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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.

Authors+Show Affiliations

Epidemiology and Surveillance Division, National Immunization Program, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. lec3@cdc.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 -