向疫苗不良事件报告系统报告的孕妇接种甲型 H1N1 流感 2009 单价疫苗后的不良事件。
Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System.
机构信息
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
出版信息
Am J Obstet Gynecol. 2011 Nov;205(5):473.e1-9. doi: 10.1016/j.ajog.2011.06.047. Epub 2011 Jun 21.
Abstract
OBJECTIVE
The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems.
STUDY DESIGN
We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010.
RESULTS
VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (<20 weeks); 18 stillbirths (≥20 weeks); 7 preterm deliveries (<37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip.
CONCLUSION
Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.
摘要
目的
本研究旨在评估并总结 2009 年甲型 H1N1 流感单价疫苗接种于孕妇的疫苗不良事件报告系统（VAERS）自发报告中的报告，以评估潜在的疫苗安全性问题。
研究设计
我们回顾了 2009 年 10 月 1 日至 2010 年 2 月 28 日期间接种 2009-H1N1 疫苗的孕妇不良事件（AE）报告。
结果
VAERS 收到了 294 例接种 2009-H1N1 疫苗的孕妇 AE 报告：288 例来自灭活疫苗，6 例来自减毒活疫苗。报告了两例产妇死亡。59 名妇女（20.1%）住院。我们验证了 131 例妊娠特异性结局：95 例自发流产（<20 周）；18 例死产（≥20 周）；7 例早产（<37 周）；3 例先兆流产；2 例早产；2 例先兆子痫；1 例胎儿肾积水、胎儿心动过速、宫内生长受限和唇裂。
结论
对孕妇接种 H1N1 疫苗后 VAERS 的报告进行审查，未发现任何与母亲或胎儿结局有关的不良模式。
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