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

ABSTRACT

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.