کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6221536 | 1607444 | 2015 | 6 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Adverse Events following Haemophilus influenzae Type b Vaccines in the Vaccine Adverse Event Reporting System, 1990-2013 Adverse Events following Haemophilus influenzae Type b Vaccines in the Vaccine Adverse Event Reporting System, 1990-2013](/preview/png/6221536.png)
ObjectiveTo 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 designWe 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.ResultsVAERS received 29â747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6Â months (range 0-1022Â 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.ConclusionReview of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.
Journal: The Journal of Pediatrics - Volume 166, Issue 4, April 2015, Pages 992-997