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- Title
A Process for Sentinel Case Review to Assess Causal Relationships between Smallpox Vaccination and Adverse Outcomes, 2003-2004.
- Authors
Chapman, Louisa E.; Iskander, John K.; Chen, Robert T.; Neff, John; Birkhead, Guthrie S.; Poland, Gregory; Gray, Gregory C.; Siegei, Jane; Sepkowitz, Kent; Robertson, Rose Marie; Yancy, Clyde; Guerra, Fernando A.; Gardner, Pierce; Modlin, John F.; Maurer, Toby; Berger, Tim; Flanders, W. Dana; Shope, Robert
- Abstract
The US Department of Defense requested that the Advisory Committee on Immunization Practices-Armed Forces Epidemiological Board joint Smallpox Vaccine Safety Working Group define the likelihood that smallpox vaccination played a causal role in the fatal illness of an Army reservist. Reported serious adverse events for which there was no a priori reason to discount the existence of a causal association with smallpox vaccine were reviewed to assess whether they were signals of constellations of vaccine-associated adverse events. A causal relationship between the immunization experience and the index patient's death was favored, but the implication of an individual vaccine was precluded. No new smallpox vaccine-associated clinical syndromes were identified. The data supported neutrality regarding the hypothesis that dilated cardiomyopathy was causally associated with smallpox vaccine-induced myocarditis. This review of sentinel cases augmented the ongoing safety review process and was transparent, but it shares limitations with other case-based causality-assessment methods.
- Subjects
UNITED States; SMALLPOX; POXVIRUS diseases; PREVENTIVE medicine; SMALLPOX vaccines; VIRAL vaccines; UNITED States. Dept. of Defense; GOVERNMENT policy
- Publication
Clinical Infectious Diseases, 2008, Vol 46, pS271
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1086/524750