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Update: Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions Recommendations of the Advisory Committee on Immunization Practices (ACIP) Summary This report provides updated information concerning the potential adverse events associated with vaccination for hepatitis B, poliomyelitis, measles, mumps, diphtheria, tetanus, and pertussis. This information incorporates findings from a series of recent literature reviews, conducted by an expert committee at the Institute of Medicine (IOM), of all evidence regarding the possible adverse consequences of vaccines administered to children. This report contains modifications to the previously published recommendations of the Advisory Committee on Immunization Practices (ACIP) and is based on an ACIP review of the IOM findings and new research on vaccine safety. In addition, this report incorporates information contained in the "Recommendations of the Advisory Committee on Immunization Practices: Use of Vaccines and Immune Globulins in Persons with Altered Immunocompetence" (MMWR 1993;42{No. RR-4}) and the "General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" (MMWR 1994;43{No. RR-1}). Major changes to the previous recommendations are highlighted within the text, and specific information concerning the following vaccines and the possible adverse events associated with their administration are included: hepatitis B vaccine and anaphylaxis; measles vaccine and a) thrombocytopenia and b) possible risk for death resulting from anaphylaxis or disseminated disease in immunocompromised persons; diphtheria and tetanus toxoids and pertussis vaccine (DTP) and chronic encephalopathy; and tetanus-toxoid-containing vaccines and a) Guillain-Barre syndrome, b) brachial neuritis, and c) possible risk for death resulting from anaphylaxis. These modifications will be incorporated into more comprehensive ACIP recommendations for each vaccine when such statements are revised. Also included in this report are interim recommendations concerning the use of measles and mumps vaccines in
INTRODUCTION Immunization has enabled the global eradication of smallpox (1), the elimination of poliomyelitis from the Western hemisphere (2), and major reductions in the incidence of other vaccine-preventable diseases in the United States (Table_1). However, although immunization has successfully reduced the incidence of vaccine-preventable diseases, vaccination can cause both minor and, rarely, serious side effects. Public awareness of and controversy about vaccine safety has increased, primarily because increases in vaccine coverage resulted in an increased number of adverse events that occurred after vaccination. Such adverse events include both true reactions to vaccine and events coincidental to, but not caused by, vaccination. Despite concerns about vaccine safety, vaccination is safer than accepting the risks for the diseases these vaccines prevent. Unless a disease has been eradicated (e.g., smallpox), failure to vaccinate increases the risks to both the individual and society. In response to concerns about vaccine safety, the National Childhood Vaccine Injury Act of 1986 established a no-fault compensation process for persons possibly injured by selected vaccines (3). The Act also mandated that the Institute of Medicine * (IOM) review scientific and other evidence regarding the possible adverse consequences of vaccines administered to children. IOM constituted an expert committee to review all available information on these vaccine adverse events; such information included epidemiologic studies, case series, individual case reports, and testimonials. To derive their conclusions, the IOM committee members created five categories of causality to describe the relationships between the vaccines and specific adverse events. The first IOM review examined certain events occurring after administration of pertussis and rubella vaccines (Table_2) (4). The second IOM review examined events occurring after administration of all other vaccines usually administered during childhood (i.e., diphtheria and tetanus toxoids and measles, mumps, hepatitis B, Haemophilus influenzae type b {Hib}, and poliovirus vaccines) (Table_3) (5). Two other IOM committees have met since the findings of the second review were published. These two committees have published their findings concerning both the diphtheria and tetanus toxoids and pertussis vaccine (DTP) and chronic nervous system dysfunction (Figure_1) (6) and research strategies for vaccine-associated adverse events (7). The Advisory Committee on Immunization Practices (ACIP) recently reviewed the findings of the IOM committees and modified the previously published ACIP recommendations to ensure consistency with IOM conclusions. These recommendations, which are included in this report, update all previously published ACIP recommendations pertaining to the precautions, contraindications, side effects, and adverse reactions ** associated with specific vaccines. ACIP accepted the IOM conclusions for almost all vaccine adverse events; the few exceptions generally occurred because new information that was available to ACIP had not been available when the IOM committees published their recommendations. These exceptions included a) oral poliovirus vaccine (OPV) and Guillain-Barre syndrome (GBS), b) tetanus-toxoid- containing vaccines and GBS, and c) DTP and chronic nervous system dysfunction. In addition, this report incorporates information contained in the "Recommendations of the Advisory Committee on Immunization Practices: Use of Vaccines and Immune Globulins in Persons with Altered Immunocompetence" (MMWR 1993; 42{No. RR-4}) and the "General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" (MMWR 1994;43{No. RR-1}). To facilitate recognition of the new recommendations in this report, all major changes that are being made to the previously published ACIP statements are highlighted within the text. These changes include information on the following vaccines and the possible adverse events associated with their administration:
The modifications contained in this report, and possibly other changes as new information becomes available, will be incorporated into more comprehensive ACIP recommendations for each vaccine when such statements are revised. HEPATITIS B VACCINE The following recommendations concerning adverse events associated with hepatitis B vaccination update those applicable sections in "Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination -- Recommendations of the Immunization Practices Advisory Committee (ACIP)" (MMWR 1991;40{No. RR-13}). Vaccine Side Effects and Adverse Reactions Hepatitis B vaccines are safe to administer to adults and children. More than an estimated 10 million adults and 2 million infants and children have been vaccinated in the United States, and at least 12 million children have been vaccinated worldwide. Vaccine-Associated Side Effects Pain at the injection site (3%-29%) and a temperature greater than 37.7 C (1%-6%) have been among the most frequently reported side effects among adults and children receiving vaccine (8-12). In placebo-controlled studies, these side effects were reported no more frequently among vaccinees than among persons receiving a placebo (11,12). Among children receiving both hepatitis B vaccine and DTP, these mild side effects have been observed no more frequently than among children receiving only DTP. The recommendation to begin hepatitis B vaccination soon after birth has raised the concern that a substantial number of infants will require an extensive medical evaluation for elevated temperatures secondary to hepatitis B vaccination. Several population-based studies to evaluate this possibility are in progress.
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