Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
Clin Infect Dis. 2008 Mar 15;46 Suppl 3:S271-93. doi: 10.1086/524750.

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

Author information

  • 1Epidemiology and Surveillance Division, National Immunization Program, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lec3@cdc.gov

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.

PMID:
18284368
[PubMed - indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire
    Loading ...
    Write to the Help Desk