Journal of South Asian Federation of Obstetrics and Gynaecology

Register      Login

VOLUME 15 , ISSUE 1 ( January-February, 2023 ) > List of Articles

ORIGINAL RESEARCH

Comparison of Immediate Adverse Effects of COVID-19 Vaccine (COVAXIN BBV152) in Pregnant vs Nonpregnant Women

Indumathi H Kantharaja, Shashikala B Patil, Rashmi Kumar Karning, Radhika Chetan, Geetha Shivamurthy, Bevinahalli Nandisha Prashanth

Keywords : Adverse events, SARS COV 2, Vaccination

Citation Information : Kantharaja IH, Patil SB, Karning RK, Chetan R, Shivamurthy G, Prashanth BN. Comparison of Immediate Adverse Effects of COVID-19 Vaccine (COVAXIN BBV152) in Pregnant vs Nonpregnant Women. J South Asian Feder Obs Gynae 2023; 15 (1):57-60.

DOI: 10.5005/jp-journals-10006-2184

License: CC BY-NC 4.0

Published Online: 19-04-2023

Copyright Statement:  Copyright © 2023; The Author(s).


Abstract

Aims and objectives: The aim of this study was to compare the immediate adverse effects of the coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) in a pregnant woman with that of a nonpregnant woman. Materials and methods: It is a prospective observational study done at Vanivilas Hospital, Bangalore Medical College & Research Institute (BMCRI) for 2 months. The sample size was 100 pregnant and 100 nonpregnant women. Telephonically, patients were followed-up, and details of the side/adverse effects were collected in a proforma after 2 and 14 days. Data collected from both groups were analyzed using the Chi-square test or Fisher's exact test. Results: The majority of women were in the age group of ≤25 years (64.0% and 36.0%, respectively) with a mean age of 25.01 ± 3.71 years among the pregnant and 28.52 ± 6.00 years among nonpregnant women. About 25.0% of pregnant women and 38.0% of nonpregnant women reported side effects. About 15.0% and 22.0% had taken treatment for side effects among pregnant women and nonpregnant women, respectively. Among the pregnant women, the common side effects reported were injection site pain (17) followed by fever (5), fatigue (4), and myalgia (03). Whereas among the nonpregnant women, the common side effects reported were injection site pain (28) followed by fever (6), myalgia (3), headache (2), and fatigue (1). Conclusion: Side effects reported following the administration of Covaxin in pregnant and nonpregnant women are fever, fatigue, injection site pain, myalgia, and headache. The proportion of side effects was not significantly different in the pregnant and nonpregnant women following Covaxin administration. Clinical significance: Covaxin is an inactivated killed vaccine against COVID-19 by Bharat Biotech. The vaccine has been recommended for pregnant women by the Government of India during corona pandemic. Studies are lacking regarding the difference in adverse events in pregnant versus nonpregnant women, after vaccine administration.


PDF Share
  1. Wei SQ, Bilodeau-Bertrand M, Liu S, et al. The impact of COVID-19 on pregnancy outcomes: A systematic review and meta-analysis. CMAJ 2021;193(16):E540–E548. DOI: 10.1503/cmaj.202604.
  2. Umashankar K, Kanakannavar S, Devoor A, et al. Analysis of maternal mortality in COVID-positive pregnant mothers at tertiary care hospital. J South Asian Feder Obs Gynae 2022;14(5):534–540. DOI: 10.5005/jp-journals-10006-2127.
  3. Kapadia SN, Mehta A, Mehta CR, et al. Study of pregnancy with COVID-19 and its clinical outcomes in a tertiary care teaching hospital in Western India. J South Asian Feder Obst Gynae 2021;13(2):125–130. DOI: https://doi.org/10.5005/jp-journals-10006-1886.
  4. Shimabukuro TT, Kim SY, Myers TR. Preliminary findings of mRNA COVID-19 vaccine safety in pregnant persons. N Engl J Med 2021;384:2273–2282. DOI: 10.1056/NEJMoa2104983.
  5. Ministry of Health and Family Welfare, Government of India. Operational guidance for COVID 19 vaccination of pregnant women. (Accessed on: 07 October, 2022).
  6. Royal College of Obstetricians and Gynecologists (RCOG). COVID-19 vaccines, pregnancy and breastfeeding, available from: https://www.rcog.org.uk/en/guidelinesresearchservices/coronavirus-COVID-19-pregnancy-and-womens-health/COVID-19- vaccinesandpregnancy/COVID-19-vaccines-pregnancy-and-breastfeeding/ (Accessed on: 16 October, 2022).
  7. Parida SP, Sahu DP, Singh AK, et al. Adverse events following immunization of COVID-19 (Covaxin) vaccine at a tertiary care center of India. J Med Virol 2022;94:2453–2459. DOI: 10.1002/jmv.27655.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.