| アブストラクト | 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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| 投稿日 | 2015/1/20 |
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| 投稿者 | Moro, Pedro L; Jankosky, Christopher; Menschik, David; Lewis, Paige; Duffy, Jonathan; Stewart, Brock; Shimabukuro, Tom T |
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| ジャーナル名 | The Journal of pediatrics |
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| 組織名 | Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta,;GA. Electronic address: pmoro@cdc.gov.;Center for Biologics Evaluation and Research, US Food and Drug Administration,;Silver Spring, MD.;GA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/25598306/ |
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