Adverse events associated with hepatitis B vaccine in US children less than six years of age, 1993 and 1994

PURPOSE: This study evaluated infrequent adverse reactions to hepatitis B v accine by investigating the association of this vaccine with adverse health outcomes for U.S. children less than six years of age. The evaluation of t he association between hepatitis B vaccine and chronic arthritis provides n eeded data, relevant to the Institute of Medicine's Report that there are i nadequate data available to assess the causal relationship of hepatitis B v accine 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-mark eting surveillance data from probability samples of the U.S, population. in cident cases of adverse events were determined from the temporal associatio n between the hepatitis B vaccination and the adverse events. Logistic regr ession modeling was used to adjust for potential confounding. RESULTS: Controlling for age, race, and gender simultaneously in the 1994 N HIS, hepatitis B vaccine was found to be associated with prevalent arthriti s [odds ratio (OR) = 5.91, 95% confidence interval (CI) = 1.05-33.14], inci dent acute ear infections (OR = 1.60, 95% CI = 1.00-2.58), and incident pha ryngitis/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 populatio n of US children. (C) 2000 Elsevier Science Inc. All rights reserved.