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J Pediatr. 2015 Apr;166(4):992-7. doi: 10.1016/j.jpeds.2014.12.014. Epub 2015 Jan 15.

Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013.

Author information

1
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA. Electronic address: pmoro@cdc.gov.
2
Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
3
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA.

Abstract

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.

PMID:
25598306
DOI:
10.1016/j.jpeds.2014.12.014
[Indexed for MEDLINE]
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