J Pediatr

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.

25598306

PMC6500451

CDC Public Access