Dutta Indrani, Bharti Atima
Obstetrics and Gynaecology, Manipal Tata Medical College, Jamshedpur, IND.
Obstetrics and Gynaecology, Rajendra Institute of Medical Sciences, Ranchi, IND.
Cureus. 2025 May 14;17(5):e84112. doi: 10.7759/cureus.84112. eCollection 2025 May.
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.
尽管全球卫生当局已批准在孕期接种新冠病毒疫苗，但关于孕妇不良反应和安全性的数据仍然有限，尤其是来自不同人群的数据。因此，本研究旨在比较印度东部一家三级医院中孕妇和非孕妇接种新冠病毒疫苗（Covishield和Covaxin）后的不良反应。
本前瞻性观察性研究在兰契的拉金德拉医学科学研究所进行。纳入年龄在18至45岁之间接种第一剂新冠病毒疫苗的女性，并分为以下四组：接种Covishield的孕妇（A组，n = 300）、接种Covaxin的孕妇（B组，n = 357）、接种Covishield的非孕妇（C组，n = 446）和接种Covaxin的非孕妇（D组，n = 100）。在24小时内、7至14天、1个月后以及分娩时（针对孕妇）对参与者进行随访。使用SPSS 24.0版（美国纽约州阿蒙克市IBM公司）记录和分析免疫接种后不良事件（AEFI）。
孕妇的疫苗接受率为54.6%，非孕妇为45.39%。Covaxin接种者的总体AEFI发生率为41%，Covishield接种者为24%（p < 0.001）。过敏的存在（调整优势比（AOR）= 1.950，95%置信区间（CI）= 1.379 - 2.757，p < 0.001）和疫苗类型（AOR = 1.808，95% CI = 1.408 - 2.322，p < 0.001）与AEFI显著相关。24小时内的常见不良反应包括发热、注射部位局部疼痛和身体疼痛，孕妇和非孕妇的情况相似。未发现疫苗接种导致明显的不良母体或胎儿结局。
Covishield和Covaxin在孕妇和非孕妇中均显示出可接受的安全性，尽管Covaxin的AEFI率较高。孕妇和非孕妇的不良反应类型和频率相当，表明孕期可安全接种新冠病毒疫苗。
