The committee did not identify any reports of fatal anaphylaxis following hepatitis B vaccination.

Available Data Were Insufficient to Allow a Judgment of Cause Two deaths following hepatitis B vaccination were reported to MSAEFI for the years 1979 to 1990. Both deaths occurred in vaccinees who concurrently received DPT and OPV. No other data regarding deaths were obtained from MSAEFI.

The committee identified nine reports in VAERS (submitted between November 1990 and July 1992) of death that occurred in association with administration of hepatitis B vaccines. Six of these were associated with administration of hepatitis B vaccine only; the other three were associated with administration of hepatitis B vaccine in conjunction with other vaccines. The ages of the vaccinees ranged from 1 month to 70 years, and the interval from vaccination to death ranged from 1 to 30 days.

The evidence establishes a causal relation between hepatitis B vaccine and anaphylaxis (see Chapter 8). 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 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.