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

Overview

MeSH Major

  • Adverse Drug Reaction Reporting Systems
  • Case-Control Studies
  • Mass Vaccination
  • Sentinel Surveillance
  • Smallpox Vaccine

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 date

  • March 15, 2008

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1086/524750

PubMed ID

  • 18284368

Additional Document Info

start page

  • S271

end page

  • 93

volume

  • 46

number

  • SUPPL. 3