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To evaluate the postmarketing safety of recombinant hepatitis B (HB) vaccine given to neonates and infants in the US.US reports associated with HB vaccination and received between January 1, 1991, and May 31, 1995, by the national Vaccine Adverse Events Reporting System (VAERS) were reviewed as a case series.During 1991 through 1994, 12 520 (32%) VAERS reports were received for events temporally associated with administration of HB vaccine, of which 14% were received for neonates and infants. More reports described serious outcomes for neonates (<0.1 year old) than for other age groups (40% vs. 6 to 15%). HB alone was administered to 58 (97%) neonates; review of these reports did not reveal unexpected serious events. Among infants (0.1 to 0.9 years old) 192 (9%) received HB vaccine alone and 1469 (66%) received HB in combination with diphtheria-tetanus-pertussis (DTP) vaccine. Similar serious adverse events reported in neonates and infants included fever, agitation and apnea. Events reported for infants receiving HB/DTP and DTP alone were similar and differed from reports filed for infants receiving HB vaccine alone, suggesting that these events may be associated with use of DTP vaccine.This review shows no unexpected adverse events in neonates and infants given HB vaccine despite use of at least 12 million doses of vaccine given in these age groups. Although VAERS lacks the ability to distinguish coincidental events from true vaccine reactions, this database represents the largest case series of events temporally associated with HB vaccination of neonates and infants.