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Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).
Pharmacoepidemiol Drug Saf. 2004 Dec; 13(12):825-40.PD

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics, Obstetrics and Gynecology, The Children's National Medical Center, George Washington University, Washington, DC 20010-2970, USA. jsever@cnmc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Review

Language

eng

PubMed ID

15386719

Citation

Sever, John L., et al. "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, vol. 13, no. 12, 2004, pp. 825-40.
Sever JL, Brenner AI, Gale AD, et al. Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiol Drug Saf. 2004;13(12):825-40.
Sever, J. L., Brenner, A. I., Gale, A. D., Lyle, J. M., Moulton, L. H., Ward, B. J., & West, D. J. (2004). 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, 13(12), 825-40.
Sever JL, et al. Safety of Anthrax Vaccine: an Expanded Review and Evaluation of Adverse Events Reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiol Drug Saf. 2004;13(12):825-40. PubMed PMID: 15386719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). AU - Sever,John L, AU - Brenner,Alan I, AU - Gale,Arnold D, AU - Lyle,Jerry M, AU - Moulton,Lawrence H, AU - Ward,Brian J, AU - West,David J, PY - 2004/9/24/pubmed PY - 2005/4/21/medline PY - 2004/9/24/entrez SP - 825 EP - 40 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 13 IS - 12 N2 - 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. SN - 1053-8569 UR - https://www.unboundmedicine.com/medline/citation/15386719/Safety_of_anthrax_vaccine:_an_expanded_review_and_evaluation_of_adverse_events_reported_to_the_Vaccine_Adverse_Event_Reporting_System__VAERS__ L2 - https://doi.org/10.1002/pds.936 DB - PRIME DP - Unbound Medicine ER -