Thanh Nguyen Thi Minh, Hang Le Thi, Hung Mai Trong, Phuong Tran Hoa, Lan Nguyen Thi Phuong, Tuan Mac Dang, Bach Nguyen Xuan, Anh Nguyen Duy
Expert Examination Department, Hanoi Obstetrics & Gynecology Hospital, Hanoi 100000, Vietnam.
Faculty of Medicine, VNU University of Medicine and Pharmacy, Hanoi 100000, Vietnam.
Med Sci (Basel). 2025 Apr 1;13(2):38. doi: 10.3390/medsci13020038.
This study aimed to evaluate the incidence of adverse reactions to the COVID-19 vaccine among pregnant and breastfeeding women and identify associated demographic and clinical factors.
A cross-sectional study was conducted at a hospital in Hanoi, Vietnam, from November 2021 to March 2022. A total of 1204 participants, including 991 pregnant women beyond 13 weeks of gestation and 213 breastfeeding women, were recruited through convenience sampling. Data were collected using a self-administered questionnaire designed to capture demographic information and adverse reactions occurring within seven to 28 days post-vaccination. Statistical analyses, including chi-square tests, Fisher's exact tests, and logistic regression, were performed using Stata 16.0, with the significance set at < 0.05.
The most common adverse reactions were localized pain at the injection site (26.2%), dizziness and fatigue (19.2%), and fever below 39 °C (29.1%). Severe adverse reactions, such as a tight throat, coma, and premature birth, were rare. A multivariate analysis identified the significant factors associated with the adverse reactions, including age (aOR = 2.04 for participants aged 36-40 years), occupation (lower odds for farmers and business professionals), urban residency (aOR = 0.64), and a history of allergies (aOR = 1.59). Education level, number of children, and gestational age were not significantly associated with adverse events.
The findings support the safety of the COVID-19 vaccine in pregnant and breastfeeding women, with most of the adverse reactions being mild and self-limiting.
本研究旨在评估孕妇和哺乳期妇女对新冠疫苗的不良反应发生率，并确定相关的人口统计学和临床因素。
2021年11月至2022年3月在越南河内的一家医院进行了一项横断面研究。通过便利抽样招募了1204名参与者，包括991名妊娠13周以上的孕妇和213名哺乳期妇女。使用自行填写的问卷收集数据，该问卷旨在获取人口统计学信息以及接种疫苗后7至28天内发生的不良反应。使用Stata 16.0进行统计分析，包括卡方检验、费舍尔精确检验和逻辑回归，显著性设定为<0.05。
最常见的不良反应是注射部位局部疼痛（26.2%）、头晕和疲劳（19.2%）以及体温低于39°C的发热（29.1%）。严重不良反应，如喉咙发紧、昏迷和早产，较为罕见。多变量分析确定了与不良反应相关的显著因素，包括年龄（36至40岁参与者的调整后比值比为2.04）、职业（农民和商业专业人员的比值较低）、城市居住情况（调整后比值比为0.64）以及过敏史（调整后比值比为1.59）。教育水平、子女数量和孕周与不良事件无显著关联。
研究结果支持新冠疫苗在孕妇和哺乳期妇女中的安全性，大多数不良反应为轻度且具有自限性。
