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: Ann Epidemiol 2001 Jan;11(1):13-21 |
Adverse events associated with hepatitis B
vaccine in U.S. children less than six years of age, 1993 and 1994.
Fisher MA, Eklund SA, James SA, Lin X.
Department of Community Medicine, School of Medicine, West Virginia University,
Morgantown, USA.
PURPOSE: This study evaluated infrequent adverse reactions to hepatitis B
vaccine by investigating the association of this vaccine with adverse health
outcomes for U.S. children less than six years of age. The evaluation of the
association between hepatitis B vaccine and chronic arthritis provides needed
data, relevant to the Institute of Medicine's Report that there are inadequate
data available to assess the causal relationship of hepatitis B vaccine to
arthritis risk. METHODS: The 1993 (n = 5505 children) and 1994 (n = 6515
children) National Health Interview Survey (NHIS) datasets were analyzed to
provide post-marketing surveillance data from probability samples of the U.S.
population. Incident cases of adverse events were determined from the temporal
association between the hepatitis B vaccination and the adverse events.
Logistic regression modeling was used to adjust for potential confounding.
RESULTS: Controlling for age, race, and gender simultaneously in the 1994 NHIS,
hepatitis B vaccine was found to be associated with prevalent arthritis [odds
ratio (OR) = 5.91, 95% confidence interval (CI) = 1.05-33.14], incident acute
ear infections (OR = 1.60, 95% CI = 1.00-2.58), and incident
pharyngitis/nasopharyngitis (OR = 1.41, 95% CI = 0.95-2.09). CONCLUSIONS: Evidence
from this study suggests that hepatitis B vaccine is positively associated with
adverse health outcomes in the general population of US children.
PMID: 11164115 [PubMed - indexed for MEDLINE]