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The Vaccine Adverse Event Reporting System, 1991-1998

Manette T. Niu, MD; Marcel E. Salive, MD, MPH; Susan S. Ellenberg, PhD

Arch Pediatr Adolesc Med. 1999;153:1279-1282.

Objective  To evaluate reports of neonatal deaths (aged 0-28 days) after hepatitis B (HepB) immunization reported to the national Vaccine Adverse Event Reporting System (VAERS).

Design  Case series; review of autopsy reports.

Setting  Voluntary reports submitted to VAERS, a passive surveillance system, from the US population.

Patients  All US neonates (0-28 days of age) whose deaths after HepB vaccination given alone were reported to VAERS, occurring from January 1, 1991, through October 5, 1998.

Intervention  None (observational database).

Results  Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 girls (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 symptoms was 2 days (range, 0-20 days); and median time from symptoms to death was 0 days (range, 0-15 days). The mean birth weight of the neonates (n = 15) was 3034 g (range, 1828-4678 g). The causes of death for the 17 autopsied cases were sudden infant death syndrome for 12, infection for 3, and 1 case each of intracerebral hemorrhage, accidental suffocation, and congenital heart disease.

Conclusion  Few neonatal deaths following HepB vaccination have been reported, despite the use of at least 86 million doses of pediatric vaccine given in the United States since 1991. While the limitations of passive surveillance systems do not permit definitive inference, these data suggest that HepB immunization is not causing a clear increase in neonatal deaths.

From the Division of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, US Food and Drug Administration, Rockville, Md.

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