no estimate of incidence or relative risk is available. It would seem to be low.
Anaphylaxis may occur, albeit rarely, following hepatitis B vaccination, and there are no known risk factors that predict the likelihood of anaphylaxis after hepatitis B vaccination. Although prior sensitization to thimerosal or yeast protein may predict greater local swelling at the site of vaccination, such sensitization has not been documented to predict anaphylaxis.
The evidence establishes a causal relation between hepatitis B vaccine and anaphylaxis. Anaphylaxis can be fatal. Although there is no direct evidence of fatal anaphylaxis following hepatitis B vaccination, in the committee's judgment hepatitis B vaccine could cause fatal anaphylaxis. There is no evidence or reason to believe that the case fatality rate for vaccine-associated anaphylaxis would differ from the case fatality rate for anaphylaxis associated with any other cause.
Hepatitis B vaccine has only recently begun to be administered to the age group that is affected by sudden infant death syndrome (SIDS). There are no published studies of a possible causal relation between hepatitis B vaccine and SIDS. There are reports in VAERS of SIDS following immunization with hepatitis B vaccine given in conjunction with other vaccines.
The evidence establishes a causal relation between hepatitis B vaccine and fatal anaphylaxis. There is no direct evidence for this; the conclusion is based on the potential for anaphylaxis to be fatal. The risk would appear to be extraordinarily low.
The evidence is inadequate to accept or reject a causal relation between hepatitis B vaccine and SIDS.
The evidence is inadequate to accept or reject a causal relation between hepatitis B vaccine and death from any cause other than those listed above.