A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004 Journal Article
| Authors: | 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. |
| Article 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. © 2008 by the Infectious Diseases Society of America. All rights reserved. |
| Keywords: | treatment outcome; leukemia; unclassified drug; case control study; case-control studies; clinical feature; disease course; drug safety; hypertension; united states; clinical practice; organization and management; diagnostic procedure; statistics; health survey; patient monitoring; dyspnea; fever; lung embolism; cause of death; drug fatality; heart palpitation; emergency ward; thorax pain; drug surveillance program; adverse drug reaction reporting systems; anxiety disorder; hyperthermia; epidemiology; heart atrium fibrillation; congestive heart failure; ischemic heart disease; tachycardia; pericarditis; immunization; vaccinia; smallpox; lupus like syndrome; consciousness disorder; smallpox vaccine; dryvax vaccine; congestive cardiomyopathy; myocarditis; mass immunization; causality; sentinel surveillance |
| Journal Title: | Clinical Infectious Diseases |
| Volume: | 46 |
| Issue: | SUPPL. 3 |
| ISSN: | 1058-4838 |
| Publisher: | Oxford University Press |
| Date Published: | 2008-01-01 |
| Start Page: | S271 |
| End Page: | S293 |
| Language: | English |
| DOI: | 10.1086/524750 |
| PUBMED: | 18284368 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 6" - "Export Date: 17 November 2011" - "CODEN: CIDIE" - "Source: Scopus" |
