Adverse Events Associated with Hepatitis B Vaccine in U.S. Children Less Than Six Years of Age, 1993 and 1994

Abstract

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.