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Section 1. Active and Passive Immunization
ACTIVE IMMUNIZATION
Reporting of Adverse Events
Before administering a dose of any vaccine, parents and patients should be questioned about adverse events and possible reactions after previous doses. No recommendations can anticipate all possible adverse events, particularly with newly licensed vaccines or a dose being administered as the first in a series. 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 a VAERS report should be made. There is no time limit for reporting an adverse event. A possible reaction should be reported when the reaction is recognized.
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 852) or listed as a contraindication to additional doses of vaccine in the manufacturers package insert. The vaccines to which these requirements apply, as of January 2006, are measles, mumps, rubella, varicella, poliovirus, hepatitis A, hepatitis B, pertussis, diphtheria, tetanus, rotavirus, Hib, pneumococcal conjugate, meningococcal conjugate, and influenza vaccines (see Record Keeping and Immunization Information Systems, p 37).
Vaccine Adverse Event Reporting System (VAERS)
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Clinically significant adverse events other than those listed in Appendix IV (p 852), as well as those occurring after administration of other vaccines not listed in Appendix IV, also should be reported to the VAERS. Vaccine failures (disease in an
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