# Safety of and Adverse Reactions to the COVID-19 Vaccine Among Pregnant and Breastfeeding Women

## TL;DR

This study found that the COVID-19 vaccine is generally safe for pregnant and breastfeeding women, with most side effects being mild.

## Contribution

The study provides new evidence on vaccine safety in pregnant and breastfeeding women in Vietnam.

## Key findings

- Localized pain at the injection site was the most common adverse reaction (26.2%).
- Most adverse reactions were mild, with severe events like coma or premature birth being rare.
- Factors like age, occupation, and allergy history were associated with adverse reactions.

## Abstract

Objectives: 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. Methods: 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 p < 0.05. Results: 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. Conclusions: 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.