We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- 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; Siegel, 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.
- Publication
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2008, Vol 46 Suppl 3, pS271
- ISSN
1537-6591
- Publication type
Journal Article
- DOI
10.1086/524750