AbstractPurposeTo examine the fatalities reported to the federally administered Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, in its first 7 years.MethodsThe working data set included variables such as demographic information, dates of vaccination, adverse event onset and death, vaccines administered, and vaccination facility data. Frequencies for these data and state reporting rates were calculated.ResultsA total of 1266 fatalities were reported to VAERS during July 1990 through June 1997. The number of death reports peaked in 1992–1993 and then declined. The overall median age of cases was 0.4 years, with a range of 1 day to 104 years. Nearly half of the deaths were attributed to sudden infant death syndrome (SIDS).ConclusionsThe trend of decreasing numbers of deaths reported to VAERS since 1992–1993 follows that observed for SIDS overall for the US general population following implementation of the ‘Back to Sleep’ program. These data may support findings of past controlled studies showing that the association between infant vaccination and SIDS is coincidental and not causal. VAERS reports of death after vaccination may be stimulated by the temporal association, rather than by any causal relationship. Published in 2001 by John Wiley & Sons, Ltd.