PMID- 12051118
OWN - NLM
STAT- MEDLINE
DCOM- 20021126
LR  - 20051116
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 11
IP  - 3
DP  - 2002 Apr-May
TI  - Safety of anthrax vaccine: a review by the Anthrax Vaccine Expert Committee 
      (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System 
      (VAERS).
PG  - 189-202
AB  - PURPOSE: To assess the safety of a licensed anthrax vaccine given to nearly 
      400,000 US military personnel, reports of adverse events (AEs) submitted to the 
      Vaccine Adverse Event Reporting System (VAERS) were reviewed and evaluated 
      medically. METHODS: The Anthrax Vaccine Expert Committee (AVEC), a civilian panel 
      of private-sector physicians and other scientists, reviewed 602 VAERS reports 
      using a Delphic approach (structured expert consensus) to assess the causal 
      relationship between vaccination and the reported AEs and sought to identify 
      unexpected patterns in the occurrence of medically important events. Reports were 
      entered into a database and used to profile AEs with respect to person, 
      type/location, relative frequency, severity/impact, concomitant illness or 
      receipt of other drugs or vaccines, and vaccine lot. RESULTS: Nearly half the 
      reports noted a local injection-site AE, with more than one-third of these 
      involving a moderate to large degree of inflammation. Six events qualified as 
      serious AEs (SAEs), and all were judged to be certain consequences of 
      vaccination. Three-quarters of the reports cited a systemic AE (most common: 
      flu-like symptoms, malaise, rash, arthralgia, headache), but only six individual 
      medically important events were judged possibly or probably due to vaccine 
      (aggravation of spondyloarthropathy (2), anaphylactoid reaction, arthritis (2), 
      bronchiolitis obliterans organizing pneumonia). CONCLUSIONS: Since some cases of 
      local inflammation involved distal paresthesia, AVEC recommends giving 
      subcutaneous injections of AVA over the inferior deltoid instead of the triceps 
      to avoid compression injury to the ulnar nerve. At this time, ongoing evaluation 
      of VAERS reports does not suggest a high frequency or unusual pattern of serious 
      or other medically important AEs.
FAU - Sever, John L
AU  - Sever JL
AD  - Departments of Pediatrics, Obstetrics and Gynecology, Microbiology and 
      Immunology, Children's National Medical Center, George Washington University, 
      School of Medicine, 111 Michigan Avenue, N.W., 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 - West, David J
AU  - West DJ
CN  - Anthrax Vaccine Export Committee
LA  - eng
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  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Anthrax Vaccines/*adverse effects/immunology
MH  - Causality
MH  - Female
MH  - Humans
MH  - Male
MH  - Military Personnel
MH  - Product Surveillance, Postmarketing
MH  - United States
RF  - 35
EDAT- 2002/06/08 10:00
MHDA- 2002/11/28 04:00
CRDT- 2002/06/08 10:00
PHST- 2002/06/08 10:00 [pubmed]
PHST- 2002/11/28 04:00 [medline]
PHST- 2002/06/08 10:00 [entrez]
AID - 10.1002/pds.712 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2002 Apr-May;11(3):189-202. doi: 10.1002/pds.712.