疫苗不良事件报告系统中六价疫苗的上市后安全性监测。
Postmarketing Safety Surveillance of a Hexavalent Vaccine in the Vaccine Adverse Event Reporting System.
机构信息
Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD.
Immunization Safety Office, Division of Healthcare Quality Promotion CDC, Silver Spring, MD.
出版信息
J Pediatr. 2023 Nov;262:113643. doi: 10.1016/j.jpeds.2023.113643. Epub 2023 Jul 28.
Abstract
We assessed the safety of hexavalent vaccine diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, hepatitis b, and haemophilus influenzae b conjugate vaccine in the Vaccine Adverse Event Reporting System. Five hundred-one reports of adverse events (AEs) were identified; 21 (4.2%) were serious. Most frequently reported AEs were fever (10.2%) and injection site erythema (5.4%). AEs reported were consistent with findings from prelicensure studies.
摘要
我们评估了六价疫苗白喉和破伤风类毒素以及无细胞百日咳、灭活脊髓灰质炎、乙型肝炎和流感嗜血杆菌 b 型结合疫苗在疫苗不良事件报告系统中的安全性。确定了 501 份不良事件报告（AE）；其中 21 份（4.2%）为严重事件。报告的最常见不良事件是发热（10.2%）和注射部位红斑（5.4%）。报告的不良事件与上市前研究的结果一致。
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