Comparison of Perceived Adverse Events After COVID-19 Vaccination Between Pregnant and NonPregnant Women Using Two Cohort Studies in the Netherlands

IF 1.6 4区医学 Q4 DEVELOPMENTAL BIOLOGY

Birth Defects Research Pub Date : 2025-06-06 DOI:10.1002/bdr2.2490

Petra J. Woestenberg, Annika W. Terpstra, Florence van Hunsel, Thomas Lieber, Veronique Y. F. Maas

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引用次数: 0

Abstract

Background

Maternal vaccines are upcoming. A clear picture of the adverse events (AEs) after maternal vaccination and whether this is comparable to a nonpregnant population is important. The objective of our study was to compare perceived AEs after COVID-19 vaccination between pregnant and nonpregnant women and to study if it is feasible to compare AEs within two independent Dutch cohort studies.

Methods

Data from the Dutch Pregnancy Drug Register (DPDR) and the cohort event monitoring (CEM) study on COVID-19 vaccines were used. At least one self-reported (solicited) AE, more than one AE, and specific self-reported AEs after the first doses of an mRNA COVID-19 vaccine were compared between pregnant and nonpregnant women using multivariable logistic regression analysis.

Results

The pattern of AEs was similar between pregnant (n = 2204) and nonpregnant (n = 2684) women, with the four most frequently reported AEs being: injection site reaction, myalgia, fatigue, and headache. Pregnant women reported less often at least one AE compared to nonpregnant women (65.9% vs. 72.3%; adjusted odds ratio [aOR] = 0.78; 95% confidence interval [CI] = 0.67–0.90), more than one AE, or specific AEs: nausea, chills, pyrexia, and arthralgia. Myalgia was more often reported among pregnant women compared to nonpregnant women.

Conclusions

Pregnant women perceived comparable or less often AEs after the first mRNA COVID-19 vaccination compared to nonpregnant women. The results aid pregnant women in making an informed decision about vaccination. A comparison between the pregnancy registry and the CEM study was feasible and this method can be used to compare AEs for other/future maternal vaccines.

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使用荷兰的两项队列研究比较孕妇和非孕妇接种COVID-19疫苗后感知的不良事件

背景：孕产妇疫苗即将问世。清楚了解母亲接种疫苗后的不良事件（ae）及其是否与未怀孕人群相当是很重要的。本研究的目的是比较孕妇和非孕妇接种COVID-19疫苗后的不良事件，并研究在两项独立的荷兰队列研究中比较不良事件是否可行。方法采用荷兰妊娠药物登记（DPDR）和COVID-19疫苗队列事件监测（CEM）研究数据。使用多变量logistic回归分析比较了首次接种mRNA COVID-19疫苗后孕妇和非孕妇之间至少一次自我报告（请求）AE、一次以上AE和特异性自我报告AE。结果孕妇（n = 2204）和非孕妇（n = 2684）的ae类型相似，最常见的ae为：注射部位反应、肌痛、疲劳和头痛。与非孕妇相比，孕妇报告至少一次AE的频率更低(65.9% vs. 72.3%；调整优势比[aOR] = 0.78；95%可信区间[CI] = 0.67-0.90)，一个以上AE，或特定AE：恶心、寒战、发热和关节痛。与非孕妇相比，肌痛在孕妇中更常见。结论：与非孕妇相比，孕妇在第一次mRNA - COVID-19疫苗接种后发生的不良反应相当或更少。研究结果有助于孕妇对疫苗接种做出明智的决定。妊娠登记和CEM研究之间的比较是可行的，该方法可用于比较其他/未来孕产妇疫苗的ae。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Birth Defects Research Medicine-Embryology

CiteScore

3.60

自引率

9.50%

发文量

153

期刊介绍： The journal Birth Defects Research publishes original research and reviews in areas related to the etiology of adverse developmental and reproductive outcome. In particular the journal is devoted to the publication of original scientific research that contributes to the understanding of the biology of embryonic development and the prenatal causative factors and mechanisms leading to adverse pregnancy outcomes, namely structural and functional birth defects, pregnancy loss, postnatal functional defects in the human population, and to the identification of prenatal factors and biological mechanisms that reduce these risks. Adverse reproductive and developmental outcomes may have genetic, environmental, nutritional or epigenetic causes. Accordingly, the journal Birth Defects Research takes an integrated, multidisciplinary approach in its organization and publication strategy. The journal Birth Defects Research contains separate sections for clinical and molecular teratology, developmental and reproductive toxicology, and reviews in developmental biology to acknowledge and accommodate the integrative nature of research in this field. Each section has a dedicated editor who is a leader in his/her field and who has full editorial authority in his/her area.