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Adverse events following Haemophilus influenzae type b (Hib) vaccines in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013
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4 2015
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Source: J Pediatr. 166(4):992-997
[PDF-83.98 KB]
Details:
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Alternative Title:J Pediatr
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Personal Author:
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Description:Background:
There are currently five Haemophilus influenzae type b (Hib) vaccines available in the United States for use in the primary vaccination series and/or for the booster dose. Few post-licensure safety studies of these vaccines have been conducted.
Objective:
To characterize adverse events (AEs) after Hib vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
Methods:
We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990-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 following Hib vaccines.
Results:
VAERS received 29,747 reports after Hib vaccines; 5,179 (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 non-death serious AE categories were neurological conditions (80;37%), other non-infectious (46;22%) (comprised mainly of constitutional signs and symptoms); and gastrointestinal (39;18%). No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold.
Conclusions:
Review of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.
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Pubmed ID:25598306
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Pubmed Central ID:PMC6500451
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Volume:166
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Issue:4
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