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.
Am J Obstet Gynecol. 2011 Feb;204(2):146.e1-7. doi: 10.1016/j.ajog.2010.08.050. Epub 2010 Oct 20.
The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received seasonal influenza vaccines to assess for potential vaccine safety concerns.
We searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine (TIV) from July 1, 1990 through June 30, 2009, or live attenuated influenza vaccine (LAIV) from July 1, 2003, through June 30, 2009.
A total of 148 reports after TIV and 27 reports after LAIV were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified as serious. No specific AEs were reported in 30 TIV (20.3%) and 16 LAIV (59%) reports. The most common pregnancy-specific AE was spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated.
No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of TIV or LAIV.
本研究旨在对疫苗不良事件报告系统（VAERS）中接种季节性流感疫苗的孕妇报告进行特征描述，以评估潜在的疫苗安全性问题。
我们在 VAERS 中搜索了自 1990 年 7 月 1 日至 2009 年 6 月 30 日期间接种三价灭活流感疫苗（TIV）或 2003 年 7 月 1 日至 2009 年 6 月 30 日期间接种减毒活流感疫苗（LAIV）的孕妇不良事件报告。
共发现 TIV 后 148 例报告和 LAIV 后 27 例报告。20 例 TIV（13.5%）和 1 例 LAIV（4%）报告被归类为严重。30 例 TIV（20.3%）和 16 例 LAIV（59%）报告未报告特定不良事件。最常见的妊娠特异性不良事件是自然流产：TIV 后 17 例（11.5%），LAIV 后 3 例（11%）。接种疫苗的孕妇自然流产报告率为每百万孕妇 1.9 例。
在 TIV 或 LAIV 接种后的 VAERS 报告中，未观察到孕妇妊娠并发症或胎儿结局的异常模式。
