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


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


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


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


METHODS
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.
Kaiser Permanente, Southern California, Pasadena, CA 91101, USA.
H F
HF
Tseng
A
A
Liu
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L
Sy
S M
SM
Marcy
B
B
Fireman
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E
Weintraub
J
J
Baggs
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S
Weinmann
R
R
Baxter
J
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Nordin
M F
MF
Daley
L
L
Jackson
S J
SJ
Jacobsen
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000209:etiology / Q000276:immunology; D015331:Cohort Studies; D005260:Female; D006562:Herpes Zoster / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000209:etiology / Q000276:immunology; D011159:Population Surveillance; D018570:Risk Assessment; D013997:Time Factors; D014481:United States / Q000453:epidemiology
D053061:Herpes Zoster Vaccine