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Section 1. Active and Passive Immunization
Active Immunization
Reporting of Adverse Events
Before administering a dose of any vaccine, health care professionals should ask parents and patients if they have experienced adverse events following immunization with previous doses. Although extensive safety testing is required before vaccine licensure, these prelicensure studies may not be large enough to detect rare adverse events or determine the rate of adverse events previously linked with the vaccine. Unexpected events after administration of any vaccine, particularly events judged to be clinically significant, should be described in detail in the patient’s medical record and subsequently submitted to the VAERS (http://vaers.hhs.gov). There is no time limit for reporting an adverse event. The FDA and CDC encourage reporting of any significant adverse event following an immunization, even if it is uncertain that the event was caused by the vaccine.
The National Childhood Vaccine Injury Act of 1986 requires physicians and other health care professionals who administer vaccines covered under the National Vaccine Injury Compensation Program to maintain permanent immunization records and to report to the VAERS any condition listed on the reportable events table (see Appendix IV, p 842) or listed in the manufacturer’s package insert as a contraindication to additional doses of vaccine. The antigens to which these requirements apply, as of January 2009, are measles, mumps, rubella, varicella, poliovirus, hepatitis A, hepatitis B, pertussis, diphtheria, tetanus, rotavirus, Hib, pneumococcal conjugate, meningococcal (conjugate and polysaccharide), human papillomavirus, and influenza (inactivated and live intranasal) vaccines (see Record Keeping and Immunization Information Systems, p 38).
Vaccine Adverse Event Reporting System (VAERS)Vaccine Safety Datalink Project
Clinical Immunization Safety Assessment (CISA) Network
Vaccine Injury Compensation
Vaccine Contraindications And Precautions
Hypersensitivity Reactions After Immunization
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VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS)
VAERS is a national passive surveillance system that
Related text in Red Book:
- Summary of Major Changes in the 2009 Red Book
Red Book 2009: XXIX.[Extract] [Full Version] - Record Keeping and Immunization Information Systems
Red Book 2009: 38-39.[Extract] [Full Version] - Vaccine Safety and Contraindications
Red Book 2009: 40-41.[Extract] [Full Version] - Vaccine Administration
Red Book 2009: 17-20.[Extract] [Full Version] - Treatment of Anaphylactic Reactions
Red Book 2009: 65-67.[Extract] [Full Version] - Preterm and Low Birth Weight Infants
Red Book 2009: 68-70.[Extract] [Full Version] - Immunocompromised Children
Red Book 2009: 72-86.[Extract] [Full Version] - Children With a Personal or Family History of Seizures
Red Book 2009: 86.[Extract] [Full Version] - Poliovirus Infections
Red Book 2009: 541-545.[Extract] [Full Version] - Rabies
Red Book 2009: 552-559.[Extract] [Full Version] - Tetanus (Lockjaw)
Red Book 2009: 655-660.[Extract] [Full Version] - Tuberculosis
Red Book 2009: 680-701.[Extract] [Full Version] - Varicella-Zoster Infections
Red Book 2009: 714-727.[Extract] [Full Version] - Hepatitis B
Red Book 2009: 337-356.[Extract] [Full Version] - Arboviruses (also see West Nile Virus, p 730)
Red Book 2009: 214-220.[Extract] [Full Version] - Influenza
Red Book 2009: 400-412.[Extract] [Full Version] - Pertussis (Whooping Cough)
Red Book 2009: 504-519.[Extract] [Full Version] - MedWatch—The FDA Safety Information and Adverse Event Reporting Program
Red Book 2009: 817-818.[Extract] [Full Version] - Appendix I. Directory of Resources
Red Book 2009: 831-834.[Extract] [Full Version] - Appendix IV. National Childhood Vaccine Injury Act and Reporting and Vaccine Injury Table
Red Book 2009: 842-844.[Extract] [Full Version] - Appendix VI. Guide to Contraindications and Precautions to Immunizations
Red Book 2009: 847-853.[Extract] [Full Version] - Appendix VII. Standards for Child and Adolescent Immunization Practices
Red Book 2009: 854-856.[Extract] [Full Version]
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