{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T05:38:39Z","timestamp":1790919519184,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2004,2,12]],"date-time":"2004-02-12T00:00:00Z","timestamp":1076544000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2004,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To assess the safety of a licensed anthrax vaccine (AVA) given to more than 500\u2009000 US military personnel, through review and medical evaluation of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The Anthrax Vaccine Expert Committee (AVEC) reviewed 1841 reports describing 3991 AEs (9.4 reports\/10\u2009000 doses of AVA) that were submitted to VAERS from 1Q1998 through 4Q2001. One hundred forty\u2010seven reports described an SAE or OMIAE, of which 26 were tentatively rated as possible, probable or certain consequences of vaccination (injection\u2010site reaction [12], \u2018anaphylactic\u2010like reaction\u2019 [5] and eight other systemic AEs [1\u20132 each]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>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. Copyright \u00a9 2004 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.936","type":"journal-article","created":{"date-parts":[[2004,11,22]],"date-time":"2004-11-22T17:19:38Z","timestamp":1101143978000},"page":"825-840","source":"Crossref","is-referenced-by-count":59,"title":["Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)"],"prefix":"10.1002","volume":"13","author":[{"given":"John L.","family":"Sever","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan I.","family":"Brenner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnold D.","family":"Gale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry M.","family":"Lyle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence H.","family":"Moulton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian J.","family":"Ward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"West","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2004,2,12]]},"reference":[{"key":"e_1_2_1_2_2","first-page":"260","article-title":"Protecting the health of U.S. military forces: a national obligation","volume":"71","author":"Mazzuchi JF","year":"2000","journal-title":"Aviat Space Environ Med"},{"key":"e_1_2_1_3_2","first-page":"51002","article-title":"Biological products; bacterial vaccines and toxoids; implementation of efficacy review","volume":"50","author":"Food and Drug Administration","year":"1985","journal-title":"Fed Reg"},{"issue":"15","key":"e_1_2_1_4_2","first-page":"1","article-title":"Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"49","author":"Centers for Disease Control and Prevention","year":"2000","journal-title":"Morb Mort Wkly Rep"},{"key":"e_1_2_1_5_2","unstructured":"Congressional Testimony before Subcommitee on National Security Veterans Affairs and International Relations (29 April 1999) (testimony of K. 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