Immunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD.
Am J Obstet Gynecol. 2014 Jun;210(6):561.e1-6. doi: 10.1016/j.ajog.2013.12.036. Epub 2013 Dec 27.
To characterize adverse events (AEs) after hepatitis A vaccines (Hep A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
We searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from Jan. 1, 1996-April 5, 2013. Clinicians reviewed all reports and available medical records.
VAERS received 139 reports of AEs in pregnant women; 7 (5.0%) were serious; no maternal or infant deaths were identified. Sixty-five (46.8%) did not describe any AEs. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 (7.2%), and preterm delivery in 7 (5.0%) reports. The most common nonpregnancy specific outcome was urinary tract infection and nausea/vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization.
This review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal Hep A or Hep AB immunizations during pregnancy.
通过疫苗不良事件报告系统（VAERS），对报告给该系统的妊娠女性接种甲型肝炎疫苗（Hep A）和甲型肝炎与乙型肝炎联合疫苗（Hep AB）后发生的不良事件（AE）进行分析，VAERS 是一个自发报告监测系统。
我们检索了 VAERS 中自 1996 年 1 月 1 日至 2013 年 4 月 5 日期间妊娠女性接种 Hep A 或 Hep AB 的 AE 报告。临床医生对所有报告和可用病历进行了审查。
VAERS 共收到 139 例妊娠女性 AE 报告；7 例（5.0%）为严重报告；未发现母婴死亡。65 例（46.8%）未描述任何 AE。对于那些提供了妊娠时间的女性，大多数在妊娠早期接种疫苗，50/60（83.3%）例接种 Hep A，18/21（85.7%）例接种 Hep AB。接种 Hep A 或 Hep AB 后最常见的妊娠特异性结局是 15 例（10.8%）报告自然流产，10 例（7.2%）报告选择性终止妊娠，7 例（5.0%）报告早产。最常见的非妊娠特异性结局是各有 3 例（2.2%）报告的尿路感染和恶心/呕吐。1 例婴儿下肢缺如发生在母亲接种 Hep A 后。
本研究对 VAERS 报告的分析并未发现妊娠女性或其婴儿在妊娠期间接种 Hep A 或 Hep AB 后出现不良事件的不良模式。
