Neonatal deaths after hepatitis B vaccine - The vaccine adverse event reporting system, 1991-1998

Objective: To evaluate reports of neonatal deaths (aged 0-28 days), after h epatitis B (HepB) immunization reported to: the national Vaccine Adverse Ev ent Reporting System (VAERS). Design: Case series; review of autopsy reports. Setting: Voluntary reports submitted to VAERS, a pas- surveillance system, from the US population, Patients: All US neonates (0-28 days of age) whose deaths after HepB vaccin ation given alone were reported to VAERS, occurring from January 1, 1991, t hrough October 5, 1998. Intervention: None (observational database). Results: Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 gir ls (1 patient unclassified). The mean age at vaccination for these 18 cases was 12 days (range, 1-27 days): median time from vaccination to onset of s ymptoms was 2 days (range, 0-20 days); and I : median time from symptoms to death was 0 days I (range, 0-15 days). The mean birth weight of the neonat es (n = 15) was 3034 g (range, 1828-4678 g). The The causes of death for th e 17 autopsied cases were sudden infant death syndrome for 12, infection fo r 3, and 1 case each of intracerebral hemorrhage, accidental suffocation, a nd congenital heart disease. Conclusion: Few neonatal deaths following HepB vaccination have been report ed, despite the use of at least 86 million doses of pediatric vaccine given in the united 1 States since 1991. While the limitations of passive survei llance systems do not permit definitive inference, these data suggest that HepB immunization is not causing a clear increase in neonatal deaths.