Abstract
Background Although COVID-19 vaccination in pregnancy has been approved by health authorities worldwide, data on adverse effects and safety profiles in pregnant women remain limited, particularly from diverse populations. Hence, this study aimed to compare the adverse effects following COVID-19 vaccination (Covishield and Covaxin) in pregnant and non-pregnant women in a tertiary care hospital in eastern India. Methodology This prospective, observational study was conducted at Rajendra Institute of Medical Sciences, Ranchi. Women aged 18-45 years receiving their first dose of COVID-19 vaccination were included and categorized into the following four groups: pregnant women receiving Covishield (Group A, n = 300), pregnant women receiving Covaxin (Group B, n = 357), non-pregnant women receiving Covishield (Group C, n = 446), and non-pregnant women receiving Covaxin (Group D, n = 100). Participants were followed up within 24 hours, at 7-14 days, after one month, and at delivery (for pregnant women). Adverse events following immunization (AEFIs) were recorded and analyzed using SPSS version 24.0 (IBM Corp., Armonk, NY, USA). Results Vaccine acceptance was 54.6% among pregnant women and 45.39% among non-pregnant women. The overall AEFI incidence rate was 41% for Covaxin and 24% for Covishield recipients (p < 0.001). Presence of allergy (adjusted odds ratio (AOR) = 1.950, 95% confidence interval (CI) = 1.379-2.757, p < 0.001) and vaccine type (AOR = 1.808, 95% CI = 1.408-2.322, p < 0.001) were significantly associated with AEFIs. Common adverse effects within 24 hours included fever, local pain at the injection site, and body aches, with similar profiles between pregnant and non-pregnant women. No significant adverse maternal or fetal outcomes were attributed to vaccination. Conclusions Both Covishield and Covaxin demonstrated acceptable safety profiles in pregnant and non-pregnant women, though Covaxin showed a higher AEFI rate. The types and frequencies of adverse effects were comparable between pregnant and non-pregnant women, suggesting that COVID-19 vaccination can be safely administered during pregnancy.