title: Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007.
abstract: During the period March 1, 1998 to January 14, 2007, approximately 6 million doses of Anthrax vaccine adsorbed (AVA) vaccine were administered. As of January 16, 2007, 4753 reports of adverse events following receipt of AVA vaccination had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Taken together, reports to VAERS did not definitively link any serious unexpected risk to this vaccine, and review of death and serious reports did not show a distinctive pattern indicative of a causal relationship to AVA vaccination. Continued monitoring of VAERS and analysis of potential associations between AVA vaccination and rare, serious events is warranted.
authors.affiliation: Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Division of Epidemiology, Vaccine Safety Branch, 1401 Rockville Pike, HFM-220, Rockville, MD 20852, United States. manette.niu@fda.hhs.gov
authors.forename: Manette T
authors.initials: MT
authors.lastname: Niu
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: Emily Jane
authors.initials: EJ
authors.lastname: Woo
authors.forename: Dale R
authors.initials: DR
authors.lastname: Burwen
authors.forename: Maureen
authors.initials: M
authors.lastname: Knippen
authors.forename: M Miles
authors.initials: MM
authors.lastname: Braun
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000881:Anthrax / Q000517:prevention & control*; D022122:Anthrax Vaccines / Q000009:adverse effects*; D001499:Bayes Theorem; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D014481:United States; D014611:Vaccination / Q000009:adverse effects; D014612:Vaccines / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D022122:Anthrax Vaccines; D014612:Vaccines