OBJECTIVE: 

To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant people who received a booster dose of mRNA coronavirus disease 2019 (COVID-19) vaccine.

METHODS: 

We searched VAERS for U.S. reports of adverse events in pregnant people who received a booster dose of an mRNA COVID-19 vaccine from September 22, 2021, to March 24, 2022. Clinicians reviewed reports and available medical records.

RESULTS: 

The Vaccine Adverse Event Reporting System received 323 reports of adverse events in pregnant people who received a booster dose of COVID-19 vaccine; 178 (55.1%) after BNT162b2 from Pfizer–BioNTech and 145 (44.9%) after mRNA-1273 from Moderna. Seventy-two (22.3%) reports were coded as serious. One neonatal death was reported, but no maternal deaths occurred. Pregnancy-specific outcomes included 56 (17.3%) spontaneous abortions (before 20 weeks of gestation), eight (2.5%) episodes of vaginal bleeding, five (1.5%) stillbirths (at or after 20 weeks of gestation), four (1.2%) episodes of preeclampsia, and two (0.6%) preterm deliveries. Reporting rates for stillbirth and preterm delivery were below background rates. Ten instances of adverse events in neonates were reported, which included two reports of birth defects. Non–pregnancy-specific adverse events (n=207; 64.1%) were mostly systemic (eg, headache, fatigue) and local reactions and occurred in proportions comparable with those seen in pregnant people who received the primary COVID-19 vaccination series and reported to VAERS during the same period.

CONCLUSION: 

Review of reports after a booster dose of mRNA COVID-19 vaccine in pregnant people in VAERS found their safety profile was comparable with that of published reports after primary COVID-19 vaccination in pregnant people.

中文翻译：

---

疫苗不良事件报告系统中 2019 年冠状病毒病 (COVID-19) 疫苗在妊娠期加强剂量的安全性

客观的： 

评估和总结疫苗不良事件报告系统 (VAERS) 的报告，该系统是一个国家自发报告系统，针对接受了 mRNA 冠状病毒病 2019 (COVID-19) 疫苗加强剂量的孕妇。

方法： 

我们在 VAERS 中搜索了美国关于 2021 年 9 月 22 日至 2022 年 3 月 24 日期间接受 mRNA COVID-19 疫苗加强剂量的孕妇不良事件的报告。临床医生审查了报告和可用的医疗记录。

结果： 

疫苗不良事件报告系统收到了 323 份关于接受加强剂量 COVID-19 疫苗的孕妇不良事件的报告；178 (55.1%) 名来自 Pfizer–BioNTech 的 BNT162b2，145 (44.9%) 名来自 Moderna 的 mRNA-1273。72 份 (22.3%) 报告被标记为严重。报告了 1 例新生儿死亡，但没有发生孕产妇死亡。妊娠特异性结局包括 56 例 (17.3%) 自然流产（妊娠 20 周前）、8 例 (2.5%) 阴道出血、5 例 (1.5%) 死产（妊娠 20 周时或之后）、4 例 (1.2%) ) 先兆子痫发作和两次 (0.6%) 早产。死产和早产的报告率低于背景率。报告了 10 起新生儿不良事件，其中包括两起出生缺陷报告。

结论： 

审查 VAERS 中孕妇接种 mRNA COVID-19 疫苗加强剂量后的报告发现，它们的安全性与已发表的孕妇初次接种 COVID-19 疫苗后的报告相当。