A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004.


Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Chapman, LE; Iskander, JK; Chen, RT; Neff, J; Birkhead, GS; Poland, G; Gray, GC; Siegel, J; Sepkowitz, K; Robertson, RM; Yancy, C; Guerra, FA; Gardner, P; Modlin, JF; Maurer, T; Berger, T; Flanders, WD; Shope, R

Published Date

  • March 15, 2008

Published In

Volume / Issue

  • 46 Suppl 3 /

Start / End Page

  • S271 - S293

PubMed ID

  • 18284368

Pubmed Central ID

  • 18284368

Electronic International Standard Serial Number (EISSN)

  • 1537-6591

Digital Object Identifier (DOI)

  • 10.1086/524750


  • eng

Conference Location

  • United States