 29. Trained staff (other than staff designated to record the temperatures) review the logs weekly. 30. We keep the temperature logs on file for at least 3 years. Take Emergency Action As Needed YES YES YES YES YES NO NO NO NO NO NO NO NO NO NO NO NO 31. In the event that vaccines are exposed to improper storage conditions, we take the following steps: a. We restore proper storage conditions as quickly as possible; if necessary, we move the vaccine to our planned back-up storage unit. We address the storage unit s mechanical or electrical problems according to guidance from the manufacturer or repair service. b. In responding to improper storage conditions, we do NOT make frequent or large changes in thermostat settings. After changing the setting, we give the unit at least a day to stabilize its temperature. c. We temporarily label exposed vaccines Do not use and keep them separate from any unexposed vaccines. We do not use exposed vaccines until our state health department s immunization program or the vaccine manufacturer gives us approval. d. We document exactly what happened, noting the temperature in the storage unit and the amount of time the vaccines were out of proper storage conditions. We contact our state health department s immunization program or the vaccine manufacturer to determine how to handle the exposed vaccines. e. We follow the health department or manufacturer s instructions and keep a record detailing the event. Where applicable, we mark the exposed vials with a revised expiration date provided by the manufacturer. If we answer YES to all of the above, we give ourselves a pat on the back! If not, we assign someone to implement needed changes! Immunization Action Coalition Item #P3035 (7/11) 54

56 VACCINE HANDLING Section 4 Section 4 55

57 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Vaccine Wastage/Expiration/and Transfers 4a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 3 SIGNATURE OF APPROVAL: TITLE SIGNER: Purpose: To provide a guideline for handling vaccines losses. Policy: A. Vaccine Wastage/Expired Procedures 1. The Vaccine Loss and Replacement Protocol is the policy to follow when incidents occur that result in loss of VFC vaccine. The Illinois VFC program requires providers to replace vaccine that has been wasted do to negligence or failing to correctly store, handle or transport vaccine. The action taken by the Illinois VFC program will depend on the category of the vaccine loss. Refer to the Vaccine Loss and Replacement Protocol (Attachment) and at that is signed at enrollment, regarding the categories. The Illinois VFC program will require providers to replace vaccine that has been wasted due to negligence or failing to correctly store, handle or transport vaccine. 2. Vaccine that has been deemed wasted and unstable should be entered in the Doses Wasted or Expired section of the Illinois VFC Pediatric Vaccine Order, Inventory and Accountability Form (Attachment) and at 3. The wasted/expired vaccine listed on the Illinois VFC Pediatric Vaccine Order, Inventory and Accountability Form should be returned for excise tax credit. All returns must be completed with six months of product expiration or waste date. Return wasted/expires VFC vaccines to McKesson by completing the Vaccine Waste Packing List for Excise Tax Credit and Disposal (Attachment) and at Follow the steps as outlined on the Vaccine Waste form for returning wasted/expired vaccine. Contact the Illinois VFC Program at Complete the Vaccine Waste Packing List for Excise Tax Credit and Disposal form for the return of wasted/expired vaccines. NOTE: McKesson no longer requires holding until at least 50 doses are available to return. Make sure you indicate why the vaccine was wasted in the area provided. Put a copy of the completed form in a box with the expired/wasted vaccines. Fax a copy of the Vaccine Waste Packing List for Excise Tax Credit and Disposal form to the Illinois VFC Program (IPC)

58 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Vaccine Wastage/Expiration/and Transfers 4a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 3 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): The Illinois VFC program (IPC) will arrange to have McKesson MAIL a return label to you so that your clinic can ship\the expire/wasted vaccines back to McKesson in the vaccine shipping box you maintain. Make sure the wasted/expired vaccine returned to McKesson are listed on the Illinois VFC Pediatric Vaccine Order, Inventory and Accountability Form. B. Vaccine Transfers 1. VFC providers are now responsible for finding a VFC home for their short dated vaccines. No less than 90 days before the expiration date, contact either your local health department and/or the Illinois VFC program to see if it can be transferred. Network with area VFC providers or consult with IPC staff to identify a possible recipient for surplus vaccine. Use the Vaccine Transfer Form (Attachment) and at Transferring Provider Complete the name/address/pin/date shipped information for both sending and receiving providers. Fill in vaccine name, NDC number, Lot Number, expiration date, and amount being transferred. Transferring provider will be held accountable for vaccine until receiving facility sends a completed copy of the Vaccine Transfer Form to the Illinois VFC Program. Receiving Provider Double check transfer form with vaccine shipped. After receiving the vaccine shipment, fax copy of the Vaccine Transfer Form to the Illinois VFC Program at Completion and submission of the Vaccine Transfer Form by the receiving provider assumes the vaccine was received in usable condition. If vaccine in NOT usable when received, call the Illinois VFC program at or dph.vaccines@illinois,gov for further instructions. Keep copy of the Vaccine Transfer Form in your files for future reference. 57

59 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Vaccine Wastage/Expiration/and Transfers 4a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 3 of 3 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): C. Attachments Vaccine Loss and Replacement Protocol VFC Pediatric Vaccine Order, Inventory, and Accountability For Vaccine Waste Packing List for Excise Tax Credit and Disposal Form Vaccine Transfer Form Transporting Refrigerated Vaccine Guidelines 58

60 Illinois Department of Public Health Immunization Program Vaccines for Children (VFC) Program Vaccine Loss and Replacement Protocol 2012 This document will serve as the Illinois Department of Public Health, Immunization Program s policy for management of incidents that result in loss of vaccine supplied by the Illinois Vaccines for Children (VFC) program. The Illinois VFC program will require providers to replace vaccine that has been wasted due to negligence or failing to correctly store, handle or transport vaccine. Note: If nonviable vaccine was administered, you also may need to supply vaccine to re vaccinate patients, since Illinois VFC may not be able to cover the cost. The action taken by the Illinois VFC program will depend on the category of the vaccine loss. For this policy, loss of vaccine is divided into three categories: Category 1 Non preventable Loss Category 2 Non compliance Category 3 Negligence Category 1 Non preventable Loss Vaccine loss due to non preventable circumstances, such as: 1. Area power outages due to severe weather or other unavoidable and unanticipated causes. 2. Refrigerator/freezer failure unavoidable or unanticipated. (Refer to your refrigerator manufacturers manual and CDC's Vaccine Storage and Handling Toolkit at: 3. Transport company error (i.e., FedEx, UPS, etc.). Failure of the provider to notify VFC of a change in office hours or address will not be considered a transport company error. *** Category 2 Vaccine Loss Due to Non compliance Vaccine loss due to non compliance is defined as: 1. VFC vaccine not accounted for on Illinois VFC Accountability Form and Waste Form. This can be reflected by usage data or inventory discrepancies that reflect lost vaccine supply. Examples include the following: A. Failure to document doses administered; B. Failure to report inventory; IDPH VFC Program Waste Protocol 11/10/2011 Page 1 of 4 59

61 C. Inaccurate reporting of inventory; D. Failure to report expired/wasted vaccine. 2. VFC vaccine knowingly administered to children who do not meet VFC program eligibility criteria, including the following: A. Administration of VFC vaccine to patients who are older than 18 years of age; B. Administration of VFC vaccine to every patient in the practice (except in federally qualified health centers (FQHC) and rural health clinics (RHC)) whether VFC eligible or not (i.e., a provider discontinues purchasing private stocks of vaccine for administration to patients whose insurance covers immunizations or to patients who can afford vaccine); C. Administration of VFC vaccine in lieu of privately purchased vaccine because the reimbursement rate of the child s insurance company is low; D. Administration of VFC vaccine to a child who is fully insured (has insurance and vaccines are a covered benefit), including administration of VFC vaccine to a child who has not met their deductible in order to save the parent the cost of the deductible (a child is considered fully insured even when the deductible has not been met); or E. Administration of VFC vaccine to a child even though the insurance company provides a maximum amount of reimbursement for immunizations for the year (upon reaching the maximum amount, the child is then eligible for certain VFC vaccines if received in a private office, and all VFC vaccines if received in a RHC or FQHC). 3. Accepting reimbursement from insurance companies or patients for VFC vaccine as evidenced by: A. Administering VFC vaccine to a child and subsequently billing the child's insurance for the cost of the vaccine; B. Charging the patient for the cost of the vaccine; C. Charging a Medicaid recipient any fee at all. Category 3 Negligence Negligence is defined as loss of vaccine on the part of the provider/clinic staff. The following situations qualify in this category: 1. Vaccine stored improperly (i.e., refrigerating vaccine that should have been frozen, or freezing vaccine that should have been refrigerated). 2. Vaccine left out of refrigerator or freezer. 3. Refrigerator or freezer unplugged or electrical service interrupted (circuit breaker). 4. Door of refrigerator or freezer left ajar resulting in unit temperatures outside the acceptable range. 5. Improper maintenance of recommended refrigerator and freezer temperatures resulting in vaccine spoilage, including prolonged storage of vaccines when out of range temperatures are recorded. (Note: Temperatures recorded on temperature logs will be considered official in making vaccine viability decisions. Also, a thermometer s margin of error will not be considered when temperatures are recorded at or below 35 F/2 C for refrigerators and at or above 6 F/15 C for freezers.) 6. Failure to properly read and record refrigerator(s) and freezer(s) temperatures, and/or failure to take immediate corrective actions when temperatures are out of appropriate range. IDPH VFC Program Waste Protocol 11/10/2011 Page 2 of 4 60

62 7. Pre drawing or pre mixing vaccine, then not administering in accordance with vaccine manufacturer/cdc recommendations. 8. Transporting vaccine inappropriately (not using ice packs or dry ice), thus not maintaining the cold chain. 9. Failure to notify the VFC program within two hours of vaccine receipt of any errors, shortages, temperature issues or damage to vaccine shipment from distributor. 10. Failure to notify the VFC program when provider office hours change or the practice moves, resulting in vaccines being undeliverable and consequently becoming non viable. 11. Discarding vaccine prior to the manufacturer s stated expiration date (e.g., discarding vaccine in a multi dose vial 30 days after the vial is first used). 12. Vaccine expired due to failure of the provider to notify the VFC program three months prior to expiration date so that vaccine could be transferred. 13. Failure to rotate stock appropriately. 14. Using dorm style refrigerators or using improper refrigeration unit to store the vaccine. 15. Not having correct/certified thermometers and/or placing them incorrectly. Reimbursing the Illinois VFC program for wasted vaccine. 1. The Illinois VFC program will review all instances of spoiled or expired VFC vaccine on a case bycase basis. This review will help determine whether negligence was involved. 2. Negligent wasting of vaccine is considered to be fraud and abuse of the Illinois VFC program. 3. If negligence is found and restitution is necessary, The Illinois VFC program will send the provider a letter informing them of the cost of the wasted vaccine. All further VFC vaccine orders from the provider will be suspended until the Illinois VFC program is provided with a packing list or paid invoice showing that privately purchased vaccine has been received and transferred into the provider s VFC inventory. Definitions Wasted: Any vaccine that cannot be used. This includes expired, non-viable and lost vaccines. Expired: Any vaccine with an expiration date that has passed. Non-viable: Any vaccine that exceeds the limits of the approved cold chain procedures or is predrawn and not used within acceptable time frames. Always consult VFC program before determining the vaccine is non-viable. Lost: UPS, FedEx, or other delivery service does not deliver the vaccine or does not deliver in a timely manner. Abuse: Provider practices that are inconsistent with sound fiscal, business, or medical practices, and result in unnecessary cost to the Medicaid program, or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care. Fraud: An intentional deception, or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to him or some other person. IDPH VFC Program Waste Protocol 11/10/2011 Page 3 of 4 61

63 I have read the Illinois Department of Public Health, Immunization Program s Vaccines for Children Vaccine Loss and Replacement Protocol 2012 (Please print) Provider Name: PIN: Address: Telephone Signature Fax: Date: Sign and return to IDPH Immunization, VFC Program Fax to: or Mail to: Illinois Department of Public Health Immunization Program/Vaccines for Children 2840 Via Verde St. Springfield, IL IDPH VFC Program Waste Protocol 11/10/2011 Page 4 of 4 62

64 Date: / / Illinois VFC Pediatric Vaccine Order, Inventory & Accountability Form PIN#: Practice Name: Phone: Fax: Report period start: end: Vaccine Delivery Street Address: City: ZIP: Facility Office Days & Hours: Mon Tues Wed Thurs Fri Form Completed By: Dates Office Closed (next 30 days): Fax Order to: Physician's signature: Form Revised 2/10/2011 Vaccine DTaP DTaP-HepB-IPV DTaP-IPV-HIB DTaP-IPV HepA-Peds HepB HepB-Hib Hib Hib - Booster dose HPV Brand Daptacel- Sanofi Infanrix-GSK Vial Infanrix-GSK Syringe Pediarix Pentacel Kinrix-GSK Vial Kinrix-GSK Syringe Havrix-GSK Vial Havrix-GSK Syringe Vaqta-Merck Engerix-GSK Vial Engerix-GSK Syringe Recombivax- Merck Comvax ActHIB-Sanofi PedvaxHIB- Merck Hiberix Gardasil-Merck Cervarix-GSK Vial Cervarix-GSK Syringe VFC Order-Inv-Acct.pdf NDC Doses on Hand Lot Number / Expiration Date Doses on Hand Lot Number / Expiration Date Doses on Hand Lot Number / Expiration Date Page 1 of 2 Wasted/Expired Vaccine Doses Administered by Year of Age DOSES Lot Num / Exp date Doses < TOTAL REQUESTED DTaP 63 Pediarix Pentacel Kinrix HepA - Peds HepB HepB-Hib Hib Hib-booster HPV

65 Date: / / Illinois VFC Pediatric Vaccine Order & Accountability Form PIN#: Practice Name: Phone: Fax: Report period start: end: Vaccine Delivery Street Address: City: ZIP: Vaccine Meningococcal (MCV4) MMR-V MMR Polio (eipv) Brand Menactra- Sanofi Menveo- Novartis ProQuad MMRII IPOL - vial NDC Doses on Hand Lot Number / Expiration Date Doses on Hand Lot Number / Expiration Date Fax Order to: Doses on Lot Number / Hand Expiration Date Facility Wasted/Expired Vaccine Doses Administered by Year of Age DOSES Lot Num / Exp date Doses < TOTAL REQUESTED MCV4 MMR-V Not Available MMR Polio - IPV PCV13 PPSV 23 Rotavirus Td Prevnar Pneumovax Rotateq-Merck Rotarix-GSK Decavac- Sanofi Vial Decavac- Sanofi Syr Adacel-Sanofi Vial Prevnar PPSV23 Rotavirus Td Tdap Tdap Adacel-Sanofi Syr Boostrix-GSK Vial Varicella Boostrix-GSK Syringe Varivax Varicella Influenza Influenza - Multidose Influenza ml single dose Influenza Flumist Fluzone-Sanofi Vial Fluvirin- Novartis Vial Fluzone-Sanofi Vial Fluzone-Sanofi Syr Fluzone-Sanofi.25 syr Use flu order form to place order. Page 2 of 2

66 Facility Name Vaccine Waste Packing List for Return to McKesson For Excise Tax Credit and Disposal VACCINES FOR CHILDREN IMMUNIZATION PROGRAM (Minimum 50 doses total) All of the following information is required PIN Address City, State ZIP Date Shipped Contact Person Why bother? Returning VFC vaccines that are not usable is very important for our accountability to the Centers for Disease Control and Prevention (CDC) National Immunization Program. Returning unusable vaccine also allows us the ability to receive excise tax credits. Returning it also gets it out of your office. Vaccine Manufacturer Lot number Expiration Date Doses Steps to returning wasted vaccine for excise tax credit: 1. Fill out this form for return of 50 doses or more of expired/wasted vaccine. 2. Put a copy of the completed form in a box with the vaccine. 3. Fax a copy of this form to: Fax Illinois Dept. of Public Health Immunization Program IPC 4. IPC will arrange with McKesson for a return label to be MAILED to you so you can return the wasted vaccine to McKesson. Make sure you also have listed the expired/wasted vaccines on your Vaccine Accountability Form. REMINDER: Make sure you also have listed ALL of these as wasted on your VFC Vaccine Accountability Form! Illinois Department of Public Health Vaccines for Children Immunization Program Phone Fax dph.vaccines@illinois.gov Revised 11/2011 Printed by Authority of the State of Illinois P.O. # M 10/10 65

67 NONVIABLE VACCINE RETURNS What NOT to Return to McKesson The following items should NEVER be returned to McKesson: Syringes that you filled yourself but did not use. Any used syringes with or without needles attached. Broken vials. Any multidose vial from which some doses have already been withdrawn. The items listed above should be disposed of according to usual medical biosafety procedures, and according to your immunization program s procedures. What Should be Returned to McKesson The following items should be returned to McKesson: Spoiled or expired product in its original vial or pre-filled syringe. Unused pre-filled syringes from manufacturers with an NDC printed on them. Unused Novartis Fluvirin pre-filled syringes with staked needles (NDC ) are the ONLY items that can be returned with a needle. The needle should be capped and the syringes returned in their original packaging to the extent possible. (Absolutely no other needle can be returned to McKesson.) Federal excise tax (FET) credits can only be processed for unopened vials and for unopened manufacturer pre-filled syringes. Returns of product other than these are not eligible for FET credit. Reminder: These returns should be sent back to McKesson with a completed return form in the McKesson box with the preprinted return label. 66

68 VACCINE TRANSFER FORM ILLINOIS DEPARTMENT OF PUBLIC HEALTH VACCINE FOR CHILDREN IMMUNIZATION PROGRAM Transfer FROM Facility Name Facility Name PIN PIN Address Address City, State Zip City, State Zip Date Shipped Date Received Contact Person Contact Person Transferred TO Vaccine Manufacturer Lot number Expiration Date Doses DTaP DTaP/HebB/IPV HepA Pediatric Hepatitis B Hep B/Hib Hib e-ipv Meningococcal Conjugate (MCV4) Pneumococcal Conjugate (PNU7) Td Tdap Rotavirus HPV Varicella MMR/Varicella MMR Transfer FROM facility: Make sure a completed copy of this form goes with the product to the receiving facility and follow up on the transfer. You will be held accountable for the vaccine until receiving facility sends a completed copy of this form to the Immunization Program acknowledging receipt. Transfer TO facility: After receiving vaccine, please submit completed form immediately to: Illinois Department of Public Health Immunization Program 2840 Via Verde Springfield, IL Fax: (217) Completion and submission of this form by the receiving provider assumes that the vaccine was received in usable condition. If vaccine is NOT usable when received, call (217) for further instructions. Pneumo 23 Other - Specify Comments Rev 6/08 vc g:\vaccine distribution site directory\forms\vaccine transfer form.doc 67

69 Transporting Refrigerated Vaccine Guidelines for vaccine transport and short-term storage The procedure below for packing vaccine will keep all vaccines ( except varicella vaccine) within recommended temperatures for 12 hours during transport and/or storage at room temperatures (inside a car, building, etc.). It will also maintain recommended temperatures if the cooler is exposed to outside temperatures as low as -4ºF for one of those 12 hours. If the vaccine will be stored in refrigerators after transport, be sure those refrigerators have maintained temperatures between 35ºF and 46ºF for at least 3 to 5 days. Assemble packing supplies 1. Cooler. Use hard plastic Igloo-type coolers. Attach a Vaccines: Do Not Freeze label to the cooler. 2. Conditioned cold packs. Condition frozen gel packs by leaving them at room temperature for 1 to 2 hours until the edges have defrosted and packs look like they ve been sweating. Cold packs that are not conditioned can freeze vaccine. Do not use dry ice. 3. Thermometer. Prepare the thermometer by placing it in the refrigerator at least 2 hours before you pack the vaccine. 4. Packing material. Use two 2-inch layers of bubble wrap. Not using enough bubble wrap can cause the vaccine to freeze. Pack vaccine 1. Cold packs Spread conditioned cold packs to cover only half of the bottom of the cooler. 2. Bubble wrap & Thermometer Completely cover the cold packs with a 2-inch layer of bubble wrap. Then, place the thermometer/ probe on top of the bubble wrap directly above a cold pack. 3. Vaccine Stack layers of vaccine boxes on the bubble wrap. Do not let the boxes of vaccine touch the cold packs. 4. Bubble wrap Completely cover the vaccine with another 2-inch layer of bubble wrap. 5. Cold packs Spread conditioned cold packs to cover only half of the bubble wrap. Make sure that the cold packs do not touch the boxes of vaccine. 6. Form & display Fill the cooler to the top with bubble wrap. Place the thermometer s digital display and the Return or Transfer of Vaccines Report form on top. It s ok if temperatures go above 46ºF while packing. As soon as you reach the destination site, check the vaccine temperature. If the vaccine is: Between 35ºF and 46ºF, put it in the refrigerator. Below 35ºF or above 46ºF, contact your VFC Rep or the VFC program immediately at For H1N1 vaccine, call Then label the vaccine Do Not Use and put it in the refrigerator. California Department of Public Health, Immunization Branch 68 IMM-983 (2/10)

70 VACCINE ORDERING AND ACCOUNTABILITY Section 5 Section 5 69

71 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Vaccine Receiving, Ordering, Accountability, & Borrowing POLICY NUMBER: 5a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: Purpose: To enforce the importance of maintaining the cold chain as vaccines are received, that they are stored properly until they are administered, and that accurate inventory is kept especially if borrowing becomes necessary. Policy: All staff who accepts vaccine deliveries must be instructed on the importance of maintaining the cold chain. Vaccine must be stored properly from the time they are manufactured until the time they are administered. Excess heat or cold will reduce their potency and increase the risk that recipients will not be protected. A. Vaccine Receiving 1. When the vaccine is received by the front desk personnel, the vaccine coordinator, backup coordinator and/or designee will be notified immediately. The box will be taken to the storage area and unpacked in the following manner: Open the shipping container immediately and examine the contents for signs of physical damage or temperature out of range. Ø Check the color of the temperature indicator (McKesson s MonitorMark or ColdMark Freeze Indicators) enclosed with the vaccine shipment. Vaccines to be refrigerated should be cold, but not frozen. Ø Check the interval between shipment from the supplier and arrival of the product at the office. o If this period is more than 48 ours, the vaccine could have been exposed to excessive heat or cold that might have affected the integrity of the vaccine. o Mark the vaccine as DO NOT USE and place it in specially marked, segregated tray in the refrigerator or freezer. Do not leave the vaccine out and assume it is not viable. It may still be viable. 2. WITHIN TWO (2) HOURS OF VACCINE DELIVERY: If any damage, excessive shipping time, cold chain breach has occurred, provider must call McKesson immediately at 877-TEMP123 or Provider also must notify the Illinois VFC program: or dph.vaccine@illinoisgov. The McKesson telephone numbers are staffed Monday through Friday from 8a.m. until 8 p.m. Eastern Time except for the following holidays: New Year s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and the Friday after, Christmas Eve, and Christmas Day. With the shortest expiration report discrepancies and/or cold chain issues, this constitutes provider negligence in accordance with Vaccine Loss and Replacement Protocol

72 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Vaccine Receiving, Ordering, Accountability, & Borrowing POLICY NUMBER: 5a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): (See Attached. Category 3, point 9), Failure to notify the VFC program within two (2) hours of vaccine receipt of any errors, shortages, temperature issues or damage to vaccine shipment from distributor. Shipments that result in vaccine loss negatively impact the Illinois vaccine budget. When calling McKesson about a vaccine delivery: Expect that McKesson staff will have provider staff report on temperature indicators. If anything is wrong, (cold chain breach indicated), McKesson staff will advise provider staff to contact Illinois VFC program, and the providers will be instructed to put the questionable vaccine supply into a refrigerator. A questionnaire will be completed with the Illinois VFC program and CDC/manufacturer to determine viability. Provider staff should store the vaccine appropriately and maintain the shipment packing list. Ensure that temperature logs are maintained for the vaccine in question. Both the CDC and McKesson WILL ask for this paperwork. 3. With each vaccine delivery, check the actual vaccines received against the shipping invoice to verify all vaccines were received. Compare original order against what was received. If there is a discrepancy with the order, contact the Illinois VF program at or dph.vaccines@illinois.gov. Make sure diluents that accompany MMR, MMRV, and varicella match the amount of vaccine ordered. 4. Place the new vaccines into the refrigerator and/or freezer immediately with the shortest expiration dates in the front of the pack. Separate the VFC vaccines from the private supply by tagging the VFC vaccines and placing them in a separate labeled area of the refrigerator and/or freezer. Vaccines should be kept in their original packaging with the lids in place until ready for administration and stacked in rows with vaccines of the same type. 5. Store Refrigerated diluents with corresponding vaccine (these diluents may contain vaccine antigen). 6. Keep at least one (1) of the McKesson shipping containers for possible vaccine transfers or vaccine relocation in the event of an emergency situation. McKesson asks that the provider dispose of them in an environmentally conscious manner. 71

73 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Vaccine Receiving, Ordering, Accountability, & Borrowing POLICY NUMBER: 5a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 3 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): B. Vaccine Ordering, Accountability and Inventory 1. In 2010, the CDC placed all VFC providers in Economic Ordering Tiers. These four (4) tiers are based on annual vaccine doses administered. The Illinois Immunization Program began working with providers to implement this mid Currently the four (4) tiers and ordering frequency are: 6,000 annual doses Order monthly 800-5,999 doses Order bi-monthly doses Order quarterly Less than 199 doses Order as needed Order vaccine in accordance with actual vaccine need; avoid stockpiling or build-up of more than a 60-day supply. 2. Orders take 10 days to three (3) weeks from submission of correct paperwork to vaccine delivery. Fill out the entire Illinois VFC Pediatric Vaccine Order, Inventory, and Accountability Form (See Attached), including hours of operation, dates of office closures, , and signature. Complete the Accountability and Waste Section since the last submitted order. Ø List your entire vaccine inventory on hand by the NDC, Brand, Lot number, and expiration date. Record doses administered by age and by vaccine Brand. Ø Make sure that you total the vaccine doses used. Ø Note: Doses administered no longer recorded by doses in schedule. Order vaccine multiples of ten (10) (or five (5) by vaccine presentation. REMEMBER that vaccines are Brand specific. Submit Temporary log with each completed Illinois VFC Pediatric Vaccine Order, Inventory, and Accountability Form (See Attached). Fax temperature log for the past 30 days only. Temperatures should be physically verified and logged twice a day. C. VFC Vaccine Borrowing Report 1. VFC-enrolled providers are expected to maintain an adequate inventory of vaccine for their non VFC-eligible patients. VFC vaccine cannot be used as a replacement system for 72

74 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Vaccine Receiving, Ordering, Accountability, & Borrowing POLICY NUMBER: 5a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 4 of 4 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): a provider s privately purchased vaccine inventory. The provider must assure that the VFC supply is adequate to meet the needs of the provider s VFC-eligible patients and that borrowing VFC vaccine will not prevent a VFC-eligible child from receiving a needed vaccination because a VFC vaccine was administered to a non VFC-eligible child. Borrowing should only occur when there is a lack of private stock vaccine due to unexpected circumstances such as: Delayed vaccine shipment Vaccine spoiled while in transit to provider New staff calculated ordering time incorrectly NOTE: The reason cannot be provider-planned borrowing from VFC stock. When a provider borrowed VFC vaccine for administration to a non VFC-eligible child, complete the Illinois VFC Vaccine Borrowing Report (See Attached). Be sure to document on this report the Date Vaccine Returned to VFC Stock column. These borrowing reports must be kept as part of the VFC program records and be made available upon request by the Illinois Department of Public Health and the VFC staff. D. Attachments Vaccine Loss & Replacement Protocol 2012 Illinois VFC Pediatric Vaccine Order, Inventory & Accountability Form Illinois VFC Vaccine Borrowing Report 73

75 Date: / / Illinois VFC Pediatric Vaccine Order, Inventory & Accountability Form PIN#: Practice Name: Phone: Fax: Report period start: end: Vaccine Delivery Street Address: City: ZIP: Facility Office Days & Hours: Mon Tues Wed Thurs Fri Form Completed By: Dates Office Closed (next 30 days): Fax Order to: Physician's signature: Form Revised 2/10/2011 Vaccine DTaP DTaP-HepB-IPV DTaP-IPV-HIB DTaP-IPV HepA-Peds HepB HepB-Hib Hib Hib - Booster dose HPV Brand Daptacel- Sanofi Infanrix-GSK Vial Infanrix-GSK Syringe Pediarix Pentacel Kinrix-GSK Vial Kinrix-GSK Syringe Havrix-GSK Vial Havrix-GSK Syringe Vaqta-Merck Engerix-GSK Vial Engerix-GSK Syringe Recombivax- Merck Comvax ActHIB-Sanofi PedvaxHIB- Merck Hiberix Gardasil-Merck Cervarix-GSK Vial Cervarix-GSK Syringe VFC Order-Inv-Acct.pdf NDC Doses on Hand Lot Number / Expiration Date Doses on Hand Lot Number / Expiration Date Doses on Hand Lot Number / Expiration Date Page 1 of 2 Wasted/Expired Vaccine Doses Administered by Year of Age DOSES Lot Num / Exp date Doses < TOTAL REQUESTED DTaP 74 Pediarix Pentacel Kinrix HepA - Peds HepB HepB-Hib Hib Hib-booster HPV

76 Date: / / Illinois VFC Pediatric Vaccine Order & Accountability Form PIN#: Practice Name: Phone: Fax: Report period start: end: Vaccine Delivery Street Address: City: ZIP: Vaccine Meningococcal (MCV4) MMR-V MMR Polio (eipv) Brand Menactra- Sanofi Menveo- Novartis ProQuad MMRII IPOL - vial NDC Doses on Hand Lot Number / Expiration Date Doses on Hand Lot Number / Expiration Date Fax Order to: Doses on Lot Number / Hand Expiration Date Facility Wasted/Expired Vaccine Doses Administered by Year of Age DOSES Lot Num / Exp date Doses < TOTAL REQUESTED MCV4 MMR-V Not Available MMR Polio - IPV PCV13 PPSV 23 Rotavirus Td Prevnar Pneumovax Rotateq-Merck Rotarix-GSK Decavac- Sanofi Vial Decavac- Sanofi Syr Adacel-Sanofi Vial Prevnar PPSV23 Rotavirus Td Tdap Tdap Adacel-Sanofi Syr Boostrix-GSK Vial Varicella Boostrix-GSK Syringe Varivax Varicella Influenza Influenza - Multidose Influenza ml single dose Influenza Flumist Fluzone-Sanofi Vial Fluvirin- Novartis Vial Fluzone-Sanofi Vial Fluzone-Sanofi Syr Fluzone-Sanofi.25 syr Use flu order form to place order. Page 2 of 2

77 Illinois Vaccines For Children Vaccine Borrowing Report Guidance: VFC-enrolled providers are expected to maintain and adequate inventory of vaccine for their non-vfceligible patients. VFC vaccine cannot be used as a replacement system for a provider s privately purchased vaccine inventory. The provider must assure that VFC vaccine supply is adequate to meet the needs of the provider s VFC-eligible patients and that borrowing VFC vaccine will not prevent a VFCeligible child from receiving a needed vaccination because VFC vaccine was administered to a non-vfc eligible child. Borrowing will occur only when there is lack of private-stock vaccine due to unexpected circumstances such as a delayed vaccine shipment, vaccine spoiled while in-transit to provider, or new staff that calculated ordering time incorrectly. The reason cannot be provider planned borrowing from VFC stock. Directions for use of this form: When a provider has borrowed VFC vaccine for administration to a non-vfc-eligible child, this form must be COMPLETELY FILLED OUT for each non-vfc-eligible receiving a VFC vaccine. Each VFC vaccine a child receives must be listed on a separate row. As soon as the borrowed doses of VFC vaccine are replaced by private stock vaccine, the form must be faxed to the Illinois VFC Program: Attention: Fax Number: 217/ Time period of to Clinic/Provider Name: Office Contact Name: Telephone Number/fax: / address: VFC Provider Number (PIN): January

78 ILLINOIS VFC IMMUNIZATION PROGRAM VACCINE LOSS AND REPLACEMENT POLICY Current state and federal vaccine contracts stipulate that spoiled or expired vaccines cannot be returned to the manufacturer for credit or replacement. Such vaccine losses are absorbed directly by our program s budget. Since the Illinois Department of Public Health (IDPH) Vaccines for Children (VFC) Program is so important to the health and well being of the people of Illinois, it is essential that all of us work together to ensure that every dose of vaccine is used to provide protection against preventable diseases. As a provider responsible for state supplied vaccines, you and your staff should continually monitor vaccine storage and handling practices. Please notify the IDPH VFC Program if you or your staff would like to receive an educational visit regarding vaccine storage and handling. Vaccines for Children Providers are required to report all wasted, expired, spoiled or lost vaccine to the Illinois VFC Program. This document serves as the IDPH VFC Program s policy for management of incidents that result in loss of state supplied vaccine. Dose for dose reimbursement for state supplied vaccine will be requested if wastage was due to the provider s failure to properly store, handle or rotate vaccine inventory. DEFINITIONS Wasted: Any vaccine that cannot be used. This includes expired, spoiled and lost vaccines. Expired: Any vaccine with an expiration date that has passed. Spoiled: Any vaccine that exceeds the limits of the approved cold chain procedures or is pre drawn and not used within acceptable time frames. Always consult with the vaccine manufacturer and Illinois VFC Program before determining that the vaccine is non viable. Lost: Commercial carrier (FedEx or UPS) or United State Postal Service (USPS) does not deliver the vaccine or does not deliver in a timely manner. Illinois VFC Immunization Program Loss and Replacement Policy Updated 9/ of 6 77

79 SITUATIONS THAT REQUIRE VACCINE REPLACEMENT Expired Vaccine Failure to rotate or attempt to transfer vaccine that results in expired vaccine. Spoiled Vaccine Pre drawn vaccine that is not used. Please note the Illinois VFC Program strongly discourages the practice of pre drawing vaccine. Handling and storage mishaps by provider staff. Vaccine that is left out of the refrigerator or freezer and becomes non viable. Call the vaccine manufacturer first to help you determine the stability/viability of vaccine left out of the refrigerator/freezer. Vaccine stored in dorm style refrigerators. Freezing vaccine that is supposed to be refrigerated. Refrigerating vaccine that is supposed to be frozen. Refrigerator/freezer left unplugged. Refrigerator/freezer door left open or ajar. Refrigerator/freezer equipment problems where proof of repair or equipment replacement is not provided to the Illinois VFC Program within 30 days from the date you became aware of the situation. Power outages in which the provider fails to follow the facility s VACCINE STORAGE AND EMERGENCY RESPONSE PLANS. Vaccine that is considered spoiled due to the provider not checking, reviewing and recording refrigerator and freezer temperatures or failing to use currently certified calibrated thermometer to check temperatures twice daily. Vaccine that is considered spoiled because a provider did not take immediate or appropriate action on out of range temperatures. Replacement vaccine: health care providers who must re vaccinate due to negligence in failure to keep vaccine viable (temperatures out of acceptable range) or improper administration will be responsible for replacement of the vaccine needed to re vaccinate. Illinois VFC Immunization Program Loss and Replacement Policy Updated 9/ of 6 78

80 Wasted Vaccine State provided vaccine given to children or adults who are not eligible to receive it based on the most recent VFC eligibility criteria and Illinois immunization guidelines. Discarding vaccine before the manufacturer s expiration date (includes multi dose vials discarded after 30 days). SITUATIONS THAT DO NOT REQUIRE VACCINE REPLACEMENT Below is a list of situations that are NOT considered provider negligence. This list is not exhaustive. In these situations, the provider is deemed not to be at fault. You may be required to produce a letter from the alarm/alert company or the power company. A commercial carrier or USPS does not deliver to the provider in a timely manner. Before making the determination that the vaccine is non viable, first call the vaccine manufacturer. A provider who has a contract with an alert/alarm company has a refrigerator that malfunctions, and the alarm/alert company does not notify the provider. A provider moves vaccine to a nearby hospital due to anticipated inclement weather, the hospital experiences a power failure, and the Illinois VFC Program later deems the vaccine not viable. Power was interrupted or discontinued due to a storm, provider is able to confirm that the facility s VACCINE STORAGE AND EMERGENCY RESPONSE PLAN was followed and after consultation with the vaccine manufacturer and the Illinois VFC Program, it is determined that vaccine is not viable. A vial that is accidentally dropped or broken by a provider. Vaccine that is drawn at the time of the visit but not administered due to parental refusal or a change in physician orders. Expired vaccine that is not due to provider negligence (including seasonal influenza vaccine). Extraordinary situations not listed above which are deemed by Illinois VFC Program to be beyond the provider s control. Refrigerator/freezer equipment problems where proof of repair or equipment replacement is provided to the Illinois VFC Program within 30 days from the date you became aware of the situation. Illinois VFC Immunization Program Loss and Replacement Policy Updated 9/ of 6 79

81 PROCEDURES FOR RETURNING NONVIABLE VACCINE TO MCKESSON SPECIALTY Call the vaccine manufacturer and the Illinois VFC Program as soon as you suspect vaccine may not be viable. Failure to report wasted vaccine to the Illinois VFC Program may result in your facility no longer being able to receive state supplied vaccine. Return all unopened vials and manufacturer s pre filled syringes of spoiled or expired vaccine with a completed Vaccine Waste Packing List for Return to McKesson For Excise Tax Credit and Disposal to McKesson Specialty regardless of any financial restitution status applied to the vaccine. Vaccine provided by the Illinois VFC Program should never be discarded. The only exception is open vials or syringes, including multi dose vials, from which some doses have already been withdrawn. These can no longer be sent back to McKesson. A wastage form must still be filled out and sent to the Illinois VFC Program, and the open vials and syringes should then be discarded per your facility s policy. Procedure for returning unopened non viable vaccine to McKesson: o o o o o o o o o Complete a Vaccine Waste Packing List for Return to McKesson For Excise Tax Credit and Disposal before returning non viable vaccine. Either faxing or ing the completed form is acceptable. Make two copies of the form or confirmation page, one for your records and one for McKesson. Prior to shipping non viable vaccine, fax the paper form to the Illinois VFC Program at or to dph.vaccines@illinois.gov. Providers may NOT contact McKesson to coordinate pickup of wasted/expired vaccine. McKesson is no longer including pre printed return labels with its shipments. You must contact the Illinois VFC Program when you need to return nonviable vaccine. McKesson will send a return label via USPS to providers. The provider may then send the labeled box of wasted/expired vaccine with the UPS driver. For providers who do not have a regular UPS pickup, McKesson will contact UPS to arrange the pickup. Use a container from a previous vaccine shipment to send non viable vaccine and a copy of the completed return form to McKesson. Wasted/expired vaccine does not need to be refrigerated or frozen. DO NOT ship viable vaccine to McKesson. Illinois VFC Immunization Program Loss and Replacement Policy Updated 9/ of 6 80

82 o DO NOT ship viable or non viable vaccine to the Illinois VFC Program. PROCEDURES FOR VACCINE REPLACEMENT This updated policy applies to any vaccine received as wasted by the Illinois VFC Program on or after January 1, The provider will receive a notice from the Illinois VFC Program requesting proof of replacement of vaccine reported as wasted to the Illinois VFC Program. Acceptable proof is packing list or paid invoice showing type, amount, lot number and expiration date of privately purchased vaccine that will then marked and used as VFC vaccine. OR If the provider is using the VFC ordering and inventory module in I CARE, I CARE support must be notified immediately when the purchased vaccine arrives so that the lot numbers can be entered into the I CARE system as VFC vaccine. Replacement of the vaccine is due within 30 days of receiving the Illinois VFC Program notice. If replacement is not received within 30 days, the Illinois VFC Program will not supply vaccine to the negligent provider until restitution has been made. PROVIDER TO PROVIDER TRANSFER OF VACCINES Providers who have excess vaccine on hand that will not be used before expiration are encouraged to transfer this vaccine to other Illinois VFC providers to utilize, and thus avoid being charged for wasted vaccine. Providers should begin this process within 3 6 months of the vaccine expiring. It is the provider s responsibility to find another provider willing to accept the vaccine, and also to properly pack and ship the vaccine to that provider following standard cold chain procedures. While the IDPH VFC Program is willing to assist when possible, it is very difficult to match odd numbers of vaccines with other provider orders and to try to arrange for shipments between providers. Providers can find contact information for other VFC providers in their area within the I CARE Reports tab. Providers must also transfer the doses in I CARE. Transfers of vaccine will not be deducted from the transferring provider s stock until both the receiving facility and VFC staff have approved the transfer. If you have any questions concerning this policy, please call the Illinois Vaccine for Children Program at or by to dph.vaccines@illinois.gov. Illinois VFC Immunization Program Loss and Replacement Policy Updated 9/ of 6 81

83 (Please print) I have read and agree to abide by the ILLINOIS VFC IMMUNIZATION PROGRAM VACCINE LOSS AND REPLACEMENT POLICY Provider Name: PIN: Address: Telephone Physician s Signature Fax: Date: Sign and return this form to IDPH Immunization, VFC Program Fax to: or send a scanned electronic copy by to Dph.vaccines@illinois.gov Illinois Department of Public Health Immunization Program/Vaccines for Children 2840 Via Verde St. Springfield, IL Illinois VFC Immunization Program Loss and Replacement Policy Updated 9/ of 6 82

84 Section 6 ADULT VACCINE SCREENING Section 6 83

85 Summary of Recommendations for Adult Immunization (Age 19 years & older) (Page 1 of 4) Vaccine name and route People for whom vaccination is recommended Schedule for vaccine administration (any vaccine can be given with another) Contraindications and precautions (mild illness is not a contraindication) Influenza Inactivated Influenza vaccine (IIV) Give IM or intradermally Live attenuated influenza vaccine (LAIV) Give intranasally Pneumococcal polysaccharide (PPSV) Give IM or SC Pneumococcal conjugate (PCV13) Give IM For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at p2010.pdf. Vaccination is recommended for all adults. (This includes healthy adults age 19 49yrs without risk factors.) LAIV is approved only for healthy nonpregnant people age 2 49yrs. Adults age 18 through 64yrs may be given any intramuscular IIV product or, alternatively, the intradermal IIV product (Fluzone Intradermal). Adults age 65yrs and older may be given standard-dose IIV or, alternatively, high-dose IIV (Fluzone High-Dose). Note: Healthcare personnel who care for severely immunocompromised people (i.e., those who require care in a protected environment) should receive IIV rather than LAIV. For information on other contraindications and precautions to LAIV, see far right column. For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at p2010.pdf. People age 65yrs and older. People younger than age 65yrs who have chronic illness or other risk factors, including chronic cardiac or pulmonary disease (including asthma), chronic liver disease, alcoholism, diabetes, CSF leaks, cigarette smoking, as well as candidates for or recipients of cochlear implants and people living in special environments or social settings (including American Indian/Alaska Natives age 50 through 64yrs if recommended by local public health authorities). Those at highest risk of serious pneumococcal infection, including people who - Have anatomic or functional asplenia, including sickle cell disease. - Have an immunocompromising condition, including HIV infection, leukemia, lymphoma, Hodgkin s disease, multiple myeloma, generalized malignancy, chronic renal failure, or nephrotic syndrome. - Are receiving immunosuppressive chemotherapy (including corticosteroids). - Have received an organ or bone marrow transplant. Give 1 dose every year in the fall or winter. Begin vaccination services as soon as vaccine is available and continue until the supply is depleted. Continue to give vaccine to unvaccinated adults throughout the influenza season (including when influenza activity is present in the community) and at other times when the risk of influenza exists. If 2 or more of the following live virus vaccines are to be given LAIV, MMR, Var, HZV, and/or yellow fever they should be given on the same day. If they are not, space them by at least 28d. Give 1 dose if unvaccinated or if previous vaccination history is unknown. Give a 1-time revaccination to people - Age 65yrs and older if 1st dose was given prior to age 65yrs and 5yrs have elapsed since dose #1. - Age 19 through 64yrs who are at highest risk of fatal pneumococcal infection or rapid antibody loss (see the 3rd bullet in the box to left for listings of people at highest risk) and 5yrs have elapsed since dose #1. Give 1 dose of PCV13 to people age 19yrs and older at highest risk of serious pneumococcal infection (see column to left), and to those who have CSF leaks, or are candidates for or recipient of cochlear implants. If previously vaccinated with PPSV, give PCV13 at least 12m following PPSV; if not previously vaccinated with PPSV, give PCV13 first, followed by PPSV in 8wks. Contraindications Previous anaphylactic reaction to this vaccine, to any of its components, including egg protein. For LAIV only: pregnancy; chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurological/neuromuscular, hematologic, or metabolic (including diabetes) disorders; immunosuppression (including that caused by medications or HIV). For adults who experience only hives with exposure to eggs, give IIV with additional safety precautions as found in the 2012 ACIP influenza recommendations, pages * Precautions Moderate or severe acute illness. History of Guillain-Barré syndrome (GBS) within 6wks following previous influenza vaccination. For LAIV only: receipt of specific antivirals (i.e., amantadine, rimantadine, zanamivir, or oseltamivir) 48hrs before vaccination. Avoid use of these antiviral drugs for 14d after vaccination. Contraindication Previous anaphylactic reaction to this vaccine, including (for PCV13) to any diphtheria toxoid-containing vaccine, or to any of its components. Precaution Moderate or severe acute illness. * This document was adapted from the recommendations of the Advisory Committee on Immunization Practices (ACIP). To obtain copies of these recommendations, visit CDC s website at pubs/acip-list.htm or visit the Immunization Action Coalition (IAC) website at This table is revised periodically. Visit IAC s website at to make sure you have the most current version. Technical content reviewed by the Centers for Disease Control and Prevention Item #P2011 (2/13) 84 Immunization Action Coalition 1573 Selby Avenue Saint Paul, MN (651) admin@immunize.org

86 Summary of Recommendations for Adult Immunization (Age 19 years & older) (Page 2 of 4) Vaccine name and route MMR (Measles, mumps, rubella) Give SC People for whom vaccination is recommended For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at p2010.pdf. People born in 1957 or later (especially those born outside the U.S.) should receive at least 1 dose of MMR if they have no laboratory evidence of immunity to each of the 3 diseases or documentation of a dose given on or after the first birthday. People in high-risk groups, such as healthcare personnel (paid, unpaid, or volunteer), students entering college and other post high school educational institutions, and international travelers, should receive a total of 2 doses. People born before 1957 are usually considered immune, but evidence of immunity (serology or documented history of 2 doses of MMR) should be considered for healthcare personnel. Women of childbearing age who do not have acceptable evidence of rubella immunity or vaccination. Schedule for vaccine administration (any vaccine can be given with another) Give 1 or 2 doses (see criteria in 1st and 2nd bullets in box to left). If dose #2 is recommended, give it no sooner than 4wks after dose #1. If a pregnant woman is found to be rubella susceptible, give 1 dose of MMR postpartum. If 2 or more of the following live virus vaccines are to be given LAIV, MMR, Var, HZV, and/or yellow fever they should be given on the same day. If they are not, space them by at least 28d. Within 72hrs of measles exposure, give 1 dose as postexposure prophylaxis to susceptible adults. Note: Routine post-vaccination serologic testing is not recommended. Contraindications and precautions (mild illness is not a contraindication) Contraindications Previous anaphylactic reaction to this vaccine or to any of its components. Pregnancy or possibility of pregnancy within 4wks. Severe immunodeficiency (e.g., hematologic and solid tumors; receiving chemotherapy; congenital immunodeficiency; longterm immunosuppressive therapy; or severely symptomatic HIV). Note: HIV infection is NOT a contraindication to MMR for those who are not severely immunocompromised (i.e., CD4+ T-lymphocyte counts are greater than or equal to 200 cells/µl) for 6 months.* Precautions Moderate or severe acute illness. If blood, plasma, and/or immune globulin were given in past 11m, see ACIP s General Recommendations on Immunization* regarding time to wait before vaccinating. History of thrombocytopenia or thrombocytopenic purpura. Note: If TST (tuberculosis skin test) and MMR are both needed but not given on same day, delay TST for 4 6wks after MMR. Varicella (chickenpox) (Var) Give SC For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at p2010.pdf. All adults without evidence of immunity. Note: Evidence of immunity is defined as written documentation of 2 doses of varicella vaccine; a history of varicella disease or herpes zoster (shingles) based on healthcare-provider diagnosis; laboratory evidence of immunity or confirmation of disease; and/or birth in the U.S. before 1980, with the exceptions that follow. - Healthcare personnel born in the U.S. before 1980 who do not meet any of the criteria above should be tested or given the 2-dose vaccine series. If testing indicates they are not immune, give the 1st dose of varicella vaccine immediately. Give the 2nd dose 4 8 wks later. - Pregnant women born in the U.S. before 1980 who do not meet any of the criteria above should either 1) be tested for susceptibility during pregnancy and if found susceptible, given the 1st dose of varicella vaccine postpartum before hospital discharge, or 2) not be tested for susceptibility and given the 1st dose of varicella vaccine postpartum before hospital discharge. Give the 2nd dose 4 8wks later. Give 2 doses. Dose #2 is given 4 8wks after dose #1. If dose #2 is delayed, do not repeat dose #1. Just give dose #2. If 2 or more of the following live virus vaccines are to be given LAIV, MMR, Var, HZV, and/or yellow fever they should be given on the same day. If they are not, space them by at least 28d. May use as postexposure prophylaxis if given within 5d. Note: Routine post-vaccination serologic testing is not recommended. Contraindications Previous anaphylactic reaction to this vaccine or to any of its components. Pregnancy or possibility of pregnancy within 4wks. People on long-term immunosuppressive therapy or who are immunocompromised because of malignancy and primary or acquired immunodeficiency, including HIV/AIDS (although vaccination may be considered if CD4+ T-lymphocyte counts are greater than or equal to 200 cells/µl. See MMWR 2007;56,RR-4). Precautions Moderate or severe acute illness. If blood, plasma, and/or immune globulin (IG or VZIG) were given in past 11m, see ACIP s General Recommendations on Immunization* regarding time to wait before vaccinating. Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24hrs before vaccination, if possible; delay resumption of these antiviral drugs for 14d after vaccination. Zoster (shingles) (HZV) Give SC People age 60yrs and older. Give 1-time dose if unvaccinated, regardless of previous history of herpes zoster (shingles) or chickenpox. If 2 or more of the following live virus vaccines are to be given MMR, Var, HZV and/or yellow fever they should be given on the same day. If they are not, space them by at least 28d. Contraindications Previous anaphylactic reaction to any component of zoster vaccine. Primary cellular or acquired immunodeficiency. Pregnancy. Precautions Moderate or severe acute illness. Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24hrs before vaccination, if possible; delay resumption of these antiviral drugs for 14d after vaccination. 85 February 2013

87 Summary of Recommendations for Adult Immunization (Age 19 years & older) (Page 3 of 4) Vaccine name and route Hepatitis A (HepA) Give IM Brands may be used interchangeably. Hepatitis B (HepB) Give IM Brands may be used interchangeably. Inactivated Polio (IPV) Give IM or SC People for whom vaccination is recommended For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at All people who want to be protected from hepatitis A virus (HAV) infection and lack a specific risk factor. People who travel or work anywhere EXCEPT the U.S., Western Europe, New Zealand, Australia, Canada, and Japan. People with chronic liver disease; injecting and non-injecting drug users; men who have sex with men; people who receive clotting-factor concentrates; people who work with HAV in experimental lab settings; food handlers when health authorities or private employers determine vaccination to be appropriate. People who anticipate close personal contact with an international adoptee from a country of high or intermediate endemicity during the first 60 days following the adoptee s arrival in the U.S. Adults age 40yrs or younger with recent (within 2 wks) exposure to HAV. For people older than age 40yrs with recent (within 2 wks) exposure to HAV, immune globulin is preferred over HepA vaccine. For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at All adults who want to be protected from hepatitis B virus infection and lack a specific risk factor. Household contacts and sex partners of HBsAg-positive people; injecting drug users; sexually active people not in a long-term, mutually monogamous relationship; men who have sex with men; people with HIV; people seeking STD evaluation or treatment; hemodialysis patients and those with renal disease that may result in dialysis; diabetics younger than age 60yrs (diabetics age 60yrs and older may be vaccinated at the clinician s discretion [see ACIP recommendations*]); healthcare personnel and public safety workers who are exposed to blood; clients and staff of institutions for the developmentally disabled; inmates of long-term correctional facilities; certain international travelers; and people with chronic liver disease. Note: Provide serologic screening for immigrants from endemic areas. If patient is chronically infected, assure appropriate disease management. For sex partners and household contacts of HBsAg-positive people, provide serologic screening and administer initial dose of HepB vaccine at same visit. For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at Not routinely recommended for U.S. residents age 18yrs and older. Note: Adults living in the U.S. who never received or completed a primary series of polio vaccine need not be vaccinated unless they intend to travel to areas where exposure to wild-type virus is likely. Previously vaccinated adults can receive 1 booster dose if traveling to polio endemic areas or to areas where the risk of exposure is high. Schedule for vaccine administration (any vaccine can be given with another) Give 2 doses, spaced 6 12m apart. If dose #2 is delayed, do not repeat dose #1. Just give dose #2. For Twinrix (hepatitis A and B combination vaccine [GSK]) for patients age 18yrs and older only: give 3 doses on a 0, 1, 6m schedule. There must be at least 4wks between doses #1 and #2, and at least 5m between doses #2 and #3. An alternative schedule can also be used at 0, 7d, 21 30d, and a booster at 12m. Give 3 doses on a 0, 1, 6m schedule. Alternative timing options for vaccination include 0, 2, 4m; 0, 1, 4m; and 0, 1, 2, 12m (Engerix brand only). There must be at least 4wks between doses #1 and #2, and at least 8wks between doses #2 and #3. Overall, there must be at least 16wks between doses #1 and #3. Give adults on hemodialysis or with other immunocompromising conditions 1 dose of 40μg/mL (Recombivax HB) at 0, 1, 6m or 2 doses of 20 μg/ ml (Engerix-B) given simultaneously at 0, 1, 2, 6m. Schedule for those who have fallen behind: If the series is delayed between doses, DO NOT start the series over. Continue from where you left off. Refer to ACIP recommendations* regarding unique situations, schedules, and dosing information. Contraindications and precautions (mild illness is not a contraindication) Contraindication Previous anaphylactic reaction to this vaccine or to any of its components. Precaution Moderate or severe acute illness. Contraindication Previous anaphylactic reaction to this vaccine or to any of its components. Precaution Moderate or severe acute illness. Contraindication Previous anaphylactic reaction to this vaccine or to any of its components. Precautions Moderate or severe acute illness. Pregnancy. 86 February 2013

88 Summary of Recommendations for Adult Immunization (Age 19 years & older) (Page 4 of 4) Vaccine name and route People for whom vaccination is recommended Schedule for vaccine administration (any vaccine can be given with another) Contraindications and precautions (mild illness is not a contraindication) Human papillomavirus (HPV) (HPV2, Cervarix) (HPV4, Gardasil) Give IM Meningococcal conjugate vaccine, quadrivalent (MCV4) Menactra, Menveo Give IM Meningococcal polysaccharide vaccine (MPSV4) Menomune Give SC For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at catg.d/p2010.pdf. All previously unvaccinated women through age 26yrs and men through age 21yrs. All previously unvaccinated men through age 26yrs who 1) have sex with men or 2) are immunocompromised as a result of infection (including HIV), disease, or medications or who lack either of the preceding risk factors but want to be vaccinated. For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at catg.d/p2010.pdf. People with anatomic or functional asplenia or persistent complement component deficiency. People who travel to or reside in countries in which meningococcal disease is hyperendemic or epidemic (e.g., the meningitis belt of Sub-Saharan Africa). Microbiologists routinely exposed to isolates of N. meningitidis. First year college students through age 21yrs who live in residence halls; see 5th bullet in the box to the right for details. Give 3 doses on a 0, 2, 6m schedule. Use either HPV2 or HPV4 for women, and only HPV4 for men. There must be at least 4wks between doses #1 and #2 and at least 12wks between doses #2 and #3. Overall, there must be at least 24wks between doses #1 and #3. If possible, use the same vaccine product for all three doses. Give 2 initial doses of MCV4 separated by 2m to adults 55yrs and younger with risk factors listed in 1st bullet in column to left or if vaccinating adults with HIV infection in this age group. Give 1 dose of MPSV4 to adults 56yrs and older with risk factors. Give 1 initial dose to all other adults with risk factors (see 2nd 4th bullets in column to left). Give booster doses every 5yrs to adults with continuing risk (see the 1st 3rd bullets in column to left for listings of people with possible continuing risk). MCV4 is preferred over MPSV4 for people age 55yrs and younger; use MPSV4 ONLY if age 56yrs or older or if there is a permanent contraindication/precaution to MCV4. For first year college students age 19 21yrs living in residence halls, give 1 initial dose if unvaccinated and give booster dose if most recent dose was given when younger than age 16yrs. Contraindication Previous anaphylactic reaction to this vaccine or to any of its components. Precautions Moderate or severe acute illness. Pregnancy. Contraindication Previous anaphylactic reaction to this vaccine or to any of its components. Precaution Moderate or severe acute illness. Tdap, Td (Tetanus, diphtheria, acellular pertussis) Give IM Using tetanus toxoid (TT) instead of Tdap or Td is not recommended. For people through age 18 years, consult Summary of Recommendations for Child/Teen Immunization at catg.d/p2010.pdf. All people who lack written documentation of a primary series consisting of at least 3 doses of tetanus- and diphtheria-toxoidcontaining vaccine. A booster dose of Td or Tdap may be needed for wound management, so consult ACIP recommendations.* For Tdap only: Adults who have not already received Tdap. Healthcare personnel of all ages. Give Tdap to pregnant women during each pregnancy (preferred during weeks gestation), regardless of number of years since prior Td or Tdap. For people who are unvaccinated or behind, complete the primary Td series (spaced at 0, 1 2m, 6 12m intervals); substitute a one-time dose of Tdap for one of the doses in the series, preferably the first. Give Td booster every 10yrs after the primary series has been completed. Tdap should be given regardless of interval since previous Td. Contraindications Previous anaphylactic reaction to this vaccine or to any of its components. For Tdap only, history of encephalopathy not attributable to an identifiable cause, within 7d following DTP/DTaP, or Tdap. Precautions Moderate or severe acute illness. Guillain-Barré syndrome within 6wks following previous dose of tetanus toxoid-containing vaccine. History of arthus reaction following a prior dose of tetanus- or diphtheria toxoid-containing vaccine (including MCV4); defer vaccination until at least 10yrs have elapsed since the last tetanus toxoid-containing vaccine. For Tdap only, progressive or unstable neurologic disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized. February

89 If you are this age, Recommended Immunizations for Adults Talk to your doctor or nurse about these vaccines: Influenza (Flu) 1 Tetanus, diphtheria, pertussis (Td/Tdap) 2 Varicella (Chickenpox) HPV Vaccine for Women years years years years years 65+ years Get a flu vaccine every year Get a Tdap vaccine once, then a Td booster vaccine every 10 years 2 doses 3 doses HPV Vaccine for Men 3 3 doses 3 doses Zoster (Shingles) 1 dose Measles, mumps, rubella (MMR) 4 1 or 2 doses Pneumococcal doses 1 dose Meningococcal Hepatitis A Hepatitis B 1 or more doses 2 doses 3 doses Boxes this color show that the vaccine is recommended for all adults who have not been vaccinated, unless your doctor or nurse tells you that you cannot safely receive the vaccine or that you do not need it. Boxes this color show when the vaccine is recommended for adults with certain risks related to their health, job or lifestyle that put them at higher risk for serious diseases. Talk to your doctor or nurse to see if you are at higher risk. No recommendation FOOTNOTES: (Influenza vaccine) There are four different types of flu vaccines available talk to your doctor or nurse about which flu vaccine is right for you. ¹ (Tdap vaccine) Pregnant women are recommended to get Tdap vaccine with each pregnancy to increase protection for infants who are too young for vaccination but at highest risk for severe illness and death from pertussis (whooping cough). ² (HPV vaccine) 3 There are two different kinds of HPV vaccine but only one HPV vaccine (Gardasil ) can be given to men. Gay men or men who have sex with men who are 22 through 26 years old should get HPV vaccine if they haven t already started or completed the series. (MMR vaccine) 4 If you were born in 1957 or after, and don t have a record of being vaccinated or having had these infections, talk to your doctor or nurse about how many doses you may need. (Pneumococcal vaccine) 5 There are two different types of pneumococcal vaccine: PCV13 and PPSV23. Talk with your doctor or nurse to find out if one or both pneumococcal vaccines are recommended for you. If you are traveling outside of the United States, you may need additional vaccines. Ask your doctor or nurse which vaccines you may need. For more information, call toll free CDC-INFO ( ) or visit 88

90 Vaccine-Preventable Diseases and the Vaccines that Prevent Them Diphtheria (Can be prevented by Tdap vaccine) Diphtheria is a very contagious bacterial disease that affects the respiratory system, including the lungs. Diphtheria bacteria can be passed from person to person by direct contact with droplets from an infected person s cough or sneeze. When people are infected, the diptheria bacteria produce a toxin (poison) in the body that can cause weakness, sore throat, low-grade fever, and swollen glands in the neck. Effects from this toxin can also lead to swelling of the heart muscle and, in some cases, heart failure. In severe cases, the illness can cause coma, paralysis, and even death. Hepatitis A (Can be prevented by HepA vaccine) Hepatitis A is an infection in the liver caused by hepatitis A virus. The virus is spread primarily person-to-person through the fecal-oral route. In other words, the virus is taken in by mouth from contact with objects, food, or drinks contaminated by the feces (stool) of an infected person. Symptoms include fever, tiredness, loss of appetite, nausea, abdominal discomfort, dark urine, and jaundice (yellowing of the skin and eyes). An infected person may have no symptoms, may have mild illness for a week or two, or may have severe illness for several months that requires hospitalization. In the U.S., about 100 people a year die from hepatitis A. Hepatitis B (Can be prevented by HepB vaccine) Hepatitis B is an infection of the liver caused by hepatitis B virus. The virus spreads through exchange of blood or other body fluids, for example, from sharing personal items, such as razors, diabetes blood sugar monitors, or during sex. Hepatitis B causes a flu-like illness with loss of appetite, nausea, vomiting, rashes, joint pain, and jaundice. The virus stays in the liver of some people for the rest of their lives and can result in severe liver diseases, including fatal cancer. Human Papillomavirus (Can be prevented by HPV vaccine) Human papillomavirus is a common virus. HPV is most common in people in their teens and early 20s. It is the major cause of cervical cancer in women, as well as anal cancer and genital warts in both women and men. The strains of HPV that cause cervical cancer and genital warts are spread during sex. Influenza (Can be prevented by annual flu vaccine) Influenza is a contagious viral infection of the nose, throat, and lungs. The virus spreads when an infected person coughs, sneezes, or talks and can cause mild to severe illness. Typical symptoms include a sudden high fever, chills, cough, headache, runny nose, sore throat, and muscle and joint pain. Extreme fatigue can last from several days to weeks. Influenza may lead to hospitalization or even death, even among previously ealthy children and adults. Measles (Can be prevented by MMR vaccine) Measles is one of the most contagious vaccine-preventable diseases. Measles virus is spread by direct contact with the airborne respiratory droplets of an infected person. Measles is so contagious that just being in the same room after a person who has measles has already left can result in infection in a susceptible person. Symptoms usually include a rash, fever, cough, and red, watery eyes. Fever can be high rash can last for up to a week, and coughing can last about 10 days. Measles can also cause pneumonia, seizures, brain damage, or death. Meningococcal Disease (Can be prevented by MCV vaccine) Meningococcal disease is caused by bacteria and is a leading cause of bacterial meningitis (infection around the brain and spinal cord) in children. The bacteria are spread through the exchange of nose and throat droplets, such as when coughing, sneezing or kissing. Symptoms of meningitis include sudden onset of fever, headache and stiff neck, often with nausea, vomiting, sensitivity to light, and confusion. Meningococcal disease also causes blood infections. About one of every ten people who get the disease dies from it. Survivors of meningococcal disease may lose their arms or legs, become deaf, have problems with their nervous systems, become developmentally disabled, or suffer seizures or strokes. Mumps (Can be prevented by MMR vaccine) Mumps is an infectious disease caused by the mumps virus, which is spread in the air by a cough or sneeze from an infected person. A person can also get infected with mumps by coming in contact with a contaminated object, like a toy. The mumps virus causes fever, headaches, painful swelling of the salivary glands under the jaw, fever, muscle aches, tiredness, and loss of appetite. Severe complications for people who get mumps are uncommon, but can include meningitis (infection of the covering of the brain and spinal cord), encephalitis (inflammation of the brain), permanent hearing loss, or swelling of the testes, which rarely can lead to sterility in men. Pertussis (Whooping Cough) (Can be prevented by Tdap vaccine) Pertussis is caused by bacteria spread through direct contact with respiratory droplets when an infected person coughs or sneezes. In the beginning, symptoms of pertussis are similar to the common cold, including runny nose, sneezing, and cough. After 1-2 weeks, pertussis can cause spells of violent coughing and choking, making it hard to breathe, drink, or eat. This cough can last for weeks. Pertussis is most serious for babies, who can get pneumonia, have seizures, become brain damaged, or even die. More than half of children under 1 year of age who get pertussis are hospitalized. Pneumococcal Disease (Can be prevented by Pneumococcal vaccine) Pneumonia is an infection of the lungs that can be caused by the bacteria called pneumococcus. This bacteria can cause other types of infections too, such as ear infections, sinus infections, meningitis (infection of the covering around the brain and spinal cord), bacteremia and sepsis (blood stream infection). Sinus and ear infections are usually mild and are much more common than the more severe forms of pneumococcal disease. However, in some cases pneumococcal disease can be fatal or result in long-term problems, like brain damage, hearing loss and limb loss. Pneumococcal disease spreads when people cough or sneeze. Many people have the bacteria in their nose or throat at one time or another without being ill this is known as being a carrier. Rubella (German Measles) (Can be prevented by MMR vaccine) Rubella is caused by a virus that is spread through coughing and sneezing. In children rubella usually causes a mild illness with fever, swollen glands, and a rash that lasts about 3 days. Rubella rarely causes serious illness or complications in children, but can be very serious to a baby in the womb. If a pregnant woman is infected, the result to the baby can be devastating, including miscarriage, serious heart defects, mental retardation and loss of hearing and eye sight. Tetanus (Lockjaw) (Can be prevented by Tdap vaccine) Tetanus is caused by bacteria found in soil, dust, and maure. The bacteria enters the body through a wound, such as a deep cut. When people are infected, the bacteria produce a toxin (poison) in the body that causes serious, painful spasms and stiffness of all muscles in the body. This can lead to locking of the jaw so a person cannot open his or her mouth, swallow, or breathe. Complete recovery from tetanus can take months. Ten to 20% of people who get tetanus die from the disease. Varicella (Chickenpox) (Can be prevented by varicella vaccine) Chickenpox is caused by the varicella zoster virus. Chickenpox is very contagious and spreads very easily from infected people. The virus can spread from either a cough, sneeze. It can also spread from the blisters on the skin, either by touching them or by breathing in these viral particles. Typical symptoms of chickenpox include an itchy rash with blisters, tiredness, headache and fever. Chickenpox is usually mild, but it can lead to severe skin infections, pneumonia, encephalitis (brain swelling), or even death. Zoster (Shingles, Herpes Zoster) (Can be prevented by the zoster vaccine) Shingles is caused by the varicella zoster virus, the same virus that causes chickenpox. After a person recovers from chickenpox, the virus stays in the body in a dormant (inactive) state. For reasons that are not fully known, the virus can reactivate years later, causing shingles. Almost 1 out of every 3 people in the United States will develop shingles, also known as zoster or herpes zoster. About half of all cases occur among men and women 60 years old or older. People who develop shingles typically have only one episode in their lifetime. In rare cases, however, a person can have a second or even a third episode. Herpes zoster is not caused by the same virus that causes genital herpes, a sexually transmitted disease. If you have any questions about vaccines, talk to your doctor or nurse. 89 January 31, 2013 CS238094

91 Immunization & Pregnancy Vaccines help keep a pregnant woman and her growing family healthy. Vaccine Before pregnancy During pregnancy After pregnancy Type of Vaccine Hepatitis A Yes, if indicated Yes, if indicated Yes, if indicated Inactivated Hepatitis B Yes, if indicated Yes, if indicated Yes, if indicated Inactivated Human Papillomavirus (HPV) Yes, if indicated, through 26 years of age No, under study Yes, if indicated, through 26 years of age Inactivated Influenza IIV Yes Yes Yes Inactivated Influenza LAIV MMR Meningococcal: polysaccharide conjugate Pneumococcal Polysaccharide Tdap Tetanus/Diphtheria Td Yes, if less than 50 years of age and healthy; avoid conception for 4 weeks Yes, if indicated, avoid conception for 4 weeks No No If indicated If indicated If indicated Yes, if less than 50 years of age and healthy; avoid conception for 4 weeks Yes, if indicated, give immediately postpartum if susceptible to rubella Live Live Inactivated Inactivated If indicated If indicated If indicated Inactivated Yes, if indicated Yes, if indicated Yes, vaccinate during each pregnancy ideally between 27 and 36 weeks of gestation Yes, if indicated, Tdap preferred Yes, immediately postpartum, if not received previously Yes, if indicated Toxoid/ inactivated Toxoid Varicella Yes, if indicated, avoid conception for 4 weeks No Yes, if indicated, give immediately postpartum if susceptible Live For information on all vaccines, including travel vaccines, use this table with Get an answer to your specific question by ing cdcinfo@cdc.gov or calling 800-CDC-INFO ( ) English or Spanish National Center for Immunization and Respiratory Diseases Immunization Services Division CS238938B 03/

92 Guide to Contraindications and Precautions to Commonly Used Vaccines in Adults 1, *, Vaccine Contraindications 1 Precautions 1 Influenza, inactivated injectable (IIV) Influenza, live attenuated (LAIV) 2 Tetanus, diphtheria, pertussis (Tdap) Tetanus, diphtheria (Td) Varicella (Var) 2 Human papillomavirus (HPV) Zoster (HZV) Measles, mumps, rubella (MMR) 2 Pneumococcal (PCV13 or PPSV23) Meningococcal: conjugate (MCV4), polysaccharide (MPSV4) Hepatitis A (HepA) Hepatitis B (HepB) Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any influenza vaccine or to a vaccine component, including egg protein Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any influenza vaccine or to a vaccine component, including egg protein Conditions for which the ACIP recommends against use, but which are not contraindications in vaccine package insert: immune suppression, certain chronic medical conditions such as asthma, diabetes, heart or kidney disease, and pregnancy 3 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component For Tdap only: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) not attributable to another identifiable cause within 7 days of administration of previous dose of DTP, DTaP, or Tdap Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, primary or acquired immunodeficiency, or long-term immunosuppressive therapy 4 or patients with human immunodeficiency virus [HIV] infection who are severely immunocompromised) Pregnancy Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, or long-term immunosuppressive therapy 4 or patients with HIV infection who are severely immunocompromised) Pregnancy Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy 4 or patients with HIV infection who are severely immunocompromised) Pregnancy Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component (including to any vaccine containing diphtheria toxoid for PCV13) Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component Moderate or severe acute illness with or without fever History of Guillain-Barré Syndrome (GBS) within 6 weeks of previous influenza vaccination Persons who experience only hives with exposure to eggs should receive IIV with the additional safety precautions found in the ACIP influenza recommendations, pages at Moderate or severe acute illness with or without fever History of GBS within 6 weeks of previous influenza vaccination Receipt of specific antivirals (i.e., amantadine, rimantadine, zanamivir, or oseltamivir) 48 hours before vaccination. Avoid use of these antiviral drugs for 14 days after vaccination Moderate or severe acute illness with or without fever GBS within 6 weeks after a previous dose of tetanus toxoid-containing vaccine History of arthus-type hypersensitivity reactions after a previous dose of tetanus or diphtheria toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid containing vaccine For Tdap only: Progressive or unstable neurologic disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized Moderate or severe acute illness with or without fever Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product) 5 Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination; avoid use of these antiviral drugs for 14 days after vaccination Moderate or severe acute illness with or without fever Pregnancy Moderate or severe acute illness with or without fever Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24 hours before vaccination; avoid use of these antiviral drugs for 14 days after vaccination Moderate or severe acute illness with or without fever Recent (within 11 months) receipt of antibody-containing blood product (specific interval depends on product) 5 History of thrombocytopenia or thrombocytopenic purpura Need for tuberculin skin testing 6 Moderate or severe acute illness with or without fever Moderate or severe acute illness with or without fever Moderate or severe acute illness with or without fever Moderate or severe acute illness with or without fever Footnotes 1. Vaccine package inserts and the full ACIP recommendations for these vaccines should be consulted for additional information on vaccine-related contraindications and precautions and for more information on vaccine excipients. Events or conditions listed as precautions should be reviewed carefully. Benefits of and risks for administering a specific vaccine to a person under these circumstances should be considered. If the risk from the vaccine is believed to outweigh the benefit, the vaccine should not be administered. If the benefit of vaccination is believed to outweigh the risk, the vaccine should be administered. A contraindication increases the chance of a serious adverse reaction. Therefore, a vaccine should not be administered when a contraindication is present. 2. LAIV, MMR, and varicella vaccines can be administered on the same day. If not administered on the same day, these live vaccines should be separated by at least 28 days. 3. For a complete list of conditions that CDC considers to be reasons to avoid getting LAIV, see CDC. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 2010;59(No. RR-8), available at 4. Immunosuppressive steroid dose is considered to be 2 or more weeks of daily receipt of 20 mg prednisone or equivalent. Vaccination should be deferred for at least 1 month after discontinuation of such therapy. Providers should consult ACIP recommendations for complete information on the use of specific live vaccines among persons on immune-suppressing medications or with immune suppression because of other reasons. 5. Vaccine should be deferred for the appropriate interval if replacement immune globulin products are being administered (see Table 5 in CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2011;60(No. RR-2), available at 6. Measles vaccination might suppress tuberculin reactivity temporarily. Measles-containing vaccine may be administered on the same day as tuberculin skin testing. If testing cannot be performed until after the day of MMR vaccination, the test should be postponed for at least 4 weeks after the vaccination. If an urgent need exists to skin test, do so with the understanding that reactivity might be reduced by the vaccine. * Adapted from Table 6. Contraindications and Precautions to Commonly Used Vaccines found in: CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60(No. RR-2), p , and from Atkinson W, Wolfe S, Hamborsky J, eds. Appendix A. Epidemiology and Prevention of Vaccine-Preventable Diseases ( Regarding latex allergy: some types of prefilled syringes contain natural rubber latex or dry natural latex rubber. Consult the package insert for any vaccine given. Item #P3072 (3/13) 91 Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) Technical content reviewed by the Centers for Disease Control and Prevention

93 It s Federal Law! You must give your patients current Vaccine Information Statements (VISs) To obtain current VISs in more than 30 languages, visit the Immunization Action Coalition s website at As healthcare professionals understand, the risks of serious consequences following vaccination are many hundreds or thousands of times less likely than the risks associated with the diseases that the vaccines protect against. Most adverse reactions from vaccines are mild and self-limited. Serious complications are rare, but they can have a devastating effect on the recipient, family members, and the providers involved with the care of the patient. We must continue the efforts to make vaccines as safe as possible. Equally important is the need to furnish vaccine recipients (or the parents/legal representatives of minors) with objective information on vaccine safety and the diseases that the vaccines protect against, so that they are actively involved in making decisions affecting their health or the health of their children. When people are not informed about vaccine adverse events, even common, mild events, they can lose their trust in healthcare providers and vaccines. Vaccine Information Statements (VISs) provide a standardized way to present objective information about vaccine benefits and adverse events. What are VISs? VISs are developed by the staff of the Centers for Disease Control and Prevention (CDC) and undergo intense scrutiny by panels of experts for accuracy. Each VIS provides information to properly inform the adult vaccine recipient or the minor child s parent or legal representative about the risks and benefits of each vaccine. VISs are not meant to replace interactions with healthcare providers, who should answer According to CDC, every time one of these vaccines is given regardless of what combination vaccine it is given in regardless of whether it is given by a public health clinic or a private provider regardless of how the vaccine was purchased and regardless of the age of the recipient the appropriate VIS must be given out prior to the vaccination. Source: questions and address concerns that the recipient or the parent/legal representative may have. Use of the VIS is mandatory! Before a healthcare provider vaccinates a child or an adult with a dose of any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) vaccine, the provider is required by the National Childhood Vaccine Injury Act (NCVIA) to provide a copy of the VIS to either the adult recipient or to the child s parent/legal representative. How to get VISs All available VISs can be downloaded from the website of the Immunization Action Coalition at or from CDC s website at Ready-to-copy versions may also be available from your state or local health department. You can find VISs in more than 30 languages on the Immunization Action Coalition website at To find VISs in alternative formats (e.g., audio, web-video), go to: Most current versions of VISs As of February 27, 2013, the most recent versions of the VISs are as follows: DTaP/DT...5/17/07 Hepatitis A...10/25/11 Hepatitis B...2/2/12 Hib...12/16/98 HPV... Cervarix...5/3/11 Gardasil...2/22/12 Influenza (inactive)...7/2/12 Influenza (live)...7/2/12 Japanese encephalitis...12/7/11 MMR...4/20/12 MMRV...5/21/10 PCV13...2/27/13 PPSV...10/6/09 Polio...11/8/11 Rabies...10/6/09 Rotavirus...12/6/10 Shingles...10/6/09 Td/Tdap...1/24/12 Typhoid...5/29/12 Varicella (chickenpox)...3/13/08 Meningococcal... 10/14/11 Yellow fever...3/30/11 Multi-vaccine VIS... 11/16/12 (for 6 vaccines given to infants/children: DTaP, IPV, Hib, Hep B, PCV, RV) (Page 1 of 2) Item #P2027 (4/13) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

94 It s Federal Law... you must give your patients current VISs Page 2 of 2 Top 10 Facts about VISs Fact 1 It s federal law! Federal law requires that VISs must be used for the following vaccines when vaccinating patients of ALL ages: DTaP (includes DT) Td/Tdap Hib hepatitis A hepatitis B HPV influenza (inactivated and live vaccines) MMR and MMRV meningococcal pneumococcal conjugate polio rotavirus varicella According to CDC, every time one of these vaccines is given regardless of what combination vaccine it is given in regardless of whether it is given by a public health clinic or a private provider regardless of how the vaccine was purchased and regardless of the age of the recipient the appropriate VIS must be given out prior to the vaccination. There are also VISs for vaccines not covered by NCVIA: anthrax, Japanese encephalitis, pneumococcal polysaccharide, rabies, shingles, smallpox, typhoid, and yellow fever. CDC recommends the use of VISs whenever these vaccines are given. The VIS must always be used if vaccine was purchased under CDC contract. By using the VISs with your patients, you are helping to develop a better educated patient population and you are doing the right thing. coccal (PCV), polio (IPV), or rotavirus (RV). The multi-vaccine VIS can also be used when giving combination vaccines (e.g., Pediarix, Pentacel, Comvax) or when giving two or more routine vaccines at other pediatric visits (e.g., months, 4 6 years). However, when giving combination vaccines for which no VIS exist (e.g., Twinrix), give out all relevant single VISs. For example, before administering Twinrix give your patient the VISs for both hepatitis A and hepatitis B vaccines. Fact 6 VISs are available in other formats, including more than 30 languages You may use laminated copies of VISs for patients and parents to read and return before leaving the clinic, but you must also offer the patient (parent/legal representative) a printed copy of the VIS to take home. If they prefer to download the VIS onto a mobile device, direct them to CDC s VIS Mobile Downloads web page: To download VISs in other languages, visit Fact 7 Federal law does not require signed consent in order for a person to be vaccinated Signed consent is not required by federal law (although some states may require them). Fact 2 VISs are required for both public and private sectors Federal law requires use of VISs in both the public and private sector settings and regardless of the source of payment for the vaccine. Fact 3 VIS must be provided before vaccine is administered to the patient The VIS provides information about the disease and the vaccine and should be given to the patient before vaccine is administered. It is also acceptable to hand out the VIS well before administering vaccines (e.g., at a prenatal visit or at birth for vaccines an infant will receive during infancy), as long as you still provide the VIS right before administering vaccines. Fact 4 You must provide a current VIS for each dose of vaccine The most current VIS must be provided before each dose of vaccine is given, including vaccines given as a series of doses. If five doses of a single vaccine are required, the patient (parent/legal representative) must have the opportunity to read the information on the VIS before each dose is given. Fact 5 You must provide VISs for combination vaccines too There is a VIS available for MMRV (ProQuad). An alternative VIS the multi-vaccine VIS is an option to providing singlevaccine VISs when administering one or more of these routine birth-through-6-month vaccines: DTaP, hepatitis B, Hib, pneumo- Fact 8 To verify that a VIS was given, providers must record in the patient s chart (or permanent office log or file) the following information: The published date of the VIS The date the VIS is given to the patient Name, address (office address), and title of the person who administers the vaccine The date the vaccine is administered The vaccine manufacturer and lot number of each dose administered Fact 9 VISs should not be altered before giving them to patients Providers should not change a VIS or write their own VISs. It is permissible to add a practice s name, address, or phone number to an existing VIS. Providers are encouraged to supplement the VIS with additional patient-education materials. Fact 10 Provide VISs to all patients For patients who don t read or speak English, the law requires that providers ensure all patients (parent/legal representatives) receive a VIS, regardless of their ability to read English. If available, provide a translation of the VIS in the patient s language. Translations of VISs in more than 30 languages are available from IAC. Go to for VISs in multiple languages as well as in other formats. Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

95 Influenza Vaccine Inactivated What You Need to Know 1 Why get vaccinated? Influenza ( flu ) is a contagious disease. It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions. Anyone can get influenza, but rates of infection are highest among children. For most people, symptoms last only a few days. They include: fever/chills sore throat muscle aches fatigue cough headache runny or stuffy nose Other illnesses can have the same symptoms and are often mistaken for influenza. Young children, people 65 and older, pregnant women, and people with certain health conditions such as heart, lung or kidney disease, or a weakened immune system can get much sicker. Flu can cause high fever and pneumonia, and make existing medical conditions worse. It can cause diarrhea and seizures in children. Each year thousands of people die from influenza and even more require hospitalization. By getting flu vaccine you can protect yourself from influenza and may also avoid spreading influenza to others. 2 Inactivated influenza vaccine There are two types of influenza vaccine: 1. Inactivated (killed) vaccine, the flu shot, is given by injection with a needle. 2. Live, attenuated (weakened) influenza vaccine is sprayed into the nostrils. This vaccine is described in a separate Vaccine Information Statement. A high-dose inactivated influenza vaccine is available for people 65 years of age and older. Ask your doctor for more information. Influenza viruses are always changing, so annual vaccination is recommended. Each year scientists try to match the viruses in the vaccine to those most likely to cause flu that year. Flu vaccine will not prevent disease from other viruses, including flu viruses not contained in the vaccine. It takes up to 2 weeks for protection to develop after the shot. Protection lasts about a year. VACCINE INFORMATION STATEMENT Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite Some inactivated influenza vaccine contains a preservative called thimerosal. Thimerosal-free influenza vaccine is available. Ask your doctor for more information. 3 WHO Who should get inactivated influenza vaccine and when? All people 6 months of age and older should get flu vaccine. Vaccination is especially important for people at higher risk of severe influenza and their close contacts, including healthcare personnel and close contacts of children younger than 6 months. WHEN Get the vaccine as soon as it is available. This should provide protection if the flu season comes early. You can get the vaccine as long as illness is occurring in your community. Influenza can occur at any time, but most influenza occurs from October through May. In recent seasons, most infections have occurred in January and February. Getting vaccinated in December, or even later, will still be beneficial in most years. Adults and older children need one dose of influenza vaccine each year. But some children younger than 9 years of age need two doses to be protected. Ask your doctor. Influenza vaccine may be given at the same time as other vaccines, including pneumococcal vaccine. 4 Some people should not get inactivated influenza vaccine or should wait. Tell your doctor if you have any severe (lifethreatening) allergies, including a severe allergy to eggs. A severe allergy to any vaccine component may be a reason not to get the vaccine. Allergic reactions to influenza vaccine are rare. 94

96 Tell your doctor if you ever had a severe reaction after a dose of influenza vaccine. Tell your doctor if you ever had Guillain-Barré Syndrome (a severe paralytic illness, also called GBS). Your doctor will help you decide whether the vaccine is recommended for you. People who are moderately or severely ill should usually wait until they recover before getting flu vaccine. If you are ill, talk to your doctor about whether to reschedule the vaccination. People with a mild illness can usually get the vaccine. 5 What are the risks from inactivated influenza vaccine? A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of a vaccine causing serious harm, or death, is extremely small. Serious problems from inactivated influenza vaccine are very rare. The viruses in inactivated influenza vaccine have been killed, so you cannot get influenza from the vaccine. Mild problems: soreness, redness, or swelling where the shot was given hoarseness; sore, red or itchy eyes; cough fever aches headache itching fatigue If these problems occur, they usually begin soon after the shot and last 1-2 days. Moderate problems: Young children who get inactivated flu vaccine and pneumococcal vaccine (PCV13) at the same time appear to be at increased risk for seizures caused by fever. Ask your doctor for more information. Tell your doctor if a child who is getting flu vaccine has ever had a seizure. Severe problems: Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the shot. In 1976, a type of inactivated influenza (swine flu) vaccine was associated with Guillain-Barré Syndrome (GBS). Since then, flu vaccines have not been clearly linked to GBS. However, if there is a risk of GBS from current flu vaccines, it would be no more than 1 or 2 cases per million people vaccinated. This is much lower than the risk of severe influenza, which can be prevented by vaccination. The safety of vaccines is always being monitored. For more information, visit: and 6 One brand of inactivated flu vaccine, called Afluria, should not be given to children 8 years of age or younger, except in special circumstances. A related vaccine was associated with fevers and fever-related seizures in young children in Australia. Your doctor can give you more information. What if there is a severe reaction? What should I look for? Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at or by calling VAERS does not provide medical advice. 7 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in People who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Ask your doctor. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Influenza Vaccine (Inactivated) 7/2/ U.S.C. 300aa-26 Office Use Only 95

97 VACUNA DESACTIVADA CONTRA LA INFLUENZA LO QUE USTED NECESITA SABER Hojas de Información sobre las Vacunas están disponibles en español y en muchos otros idiomas. Visite 1 Por qué vacunarse? La influenza (conocida como gripe o flu ) es una enfermedad contagiosa. Es causada por el virus de la influenza, que se puede transmitir al toser, estornudar o mediante las secreciones nasales. A cualquiera le puede dar influenza, pero los índices de infección son mayores entre los niños. La mayoría de las personas solo experimentan síntomas por unos pocos días e incluyen: fiebre/escalofríos dolor de garganta tos dolores musculares cansancio dolor de cabeza nariz moquienta o congestionada Otras enfermedades pueden tener los mismos síntomas y a menudo se confunden con la influenza. Los niños pequeños, las personas mayores de 65 años de edad, las mujeres embarazadas y las personas con ciertas condiciones de salud, como enfermedades del corazón, pulmón o riñón o un sistema inmunológico debilitado, se pueden enfermar mucho más. La influenza puede causar fiebre alta y neumonía y puede empeorar condiciones de salud preexistentes. Puede causar diarrea y convulsiones en los niños. Miles de personas mueren cada año por la influenza y muchas más requieren hospitalización. Si se vacuna, puede protegerse usted mismo y evitar contagiar a otros. 2 Vacuna desactivada contra la influenza Hay dos tipos de vacuna contra la influenza: 1. La vacuna desactivada (virus muerto), o vacuna contra la influenza que se inyecta en el músculo. 2. La vacuna viva atenuada (debilitada), que se aplica como rocío en las fosas nasales. Esta vacuna se describe en una Hoja de Información sobre las Vacunas, por separado. Hay una dosis más alta de vacuna desactivada disponible para personas mayores de 65 años. Para más información, consulte a su doctor. Cada año los científicos tratan de que los virus de la vacuna coincidan con los que tienen más probabilidades de causar la influenza ese año. La vacuna contra la influenza no prevendrá otras enfermedades causadas por otros virus, incluyendo los virus de influenza que no están incluidos en la vacuna. Después de la vacunación, toma hasta 2 semanas para desarrollar protección. La protección dura hasta un año. Algunas vacunas desactivadas contra la influenza contienen un conservante llamado timerosal. La vacuna libre de timerosal también está disponible. Consulte a su doctor para más información. 3 Quiénes deben recibir la vacuna desactivada contra la influenza y cuándo? QUIÉNES Todas las personas mayores de 6 meses de edad deben recibir la vacuna contra la influenza. La vacunación es especialmente importante para las personas con mayor riesgo de experimentar un caso grave de influenza y las que están en contacto directo con ellas, incluyendo al personal médico, y las personas en contacto cercano con bebés menores de 6 meses de edad. CUÁNDO Reciba la vacuna tan pronto como esté disponible. Esto le dará la protección necesaria en caso de que la temporada de influenza llegue temprano. Puede vacunarse durante todo el tiempo en el que la enfermedad siga ocurriendo en su comunidad. La influenza puede ocurrir a cualquier momento, pero la mayoría de influenza ocurre desde octubre hasta mayo. En las últimas temporadas, la mayoría de las infecciones han ocurrido en enero y febrero. Vacunándose en diciembre, o aún después, será beneficioso en casi todos los años. Los adultos y los niños mayores requieren una dosis de la vacuna contra la influenza cada año. Sin embargo, algunos niños menores de 9 años de edad necesitan dos dosis para estar protegidos. Consulte a su doctor. Se puede dar la vacuna contra la influenza a la misma vez que otras vacunas, incluyendo la vacuna antineumocócica. 4 Algunas personas no deben recibir la vacuna desactivada contra la influenza o deben esperar Diga a su doctor si tiene cualquier alergia grave (que amenaza la vida), incluyendo alergia grave a los huevos. Una grave alergia a cualquier componente de la vacuna puede ser razón para no vacunarse. Las reacciones alérgicas a la vacuna contra la influenza son poco comunes. Diga a su doctor si alguna vez ha tenido una reacción grave después de haber recibido una dosis de la vacuna contra la influenza. Diga a su doctor si alguna vez ha tenido el síndrome de Guillain-Barre (una enfermedad paralítica grave, también conocida como GBS). Su doctor le puede ayudar a decidir si es recomendable vacunarse. Influenza (inactivated) VIS - Spanish (7/2/12) 96

98 Las personas moderadamente o muy enfermas por lo general deben esperar hasta recuperarse antes de vacunarse contra la influenza. Si está enfermo, hable con su doctor sobre si debe cambiar la cita para vacunarse. Las personas con una enfermedad leve por lo general se pueden vacunar. 5 Cuáles son los riesgos de la vacuna desactivada contra la influenza? Las vacunas, como cualquier medicamento, pueden causar problemas serios, como reacciones alérgicas graves. El riesgo de que la vacuna cause un daño serio, o la muerte, es sumamente pequeño. Problemas serios de la vacuna desactivada contra la influenza ocurren muy rara vez. Los virus en la vacuna desactivada están muertos o sea que no se puede enfermar de influenza mediante la vacuna. Problemas leves: molestia, hinchazón o enrojecimiento o en el lugar donde lo vacunaron ronquera; dolor, enrojecimiento y picazón en los ojos; tos fiebre dolores dolor de cabeza picazón cansancio Si estos problemas ocurren, en general comienzan poco tiempo después de vacunarse y duran 1 ó 2 días. Problemas moderados: Los niños pequeños que reciben la vacuna contra la influenza desactivada y la vacuna antineumocócica (PCV13) durante la misma cita parecen correr mayor riego de tener convulsiones por causa de fiebre. Consulte a su doctor para más información. Diga a su doctor si el niño que está recibiendo la vacuna contra la influenza ha tenido una convulsión. Problemas graves: Las reacciones alérgicas que amenazan la vida ocurren muy rara vez después de la vacunación. Si ocurren, por lo general es a los pocos minutos o a las pocas horas de haberse vacunado. En 1976, un tipo de la vacuna desactivada contra la influenza (gripe porcina) estuvo asociado al síndrome de Guillain-Barré (GBS). Desde entonces, las vacunas contra la influenza no se han asociado claramente al GBS. Sin embargo, si hay un riesgo de GBS por las vacunas contra la influenza que se usan actualmente, no debe ser de más de 1 ó 2 casos por millón de personas vacunadas. Eso es mucho menor que el riesgo de tener una influenza fuerte, que se puede prevenir con vacunación. Una marca de la vacuna desactivada contra la influenza, llamada Afluria, no se debe dar a niños menores de 8 años de edad, con la excepción de circunstancias especiales. En Australia una vacuna relacionada estuvo asociada a fiebre y convulsiones febriles en niños pequeños. Su doctor le puede proporcionar más información. Siempre se seguirá prestando atención a la seguridad de las vacunas. Para más información visite: y 6 Qué pasa si hay una reacción grave? A qué debo prestar atención? A cualquier condición fuera de lo común, como fiebre alta o cambios en el comportamiento. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o sibilancias, ronchas, palidez, debilidad, latidos rápidos del corazón o mareos. Qué debo hacer? Llame a un doctor o lleve a la persona inmediatamente a un doctor. Diga a su doctor lo que ocurrió, la fecha y la hora en que ocurrió, y cuando recibió la vacuna. Pida a su doctor que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (VAERS).O puede presentar este informe mediante el sitio Web de VAERS, en: o llamando al: VAERS no proporciona consejos médicos. 7 8 Programa Nacional de Compensación por Lesiones Causadas por las Vacunas El Programa Nacional de Compensación por Lesiones Causadas por las Vacunas (VICP) fue creado en Las personas que piensan haber sido lesionadas por alguna vacuna pueden aprender acerca del programa y cómo presentar una reclamación llamando al: , o visitando el sitio Web de VICP en Cómo puedo obtener más información? Consulte a su doctor. Le pueden dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al (1-800-CDC-INFO) - Visite el sitio Web de los CDC en DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Inactivated Influenza Vaccine Vaccine - Spanish (7/26/11) (7/2/12) 42 U.S.C. 300aa-26 Translation provided by the California Department of Public Health 97

99 Influenza Vaccine Live, Intranasal What You Need to Know 1 Why get vaccinated? Influenza ( flu ) is a contagious disease. It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions. Anyone can get influenza, but rates of infection are highest among children. For most people, symptoms last only a few days. They include: fever/chills sore throat muscle aches fatigue cough headache runny or stuffy nose Other illnesses can have the same symptoms and are often mistaken for influenza. Young children, people 65 and older, pregnant women, and people with certain health conditions such as heart, lung or kidney disease, or a weakened immune system can get much sicker. Flu can cause high fever and pneumonia, and make existing medical conditions worse. It can cause diarrhea and seizures in children. Each year thousands of people die from influenza and even more require hospitalization. By getting flu vaccine you can protect yourself from influenza and may also avoid spreading influenza to others. 2 Live, attenuated influenza vaccine - LAIV (nasal spray) There are two types of influenza vaccine: 1. Live, attenuated influenza vaccine (LAIV) contains live but attenuated (weakened) influenza virus. It is sprayed into the nostrils. 2. Inactivated (killed) influenza vaccine, the flu shot, is given by injection with a needle. This vaccine is described in a separate Vaccine Information Statement. Influenza viruses are always changing, so annual vaccination is recommended. Each year scientists try to match the viruses in the vaccine to those most likely to cause flu that year. Flu vaccine will not prevent disease from other viruses, including flu viruses not contained in the vaccine. It takes up to 2 weeks for protection to develop after the vaccination. Protection lasts about a year. LAIV does not contain thimerosal or other preservatives. VACCINE INFORMATION STATEMENT Many Vaccine Information Statements are available in Spanish and other languages. See 3 Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite Who can receive LAIV? LAIV is recommended for healthy people 2 through 49 years of age, who are not pregnant and do not have certain health conditions (see #4, below). 4 Some people should not receive LAIV LAIV is not recommended for everyone. The following people should get the inactivated vaccine (flu shot) instead: Adults 50 years of age and older or children from 6 through 23 months of age. (Children younger than 6 months should not get either influenza vaccine.) Children younger than 5 years with asthma or one or more episodes of wheezing within the past year. Pregnant women. People who have long-term health problems with: - heart disease - kidney or liver disease - lung disease - metabolic disease, such as diabetes - asthma - anemia, and other blood disorders Anyone with certain muscle or nerve disorders (such as seizure disorders or cerebral palsy) that can lead to breathing or swallowing problems. Anyone with a weakened immune system. Anyone in close contact with someone whose immune system is so weak they require care in a protected environment (such as a bone marrow transplant unit). Close contacts of other people with a weakened immune system (such as those with HIV) may receive LAIV. Healthcare personnel in neonatal intensive care units or oncology clinics may receive LAIV. Children or adolescents on long-term aspirin treatment. Tell your doctor if you have any severe (life-threatening) allergies, including a severe allergy to eggs. A severe allergy to any vaccine component may be a reason not to get the vaccine. Allergic reactions to influenza vaccine are rare. Tell your doctor if you ever had a severe reaction after a dose of influenza vaccine. Tell your doctor if you ever had Guillain-Barré Syndrome (a severe paralytic illness, also called GBS). Your doctor will help you decide whether the vaccine is recommended for you. 98

100 Tell your doctor if you have gotten any other vaccines in the past 4 weeks. Anyone with a nasal condition serious enough to make breathing difficult, such as a very stuffy nose, should get the flu shot instead. People who are moderately or severely ill should usually wait until they recover before getting flu vaccine. If you are ill, talk to your doctor about whether to reschedule the vaccination. People with a mild illness can usually get the vaccine. 5 When should I receive influenza vaccine? Get the vaccine as soon as it is available. This should provide protection if the flu season comes early. You can get the vaccine as long as illness is occurring in your community. Influenza can occur any time, but most influenza occurs from October through May. In recent seasons, most infections have occurred in January and February. Getting vaccinated in December, or even later, will still be beneficial in most years. Adults and older children need one dose of influenza vaccine each year. But some children younger than 9 years of age need two doses to be protected. Ask your doctor. Influenza vaccine may be given at the same time as other vaccines. 6 What are the risks from LAIV? A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of a vaccine causing serious harm, or death, is extremely small. Live influenza vaccine viruses very rarely spread from person to person. Even if they do, they are not likely to cause illness. LAIV is made from weakened virus and does not cause influenza. The vaccine can cause mild symptoms in people who get it (see below). Mild problems: Some children and adolescents 2-17 years of age have reported: runny nose, nasal congestion or cough fever headache and muscle aches wheezing abdominal pain or occasional vomiting or diarrhea Some adults years of age have reported: runny nose or nasal congestion sore throat cough, chills, tiredness/weakness headache Severe problems: Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the vaccination. If rare reactions occur with any product, they may not be identified until thousands, or millions, of people have used it. Millions of doses of LAIV have been distributed since it was licensed, and the vaccine has not been associated with any serious problems. The safety of vaccines is always being monitored. For more information, visit: and 7 What if there is a severe reaction? What should I look for? Any unusual condition, such as a high fever or behavior changes. Signs of a severe allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell the doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. 8 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling , or visiting the VICP website at 9 How can I learn more? Ask your doctor. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Influenza Vaccine (Live, Attenuated) 7/2/ U.S.C. 300aa-26 Office Use Only 99

101 INTRANASAL VIVA CONTRA LA VACUNAINFLUENZA LO QUE USTED NECESITA SABER Hojas de Información sobre las Vacunas están disponibles en español y en muchos otros idiomas. Visite 1 Por qué vacunarse? 3 Quiénes deben recibir la LAIV? La influenza (conocida como gripe o flu ) es una enfermedad contagiosa. Es causada por el virus de la influenza, que se puede transmitir al toser, estornudar o mediante las secreciones nasales. A cualquiera le puede dar influenza, pero los índices de infección son mayores entre los niños. La mayoría de las personas solo experimentan síntomas por unos pocos días e incluyen: fiebre/escalofríos dolor de garganta dolores musculares cansancio tos dolor de cabeza nariz moquienta o congestionada Otras enfermedades pueden tener los mismos síntomas y a menudo se confunden con la influenza. Los niños pequeños, las personas mayores de 65 años de edad, las mujeres embarazadas y las personas con ciertas condiciones de salud, como enfermedades del corazón, pulmón o riñón o un sistema inmunológico debilitado, se pueden enfermar mucho más. La influenza puede causar fiebre alta y neumonía y puede empeorar condiciones de salud preexistentes. Puede causar diarrea y convulsiones en los niños. Miles de personas mueren cada año por la influenza y muchas más requieren hospitalización. Si se vacuna, puede protegerse usted mismo y evitar contagiar a otros. 2 Vacuna viva atenuada contra la influenza LAIV (rocío nasal) Hay dos tipos de vacuna contra la influenza: 1. La vacuna viva atenuada contra la influenza (LAIV) contiene el virus de influenza vivo pero atenuado (debilitado). Se aplica como rocío en las fosas nasales. 2. La vacuna desactivada (virus muerto) contra la influenza, conocida como la vacuna contra la influenza, se inyecta en el músculo. Esta vacuna se describe en una Hoja de Información sobre las Vacunas, por separado. Los virus de la influenza cambian constantemente. Por eso, se recomienda una vacunación anual. Cada año los científicos tratan de que los virus de la vacuna coincidan con los que tienen más probabilidades de causar la influenza ese año. La vacuna contra la influenza no prevendrá otras enfermedades causadas por otros virus, incluyendo los virus de influenza que no están incluidos en la vacuna. Después de la vacunación, toma hasta 2 semanas para desarrollar protección. La protección dura hasta un año. La LAIV no contiene timerosal u otros conservantes. La LAIV está recomendada para las personas sanas de 2 a 49 años de edad, que no estén embarazadas y que no tengan ciertos problemas de salud (vea el No. 4 abajo). 4 Algunas personas no deben recibir la LAIV La LAIV no está recomendada para todos. Las siguientes personas deben recibir la vacuna desactivada (que se inyecta) en vez de LAIV. Los adultos mayores de 50 años de edad o los niños de 6 a 23 meses de edad. (A niños menores de 6 meses de edad no se les debe aplicar ninguna de las vacunas contra la influenza). Los niños menores de 5 años de edad con asma o con uno o más episodios de sibilancias durante el año pasado. Las mujeres embarazadas. Las personas que tienen problemas de salud a largo plazo con: - enfermedad del corazón - enfermedad de los riñones o del hígado - enfermedad de los pulmones - enfermedad metabólica, como la diabetes - asma - anemia y otras enfermedades de la sangre Cualquier persona que tenga ciertas enfermedades de los músculos o de los nervios (como las enfermedades que causan convulsiones o parálisis cerebral) que puedan causar problemas para respirar o para tragar. Cualquier persona que tenga el sistema inmunológico debilitado. Cualquier persona que esté en contacto cercano con personas que tienen el sistema inmunológico debilitado requiriendo cuidado en un ambiente protegido (como la unidad de trasplante de medula ósea). Las personas con contacto cercano a otras personas con el sistema inmunológico debilitado (como aquellas con VIH) pueden recibir LAIV. Personal trabajando en la unidad de cuidado intensivo neonatal o clínicas de oncología pueden recibir LAIV. Los niños o adolescentes en tratamiento de aspirina a largo plazo. Diga a su doctor si tiene cualquier alergia grave (que amenaza la vida), incluyendo alergia grave a los huevos. Una grave alergia a cualquier componente de la vacuna puede ser razón para no vacunarse. Las reacciones alérgicas a la vacuna contra la influenza son poco comunes. Diga a su doctor si alguna vez ha tenido una reacción grave después de haber recibido una dosis de la vacuna contra la influenza. Influenza, (live, intranasal) VIS - Spanish (7/2/12) 100

102 Diga a su doctor si alguna vez ha tenido el síndrome de Guillain-Barre (una enfermedad paralítica grave, también conocida como GBS). Su doctor le puede ayudar a decidir si es recomendable vacunarse. Diga a su doctor si ha recibido alguna otra vacuna en las 4 últimas semanas. Cualquier persona con un problema nasal lo suficientemente grave como para causar dificultad para respirar, como una nariz congestionada, deben recibir la vacuna contra la influenza que se inyecta en vez de LAIV. Las personas moderadamente o muy enfermas por lo general deben esperar hasta recuperarse antes de vacunarse contra la influenza. Si está enfermo, hable con su doctor sobre si debe cambiar la cita para vacunarse. Las personas con una enfermedad leve por lo general se pueden vacunar. 5 6 Cuándo debo recibir la vacuna contra la influenza? Reciba la vacuna tan pronto como esté disponible. Esto le dará la protección necesaria en caso de que la temporada de influenza llegue temprano. Puede vacunarse durante todo el tiempo en el que la enfermedad siga ocurriendo en su comunidad. La influenza puede ocurrir a cualquier momento, pero la mayoría de influenza ocurre desde octubre hasta mayo. En las últimas temporadas, la mayoría de las infecciones han ocurrido en enero y febrero. Vacunándose en diciembre, o aún después, será beneficioso en casi todos los años. Los adultos y los niños mayores requieren una dosis de la vacuna contra la influenza cada año. Sin embargo, algunos niños menores de 9 años de edad necesitan dos dosis para estar protegidos. Consulte a su doctor. Se puede dar la vacuna contra la influenza a la misma vez que otras vacunas. Cuáles son los riesgos de la LAIV? Las vacunas, como cualquier medicamento, pueden causar problemas serios, como reacciones alérgicas graves. El riesgo de que la vacuna cause un daño serio, o la muerte, es sumamente pequeño. Los virus de la vacuna viva contra la influenza muy rara vez se pasan de una persona a otra. Incluso si lo hacen, es poco probable que causen enfermedad. LAIV está hecha de virus debilitados y no causa influenza. La vacuna puede causar síntomas leves en las personas que la reciben (vea a continuación). Problemas leves: Algunos niños y adolescentes de 2 a 17 años de edad dijeron haber tenido: nariz moquienta o congestionada o tos fiebre dolor de cabeza y dolores musculares sibilancias dolor abdominal, vómitos ocasionales o diarrea Algunos adultos de 18 a 49 años de edad dijeron haber tenido: nariz moquienta o congestionada dolor de garganta tos, escalofríos, cansancio/debilidad dolor de cabeza Problemas graves: Las reacciones alérgicas a causa de las vacunas que amenazan la vida ocurren muy rara vez. Si ocurren, por lo general es a los pocos minutos o a las pocas horas de haberse vacunado. Si ocurren reacciones poco comunes con cualquier producto nuevo, es posible que no se identifiquen hasta que lo hayan usado miles o millones de personas. Desde que fue autorizada se han distribuido millones de dosis de la LAIV y la vacuna no ha sido asociada a ningún problema serio. Siempre se seguirá prestando atención a la seguridad de las vacunas. Para más información visite: y 7 A qué debo prestar atención? A cualquier condición fuera de lo común, como fiebre alta o cambios en el comportamiento. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o sibilancias, ronchas, palidez, debilidad, latidos rápidos del corazón o mareos. Qué debo hacer? Llame a un doctor o lleve a la persona inmediatamente a un doctor. Diga a su doctor lo que ocurrió, la fecha y la hora en que ocurrió, y cuando recibió la vacuna. Pida a su doctor que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (VAERS).O puede presentar este informe mediante el sitio Web de VAERS, en: o llamando al: VAERS no proporciona consejos médicos. 8 Qué pasa si hay una reacción grave? Programa Nacional de Compensación por Lesiones Causadas por las Vacunas El Programa Nacional de Compensación por Lesiones Causadas por las Vacunas (VICP) fue creado en Las personas que piensan haber sido lesionadas por alguna vacuna pueden aprender acerca del programa y cómo presentar una reclamación llamando al: , o visitando el sitio Web de VICP en: 9 Cómo puedo obtener más información? Consulte a su doctor. Le pueden dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al: (1-800-CDC-INFO) - Visite el sitio Web de los CDC en: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Live, Inactivated Attenuated Influenza VIS Vaccine - Spanish (7/26/11) (7/2/12) 42 U.S.C. 300aa-26 Translation provided by the California Department of Public Health, Immunization Branch 101

103 Td or Tdap What You Need to Know VACCINE INFORMATION STATEMENT (Tetanus-Diphtheria or Tetanus-Diphtheria-Pertussis) Vaccine Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 Why get vaccinated? Tetanus, diphtheria and pertussis can be very serious diseases. TETANUS (Lockjaw) causes painful muscle spasms and stiffness, usually all over the body. It can lead to tightening of muscles in the head and neck so the victim cannot open his mouth or swallow, or sometimes even breathe. Tetanus kills about 1 out of 5 people who are infected. DIPHTHERIA can cause a thick membrane to cover the back of the throat. It can lead to breathing problems, paralysis, heart failure, and even death. PERTUSSIS (Whooping Cough) causes severe coughing spells which can lead to difficulty breathing, vomiting, and disturbed sleep. It can lead to weight loss, incontinence, rib fractures and passing out from violent coughing. Up to 2 in 100 adolescents and 5 in 100 adults with pertussis are hospitalized or have complications, including pneumonia and death. These three diseases are all caused by bacteria. Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts, scratches, or wounds. The United States saw as many as 200,000 cases a year of diphtheria and pertussis before vaccines were available, and hundreds of cases of tetanus. Since then, tetanus and diphtheria cases have dropped by about 99% and pertussis cases by about 92%. Children 6 years of age and younger get DTaP vaccine to protect them from these three diseases. But older children, adolescents, and adults need protection too. 2 Vaccines for adolescents and adults: Td and Tdap Two vaccines are available to protect people 7 years of age and older from these diseases: Td vaccine has been used for many years. It protects against tetanus and diphtheria. Tdap vaccine was licensed in It is the first vaccine for adolescents and adults that protects against pertussis as well as tetanus and diphtheria. A Td booster dose is recommended every 10 years. Tdap is given only once. 3 Which vaccine, and when? Ages 7 through 18 years A dose of Tdap is recommended at age 11 or 12. This dose could be given as early as age 7 for children who missed one or more childhood doses of DTaP. Children and adolescents who did not get a complete series of DTaP shots by age 7 should complete the series using a combination of Td and Tdap. Age 19 years and Older All adults should get a booster dose of Td every 10 years. Adults under 65 who have never gotten Tdap should get a dose of Tdap as their next booster dose. Adults 65 and older may get one booster dose of Tdap. Adults (including women who may become pregnant and adults 65 and older) who expect to have close contact with a baby younger than 12 months of age should get a dose of Tdap to help protect the baby from pertussis. Healthcare professionals who have direct patient contact in hospitals or clinics should get one dose of Tdap. Protection After a Wound A person who gets a severe cut or burn might need a dose of Td or Tdap to prevent tetanus infection. Tdap should be used for anyone who has never had a dose previously. Td should be used if Tdap is not available, or for: - anybody who has already had a dose of Tdap, - children 7 through 9 years of age who completed the childhood DTaP series, or - adults 65 and older. Pregnant Women Pregnant women who have never had a dose of Tdap should get one, after the 20th week of gestation and preferably during the 3rd trimester. If they do not get Tdap during their pregnancy they should get a dose as soon as possible after delivery. Pregnant women who have previously received Tdap and need tetanus or diphtheria vaccine while pregnant should get Td. Tdap or Td may be given at the same time as other vaccines. 4 Some people should not be vaccinated or should wait Anyone who has had a life-threatening allergic reaction after a dose of any tetanus, diphtheria, or pertussis containing vaccine should not get Td or Tdap. Anyone who has a severe allergy to any component of a vaccine should not get that vaccine. Tell your doctor if the person getting the vaccine has any severe allergies. Anyone who had a coma, or long or multiple seizures within 7 days after a dose of DTP or DTaP should not get Tdap, unless a cause other than the vaccine was found. These people may get Td. 102

104 Talk to your doctor if the person getting either vaccine: - has epilepsy or another nervous system problem, - had severe swelling or severe pain after a previous dose of DTP, DTaP, DT, Td, or Tdap vaccine, or - has had Guillain Barré Syndrome (GBS). Anyone who has a moderate or severe illness on the day the shot is scheduled should usually wait until they recover before getting Tdap or Td vaccine. A person with a mild illness or low fever can usually be vaccinated. 5 What are the risks from Tdap and Td vaccines? With a vaccine, as with any medicine, there is always a small risk of a life-threatening allergic reaction or other serious problem. Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. Tell your doctor if the patient feels dizzy or light-headed, or has vision changes or ringing in the ears. Getting tetanus, diphtheria or pertussis disease would be much more likely to lead to severe problems than getting either Td or Tdap vaccine. Problems reported after Td and Tdap vaccines are listed below. Mild Problems (Noticeable, but did not interfere with activities) Tdap Pain (about 3 in 4 adolescents and 2 in 3 adults) Redness or swelling at the injection site (about 1 in 5) Mild fever of at least F (up to about 1 in 25 adolescents and 1 in 100 adults) Headache (about 4 in 10 adolescents and 3 in 10 adults) Tiredness (about 1 in 3 adolescents and 1 in 4 adults) Nausea, vomiting, diarrhea, stomach ache (up to 1 in 4 adolescents and 1 in 10 adults) Chills, body aches, sore joints, rash, swollen glands (uncommon) Td Pain (up to about 8 in 10) Redness or swelling at the injection site (up to about 1 in 3) Mild fever (up to about 1 in 15) Headache or tiredness (uncommon) Moderate Problems (Interfered with activities, but did not require medical attention) Tdap Pain at the injection site (about 1 in 20 adolescents and 1 in 100 adults) Redness or swelling at the injection site (up to about 1 in 16 adolescents and 1in 25 adults) Fever over 102 F (about 1 in 100 adolescents and 1 in 250 adults) Headache (1 in 300) Nausea, vomiting, diarrhea, stomach ache (up to 3 in 100 adolescents and 1 in 100 adults) Td Fever over 102 F (rare) Tdap or Td Extensive swelling of the arm where the shot was given (up to about 3 in 100). Severe Problems (Unable to perform usual activities; required medical attention) Tdap or Td Swelling, severe pain, bleeding and redness in the arm where the shot was given (rare). A severe allergic reaction could occur after any vaccine. They are estimated to occur less than once in a million doses. 6 What if there is a severe reaction? What should I look for? Any unusual condition, such as a severe allergic reaction or a high fever. If a severe allergic reaction occurred, it would be within a few minutes to an hour after the shot. Signs of a serious allergic reaction can include difficulty breathing, weakness, hoarseness or wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of the throat. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. 7 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Your doctor can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Td & Tdap Vaccines 1/24/ U.S.C. 300aa-26 Office Use Only 103

105 Vacuna Td o Tdap Lo que usted necesita saber DECLARACIÓN DE INFORMACIÓN SOBRE VACUNAS (Tétanos-Difteria o Tétanos-Difteria-Tos ferina) Muchas de las declaraciones informativas sobre vacunas están disponibles en español y otros idiomas. Consulte Las hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite 1 Por qué es necesario vacunarse? El tétanos, la difteria y la tos ferina pueden ser enfermedades muy graves. El TÉTANOS (trismo) causa espasmos musculares dolorosos y rigidez, por lo general en todo el cuerpo. Puede resultar en tensión de los músculos de la cabeza y del cuello por lo que la víctima no puede abrir la boca ni tragar, y a veces incluso no puede respirar. El tétanos mata aproximadamente a 1 de cada 5 personas infectadas. La DIFTERIA puede ocasionar que una membrana gruesa cubra la parte posterior de la garganta, lo cual puede resultar en problemas para respirar, parálisis, insuficiencia cardíaca e incluso la muerte. La TOS FERINA (tos convulsiva) causa accesos de tos severos que pueden resultar en dificultad para respirar, vómitos y alteraciones del sueño. Puede dar lugar a pérdida de peso, incontinencia, fractura de costillas y desmayos por la tos violenta. Hasta 2 de cada 100 adolescentes y 5 de cada 100 adultos con tos ferina son hospitalizados o tienen complicaciones, incluyendo pulmonía y la muerte. Estas tres enfermedades son causadas por bacterias. La difteria y la tos ferina se contagian de persona a persona. El tétanos entra en el cuerpo a través de cortadas, raspones o heridas. En los Estados Unidos se presentaban hasta 200,000 casos al año de difteria y tos ferina antes de que las vacunas estuvieran disponibles, y centenares de casos de tétanos. Desde entonces, los casos de tétanos y difteria se han reducido aproximadamente hasta un 99% y los casos de tos ferina hasta un 92%. Los niños de 6 años y menores reciben la vacuna DTaP para protegerlos contra estas tres enfermedades. Pero los niños más grandes, adolescentes y adultos también necesitan protección. 2 Vacunas para adolescentes y adultos: Td y Tdap Existen dos vacunas disponibles para proteger a las personas de 7 años de edad y mayores de estas enfermedades: La vacuna Td se ha usado desde hace muchos años. Protege contra el tétanos y la difteria. La vacuna Tdap fue autorizada en Es la primera vacuna para adolescentes y adultos que protege contra la tos ferina, el tétanos y la difteria. Se recomienda una dosis de refuerzo de la vacuna Td cada 10 años. La Tdap se aplica solo una vez. 3 Cuál vacuna y cuándo? Entre los 7 y los 18 años de edad Se recomienda una dosis de Tdap a los 11 o 12 años. Esta dosis podría ser administrada a niños desde 7 años que se saltaron una o más dosis infantiles de DTaP. Los niños y adolescentes que no recibieron la serie completa de inyecciones de DTaP cuando tenían 7 años deben completar la serie con una combinación de Td y Tdap. Personas de 19 años y mayores Todos los adultos deben aplicarse una dosis de refuerzo de Td cada 10 años. Los adultos menores de 65 años que nunca hayan recibido la Tdap deben aplicarse una dosis de Tdap como su próxima dosis de refuerzo. Los adultos de 65 años y mayores pueden aplicarse una dosis de refuerzo de Tdap. Td & Tdap VIS - Spanish (1/24/12) Los adultos (incluidas las mujeres que tengan la posibilidad de quedar embarazadas y los adultos de 65 años y mayores) que esperan estar en contacto cercano con un bebé de menos de 12 meses de edad deberán recibir una dosis de Tdap con el fin de proteger al bebé de la tos ferina. Los profesionales de atención médica que tengan contacto directo con pacientes en hospitales o clínicas deben recibir una dosis de Tdap. Protección después de una herida Es posible que una persona que sufra una cortada o quemadura severa necesite una dosis de Td o Tdap para evitar una infección por tétanos. Se debe aplicar la vacuna Tdap en cualquier persona que nunca antes haya recibido una dosis. Se debe aplicar la vacuna Td si la vacuna Tdap no está disponible o en: - cualquier persona que ya haya recibido una dosis de Tdap, - niños de 7 a 9 años de edad que hayan completado la serie de DTaP infantil, o - adultos de 65 años y mayores. Mujeres embarazadas Las mujeres embarazadas que nunca se hayan aplicado una dosis de Tdap deben aplicarse una, después de las 20 semanas de gestación y de preferencia durante el tercer trimestre. Si no se aplican la vacuna Tdap durante el embarazo, deberán aplicarse una dosis tan pronto como sea posible después del parto. Las mujeres embarazadas que ya antes se hayan aplicado la vacuna Tdap y necesiten una vacuna contra el tétanos o contra la difteria mientras están embarazadas deben aplicarse la vacuna Td. La vacuna Tdap o Td pueden aplicarse al mismo tiempo que otras vacunas. 4 Algunas personas no deben vacunarse o deben esperar Cualquier persona que haya presentado una reacción alérgica después de la aplicación de una dosis de cualquier vacuna contra el tétanos, la difteria o la tos ferina no debe aplicarse la Td ni la Tdap. Cualquier persona que tenga alergia severa a cualquiera de los componentes de una vacuna no deberá aplicarse esa vacuna. Informe a su médico si la persona a la que se le aplicará la vacuna tiene alguna alergia severa. Cualquier persona que haya estado en coma, o que haya tenido convulsiones largas o múltiples dentro de los deberá aplicarse la vacuna Tdap, a menos que se haya encontrado una causa diferente a la vacuna. Estas personas pueden aplicarse la vacuna Td. Informe a su médico si la persona que se aplicará alguna de las vacunas: - tiene epilepsia u otro problema del sistema nervioso, - tuvo hinchazón severa o dolor severo después de una dosis previa de de las vacunas DTP, DTaP, DT, Td o Tdap, o - tuvo síndrome de Guillain Barré (GBS). 104

106 Cualquier persona que tenga una enfermedad moderada o severa el día en que esté programada la aplicación de la vacuna por lo general debe esperar hasta recuperarse antes de ponerse la vacuna Tdap o Td. Por lo general, una persona con una enfermedad leve o con poca fiebre puede vacunarse. 5 Cuáles son los riesgos de las vacunas Tdap y Td? Con una vacuna, como con cualquier medicina, siempre hay un pequeño riesgo de reacción alérgica que pueda poner en peligro la vida u ocasionar otro problema grave. Después de cualquier procedimiento médico, incluida la vacunación, pueden presentarse desmayos y síntomas relacionados (como movimientos espasmódicos repentinos). Sentarse o acostarse durante unos 15 minutos después de una vacunación puede ayudar a evitar desmayos y lesiones causadas por caídas. Informe a su médico si el paciente se siente mareado o aturdido, o si tiene cambios en la visión o zumbido en los oídos. Es mucho más probable que al contraer la enfermedad de tétanos, difteria o tos ferina se produzcan problemas mucho más severos que al ponerse las vacunas Td o Tdap. Los problemas reportados después de las vacunas Td y Tdap se enumeran a continuación. Problemas leves (Perceptible, pero no interfirió con las actividades normales) Tdap Dolor (aproximadamente 3 de cada 4 adolescentes y 2 de cada 3 adultos) Enrojecimiento o hinchazón en el lugar de la inyección (aproximadamente 1 de cada 5) Fiebre leve de por lo menos 38 C o F (hasta en 1 de cada 25 adolescentes y 1 de cada 100 adultos) Dolor de cabeza (aproximadamente 4 de cada 10 adolescentes y 3 de cada 10 adultos) Cansancio (aproximadamente 1 de cada 3 adolescentes y 1 de cada 4 adultos) Náuseas, vómitos, diarrea, dolor de estómago (hasta en 1 de cada 4 adolescentes y 1 de cada 10 adultos) Escalofríos, dolores corporales, dolores en las articulaciones, erupción, hinchazón de los ganglios (poco frecuentes) Td Dolor (hasta en 8 de cada 10) Enrojecimiento o hinchazón en el lugar de la inyección (aproximadamente 1 de cada 3) Fiebre leve (hasta en 1 de cada 15) Dolor de cabeza o cansancio (poco frecuente) Problemas moderados (Interfirieron con las actividades, pero no requieren atención médica) Tdap Dolor en el lugar de la inyección (aproximadamente 1 de cada 20 adolescentes y 1 de cada 100 adultos) Enrojecimiento o hinchazón en el lugar de la inyección (aproximadamente 1 de cada 16 adolescentes y 1 de cada 25 adultos) Fiebre de más de 38.8 C o 102 F (aproximadamente 1 de cada 100 adolescentes y 1 de cada 250 adultos) Dolor de cabeza (1 de cada 300) Náuseas, vómitos, diarrea, dolor de estómago (hasta 3 de cada 100 adolescentes y 1 de cada 100 adultos) Td Fiebre de más de 38.8 C o 102 F (poco frecuente) Tdap o Td Hinchazón extendida del brazo en donde se aplicó la inyección (hasta en 3 de cada 100). Problemas severos (Imposibilidad para realizar actividades usuales; se requirió atención médica) Tdap o Td Hinchazón, dolor severo, sangrado y enrojecimiento del brazo en donde se aplicó la inyección (poco frecuente). Después de la vacuna podría ocurrir una reacción alérgica severa. Se estima que ocurre menos de una en un millón de dosis. 6 De qué debo estar pendiente? De todo signo inusual, como una reacción alérgica severa o fiebre alta. Si ocurriera una reacción alérgica severa, esta debería presentarse en cuestión de minutos y hasta una hora después de la inyección. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, debilidad, ronquera o jadeos, pulso acelerado, urticaria, mareos, palidez o hinchazón de la garganta. Qué debo hacer? Llame a un médico o lleve a la persona al médico de inmediato. Dígale al médico lo que ocurrió, la fecha y la hora en la que ocurrió, y cuándo le pusieron la vacuna. Pídale a su proveedor que reporte la reacción presentando un formulario del Sistema de reporte de eventos adversos derivados de las vacunas (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este reporte a través del sitio web de VAERS en o llamando al El VAERS no ofrece consejos médicos. 7 Qué hago si ocurre una reacción severa? Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas En 1986 se creó el Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas (National Vaccine Injury Compensation Program, VICP). Las personas que consideren que pueden haber resultado lesionadas por una vacuna pueden informarse sobre el programa y sobre cómo presentar una reclamación llamando al o visitando el sitio web del VICP en 8 Dónde puedo obtener más información? Su médico puede darle el folleto informativo de la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al (1-800-CDC-INFO) o - Visite el sitio web de los CDC en Vaccine Information Statement (Interim) Td & Tdap Vaccines 1/24/2012 Spanish 42 U.S.C. 300aa-26 Translation provided by the Immunization Action Coalition 105

107 DIPHTHERIA VACCINES TETANUS & PERTUSSIS W H A T Y O U N E E D T O K N O W Many Vaccine Information Statements are available in Spanish and other languages. See 1 Why get vaccinated? Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria. Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. Children with minor illnesses, such as a cold, may be vaccinated. But children who are moderately DIPHTHERIA causes a thick covering in the back of the or severely ill should usually wait until they recover throat. before getting DTaP vaccine. It can lead to breathing problems, paralysis, heart Any child who had a life-threatening allergic failure, and even death. reaction after a dose of DTaP should not get another dose. TETANUS (Lockjaw) causes painful tightening of the muscles, usually all over the body. Any child who suffered a brain or nervous system It can lead to locking of the jaw so the victim disease within 7 days after a dose of DTaP should cannot open his mouth or swallow. Tetanus leads not get another dose. to death in up to 2 out of 10 cases. Talk with your doctor if your child: PERTUSSIS (Whooping Cough) causes coughing - had a seizure or collapsed after a dose of DTaP, spells so bad that it is hard for infants to eat, drink, - cried non-stop for 3 hours or more after a dose of or breathe. These spells can last for weeks. DTaP, It can lead to pneumonia, seizures (jerking and - had a fever over 105 o F after a dose of DTaP. staring spells), brain damage, and death. Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood. Many more children would get these diseases if we stopped vaccinating. DTaP is a safer version of an older vaccine called DTP. DTP is no longer used in the United States. 2 Who should get DTaP vaccine and when? Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 3 2 months 3 4 months 3 6 months months years DTaP may be given at the same time as other vaccines. 3 Some children should not get DTaP vaccine or should wait Ask your health care provider for more information. Some of these children should not get another dose of pertussis vaccine, but may get a vaccine without pertussis, called DT. 4 Older children and adults DTaP is not licensed for adolescents, adults, or children 7 years of age and older. But older people still need protection. A vaccine called Tdap is similar to DTaP. A single dose of Tdap is recommended for people 11 through 64 years of age. Another vaccine, called Td, protects against tetanus and diphtheria, but not pertussis. It is recommended every 10 years. There are separate Vaccine Information Statements for these vaccines. Diphtheria/Tetanus/Pertussis 5/17/

108 5 What are the risks from DTaP vaccine? Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of DTaP vaccine causing serious harm, or death, is extremely small. Mild Problems (Common) Fever (up to about 1 child in 4) Redness or swelling where the shot was given (up to about 1 child in 4) Soreness or tenderness where the shot was given (up to about 1 child in 4) These problems occur more often after the 4th and 5th doses of the DTaP series than after earlier doses. Sometimes the 4th or 5th dose of DTaP vaccine is followed by swelling of the entire arm or leg in which the shot was given, lasting 1-7 days (up to about 1 child in 30). Other mild problems include: Fussiness (up to about 1 child in 3) Tiredness or poor appetite (up to about 1 child in 10) Vomiting (up to about 1 child in 50) These problems generally occur 1-3 days after the shot. Moderate Problems (Uncommon) Seizure (jerking or staring) (about 1 child out of 14,000) Non-stop crying, for 3 hours or more (up to about 1 child out of 1,000) High fever, over 105 o F (about 1 child out of 16,000) Severe Problems (Very Rare) Serious allergic reaction (less than 1 out of a million doses) Several other severe problems have been reported after DTaP vaccine. These include: - Long-term seizures, coma, or lowered consciousness - Permanent brain damage. These are so rare it is hard to tell if they are caused by the vaccine. Controlling fever is especially important for children who have had seizures, for any reason. It is also important if another family member has had seizures. You can reduce fever and pain by giving your child an aspirin-free pain reliever when the shot is given, and for the next 24 hours, following the package instructions. 6 What if there is a moderate or severe reaction? What should I look for? Any unusual conditions, such as a serious allergic reaction, high fever or unusual behavior. Serious allergic reactions are extremely rare with any vaccine. If one were to occur, it would most likely be within a few minutes to a few hours after the shot. Signs can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. If a high fever or seizure were to occur, it would usually be within a week after the shot. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at or by calling VAERS does not provide medical advice 7 The National Vaccine Injury Compensation Program In the rare event that you or your child has a serious reaction to a vaccine, a federal program has been created to help pay for the care of those who have been harmed. For details about the National Vaccine Injury Compensation Program, call or visit the program s website at 8 How can I learn more? Ask your health care provider. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department s immunization program. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) - Visit the National Immunization Program s website at U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement DTaP (5/17/07) 42 U.S.C. 300aa

109 VACUNAS LO QUE USTED NECESITA SABER 1 La difteria, el tétano y la tos ferina son enfermedades graves causadas por bacterias. La difteria y la tos ferina pasan de una persona a otra. El tétano entra al cuerpo por cortadas o heridas. LA DIFTERIA causa un recubrimiento espeso en la parte posterior de la garganta. Esto puede causar problemas respiratorios, parálisis, fallo cardíaco y hasta la muerte. EL TÉTANO causa espasmos dolorosos de los músculos, por lo general en todo el cuerpo. Puede causar trabadura de la mandíbula, de modo que la víctima no puede abrir la boca ni tragar. El tétano es mortal en hasta 2 de cada 10 casos. LA TOS FERINA (Pertusis) produce ataques de tos tan intensos que a los bebés les resulta difícil comer, beber o respirar. Estos ataques pueden durar semanas. Puede causar neumonía, convulsiones (ataques de sacudidas del cuerpo y fijación de la mirada), daño al cerebro y la muerte. La vacuna contra la difteria, el tétano y la tos ferina (DTaP) puede ayudar a prevenir estas enfermedades. La mayoría de los niños que reciben la vacuna DTaP estarán protegidos durante toda la niñez. Si dejáramos de vacunarlos, muchos más niños tendrían estas enfermedades. La vacuna DTaP es una versión más segura de una vacuna más vieja llamada DTP. La DTP se ha dejado de usar en los Estados Unidos. 2 Por qué vacunarse? Los niños deben recibir 5 dosis de la vacuna contra DTaP, una dosis en cada una de las siguientes edades. A los: 2 meses 4 meses 6 meses meses 4-6 años La DTaP se puede dar al mismo tiempo que otras vacunas. 5 DIFTERIA TÉTANO Y TOS FERINA Muchas Hojas de Información sobre Vacunas están disponibles en español y en otros idiomas. Visite Quiénes deben vacunarse contra la DTaP, y cuándo? 3 Algunas personas no deben recibir la DTaP, o deben esperar Los niños con enfermedades leves, como un resfrío, se pueden vacunar. Pero los niños que están moderadamente o muy enfermos por lo general deben esperar hasta recuperarse para vacunarse. Todos los niños que tuvieron una reacción alérgica que puso en peligro su vida después de una dosis de la DTaP no deben recibir otra. Todos los niños que sufrieron una enfermedad del cerebro o del sistema nervioso dentro de los 7 días de haber recibido una dosis de la DTaP no deben recibir otra. Hable con su doctor si su hijo: - tuvo convulsiones o sufrió un colapso después de una dosis de la DTaP - lloró sin parar 3 horas o más después de una dosis de la DTaP - tuvo fiebre de más de 105ºF después de una dosis de la DTaP. Pida más información a su profesional de la salud. Algunos de estos niños no deben recibir otra dosis de la vacuna contra la tos ferina, pero pueden recibir una vacuna sin tos ferina llamada DT. 4 Niños de mayor edad y adultos La vacuna DTaP no está autorizada para adolescentes, adultos ni niños de 7 años de edad y mayores. Pero las personas mayores también necesitan protección. Existe una vacuna llamada Tdap, que es similar a la DTaP. Se recomienda una sola dosis de la vacuna Tdap para las personas de 11 a 64 años de edad. Otra vacuna, llamada Td, protege contra el tétano y la difteria, pero no contra la tos ferina. Se recomienda cada 10 años. Cada una de estas vacunas tiene su propia Hoja de Información sobre la Vacuna. Cuáles son los riesgos de la vacuna DTaP? Enfermarse de la difteria, tétano o tos ferina es mucho más peligroso que recibir la vacuna contra DTaP. Diphtheria/Tetanus/Pertussis - Spanish 5/17/

110 Sin embargo, una vacuna, como cualquier otro medicamento, puede causar problemas serios, como reacciones alérgicas graves. El riesgo de que la vacuna DTaP cause daños graves o la muerte es extremadamente pequeño. Problemas leves (comunes) Fiebre (aproximadamente 1 de cada 4 niños) Enrojecimiento o hinchazón en el sitio de inyección (aproximadamente 1 de cada 4 niños) Dolor en el sitio de inyección (aproximadamente 1 de cada 4 niños) Estos problemas ocurren con más frecuencia después de la 4ª y 5ª dosis de la serie de DTaP que en dosis anteriores. A veces después de la 4ª o 5ª dosis de la DTaP se hincha todo el brazo o la pierna en que se puso la vacuna y esa hinchazón dura entre 1 y 7 días (aproximadamente 1 de cada 30 niños). Otros problemas leves incluyen: Sentirse molesto (aproximadamente 1 de cada 3 niños) Cansancio o sin ganas de comer (aproximadamente 1 de cada 10 niños) Vómitos (aproximadamente 1 de cada 50 niños) Estos problemas ocurren generalmente 1 a 3 días después de la inyección. Problemas moderados (poco comunes) Convulsiones (sacudidas del cuerpo o fijación de la mirada) (aproximadamente 1 de cada 14,000 niños) Llanto sin parar por 3 horas o más (hasta aproximadamente 1 de cada 1,000 niños) Fiebre alta, de más de 105ºF (aproximadamente 1 de cada 16,000 niños) Problemas serios (muy raros) Reacción alérgica seria (menos de 1 por millón de dosis) Varios otros problemas graves han ocurrido después de recibir la vacuna DTaP. Éstos incluyen: - Convulsiones a largo plazo, coma o reducción de la conciencia. - Daño permanente al cerebro. Estos son tan raros que es difícil saber si fueron causados por la vacuna. Controlar la fiebre es especialmente importante para los niños que tuvieron convulsiones, por cualquier motivo. También es importante si algún otro miembro de la familia tuvo convulsiones. Puede reducir la fiebre y el dolor dando a su hijo un calmante del dolor sin aspirina en el momento de recibir la vacuna y durante las próximas 24 horas, siguiendo las instrucciones del paquete del medicamento. 6 Qué pasa si hay una reacción moderada a seria? A qué debo prestar atención? A cualquier cosa fuera de lo común, como una reacción alérgica seria, fiebre alta o comportamiento fuera de lo normal. Las reacciones alérgicas serias son muy raras en el caso de todas las vacunas. Si ocurriera una reacción seria, sería dentro de los pocos minutos hasta varias horas después de la inyección. Las señales pueden incluir dificultad para respirar, ronquera o ruidos al respirar, ronchas, palidez, debilidad o latidos rápidos del corazón o mareos. Si ocurrieran fiebre o convulsiones, por lo general sería dentro de una semana después de la inyección. Qué debo hacer? Llame a un doctor o lleve la persona inmediatamente a un doctor. Diga a su doctor lo que ocurrió, la fecha y la hora en que ocurrió y cuándo recibió la vacuna. Pida a su doctor, enfermera o departamento de salud que informe la reacción presentando un formulario del Sistema de Información Sobre Eventos Adversos a una Vacuna (Vaccine Adverse Event Reporting, VAERS). O puede presentar este informe mediante el sitio Web de VAERS, en: o puede llamar al: VAERS no proporciona consejos médicos. 7 En el raro evento en que usted o su hijo tengan una reacción grave a una vacuna, se ha creado un programa federal para ayudarlo a pagar la atención de los lesionados. Para mayores detalles sobre el Programa Nacional de Compensación por Lesiones Causadas por Vacunas (National Vaccine Injury Compensation Program), llame al o visite el sitio web del programa en 8 El Programa Nacional de Compensación por Lesiones Causadas por Vacunas Cómo puedo obtener más información? Hable con su profesional de la salud. Le pueden dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al programa de vacunación del departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al (1-800-CDC-INFO) - Visite el sitio web del Programa Nacional de Vacunación, en U.S. DEPARTMENT OF HEALTH U & HUMAN SERVICES Centers for Disease Control and Prevention U Vaccine Information Statement DTaP IMM-509S - Spanish (5/17/07) Translated by Transcend Translations, Davis, CA 42 U.S.C. 300aa

111 CHICKENPOX VACCINE W H A T Y O U N E E D T O K N O W Many Vaccine Information Statements are available in Spanish and other languages. See 1 Why get vaccinated? Chickenpox (also called varicella) is a common childhood disease. It is usually mild, but it can be serious, especially in young infants and adults. It causes a rash, itching, fever, and tiredness. It can lead to severe skin infection, scars, pneumonia, brain damage, or death. The chickenpox virus can be spread from person to person through the air, or by contact with fluid from chickenpox blisters. A person who has had chickenpox can get a painful rash called shingles years later. Before the vaccine, about 11,000 people were hospitalized for chickenpox each year in the United States. Before the vaccine, about 100 people died each year as a result of chickenpox in the United States. Chickenpox vaccine can prevent chickenpox. Most people who get chickenpox vaccine will not get chickenpox. But if someone who has been vaccinated does get chickenpox, it is usually very mild. They will have fewer blisters, are less likely to have a fever, and will recover faster. 2 Routine Who should get chickenpox vaccine and when? Children who have never had chickenpox should get 2 doses of chickenpox vaccine at these ages: 1st Dose: months of age 2nd Dose: 4-6 years of age (may be given earlier, if at least 3 months after the 1st dose) People 13 years of age and older (who have never had chickenpox or received chickenpox vaccine) should get two doses at least 28 days apart. Chickenpox 3/13/08 Catch-Up Anyone who is not fully vaccinated, and never had chickenpox, should receive one or two doses of chickenpox vaccine. The timing of these doses depends on the person s age. Ask your provider. Chickenpox vaccine may be given at the same time as other vaccines. Note: A combination vaccine called MMRV, which contains both chickenpox and MMR vaccines, may be given instead of the two individual vaccines to people 12 years of age and younger. 3 Some people should not get chickenpox vaccine or should wait People should not get chickenpox vaccine if they have ever had a life-threatening allergic reaction to a previous dose of chickenpox vaccine or to gelatin or the antibiotic neomycin. People who are moderately or severely ill at the time the shot is scheduled should usually wait until they recover before getting chickenpox vaccine. Pregnant women should wait to get chickenpox vaccine until after they have given birth. Women should not get pregnant for 1 month after getting chickenpox vaccine. Some people should check with their doctor about whether they should get chickenpox vaccine, including anyone who: - Has HIV/AIDS or another disease that affects the immune system - Is being treated with drugs that affect the immune system, such as steroids, for 2 weeks or longer - Has any kind of cancer - Is getting cancer treatment with radiation or drugs People who recently had a transfusion or were given other blood products should ask their doctor when they may get chickenpox vaccine. Ask your provider for more information. 110

112 4 What are the risks from chickenpox vaccine? A vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of chickenpox vaccine causing serious harm, or death, is extremely small. Getting chickenpox vaccine is much safer than getting chickenpox disease. Most people who get chickenpox vaccine do not have any problems with it. Reactions are usually more likely after the first dose than after the second. Mild Problems Soreness or swelling where the shot was given (about 1 out of 5 children and up to 1 out of 3 adolescents and adults) Fever (1 person out of 10, or less) Mild rash, up to a month after vaccination (1 person out of 25). It is possible for these people to infect other members of their household, but this is extremely rare. Moderate Problems Seizure (jerking or staring) caused by fever (very rare). Severe Problems Pneumonia (very rare) Other serious problems, including severe brain reactions and low blood count, have been reported after chickenpox vaccination. These happen so rarely experts cannot tell whether they are caused by the vaccine or not. If they are, it is extremely rare. 5 Note: The first dose of MMRV vaccine has been associated with rash and higher rates of fever than MMR and varicella vaccines given separately. Rash has been reported in about 1 person in 20 and fever in about 1 person in 5. Seizures caused by a fever are also reported more often after MMRV. These usually occur 5-12 days after the first dose. What if there is a moderate or severe reaction? What should I look for? Any unusual condition, such as a high fever, weakness, or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. 6 The National Vaccine Injury Compensation Program A federal program has been created to help people who may have been harmed by a vaccine. For details about the National Vaccine Injury Compensation Program, call or visit their website at 7 How can I learn more? Ask your provider. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) - Visit CDC website at: department of health and human services Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Varicella Vaccine (3/13/08) 42 U.S.C. 300aa

113 VACunA COnTRA LA VARICELA L O Q U E U S T E D N E C E S I TA S A B E R 1 2 Muchas de las hojas informativas sobre vacunas están disponibles en español y en otros idiomas. Ver Por qué vacunarse? La varicela es una enfermedad común de la niñez. Por lo general es leve, pero puede ser seria, especialmente en bebes pequeños y en adultos. Causa sarpullido, picazón, fiebre y cansancio. Puede conducir a infecciones serias de la piel, cicatrices, neumonía, daño cerebral o la muerte. El virus de la varicela se puede transmitir de una persona a otra por el aire o por contacto con el líquido de las ampollas de la varicela. Años después, a una persona que tuvo varicela le puede dar un sarpullido doloroso llamado culebrilla. Antes de la vacuna, en Estados Unidos cada año unas 11,000 personas eran hospitalizadas por varicela. Antes de la vacuna, en Estados Unidos cada año unas 10 personas morían debido a la varicela. La vacuna contra la varicela puede prevenir la varicela. A la mayoría de las personas vacunadas contra la varicela no les da varicela. Pero si alguien vacunado se enferma de varicela, por lo general es muy leve. Tendrá menos ampollas, será menos propenso a tener fiebre y se recuperará más pronto. Quiénes deben vacunarse contra la varicela y cuándo? Rutina Los niños que nunca tuvieron varicela deben recibir 2 dosis de la vacuna contra la varicela a las siguientes edades: 1a dosis: 12 a 15 meses de edad 2a dosis: 4 a 6 años de edad (se puede dar antes, pero tiene que ser al menos 3 meses después de la la dosis) Las personas de 13 años de edad o mayores (que nunca tuvieron varicela ni se vacunaron contra la varicela) deben recibir dos dosis, la segunda al menos 28 días después de la primera. Vacuna para ponerse al día Cualquier persona que no esté completamente vacunada y que nunca tuvo varicela, debe recibir una o dos dosis de la Chickenpox - Spanish 3/13/08 vacuna contra la varicela. La edad de la persona determina cuando se dan estas dosis. Consulte con su profesional de la salud. La vacuna contra la varicela se puede dar al mismo tiempo que otras vacunas. Nota: Una vacuna combinada llamada MMRV, la cual contiene tanto la vacuna contra la varicela como la vacuna contra el sarampión, las paperas y la rubéola (MMR), puede ser administrada en lugar de dos vacunas individuales para las personas de 12 años de edad o menos. 3 Algunas personas no deben vacunarse contra la varicela o deben esperar No debe vacunarse contra la varicela nadie que haya tenido una reacción alérgica a la gelatina, al antibiótico neomicina o a una dosis anterior de la vacuna contra la varicela, que amenazó su vida. Las personas que tengan enfermedades moderadas o graves en el día de la vacuna por lo general deben esperar hasta recuperarse antes de vacunarse contra la varicela. Las mujeres embarazadas deben esperar hasta después de haber dado a luz para vacunarse contra la varicela. Las mujeres no deben quedar embarazadas por 1 mes después de haberse vacunado contra la varicela. Algunas personas deben consultar con su médico sobre si se deben vacunar contra la varicela, incluyendo a las personas que: - tienen VIH/SIDA o alguna otra enfermedad que afecte el sistema inmunológico - están en tratamiento con medicamentos que afectan el sistema inmunológico, como esteroides, por 2 semanas o mas - tienen cualquier tipo de cáncer - están en tratamiento de cáncer con radiación o medicamentos Las personas que hace poco tuvieron una transfusión de sangre o recibieron otros productos de la sangre deben preguntar a su médico cuando se pueden vacunar contra la varicela. Pida más información a su médico o enfermera. 112

114 4 Cuales son los riesgos de la vacuna contra la varicela? Vacunarse contra la varicela es mucho menos peligroso que tener la enfermedad. La mayoría de las personas que se vacunan contra la varicela no tienen ningún problema con la vacuna. Sin embargo, las vacunas, como cualquier medicamento, pueden causar problemas serios, como reacciones alergicas graves. El riesgo de que la vacuna contra la varicela cause un daño serio, o la muerte, es sumamente pequeño. Problemas leves Dolor o hinchazón en el lugar donde se aplico la inyección (cerca de 1 de cada 5 niños y hasta 1 de cada 3 adolescentes y adultos) Fiebre (1 persona de cada 10, 6 menos) Un sarpullido leve hasta un mes despues de la vacuna (1 persona de cada 20, 6 menos). Es posible que estas personas infecten a otras personas que viven con ellas, pero esto ocurre muy rara vez. Problemas moderados Convulsiones (ataques de sacudidas del cuerpo y fijación de la mirada) causadas por fiebre (menos de 1 persona de cada 1,000). Problemas graves Neumonía (ocurre muy rara vez) Después de la aplicación de la vacuna contra la varicela se han informado otros problemas serios, incluyendo reacciones cerebrales graves y bajo recuento sanguíneo. Estos problemas ocurren tan rara vez que los expertos no pueden decir si fueron causados o no por la vacuna. Si son causados por ella, es algo que ocurre muy rara vez. Nota: La primera dosis de la vacuna MMRV se ha relacionado con sarpullido e índices más elevados de fiebre que las vacunas contra MMR y contra la varicela administradas por separado. Se ha reportado sarpullido en alrededor de 1 persona de cada 20 y fiebre en alrededor de 1 persona de cada 5. Las convulsiones causadas por fiebre también se reportan más frecuentemente después de recibir la vacuna MMRV. Por lo general, esto ocurre entre los 5 y 12 días después de la primera dosis. 5 Qué pasa si hay una reacción moderada o grave? A qué debo prestar atención? Preste atención a cualquier cosa fuera de lo común, como fiebre alta o cambios en el comportamiento. Los signos de reacción alérgica seria pueden incluir dificultad para respirar, ronquera o sibilancias, urticaria, palidez, debilidad, latidos rápidos del corazón o mareos. Qué debo hacer? Llame a un médico o lleve a la persona inmediatamente a un medico. Diga al médico lo que ocurrió, la fecha y la hora en que ocurrió y cuando recibió la vacuna. Pida a su médico, enfermera o departamento de salud que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (VAERS). O puede presentar este informe mediante el sitio web de VAERS, en o llamando al VAERS no proporciona consejos médicos. 6 El Programa Nacional de Compensación por Lesiones Causadas por las Vacunas Se creó un programa federal para ayudar a las personas que hayan podido ser lesionadas por una vacuna. Para detalles sobre el Programa Nacional de Compensación por Lesiones Causadas por las Vacunas, llame al ó visite su sitio web, en 7 Cómo puedo obtener más información? Consulte con su médico o enfermera. Le pueden dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al (1-800-CDC-INFO) - Visite el sitio web de los CDC, en: DEPARTMENT OF HEALT-H AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION Vaccine Information Statement (Interim) Varicella Vaccine (3/13/08) Spanish 42 U.S.C. 300aa-26 Translation provided the Department of Human Services, Oregon Immunization Program. 113

115 HPV(HUMAN PAPILLOMAVIRUS)VACCINE Cervarix W H A T Y O U N E E D T O K N O W Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 What is HPV? Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States. More than half of sexually active men and women are infected with HPV at some time in their lives. About 20 million Americans are currently infected, and about 6 million more get infected each year. HPV is usually spread through sexual contact. Most HPV infections don t cause any symptoms, and go away on their own. But HPV can cause cervical cancer in women. Cervical cancer is the 2nd leading cause of cancer deaths among women around the world. In the United States, about 10,000 women get cervical cancer every year and about 4,000 are expected to die from it. HPV is also associated with several less common cancers, such as vaginal and vulvar cancers in women and other types of cancer in both men and women. It can also cause genital warts and warts in the throat. There is no cure for HPV infection, but some of the problems it causes can be treated. HPV vaccine - Why get 2 vaccinated? HPV vaccine is important because it can prevent most cases of cervical cancer in females, if it is given before a person is exposed to the virus. Protection from HPV vaccine is expected to be longlasting. But vaccination is not a substitute for cervical cancer screening. Women should still get regular Pap tests. The vaccine you are getting is one of two HPV vaccines that can be given to prevent cervical cancer. It is given to females only. The other vaccine may be given to both males and females. It can also prevent most genital warts. It has also been shown to prevent some vaginal, vulvar and anal cancers. 3 Who should get this HPV vaccine and when? Routine Vaccination HPV vaccine is recommended for girls 11 or 12 years of age. It may be given to girls starting at age 9. Why is HPV vaccine given to girls at this age? It is important for girls to get HPV vaccine before their first sexual contact because they won t have been exposed to human papillomavirus. Once a girl or woman has been infected with the virus, the vaccine might not work as well or might not work at all. Catch-Up Vaccination The vaccine is also recommended for girls and women 13 through 26 years of age who did not get all 3 doses when they were younger. HPV vaccine is given as a 3-dose series 1st Dose Now 2nd Dose 1 to 2 months after Dose 1 3rd Dose 6 months after Dose 1 Additional (booster) doses are not recommended. HPV vaccine may be given at the same time as other vaccines. Some people should not get HPV 4 vaccine or should wait Anyone who has ever had a life-threatening allergic reaction to any component of HPV vaccine, or to a previous dose of HPV vaccine, should not get the vaccine. Tell your doctor if the person getting vaccinated has any severe allergies, including an allergy to latex. HPV vaccine is not recommended for pregnant women. However, receiving HPV vaccine when pregnant is not a reason to consider terminating the pregnancy. Women who are breast feeding may get the vaccine. 114

116 Any woman who learns she was pregnant when she got this HPV vaccine is encouraged to contact the manufacturer s HPV in pregnancy registry at This will help us learn how pregnant women respond to the vaccine. People who are mildly ill when a dose of HPV vaccine is planned can still be vaccinated. People with a moderate or severe illness should wait until they are better. 5 What are the risks from this vaccine? This HPV vaccine has been in use around the world for several years and has been very safe. However, any medicine could possibly cause a serious problem, such as a severe allergic reaction. The risk of any vaccine causing a serious injury, or death, is extremely small. Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination. Several mild to moderate problems are known to occur with HPV vaccine. These do not last long and go away on their own. Reactions where the shot was given: - Pain (about 9 people in 10) - Redness or swelling (about 1 person in 2) Other mild reactions: - Fever of 99.5 F or higher (about 1 person in 8) - Headache or fatigue (about 1 person in 2) - Nausea, vomiting, diarrhea, or abdominal pain (about 1 person in 4) - Muscle or joint pain (up to 1 person in 2) Fainting: Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. Tell your doctor if the patient feels dizzy or light-headed, or has vision changes or ringing in the ears. Like all vaccines, HPV vaccines will continue to be monitored for unusual or severe problems. 6 What if there is a severe reaction? What should I look for? Serious allergic reactions including rash; swelling of the hands and feet, face, or lips; and breathing difficulty. What should I do? Call a doctor, or get the person to a doctor right away. Tell the doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. The National Vaccine Injury 7 Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Ask your doctor. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at and DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Human Papillomavirus (HPV) Cervarix 5/3/

117 CONTRA EL VPH VACUNA(VIRUS DEL PAPILOMA HUMANO) Cervarix LO QUE USTED NECESITA SABER 1 Las hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite Qué es el VPH? El virus del papiloma humano (VPH) genital es el virus de transmisión sexual más común en los Estados Unidos. Más de la mitad de los hombres y mujeres sexualmente activos están infectados con VPH en algún momento de sus vidas. Alrededor de 20 millones de estadounidenses están infectados actualmente, y alrededor de 6 millones más se infectan cada año. El VPH se contagia generalmente por contacto sexual. La mayoría de las infecciones por el VPH no producen ningún síntoma, y desaparecen solas. Pero el VPH puede provocar cáncer de cuello uterino en las mujeres. El cáncer de cuello uterino es la segunda causa principal de muerte por cáncer en las mujeres de todo el mundo. Cada año, en los Estados Unidos, alrededor de 10,000 mujeres contraen cáncer de cuello uterino y se prevé que alrededor de 4000 morirán por esta causa. El VPH también está relacionado con varios tipos de cáncer menos comunes, como el cáncer vaginal y vulvar en las mujeres y otros tipos de cáncer tanto en hombres como en mujeres. También puede provocar verrugas genitales y verrugas en la garganta. No existe cura para la infección por el VPH, pero algunos de los problemas que provoca pueden tratarse. 3 Quién debería recibir esta vacuna contra el VPH y cuándo? Vacunación de rutina Se recomienda la vacuna contra el VPH para las niñas de 11 ó 12 años. Puede aplicarse a las niñas a partir de los 9 años. Por qué se aplica la vacuna contra el VPH a las niñas a esta edad? Es importante que las niñas reciban la vacuna contra el VPH antes de su primer contacto sexual, porque no habrán estado expuestas al virus del papiloma humano. Una vez que una niña o mujer se ha infectado con el virus, es posible que la vacuna no funcione tan bien o que no funcione en absoluto. Vacunación de actualización La vacuna también se recomienda para niñas y mujeres de entre 13 y 26 años que no recibieron las 3 dosis anteriormente. La vacuna contra el VPH se administra en una serie de 3 dosis 1. a dosis Ahora 2. a dosis De 1 a 2 meses después de la Dosis 1 3. a dosis 6 meses después de la Dosis 1 2 Vacuna contra el VPH: Por qué vacunarse? La vacuna contra el VPH es importante porque puede prevenir la mayoría de los casos de cáncer de cuello uterino en mujeres si se administra antes de que una persona se exponga al virus. Se estima que la protección que ofrece la vacuna contra el VPH es duradera. Sin embargo, la vacunación contra el VPH no sustituye al análisis de detección del cáncer de cuello uterino. De todos modos, las mujeres deberían realizarse las pruebas de Papanicolaou con regularidad. La vacuna que está recibiendo es una de las dos vacunas contra el VPH que pueden administrarse para prevenir el cáncer de cuello uterino. Se administra a mujeres solamente. La otra vacuna puede administrarse tanto a hombres como a mujeres. También puede prevenir la mayoría de las verrugas genitales. Se ha observado que también previene algunos tipos de cáncer vaginal, vulvar y anal. HPV (Cervarix) VIS - Spanish (5/3/11) No se recomiendan dosis adicionales (de refuerzo). La vacuna contra el VPH puede aplicarse simultáneamente con otras vacunas. 4 Algunas personas no deben aplicarse la vacuna contra el VPH o deben esperar para hacerlo Cualquier persona que haya tenido una reacción alérgica a algún componente de la vacuna contra el VPH o a una dosis anterior de la vacuna contra el VPH que haya puesto en riesgo su vida no deberá vacunarse. Informe a su médico si la persona que recibe la vacuna tiene alguna alergia severa, incluida una alergia al látex. No se recomienda la vacuna contra el VPH para las mujeres embarazadas. Sin embargo, la administración de la vacuna contra el VPH durante el embarazo no es un motivo para considerar la interrupción del embarazo. Las mujeres que están amamantando pueden recibir la vacuna. 116

118 Se recomienda que cualquier mujer que se entere de que estaba embarazada cuando recibió la vacuna contra el VPH se comunique con el registro de VPH en el embarazo del fabricante al Esto nos ayudará a saber cómo responden las mujeres embarazadas a la vacuna. Las personas que están levemente enfermas cuando se planea aplicar una dosis de la vacuna contra el VPH pueden recibir la vacuna de todos modos. Las personas con una enfermedad moderada o severa deben esperar hasta que se sientan mejor. 5 Cuáles son los riesgos de esta vacuna? La vacuna contra el VPH se ha utilizado en todo el mundo durante varios años y su uso ha sido muy seguro. Sin embargo, cualquier medicamento puede provocar un problema grave, como una reacción alérgica severa. El riesgo de que una vacuna provoque una lesión grave o la muerte es muy poco. Son muy poco frecuentes las reacciones alérgicas a las vacunas que ponen en riesgo la vida. En caso de que ocurran dichas reacciones, ocurrirían en el término de unos pocos minutos a unas pocas horas luego de la vacunación. Se sabe que ocurren varios problemas de leves a moderados con la vacuna contra el VPH. Estos no duran mucho y desaparecen solos. Reacciones en el lugar en que se aplicó la inyección: - Dolor (en alrededor de 9 de cada 10 personas) - Enrojecimiento o hinchazón (en alrededor de 1 de cada 2 personas) Otras reacciones leves: - Fiebre de 99.5 F o más alta (en alrededor de 1 de cada 8 personas) - Dolor de cabeza o fatiga (en alrededor de 1 de cada 2 personas) - Náuseas, vómitos, diarrea o dolor abdominal (en alrededor de 1 de cada 4 personas) - Dolor muscular o articular (hasta en 1 de cada 2 personas) Desmayos: Pueden ocurrir breves episodios de desmayos y síntomas relacionados (tales como sacudidas) luego de cualquier procedimiento médico, incluida la vacunación. Sentarse o acostarse durante unos 15 minutos luego de una vacunación puede ayudar a prevenir desmayos y lesiones provocadas por las caídas. Avise a su médico si el paciente se siente mareado o aturdido o tiene cambios en la visión, o zumbidos en los oídos. Como sucede con todas las vacunas, se seguirán controlando las vacunas contra el VPH para detectar problemas inusuales o severos. 6 Qué hago si ocurre una reacción severa? De qué debo estar pendiente? De reacciones alérgicas graves, incluidas la erupción; la hinchazón de las manos y los pies, la cara o los labios; y dificultades para respirar. Qué debo hacer? Llame a un médico o lleve a la persona al médico de inmediato. Dígale al médico lo que ocurrió, la fecha y la hora en la que ocurrió, y cuándo le aplicaron la vacuna. Pida al médico que informe la reacción presentando un formulario del Sistema de notificación de eventos adversos derivados de las vacunas (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este informe a través del sitio web de VAERS en o llamando al El VAERS no ofrece consejos médicos. 7 8 Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas En 1986 se creó el Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas (Vaccine Injury Compensation Program, VICP). Las personas que consideren que pueden haber sufrido lesiones ocasionadas por una vacuna pueden informarse sobre el programa y sobre cómo presentar una reclamación llamando al o visitando el sitio web del VICP en: Cómo puedo informarme más? Pregúntele a su médico. El médico puede darle el prospecto de la vacuna o sugerirle otras fuentes de información. Llame a su departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al (1-800-CDC-INFO) o - Visite el sitio web de los CDC en y DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement (Interim) Human Papillomavirus (HPV) Cervarix 5/3/2011 Spanish Translation provided by the Immunization Action Coalition 117

119 HPV (Human Papillomavirus) What You Need to Know VACCINE INFORMATION STATEMENT Vaccine Gardasil Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 What is HPV? Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States. More than half of sexually active men and women are infected with HPV at some time in their lives. About 20 million Americans are currently infected, and about 6 million more get infected each year. HPV is usually spread through sexual contact. Most HPV infections don t cause any symptoms, and go away on their own. But HPV can cause cervical cancer in women. Cervical cancer is the 2nd leading cause of cancer deaths among women around the world. In the United States, about 12,000 women get cervical cancer every year and about 4,000 are expected to die from it. HPV is also associated with several less common cancers, such as vaginal and vulvar cancers in women, and anal and oropharyngeal (back of the throat, including base of tongue and tonsils) cancers in both men and women. HPV can also cause genital warts and warts in the throat. There is no cure for HPV infection, but some of the problems it causes can be treated. 2 HPV vaccine: Why get vaccinated? The HPV vaccine you are getting is one of two vaccines that can be given to prevent HPV. It may be given to both males and females. This vaccine can prevent most cases of cervical cancer in females, if it is given before exposure to the virus. In addition, it can prevent vaginal and vulvar cancer in females, and genital warts and anal cancer in both males and females. Protection from HPV vaccine is expected to be long-lasting. But vaccination is not a substitute for cervical cancer screening. Women should still get regular Pap tests. 3 Who should get this HPV vaccine and when? HPV vaccine is given as a 3-dose series 1st Dose Now 2nd Dose 1 to 2 months after Dose 1 3rd Dose 6 months after Dose 1 Additional (booster) doses are not recommended. Routine Vaccination This HPV vaccine is recommended for girls and boys 11 or 12 years of age. It may be given starting at age 9. Why is HPV vaccine recommended at 11 or 12 years of age? HPV infection is easily acquired, even with only one sex partner. That is why it is important to get HPV vaccine before any sexual contact takes place. Also, response to the vaccine is better at this age than at older ages. Catch-Up Vaccination This vaccine is recommended for the following people who have not completed the 3-dose series: Females 13 through 26 years of age. Males 13 through 21 years of age. This vaccine may be given to men 22 through 26 years of age who have not completed the 3-dose series. It is recommended for men through age 26 who have sex with men or whose immune system is weakened because of HIV infection, other illness, or medications. HPV vaccine may be given at the same time as other vaccines. 118

120 4 Some people should not get HPV vaccine or should wait. Anyone who has ever had a life-threatening allergic reaction to any component of HPV vaccine, or to a previous dose of HPV vaccine, should not get the vaccine. Tell your doctor if the person getting vaccinated has any severe allergies, including an allergy to yeast. HPV vaccine is not recommended for pregnant women. However, receiving HPV vaccine when pregnant is not a reason to consider terminating the pregnancy. Women who are breast feeding may get the vaccine. Any woman who learns she was pregnant when she got this HPV vaccine is encouraged to contact the manufacturer s HPV-in-pregnancy registry at This will help us learn more about how pregnant women respond to the vaccine. People who are mildly ill when a dose of HPV vaccine is planned can still be vaccinated. People with a moderate or severe illness should wait until they are better. 5 What are the risks from this vaccine? This HPV vaccine has been used in the U.S. and around the world for about six years and has been very safe. However, any medicine could possibly cause a serious problem, such as a severe allergic reaction. The risk of any vaccine causing a serious injury, or death, is extremely small. Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination. Several mild to moderate problems are known to occur with this HPV vaccine. These do not last long and go away on their own. Reactions in the arm where the shot was given: - Pain (about 8 people in 10) - Redness or swelling (about 1 person in 4) Fever: - Mild (100 F) (about 1 person in 10) - Moderate (102 F) (about 1 person in 65) Other problems: - Headache (about 1 person in 3) Fainting: Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. Tell your doctor if the patient feels dizzy or lightheaded, or has vision changes or ringing in the ears. Like all vaccines, HPV vaccines will continue to be monitored for unusual or severe problems. 6 What if there is a moderate or severe reaction? What should I look for? Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at or by calling VAERS does not provide medical advice. 7 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Ask your doctor. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) HPV Vaccine (Gardasil) Office Use Only 2/22/ U.S.C. 300aa

121 Vacuna contra el VPH Gardasil Lo que usted necesita saber 1 Qué es el VPH? El virus del papiloma humano (VPH) genital es el virus de transmisión sexual más común en los Estados Unidos. Más de la mitad de los hombres y las mujeres sexualmente activos contraerán la infección del VPH en algún momento de sus vidas. Alrededor de 20 millones de estadounidenses están infectados en la actualidad y aproximadamente 6 millones más contraen la infección cada año. El VPH generalmente se transmite a través de contacto sexual. La mayoría de las infecciones por VPH no presentan síntomas y desaparecen por sí solas. Pero el VPH puede causar cáncer cervical en mujeres. El cáncer cervical es la segunda causa de muerte por cáncer entre las mujeres alrededor del mundo. En los Estados Unidos, aproximadamente 12,000 mujeres son diagnosticadas con cáncer cervical cada año y se estima que alrededor de 4,000 morirán a causa de esta enfermedad. El VPH también está asociado con muchos cánceres menos comunes, como cáncer vaginal y cáncer vulvar en mujeres, y cáncer anal y cáncer orofaríngeo (parte posterior de la garganta, incluyendo la base de la lengua y las amígdalas) tanto en hombres como en mujeres. El VPH también puede causar verrugas genitales y en la garganta. No existe una cura para la infección por VPH, pero algunos de los problemas que causa pueden ser tratados. Vacuna contra el VPH: Por 2 qué es necesario vacunarse? La vacuna contra el VPH que usted recibirá es una de las dos vacunas que pueden administrarse para prevenir el VPH. Puede adminsitrarse tanto a hombres como a mujeres. Esta vacuna también puede prevenir la mayoría de las causas de cáncer cervical en mujeres, si se aplica antes de la exposición al virus. Además, puede prevenir el cáncer vaginal y vulvar en mujeres, así como las verrugas genitales y el cáncer anal tanto en hombres como en mujeres. Se prevé que la protección de la vacuna contra el VPH sea de larga duración. Pero la vacunación no es un sustituto de los estudios de detección de cáncer cervical. Las mujeres deberían seguir haciéndose exámenes de Papanicolau de rutina. HPV (Gardasil) VIS - Spanish (2/22/12) DECLARACIÓN DE INFORMACIÓN SOBRE VACUNAS (Virus del Papiloma Humano) Muchas de las declaraciones informativas sobre vacunas están disponibles en español y otros idiomas. Consulte Las hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite 3 Quién debería vacunarse contra el VPH y cuándo? La vacuna contra el VPH se aplica como una serie de 3 dosis 1ª dosis Ahora 2ª dosis 1 o 2 meses después de la Dosis 1 3ª dosis 6 meses después de la Dosis 1 No se recomiendan dosis adicionales (refuerzos). Aplicación rutinaria de la vacuna Esta vacuna contra el VPH se recomienda para niñas y niños de 11 o 12 años de edad. Puede aplicarse desde los 9 años de edad. Por qué se recomienda la vacuna contra el VPH a los 11 o 12 años de edad La infección por VPH es muy fácil de contraer, incluso con una sola pareja sexual. Por eso es importante recibir la vacuna contra el VPH antes de llevar a cabo cualquier contacto sexual. Además, la respuesta a la vacuna es mejor a esta edad que a una edad mayor. Vacuna de actualización Esta vacuna se recomienda para las siguientes personas que no completaron la serie de 3 dosis: Mujeres de 13 a 26 años de edad. Hombres de 13 a 21 años de edad. Esta vacuna se puede aplicar a hombres de 22 a 26 años de edad que no han completado la serie de 3 dosis. Se recomienda para hombres de hasta 26 años que tengan relaciones sexuales con hombres o cuyos sistemas inmunitarios estén debilitados a causa de una infección por VIH, otra enfermedad o medicamentos. La vacuna contra el VPH puede administrarse al mismo tiempo que otras vacunas. 120

122 4 Algunas personas no deben recibir la vacuna contra el VPH o deben esperar. Cualquier persona que haya tenido una reacción alérgica a cualquiera de los componentes de la vacuna VPH, que haya puesto en riesgo su vida, o a una dosis previa de la vacuna contra el VPH, no debe recibir la vacuna. Informe a su médico si la persona que recibe la vacuna tiene alguna alergia severa, incluyendo una alergia a la levadura. No se recomienda administrar la vacuna contra el VPH a mujeres embarazadas. Sin embargo, recibir la vacuna contra el VPH en el embarazo no es una razón para considerar la interrupción del embarazo. Las mujeres que estén amamantando pueden recibir la vacuna. Cualquier mujer que sepa que está embarazada cuando reciba esta vacuna contra el VPH es alentada a comunicarse al registro de VPH en el embarazo del fabricante llamando al Esto nos ayudará a saber más acerca de cómo responden las mujeres embarazadas a la vacuna. Las personas que estén ligeramente enfermas cuando se planee que reciban una dosis de la vacuna contra el VPH pueden vacunarse de todas formas. Las personas con una enfermedad moderada o grave deben esperar hasta sentirse mejor. Cuáles son los riesgos de 5 esta vacuna? Esta vacuna contra el VPH se ha utilizado en los EE. UU. y alrededor del mundo desde hace aproximadamente seis años y ha sido muy segura. Sin embargo, cualquier medicina puede causar un problema serio, como una reacción alérgica severa. El riesgo de cualquier vacuna de ocasionar una lesión grave, o la muerte, es extremadamente pequeño. Las reacciones alérgicas a las vacunas que pueden poner en riesgo la vida son muy poco frecuentes. Si se presentan, será en pocos minutos hasta pocas horas después de la vacuna. Se sabe que muchos problemas leves a moderados ocurren con esta vacuna contra el VPH. Estos problemas no duran mucho y desaparecen por sí solos. Reacciones en el brazo en donde se aplicó la inyección: - Dolor (aproximadamente 8 de cada 10 personas) - Enrojecimiento o hinchazón (aproximadamente 1 de cada 4 personas) Fiebre: - Leve (37.7 C o 100 F) (aproximadamente 1 de cada 10 personas) - Moderada (38.8 C o 102 F) (aproximadamente 1 de cada 65 personas) Otros problemas: - Dolor de cabeza (aproximadamente 1 de cada 3 personas) Desmayos: Después de cualquier procedimiento médico, incluyendo la vacunación, se pueden presentar desmayos y síntomas relacionados (como movimientos espasmódicos repentinos). Sentarse o acostarse durante unos 15 minutos después de recibir una vacuna puede ayudar a evitar desmayos y lesiones causadas por caídas. Informe a su médico si el paciente se siente mareado o aturdido, o si tiene cambios en la visión o zumbido en los oídos. Al igual que con todas las vacunas, las vacunas contra el VPH continuarán siendo monitoreadas en busca de problemas severos o poco frecuentes. 6 7 Qué hacer en caso de una reacción moderada o severa? De qué debo estar pendiente? De todo signo inusual, como fiebre alta o comportamiento inusual. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o jadeos, urticaria, palidez, debilidad, pulso acelerado o mareos. Qué debo hacer? Llame a un médico o lleve a la persona al médico de inmediato. Dígale al médico lo que ocurrió, la fecha y la hora en la que ocurrió, y cuándo le pusieron la vacuna. Pida al médico, al personal de enfermería o al departamento de salud que reporten la reacción presentando un formulario del Sistema de reporte de eventos adversos derivados de las vacunas (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este reporte a través del sitio web de VAERS: o llamando al El VAERS no ofrece consejos médicos. Programa Nacional de Compensación por Lesiones ocasionadas por Vacunas En 1986 se creó el Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas (National Vaccine Injury Compensation Program, VICP). Las personas que consideren que pueden haber tenido lesiones ocasionadas por una vacuna pueden informarse sobre el programa y sobre cómo presentar una reclamación llamando al o visitando el sitio web del VICP en: 8 Dónde puedo obtener más información? Pregúntele a su médico. El médico puededarle el prospecto de la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al (1-800-CDC-INFO) o - Visite el sitio web de los CDC en Vaccine Information Statement (Interim) HPV Vaccine (Gardasil) 2/22/2012 Spanish 42 U.S.C. 300aa-26 Translation provided by the Immunization Action 121 Coalition

123 Policy Number: 6fviii SHINGLES VACCINE W H A T Y O U N E E D T O K N O W Many Vaccine Information Statements are available in Spanish and other languages. See 1 What is shingles? Shingles is a painful skin rash, often with blisters. It is also called Herpes Zoster, or just Zoster. A shingles rash usually appears on one side of the face or body and lasts from 2 to 4 weeks. Its main symptom is pain, which can be quite severe. Other symptoms of shingles can include fever, headache, chills and upset stomach. Very rarely, a shingles infection can lead to pneumonia, hearing problems, blindness, brain inflammation (encephalitis) or death. Shingles is far more common in people 50 years of age and older than in younger people. It is also more common in people whose immune systems are weakened because of a disease such as cancer, or drugs such as steroids or chemotherapy. At least 1 million people a year in the United States get shingles. 2 Shingles vaccine A vaccine for shingles was licensed in In clinical trials, the vaccine reduced the risk of shingles by 50%. It can also reduce pain in people who still get shingles after being vaccinated. A single dose of shingles vaccine is recommended for adults 60 years of age and older. Some people should not get For about 1 person in 5, shingles vaccine or should wait severe pain can continue even long after the rash A person should not get shingles vaccine clears up. This is called who: post-herpetic neuralgia. has ever had a life-threatening allergic reaction to gelatin, the antibiotic Shingles is caused by the Varicella Zoster neomycin, or any other component of virus, the same virus that causes chickenpox. shingles vaccine. Tell your doctor if you Only someone who has had chickenpox or, have any severe allergies. rarely, has gotten chickenpox vaccine can has a weakened immune system because get shingles. The virus stays in your body, of current: and can cause shingles many years later. - AIDS or another disease that affects You can t catch shingles from another the immune system, person with shingles. However, a person - treatment with drugs that affect the who has never had chickenpox (or chicken immune system, such as prolonged use pox vaccine) could get chickenpox from of high-dose steroids, someone with shingles. This is not very - cancer treatment such as radiation or common. chemotherapy, 3 122

124 - cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma. is pregnant, or might be pregnant. Women should not become pregnant until at least 4 weeks after getting shingles vaccine. Someone with a minor acute illness, such as a cold, may be vaccinated. But anyone with a moderate or severe acute illness should usually wait until they recover before getting the vaccine. This includes anyone with a temperature of F or higher. 4 What are the risks from shingles vaccine? A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. However, the risk of a vaccine causing serious harm, or death, is extremely small. No serious problems have been identified with shingles vaccine. Mild Problems Redness, soreness, swelling, or itching at the site of the injection (about 1 person in 3). Headache (about 1 person in 70). Like all vaccines, shingles vaccine is being closely monitored for unusual or severe problems. include difficulty breathing, weakness, hoarseness or wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of the throat. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. 6 How can I learn more? Ask your doctor or other health care provider. They can give you the vaccine package insert or suggest other sources of information. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) - Visit the CDC s website at 5 What if there is a moderate or severe reaction? What should I look for? Any unusual condition, such as a severe allergic reaction or a high fever. If a severe allergic reaction occurred, it would be within a few minutes to an hour after the shot. Signs of a serious allergic reaction can U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Shingles Vaccine Information Statement 10/6/

125 VACUNA CONTRA LA CULEBRILLA L O Q U E U S T E D N E C E S I T A S A B E R Muchas Hojas de Información sobre Vacunas están disponibles en español y en otros idiomas. Visite 1 Qué es la culebrilla? La culebrilla consiste de erupciones dolorosas en la piel, a menudo con ampollas. También se llama herpes zóster o simplemente zóster. Las erupciones en la piel a causa de la culebrilla por lo general aparecen en un lado de la cara o del cuerpo y duran entre 2 y 4 semanas. Su síntoma principal es dolor, que puede ser bastante grave. Otros síntomas de la culebrilla pueden ser fiebre, dolor de cabeza, escalofríos y malestar estomacal. En muy raras ocasiones una infección de culebrilla puede causar neumonía, problemas de audición, ceguera, inflamación del cerebro (encefalitis) o la muerte. Casi 1 de cada 5 personas puede persistir un dolor grave incluso mucho después de que desaparecen las erupciones en la piel. Esto se llama neuralgia posherpética. La culebrilla es causada por el virus varicela zóster, el mismo que causa la varicela. Sólo alguien que tuvo varicela o en ocasiones poco comunes, alguien que se vacunó contra la varicela puede contraer culebrilla. El virus permanece en el cuerpo y puede causar culebrilla muchos años después. No se puede contagiar la culebrilla de una persona a otra. Sin embargo, una persona que nunca tuvo varicela (o que nunca se vacunó contra la varicela) puede contraer varicela de alguien con culebrilla. Esto no es muy común. La culebrilla es más común en las personas de 50 años o más que en las personas más jóvenes. También es más común en las personas con sistemas inmunológicos debilitados por una enfermedad, como el cáncer, o por medicamentos, como los esteroides o la quimioterapia. Todos los años, al menos 1 millón de personas contraen culebrilla en los Estados Unidos. 2 La vacuna contra la culebrilla Una vacuna contra la culebrilla fue autorizada en el En ensayos clínicos la vacuna redujo el riesgo de contraer culebrilla por un 50%. También puede reducir el dolor en las personas que contraen culebrilla incluso después de haberse vacunado. Se recomienda una sola dosis de la vacuna contra la culebrilla para los adultos de 60 años de edad y mayores. 3 Algunas personas no deben vacunarse contra la culebrilla o deben esperar Una persona no debe vacunarse contra la culebrilla si: tuvo alguna vez una reacción alérgica a la gelatina, al antibiótico neomicina o a cualquier otro componente de la vacuna contra la culebrilla que puso en peligro su vida. Diga a su doctor si tiene alergias graves. tiene el sistema inmunológico debilitado a causa de que en la actualidad tiene: - SIDA o alguna otra enfermedad que afecte el sistema inmunológico, - un tratamiento con medicamentos que afectan el sistema inmunológico, como el uso prolongado de dosis altas de esteroides, - un tratamiento del cáncer, como radiación o quimioterapia, Shingles - Spanish (10/6/09) 124

126 - cáncer que afecta la médula ósea o el sistema linfático, como la leucemia o linfoma. está o puede estar embarazada. Las mujeres no deben quedar embarazadas hasta al menos 4 semanas después de haberse vacunado contra la culebrilla. Alguien con una enfermedad aguda menor, como un resfriado, se puede vacunar. Pero las personas con enfermedades agudas moderadas o graves por lo general deben esperar hasta recuperarse para aplicarse la vacuna. Esto incluye a todos los que tengan una temperatura de F o más. 4 Cuáles son los riesgos de la vacuna contra la culebrilla? Las vacunas, como cualquier medicamento, pueden causar problemas serios, como reacciones alérgicas graves. Sin embargo, el riesgo de que una vacuna cause un daño serio, o la muerte, es sumamente mínimo. No se han identificado problemas serios con la vacuna contra la culebrilla. Problemas leves Enrojecimiento, dolor, hinchazón o picazón en el lugar donde se aplicó la inyección (cerca de 1 persona de cada 3). Dolor de cabeza (cerca de 1 persona de cada 70). Como con todas las vacunas, se está prestando atención si la vacuna contra la culebrilla causa problemas graves o inusuales. seria pueden incluir dificultad para respirar, debilidad, ronquera o sibilancias, latidos rápidos del corazón, urticaria, mareos, palidez o hinchazón de la garganta. Qué debo hacer? Llame a un doctor o lleve a la persona inmediatamente a un doctor. Diga al doctor lo que ocurrió, la fecha y la hora en que ocurrió y cuándo recibió la vacuna. Pida a su su doctor que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este informe mediante el sitio Web de VAERS, en: o puede llamar al: VAERS no proporciona consejos médicos. 6 Cómo puedo obtener más información? Consulte con su doctor o con otro profesional de la salud. Ellos le pueden dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al: (1-800-CDC-INFO) - Visite el sitio Web de los CDC, en: 5 Qué pasa si hay una reacción moderada o grave? A qué debo prestar atención? Preste atención a cualquier cosa fuera de lo común, como una reacción alérgica grave o fiebre alta. Si ocurre una reacción alérgica grave, ocurrirá entre unos pocos minutos hasta una hora después de la aplicación de la inyección. Algunos de los signos de una reacción alérgica U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement Shingles Vaccine IMM-868S Spanish (10/6/2009) Translated by Transcend Translations, Davis, CA 42 U.S.C. 300aa

127 MMR VACCINE INFORMATION STATEMENT (Measles, Mumps, & Rubella) Vaccine What You Need to Know Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 Why get vaccinated? Measles, mumps, and rubella are serious diseases. Before vaccines they were very common, especially among children. Measles Measles virus causes rash, cough, runny nose, eye irritation, and fever. It can lead to ear infection, pneumonia, seizures (jerking and staring), brain damage, and death. Mumps Mumps virus causes fever, headache, muscle pain, loss of appetite, and swollen glands. It can lead to deafness, meningitis (infection of the brain and spinal cord covering), painful swelling of the testicles or ovaries, and rarely sterility. Rubella (German Measles) Rubella virus causes rash, arthritis (mostly in women), and mild fever. If a woman gets rubella while she is pregnant, she could have a miscarriage or her baby could be born with serious birth defects. These diseases spread from person to person through the air. You can easily catch them by being around someone who is already infected. Measles, mumps, and rubella (MMR) vaccine can protect children (and adults) from all three of these diseases. Thanks to successful vaccination programs these diseases are much less common in the U.S. than they used to be. But if we stopped vaccinating they would return. 2 Who should get MMR vaccine and when? Children should get 2 doses of MMR vaccine: First Dose: months of age Second Dose: 4-6 years of age (may be given earlier, if at least 28 days after the 1st dose) Some infants younger than 12 months should get a dose of MMR if they are traveling out of the country. (This dose will not count toward their routine series.) Some adults should also get MMR vaccine: Generally, anyone 18 years of age or older who was born after 1956 should get at least one dose of MMR vaccine, unless they can show that they have either been vaccinated or had all three diseases. MMR vaccine may be given at the same time as other vaccines. Children between 1 and 12 years of age can get a combination vaccine called MMRV, which contains both MMR and varicella (chickenpox) vaccines. There is a separate Vaccine Information Statement for MMRV. 3 Some people should not get MMR vaccine or should wait. Anyone who has ever had a life-threatening allergic reaction to the antibiotic neomycin, or any other component of MMR vaccine, should not get the vaccine. Tell your doctor if you have any severe allergies. Anyone who had a life-threatening allergic reaction to a previous dose of MMR or MMRV vaccine should not get another dose. Some people who are sick at the time the shot is scheduled may be advised to wait until they recover before getting MMR vaccine. Pregnant women should not get MMR vaccine. Pregnant women who need the vaccine should wait until after giving birth. Women should avoid getting pregnant for 4 weeks after vaccination with MMR vaccine. 126

128 Tell your doctor if the person getting the vaccine: - Has HIV/AIDS, or another disease that affects the immune system - Is being treated with drugs that affect the immune system, such as steroids - Has any kind of cancer - Is being treated for cancer with radiation or drugs - Has ever had a low platelet count (a blood disorder) - Has gotten another vaccine within the past 4 weeks - Has recently had a transfusion or received other blood products Any of these might be a reason to not get the vaccine, or delay vaccination until later. 4 What are the risks from MMR vaccine? A vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of MMR vaccine causing serious harm, or death, is extremely small. Getting MMR vaccine is much safer than getting measles, mumps or rubella. Most people who get MMR vaccine do not have any serious problems with it. Mild Problems Fever (up to 1 person out of 6) Mild rash (about 1 person out of 20) Swelling of glands in the cheeks or neck (about 1 person out of 75) If these problems occur, it is usually within 6-14 days after the shot. They occur less often after the second dose. Moderate Problems Seizure (jerking or staring) caused by fever (about 1 out of 3,000 doses) Temporary pain and stiffness in the joints, mostly in teenage or adult women (up to 1 out of 4) Temporary low platelet count, which can cause a bleeding disorder (about 1 out of 30,000 doses) Severe Problems (Very Rare) Serious allergic reaction (less than 1 out of a million doses) Several other severe problems have been reported after a child gets MMR vaccine, including: - Deafness - Long-term seizures, coma, or lowered consciousness - Permanent brain damage These are so rare that it is hard to tell whether they are caused by the vaccine. 5 What if there is a serious reaction? What should I look for? Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at or by calling VAERS does not provide medical advice. 6 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 7 How can I learn more? Ask your doctor. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) MMR Vaccine 4/20/ U.S.C. 300aa-26 Office Use Only 127

129 VACUNA MMRV 1 El sarampión, las paperas, la rubéola y la varicela pueden ser enfermedades serias: El sarampión Causa erupciones en la piel, tos, nariz que gotea, irritación de los ojos y fiebre. Puede conducir a infección de los oídos, neumonía, ataques epilépticos (convulsiones), daño cerebral y la muerte. Las paperas Causan fiebre, dolor de cabeza, hinchazón de las glándulas. Pueden conducir a sordera, meningitis (infección de las membranas que recubren el cerebro y la médula espinal), infección del páncreas, hinchazón dolorosa de los testículos o de los ovarios y, en raras ocasiones, la muerte. La rubéola (sarampión alemán) Causa erupciones en la piel y fiebre leve y puede causar artritis (principalmente en las mujeres). Si una mujer contrae rubéola estando embarazada, puede tener un aborto espontáneo o su bebé puede nacer con graves defectos de nacimiento. La varicela Causa erupciones en la piel, picazón, fiebre, cansancio. Puede conducir a infección seria de la piel, cicatrices, neumonía, daño cerebral o la muerte. Puede volver a surgir años después como una erupción dolorosa llamada culebrilla. Estas enfermedades se pueden transmitir de persona a persona por el aire. La varicela también se puede transmitir por medio del contacto con líquido de las ampollas de la varicela. Antes de que existieran las vacunas, estas enfermedades eran muy comunes en los Estados Unidos. 2 La vacuna MMRV (CONTRA SARAMPIÓN, PAPERAS, RUBÉOLA Y VARICELA) LO QUE USTED NECESITA SABER Muchas Hojas de Información sobre Vacunas están disponibles en español y en otros idiomas. Visite El sarampión, las paperas, la rubéola y la varicela La vacuna MMRV se puede aplicar a niños de 1 a 12 años de edad para protegerlos contra estas cuatro enfermedades. Se recomiendan dos dosis de la vacuna MMRV: - La primera dosis a los 12 a 15 meses de edad - La segunda dosis a los 4 a 6 años de edad Estas son las edades recomendadas. Pero los niños pueden aplicarse la segunda dosis hasta los 12 años de edad si han pasado al menos 3 meses desde la primera dosis. Los niños también pueden aplicarse estas vacunas en 2 inyecciones separadas: Vacunas MMR (contra el sarampión, paperas y rubéola) y contra la varicela. 1 Inyección (MMRV) ó 2 inyecciones (MMR y varicela)? Ambas opciones proporcionan la misma protección. Una inyección menos con la MMRV. Los niños a quienes se les aplicó la primera dosis como MMRV tuvieron más fiebre y más ataques epilépticos (convulsiones) relacionados con la fiebre (aproximadamente 1 de cada 1,250) que los niños a quienes se les aplicó la primera dosis como vacunas separadas MMR y contra la varicela el mismo día (aproximadamente 1 de cada 2,500). Su profesional de la salud puede darle más información, incluyendo las Hojas de Información sobre las vacunas de MMR y varicela. Todas las personas de 13 años de edad o mayores que necesitan protección contra estas enfermedades deben aplicarse las vacunas MMR y contra la varicela en vacunas separadas. La MMRV se puede aplicar al mismo tiempo que otras vacunas. 3 Algunos niños no se deben aplicar la vacuna MMRV o deben esperar Los niños no se deben aplicar la vacuna MMRV si: Alguna vez tuvieron una reacción alérgica que puso en peligro su vida a una dosis anterior de la vacuna MMRV o a las vacunas MMR o contra la varicela. Alguna vez tuvieron una reacción alérgica que puso en peligro su vida a algún componente de la vacuna, incluyendo gelatina o el antibiótico neomicina. Si su niño tiene alergias serias, dígaselo al doctor. Tienen VIH/SIDA o alguna otra enfermedad que afecte el sistema inmunológico. Están siendo tratados con medicamentos que afectan el sistema inmunológico, incluyendo dosis elevadas de esteroides orales por 2 semanas o más. Tienen cualquier tipo de cáncer. Están siendo tratados por cáncer con radiación o medicamentos. MMRV - Spanish (5/21/10) 128

130 Consulte a su doctor si el niño: Tiene antecedentes de ataques epilépticos (convulsiones) o tiene un padre, una madre o un hermano o hermana con antecedentes de ataques epilépticos (convulsiones). Tiene un padre, una madre o un hermano o hermana con antecedentes de problemas del sistema inmunológico. Alguna vez tuvo un recuento bajo de plaquetas o algún otro trastorno de la sangre. Le hicieron recientemente una transfusión de sangre o recibió otros productos de la sangre. Puede estar embarazada. Los niños que están moderada o seriamente enfermos el día en que les van a aplicar la vacuna por lo general tienen que esperar hasta recuperarse antes de aplicarse la vacuna MMRV. Los niños que están sólo levemente enfermos por lo general pueden aplicarse la vacuna. Pida más información a su profesional de la salud. 4 Cuáles son los riesgos de la vacuna MMRV? Como todos los medicamentos, las vacunas pueden causar problemas serios, como reacciones alérgicas graves. El riesgo de que la vacuna MMRV cause daños graves o la muerte es extremadamente pequeño. Aplicarse la vacuna MMRV es mucho menos peligroso que tener sarampión, paperas, rubéola o varicela. La mayoría de los niños a quienes se les aplica la vacuna MMRV no tienen problemas a causa de ello. Problemas leves Fiebre (aproximadamente 1 niño de cada 5). Erupciones en la piel leves (aproximadamente 1 niño de cada 20). Hinchazón de las glándulas en las mejillas o en el cuello (ocurre rara vez). Si ocurren estos problemas, en general pasa dentro de los 5 a 12 días después de la primera dosis. Ocurren menos a menudo después de la segunda dosis. Problemas moderados Ataque epiléptico (convulsión) causado por fiebre (aproximadamente 1 niño de cada 1,250 al que se le aplica la MMRV), por lo general 5 a 12 días después de la primera dosis. Ocurren menos a menudo cuando las vacunas MMR y contra la varicela se aplican en la misma visita en inyecciones separadas (aproximadamente 1 niño de cada 2,500 al que se le aplican estas dos vacunas) y rara vez después de una 2ª dosis de la MMRV. Bajo recuento temporal de plaquetas, que puede causar un trastorno de sangrado (aproximadamente 1 niño de cada 40,000). Problemas serios (ocurren muy rara vez) Se han informado varios problemas serios después de la aplicación de la vacuna MMR, que también pueden ocurrir después de la MMRV. Estos problemas incluyen reacciones alérgicas serias (menos de 4 por millón) y problemas como: - Sordera. - Ataques epilépticos (convulsiones) a largo plazo, coma, nivel de conocimiento reducido. - Daño cerebral permanente. Debido a que estos problemas ocurren tan rara vez, no sabemos con seguridad si están causados o no por la vacuna. 5 A qué debo prestar atención? Cualquier cosa fuera de lo común, como fiebre alta o cambios en el comportamiento. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o sibilancias, ronchas, palidez, debilidad, latidos rápidos del corazón o mareos. Qué debo hacer? Llame a un doctor o lleve a la persona inmediatamente a un doctor. Diga a su doctor lo que ocurrió, la fecha y la hora en que ocurrió y cuándo recibió la vacuna. Pida a su profesional de la salud que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este informe mediante el sitio Web de VAERS, en: o puede llamar al: VAERS no proporciona consejos médicos. 6 7 Qué pasa si hay una reacción grave? Programa Nacional de Compensación por Lesiones Causadas por las Vacunas El Programa Nacional de Compensación por Lesiones Causadas por las Vacunas (National Vaccine Injury Compensation Program, VICP) fue creado en Las personas que creen que pudieron haber sido lesionadas por una vacuna pueden presentar un reclamo ante el VICP llamando al ó visitando su sitio Web en Cómo puedo obtener más información? Consulte con su profesional de la salud. Le puede dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al: (1-800-CDC-INFO) - Visite el sitio Web de los CDC en: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement (Interim) MMRV Vaccine IMM-1013S Spanish (5/21/10) 42 U.S.C. 300aa-26 Translated by Transcend Translations, Davis, CA 5/21/

131 PNEUMOCOCCAL VACCINE POLYSACCHARIDE W H A T Y O U N E E D T O K N O W Many Vaccine Information Statements are available in Spanish and other languages. See 1 Pneumococcal disease Pneumococcal disease is caused by Streptococcus pneumoniae bacteria. It is a leading cause of vaccinepreventable illness and death in the United States. Anyone can get pneumococcal disease, but some people are at greater risk than others: People 65 years and older The very young People with certain health problems People with a weakened immune system Smokers Pneumococcal disease can lead to serious infections of the: Lungs (pneumonia), Blood (bacteremia), and Covering of the brain (meningitis). Pneumococcal pneumonia kills about 1 out of 20 people who get it. Bacteremia kills about 1 person in 5, and meningitis about 3 people in 10. People with the health problems described in Section 3 of this statement may be more likely to die from the disease. 2 Pneumococcal polysaccharide vaccine (PPSV) Treatment of pneumococcal infections with penicillin and other drugs used to be more effective. But some strains of the disease have become resistant to these drugs. This makes prevention of the disease, through vaccination, even more important. Pneumococcal polysaccharide vaccine (PPSV) protects against 23 types of pneumococcal bacteria, including those most likely to cause serious disease. Most healthy adults who get the vaccine develop protection to most or all of these types within 2 to 3 weeks of getting the shot. Very old people, children under 2 years of age, and people with some long-term illnesses might not respond as well, or at all. Another type of pneumococcal vaccine (pneumococcal conjugate vaccine, or PCV) is routinely recommended for children younger than 5 years of age. PCV is described in a separate Vaccine Information Statement. 3 Who should get PPSV? All adults 65 years of age and older. Anyone 2 through 64 years of age who has a longterm health problem such as: -heart disease -lung disease -sickle cell disease -diabetes -alcoholism -cirrhosis -leaks of cerebrospinal fluid or cochlear implant Anyone 2 through 64 years of age who has a disease or condition that lowers the body s resistance to infection, such as: - Hodgkin s disease - lymphoma or leukemia - kidney failure - multiple myeloma - nephrotic syndrome - HIV infection or AIDS - damaged spleen, or no spleen - organ transplant Anyone 2 through 64 years of age who is taking a drug or treatment that lowers the body s resistance to infection, such as: - long-term steroids - certain cancer drugs - radiation therapy Any adult 19 through 64 years of age who: - is a smoker - has asthma PPSV may be less effective for some people, especially those with lower resistance to infection. 130

132 But these people should still be vaccinated, because they are more likely to have serious complications if they get pneumococcal disease. Children who often get ear infections, sinus infections, or other upper respiratory diseases, but who are otherwise healthy, do not need to get PPSV because it is not effective against those conditions. 4 How many doses of PPSV are needed, and when? Usually only one dose of PPSV is needed, but under some circumstances a second dose may be given. A second dose is recommended for people 65 years and older who got their first dose when they were younger than 65 and it has been 5 or more years since the first dose. A second dose is recommended for people 2 through 64 years of age who: - have a damaged spleen or no spleen - have sickle-cell disease - have HIV infection or AIDS - have cancer, leukemia, lymphoma, multiple myeloma - have nephrotic syndrome - have had an organ or bone marrow transplant - are taking medication that lowers immunity (such as chemotherapy or long-term steroids) When a second dose is given, it should be given 5 years after the first dose. 5 Some people should not get PPSV or should wait Anyone who has had a life-threatening allergic reaction to PPSV should not get another dose. Anyone who has a severe allergy to any component of a vaccine should not get that vaccine. Tell your provider if you have any severe allergies. Anyone who is moderately or severely ill when the shot is scheduled may be asked to wait until they recover before getting the vaccine. Someone with a mild illness can usually be vaccinated. While there is no evidence that PPSV is harmful to either a pregnant woman or to her fetus, as a precaution, women with conditions that put them at risk for pneumococcal disease should be vaccinated before becoming pregnant, if possible. 6 What are the risks from PPSV? About half of people who get PPSV have mild side effects, such as redness or pain where the shot is given. Less than 1% develop a fever, muscle aches, or more severe local reactions. A vaccine, like any medicine, could cause a serious reaction. But the risk of a vaccine causing serious harm, or death, is extremely small. 7 What if there is a severe reaction? What should I look for? Any unusual condition, such as a high fever or behavior changes. Signs of a severe allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell the doctor what happened, the date and time it happened, and when the vaccination was given. Ask your provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. 8 How can I learn more? Ask your provider. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention PPSV (10/6/09) Vaccine Information Statement 131

133 VACUNA 1 ANTINEUMOCÓCICA POLISACÁRIDA LO QUE USTED NECESITA SABER La enfermedad neumocócica La enfermedad neumocócica es causada por la bacteria Streptococcus pneumoniae. Es una de las causas principales de enfermedades y muertes que se pueden prevenir con las vacunas en los Estados Unidos. Cualquiera puede contraer la enfermedad neumocócica, pero algunas personas corren más riesgo que otras: Personas de 65 años de edad y mayores Los muy jóvenes Personas con ciertos problemas de salud Personas con el sistema inmunológico debilitado Fumadores La enfermedad neumocócica puede conducir a infecciones serias de: los pulmones (neumonía) la sangre (bacteriemia) y el recubrimiento del cerebro (meningitis). La neumonía neumocócica mata a aproximadamente 1 de cada 20 personas que la contraen. La bacteriemia mata a aproximadamente 1 persona de cada 5 y la meningitis a unas 3 personas de cada 10. Las personas con los problemas de salud descritos en la Sección 3 de esta hoja de información podrían ser más propensas a morir de la enfermedad. 2 Muchas Hojas de Información sobre Vacunas están disponibles en español y en otros idiomas. Visite La vacuna antineumocócica polisacárida (PPSV) El tratamiento de las infecciones neumocócicas con penicilina y otros medicamentos solía ser más efectivo. Pero algunos tipos de la enfermedad han desarrollado resistencia a estos medicamentos. Esto hace que la prevención de la enfermedad, por medio de la vacunación, sea todavía más importante. La vacuna antineumocócica polisacárida (PPSV) protege contra 23 tipos de bacterias neumocócicas, incluyendo las que tienen mayor probabilidad de causar una enfermedad seria. La mayoría de los adultos sanos que se vacunan desarrollan protección contra la mayoría de estos tipos, o todos, dentro de las 2 ó 3 semanas de haberse vacunado. Las personas de edad muy avanzada, los niños menores de 2 años de edad y las personas con algunas enfermedades a largo plazo podrían no responder tan bien, o no responder en absoluto. Otro tipo de vacuna antineumocócica (vacuna antineumocócica conjugada o PCV) se recomienda de rutina para los niños menores de 5 años de edad. La PCV se describe en otra Hoja de Información sobre la Vacuna. 3 Quiénes deben vacunarse con la PPSV? Todos los adultos de 65 años de edad y mayores. Todas las personas de 2 a 64 años de edad que tienen un problema de salud a largo plazo, como: - enfermedad del corazón - enfermedad de los pulmones - enfermedad de células falciformes - diabetes - alcoholismo - cirrosis - pérdida de líquido cefalorraquídeo o implante coclear Todas las personas de 2 a 64 años de edad con una enfermedad o problema médico que reduce la resistencia del cuerpo a las infecciones, como: - enfermedad de Hodgkin - linfoma o leucemia - insuficiencia renal - mieloma múltiple - síndrome nefrótico - infección por el VIH o SIDA - bazo dañado o no tener bazo - trasplante de órgano Todas las personas de 2 a 64 años de edad que están tomando un medicamento o tratamiento que reduce la resistencia del cuerpo a las infecciones, como: - esteroides a largo plazo - ciertos medicamentos contra el cáncer - terapia de radiación Todos los adultos de 19 a 64 años de edad que: - fuman - tienen asma La PPSV puede ser menos efectiva en algunas personas, especialmente las que tienen una menor resistencia a las infecciones. Pero estas personas de todos modos se deben vacunar porque son más propensas a tener complicaciones serias si contraen la enfermedad. PPSV Spanish (10/06/09) 132

134 Los niños que a menudo tienen infecciones de los oídos, infecciones de los senos nasales u otras enfermedades de las vías respiratorias superiores, pero que de lo contrario son sanos, no necesitan vacunarse con la PPSV porque no es efectiva contra esos problemas médicos. 4 Cuántas dosis de la PPSV se necesitan y cuándo? Por lo general se necesita una sola dosis de la PPSV, pero en algunas circunstancias se puede poner una segunda dosis. Se recomienda una segunda dosis para las personas de 65 años de edad y mayores que recibieron la primera dosis cuando tenían menos de 65 años de edad y que además hayan pasado 5 años o más desde la primera dosis. Se recomienda una segunda dosis para las personas de 2 a 64 años de edad que: - tienen el bazo dañado o no tienen bazo - tienen enfermedad de células falciformes - están infectadas por el VIH o tienen SIDA - tienen cáncer, leucemia, linfoma, mieloma múltiple - tienen el síndrome nefrótico - tuvieron un trasplante de órgano o de médula ósea - están tomando medicamentos que reducen la inmunidad (como quimioterapia o esteroides a largo plazo) Cuando se pone una segunda dosis debe hacerse 5 años después de la primera. 5 Algunas personas no deben recibir la PPSV o deben esperar Las personas que tuvieron una reacción alérgica a la PPSV que puso en peligro su vida no deben recibir otra dosis de la vacuna. Las personas que tuvieron una reacción alérgica grave a algún componente de una vacuna no deben recibir esa vacuna. Diga a su doctor si tiene alergias graves. A las personas que tengan una enfermedad moderada o grave el día de la vacuna tal vez se les pida que esperen hasta recuperarse antes de vacunarse. Por lo general, las personas con una enfermedad leve se pueden vacunar. Aunque no hay pruebas de que la PPSV es dañina para las mujeres embarazadas o sus fetos, como precaución, las mujeres con problemas médicos que las pongan en riesgo de contraer la enfermedad neumocócica se deben vacunar antes de quedar embarazadas, si es posible. 6 Cuáles son los riesgos de la PPSV? Aproximadamente la mitad de las personas vacunadas con la PPSV tienen efectos secundarios leves, como enrojecimiento o malestar en el lugar donde se aplicó la vacuna. A menos del 1% les da fiebre, dolores musculares o reacciones locales más fuertes. Una vacuna, como cualquier otro medicamento, podría causar una reacción seria. Pero el riesgo de que una vacuna cause un daño serio, o la muerte, es sumamente pequeño. 7 Qué pasa si hay una reacción grave? A qué debo prestar atención? Preste atención a cualquier cosa fuera de lo común, como fiebre alta o cambios en el comportamiento. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o sibilancias, ronchas, palidez, debilidad, latidos rápidos del corazón o mareos. Qué debo hacer? Llame a un doctor o lleve a la persona inmediatamente a un doctor. Diga al doctor lo que ocurrió, la fecha y la hora en que ocurrió, y cuándo recibió la vacuna. Pida a su doctor que informe la reacción presentando un formulario del Sistema de Información sobre Eventos Adversos a una Vacuna (Vaccine Adverse Event Reporting System, VAERS). O usted puede presentar este informe mediante el sitio Web del VAERS, en o puede llamar al VAERS no proporciona consejos médicos. 8 Cómo puedo obtener más información? Consulte con su doctor. Le puede dar el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al (1-800-CDC-INFO) o - Visite el sitio Web de los CDC, en DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Vaccine Information Statement PPSV IMM-693S Spanish (10/6/09) Translated by Transcend Translations, Davis, CA 42 U.S.C. 300aa

135 VACCINE INFORMATION STATEMENT Meningococcal Vaccines What You Need to Know Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 What is meningococcal disease? Meningococcal disease is a serious bacterial illness. It is a leading cause of bacterial meningitis in children 2 through 18 years old in the United States. Meningitis is an infection of the covering of the brain and the spinal cord. Meningococcal disease also causes blood infections. About 1,000 1,200 people get meningococcal disease each year in the U.S. Even when they are treated with antibiotics, 10-15% of these people die. Of those who live, another 11%-19% lose their arms or legs, have problems with their nervous systems, become deaf, or suffer seizures or strokes. Anyone can get meningococcal disease. But it is most common in infants less than one year of age and people years. Children with certain medical conditions, such as lack of a spleen, have an increased risk of getting meningococcal disease. College freshmen living in dorms are also at increased risk. Meningococcal infections can be treated with drugs such as penicillin. Still, many people who get the disease die from it, and many others are affected for life. This is why preventing the disease through use of meningococcal vaccine is important for people at highest risk. 2 Meningococcal vaccine There are two kinds of meningococcal vaccine in the U.S.: Meningococcal conjugate vaccine (MCV4) is the preferred vaccine for people 55 years of age and younger. Meningococcal polysaccharide vaccine (MPSV4) has been available since the 1970s. It is the only meningococcal vaccine licensed for people older than 55. Both vaccines can prevent 4 types of meningococcal disease, including 2 of the 3 types most common in the United States and a type that causes epidemics in Africa. There are other types of meningococcal disease; the vaccines do not protect against these. 3 Who should get meningococcal vaccine and when? Routine Vaccination Two doses of MCV4 are recommended for adolescents 11 through 18 years of age: the first dose at 11 or 12 years of age, with a booster dose at age 16. Adolescents in this age group with HIV infection should get three doses: 2 doses 2 months apart at 11 or 12 years, plus a booster at age 16. If the first dose (or series) is given between 13 and 15 years of age, the booster should be given between 16 and 18. If the first dose (or series) is given after the 16th birthday, a booster is not needed. Other People at Increased Risk College freshmen living in dormitories. Laboratory personnel who are routinely exposed to meningococcal bacteria. U.S. military recruits. Anyone traveling to, or living in, a part of the world where meningococcal disease is common, such as parts of Africa. Anyone who has a damaged spleen, or whose spleen has been removed. Anyone who has persistent complement component deficiency (an immune system disorder). People who might have been exposed to meningitis during an outbreak. Children between 9 and 23 months of age, and anyone else with certain medical conditions need 2 doses for adequate protection. Ask your doctor about the number and timing of doses, and the need for booster doses. MCV4 is the preferred vaccine for people in these groups who are 9 months through 55 years of age. MPSV4 can be used for adults older than

136 4 Some people should not get meningococcal vaccine or should wait. Anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of MCV4 or MPSV4 vaccine should not get another dose of either vaccine. Anyone who has a severe (life threatening) allergy to any vaccine component should not get the vaccine. Tell your doctor if you have any severe allergies. Anyone who is moderately or severely ill at the time the shot is scheduled should probably wait until they recover. Ask your doctor. People with a mild illness can usually get the vaccine. Meningococcal vaccines may be given to pregnant women. MCV4 is a fairly new vaccine and has not been studied in pregnant women as much as MPSV4 has. It should be used only if clearly needed. The manufacturers of MCV4 maintain pregnancy registries for women who are vaccinated while pregnant. Except for children with sickle cell disease or without a working spleen, meningococcal vaccines may be given at the same time as other vaccines. 5 What are the risks from meningococcal vaccines? A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of meningococcal vaccine causing serious harm, or death, is extremely small. Brief fainting spells and related symptoms (such as jerking or seizure-like movements) can follow a vaccination. They happen most often with adolescents, and they can result in falls and injuries. Sitting or lying down for about 15 minutes after getting the shot especially if you feel faint can help prevent these injuries. Mild problems As many as half the people who get meningococcal vaccines have mild side effects, such as redness or pain where the shot was given. If these problems occur, they usually last for 1 or 2 days. They are more common after MCV4 than after MPSV4. A small percentage of people who receive the vaccine develop a mild fever. Severe problems Serious allergic reactions, within a few minutes to a few hours of the shot, are very rare. 6 What if there is a moderate or severe reaction? What should I look for? Any unusual condition, such as a severe allergic reaction or a high fever. If a severe allergic reaction occurred, it would be within a few minutes to an hour after the shot. Signs of a serious allergic reaction can include difficulty breathing, weakness, hoarseness or wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of the throat. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your provider to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS website at or by calling VAERS does not provide medical advice. 7 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Your doctor can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Meningococcal Vaccines 10/14/ U.S.C. 300aa-26 Office Use Only 135

137 DECLARACIÓN DE INFORMACIÓN SOBRE VACUNAS Vacunas contra el meningococo Lo que necesita saber Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 Qué es la enfermedad meningocócica? La enfermedad meningocócica es una enfermedad grave causada por una bacteria. Es una de las causas principales de meningitis bacteriana en niños de 2 a 18 años en los Estados Unidos. La meningitis es una infección de las membranas que cubren el cerebro y la médula espinal. La enfermedad meningocócica también causa infecciones de la sangre En los Estados Unidos, aproximadamente entre 1,000 y 1,200 personas por año contraen la enfermedad meningocócica. Entre el 10% y el 15% de ellas mueren, incluso si se las tratan con antibióticos. De las que sobreviven, entre el 11% y el 19% pierden los brazos o las piernas, presentan problemas en el sistema nervioso, quedan sordas o con retraso mental, o sufren convulsiones o derrames cerebrales. Cualquiera puede contraer la enfermedad meningocócica, pero es más común en bebés de menos de un año y en personas entre 16 y 21 años. Los niños con ciertos problemas médicos, como la falta de bazo, tienen mayor riesgo de contraer la enfermedad meningocócica. El riesgo también es mayor en estudiantes universitarios de primer año que viven en residencias estudiantiles. Las infecciones meningocócicas se pueden tratar con medicamentos como la penicilina. Aun así, muchas personas que contraen la enfermedad mueren a causa de ella y muchas otras quedan afectadas de por vida. Por eso, la prevención de la enfermedad a través de la vacuna contra el meningococo es importante para las personas con mayor riesgo. 2 Vacuna contra el meningococo Existen dos tipos de vacuna contra el meningococo en los Estados Unidos: La vacuna conjugada contra el meningococo (MCV4) se recomienda para personas menores de 55 años. La vacuna polisacárida contra el meningococo (MPSV4) ha estado disponible desde los años setenta. Es la única vacuna contra el meningococo autorizada para personas mayores de 55 años. Ambas vacunas pueden prevenir 4 tipos de enfermedades meningocócicas, incluyendo 2 de los 3 tipos más comunes en los Estados Unidos y un tipo que causa epidemias en África. Existen otros tipos de enfermedades meningocócicas, pero las vacunas no protegen contra ellos. 3 Quién debe ponerse la vacuna contra el meningococo y cuándo? Vacunación de rutina Se recomiendan dos dosis de MCV4 para los adolescentes de 11 a 18 años: la primera dosis a los 11 ó 12 años, con una dosis de refuerzo a los 16 años. Los adolescentes en este grupo de edad con infección de VIH se deben poner tres dosis: 2 dosis con 2 meses de diferencia a los 11 ó 12 años, más un refuerzo a los 16. Si la primera dosis (o serie) se pone entre los 13 y 15 años, el refuerzo se debe poner entre los 16 y los 18 años. Si la primera dosis (o serie) se pone después de cumplir los 16 años, no se necesita un refuerzo. Otras personas con mayor riesgo Estudiantes universitarios de primer año que viven en residencias estudiantiles. Personal de laboratorio que está expuesto habitualmente a la bacteria meningocócica. Reclutas militares de los Estados Unidos. Cualquier persona que viaje a cualquier parte del mundo donde la enfermedad meningocócica sea común, como en algunas partes de África, o que viva en tales zonas. Cualquier persona cuyo bazo esté dañado o se le haya extirpado. Cualquier persona que tenga una deficiencia del complejo terminal del complemento (un trastorno del sistema inmunitario). Personas que podrían haber estado expuestas a meningitis durante un brote. Los niños entre 9 y 23 meses y cualquier otra persona con ciertas afecciones médicas necesitan 2 dosis para tener una protección adecuada. Pregunte a su médico sobre la cantidad de dosis y el momento en que se deben aplicar, y la necesidad de dosis de refuerzo. La MCV4 es la recomendada para las personas entre 9 meses y 55 años que se encuentran en estos grupos. La MPSV4 se puede usar en adultos mayores de 55 años. Meningococcal VIS - Spanish (10/14/11) 136

138 4 5 Algunas personas no se deben poner la vacuna contra el meningococo o deben esperar. Las personas que hayan tenido una reacción alérgica grave (que haya puesto en peligro su vida) a una dosis previa de la vacuna MCV4 o MPSV4 no deben ponerse otra dosis. Las personas que tenga una alergia grave (que ponga en peligro su vida) a cualquier componente de la vacuna no deben ponerse la vacuna. Informe a su médico si tiene alergias graves. Las personas que tengan una enfermedad moderada o grave al momento de ponerse la vacuna deben esperar hasta recuperarse. Pregunte a su médico. Las personas con una enfermedad leve generalmente se pueden vacunar. Las vacunas contra el meningococo pueden aplicarse a mujeres embarazadas. La MCV4 es una vacuna bastante nueva y no se ha estudiado tanto en mujeres embarazadas como la MPSV4. Se debe emplear solo en casos claramente necesarios. Los fabricantes de MCV4 mantienen registros de las mujeres embarazadas que reciben la vacuna. A excepción de los niños con anemia de células falciformes o que no tienen un bazo funcional, las vacunas contra el meningococo se pueden aplicar al mismo tiempo que otras vacunas. Cuáles son los riesgos relacionados con las vacunas contra el meningococo? Al igual que cualquier medicamento, las vacunas podrían causar graves problemas, como reacciones alérgicas graves. El riesgo de que la vacuna contra el meningococo provoque daños graves, o la muerte, es sumamente bajo. Después de una vacunación, pueden ocurrir episodios de desmayo de corta duración y síntomas relacionados (como espasmos o movimientos similares a una convulsión). Estos suceden más a menudo en adolescentes y pueden provocar caídas y lesiones. Sentarse o recostarse por unos 15 minutos después de obtener la vacuna, en especial si se siente mareado, puede ayudar a prevenir estas lesiones. Problemas leves La mitad de las personas que se ponen las vacunas contra el meningococo tienen efectos secundarios leves, como enrojecimiento o dolor en el lugar de la inyección. Si se producen estos problemas, por lo general duran 1 ó 2 días. Son más comunes después de la aplicación de la MCV4 que de la MPSV4. Un pequeño porcentaje de las personas que reciben la vacuna presentan un poco de fiebre. Problemas graves Las reacciones alérgicas, después de unos minutos o unas horas de ponerse la vacuna, son muy poco frecuentes. 6 7 Qué sucede si se produce una reacción moderada o grave? A qué debo prestar atención? Preste atención a cualquier cosa fuera de lo común, como una reacción alérgica grave o fiebre alta. Si ocurriera una reacción alérgica grave, se produciría entre unos pocos minutos a una hora de ponerse la vacuna. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, debilidad, ronquera o sibilancias, latidos rápidos del corazón, urticaria, mareos, palidez o inflamación de la garganta. Qué debo hacer? Llame a un médico o lleve a la persona de inmediato a un médico. Informe a su médico lo que ocurrió, la fecha y la hora en que ocurrió y cuándo se puso la vacuna. Pida a su proveedor de salud que informe la reacción mediante la presentación de un formulario del Sistema para Reportar Reacciones Adversas a las Vacunas (VAERS). O puede presentar este informe a través del sitio web del VAERS en o llamando al VAERS no da consejos médicos. Programa Nacional de Compensación por Daños Derivados de Vacunas El Programa Nacional de Compensación por Daños Derivados de Vacunas (VICP) se creó en Las personas que creen que pueden haber sufrido daños a causa de una vacuna pueden obtener información sobre el programa y sobre la presentación de una reclamación llamando al o visitando el sitio web del VICP en 8 Cómo puedo obtener más información? Su médico puede darle el folleto de información que viene con la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (CDC): - Llame al (1-800-CDC-INFO). - Visite el sitio web de los CDC en Vaccine Information Statement (Interim) Meningococcal Vaccines Spanish 10/14/ U.S.C. 300aa-26 Translated by Carmazzi Global Solutions, CA 137

139 Hepatitis a General Information What is hepatitis? Hepatitis means inflammation of the liver. Hepatitis is most often caused by one of several viruses, such as hepatitis A virus, hepatitis B virus, or hepatitis C virus. Toxins, certain drugs, some diseases, heavy alcohol use, bacterial infections, and viral infections can also cause hepatitis. What is hepatitis A? Hepatitis A is a contagious liver disease that results from infection with the hepatitis A virus. It can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. How common is hepatitis A in the United States? Hepatitis A still occurs in the United States, although not as frequently as it once did. During the last 20 years, the number of cases of hepatitis A has steadily declined. The estimated 373,000 new infections in 1990 dropped to 143,000 by the year New cases are now estimated to be around 30,000 each year. Many experts believe this decline is a result of the vaccination of children and people at risk for hepatitis A. Hepatitis A can be prevented with a safe and effective vaccine. Who is at risk? Although anyone can get hepatitis A, some people are at greater risk, such as those who: Travel to or live in countries where hepatitis A is common Have sexual contact with someone who has hepatitis A Are men who have sexual contact with other men Use certain illegal drugs, whether injected or not Have clotting-factor disorders, such as hemophilia Are household members or caregivers of a person infected with hepatitis A How is hepatitis A spread? Hepatitis A is usually spread when a person ingests fecal matter even in microscopic amounts from contact with objects, food, or drinks contaminated by the feces or stool from an infected person. It can be spread when: An infected person does not wash his/her hands properly after going to the bathroom and then touches objects or food A caregiver does not properly wash his or her hands after changing diapers or cleaning up the stool of an infected person Someone engages in certain sexual activities, such as oral-anal contact with an infected person Hepatitis A can also be spread through contaminated food or water. This most often occurs in countries where hepatitis A is common, especially if sanitary conditions or personal hygiene are poor. Contamination of food can happen at any point: growing, harvesting, processing, handling, and even after cooking. 138

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Sometimes hepatitis A can cause liver failure and death, although this is rarehepatitis and occurs commonly in people older than 50 and people Can A more be prevented? Can hepatitis A with other liver diseases. Can hepatitis A be be prevented? prevented? Yes. The best way to prevent hepatitis A is by getting vaccinated. Experts Yes. way to A is vaccinated. Experts recommend vaccine for allhepatitis children, international travelers, and Yes. The The best bestthe way to prevent prevent hepatitis A some is by by getting getting vaccinated. Experts recommend the vaccine for all children, some international travelers, and people with certain risk factors and medical conditions. The hepatitis A recommend the vaccine for all children, some international travelers, and Can hepatitis A be prevented? people with certain risk factors and medical conditions. The hepatitis vaccine is safe and effective and given as 2 shots, 6 months apart. 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141 Patient name: Identification number: Today s date: / / (mo.) (day) (yr.) Should You Be Vaccinated Against Hepatitis A? A screening questionnaire for adults Hepatitis A is a serious liver disease caused by the hepatitis A virus (HAV). HAV is found in the feces (poop) of people with hepatitis A and is usually spread by close personal contact such as living in a household with or having sex with an infected person. HAV can also be spread by eating food or drinking water contaminated with HAV. Symptoms of HAV can include yellowing of the skin and eyes, nausea, fever, fatigue, belly pain, and dark urine. You can be sick for several weeks. Sometimes hepatitis A is fatal. The Centers for Disease Control and Prevention (CDC) recommends hepatitis A vaccination for all children in the United States at one year of age, as well as for people who are in the risk groups listed below. CDC also recommends hepatitis A vaccine for any person who wishes to be protected from HAV infection. Please review the checklist below to see if you should be vaccinated. (Some people should have their blood tested to find out if they have already been infected with HAV. Talk to your healthcare provider about whether this applies to you.) My answer: Yes. I would like to be protected from hepatitis A. Please vaccinate me, or I am in one of the risk groups below (and do not need to specify which one). Please vaccinate me. I travel or work in areas outside the United States where hepatitis A is common. (This includes everywhere except Australia, New Zealand, Northern and Western Europe, Japan, and Canada.) I have chronic liver disease. I have a blood clotting-factor disorder (for example, hemophilia). I am a man who has sex with men. I use street drugs. I might have been exposed to the hepatitis A virus in the past two weeks. I m not sure. I would like more information about hepatitis A and hepatitis A vaccine. No. I do not want to be vaccinated against hepatitis A today. Item #P2190 (6/08) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

142 VACCINE INFORMATION STATEMENT Hepatitis A Vaccine What You Need to Know Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 What is hepatitis A? Hepatitis A is a serious liver disease caused by the hepatitis A virus (HAV). HAV is found in the stool of people with hepatitis A. It is usually spread by close personal contact and sometimes by eating food or drinking water containing HAV. A person who has hepatitis A can easily pass the disease to others within the same household. Hepatitis A can cause: flu-like illness jaundice (yellow skin or eyes, dark urine) severe stomach pains and diarrhea (children) People with hepatitis A often have to be hospitalized (up to about 1 person in 5). Adults with hepatitis A are often too ill to work for up to a month. Sometimes, people die as a result of hepatitis A (about 3-6 deaths per 1,000 cases). Hepatitis A vaccine can prevent hepatitis A. 2 Who should get hepatitis A vaccine and when? WHO? Some people should be routinely vaccinated with hepatitis A vaccine: All children between their first and second birthdays (12 through 23 months of age). Anyone 1 year of age and older traveling to or working in countries with high or intermediate prevalence of hepatitis A, such as those located in Central or South America, Mexico, Asia (except Japan), Africa, and eastern Europe. For more information see Children and adolescents 2 through 18 years of age who live in states or communities where routine vaccination has been implemented because of high disease incidence. Men who have sex with men. People who use street drugs. People with chronic liver disease. People who are treated with clotting factor concentrates. People who work with HAV-infected primates or who work with HAV in research laboratories. Members of households planning to adopt a child, or care for a newly arriving adopted child, from a country where hepatitis A is common. Other people might get hepatitis A vaccine in certain situations (ask your doctor for more details): Unvaccinated children or adolescents in communities where outbreaks of hepatitis A are occurring. Unvaccinated people who have been exposed to hepatitis A virus. Anyone 1 year of age or older who wants protection from hepatitis A. Hepatitis A vaccine is not licensed for children younger than 1 year of age. WHEN? For children, the first dose should be given at 12 through 23 months of age. Children who are not vaccinated by 2 years of age can be vaccinated at later visits. For others at risk, the hepatitis A vaccine series may be started whenever a person wishes to be protected or is at risk of infection. For travelers, it is best to start the vaccine series at least one month before traveling. (Some protection may still result if the vaccine is given on or closer to the travel date.) Some people who cannot get the vaccine before traveling, or for whom the vaccine might not be effective, can get a shot called immune globulin (IG). IG gives immediate, temporary protection. Two doses of the vaccine are needed for lasting protection. These doses should be given at least 6 months apart. Hepatitis A vaccine may be given at the same time as other vaccines. 141

143 3 Some people should not get hepatitis A vaccine or should wait. Anyone who has ever had a severe (life threatening) allergic reaction to a previous dose of hepatitis A vaccine should not get another dose. Anyone who has a severe (life threatening) allergy to any vaccine component should not get the vaccine. Tell your doctor if you have any severe allergies, including a severe allergy to latex. All hepatitis A vaccines contain alum, and some hepatitis A vaccines contain 2-phenoxyethanol. Anyone who is moderately or severely ill at the time the shot is scheduled should probably wait until they recover. Ask your doctor. People with a mild illness can usually get the vaccine. Tell your doctor if you are pregnant. Because hepatitis A vaccine is inactivated (killed), the risk to a pregnant woman or her unborn baby is believed to be very low. But your doctor can weigh any theoretical risk from the vaccine against the need for protection. 4 What are the risks from hepatitis A vaccine? A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of hepatitis A vaccine causing serious harm, or death, is extremely small. Getting hepatitis A vaccine is much safer than getting the disease. Mild problems soreness where the shot was given (about 1 out of 2 adults, and up to 1 out of 6 children) headache (about 1 out of 6 adults and 1 out of 25 children) loss of appetite (about 1 out of 12 children) tiredness (about 1 out of 14 adults) 5 What if there is a moderate or severe reaction? What should I look for? Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at or by calling VAERS does not provide medical advice. 6 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 7 How can I learn more? Ask your doctor. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at If these problems occur, they usually last 1 or 2 days. Severe problems serious allergic reaction, within a few minutes to a few hours after the shot (very rare). Vaccine Information Statement (Interim) Hepatitis A Vaccine Office Use Only 10/25/ U.S.C. 300aa

144 DECLARACIÓN DE INFORMACIÓN SOBRE VACUNAS Vacuna contra la hepatitis A Lo que usted necesita saber Las hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite 1 Qué es la hepatitis A? La hepatitis A es una enfermedad hepática grave provocada por el virus de la hepatitis A (VHA). El VHA se encuentra en las heces de las personas infectadas con hepatitis A. Normalmente se contagia por contacto personal cercano y, a veces, al ingerir alimentos o agua que contienen el VHA. Una persona que tiene hepatitis A puede contagiar fácilmente la enfermedad a otras personas que conviven con ella en la misma casa. La hepatitis A puede provocar: enfermedad similar a la gripe ictericia (coloración amarilla en la piel o los ojos, orina de color oscuro) dolores de estómago y diarrea severos (niños) Las personas con hepatitis A a menudo deben ser hospitalizadas (alrededor de 1 de cada 5 personas). Los adultos con hepatitis A a menudo se sienten demasiado enfermos como para trabajar durante hasta un mes. A veces, las personas mueren como resultado de la hepatitis A (alrededor de 3 a 6 muertes cada 1000 casos). La vacuna contra la hepatitis A puede prevenir la hepatitis A. 2 Quién debe vacunarse contra la hepatitis A y cuándo? QUIÉN? Algunas personas deberían ponerse sistemáticamente la vacuna contra la hepatitis A: Todos los niños entre su primer y segundo año de vida (de 12 a 23 meses). Cualquier persona de 1 año en adelante que viaje a o trabaje en países con prevalencia alta o intermedia de hepatitis A, tales como aquellos ubicados en América Central o América del Sur, México, Asia (excepto Japón), África y Europa Oriental. Para obtener más información, consulte Niños y adolescentes de 2 a 18 años que viven en estados o comunidades en los cuales se ha implementado la vacunación de rutina debido a la alta incidencia de la enfermedad. Los hombres que tienen relaciones sexuales con hombres. Las personas que consumen drogas callejeras. Las personas con una enfermedad hepática crónica. Las personas tratadas con concentrados de factor de coagulación. Las personas que trabajan con primates infectados con el VHA o que trabajan con el VHA en laboratorios de investigación. Los miembros de hogares que planean adoptar a un niño o que cuidan a un niño adoptado que ha llegado recientemente al hogar de un país en el cual es común la hepatitis A. Otras personas podrían vacunarse contra la hepatitis A en determinadas situaciones (consulte a su médico para obtener más detalles): Niños o adolescentes que no están vacunados, en comunidades en las que haya brotes de hepatitis A. Personas que no estén vacunadas y que hayan estado expuestas al virus de la hepatitis A. Cualquier persona de 1 año en adelante que quiera protegerse contra la hepatitis A. La vacuna contra la hepatitis A no está autorizada para niños menores de 1 año. CUÁNDO? Para los niños, la primera dosis debe ponerse entre los 12 y los 23 meses. Los niños que no estén vacunados a los 2 años pueden vacunarse en visitas posteriores. Para otras personas en riesgo, podrá comenzarse la serie de vacunas contra la hepatitis A cuando una persona desee protegerse contra la enfermedad o se encuentre en riesgo de infectarse. Para las personas que viajan, es mejor comenzar la serie de vacunas al menos un mes antes de comenzar el viaje. (De todos modos, puede obtenerse alguna protección si la vacuna se pone el día del viaje o más próximo a dicha fecha). Algunas personas que no pueden vacunarse antes de viajar o para las cuales la vacuna puede no resultar efectiva pueden ponerse una inyección llamada inmunoglobulina (IG). La IG les proporciona una protección temporal inmediata. Se necesitan dos dosis de la vacuna para obtener una protección duradera. Estas dosis deberían darse con un intervalo de, al menos, 6 meses. La vacuna contra la hepatitis A puede aplicarse simultáneamente con otras vacunas. Hepatitis A VIS - Spanish (10/25/11) 143

145 3 Algunas personas no deberían vacunarse contra la hepatitis A o deberían esperar. Cualquier persona que haya tenido una reacción alérgica severa (que haya puesto en riesgo su vida) a una dosis anterior de la vacuna contra la hepatitis A no debería ponerse otra dosis. Cualquier persona que haya tenido una reacción alérgica severa (que haya puesto en riesgo su vida) a algún componente de la vacuna no debería vacunarse. Informe a su médico si ha tenido alguna alergia severa, incluida una alergia severa al látex. Todas las vacunas contra la hepatitis A contienen alumbre y algunas vacunas contra la hepatitis A contienen 2-fenoxietanol. Cualquier persona con una enfermedad moderada o severa en el momento de ponerse la inyección probablemente deba esperar hasta que se recupere. Pregúntele a su médico. Las personas con una enfermedad leve pueden, por lo general, recibir la vacuna. Informe a su médico si está embarazada. Como la vacuna contra la hepatitis A está inactivada (elaborada con virus muerto), se cree que el riesgo para una mujer embarazada o su hijo por nacer es muy bajo. Pero su médico puede evaluar cualquier riesgo teórico de la vacuna en relación con la necesidad de protección. 4 Cuáles son los riesgos de la vacuna contra la hepatitis A? Una vacuna, como cualquier medicamento, puede provocar problemas graves, como reacciones alérgicas severas. Sin embargo, el riesgo de que la vacuna contra la hepatitis A ocasione un daño grave, o la muerte, es casi insignificante. Vacunarse contra la hepatitis A es mucho más seguro que contraer la enfermedad. Problemas leves dolor en el lugar donde se puso la inyección (alrededor de 1 de cada 2 adultos, y hasta 1 de cada 6 niños) dolor de cabeza (alrededor de 1 de cada 6 adultos y 1 de cada 25 niños) pérdida del apetito (alrededor de 1 de cada 12 niños) cansancio (alrededor de 1 de cada 14 adultos) Si estos problemas ocurren, normalmente duran entre 1 y 2 días. Problemas severos reacción alérgica grave, en el término de unos pocos minutos a unas pocas horas luego de la inyección (muy poco frecuente). 5 Qué hago si ocurre una reacción moderada o severa? De qué debo estar pendiente? De todo signo inusual, como fiebre alta o cambios inusuales en la conducta. Los signos de una reacción alérgica grave pueden incluir dificultades para respirar, ronquera o sibilancia, urticaria, palidez, debilidad, pulso acelerado o mareos. Qué debo hacer? Llame a un médico o lleve a la persona al médico de inmediato. Dígale al médico lo que ocurrió, la fecha y la hora en la que ocurrió, y cuándo le pusieron la vacuna. Pida al médico, al personal de enfermería o al departamento de salud que informen la reacción presentando un formulario del Sistema de notificación de eventos adversos derivados de las vacunas (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este informe a través del sitio web de VAERS: o llamando al El VAERS no ofrece consejos médicos. 6 Programa Nacional de Compensación por Lesiones ocasionadas por Vacunas En 1986 se creó el Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas (National Vaccine Injury Compensation Program, VICP). Las personas que consideren que pueden haber tenido lesiones ocasionadas por una vacuna pueden informarse sobre el programa y sobre cómo presentar una reclamación llamando al o visitando el sitio web del VICP en: 7 Cómo puedo informarme más? Pregúntele a su médico. El médico puede darle el prospecto de la vacuna o sugerirle otras fuentes de información. Llame a su departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al (1-800-CDC-INFO) o - Visite el sitio web de los CDC en Vaccine Information Statement (Interim) Hepatitis A Vaccine 10/25/2011 Spanish 42 U.S.C. 300aa-26 Translation provided by the Immunization Action Coalition 144

146 Patient name: Identification number: Today s date: / / (mo.) (day) (yr.) Should You Be Vaccinated Against Hepatitis B? A screening questionnaire for adults Hepatitis B is a serious liver disease caused by the hepatitis B virus (HBV). HBV is spread through contact with blood or certain body fluids of an infected person. If you get hepatitis B, you may or may not have symptoms. Symptoms can last several weeks and may include yellowing of the skin and eyes, nausea, fever, fatigue, belly pain, and dark urine. Sometimes HBV stays in your body for years and causes long-lasting illness (chronic HBV infection) that can lead to liver damage, liver cancer, and death. The Centers for Disease Control and Prevention (CDC) recommends hepatitis B vaccine for all persons 0 18 years of age. CDC also recommends hepatitis B vaccination for all adults who are in risk groups for HBV infection, as well as for any adults who want to be protected from hepatitis B. You don t have to say that you are in one of the risk groups (listed below) to be vaccinated against hepatitis B. Some people in risk groups should be tested for hepatitis B, depending on the person s particular situation. If you ve been infected with HBV in the past and then get vaccinated, the vaccination will not hurt you, it just won t help. Talk to your healthcare provider. You should be vaccinated if any of the following apply to you: I want to be protected from hepatitis B. I have diabetes. I am sexually active but am not in a long-term, mutually monogamous relationship. I am a sex partner of someone who has HBV infection. I am a man who has sex with men. I have been evaluated or treated for a sexually transmitted disease. I am a healthcare or public safety worker who might be exposed to blood or blood-contaminated body fluids. I work or live in a facility for developmentally disabled persons. I am currently receiving dialysis or will be receiving it in the future. I have HIV infection. I inject illegal drugs or have done so recently. I am planning to travel in an area of the world where hepatitis B is common (Asia, Africa, the Amazon Basin in South America, the Pacific Islands, Eastern Europe, or the Middle East). I am a household contact of someone who has chronic HBV infection. I have chronic liver disease. Technical content reviewed by the Centers for Disease Control and Prevention Item #P2191 (4/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

147 VACCINE INFORMATION STATEMENT Hepatitis B Vaccine What You Need to Know Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite 1 What is hepatitis B? Hepatitis B is a serious infection that affects the liver. It is caused by the hepatitis B virus. In 2009, about 38,000 people became infected with hepatitis B. Each year about 2,000 to 4,000 people die in the United States from cirrhosis or liver cancer caused by hepatitis B. Hepatitis B can cause: Acute (short-term) illness. This can lead to: loss of appetite diarrhea and vomiting tiredness jaundice (yellow skin or eyes) pain in muscles, joints, and stomach Acute illness, with symptoms, is more common among adults. Children who become infected usually do not have symptoms. Chronic (long-term) infection. Some people go on to develop chronic hepatitis B infection. Most of them do not have symptoms, but the infection is still very serious, and can lead to: liver damage (cirrhosis) liver cancer death Chronic infection is more common among infants and children than among adults. People who are chronically infected can spread hepatitis B virus to others, even if they don t look or feel sick. Up to 1.4 million people in the United States may have chronic hepatitis B infection. Hepatitis B virus is easily spread through contact with the blood or other body fluids of an infected person. People can also be infected from contact with a contaminated object, where the virus can live for up to 7 days. A baby whose mother is infected can be infected at birth; Children, adolescents, and adults can become infected by: - contact with blood and body fluids through breaks in the skin such as bites, cuts, or sores; - contact with objects that have blood or body fluids on them such as toothbrushes, razors, or monitoring and treatment devices for diabetes; - having unprotected sex with an infected person; - sharing needles when injecting drugs; - being stuck with a used needle. 2 Hepatitis B vaccine: Why get vaccinated? Hepatitis B vaccine can prevent hepatitis B, and the serious consequences of hepatitis B infection, including liver cancer and cirrhosis. Hepatitis B vaccine may be given by itself or in the same shot with other vaccines. Routine hepatitis B vaccination was recommended for some U.S. adults and children beginning in 1982, and for all children in Since 1990, new hepatitis B infections among children and adolescents have dropped by more than 95% and by 75% in other age groups. Vaccination gives long-term protection from hepatitis B infection, possibly lifelong. 3 Who should get hepatitis B vaccine and when? Children and Adolescents Babies normally get 3 doses of hepatitis B vaccine: 1st Dose: Birth 2nd Dose: 1-2 months of age 3rd Dose: 6-18 months of age Some babies might get 4 doses, for example, if a combination vaccine containing hepatitis B is used. (This is a single shot containing several vaccines.) The extra dose is not harmful. Anyone through 18 years of age who didn t get the vaccine when they were younger should also be vaccinated. Adults All unvaccinated adults at risk for hepatitis B infection should be vaccinated. This includes: - sex partners of people infected with hepatitis B, - men who have sex with men, - people who inject street drugs, - people with more than one sex partner, - people with chronic liver or kidney disease, - people under 60 years of age with diabetes, - people with jobs that expose them to human blood or other body fluids, 146

148 - household contacts of people infected with hepatitis B, - residents and staff in institutions for the developmentally disabled, - kidney dialysis patients, - people who travel to countries where hepatitis B is common, - people with HIV infection. Other people may be encouraged by their doctor to get hepatitis B vaccine; for example, adults 60 and older with diabetes. Anyone else who wants to be protected from hepatitis B infection may get the vaccine. Pregnant women who are at risk for one of the reasons stated above should be vaccinated. Other pregnant women who want protection may be vaccinated. Adults getting hepatitis B vaccine should get 3 doses with the second dose given 4 weeks after the first and the third dose 5 months after the second. Your doctor can tell you about other dosing schedules that might be used in certain circumstances. 4 5 Who should not get hepatitis B vaccine? Anyone with a life-threatening allergy to yeast, or to any other component of the vaccine, should not get hepatitis B vaccine. Tell your doctor if you have any severe allergies. Anyone who has had a life-threatening allergic reaction to a previous dose of hepatitis B vaccine should not get another dose. Anyone who is moderately or severely ill when a dose of vaccine is scheduled should probably wait until they recover before getting the vaccine. Your doctor can give you more information about these precautions. Note: You might be asked to wait 28 days before donating blood after getting hepatitis B vaccine. This is because the screening test could mistake vaccine in the bloodstream (which is not infectious) for hepatitis B infection. What are the risks from hepatitis B vaccine? Hepatitis B is a very safe vaccine. Most people do not have any problems with it. The vaccine contains non-infectious material, and cannot cause hepatitis B infection. Some mild problems have been reported: Soreness where the shot was given (up to about 1 person in 4). Temperature of 99.9 F or higher (up to about 1 person in 15). Severe problems are extremely rare. Severe allergic reactions are believed to occur about once in 1.1 million doses. A vaccine, like any medicine, could cause a serious reaction. But the risk of a vaccine causing serious harm, or death, is extremely small. More than 100 million people in the United States have been vaccinated with hepatitis B vaccine. 6 What if there is a moderate or severe reaction? What should I look for? Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? Call a doctor, or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at or by calling VAERS does not provide medical advice. 7 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Ask your doctor They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Hepatitis B Vaccine 2/2/ U.S.C. 300aa-26 Office Use Only 147

149 Vacuna contra la hepatitis B Lo que usted necesita saber DECLARACIÓN DE INFORMACIÓN SOBRE VACUNAS Muchas de las declaraciones informativas sobre vacunas están disponibles en español y otros idiomas. Consulte Las hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite 1 Qué es la hepatitis B? La hepatitis B es una infección grave que afecta al hígado y que es causada por el virus de la hepatitis B. En 2009, alrededor de 38,000 personas se infectaron con hepatitis B. Cada año entre 2,000 y 4,000 personas mueren en los Estados Unidos de cirrosis o cáncer hepático causado por hepatitis B. La hepatitis B puede causar: Enfermedad aguda (a corto plazo). Esto puede dar lugar a: pérdida del apetito diarrea y vómitos cansancio ictericia (coloración amarilla dolor en los músculos, de la piel o los ojos) en las articulaciones y en el estómago La enfermedad aguda, con síntomas, es más común entre los adultos. Los niños que se infectan con frecuencia no presentan síntomas. Infección crónica (a largo plazo). Algunas personas llegan a desarrollar infección crónica de hepatitis B. La mayoría de ellas no tienen síntomas, pero aún así la infección es muy grave y puede resultar en: daño hepático (cirrosis) cáncer hepático muerte La infección crónica es más común entre bebés y niños que entre adultos. Las personas que tienen una infección crónica pueden contagiar el virus de la hepatitis B a otras personas, incluso aunque no se vean o no se sientan enfermas. Hasta 1.4 millones de personas en los Estados Unidos pueden tener una infección crónica de hepatitis B. El virus de la hepatitis B se puede diseminar fácilmente a través de contacto con la sangre o con otros fluidos corporales de una persona infectada. Las personas también se pueden infectar por medio del contacto con un objeto contaminado, en donde el virus puede vivir hasta 7 días. Un bebé cuya madre esté infectada puede contagiarse al nacer; Los niños, adolescentes y adultos se pueden infectar por: - contacto con sangre y fluidos corporales a través de cortadas en la piel como mordidas, cortes o úlceras; - contacto con objetos que tengan sangre o fluidos corporales en ellos como cepillos de dientes, navajas de rasurar, o dispositivos de monitoreo y tratamiento para la diabetes; - tener relaciones sexuales sin protección con una persona infectada; - compartir agujas al inyectarse drogas; - pincharse con una aguja usada. 2 Vacuna contra la hepatitis B: Por qué es necesario vacunarse? La vacuna contra la hepatitis B puede prevenir la hepatitis B y las graves consecuencias de la infección por hepatitis B, incluyendo el cáncer hepático y la cirrosis. La vacuna contra la hepatitis B puede administrarse sola o con otras vacunas en la misma inyección. La recomendación de la aplicación rutinaria de la vacuna contra la hepatitis B para algunos adultos y niños en los EE. UU. comenzó en 1982, y para todos los niños en Desde 1990, las infecciones nuevas por hepatitis B entre niños y adolescentes han disminuido en más del 95%, y en 75% en otros grupos de edad. La vacuna ofrece protección a largo plazo contra la infección por hepatitis B, posiblemente de por vida. Quién debe vacunarse 3 contra la hepatitis B y cuándo? Niños y adolescentes Los bebés normalmente reciben 3 dosis de la vacuna contra la hepatitis B: 1 a dosis: Nacimiento 2 a dosis: 1-2 meses de edad 3 a dosis: 6-18 meses de edad Algunos bebés podrían recibir 4 dosis, por ejemplo, si se utiliza una vacuna combinada que contenga la de hepatitis B (esta es una sola inyección que contiene varias vacunas). La dosis adicional no es perjudicial. Cualquier persona hasta los 18 años de edad que no haya recibido la vacuna cuando era más joven también debe vacunarse. Adultos Todos los adultos que no estén vacunados y estén en riesgo de una infección por hepatitis B deben vacunarse. Esto incluye a: - parejas sexuales de personas infectadas con hepatitis B, - hombres que tienen relaciones sexuales con hombres, - personas que se inyectan drogas ilegales, - personas con más de una pareja sexual, - personas con una enfermedad hepática o renal crónica, - personas menores de 60 años de edad con diabetes, - personas cuya actividad laboral las expongan a sangre humana o a otros fluidos corporales, - integrantes del hogar de personas infectadas con hepatitis B, - residentes y miembros del personal en instituciones para discapacidades relacionadas a problemas de desarrollo, Hepatitis B VIS - Spanish (2/2/12) 148

150 - pacientes con diálisis renal, - personas que viajan a países en donde la hepatitis B es común, - personas con infección por VIH. Otras personas pueden ser alentadas por sus médicos para aplicarse la vacuna contra la hepatitis B; por ejemplo, los adultos de 60 años y mayores que padecen de diabetes. Cualquier otra persona que quiera estar protegida contra la infección por hepatitis B puede aplicarse la vacuna. Las mujeres embarazadas que estén en riesgo por una de las razones antes mencionadas deben vacunarse. Otras mujeres embarazadas que quieran protección pueden vacunarse. Los adultos que se vacunen contra la hepatitis B deben ponerse 3 dosis, con la segunda dosis administrada 4 semanas después de la primera y la tercera dosis 5 meses después de la segunda. Su médico puede hablarle de otros esquemas de administración que podrían emplearse en ciertas circunstancias. 4 5 Quién no debe aplicarse la vacuna contra la hepatitis B? Cualquier persona con alergia a la levadura que pueda poner en peligro la vida o que sea alérgica a cualquier otro componente de la vacuna, no debe ponerse la vacuna contra la hepatitis B. Informe a su médico si ha tenido alguna alergia severa. Cualquier persona que haya tenido una reacción alérgica que pueda poner en peligro la vida a una dosis anterior de la vacuna contra la hepatitis B no debe aplicarse otra dosis. Cualquier persona con una enfermedad moderada o severa en el momento de aplicarse una dosis de la vacuna probablemente deba esperar hasta que esté recuperada antes de aplicarse la vacuna. Su médico puede ofrecerle más información acerca de estas precauciones. Nota: tal vez le pidan que espere 28 días antes de donar sangre después de aplicarse la vacuna contra la hepatitis B. Esto se debe a que la prueba de detección podría confundir la vacuna en el torrente sanguíneo (que no es infecciosa) con la infección por hepatitis B. Cuáles son los riesgos de la vacuna contra la hepatitis B? La vacuna contra la hepatitis B es muy segura. La mayoría de las personas no tienen problemas con ella. La vacuna contiene material no infeccioso y no puede causar una infección por hepatitis B. Se han reportado algunos problemas leves: Dolor en el lugar donde se aplicó la inyección (hasta 1 de cada 4 personas). Temperatura de 37.7 C (99.9 F) o superior (hasta 1 de cada 15 personas). Los problemas severos son extremadamente raros. Se cree que las reacciones alérgicas severas ocurren aproximadamente una vez en 1.1 millones de dosis. Una vacuna, como cualquier medicamento, puede provocar una reacción grave. Sin embargo, el riesgo de que la vacuna ocasione un daño grave, o la muerte, es extremadamente pequeño. Más de 100 millones de personas en los Estados Unidos han sido vacunadas contra la hepatitis B. 6 7 Qué hago si ocurre una reacción moderada o severa? De qué debo estar pendiente? De todo signo inusual, como fiebre alta o comportamiento inusual. Los signos de una reacción alérgica grave pueden incluir dificultad para respirar, ronquera o jadeo, urticaria, palidez, debilidad, pulso acelerado o mareos. Qué debo hacer? Llame a un médico o lleve a la persona al médico de inmediato. Dígale al médico lo que ocurrió, la fecha y la hora en la que ocurrió, y cuándo le pusieron la vacuna. Pida al médico, al personal de enfermería o al departamento de salud que reporten la reacción presentando un formulario del Sistema de reporte de eventos adversos derivados de las vacunas (Vaccine Adverse Event Reporting System, VAERS). O puede presentar este reporte a través del sitio web de VAERS: o llamando al El VAERS no ofrece consejos médicos. Programa Nacional de Compensación por Lesiones ocasionadas por Vacunas En 1986 se creó el Programa Nacional de Compensación por Lesiones Ocasionadas por Vacunas (National Vaccine Injury Compensation Program, VICP). Las personas que consideren que pueden haber tenido lesiones ocasionadas por una vacuna pueden informarse sobre el programa y sobre cómo presentar una reclamación llamando al o visitando el sitio web del VICP en: Dónde puedo obtener más 8 información? Consulte a su médico, él puede proporcionarle el folleto informativo de la vacuna o sugerirle otras fuentes de información. Llame al departamento de salud local o estatal. Comuníquese con los Centros para el Control y la Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC): - Llame al (1-800-CDC-INFO) o - Visite el sitio web de los CDC en Vaccine Information Statement (Interim) Hepatitis B Vaccine 2/2/2012 Spanish 42 U.S.C. 300aa Translation provided by the Immunization Action Coalition

151 VIRAL HEPATITIS Information for Gay/Bisexual Men Policy Number: 6g What is hepatitis? Hepatitis means inflammation of the liver. The liver is a vital organ that processes nutrients, filters the blood, and fights infections. When the liver is inflamed or damaged, its function can be affected. Heavy alcohol use, toxins, some medications, and certain medical conditions can cause hepatitis. Hepatitis is most often caused by a virus. In the United States, the most common types of viral hepatitis are Hepatitis A, Hepatitis B, and Hepatitis C. These are three different, contagious liver diseases caused by three unrelated viruses. Although all three types of hepatitis can cause similar symptoms, they have different modes of transmission. Acute and chronic viral hepatitis Hepatitis A appears only as an acute, or newly occurring infection, and usually lasts no more than 6 months. Although Hepatitis B and Hepatitis C can also begin as acute infections, each can develop into a chronic, or lifelong, infection. Over time, about 15% 25% of people with chronic hepatitis develop serious liver conditions, including liver damage, cirrhosis, liver failure, and even liver cancer. The best way to protect yourself from Hepatitis A and B is to get vaccinated. How is hepatitis spread? Are gay and bisexual men at risk for viral hepatitis? Yes. Among adults, an estimated 10% of new Hepatitis A cases and 20% of new Hepatitis B cases occur in gay or bisexual men Gay and bisexual men are at increased risk for Hepatitis C if they are involved in high-risk behaviors. Sharing needles or other injection drug equipment puts a person at risk for both HIV and Hepatitis C. Of people with HIV infection, 25% also have Hepatitis C. New research shows that gay men who are HIV-positive and have multiple sex partners may increase their risk for Hepatitis C. Hepatitis A is usually spread when a person ingests fecal matter even in microscopic amounts from an infected person. Among men who have sexual contact with other men, Hepatitis A can be spread through direct anal-oral contact or contact with fingers or objects that have been in or near the anus of an infected person. Hepatitis A can also be spread through contaminated food or water, which is why travelers to certain countries are at risk. Hepatitis B is spread when body fluids such as semen or blood from a person infected with the Hepatitis B virus enter the body of someone who is not infected. The Hepatitis B virus is times more infectious than HIV and is easily transmitted during sexual activity. Hepatitis B also can be spread through sharing needles, syringes, or other injection drug equipment. Hepatitis C is spread through contact with the blood of an infected person, primarily through sharing needles, syringes, or other injection drug equipment. Hepatitis C can also be spread through sexual contact, although scientists do not know how frequently this occurs. Having a sexually transmitted disease or HIV, sex with multiple partners, or rough sex appears to increase a person s risk for Hepatitis C. 150

152 Is viral hepatitis common? Yes. Each year, about 70,000 Americans become infected with one type of acute viral hepatitis. In addition, an estimated 1.2 million people have chronic Hepatitis B, and 3.2 million people have chronic Hepatitis C. Of those living with chronic hepatitis, many do not know they are infected. What are the symptoms of viral hepatitis? Should I be vaccinated? Yes. Experts recommend that all gay and bisexual men be vaccinated for Hepatitis A and B. The Hepatitis A and B vaccines can be given separately or as a combination vaccine. The vaccines are safe, effective, and require 2 3 shots given over a period of 6 months depending on the type of vaccine. A person should complete all shots in the series for long-term protection. Booster doses are not currently recommended. There is no vaccine for Hepatitis C. The best way to prevent Hepatitis C is by avoiding behaviors that can spread the disease, especially sharing needles or other equipment to inject drugs. Should I be tested? It depends upon the type of hepatitis and a person s risk factors. Testing is not recommended for Hepatitis A. Testing is recommended for Hepatitis B. If at all possible, gay and bisexual men should be tested for Hepatitis B at the same time they get their first dose of vaccine. If tests indicate that a man has never been infected, then vaccination will protect him. If tests show that he has recovered from a past infection, he is now immune, and the vaccine offers no added benefit. If tests indicate he is chronically infected, the vaccine offers no protection, and he should get a thorough medical evaluation. Since people infected with Hepatitis B are capable of spreading the virus to others, their sexual partners should also be tested. Testing for Hepatitis C is not recommended unless a person is engaging in risky behaviors or has HIV infection. Many people with viral hepatitis do not have symptoms and do not know they are infected. Even though a person has no symptoms, the virus can still be detected in the blood. Symptoms, if they do appear, are similar for all types of hepatitis. If symptoms occur with acute viral hepatitis, they usually appear within several weeks to several months of exposure and can last up to 6 months. Symptoms of chronic viral hepatitis can take up to 30 years to develop. Damage to the liver can silently occur during this time. When symptoms do appear, they often are a sign of advanced liver disease. Symptoms for both acute and chronic viral hepatitis can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, greycolored stools, joint pain, and jaundice. How is viral hepatitis diagnosed and treated? Doctors diagnose hepatitis using one or more blood tests, depending on the type of hepatitis. For people with acute viral hepatitis, doctors usually recommend rest, adequate nutrition, fluids, and in certain situations, antiviral medication. In some cases, people with acute viral hepatitis are hospitalized. People who have acute hepatitis typically feel sick for a few months before they recover. People with chronic viral hepatitis should seek the advice of a doctor experienced in treating Hepatitis B or Hepatitis C and should be monitored on a regular basis. Some may also benefit from antiviral medication. Several treatments are available that can significantly improve health and delay or reverse the effects of liver disease. For more information Talk to your health professional, call your health department, or visit DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention Division of Viral Hepatitis Publication No June 2010

153 Current Dates of Vaccine Information Statements (VISs) as of February 27, 2013 Check your supply of VISs against this list. If you have outdated VISs, get current versions at Adenovirus...7/14/11 Anthrax...3/10/10 Chickenpox...3/13/08 DTaP...5/17/07 Hib...12/16/98 Hepatitis A...10/25/11 Hepatitis B...2/2/12 HPV-Cervarix...5/3/11 HPV-Gardasil...2/22/12 Influenza...7/2/12 Japanese enceph...12/7/11 MMR...4/20/12 MMRV...5/21/10 Meningococcal...10/14/11 Multi-vaccine...11/16/12 PCV13...2/27/13 PPSV...10/6/09 Polio...11/8/11 Rabies...10/6/09 Rotavirus...12/6/10 Shingles...10/6/09 Td/Tdap...1/24/12 Typhoid...5/29/12 Yellow fever...3/30/11 Current Dates of Vaccine Information Statements (VISs) as of February 27, 2013 Check your supply of VISs against this list. If you have outdated VISs, get current versions at Adenovirus...7/14/11 Anthrax...3/10/10 Chickenpox...3/13/08 DTaP...5/17/07 Hib...12/16/98 Hepatitis A...10/25/11 Hepatitis B...2/2/12 HPV-Cervarix...5/3/11 HPV-Gardasil...2/22/12 Influenza...7/2/12 Japanese enceph...12/7/11 MMR...4/20/12 MMRV...5/21/10 Meningococcal...10/14/11 Multi-vaccine...11/16/12 PCV13...2/27/13 PPSV...10/6/09 Polio...11/8/11 Rabies...10/6/09 Rotavirus...12/6/10 Shingles...10/6/09 Td/Tdap...1/24/12 Typhoid...5/29/12 Yellow fever...3/30/11 Immunization Action Coalition Item #P2029 (3/13) Current Dates of Vaccine Information Statements (VISs) as of February 27, 2013 Check your supply of VISs against this list. If you have outdated VISs, get current versions at Adenovirus...7/14/11 Anthrax...3/10/10 Chickenpox...3/13/08 DTaP...5/17/07 Hib...12/16/98 Hepatitis A...10/25/11 Hepatitis B...2/2/12 HPV-Cervarix...5/3/11 HPV-Gardasil...2/22/12 Influenza...7/2/12 Japanese enceph...12/7/11 MMR...4/20/12 MMRV...5/21/10 Meningococcal...10/14/11 Multi-vaccine...11/16/12 PCV13...2/27/13 PPSV...10/6/09 Polio...11/8/11 Rabies...10/6/09 Rotavirus...12/6/10 Shingles...10/6/09 Td/Tdap...1/24/12 Typhoid...5/29/12 Yellow fever...3/30/11 Immunization Action Coalition Item #P2029 (3/13) Current Dates of Vaccine Information Statements (VISs) as of February 27, 2013 Check your supply of VISs against this list. If you have outdated VISs, get current versions at Adenovirus...7/14/11 Anthrax...3/10/10 Chickenpox...3/13/08 DTaP...5/17/07 Hib...12/16/98 Hepatitis A...10/25/11 Hepatitis B...2/2/12 HPV-Cervarix...5/3/11 HPV-Gardasil...2/22/12 Influenza...7/2/12 Japanese enceph...12/7/11 MMR...4/20/12 MMRV...5/21/10 Meningococcal...10/14/11 Multi-vaccine...11/16/12 PCV13...2/27/13 PPSV...10/6/09 Polio...11/8/11 Rabies...10/6/09 Rotavirus...12/6/10 Shingles...10/6/09 Td/Tdap...1/24/12 Typhoid...5/29/12 Yellow fever...3/30/11 Immunization Action Coalition Item #P2029 (3/13) Immunization Action Coalition Item #P2029 (3/13)

154 Patient name: Date of birth: (mo.) (day) (yr.) Screening Checklist for Contraindications to Vaccines for Adults For patients: The following questions will help us determine which vaccines you may be given today. If you answer yes to any question, it does not necessarily mean you should not be vaccinated. It just means additional questions must be asked. If a question is not clear, please ask your healthcare provider to explain it. 1. Are you sick today? 2. Do you have allergies to medications, food, a vaccine component, or latex? Yes No Don t Know 3. Have you ever had a serious reaction after receiving a vaccination? 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g., diabetes), anemia, or other blood disorder? 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? 6. In the past 3 months, have you taken medications that weaken your immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or have you had radiation treatments? 7. Have you had a seizure or a brain or other nervous system problem? 8. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? 9. For women: Are you pregnant or is there a chance you could become pregnant during the next month? 10. Have you received any vaccinations in the past 4 weeks? Form completed by: Form reviewed by: Date: Date: Did you bring your immunization record card with you? yes no It is important for you to have a personal record of your vaccinations. If you don t have a personal record, ask your healthcare provider to give you one. Keep this record in a safe place and bring it with you every time you seek medical care. Make sure your healthcare provider records all your vaccinations on it. Technical content reviewed by the Centers for Disease Control and Prevention Item#P4065 (10/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

155 Information for Health Professionals about the Screening Checklist for Contraindications To Vaccines for Adults Are you interested in knowing why we included a certain question on the screening checklist? If so, read the information below. If you want to find out even more, consult the references listed at the bottom of this page. 1. Are you sick today? [all vaccines] There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse events (1). However, as a precaution with moderate or severe acute illness, all vaccines should be delayed until the illness has improved. Mild illnesses (such as upper respiratory infections or diarrhea) are NOT contraindications to vaccination. Do not withhold vaccination if a person is taking antibiotics. 2. Do you have allergies to medications, food, a vaccine component, or latex? [all vaccines] If a person reports they have an allergy to egg, ask if they can eat lightly cooked eggs (e.g., scrambled eggs). If they can, trivalent influenza vaccine (TIV) may be administered. If after eating eggs or egg-containing foods, they have a reaction consisting of only hives, TIV may be given and the person should be observed for at least 30 minutes. If a person experiences a serious systemic or anaphylactic reaction (e.g., hives and either swelling of the lips or tongue, acute respiratory distress, or collapse) after eating eggs, do not administer TIV or live attenuated influenza vaccine (LAIV). It is possible that they may be eligible to be given TIV, but only after they have seen a physician with expertise in the management of allergic conditions. If a person has anaphylaxis after eating gelatin, do not administer MMR or varicella vaccine. Local reactions are not contraindications. For a table of vaccines supplied in vials or syringes that contain latex, go to pinkbook/downloads/appendices/b/latex-table.pdf. For an extensive list of vaccine components, see reference Have you ever had a serious reaction after receiving a vaccination? [all vaccines] History of anaphylactic reaction (see question 2) to a previous dose of vaccine or vaccine component is a contraindication for subsequent doses (1). Under normal circumstances, vaccines are deferred when a precaution is present. However, situations may arise when the benefit outweighs the risk (e.g., during a community pertussis outbreak). 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g., diabetes), anemia, or other blood disorder? [LAIV] People with any of these health conditions should not be given the intranasal live attenuated influenza vaccine (LAIV). Instead, they should be vaccinated with the injectable influenza vaccine. 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? [LAIV, MMR, VAR, ZOS] Live virus vaccines (e.g., LAIV, measles-mumps-rubella [MMR], varicella [VAR], zoster [ZOS]) are usually contraindicated in immunocompromised people. However, there are exceptions. For example, MMR vaccine is recommended and varicella vaccine should be considered for adults with CD4+ T-lymphocyte counts of greater than or equal to 200 cells/µl. Immunosuppressed people should not receive LAIV. For details, consult the ACIP recommendations (3, 4, 5). 6. In the past 3 months, have you taken medications that weaken your immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or have you had radiation treatments? [LAIV, MMR, VAR, ZOS] Live virus vaccines (e.g., LAIV, MMR, VAR, ZOS) should be postponed until after chemotherapy or long-term high-dose steroid therapy has ended. For details and length of time to postpone, consult the ACIP statement (1, 5). To find specific vaccination schedules for stem cell transplant (bone marrow transplant) patients, see reference 6. LAIV can be given only to healthy nonpregnant people younger than age 50 years. 7. Have you had a seizure or a brain or other nervous system problem? [influenza, Td/Tdap] Tdap is contraindicated in people who have a history of encephalopathy within 7 days following DTP/DTaP given before age 7 years. An unstable progressive neurologic problem is a precaution to the use of Tdap. For people with stable neurologic disorders (including seizures) unrelated to vaccination, or for people with a family history of seizure, vaccinate as usual. A history of Guillain-Barré syndrome (GBS) is a consideration with the following: 1) Td/Tdap: if GBS has occurred within 6 weeks of a tetanus-containing vaccine and decision is made to continue vaccination, give Tdap instead of Td if no history of prior Tdap; 2) Influenza vaccine (TIV/LAIV): if GBS has occurred within 6 weeks of a prior influenza vaccine, vaccinate with TIV if at high risk for severe influenza complications. 8. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? [LAIV, MMR, VAR] Certain live virus vaccines (e.g., LAIV, MMR, VAR) may need to be deferred, depending on several variables. Consult the most current ACIP recommendations for current information on intervals between antiviral drugs, immune globulin or blood product administration and live virus vaccines. (1) 9. For women: Are you pregnant or is there a chance you could become pregnant during the next month? [MMR, LAIV, VAR, ZOS] Live virus vaccines (e.g., MMR, VAR, ZOS, LAIV) are contraindicated one month before and during pregnancy because of the theoretical risk of virus transmission to the fetus. Sexually active women in their childbearing years who receive live virus vaccines should be instructed to practice careful contraception for one month following receipt of the vaccine. On theoretical grounds, inactivated poliovirus vaccine should not be given during pregnancy; however, it may be given if risk of disease is imminent and immediate protection is needed (e.g., travel to endemic areas). Use of Td or Tdap is not contraindicated in pregnancy. At the provider s discretion, either vaccine may be administered during the 2nd or 3rd trimester. (1, 3, 4, 5, 7, 8) 10. Have you received any vaccinations in the past 4 weeks? [LAIV, MMR, VAR, yellow fever] If the person to be vaccinated was given either LAIV or an injectable live virus vaccine (e.g., MMR, VAR, ZOS, yellow fever) in the past 4 weeks, they should wait 28 days before receiving another vaccination of this type. Inactivated vaccines may be given at any spacing interval if they are not administered simultaneously. References: 1. CDC. General recommendations on immunization, at 2. Table of Vaccine Components: excipient-table-2.pdf. 3. CDC. Measles, mumps, and rubella vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps. MMWR 1998; 47 (RR-8). 4. CDC. Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2007; 56 (RR-4). 5. CDC. Prevention and control of influenza recommendations of ACIP, at 6. CDC. Excerpt from Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients, MMWR 2000; 49 (RR-10), 7. CDC. Notice to readers: Revised ACIP recommendation for avoiding pregnancy after receiving a rubella-containing vaccine. MMWR 2001; 50 (49). 8. CDC. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants: Recommendations of the ACIP. MMWR 2008; 57 (RR-4). 154 Immunization Action Coalition Item #P4065 p. 2

156 Nombre del paciente: Fecha de nacimiento: (mes) (día) (año) Cuestionario de contraindicaciones para vacunación de adultos A los pacientes: Las siguientes preguntas nos ayudarán a determinar cuáles vacunas le podemos dar hoy. Si contesta sí a alguna pregunta, eso no siempre quiere decir que no lo deben vacunar. Simplemente quiere decir que hay que hacerle más preguntas. Si alguna pregunta no está clara, pida a su profesional de la salud que se la explique. 1. Está enfermo hoy? 2. Es alérgico a algún medicamento, alimento, a algún componente de las vacunas o al látex? 3. Tuvo alguna vez una reacción seria después de vacunarse? Sí No No sabe 4. Tiene algún problema de salud a largo plazo, como enfermedad del corazón, enfermedad de los pulmones, asma, enfermedad de los riñones, enfermedad metabólica (como la diabetes), anemia o algún otro trastorno de la sangre? 5. Tiene cáncer, leucemia, VIH/SIDA o algún otro problema del sistema inmunológico? 6. En los últimos 3 meses, ha tomado medicamentos que debiliten su sistema inmunológico, tales como cortisona, prednisona, otros esteroides o medicamentos contra el cáncer, o le han hecho tratamientos de radiación? 7. Tuvo alguna vez convulsiones o problemas del cerebro o algún otro problema del sistema nervioso? 8. Durante el año pasado, le hicieron una transfusión de sangre o de productos de la sangre, o le dieron inmunoglobulina o gamaglobulina o un medicamento antiviral? 9. Para las mujeres: Está embarazada o hay alguna posibilidad de que quede embarazada en el próximo mes? 10. Le aplicaron alguna vacuna en las últimas 4 semanas? Formulario llenado por: Formulario revisado por: Fecha: _ Fecha: Trajo su comprobante de vacunación? sí no Es importante que tenga un comprobante de vacunación personal. Si no lo tiene, pídale a su profesional de la salud que le dé uno. Guárdelo en un lugar seguro y llévelo todas las veces que reciba atención médica. Asegúrese de que su profesional de la salud escriba allí todas las vacunas que reciba. Translation by Transcend, Davis, CA Item#P Spanish (10/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

157 Information for Health Professionals about the Screening Checklist for Contraindications To Vaccines for Adults Are you interested in knowing why we included a certain question on the screening checklist? If so, read the information below. If you want to find out even more, consult the references listed at the bottom of this page. 1. Are you sick today? [all vaccines] There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse events (1). However, as a precaution with moderate or severe acute illness, all vaccines should be delayed until the illness has improved. Mild illnesses (such as upper respiratory infections or diarrhea) are NOT contraindications to vaccination. Do not withhold vaccination if a person is taking antibiotics. 2. Do you have allergies to medications, food, a vaccine component, or latex? [all vaccines] If a person reports they have an allergy to egg, ask if they can eat lightly cooked eggs (e.g., scrambled eggs). If they can, trivalent influenza vaccine (TIV) may be administered. If after eating eggs or egg-containing foods, they have a reaction consisting of only hives, TIV may be given and the person should be observed for at least 30 minutes. If a person experiences a serious systemic or anaphylactic reaction (e.g., hives and either swelling of the lips or tongue, acute respiratory distress, or collapse) after eating eggs, do not administer TIV or live attenuated influenza vaccine (LAIV). It is possible that they may be eligible to be given TIV, but only after they have seen a physician with expertise in the management of allergic conditions. If a person has anaphylaxis after eating gelatin, do not administer MMR or varicella vaccine. Local reactions are not contraindications. For a table of vaccines supplied in vials or syringes that contain latex, go to pinkbook/downloads/appendices/b/latex-table.pdf. For an extensive list of vaccine components, see reference Have you ever had a serious reaction after receiving a vaccination? [all vaccines] History of anaphylactic reaction (see question 2) to a previous dose of vaccine or vaccine component is a contraindication for subsequent doses (1). Under normal circumstances, vaccines are deferred when a precaution is present. However, situations may arise when the benefit outweighs the risk (e.g., during a community pertussis outbreak). 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g., diabetes), anemia, or other blood disorder? [LAIV] People with any of these health conditions should not be given the intranasal live attenuated influenza vaccine (LAIV). Instead, they should be vaccinated with the injectable influenza vaccine. 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? [LAIV, MMR, VAR, ZOS] Live virus vaccines (e.g., LAIV, measles-mumps-rubella [MMR], varicella [VAR], zoster [ZOS]) are usually contraindicated in immunocompromised people. However, there are exceptions. For example, MMR vaccine is recommended and varicella vaccine should be considered for adults with CD4+ T-lymphocyte counts of greater than or equal to 200 cells/µl. Immunosuppressed people should not receive LAIV. For details, consult the ACIP recommendations (3, 4, 5). 6. In the past 3 months, have you taken medications that weaken your immune system, such as cortisone, prednisone, other steroids, or anticancer drugs, or have you had radiation treatments? [LAIV, MMR, VAR, ZOS] Live virus vaccines (e.g., LAIV, MMR, VAR, ZOS) should be postponed until after chemotherapy or long-term high-dose steroid therapy has ended. For details and length of time to postpone, consult the ACIP statement (1, 5). To find specific vaccination schedules for stem cell transplant (bone marrow transplant) patients, see reference 6. LAIV can be given only to healthy nonpregnant people younger than age 50 years. 7. Have you had a seizure or a brain or other nervous system problem? [influenza, Td/Tdap] Tdap is contraindicated in people who have a history of encephalopathy within 7 days following DTP/DTaP given before age 7 years. An unstable progressive neurologic problem is a precaution to the use of Tdap. For people with stable neurologic disorders (including seizures) unrelated to vaccination, or for people with a family history of seizure, vaccinate as usual. A history of Guillain-Barré syndrome (GBS) is a consideration with the following: 1) Td/Tdap: if GBS has occurred within 6 weeks of a tetanus-containing vaccine and decision is made to continue vaccination, give Tdap instead of Td if no history of prior Tdap; 2) Influenza vaccine (TIV/LAIV): if GBS has occurred within 6 weeks of a prior influenza vaccine, vaccinate with TIV if at high risk for severe influenza complications. 8. During the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or an antiviral drug? [LAIV, MMR, VAR] Certain live virus vaccines (e.g., LAIV, MMR, VAR) may need to be deferred, depending on several variables. Consult the most current ACIP recommendations for current information on intervals between antiviral drugs, immune globulin or blood product administration and live virus vaccines. (1) 9. For women: Are you pregnant or is there a chance you could become pregnant during the next month? [MMR, LAIV, VAR, ZOS] Live virus vaccines (e.g., MMR, VAR, ZOS, LAIV) are contraindicated one month before and during pregnancy because of the theoretical risk of virus transmission to the fetus. Sexually active women in their childbearing years who receive live virus vaccines should be instructed to practice careful contraception for one month following receipt of the vaccine. On theoretical grounds, inactivated poliovirus vaccine should not be given during pregnancy; however, it may be given if risk of disease is imminent and immediate protection is needed (e.g., travel to endemic areas). Use of Td or Tdap is not contraindicated in pregnancy. At the provider s discretion, either vaccine may be administered during the 2nd or 3rd trimester. (1, 3, 4, 5, 7, 8) 10. Have you received any vaccinations in the past 4 weeks? [LAIV, MMR, VAR, yellow fever] If the person to be vaccinated was given either LAIV or an injectable live virus vaccine (e.g., MMR, VAR, ZOS, yellow fever) in the past 4 weeks, they should wait 28 days before receiving another vaccination of this type. Inactivated vaccines may be given at any spacing interval if they are not administered simultaneously. References: 1. CDC. General recommendations on immunization, at 2. Table of Vaccine Components: excipient-table-2.pdf. 3. CDC. Measles, mumps, and rubella vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps. MMWR 1998; 47 (RR-8). 4. CDC. Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2007; 56 (RR-4). 5. CDC. Prevention and control of influenza recommendations of ACIP, at 6. CDC. Excerpt from Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients, MMWR 2000; 49 (RR-10), 7. CDC. Notice to readers: Revised ACIP recommendation for avoiding pregnancy after receiving a rubella-containing vaccine. MMWR 2001; 50 (49). 8. CDC. Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants: Recommendations of the ACIP. MMWR 2008; 57 (RR-4). 156 Immunization Action Coalition Item #P4065 p. 2

158 Before you vaccinate adults, consider their H-A-L-O! What is H-A-L-O? As shown below, it s an easy-to-use chart that can help you make an initial decision about vaccinating a patient based on four factors the patient s Health condition, Age, Lifestyle, and Occupation. In some situations, though, you can vaccinate a patient without considering these factors. For example, all adults need a Td booster every 10 years, and any adult who wants protection against influenza, hepatitis A, or hepatitis B can be vaccinated. Note that not all patients who mention one or more H-A-L-O factors will need to be vaccinated. Before you make a definitive decision about vaccinating your patient, it s important that you refer to the more detailed information found in the Immunization Action Coalition s Summary of Recommendations for Adult Immunization, located at or the complete recommendations from the CDC s Advisory Committee on Immunization Practices at pubs/acip-list.htm. How do I use H-A-L-O? Though some factors can be easily determined (e.g., age, pregnancy), you will need to ask your patient about the presence or absence of others. Once you determine which of the H-A-L-O factors apply, scan down each column of the chart to see at a glance which vaccinations are possibly indicated (they are shown with a check mark). H-A-L-O checklist of factors that indicate a possible need for adult vaccination Health factors Age factors Lifestyle factors Occupational or other factors Tdap HPV Varicella Zoster MMR Influenza Pneumococcal HepA HepB Vaccine Meningococcal Chronic disease!!!!! Pregnant!! History of STD Immunosuppressed (including HIV)!!!! Cochlear implant candidate/recipient! Age equal to or younger than 26 2, 49 3, or ! 2!? * Vaccination may be indicated depending on degree of immunosuppression.? *? * Age equal to or older than 50 5, 60 4, or 65 6 Born outside the U.S.! 3!!!! 4 5 6! Men who have sex with men Not in a long-term, mutually monogamous relationship User of injection or noninjection street drugs!!!!! International traveler!!! College student!!!!!!!! Parent or caregiver of a young child!!!! Healthcare worker!!!!! Certain lab workers!! Adults in institutional settings (e.g., chronic care, correctional)!!!! Technical content reviewed by the Centers for Disease Control and Prevention, July Item #P3070 (7/08) Immunization Action Coalition 1573 Selby Avenue St. Paul, MN (651)

159 Vaccinations for Adults with HIV Infection The table below shows which vaccinations you should have to protect your health if you have HIV infection. Make sure you and your healthcare provider keep your vaccinations up to date. Vaccine Hepatitis A (HepA) Hepatitis B (HepB) Human papillomavirus (HPV) Influenza Measles, mumps, rubella (MMR) Meningococcal (MCV4, MPSV4) Pneumococcal (PCV13, PPSV23) Do you need it? Maybe. You need this vaccine if you have a specific risk factor for hepatitis A virus infection* or simply want to be protected from this disease. The vaccine is usually given in 2 doses, 6 months apart. Yes! Because you are HIV positive, you are at higher risk for hepatitis B virus infection. If you haven t had a series of hepatitis B vaccinations, you need 3 doses of this vaccine. If you started the 3-dose series earlier but didn t complete it, you can simply continue from where you left off. Ask your healthcare provider if you need screening blood tests for hepatitis B. Maybe. You should be vaccinated against HPV if you are age 26 years or younger. The vaccine is given in 3 doses over 6 months. Yes! You need a flu shot every fall (or winter) for your protection and for the protection of others around you. Maybe. Most adults are already protected because they got MMR vaccine or were infected with measles, mumps, and rubella as children. If you weren t previously vaccinated, were born in 1957 or later, and have no HIV symptoms or only mild symptoms, you need at least 1 dose of MMR. If you have moderate or severe symptoms from HIV, you should not receive MMR. If you are exposed to measles, call your healthcare provider right away. If you get measles, you are at risk of developing severe complications because of your HIV infection. Maybe. Because of your HIV infection, you may be at increased risk for meningococcal disease, an uncommon but sometimes fatal bacterial infection. If you are age and a first-year college student living in a residence hall and you either have never been vaccinated or were vaccinated before age 16, you also need this vaccine. Talk to your healthcare provider about getting vaccinated against this disease. Yes! Vaccination with both types of pneumococcal vaccine is recommended for you because of your HIV infection. If you haven t been vaccinated with both of these vaccines, you should talk with your healthcare provider about how to schedule these vaccines. If you were younger than age 65 years when you were last vaccinated with PPSV23 and you are 65 years or older now, you should get another dose of PPSV23 now, provided at least 5 years have passed since your previous dose. Tetanus, diphtheria, whooping cough (pertussis)(tdap, Td) Yes! All adults need to get a 1-time dose of Tdap vaccine (the adult whooping cough vaccine). After that, you need a Td booster dose every 10 years. Consult your healthcare provider if you haven t had at least 3 tetanus- and diphtheria-containing shots sometime in your life or you have a deep or dirty wound. Varicella (Chickenpox) Zoster (shingles) Maybe. Most adults are already protected because they had chickenpox as children. However, if you are an adult born in the U.S. in 1980 or later, have no HIV symptoms or only mild symptoms, and have never had chickenpox or the vaccine, you can be vaccinated with this 2-dose series. Talk to your healthcare provider. Maybe. This vaccine is recommended for adults age 60 years and older to prevent shingles. If you have any symptoms of HIV, you should not be vaccinated. Talk to your healthcare provider. * Consult your healthcare provider to determine your level of risk for infection and your need for this vaccine. Are you planning to travel outside the United States? If so, you may need additional vaccines. The Centers for Disease Control and Prevention (CDC) provides information to assist travelers and their healthcare providers in deciding which vaccines, medications, and other measures are necessary to prevent illness and injury during international travel. Visit CDC s website at or call 800-CDC-INFO ( ). You may also consult a travel clinic or your healthcare provider. immunization action coalition Technical content reviewed by the Centers for Disease Control and Prevention IAC 1573 Selby Avenue Saint Paul, Minnesota Item #P4041 (8/12) 158 immunize.org

160 Vaccinations for Adults with Hepatitis C Infection This table shows which vaccinations you should have to protect your health if you have hepatitis C. Make sure you and your healthcare provider keep your vaccinations up to date. Vaccine Hepatitis A (HepA) Hepatitis B (HepB) Human papillomavirus (HPV) Influenza Measles, mumps, rubella (MMR) Meningococcal (MCV4, MPSV4) Pneumococcal polysaccharide (PPSV23) Do you need it? Yes! Your chronic liver disease puts you at risk for serious complications if you get infected with the hepatitis A virus. If you ve never been vaccinated against hepatitis A, you need 2 doses of this vaccine, usually spaced 6 months apart. Yes! Because of your chronic liver disease, you need to be vaccinated. If you haven t had a series of hepatitis B vaccinations, you need 3 doses of this vaccine. If you started the 3-dose series earlier but didn t complete it, you can simply continue from where you left off. Ask your healthcare provider if you need screening blood tests for hepatitis B. Maybe. You need this vaccine if you are a woman age 26 years or younger or a man age 21 years or younger. Men age 22 through 26 years with a risk condition* also need vaccination. Any other man age 22 through 26 who wants to be protected from HPV may receive this vaccine, too. The vaccine is given in 3 doses over 6 months. Yes! You need a dose every fall (or winter) for your protection and for the protection of others around you. Maybe. You need at least 1 dose of MMR if you were born in 1957 or later. You may also need a second dose.* Maybe. You need this vaccine if you have one of several health conditions* or if you are age years and a first-year college student living in a residence hall and you either have never been vaccinated or were vaccinated before age 16. Yes! This vaccine is specifically recommended for you because of your chronic liver disease. If you haven t been vaccinated, you should get 1 dose now. You need a second dose when you are age 65 years or older, provided at least 5 years have passed since your first dose. Tetanus, diphtheria, whooping cough (pertussis)(tdap, Td) Yes! You should get a 1-time dose of Tdap vaccine (the adult whooping cough vaccine). After that you need a Td booster dose every 10 years. Consult your healthcare provider if you haven t had at least 3 tetanus- and diphtheria-containing shots sometime in your life or if you have a deep or dirty wound. Varicella (Chickenpox) Zoster (shingles) Maybe. If you ve never had chickenpox, never were vaccinated, or were vaccinated but received only 1 dose, talk to your healthcare provider about getting this vaccine.* Maybe. If you are age 60 years or older, you should get a 1-time dose of this vaccine now. * Consult your healthcare provider to determine your level of risk for infection and your need for this vaccine. For more information about hepatitis C, call the CDC-INFO Contact Center at 800-CDC-INFO ( ), or visit Are you planning to travel outside the United States? If so, you may need additional vaccines. The Centers for Disease Control and Prevention (CDC) provides information to assist travelers and their healthcare providers in deciding which vaccines, medications, and other measures are necessary to prevent illness and injury during international travel. Visit CDC s website at or call 800-CDC-INFO ( ). You may also consult a travel clinic or your healthcare provider. immunization action coalition IAC immunize.org Technical content reviewed by the Centers for Disease Control and Prevention 1573 Selby Avenue Saint Paul, Minnesota Item #P4042 (8/12) 159

161 Vaccinations for Adults with Diabetes The table below shows which vaccinations you should have to protect your health if you have diabetes. Make sure you and your healthcare provider keep your vaccinations up to date. Vaccine Hepatitis A (HepA) Hepatitis B (HepB) Human papillomavirus (HPV) Influenza Measles, mumps, rubella (MMR) Meningococcal (MCV4, MPSV4) Pneumococcal (PCV13, PPSV23) Tetanus, diphtheria, and whooping cough (pertussis, Tdap, Td) Varicella (Chickenpox) Zoster (shingles) Do you need it? Maybe. You need this vaccine if you have a specific risk factor for hepatitis A virus infection* or simply want to be protected from this disease. The vaccine is usually given in 2 doses, 6 months apart. Yes! If you are younger than 60 and have never received or completed a series of HepB vaccine, you need to be vaccinated now. If you are 60 or older, discuss your need for HepB vaccine with your healthcare provider. Maybe. You need this vaccine if you are a woman age 26 or younger or a man age 21 or younger. Men age 22 through 26 with a risk condition* also need vaccination. Any other man age 22 through 26 who wants to be protected from HPV may receive it, too. The vaccine is given in 3 doses over 6 months. Yes! You need a flu shot every fall (or winter) for your protection and for the protection of others around you. Maybe. You need at least 1 dose of MMR if you were born in 1957 or later. You may also need a second dose.* Maybe. You need this vaccine if you have one of several health conditions, or if you are and a first-year college student living in a residence hall and you either have never been vaccinated or were vaccinated before age 16.* Yes! People with diabetes need to get vaccinated with the pneumococcal polysaccharide vaccine (PPSV23). If you are younger than 65, you will need to get another dose when you are 65 or older, as long as it s been at least 5 years since your previous dose. Adults with certain high risk conditions also need vaccination with PCV13. Talk to your healthcare provider to find out if you need this vaccine.* Yes! All adults need to get a 1-time dose of Tdap vaccine (the adult whooping cough vaccine). After that, you need a Td booster dose every 10 years. Consult your healthcare provider if you haven t had at least 3 tetanus- and diphtheria-containing shots sometime in your life or you have a deep or dirty wound. Maybe. If you are an adult born in the U.S. in 1980 or later, and have never had chickenpox or the vaccine, you should be vaccinated with this 2-dose series. Maybe. If you are 60 or older, you should get a 1-time dose of this vaccine now. * Consult your healthcare provider to determine your level of risk for infection and your need for this vaccine. If you will be traveling outside the United States, you may need additional vaccines. For information, consult your healthcare provider, a travel clinic, or the Centers for Disease Control and Prevention at immunization action coalition Technical content reviewed by the Centers for Disease Control and Prevention IAC 1573 Selby Avenue Saint Paul, Minnesota Item #P4043 (1/13) immunize.org 160

162 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT Vaccine Assessment for Adult Patients with Bleeding POLICY NUMBER: TITLE: Disorders 6n APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 1 SIGNATURE OF APPROVAL: TITLE SIGNER: Individuals with a bleeding disorder who are receiving anticoagulant therapy may develop a hematoma in IM injection sites. When any intramuscularly administered vaccine is indicated for a patient with a bleeding disorder, the vaccine should be administered intramuscularly if a physician familiar with the patient s bleeding risk determines that the vaccine can be administered by this route with reasonable safety. Prior to administration of IM vaccines, the patient or family should be instructed about the risk of hematoma formation from the injection. If the patient periodically receives anti-hemophilia or similar therapy, IM vaccine administration should be scheduled shortly after such therapy is administered. A 23-gauge or finer needle should be used and firm pressure applied to the site for at least 2 minutes after injection. The site should not be rubbed or massaged. Patients receiving anticoagulation therapy presumably have the same bleeding risk as patients with clotting factor disorders and providers should follow the same guidelines for intramuscular administration

163 (Page 1 of 2) Vaccine Administration Record for Adults Patient name: Birthdate: Chart number: Before administering any vaccines, give the patient copies of all pertinent Vaccine Information Statements (VISs) and make sure he/she understands the risks and benefits of the vaccine(s). Always provide or update the patient s personal record card. Vaccine Type of Vaccine 1 Date given (mo/day/yr) Funding source (F,S,P) 2 Site 3 Vaccine Vaccine Information Vaccinator Statement (VIS) 5 (signature or Lot # Mfr. Date on VIS 4 Date given 4 initials & title) Tetanus, Diphtheria, Pertussis (e.g., Td, Tdap) Give IM. 6 Hepatitis A 7 (e.g., HepA, HepA-HepB) Give IM. 6 Hepatitis B 7 (e.g., HepB, HepA-HepB) Give IM. 6 Human papillomavirus (HPV2, HPV4) Give IM. 6 Measles, Mumps, Rubella (MMR) Give SC. 6 Varicella (VAR) Give SC. 6 Pneumococcal polysaccharide (PPSV23) Give SC or IM. 6 Meningococcal (e.g., MCV4, conjugate; MPSV4, polysaccharide) Give MCV4 IM. 6 Give MPSV4 SC. 6 See page 2 to record influenza, zoster, and other vaccines (e.g., travel vaccines). How to Complete this Record 1. Record the generic abbreviation (e.g., Tdap) or the trade name for each vaccine (see table at right). 2. Record the funding source of the vaccine given as either F (federal), S (state), or P (private). 3. Record the site where vaccine was administered as either RA (right arm), LA (left arm), RT (right thigh), LT (left thigh), or IN (intranasal). 4. Record the publication date of each VIS as well as the date the VIS is given to the patient. 5. To meet the space constraints of this form and federal requirements for documentation, a healthcare setting may want to keep a reference list of vaccinators that includes their initials and titles. 6. IM is the abbreviation for intramuscular; SC is the abbreviation for subcutaneous. 7. For combination vaccines, fill in a row for each antigen in the combination. Abbreviation Tdap Td HepA HepB HepA-HepB HPV2 HPV4 MMR VAR PPSV23 MCV4 MPSV4 Trade Name & Manufacturer Adacel (sanofi pasteur), Boostrix (GlaxoSmithKline [GSK]) Decavac (sanofi pasteur), generic (MA Biological Labs) Havrix (GSK); Vaqta (Merck) Engerix-B (GSK), Recombivax HB (Merck) Twinrix (GSK) Cervarix (GSK) Gardasil (Merck) MMRII (Merck) Varivax (Merck) Pneumovax 23 (Merck) Menactra (sanofi pasteur); Menveo (Novartis) Menomune (sanofi pasteur) Technical content reviewed by the Centers for Disease Control and Prevention, March For additional copies, visit Item #P2023 (3/11) This form was created by the Immunization Action Coalition

164 (Page 2 of 2) Vaccine Administration Record for Adults Patient name: Birthdate: Chart number: Before administering any vaccines, give the patient copies of all pertinent Vaccine Information Statements (VISs) and make sure he/she understands the risks and benefits of the vaccine(s). Always provide or update the patient s personal record card. Vaccine Type of Vaccine 1 Date given (mo/day/yr) Funding Source (F,S,P) 2 Site 3 Vaccine Vaccine Information Vaccinator Statement (VIS) 5 (signature or Lot # Mfr. Date on VIS 4 Date given 4 initials & title) Influenza (e.g., TIV, inactivated; LAIV, live attenuated) Give TIV IM. 6 Give LAIV IN. 6 Zoster (ZOS) Give SC. 6 Other See page 1 to record Tdap/Td, hepatitis A, hepatitis B, HPV, MMR, varicella, pneumococcal, and meningococcal vaccines. How to Complete this Record 1. Record the generic abbreviation (e.g., Tdap) or the trade name for each vaccine (see table at right). 2. Record the funding source of the vaccine given as either F (federal), S (state), or P (private). 3. Record the site where vaccine was administered as either RA (right arm), LA (left arm), RT (right thigh), LT (left thigh), IN (intranasal), or. 4. Record the publication date of each VIS as well as the date the VIS is given to the patient. 5. To meet the space constraints of this form and federal requirements for documentation, a healthcare setting may want to keep a reference list of vaccinators that includes their initials and titles. 6. IM is the abbreviation for intramuscular; SC is the abbreviation for subcutaneous; IN is the abbreviation for intranasal. Abbreviation LAIV (Live attenuated influenza vaccine] TIV (Trivalent inactivated influenza vaccine) ZOS (shingles) FluMist (MedImmune) Trade Name & Manufacturer Afluria (CSL Biotherapies); Agriflu (Novartis); Fluarix (GSK); FluLaval (GSK); Fluvirin (Novartis); Fluzone (sanofi pasteur); Fluzone High-Dose (sanofi pasteur) Zostavax (Merck) Technical content reviewed by the Centers for Disease Control and Prevention, March For additional copies, visit Item #P2023 (3/11) This form was created by the Immunization Action Coalition

165 (Page 1 of 2) Vaccine Administration Record for Adults Patient name: Mohammed Sharik Birthdate: 4/14/1981 Chart number: Before administering any vaccines, give the patient copies of all pertinent Vaccine Information Statements (VISs) and make sure he/she understands the risks and benefits of the vaccine(s). Always provide or update the patient s personal record card. Vaccine Type of Vaccine 1 Date given (mo/day/yr) Tetanus, Diphtheria, Pertussis (e.g., Td, Tdap) Give IM. 6 Funding source (F,S,P) 2 Site 3 Vaccine Vaccine Information Vaccinator Statement (VIS) 5 (signature or Lot # Mfr. Date on VIS 4 Date given 4 initials & title) Td 8/01/02 P LA U0376AA AVP 6/10/94 8/1/2002 JTA Td 9/1/2002 P LA U0376AA AVP 6/10/94 9/1/2002 PWS Td 3/1/2003 P LA U0376AA AVP 6/10/94 3/1/2003 TAA Tdap 6/14/2010 P LA AC52B030AA GSK 11/18/2008 6/14/2010 JTA Hepatitis A 7 (e.g., HepA, HepA-HepB) Give IM. 6 Hepatitis B 7 (e.g., HepB, HepA-HepB) Give IM. 6 Human papillomavirus (HPV2, HPV4) Give IM. 6 HepA-HepB 8/1/2002 P RA HAB239A4 GSK 8/25/1998 8/1/2002 JTA HepA-HepB 9/1/2002 P RA HAB239A4 GSK 8/25/1998 9/1/2002 PWS HepA-HepB 3/1/2003 P RA HAB239A4 GSK 8/25/1998 3/1/2003 TAA HepA-HepB 8/1/2002 P RA HAB239A4 GSK 7/11/2001 8/1/2002 JTA HepA-HepB 9/1/2002 P RA HAB239A4 GSK 7/11/2001 9/1/2002 PWS HepA-HepB 3/1/2003 P RA HAB239A4 GSK 7/11/2001 3/1/2003 TAA 1 shot, 2 different VIS dates Measles, Mumps, Rubella (MMR) Give SC. 6 Varicella (VAR) Give SC. 6 Pneumococcal polysaccharide (PPSV23) Give SC or IM. 6 Meningococcal (e.g., MCV4, conjugate; MPSV4, polysaccharide) Give MCV4 IM. 6 Give MPSV4 SC. 6 MMR 8/1/2002 P RA 0025L MRK 6/13/2002 8/1/2002 JTA MMR 11/1/2002 P RA 0025L MRK 6/13/ /1/2002 TAA VAR 8/1/2002 P LA 0799M MRK 12/16/1998 8/1/2002 JTA VAR 11/1/2002 P RA 0689M MRK 12/16/ /1/2002 TAA Example Menveo 7/12/2010 P RA NOV 1/28/2008 7/12/2010 JTA See page 2 to record influenza, zoster, and other vaccines (e.g., travel vaccines). How to Complete this Record 1. Record the generic abbreviation (e.g., Tdap) or the trade name for each vaccine (see table at right). 2. Record the funding source of the vaccine given as either F (federal), S (state), or P (private). 3. Record the site where vaccine was administered as either RA (right arm), LA (left arm), RT (right thigh), LT (left thigh), or IN (intranasal). 4. Record the publication date of each VIS as well as the date the VIS is given to the patient. 5. To meet the space constraints of this form and federal requirements for documentation, a healthcare setting may want to keep a reference list of vaccinators that includes their initials and titles. 6. IM is the abbreviation for intramuscular; SC is the abbreviation for subcutaneous. 7. For combination vaccines, fill in a row for each antigen in the combination. Abbreviation Tdap Td HepA HepB HepA-HepB HPV2 HPV4 MMR VAR PPSV23 MCV4 MPSV4 Trade Name & Manufacturer Adacel (sanofi pasteur), Boostrix (GlaxoSmithKline [GSK]) Decavac (sanofi pasteur), generic (MA Biological Labs) Havrix (GSK); Vaqta (Merck) Engerix-B (GSK), Recombivax HB (Merck) Twinrix (GSK) Cervarix (GSK) Gardasil (Merck) MMRII (Merck) Varivax (Merck) Pneumovax 23 (Merck) Menactra (sanofi pasteur); Menveo (Novartis) Menomune (sanofi pasteur) This is a record for a 29-year-old healthcare worker who is planning to travel to Saudi Arabia for the annual Hajj. Technical content reviewed by the Centers for Disease Control and Prevention, March For additional copies, visit Item #P2023 (3/11) This form was created by the Immunization Action Coalition

166 Vaccine Administration Record for Adults Patient name: Mohammed Sharik Birthdate: 4/14/1981 Chart number: (Page 2 of 2) Before administering any vaccines, give the patient copies of all pertinent Vaccine Information Statements (VISs) and make sure he/she understands the risks and benefits of the vaccine(s). Always provide or update the patient s personal record card. Vaccine Type of Vaccine 1 Date given (mo/day/yr) Influenza (e.g., TIV, inactivated; LAIV, live attenuated) Give TIV IM. 6 Give LAIV IN. 6 Includes space to record vaccines given for international travel. Funding Source (F,S,P) 2 Site 3 Vaccine Vaccine Information Vaccinator Statement (VIS) 5 (signature or Lot # Mfr. Date on VIS 4 Date given 4 initials & title) TIV 11/1/2002 P RA U AVP 6/26/ /1/2002 PWS TIV 10/10/2003 P LA U AVP 5/6/ /10/2003 DLW Fluzone 10/8/2004 P RA U AVP 5/24/ /8/2004 TAA TIV 11/12/2005 P LA U2169MA SPI 7/18/ /12/2005 JTA Fluvirin 10/9/2006 P LA P NOV 6/30/ /9/2006 KKC Flumist 11/15/2007 P IN P MED 7/16/ /15/2007 DCP Afluria 10/12/2008 P RA A CSL 7/24/ /12/2008 JTA Flulaval 10/2/2009 P LA 2F GSK 8/11/ /2/2009 DCP H1N1 12/7/2009 F RA P NOV 10/2/ /7/2009 DLW Example Zoster (ZOS) Give SC. 6 Other Oral typhoid 7/12/2010 x 4 P po TXE355 BER 5/19/2004 7/12/2010 MAT See page 1 to record Tdap/Td, hepatitis A, hepatitis B, HPV, MMR, varicella, pneumococcal, and meningococcal vaccines. How to Complete this Record 1. Record the generic abbreviation (e.g., Tdap) or the trade name for each vaccine (see table at right). 2. Record the funding source of the vaccine given as either F (federal), S (state), or P (private). 3. Record the site where vaccine was administered as either RA (right arm), LA (left arm), RT (right thigh), LT (left thigh), or IN (intranasal). 4. Record the publication date of each VIS as well as the date the VIS is given to the patient. 5. To meet the space constraints of this form and federal requirements for documentation, a healthcare setting may want to keep a reference list of vaccinators that includes their initials and titles. 6. IM is the abbreviation for intramuscular; SC is the abbreviation for subcutaneous; IN is the abbreviation for intranasal. Abbreviation LAIV (Live attenuated influenza vaccine] TIV (Trivalent inactivated influenza vaccine) ZOS (shingles) FluMist (MedImmune) Trade Name & Manufacturer Afluria (CSL Biotherapies); Agriflu (Novartis); Fluarix (GSK); FluLaval (GSK); Fluvirin (Novartis); Fluzone (sanofi pasteur); Fluzone High-Dose (sanofi pasteur) Zostavax (Merck) This is a record for a 29-year-old healthcare worker who is planning to travel to Saudi Arabia for the annual Hajj. Technical content reviewed by the Centers for Disease Control and Prevention, March For additional copies, visit Item #P2023 (3/11) This form was created by the Immunization Action Coalition

167 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT POLICY NUMBER: TITLE: Immunization Declination Form 6p APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 1 SIGNATURE OF APPROVAL: TITLE SIGNER: I understand that my exposure to the following vaccine- preventable diseases puts me at risk of acquiring the disease. I have been given the opportunity to be vaccinated, however, I choose to decline the vaccination(s) checked below at this time. I have read the vaccine information and/or have had it explained to me by my health care provider or nurse who has answered all my questions. TYPE Measles, Mumps, Rubella (MMR) Varicella (Chicken Pox) Hepatitis A Hepatitis B Influenza (Flu) Pneumococcal (Pneumonia) Tetanus / Pertussis / Tdap TB Chest X-Ray Other Zoster (Shingles) HPV Female (Human Papillomavirus) HPV Male (Human Papillomavirus) Meningococcal (Meningitis) REASON Signed: Printed Name: Date: DOB: Witness: Date: 166

168 Illinois State Board of Education Data Analysis and Progress Reporting Division February 2010 Guidelines Applicable to Medical and Religious Immunization Exemptions The Illinois State Board of Education (ISBE) has developed these guidelines to help school administrators determine whether a medical or religious immunization exemption should be allowed and when a medical objection should be referred to the Illinois Department of Public Health (IDPH). Medical Exemptions There are two avenues by which a physician may exempt a child from a required immunization. One is a physician statement of immunity and the other is a medical objection (see IDPH rules, 77 Illinois Administrative Code and ). A physician statement of immunity or medical objection must be signed by a physician and attached to the student s Certificate of Child Health Examination form. Physician Statement of Immunity (77 IAC ) A copy of all physician statements of immunity should be forwarded to the appropriate regional IDPH Immunization Program Representative, except when a previous statement addressing the same circumstance has been reviewed by IDPH and deemed acceptable. If the circumstance of a physician statement of immunity has not been previously reviewed and deemed acceptable, the student should be counted as unprotected but in compliance until such time as the student s school receives a letter from the IDPH Immunization Program Representative stating that the exemption is accepted. If accepted, the IDPH approval letter should be attached to the student s Certificate of Child Health Examination form and the student s status should be considered protected and in compliance. If the statement is not approved, the school should forward a copy of the statement to the student s parent(s), informing them that the required immunization(s) must be given and the student is currently considered unprotected and in noncompliance. Medical Objection (77 IAC ) Medical objection statements from physicians which indicate an immunization is medically contraindicated are acceptable and should be 167

169 attached to the student s Certificate of Child Health Examination form. A copy of any medical objection statement that does not specifically state that an immunization is medically contraindicated should be forwarded to the IDPH Immunization Program Representative for review. Statements from physicians indicating a specific medical condition that predisposes a student to a potential health risk if vaccinated should also be forwarded to the IDPH Immunization Program Representative for review. If approved, the school should attach the letter of approval from IDPH to the student s Certificate of Child Health Examination form. If the statement is not approved, a copy of the IDPH letter should be forwarded to the student s parent(s), informing them that the required immunization(s) must be given. Religious Exemptions to Immunizations and Examinations According to state law (**105 ILCS 5/27-8.1(8) see Section (8) of the School Code on page 3), a religious objection must refer to each specific examination or immunization for which a religious objection is claimed. IDPH rules (see 77 Illinois Administrative Code ) clarify the basis for religious objections, including that general philosophical or moral reluctance to allow an immunization or examination will not provide a sufficient basis for an exception to statutory requirements. The statutory exemption to immunizations for religious reasons is based on constitutional principles. Parents wishing to object on these grounds are expected to state their religious belief that conflicts with a specific examination or immunization. See Lewis v. Sobel, 710 F. Supp. 506, (S.D. N.Y. 1989). The religious objection may be personal and need not be directed by the tenets of an established religious organization. See Frazee v. Illinois Department of Employment Security, 489 U.S. 829, 109 S.Ct (1989). Section of the School Code does not provide for an exemption to physical examinations or immunizations on non-religious grounds of conscience. A religious objection must be signed and state the specific religious belief that conflicts with an examination, immunization, or other medical intervention. Using forms available on the Internet and elsewhere, which purport to be legal documents and use general language, will not ensure that the necessary information is provided. We recommend that parents be asked to provide an original written statement which sets forth fully the religious belief that is the basis for their objection, instead of relying on a prepared form which may not accurately or sufficiently describe their religious belief. The parent s statement of religious objection should be attached to the student s Certificate of Child Health Examination form. 168

170 Questions regarding religious objections should be directed to ISBE Data Analysis and Progress Reporting Division at Questions regarding medical exemptions should be directed to the IDPH Immunization Section at **105 ILCS 5/27-8.1(8) Parents or legal guardians who object to health, dental, or eye examinations or any part thereof, or to immunizations, on religious grounds shall not be required to submit their children or wards to the examinations or immunizations to which they so object if such parents or legal guardians present to the appropriate local school authority a signed statement of objection, detailing the grounds for the objection. If the physical condition of the child is such that any one or more of the immunizing agents should not be administered, the examining physician, advanced practice nurse, or physician assistant responsible for the performance of the health examination shall endorse that fact upon the health examination form. Exempting a child from the health, dental, or eye examination does not exempt the child from participation in the program of physical education training provided in Sections 27-5 through 27-7 of this Code [105 ILCS 5/27-5 through 105 ILCS 5/27-7]. 169

171 Section 7 ADULT VACCINE ADMINISTRATION Section 7 170

172 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Adult Vaccine Administration POLICY NUMBER: 7a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 1 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: Purpose: To ensure safe and appropriate administration of adult immunizations. Policy: Adult vaccines will be administered by RHC clinical staff, specifically trained for adult vaccine administration. Procedure: A. Immunizations are administered by specifically trained RHC clinical staff according to the Recommended Adult Immunization Schedule for the United States that is approved by ACIP (Advisory Committee on Immunization Practices), VFC (Vaccines for Children) Program requirements and the CDC (Center for Disease Control). See attached: Summary of Recommendations for Adult Immunizations, Immunization Chart for Adults Age 19 and older, Immunization Chart for the Adult Before, During, and After Pregnancy. 1. Every effort must be made to keep patients current with their schedule utilizing the following: Guide to Contraindications to Adult Vaccination (attached), developed by the National Program, Center for Disease Control and Prevention (CDC). Standards for Adult Immunization Practices (attached) ACIP ( Advisory Committee on Immunization Practices) Manufacturers package insert Physician, Physician Assistant, Nurse Practitioner or Certified Nurse Midwife. 2. Request immunization record (shot card) from patients if available (See attached: Shop IAC: Immunization Record Cards) and verbally confirm that all immunizations given are recorded there. A complete and accurate immunization history is needed before vaccines can be given. Always initiate an immunization record, and instruct patients to present this record at each visit. Access the information in I-CARE. Assess immunization needs and distribute the appropriate Vaccine Information Statement (VIS) for the vaccines determined to be due. Offer all vaccines according to the approved schedule for immunization for adults. Answer any questions. Federal Law says you must give your patients the most current Vaccine Information Sheets (VISs). Attached: It s Federal Law! And VIS sheets for all adult vaccines in English and Spanish. 3. It is important to use the Screening Checklist for Contraindications to Vaccines for Adults (see attached), every time your patient presents for vaccination. 171

173 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Adult Vaccine Administration POLICY NUMBER: 7a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 2 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): See additional attachments when screening your patients who present with diabetes, HIV, Hepatitis C or bleeding disorders. It is required that ALL positive responses are to be discussed with the provider and documented before proceeding with the administration of vaccinations. 4. Choose vaccines for administration from VFC or private stock. 5. Return updated shot card/record to the patient. Include a rotation when the next immunization will be due if applicable. 6. All health care providers who administer one or more vaccines or toxoids must record in the patient s permanent medical record, the date the vaccine was given, the manufacturer and lot number of the vaccine, and the name and title of the person administering the vaccine. See attached sample, Vaccine Administration Record. 7. Patient Education: The provider should educate the patient about the importance of immunizations, the diseases they prevent, the recommended vaccine schedule for them, and the importance of bringing their shot record to each visit. The provider should answer all questions regarding immunizations Educational material regarding each immunization should be provided. Remember, It s Federal Law that the most current VIS (Vaccine Information Statement) regarding the vaccine being given is available before the vaccine is given, allowing time to be read and to ask questions. Prior to vaccinating, discuss contraindications, risks, and benefits specific to the immunization(s) being given. 8. Refusal of Vaccination: If after all the risks and benefits of vaccinations are discussed, the patient chooses not to have the vaccine, they must sign a refusal and document it the in patient record. See attached: Illinois Adult Immunization Declination Form. 9. Vaccines by Injection: 172

174 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Adult Vaccine Administration POLICY NUMBER: 7a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 3 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): Always check and double check vaccine vial to make sure it is the right vaccine and not expired. See attached: Vaccines with Diluent: How to Use Them and use only the diluent provided with the vaccine. Draw just the required amount for the dose in to the syringe, using proper syringe loading techniques. Note: Careful filling of the syringe will prevent vaccine wastage and enable you to use all the doses in the vial. Vaccine doses should not be drawn into a syringe until immediately before administration. The routine practice of pre-filling syringes is discouraged and may lead to administration errors and vaccine wastage. Shake vial vigorously and visually inspect if for particulate matter. If it cannot be shaken in to a relatively even suspension, it should not be used. Check the vial 3TIMES to make sure you have the right vaccine, the right dosage, for the right patient. Wash hands, wear gloves, and clean injection site with alcohol swab prior to vaccine administration. If more than one vaccine is given, a new needle and syringe must be used for each vaccination. ACIP consistently recommends administration of all indicated vaccines. There is no evidence that simultaneous administration of vaccines either reduces vaccine effectiveness or increases risk of an adverse event. Providing all needed vaccines provides protection in case the patient does not return in a timely manner. Simultaneous administration is more convenient and efficient for both the patient and the practitioner. o Injectable or nasally administered live vaccine must either be given on the same day or 4 weeks apart. o Although PPD is not a vaccine, administer PPD s on the same day or 4 weeks apart from live vaccine. o Multiple IM or SC injections given in the same extremity should be administered at least 1 inch apart. Patients should sit down prior to receiving an injection. This is to prevent serious injury from falling, in case they may feel faint at the sight of needle during the injection. The patient needs to be observed for 15 minutes following the administration of a vaccine for any adverse reaction or fainting. 173

175 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Adult Vaccine Administration POLICY NUMBER: 7a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 4 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): A serious allergic reaction (anaphylaxis) will usually occur within minutes of receiving the vaccine. See Section 7 of this toolkit for Medical Management of Vaccine Reactions in Adults. After administering the vaccine, remove the needle from the arm or leg with a smooth motion at the same angle at which it was inserted. See attached: How to Administer IM and SC Vaccine Injections to Adults, Administering Vaccines to Adults: Dose, Route, Site, and Needle Size, and sample Immunization Site Map. 10. Proper Needle and Syringe Disposal Do not recap or clip needles or separate needle and syringe, discard the uncapped used and needle, still attached to the syringe into a sharps container according to OSHA (Occupational Safety & Health Administration) guidelines. See attached. Keep your eyes on the needle continuously until it is inside the container. All adverse reactions associated with a vaccination must be reported to the U.S. Department of Health and Human Services. Adverse events are reported on a Vaccine Adverse Event Reporting System (VAERS) form. The form should be sent to the Illinois Department of Public Health if the event involves an IDPH vaccine or the VAERS office if involves other vaccines. VAERS will accept all reports of suspected adverse events after the administration of any vaccine. See attachments: VAERS Reporting Form, Instructions for Completing the VAERS paper Form, and Conditions Commonly Misperceived as Contraindications to Vaccination. See Section 8 of this toolkit, Medical Management of Vaccine Reactions in Adults. After administering the vaccine, give the patient contact information on how to reach clinic personnel with any follow up concerns or questions. It is required that selected events of a serious nature that occur after vaccination to the U.S. Department of Health and Human Services. Review the vaccine insert for more specific information and see attached VAERS Table of Reportable Events Following Vaccinations. 11. Documentation must be included: on chart notes in the patient chart and input into the I- CARE (Illinois Comprehensive Automated Immunization Registry Exchange) system. An updated I-CARE form will be printed and replaced on the chart or noted in the electronic health record. 174

176 ILLINOIS RURAL HEALTH CLINIC IMMUNIZATION PROJECT TITLE: Adult Vaccine Administration POLICY NUMBER: 7a APPROVAL DATE: LAST REVIEWED: LAST REVISED: PAGE 5 of 5 SIGNATURE OF APPROVAL: TITLE SIGNER: POLICY (continued): You must record in the medical record, the immunization, lot number, and date, site of injection and name (first initial and last name) and title of person administering the vaccine. See attached: Vaccine Administration Record for Adults Record in patient s personal record and give date of next vaccine if applicable. 12. Annual staff competencies will be administered by the clinic s designated Vaccine Coordinator, backup coordinator and/or designee. 175

177 Standing Orders for Administering Influenza Vaccine to Adults Purpose: To reduce morbidity and mortality from influenza by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate patients who meet any of the criteria below. Procedure: 1. Identify adults with no history of influenza vaccination for the current influenza season. 2. Screen all patients for contraindications and precautions to influenza vaccine: a. Contraindications: a serious systemic or anaphylactic reaction to a prior dose of the vaccine or to any of its components. For a list of vaccine components, go to excipient-table-2.pdf. Do not give live attenuated influenza vaccine (LAIV; nasal spray) to a person who has a history of either an anaphylactic or non-anaphylactic hypersensitivity to eggs, ; who is pregnant, is age 50 years or older, or who has chronic pulmonary (including asthma), cardiovascular (excluding hypertension), renal, hepatic, neurologic/ neuromuscular, hematologic, or metabolic (including diabetes) disorders; immunosuppression, including that caused by medications or HIV. b. Precautions: moderate or severe acute illness with or without fever; history of Guillain Barré syndrome within 6 weeks of a previous influenza vaccination; for LAIV only, close contact with an immunosuppressed person when the person requires protective isolation, receipt of influenza antivirals (e.g., amantadine, rimantadine, zanamivir, or oseltamivir) within the previous 48 hours or possibility of use within 14 days after vaccination. c. Other considerations: onset of hives only after ingesting eggs: healthcare providers familiar with the potential manifestations of egg allergy should administer TIV and observe patient for 30 minutes after receipt of the vaccine for signs of a reaction. 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at 4. Administer influenza vaccine as follows: a) For adults of all ages, give 0.5 ml of injectable trivalent inactivated influenza vaccine (TIV-IM) intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle. (Note: A e" needle may be used for adults weighing less than 130 lbs [<60 kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90 degree angle.) b) For healthy adults younger than age 50 years, give 0.2 ml of intranasal LAIV; 0.1 ml is sprayed into each nostril while the patient is in an upright position. c) For adults age 18 through 64 years, give 0.1 ml TIV-ID intradermally by inserting the needle of the microinjection system at a 90 degree angle in the deltoid muscle. d) For adults age 65 years and older, give 0.5 ml of high-dose TIV-IM intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle. 5. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reasons(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 6. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. 7. Report all adverse reactions to influenza vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the rescinded or until (date). (name of practice or clinic) until Medical Director s signature: Effective date: Technical content reviewed by the Centers for Disease Control and Prevention Item #P3074 (8/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

178 Standing Orders for Administering Pneumococcal (PPSV23 and PCV13) Vaccine to Adults Purpose: To reduce morbidity and mortality from pneumococcal disease by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet any of the criteria below. Procedure 1. Identify adults in need of vaccination with pneumococcal polysaccharide vaccine (PPSV23) based on the following criteria: a. Age 65 years or older with no or unknown history of prior receipt of PPSV b. Age 64 years or younger with no or unknown history of prior receipt of PPSV and any of the following conditions: i. cigarette smoker ii. chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies) iii. chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, emphysema, asthma) iv. diabetes mellitus, alcoholism or chronic liver disease (cirrhosis), v. candidate for or recipient of cochlear implant; cerebrospinal fluid leak vi. functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) vii. immunocompromising condition (e.g., HIV infection, congenital immunodeficiency, hematologic and solid tumors) viii. immunosuppressive therapy (e.g., alkylating agents, antimetabolites, long-term systemic corticosteroids, radiation therapy) ix. organ or bone marrow transplantation; chronic renal failure or nephrotic syndrome 2. Identify adults in need of an additional dose of PPSV23 if 5 or more years have elapsed since the previous dose of PPSV and the patient meets one of the following criteria: a. Age 65 years or older and received prior PPSV vaccination before age 65 years b. Age 64 years or younger and at highest risk for serious pneumococcal infection or likely to have a rapid decline in pneumococcal antibody levels (i.e., categories 1.vi. ix. above) 3. Identify adults age 19 years and older in need of vaccination with pneumococcal conjugate vaccine (PCV13) who are at highest risk for serious pneumococcal infection or likely to have a rapid decline in pneumococcal antibody levels (i.e., categories 1.v. 1.ix. above). 4. Screen all patients for contraindications and precautions to pneumococcal vaccine: a. Contraindication: a history of a serious reaction (e.g., anaphylaxis) after a previous dose of pneumococcal vaccine (PPSV or PCV) or to a vaccine component. For a list of vaccine components, go to excipient-table-2.pdf. b. Precaution: moderate or severe acute illness with or without fever 5. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). Although not required by federal law, it is prudent to document in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available; these can be found at www. immunize.org/vis. 6. Administer vaccine as follows: a. For adults identified in 1. and 2. above, administer 0.5 ml PPSV23 vaccine either intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle or subcutaneously (23 25g, 5 /8" needle) in the posterolateral fat of the upper arm. b. For adults identified in 3. above, administer 0.5 ml PCV13 intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle. For adults previously vaccinated with PPSV, give PCV13 at least 12 months following PPSV. If not previously vaccinated with PPSV, give PCV13 first, followed by PPSV23 in 8 weeks. (Note: A 5 " /8 needle may be used for IM injection for patients who weigh less than 130 lbs [<60kg] for injection in the deltoid muscle, only if the subcutaneous tissue is not bunched and the injection is made at a 90-degree angle.) 7. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 8. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. 9. Report all adverse reactions to PPSV23 and PCV13 to the federal Vaccine Adverse Event Reporting System (VAERS) at gov or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until rescinded or until (date). (name of practice or clinic) Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention,. Item #P3075 (8/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

179 Standing Orders for Administering Zoster Vaccine to Adults Purpose: To reduce morbidity and mortality from herpes zoster (shingles) by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet the criteria below. Procedure 1. Identify adults who are age 60 years or older and have no history of prior receipt of zoster vaccine. 2. Screen all patients for contraindications and precautions to zoster vaccine: a. Contraindications: a history of a serious reaction to a vaccine component, including gelatin and neomycin. For a list of vaccine components, go to primary or acquired immunodeficiency, including - leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic system - AIDS or other clinical manifestations of HIV, including persons with CD4+ T-lymphocyte values <200 per mm 3 or <15% of total lymphocytes - current immunosuppressive therapy, including high-dose corticosteroids (>20 mg/day of prednisone or equivalent) lasting two or more weeks - clinical or laboratory evidence of other unspecified cellular immunodeficiency - receipt of or history of hematopoietic stem cell transplantation - current receipt of recombinant human immune mediators and immune modulators, especially the antitumor necrosis factor agents adalimumab, infliximab, and etanercept pregnancy or possibility of pregnancy within 4 weeks of receiving vaccine b. Precaution: moderate or severe acute illness with or without fever 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). Although not required by federal law, it is prudent to document in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available; these can be found at 4. Administer entire amount (approximately 0.65 ml) of reconstituted zoster vaccine subcutaneously (23 25g, 5 /8" needle) in the posterolateral fat of the upper arm. 5. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 6. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. 7. Report all adverse reactions to zoster vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the (name of practice or clinic) until rescinded or until (date). Medical Director s signature: Effective date: Technical content reviewed by the Centers for Disease Control and Prevention, May Item #P3092 (5/08) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

180 Standing Orders for Administering Varicella (Chickenpox) Vaccine to Adults Purpose: To reduce morbidity and mortality from varicella (chickenpox) by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law), may vaccinate adults who meet any of the criteria below. Procedure 1. Identify adults in need of varicella (chickenpox) vaccination who (a) were born in the U.S. in 1980 or later or (b) are a healthcare worker or non-u.s.-born person, and who also meet any of the following criteria: lack documentation of 2 doses of varicella vaccine lack a history of varicella based on diagnosis or verification of varicella by a healthcare provider lack a history of herpes zoster based on healthcare provider diagnosis lack laboratory evidence of immunity or laboratory confirmation of disease Note: Because HIV-infected adults are at increased risk of severe disease from varicella, vaccination may be considered (2 doses, given 3 months apart) for HIV-infected adults and adolescents with CD4+ T-lymphocytes count >200 cells/µl. 2. Screen all patients for contraindications and precautions to varicella vaccine: a. Contraindications: a history of a serious reaction (e.g., anaphylaxis) after a previous dose of varicella vaccine or to a varicella vaccine component. For a list of vaccine components, go to pregnant now or may become pregnant within 1 month (pregnant women should be vaccinated upon completion or termination of pregnancy) having any malignant condition, including blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems receiving high-dose systemic immunosuppressive therapy (e.g., two weeks or more of daily recipt of 20 mg or more [or 2 mg/kg body weight or more] of prednisone or equivalent) an adult or adolescent with CD4+ T-lymphocytes count <200 cells/µl family history of congenital or hereditary immunodeficiency in first-degree relatives (e.g., parents, siblings) unless the immune competence of the potential vaccine recipient has been clinically substantiated or verified by a laboratory b. Precautions: recent (within the past 11 months) receipt of antibody-containing blood product (specific interval depends onproduct) moderate or severe acute illness with or without fever 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available; these can be found at 4. Administer 0.5 ml varicella vaccine subcutaneously (23 25g, 5 /8" needle) in the posterolateral fat of the upper arm. 5. Administer a second dose 4 8 weeks after the first dose. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. 8. Report all adverse reactions to varicella vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until rescinded or until (date). (name of practice or clinic) Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention, July Item #P3080 (7/08) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

181 Standing Orders for Administering Measles, Mumps & Rubella Vaccine to Adults Purpose: To reduce morbidity and mortality from measles, mumps, and rubella by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet any of the criteria below. Procedure 1. Identify adults in need of initial vaccination against measles, mumps, or rubella who (a) were born in 1957 or later with no history of receipt of live, measles-, mumps-, and/or rubella-containing vaccine given at age 12 months or older or other acceptable evidence of immunity (e.g., laboratory evidence); (b) are women of any age planning to become pregnant and who do not have evidence of immunity; or (c) are healthcare workers born before 1957 without evidence of immunity. Measles, mumps, and rubella (MMR) vaccine (rather than single-antigen vaccine) is recommended if one or more antigens is indicated. 2. Identify adults in need of a second dose of MMR vaccine who (a) were born in 1957 or later and are either planning to travel internationally, a student in a college, university, technical, or vocational school, or (b) are healthcare workers born before 1957 at potential risk of infection from a current mumps outbreak. 3. Screen all patients for contraindications and precautions to measles, mumps, and rubella (MMR) vaccine: a. Contraindications: a history of a serious reaction (e.g., anaphylaxis) after a previous dose of MMR vaccine or to an MMR vaccine component. For a list of vaccine components, go to B/excipient-table-2.pdf. pregnant now or may become pregnant within 1 month known severe immunodeficiency, hematologic and solid tumors; congenital immunodeficiency; receiving long-term immunosuppressive therapy, severely immunocompromised from HIV infection, including CD4+ T-lymphocyte count of less than 200 cells per µl b. Precautions: recent (within the past 11 months) receipt of antibody-containing blood product (specific interval depends on product) history of thrombocytopenia or thrombocytopenic purpura moderate or severe acute illness with or without fever 4. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non- English speaking patients with a copy of the VIS in their native language, if available; these can be found at org/vis. 5. Administer 0.5 ml MMR vaccine subcutaneously (23 25 g, 5 /8" needle) in the posterolateral fat of the upper arm. 6. For adults in need of a second dose of MMR, observe a minimum interval of 4 weeks between the first and second doses. 7. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 8. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. 9. Report all adverse reactions to MMR vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at www. vaers.hhs.gov or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until rescinded or until (name of practice or clinic) (date). Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention, January Item #P3079 (1/08) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

182 Standing Orders for Administering Tdap/Td to Adults Purpose: To reduce morbidity and mortality from tetanus, diphtheria, and pertussis by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet the criteria below. Procedure 1. Identify adults in need of vaccination against tetanus, diphtheria, and pertussis based on the following criteria: a. lack of documentation of receiving a dose of pertussis-containing vaccine (i.e., Tdap) as an adolescent or adult b. currently pregnant and no documentation of Tdap given during current pregnancy c. lack of documentation of receiving at least 3 doses of tetanus- and diphtheria-containing toxoids d. completion of a 3-dose primary series of tetanus- and diphtheria-containing toxoids with no documentation of receiving a booster dose within the previous 10 years e. recent deep and dirty wound (e.g., contaminated with dirt, feces, saliva) and lack of evidence of having received tetanus toxoid-containing vaccine in the previous 5 years 2. Screen all patients for contraindications and precautions to tetanus and diphtheria toxoids (Td) and, if applicable, pertussis vaccine (Tdap): a. Contraindications: a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Td or to a Td or Tdap component. For information on vaccine components, refer to the manufacturers package insert ( or go to pinkbook/downloads/appendices/b/excipient-table-2.pdf for Tdap only, a history of encephalopathy within 7 days following DTP/DTaP/Tdap not attributable to another identifiable cause b. Precautions: history of Guillain-Barré syndrome within 6 weeks of previous dose of tetanus toxoid-containing vaccine history of an arthus-type hypersensitivity reaction after a previous dose of tetanus or diphtheria toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus toxoid-containing vaccine moderate or severe acute illness with or without fever for Tdap only, progressive or unstable neurologic disorder, uncontrolled seizures or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at 4. Administer 0.5 ml Td or Tdap vaccine intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle or, alternatively, the anterolateral thigh also can be used. (Note: a e" needle may be used for adults weighing less than 130 lbs [60 kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90 degree angle.) 5. Provide subsequent doses of either Tdap or Td to adults as follows: a. to complete the primary 3-dose schedule: observe a minimum interval of 4 weeks between the first and second doses, and 6 calendar months between the second and third doses.* b. to boost with Tdap or Td after primary schedule is complete; prioritize use of Tdap if not previously given (Note: there is no need to observe a minimum interval between Td and the subsequent Tdap); if Tdap was already administered, boost with Td routinely every 10 years.* c. for pregnant women, administer Tdap during each pregnancy (preferably during 27 through 36 weeks gestation), regardless of number of years since prior Td or Tdap vaccination. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not administered, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. To prevent syncope, vaccinate patients while they are seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8. Report all adverse reactions to Td and Tdap vaccines to the federal Vaccine Adverse Event Reporting System (VAERS) at or (800) VAERS report forms are available at *When feasible, administer Boostrix Tdap vaccine to adults age 65 years and older; however, either Tdap vaccine product administered to a person age 65 years and older provides protection against pertussis and is considered valid. This policy and procedure shall remain in effect for all patients of the until rescinded or until (date). (name of practice or clinic) Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention Item #P3078 (4/13) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

183 Standing Orders for Administering Meningococcal Vaccine to Adults Purpose: To reduce morbidity and mortality from meningococcal disease by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet any of the criteria below. Procedure 1. Identify adults in need of vaccination against meningococcal disease based on any of the following criteria: a. First-year college student, age 19 through 21 years, living in residence hall, and lacking documentation of receipt of quadrivalent meningococcal conjugate vaccine (MCV4) at age 16 years or older. b. Anticipated travel to a country in the meningitis belt of sub-saharan Africa or other location of epidemic meningococcal disease, particularly if contact with the local population will be prolonged c. Diagnosis of anatomic or functional asplenia, including sickle-cell disease d. Diagnosis of persistent complement component deficiency (an immune system disorder) e. Employment as a microbiologist with routine exposure to isolates of N. meningitidis f. Anticipated travel to Mecca, Saudi Arabia, for the annual Hajj g. Military recruits h. History of receiving either MCV4 or meningococcal polysaccharide vaccine (MPSV4: Menomune [sanofi]) at least 5 years earlier and having continued risk for infection (e.g., living in or recurrent travel to epidemic disease areas). i. Any other adult wishing to decrease their risk for meningococcal disease 2. Screen all patients for contraindications and precautions to meningococcal vaccine: a. Contraindications: a history of a serious allergic reaction (e.g., anaphylaxis) after a previous dose of meningococcal vaccine or to a meningococcal vaccine component. For information on vaccine components, refer to the manufacturers package insert ( or go to b. Precautions: moderate or severe acute illness with or without fever 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at 4. For adults ages 55 years and younger, administer 0.5 ml MCV4 via the intramuscular route (22 25g, 1 1½" needle) in the deltoid muscle. (Note: a 5/8" needle may be used for patients weighing less than 130 lbs [<60kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90-degree angle.) If the person has a permanent contraindication or precaution to MCV4, or if MCV4 is unavailable and immediate protection is needed, MPSV4 is an acceptable alternative, although it must be given subcutaneously. For these adults and adults older than age 55 years, administer 0.5 ml MPSV4 via the subcutaneous route (23 25g, 5/8" needle) in the posterolateral fat of the upper arm. 5. Schedule additional vaccination as follows: a. For adults ages 55 years and younger who are either identified above in 1.c. or 1.d., or who have HIV infection and meet any of the criteria in 1. above, give 2 doses of MCV4, 2 months apart. b. For adults who remain at high risk (e.g., categories 1.b. through 1.e. above), give 1 dose every 5 years. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. To prevent syncope, vaccinate patients while seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8. Report all adverse reactions to meningococcal vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until rescinded or until (date). (name of practice or clinic) Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention. Item #P3081 (7/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

184 Standing Orders for Administering Human Papillomavirus Vaccine to Adults Purpose: To reduce morbidity and mortality from human papillomavirus (HPV) infection by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet the criteria below. Procedure 1. Identify adults in need of vaccination against human papillomavirus (HPV) based on the following criteria: a. Female, age 26 years or younger b. Male, age 21 years or younger c. Male, age 22 through 26 years meeting any of the following conditions: i. Immunocompromised as a result of infection (including HIV), disease, or medications ii. Has sex with other males iii. Wants to be vaccinated and lacks any of the above criteria 2. Screen all patients for contraindications and precautions to HPV vaccine: a. Contraindication: a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of HPV vaccine or to a HPV vaccine component (e.g., yeast for quadrivalent HPV vaccine [HPV 4: Gardasil, Merck] or latex for bivalent HPV vaccine [HPV2: Cervarix, GSK]). For information on vaccine components, refer to the manufacturers package insert ( org/packageinserts) or go to b. Precautions: Moderate or severe acute illness with or without fever Pregnancy; delay vaccination until after completion of the pregnancy 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at org/vis. 4. Provide 1) either HPV2 or HPV4 to women or 2) HPV4 to men. Provide either vaccine in a 3-dose schedule at 0, 2, and 6 calendar months. Administer 0.5 ml HPV vaccine intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle; the anterolateral thigh muscle may be used if deltoid is inadequate. (Note: a e" needle may be used for adults weighing less than 130 lbs [60 kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90 angle.) 5. For adults who have not received HPV vaccine at the intervals specified in #4, administer subsequent doses of HPV vaccine to complete each patient s 3-dose schedule by observing a minimum interval of 4 weeks between the first and second doses, 12 weeks between the second and third dose, and at least 24 weeks between the first and third doses. Men age 27 years and older who meet the criteria of 1.c.i. or 1.c.ii. above and women age 27 years and older who have received at least 1 dose before their 27 th birthday should complete the 3-dose series as soon as feasible. Men age 22 years and older who have received at least 1 dose before their 22 nd birthday should also complete the 3-dose series as soon as feasible. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not administered, record the reason(s) for nonreceipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. To prevent syncope, vaccinate patients while seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8. Report all adverse reactions to HPV vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at gov or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until rescinded or until (date). (name of practice or clinic) Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention Item #P3091 (11/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

185 Standing Orders for Administering Hepatitis A Vaccine to Adults Purpose: To reduce morbidity and mortality from the hepatitis A virus (HAV) infection by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet the criteria below. Procedure 1. Identify all adults in need of vaccination against hepatitis A based on the following criteria: a. any adult who wants to be protected from hepatitis A b. anticipated travel to a country with high or intermediate endemicity for hepatitis A (i.e., all except the United States, Canada, Japan, Australia, New Zealand, and Western Europe) c. a male who has sex with other males d. users of street drugs (injecting and non-injecting) e. diagnosis of chronic liver disease, including hepatitis B and C f. diagnosis of a clotting-factor disorder, such as hemophilia g. anticipated close personal contact with an international adoptee from a country of high or intermediate endemicity during the first 60 days after the arrival of the adoptee in the United States h. employment in a research laboratory requiring work with HAV or HAV-infected primates i. an unvaccinated adult age 40 years or younger with recent possible exposure to HAV (e.g., within previous two weeks). (Note: Adults older than age 40 years who have an indication for vaccination can and should receive both IG and vaccine.) 2. Screen all patients for contraindications and precautions to hepatitis A vaccine: a. Contraindications: a history of a serious reaction after a previous dose of hepatitis A vaccine or to a hepatitis A vaccine component. For a list of vaccine components, go to excipient-table-2.pdf. b. Precautions: a moderate or severe acute illness with or without fever; pregnancy 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speaking patients with a copy of the VIS in their native language, if available. These can be found at 4. For patients younger than age 19 years, administer 0.5 ml hepatitis A vaccine, and for patients age 19 years and older, administer 1.0 ml hepatitis A vaccine. Give vaccine intramuscularly (22 25 g, 1 1½" needle) in the deltoid muscle. (Note: a 5 /8" needle may be used for patients who weigh less than 130 lbs [<60 kg] for injection in the deltoid muscle, only if the skin is stretched tight, subcutaneous tissue is not bunched, and the injection is made at a 90-degree angle.) 5. Provide a subsequent dose of hepatitis A vaccine to complete each patient s 2-dose schedule by observing a minimum interval of 6 months between the first and second doses. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. 8. Report all adverse reactions to hepatitis A vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until (name of practice or clinic) rescinded or until (date). Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention, January Item #P3077 (1/11) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

186 Standing Orders for Administering Hepatitis B Vaccine to Adults Purpose: To reduce morbidity and mortality from hepatitis B virus (HBV) infection by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet any of the criteria below. Procedure: 1. Identify adults with no or unknown history of prior receipt of a complete series of hepatitis B vaccine who are in need of hepatitis B vaccination based on the following criteria (for hepatitis B vaccination of people younger than age 19 years, see a. Age 19 years or older meeting any of the following criteria: Patient with end-stage renal disease, including patients receiving hemodialysis; HIV infection; or chronic liver disease Sexually active and not in a long-term, mutually monogamous relationship (i.e., more than 1 sex partner during the previous 6 months) Under evaluation or treatment for a sexually transmitted infection (STI) A male who has sex with males or a current or recent injection-drug use At occupational risk of infection through exposure to blood or blood-contaminated body fluids (e.g., healthcare worker, public safety worker, trainee in a health professional or allied health school) Client or staff of an institution for persons with developmental disabilities Sex partner or household member of a person who is chronically infected with HBV (including an HBsAg-positive adopted child) Planned travel to a country with high or intermediate prevalence of chronic HBV infection (a list of countries is available at travel/diseases.htm) Housed in or seen for care in a setting in which a high proportion of people have risk factors for HBV infection (e.g., STI treatment settings, correctional facilities, institutions for developmentally disabled people) b. Age 19 through 59 years with diabetes mellitus c. Age 60 years or older with diabetes mellitus, at the discretion of the treating clinician d. Any person who wants to be protected from HBV infection and lacks a specific risk factor 2. Screen all patients for contraindications and precautions to hepatitis B vaccine: a. Contraindication: a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of hepatitis B vaccine or to a hepatitis B vaccine component. For information on vaccine components, refer to the manufacturers package insert ( or go to b. Precaution: moderate or severe acute illness with or without fever 3. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-english speakers with the VIS in their native language, if available and preferred; these can be found at 4. Administer hepatitis B vaccine intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle; the anterolateral thigh muscle may be used if deltoid is inadequate. (Note: a e" needle may be used for adults weighing less than 130 lbs [60 kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90 degree angle.) For people age 20 years or older, administer 1.0 ml dosage; for people age 19 years or younger, administer 0.5 ml dosage. 5. Provide subsequent doses of hepatitis B vaccine to complete each patient s 3-dose schedule by observing a minimum interval of 4 weeks between the first and second doses, 8 weeks between the second and third doses, and at least 4 months (16 weeks) between the first and third doses. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not administered, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. To prevent syncope, vaccinate patients while seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8. Report all adverse reactions to hepatitis B vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or by calling (800) VAERS report forms are available at *For persons born in Asia, the Pacific Islands, Africa, or other countries identified as having high rates of HBV infection (see MMWR 2005;54 [No. RR-16]:25), ensure that they have also been tested for hepatitis B surface antigen (HBsAg) to find out if they are chronically infected. If test is performed on same visit, administer hepatitis B vaccine after the blood draw. Do not delay initiating hepatitis B vaccination while waiting for test results. If patient is found to be HBsAg-positive, appropriate medical follow-up should be provided; no further doses of hepatitis B vaccine are indicated. This policy and procedure shall remain in effect for all patients of the until rescinded or until (name of practice or clinic) (date). Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention Item #P3076 (10/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

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189 Vaccine Brand Tip Sheet The New Hampshire Immunization Program (NHIP) recently completed a vaccine selection process to determine which brands of vaccines would be offered through the NHIP. In order to avoid confusion, we are providing the following tips regarding vaccines for which we are providing more than one brand. You may not always receive the same brand as vaccines will be distributed by shortest expiration date... not by brand name. DTaP Vaccine DTaP - IPV - HepB Combination INFANRIX produced by GlaxoSmithKline Licensed for children 6 weeks - 6 years of age PEDIARIX produced by GlaxoSmithKline Licensed for children 6 weeks - 6 years of age as any one or all of the first three doses of DTaP (primary series) may not give for DTaP4 or DTaP5 even if the child needs DTaP, IPV and Hep B. Tdap Vaccine BOOSTRIX produced by GlaxoSmithKline licensed for adolescents years of age. ADACEL produced by Sanofi Pasteur, (formerly Aventis Pasteur) licensed for adolescents and adults years of age. (May also be distributed in pre-filled syringes.) Tdap is supplied by the state for children years of age. Adacel provided by the state SHOULD NOT be used for adults 19 years of age and older. This vaccine is currently FDA approved as a one-time booster to be given instead of the Td booster. Boostrix is FDA approved for ages 10-18, while Adacel is FDA approved for ages Adacel and Boostrix supplied by the NHIP should only be used for children, as the NHIP does not have funds for adult immunizations. Td Vaccine DECAVAC produced by Sanofi Pasteur (formerly Aventis Pasteur) licensed for 7 years of age and older. Td is the only tetanus containing vaccine licensed for adults 65 and older Td is supplied by the state for children 7-18 years of age. PLEASE NOTE that Tdap is the preferred tetanus booster product for those individuals years of age who do not have a contraindication to pertussis vaccine. DECAVAC provided by the state SHOULD NOT be used for adults 19 years of age and older. 188 last updated

190 Hepatitis B Vaccine ENGERIX-B produced by GlaxoSmithKline RECOMBIVAX HB produced by Merck. Either vaccine can be given as a dose in the Hepatitis B series. Each injection counts as one dose, even though Energix B contains 10mcg/0.5ml per dose and Recombivax contains 5mcg./0.5ml per dose. Hepatitis A Vaccine HAVRIX produced by GlaxoSmithKline VAQTA produced by Merck Either vaccine can be given as a dose in the two-dose Hepatitis A vaccination series. You can give one dose with one product and the second dose with the other product, or both doses with the same product, depending on what you have received from NHIP. Department of Health and Human Services Division of Public Health Services NH Immunization Program 29 Hazen Drive Concord, NH toll free in NH x4482 TDD Number FAX:

191 Vaccine product name Manufacturer Liquid diluent (may contain vaccine) Time allowed between reconstitution and use* Diluent storage environment ActHIB (Hib) sanofi pasteur Hib 0.4% sodium chloride 24 hrs Refrigerator Hiberix (Hib) GlaxoSmithKline Hib 0.9% sodium chloride 24 hrs Refrigerator or room temp Imovax (RAB HDCV ) sanofi pasteur Rabies virus Sterile water Immediately Refrigerator M-M-R II (MMR) Merck MMR Sterile water 8 hrs MenHibrix (Hib-MenCY) Menomune (MPSV4) GlaxoSmithKline Hib-MenCY 0.9% sodium chloride Immediately sanofi pasteur MPSV4 Distilled water 30 min (single-dose vial) 35 days (multidose vial) Refrigerator or room temp Refrigerator or room temp Refrigerator Menveo (MCV4) Novartis MenA MenCWY 8 hrs Refrigerator Pentacel (DTaP-IPV/Hib) sanofi pasteur Hib DTaP-IPV ProQuad (MMRV) Merck MMRV Sterile water 30 min Immediately (i.e., within 30 minutes or less) Refrigerator Refrigerator or room temp RabAvert (RAB PCECV ) Novartis Rabies virus Sterile water Immediately Refrigerator Rotarix (RV1) GlaxoSmithKline RV1 Sterile water, calcium carbonate, and xanthan Varivax (VAR) Merck VAR Sterile water 30 min YF-VAX (YF) sanofi pasteur YF 0.9% sodium chloride 60 min Zostavax (HZV) Merck HZV Sterile water 30 min 1. For single-dose vaccine products (exceptions are Menomune in the multidose vial and Rotarix ), select a syringe and a needle of proper length to be used for both reconstitution and administration of the vaccine. Following reconstitution, Menomune in a multidose vial will require a new needle and syringe for each dose of vaccine to be administered. For Rotarix, see the package insert. 2. Before reconstituting, check labels on both the lyophilized vaccine vial and the diluent to verify the following: that they are the correct two products to mix together that the diluent is the correct volume (especially for Menomune in the multidose vial) that neither vaccine nor diluent has expired 3. Reconstitute (i.e., mix) vaccine just prior to use by removing the protective caps and wiping each stopper with an alcohol swab inserting needle of syringe into diluent vial and withdrawing entire contents Vaccines with Diluents: How to Use Them The following vaccines must be reconstituted correctly before they are administered. Reconstitution means that the lyophilized (freeze-dried) vaccine powder or wafer in one vial must be reconstituted (mixed) with the diluent (liquid) in another. Only use the diluent provided by the manufacturer for that vaccine as indicated on the chart. ALWAYS check the expiration date on the diluent and vaccine. NEVER use expired diluent or vaccine. Lyophilized vaccine (powder) Always refer to package inserts for detailed instructions on reconstituting specific vaccines. In general, follow these steps: 24 hrs Room temp Refrigerator or room temp Refrigerator or room temp Refrigerator or room temp injecting diluent into lyophilized vaccine vial and rotating or agitating to thoroughly dissolve the lyophilized powder 4. Check the appearance of the reconstituted vaccine. Reconstituted vaccine may be used if the color and appearance match the description on the package insert. If there is discoloration, extraneous particulate matter, obvious lack of resuspension, or cannot be thoroughly mixed, mark the vial as DO NOT USE, return it to proper storage conditions, and contact your state or local health department immunization program or the vaccine manufacturer. 5. If reconstituted vaccine is not used immediately or comes in a multidose vial (i.e., multi-dose Menomune), clearly mark the vial with the date and time the vaccine was reconstituted maintain the product at F (2 8 C); do not freeze protect reconstituted vaccines from light use only within the time indicated on chart above * If the reconstituted vaccine is not used within this time period, it must be discarded. MMRV contains seven times as much varicella component as does the single antigen VAR. Rotarix vaccine is administered by mouth using the applicator that contains the diluent. It is not administered as an injection. HZV contains fourteen times as much varicella component as does the single antigen VAR. Technical content reviewed by the Centers for Disease Control and Prevention Item #P3040 (12/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

192 How to Administer IM and SC Vaccine Injections to Adults Intramuscular (IM) Injections Administer these vaccines via IM route Tetanus, diphtheria (Td), or with pertussis (Tdap); hepatitis A; hepatitis B; human papillomavirus (HPV); trivalent inactivated influenza (TIV); pneumococcal conjugate (PCV13); and quadrivalent meningococcal conjugate (MCV4). Administer polio (IPV) and pneumococcal polysaccharide vaccine (PPSV23) either IM or SC. Injection site Give in the central and thickest portion of the deltoid above the level of the armpit and below the acromion (see the diagram). Needle size gauge, 1 1½" needle (see note at right) Needle insertion Use a needle long enough to reach deep into the muscle. Insert the needle at a 90 angle to the skin with a quick thrust. Separate two injections given in the same deltoid muscle by a minimum of 1". level of armpit acromion IM injection site (shaded area) elbow skin 90 angle subcutaneous tissue muscle Note: A ⅝" needle is sufficient in adults weighing less than 130 lbs (<60 kg) for IM injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90-degree angle; a 1" needle is sufficient in adults weighing lbs (60 70 kg); a 1 1½" needle is recommended in women weighing lbs (70 90 kg) and men weighing lbs ( kg); a 1½" needle is recommended in women weighing more than 200 lbs (90 kg) or men weighing more than 260 lbs (more than 118 kg). Subcutaneous (SC) Injections Administer these vaccines via SC route MMR, varicella, meningococcal polysaccharide (MPSV4), and zoster (shingles). Administer polio (IPV) and pneumococcal polysaccharide vaccine (PPSV23) either SC or IM. Injection site Give in fatty tissue over the triceps (see the diagram). Needle size gauge, 5/8" needle Needle insertion Pinch up on the tissue to prevent injection into the muscle. Insert the needle at a 45 angle to the skin. Separate two injections given in the same area of fatty tissue by a minimum of 1". 45 angle skin subcutaneous tissue muscle acromion SC injection site (shaded area) elbow Adapted by the Immunization Action Coalition, courtesy of the Minnesota Department of Health Technical content reviewed by the Centers for Disease Control and Prevention. Item #P2020A (7/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

193 Administering Vaccines to Adults: Dose, Route, Site, and Needle Size Hepatitis A (HepA) Hepatitis B HepB) Vaccine Dose Route <18 yrs: 0.5 ml >19 yrs: 1.0 ml <19 yrs: 0.5 ml >20 yrs: 1.0 ml HepA-HepB (Twinrix) >18 yrs: 1.0 ml IM Human papillomavirus (HPV) 0.5 ml IM Influenza, live attenuated (LAIV) 0.2 ml (0.1 ml into each nostril) Intranasal spray Influenza, trivalent inactivated (TIV), including Fluzone High-Dose 0.5 ml IM Influenza (TIV) Fluzone Intradermal, for ages 18 through 64 years 0.1 ml Intradermal Measles, Mumps, Rubella (MMR) 0.5 ml SC Meningococcal, conjugate (MCV4) 0.5 ml IM Meningococcal, polysaccharide (MPSV4) 0.5 ml SC Pneumococcal, conjugate (PCV13) 0.5 ml IM Pneumococcal, polysaccharide (PPSV) 0.5 ml IM SC Tetanus, Diphtheria (Td) with Pertussis (Tdap) 0.5 ml IM Varicella (VAR) 0.5 ml SC Zoster (Zos) 0.65 ml SC Injection Site and Needle Size Subcutaneous (SC) injection Use a gauge, 5 8 ", needle. Inject in fatty tissue over triceps. Intramuscular (IM) injection Use a gauge needle. Inject in deltoid muscle of arm. Choose the needle length as indicated below: Gender/Weight Needle Length Male or female less than 130 lbs 5 8 "* 1" Female lbs 1 1½" Male lbs Female 200+ lbs 1½" Male 260+ lbs *A 5 /8" needle may be used for patients weighing less than 130 lbs (<60 kg) for IM injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90-degree angle. IM IM Intramuscular (IM) injection Subcutaneous (SC) injection Intradermal (ID) administration of Fluzone ID vaccine Intranasal (IN) administration of FluMist (LAIV) vaccine 90 angle skin 90 angle 45 angle skin Administer in area of deltoid subcutaneous tissue muscle subcutaneous tissue muscle Note: Always refer to the package insert included with each biologic for complete vaccine administration information. CDC s Advisory Committee on Immunization Practices (ACIP) recommendations for the particular vaccine should be reviewed as well. Access the ACIP recommendations at Item #P3084 (7/12) Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651) Technical content reviewed by the Centers for Disease Control and Prevention

194 Policy Number: 7h INTRAMUSCULAR (IM) Vaccines given intramuscularly (IM): Diphtheria-Tetanus-Pertussis Haemophilus influenzae, type b Hepatitis A Hepatitis B Influenza Meningococcal Conjugate 90º Intramuscular (IM) Needle Size: gauge Needle Length: 1 Pneumococcal Conjugate A g e : 0 36 months Infant/Toddler Intramuscular Shot Intramuscular shots in infants and toddlers are usually given in the anterolateral thigh. The vastus lateralis muscle is on the outside of the leg in the mid- to upper-thigh. Site: Vastus Lateralis Example of two IM sites Use gauge, 1 needle. Insert entire needle at 90º angle. A g e : 3 ye a r s A d u l t Child/Adult Intramuscular Shot Intramuscular injections to children and adults are usually given in the upper arm. The deltoid muscle is found about 3 fingers below the acromion, above the level of the armpit. Site: Deltoid Use gauge, 1 needle. Insert entire needle at 90º angle. A 11/2 needle may be needed for large adults. Example of two IM sites S U B C U TANEOUS (SC) Vaccines given subcutaneously (SC): Inactivated Polio Vaccine* Measles-Mumps-Rubella Pneumococcal Po ly s a c c h a r i d e * Varicella Subcutaneous (SC) Needle Size: 45º 25 gauge Needle Length: 5/ 8 *Can also be given IM Infant/Toddler Subcutaneous Shot Site: Outer Aspect Example of two SC sites A g e : 0 36 months Subcutaneous shots in infants and toddlers are given either in the upper arm or in the fatty area of the thigh. The tissue is pinched up between the thumb and index finger. Use 25 gauge, 5/8 needle. Insert entire needle at 45º angle. Child/Adult Subcutaneous Shot A g e : 3 ye a r s A d u l t Given in the upper arm. The tissue on the back of the upper arm is pinched up between the thumb and index finger. Site: Outer Aspect Example of two SC sites Use 25 gauge, 5/8 needle. Insert entire needle at 45º angle. P roduc ed by the Immunization Branc h, California D epartment of Health Services. 193 Arnold Schwarzenegger, Governor State of California Kimberly Belshé, Secretary Health and Human Services Agency Sandra Shewry, Director Department of Health Services Immunization Branch 850 Marina Bay Parkway, Building P Richmond, CA IMM-685 (10/05) Medical Illustrations by Lynne Larson, All rights reserved. This chart is based on extensive review of the scientific literature including recommendations of the Advisory Committee on Immunization Practices (MMWR 1994; 43RR-1, 1-38) and the American Academy of Pediatrics (Red Book 2000). The purpose of this chart is to present the most customarily recommended vaccine injection sites and needle sizes. For alternatives or additional information, please refer to the vaccine manufacturer s package insert and the cited references. Devices illustrated are available with engineered sharps injury prevention mechanisms. Produced by the Immunization Branch, California Department of Health Services.

195 FactSheet Protecting Yourself When Handling Contaminated Sharps Sharps are objects that can penetrate a worker s skin, such as needles, scalpels, broken glass, capillary tubes and the exposed ends of dental wires. If blood or other potentially infectious materials (OPIM), as defined in the OSHA Bloodborne Pathogens standard (29 CFR ), are present or may be present on the sharp, it is a contaminated sharp and appropriate personal protective equipment must be worn. A needlestick or a cut from a contaminated sharp can result in a worker being infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and other bloodborne pathogens. The standard specifies measures to reduce these types of injuries and the risk of infection. Careful handling of contaminated sharps can prevent injury and reduce the risk of infection. Employers must ensure that workers follow these work practices to decrease the workers chances of contracting bloodborne diseases. Safer Medical Devices Employers are required to consider and use safer medical devices, wherever possible. These devices include those that are needleless or have built-in protection to guard workers against contact with the contaminated sharp. In addition, employers must ask non-managerial patient care workers who could be exposed to contaminated sharps injuries for their input in identifying, evaluating and selecting effective work practice and engineering controls, including safer medical devices. The employer must document consideration and implementation of these devices, and the solicitation of worker input, in the Exposure Control Plan. Prompt Disposal Employers must also ensure that contaminated sharps are disposed of in sharps disposal containers immediately or as soon as feasible after use. Sharps disposal containers must be readily accessible and located as close as feasible to the area where sharps will be used. In some cases, they may be placed on carts to prevent patients, such as psychiatric patients or children, from accessing the sharps. Containers also must be available wherever sharps may be found, such as in laundries. Contaminated sharps must never be sheared or broken. Recapping, bending, or removing needles is permissible only if there is no feasible alternative or if such actions are required for a specific medical or dental procedure. If recapping, bending, or removal is necessary, employers must ensure that workers use either a mechanical device or a one-handed technique. The cap must not be held in one hand while guiding the sharp into it or placing it over the sharp. A one-handed "scoop" technique uses the needle itself to pick up the cap, and then the cap is pushed against a hard surface to ensure a tight fit onto the device. Also, the cap may be held with tongs or forceps and placed over the needle. Contaminated broken glass must not be picked up by hand, but must be cleaned up using mechanical means, such as a brush and dust pan, tongs, or forceps. Sharps Containers Containers for contaminated sharps must be puncture-resistant. The sides and the bottom must be leakproof. They must be appropriately labeled or color-coded red to warn everyone that the contents are hazardous. Containers for disposable sharps must be closable (that is, have a lid, flap, door, or other means of closing the container), and they must be kept upright to keep the sharps and any liquids from spilling out of the container. The containers must be replaced routinely and not be overfilled, which can increase the risk of needlesticks or cuts. Sharps disposal containers that are reusable must not be opened, emptied, 194

196 or cleaned manually or in any other manner that would expose workers to the risk of sharps injury. Employers also must ensure that reusable sharps that are contaminated are not stored or processed in a manner that requires workers to reach by hand into the containers where these sharps have been placed. Handling Containers Before sharps disposal containers are removed or replaced, they must be closed to prevent spilling the contents. If there is a chance of leakage from the disposal container, the employer must ensure that it is placed in a secondary container that is closable, appropriately labeled or color-coded red, and constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping. Additional Information For more information, go to OSHA s Bloodborne Pathogens and Needlestick Prevention Safety and Health Topics web page at: SLTC/bloodbornepathogens/index.html. To file a complaint by phone, report an emergency, or get OSHA advice, assistance, or products, contact your nearest OSHA office under the U.S. Department of Labor listing in your phone book, or call us toll-free at (800) 321-OSHA (6742). This is one in a series of informational fact sheets highlighting OSHA programs, policies or standards. It does not impose any new compliance requirements. For a comprehensive list of compliance requirements of OSHA standards or regulations, refer to Title 29 of the Code of Federal Regulations. This information will be made available to sensory-impaired individuals upon request. The voice phone is (202) ; teletypewriter (TTY) number: (877) For assistance, contact us. We can help. It s confidential. Occupational Safety and Health Administration DSG 1/

197 What to Expect After Receiving Vaccines Sometimes the vaccines that protect you from serious diseases may also cause some discomfort. Reactions to vaccinations do occur, but serious reactions are rare. The more common reactions are redness, slight swelling and pain at the injection site, and fever. Today s Date You have received the vaccines that are checked below: Influenza: TIV (flu shot) Hepatitis A: hep A Influenza: LAIV (nasal spray) Hepatitis B: hep B Pneumococcal Polysaccharide: PPSV23 Varicella: Var (chickenpox) Tetanus/Diphtheria: Td Zoster: zoster (shingles) Tetanus/Diphtheria/Pertussis: Tdap Meningococcal Conjugate: MCV4 Human Papillomavirus: HPV4 or HPV2 Meningococcal Polysaccharide : MPSV4 Measles/Mumps/Rubella: MMR Other: Follow These Steps Below to Ease the Discomfort of Recent Vaccination: Apply a cold pack or cloth to the injection area for 5-10 minutes at a time Use or exercise the arm in which the vaccine was given - this will distribute the medication quickly and reduce soreness If you develop a fever greater than 100 F (38 C), do the following: o Take a fever reducing medication as directed by your health care provider: o Drink plenty of fluids o Dress lightly If you have other questions or are concerned about how you are feeling, don t hesitate to call your health care provider or the clinic where you received the vaccine. Phone Number: Your next vaccine(s) are due on or after AIM Tool Kit Adult Section December 7,