Vaccine. 2009 Jan 7;27(2):290-7. doi: 10.1016/j.vaccine.2008.10.044. Epub 2008 Nov 6.

Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007.

Niu MT¹, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM; VAERS Working Group.

Author information

1: 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

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.