Woestenberg Petra J, Terpstra Annika W, van Hunsel Florence, Lieber Thomas, Maas Veronique Y F
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands.
Faculty of Medical Sciences, Radboudumc, Radboud University, Nijmegen, the Netherlands.
Birth Defects Res. 2025 Jun;117(6):e2490. doi: 10.1002/bdr2.2490.
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.
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.
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.
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.
孕妇疫苗即将问世。清楚了解孕妇接种疫苗后的不良事件（AE）以及这是否与非孕妇群体相当很重要。我们研究的目的是比较孕妇和非孕妇接种新冠病毒疫苗后感知到的不良事件，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。
使用了荷兰孕期药物登记处（DPDR）的数据以及关于新冠病毒疫苗的队列事件监测（CEM）研究的数据。使用多变量逻辑回归分析比较了孕妇（n = 2204）和非孕妇（n = 2684）在接种第一剂mRNA新冠病毒疫苗后至少一种自我报告（主动报告）的不良事件、不止一种不良事件以及特定的自我报告不良事件。
孕妇和非孕妇的不良事件模式相似，最常报告的四种不良事件为：注射部位反应、肌痛、疲劳和头痛。与非孕妇相比，孕妇报告至少一种不良事件的频率较低（65.9%对72.3%；调整后的优势比[aOR]=0.78；95%置信区间[CI]=0.67 - 0.90），报告不止一种不良事件或特定不良事件（恶心、寒战、发热和关节痛）的频率也较低。与非孕妇相比，孕妇报告肌痛的频率更高。
与非孕妇相比，孕妇在接种第一剂mRNA新冠病毒疫苗后感知到的不良事件相当或更少。这些结果有助于孕妇在接种疫苗时做出明智的决定。孕期登记处和CEM研究之间的比较是可行的，这种方法可用于比较其他/未来孕妇疫苗的不良事件。
