Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study.

Introduction: Vaccine safety is a major barrier to the uptake of the COVID-19 vaccine by pregnant women. To bring confidence among pregnant women towards vaccine intake, there is a need to synthesize evidence on safety profile of vaccination. Objective: To assess adverse events (AEs) following COVID-19 vaccination among pregnant women. Materials and methods: A vaccine safety surveillance was conducted at 2 rural primary health centers (PHC) located in Anantapur District, India. A total of 420 pregnant women were monitored for AEs following COVID-19 vaccination for a period of 30 min and followed for 1 month for late reactions through telephonic interviews. All AEs were subjected to causality and severity assessment. Descriptive statistics were used to represent adverse events. Results: The COVID-19 vaccine acceptance rate among pregnant women was 64.4%. A total of 420 pregnant women received 670 vaccine doses (Covishield = 372, Covaxin = 298) against COVID-19. Majority of vaccine intake was observed during the second trimester. The incidence rate of AEs following the COVID-19 vaccine among pregnant women was 93.8%, and the majority include injection site pain (28.4%, 29.6%), fever (25.5%, 19.0%), myalgia (8.21%, 12.3%), and malaise (13.6%, 8.4%). Most AEs notified are probable and mild in nature. Conclusion: The COVID-19 vaccine acceptance rate among pregnant women was 64.4%. A 30 days incidence rate of AEs following COVID-19 vaccination among pregnant women was 93.8%, with the most common mild events like injection site pain, and fever. A further follow-up cohort study by taking an adequate sample size was recommended to capture fetal-maternal outcomes.