Objective
To characterize adverse events (AEs) after Haemophilus influenzae type b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS),
a spontaneous reporting surveillance system.
Study design
We searched VAERS for US reports after Hib vaccines among reports received from January
1, 1990, to December 1, 2013. We reviewed a random sample of reports and accompanying
medical records for reports classified as serious. All reports of death were reviewed.
Physicians assigned a primary clinical category to each reviewed report. We used empirical
Bayesian data mining to identify AEs that were disproportionally reported after Hib
vaccines.
Results
VAERS received 29 747 reports after Hib vaccines; 5179 (17%) were serious, including
896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant
death syndrome was the stated cause of death in 384 (51%) of 749 death reports with
autopsy/death certificate records. The most common nondeath serious AE categories
were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional
signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns
were identified after clinical review of reports of AEs that exceeded the data mining
statistical threshold.
Conclusion
Review of VAERS reports did not identify any new or unexpected safety concerns for
Hib vaccines.
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Article Info
Publication History
Published online: January 16, 2015
Accepted:
December 5,
2014
Received in revised form:
October 20,
2014
Received:
August 20,
2014
Footnotes
Funded by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC or the FDA. The authors declare no conflicts of interest.
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Published by Elsevier Inc.
