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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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier España, S.L.U.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192595/ https://www.ncbi.nlm.nih.gov/pubmed/37362835 http://dx.doi.org/10.1016/j.vacun.2023.05.003 |
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author | Goruntla, Narayana Karisetty, Basappa Nandini, Nandini Bhupasamudram, Bharadwaj Gangireddy, Himaja Reddy Veerabhadrappa, Kasturi Vishwanathasetty Ezeonwumelu, Joseph Obiezu Chukwujekwu Bandaru, Vishnuvandana |
author_facet | Goruntla, Narayana Karisetty, Basappa Nandini, Nandini Bhupasamudram, Bharadwaj Gangireddy, Himaja Reddy Veerabhadrappa, Kasturi Vishwanathasetty Ezeonwumelu, Joseph Obiezu Chukwujekwu Bandaru, Vishnuvandana |
author_sort | Goruntla, Narayana |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10192595 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier España, S.L.U. |
record_format | MEDLINE/PubMed |
spelling | pubmed-101925952023-05-18 Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study Goruntla, Narayana Karisetty, Basappa Nandini, Nandini Bhupasamudram, Bharadwaj Gangireddy, Himaja Reddy Veerabhadrappa, Kasturi Vishwanathasetty Ezeonwumelu, Joseph Obiezu Chukwujekwu Bandaru, Vishnuvandana Vacunas Original Article 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. Elsevier España, S.L.U. 2023-05-18 /pmc/articles/PMC10192595/ /pubmed/37362835 http://dx.doi.org/10.1016/j.vacun.2023.05.003 Text en © 2023 Elsevier España, S.L.U. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Original Article Goruntla, Narayana Karisetty, Basappa Nandini, Nandini Bhupasamudram, Bharadwaj Gangireddy, Himaja Reddy Veerabhadrappa, Kasturi Vishwanathasetty Ezeonwumelu, Joseph Obiezu Chukwujekwu Bandaru, Vishnuvandana Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study |
title | Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study |
title_full | Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study |
title_fullStr | Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study |
title_full_unstemmed | Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study |
title_short | Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study |
title_sort | adverse events following covid-19 vaccination among pregnant women attending primary health centers: an active-surveillance study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192595/ https://www.ncbi.nlm.nih.gov/pubmed/37362835 http://dx.doi.org/10.1016/j.vacun.2023.05.003 |
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