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A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004.
Clin Infect Dis. 2008 Mar 15; 46 Suppl 3:S271-93.CI

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.

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Authors+Show Affiliations

Chapman LE
Epidemiology and Surveillance Division, National Immunization Program, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lec3@cdc.gov
Iskander JK
No affiliation info available
Chen RT
No affiliation info available
Neff J
No affiliation info available
Birkhead GS
No affiliation info available
Poland G
No affiliation info available
Gray GC
No affiliation info available
Siegel J
No affiliation info available
Sepkowitz K
No affiliation info available
Robertson RM
No affiliation info available
Yancy C
No affiliation info available
Guerra FA
No affiliation info available
Gardner P
No affiliation info available
Modlin JF
No affiliation info available
Maurer T
No affiliation info available
Berger T
No affiliation info available
Flanders WD
No affiliation info available
Shope R
No affiliation info available

MeSH

Adverse Drug Reaction Reporting SystemsCase-Control StudiesCausalityHumansMass VaccinationSentinel SurveillanceSmallpoxSmallpox VaccineUnited States

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

18284368

Citation

Chapman, Louisa E., et al. "A Process for Sentinel Case Review to Assess Causal Relationships Between Smallpox Vaccination and Adverse Outcomes, 2003-2004." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 46 Suppl 3, 2008, pp. S271-93.
Chapman LE, Iskander JK, Chen RT, et al. A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004. Clin Infect Dis. 2008;46 Suppl 3:S271-93.
Chapman, L. E., Iskander, J. K., Chen, R. T., Neff, J., Birkhead, G. S., Poland, G., Gray, G. C., Siegel, J., Sepkowitz, K., Robertson, R. M., Yancy, C., Guerra, F. A., Gardner, P., Modlin, J. F., Maurer, T., Berger, T., Flanders, W. D., & Shope, R. (2008). A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 46 Suppl 3, S271-93. https://doi.org/10.1086/524750
Chapman LE, et al. A Process for Sentinel Case Review to Assess Causal Relationships Between Smallpox Vaccination and Adverse Outcomes, 2003-2004. Clin Infect Dis. 2008 Mar 15;46 Suppl 3:S271-93. PubMed PMID: 18284368.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004. AU - Chapman,Louisa E, AU - Iskander,John K, AU - Chen,Robert T, AU - Neff,John, AU - Birkhead,Guthrie S, AU - Poland,Gregory, AU - Gray,Gregory C, AU - Siegel,Jane, AU - Sepkowitz,Kent, AU - Robertson,Rose Marie, AU - Yancy,Clyde, AU - Guerra,Fernando A, AU - Gardner,Pierce, AU - Modlin,John F, AU - Maurer,Toby, AU - Berger,Tim, AU - Flanders,W Dana, AU - Shope,Robert, PY - 2008/3/20/pubmed PY - 2008/4/5/medline PY - 2008/3/20/entrez SP - S271 EP - 93 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 46 Suppl 3 N2 - 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. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/18284368/A_process_for_sentinel_case_review_to_assess_causal_relationships_between_smallpox_vaccination_and_adverse_outcomes_2003_2004_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/524750 DB - PRIME DP - Unbound Medicine ER -