Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)

Pharmacoepidemiology and Drug Safety
John L SeverDavid J West

Abstract

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). 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. 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]). 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 rep...Continue Reading

References

Aug 5, 1995·BMJ : British Medical Journal·J Jones, D Hunter
May 1, 1994·The American Journal of Medicine·P B Beeson
Jun 1, 1997·Arthritis Care and Research : the Official Journal of the Arthritis Health Professions Association·A A StoneA T Kaell
Sep 28, 1998·JAMA : the Journal of the American Medical Association·K FukudaW C Reeves
Nov 24, 1998·British Journal of Rheumatology·R P RiemsmaO Wiegman
Oct 20, 2001·Journal of Applied Physiology·M D Lockshin
Aug 13, 2002·Chest·Suzanne J TimmerJohn D Malone
Mar 5, 2003·Vaccine·Joanne E EnstoneJames C G Pearson
Mar 29, 2003·Journal of Occupational and Environmental Medicine·Glenn M WassermanLance G Golder

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Citations

Jul 13, 2006·Maternal and Child Health Journal·Timothy S WellsPaul A Sato
Aug 9, 2006·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Monica Vasudev, Michael C Zacharisen
Dec 14, 2006·Molecular Therapy : the Journal of the American Society of Gene Therapy·Michael J McConnellMichael J Imperiale
Jan 4, 2008·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·John D Grabenstein
Mar 20, 2008·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Louisa E ChapmanRobert Shope
Jan 16, 2009·Respirology : Official Journal of the Asian Pacific Society of Respirology·Grant W Waterer, Hannah Robertson
Nov 22, 2005·Infection and Immunity·Jason E ComerRolf König
Oct 19, 2011·BMC Research Notes·Shoichi MaedaKazumasa Ehara
Jul 5, 2008·American Journal of Epidemiology·Margaret A K RyanJ David Erickson
Jun 15, 2011·Biologicals : Journal of the International Association of Biological Standardization·Alicia Jiménez-AlbertoJuan Arciniega
Oct 20, 2009·Vaccine·Alan D T Barrett, David W C Beasley
Sep 5, 2009·Molecular Aspects of Medicine·Robert J CybulskiAlison D O'Brien
Sep 14, 2007·Vaccine·Geoffrey J GorseMarc Gurwith
Aug 10, 2012·Vaccine·Sandra I SulskyPaul J Amoroso
Aug 21, 2007·Molecular Immunology·Jianhui ZhouDonald C Reason
Mar 5, 2016·Expert Review of Vaccines·Jarad M SchifferConrad P Quinn
Sep 21, 2016·Infection and Immunity·Miriam A BalderasAnthony W Maresso
Nov 15, 2007·Journal of Occupational and Environmental Medicine·Jill DowningJohn D Grabenstein
Jun 28, 2005·Annals of Saudi Medicine·Miroslav SplinoRoman Chlibek
Feb 8, 2014·Expert Review of Vaccines·De-Chu Christopher Tang, Huan Huu Nguyen
Jun 22, 2021·Radiology Case Reports·Jeffrey J AalbergEthan M Dobrow
Nov 19, 2020·ACS Synthetic Biology·Vince W KellyShannon J Sirk

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