PMID- 15386719
OWN - NLM
STAT- MEDLINE
DCOM- 20050420
LR  - 20061115
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 13
IP  - 12
DP  - 2004 Dec
TI  - Safety of anthrax vaccine: an expanded review and evaluation of adverse events 
      reported to the Vaccine Adverse Event Reporting System (VAERS).
PG  - 825-40
AB  - PURPOSE: To assess the safety of a licensed anthrax vaccine (AVA) given to more 
      than 500,000 US military personnel, through review and medical evaluation of 
      adverse events (AEs) reported to the Vaccine Adverse Event Reporting System 
      (VAERS). METHODS: AEs were summarized by person, vaccine lot, type, frequency and 
      impact. A Delphic approach was used to tentatively assess causality in an effort 
      to detect serious AEs (SAEs) or other medically important AEs (OMIAEs) possibly 
      attributable to AVA. RESULTS: The Anthrax Vaccine Expert Committee (AVEC) 
      reviewed 1841 reports describing 3991 AEs (9.4 reports/10,000 doses of AVA) that 
      were submitted to VAERS from 1Q1998 through 4Q2001. One hundred forty-seven 
      reports described an SAE or OMIAE, of which 26 were tentatively rated as 
      possible, probable or certain consequences of vaccination (injection-site 
      reaction [12], 'anaphylactic-like reaction' [5] and eight other systemic AEs [1-2 
      each]). CONCLUSIONS: This review produced no evidence for an unusual rate of any 
      SAE or OMIAE attributable to AVA. It supported an earlier impression that AVA may 
      cause significant local inflammation and should be administered over the deltoid 
      rather than the triceps to avoid direct or compression injury to the ulnar nerve. 
      The subjects of VAERS reports tended to be older than all recipients of AVA. 
      Females generally had and/or reported AEs more often than males, but transient 
      articular reactions were surprisingly more common in males. Variations in the 
      frequency or severity (as judged by hospitalization and/or loss of duty) of 
      reported AEs did not suggest a significant problem with (1) a particular lot of 
      AVA, (2) recurrent AEs after multiple doses or (3) vaccination of persons with a 
      concomitant illness or those given other vaccines or medications.
CI  - Copyright 2004 John Wiley & Sons, Ltd.
FAU - Sever, John L
AU  - Sever JL
AD  - Department of Pediatrics, Obstetrics and Gynecology, The Children's National 
      Medical Center, George Washington University, Washington, DC 20010-2970, USA. 
      jsever@cnmc.org
FAU - Brenner, Alan I
AU  - Brenner AI
FAU - Gale, Arnold D
AU  - Gale AD
FAU - Lyle, Jerry M
AU  - Lyle JM
FAU - Moulton, Lawrence H
AU  - Moulton LH
FAU - Ward, Brian J
AU  - Ward BJ
FAU - West, David J
AU  - West DJ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Review
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Anthrax Vaccines)
SB  - IM
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Anthrax Vaccines/*adverse effects/immunology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Military Personnel
MH  - Product Surveillance, Postmarketing
MH  - Sex Factors
MH  - United States
RF  - 32
EDAT- 2004/09/24 05:00
MHDA- 2005/04/21 09:00
CRDT- 2004/09/24 05:00
PHST- 2004/09/24 05:00 [pubmed]
PHST- 2005/04/21 09:00 [medline]
PHST- 2004/09/24 05:00 [entrez]
AID - 10.1002/pds.936 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2004 Dec;13(12):825-40. doi: 10.1002/pds.936.