2020 年 12 月至 2021 年 10 月，疫苗不良事件报告系统（VAERS）中 COVID-19 疫苗接种后孕妇不良事件的授权后监测。

Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 - October 2021.

机构信息

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention (CDC).

出版信息

Vaccine. 2022 May 26;40(24):3389-3394. doi: 10.1016/j.vaccine.2022.04.031. Epub 2022 Apr 12.

DOI:10.1016/j.vaccine.2022.04.031

PMID:35489985

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9001176/

Abstract

BACKGROUND

Pregnant persons are at increased risk of severe illness from COVID-19 infection, including intensive care unit admission, mechanical ventilation, and death compared with non-pregnant persons of reproductive age. Limited data are available on the safety of COVID-19 vaccines administered during and around the time of pregnancy.

OBJECTIVE

To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant persons who received a COVID-19 vaccine to assess for potential vaccine safety problems.

METHODS

We searched VAERS for US reports of adverse events (AEs) in pregnant persons who received a COVID-19 vaccine from 12/14/2020-10/31/2021. Clinicians reviewed reports and available medical records. Crude reporting rates for selected AEs were calculated, and disproportional reporting was assessed using data mining methods.

RESULTS

VAERS received 3,462 reports of AEs in pregnant persons who received a COVID-19 vaccine; 1,831 (52.9%) after BNT162b2, 1,350 (38.9%) after mRNA-1273, and 275 (7.9%) after Ad26.COV2.S. Eight maternal deaths and 12 neonatal deaths were reported. Six-hundred twenty-one (17.9%) reports were serious. Pregnancy-specific outcomes included: 878 spontaneous abortions (<20 weeks), 101 episodes of vaginal bleeding, 76 preterm deliveries (<37 weeks), 62 stillbirths (≥20 weeks), and 33 outcomes with birth defects. Crude reporting rates for preterm deliveries and stillbirths, as well as maternal and neonatal mortality rates were below background rates from published sources. No disproportional reporting for any AE was observed.

CONCLUSIONS

Review of reports to VAERS following COVID-19 vaccines in pregnant persons did not identify any concerning patterns of maternal or infant-fetal outcomes.

摘要

背景

与生育年龄的非孕妇相比，孕妇感染 COVID-19 后患重病的风险增加，包括入住重症监护病房、需要机械通气和死亡。关于妊娠期间和妊娠前后接种 COVID-19 疫苗的安全性，可用数据有限。

目的

评估和总结 2020 年 12 月 14 日至 2021 年 10 月 31 日期间，在接受 COVID-19 疫苗的孕妇中向疫苗不良事件报告系统（VAERS）报告的不良事件（AE）报告，以评估潜在的疫苗安全性问题。

方法

我们在 VAERS 中搜索了妊娠期间接受 COVID-19 疫苗的孕妇不良事件报告。临床医生审查了报告和可用的病历。计算了选定 AE 的粗报告率，并使用数据挖掘方法评估了比例失调报告。

结果

VAERS 收到了 3462 例接受 COVID-19 疫苗的孕妇的 AE 报告；1831 例（52.9%）为 BNT162b2 后，1350 例（38.9%）为 mRNA-1273 后，275 例（7.9%）为 Ad26.COV2.S。报告了 8 例产妇死亡和 12 例新生儿死亡。621 例（17.9%）报告为严重。与妊娠相关的结局包括：878 例自发流产（<20 周），101 例阴道出血，76 例早产（<37 周），62 例死产（≥20 周）和 33 例出生缺陷。早产和死产、产妇和新生儿死亡率的粗报告率低于已发表来源的背景率。未观察到任何 AE 的比例失调报告。