title: A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004.
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.
authors.affiliation: Epidemiology and Surveillance Division, National Immunization Program, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lec3@cdc.gov
authors.forename: Louisa E
authors.initials: LE
authors.lastname: Chapman
authors.forename: John K
authors.initials: JK
authors.lastname: Iskander
authors.forename: Robert T
authors.initials: RT
authors.lastname: Chen
authors.forename: John
authors.initials: J
authors.lastname: Neff
authors.forename: Guthrie S
authors.initials: GS
authors.lastname: Birkhead
authors.forename: Gregory
authors.initials: G
authors.lastname: Poland
authors.forename: Gregory C
authors.initials: GC
authors.lastname: Gray
authors.forename: Jane
authors.initials: J
authors.lastname: Siegel
authors.forename: Kent
authors.initials: K
authors.lastname: Sepkowitz
authors.forename: Rose Marie
authors.initials: RM
authors.lastname: Robertson
authors.forename: Clyde
authors.initials: C
authors.lastname: Yancy
authors.forename: Fernando A
authors.initials: FA
authors.lastname: Guerra
authors.forename: Pierce
authors.initials: P
authors.lastname: Gardner
authors.forename: John F
authors.initials: JF
authors.lastname: Modlin
authors.forename: Toby
authors.initials: T
authors.lastname: Maurer
authors.forename: Tim
authors.initials: T
authors.lastname: Berger
authors.forename: W Dana
authors.initials: WD
authors.lastname: Flanders
authors.forename: Robert
authors.initials: R
authors.lastname: Shope
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration / Q000706:statistics & numerical data*; D016022:Case-Control Studies; D015984:Causality; D006801:Humans; D032541:Mass Vaccination / Q000009:adverse effects* / Q000706:statistics & numerical data; D018571:Sentinel Surveillance; D012899:Smallpox / Q000517:prevention & control; D012900:Smallpox Vaccine / Q000009:adverse effects*; D014481:United States
chemical_list: C078786:DryVax vaccine; D012900:Smallpox Vaccine