Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity

Introduction: Adverse Events Following Immunization (AEFI) of the COVID-19 vaccine is one of the important considerations, especially in patients with autoimmunity. This study aims to compare the number of CoronaVac AEFIs in women with and without autoimmunity. Methodology: This is a retrospective c...

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Main Authors: Stevent Sumantri, Maria Aurelia Haryanto, Euphemia Seto Anggraini Widyastuti
Format: Article
Language:English
Published: Elsevier 2023-03-01
Series:Clinical Epidemiology and Global Health
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2213398423000362
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author Stevent Sumantri
Maria Aurelia Haryanto
Euphemia Seto Anggraini Widyastuti
author_facet Stevent Sumantri
Maria Aurelia Haryanto
Euphemia Seto Anggraini Widyastuti
author_sort Stevent Sumantri
collection DOAJ
description Introduction: Adverse Events Following Immunization (AEFI) of the COVID-19 vaccine is one of the important considerations, especially in patients with autoimmunity. This study aims to compare the number of CoronaVac AEFIs in women with and without autoimmunity. Methodology: This is a retrospective cohort study with an unpaired comparative analytic design with a retrospective cohort method. We recruited 602 volunteers, 182 women with autoimmunity and 420 without autoimmunity. We included women who received the CoronaVac vaccine, aged 17–65 years. Data were analyzed using the chi-square or fisher exact method as an alternative. Results: We found a generally increased risk for AEFI in women with autoimmunity (RR = 1.179; 95% CI 1.059–1.313; p = 0.007) compared to women without autoimmunity, especially for systemic (RR = 1.1271; 95% CI 1.045–1.545; p = 0.025), allergic (RR = 2.052; 95% CI 1.070–3.932; p = 0.045), fever (RR = 2.163 95%; CI 1.093–4.282; p = 0.039), fatigue (RR = 2.182 95%; CI 1.558–3.056; p = 0.001), and headache (RR = 1.619 95%; CI 1.164–2.251; p = 0.006). On the other hand, we found no increased risk for the overall severity of AEFI (RR = 0.851 95% CI; 0.655–1.105; p = 0.256). We also found a relapse of autoimmune condition in 10.4% (n = 19) after CoronaVac vaccination. Conclusions: There is an increased risk of AEFI after CoronaVac vaccination in women with autoimmunity compared to those without the condition. Although the severity of AEFIs and risk of autoimmune relapse were relatively low.
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spelling doaj.art-5f64085f029c4c7081c1ab452a6238cc2023-04-10T04:03:56ZengElsevierClinical Epidemiology and Global Health2213-39842023-03-0120101249Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunityStevent Sumantri0Maria Aurelia Haryanto1Euphemia Seto Anggraini Widyastuti2Allergy and Clinical Immunology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Pelita Harapan, Tangerang, Indonesia; Department of Internal Medicine, Faculty of Medicine, Universitas Pelita Harapan, Tangerang, Indonesia; Corresponding author. Department of Internal Medicine, Faculty of Medicine, Universitas Pelita Harapan, Universitas Pelita Harapan Boulevard Jenderal Sudirman, Lippo Village, Karawaci, Curug, Tangerang, Banten, 15810, Indonesia.Department of Internal Medicine, Faculty of Medicine, Universitas Pelita Harapan, Tangerang, IndonesiaDepartment of Internal Medicine, Faculty of Medicine, Universitas Pelita Harapan, Tangerang, IndonesiaIntroduction: Adverse Events Following Immunization (AEFI) of the COVID-19 vaccine is one of the important considerations, especially in patients with autoimmunity. This study aims to compare the number of CoronaVac AEFIs in women with and without autoimmunity. Methodology: This is a retrospective cohort study with an unpaired comparative analytic design with a retrospective cohort method. We recruited 602 volunteers, 182 women with autoimmunity and 420 without autoimmunity. We included women who received the CoronaVac vaccine, aged 17–65 years. Data were analyzed using the chi-square or fisher exact method as an alternative. Results: We found a generally increased risk for AEFI in women with autoimmunity (RR = 1.179; 95% CI 1.059–1.313; p = 0.007) compared to women without autoimmunity, especially for systemic (RR = 1.1271; 95% CI 1.045–1.545; p = 0.025), allergic (RR = 2.052; 95% CI 1.070–3.932; p = 0.045), fever (RR = 2.163 95%; CI 1.093–4.282; p = 0.039), fatigue (RR = 2.182 95%; CI 1.558–3.056; p = 0.001), and headache (RR = 1.619 95%; CI 1.164–2.251; p = 0.006). On the other hand, we found no increased risk for the overall severity of AEFI (RR = 0.851 95% CI; 0.655–1.105; p = 0.256). We also found a relapse of autoimmune condition in 10.4% (n = 19) after CoronaVac vaccination. Conclusions: There is an increased risk of AEFI after CoronaVac vaccination in women with autoimmunity compared to those without the condition. Although the severity of AEFIs and risk of autoimmune relapse were relatively low.http://www.sciencedirect.com/science/article/pii/S2213398423000362Adverse events after immunization (AEFI)AutoimmunityCoronaVacCOVID-19
spellingShingle Stevent Sumantri
Maria Aurelia Haryanto
Euphemia Seto Anggraini Widyastuti
Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity
Clinical Epidemiology and Global Health
Adverse events after immunization (AEFI)
Autoimmunity
CoronaVac
COVID-19
title Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity
title_full Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity
title_fullStr Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity
title_full_unstemmed Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity
title_short Risk of adverse events following CoronaVac's COVID-19 vaccination in women with and without autoimmunity
title_sort risk of adverse events following coronavac s covid 19 vaccination in women with and without autoimmunity
topic Adverse events after immunization (AEFI)
Autoimmunity
CoronaVac
COVID-19
url http://www.sciencedirect.com/science/article/pii/S2213398423000362
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