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Abstract Title:

Safety of zoster vaccine in adults from a large managed-care cohort: a Vaccine Safety Datalink study.

Abstract Source:

J Intern Med. 2012 May ;271(5):510-20. Epub 2011 Nov 22. PMID: 22026504

Abstract Author(s):

H F Tseng, A Liu, L Sy, S M Marcy, B Fireman, E Weintraub, J Baggs, S Weinmann, R Baxter, J Nordin, M F Daley, L Jackson, S J Jacobsen,

Article Affiliation:

H F Tseng

Abstract:

OBJECTIVES: The aim of this study was to examine a large cohort of adults who received the zoster vaccine for evidence of an increased risk of prespecified adverse events requiring medical attention.

DESIGN: Two self-comparison approaches, including a case-centred approach and a self-controlled case series (SCCS) analysis were used.

SETTING: Eight managed-care organizations participating in the Vaccine Safety Datalink project in the United States.

SUBJECTS: A total of 193 083 adults aged 50 and older receiving a zoster vaccine from 1 January 2007 to 31 December 2008 were included.

MAIN OUTCOME MEASURES: Prespecified adverse events were identified by aggregated International Classification of Diseases, Ninth Revision (ICD-9) codes in automated health plan datasets.

RESULTS: The risk of allergic reaction was significantly increased within 1-7 days of vaccination [relative risk = 2.13, 95% confidence interval (CI): 1.87-2.40 by case-centred method and relative rate = 2.32, 95% CI: 1.85-2.91 by SCCS]. No increased risk was found for the following adverse event groupings: cerebrovascular events; cardiovascular events; meningitis; encephalitis; and encephalopathy; and Ramsay-Hunt syndrome and Bell's palsy.

CONCLUSIONS: The results of this study support the findings from the prelicensure clinical trials, providing reassurance that the zoster vaccine is generally safe and well-tolerated with a small increased risk of allergic reactions in 1-7 days after vaccination.

Study Type : Human In Vitro

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Sayer Ji
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