no estimate of incidence or relative risk is available. It would seem to be low.

Risk-Modifying Factors

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.

DEATH

A detailed discussion of the evidence regarding death following immunization can be found in Chapter 10. Only the causality argument and conclusions follow. See Chapter 10 for details.

Causality Argument

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.

Conclusion

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.



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