How safe is Covishield (ChAdOx1nCoV-19) vaccine? Experience from a tertiary care hospital in South India

Background COVID vaccine has been recently rolled out for Health care workers in India. Though vaccine trials and data are available, people, including HCWs, need more real-life data from their contexts to get over the vaccine hesitancy. We aimed to determine the incidence of Adverse Event Following Immunisation (AEFI) among HCWs after their first dose of ChAdOx1nCoV-19 vaccine Methods We conducted a cross-sectional study among 218 staff of a tertiary care hospital. We circulated a google form with informed consent on the hospital WhatsApp platform and asked them to self-report their vaccination experience. Results Two thirds (69.7% (152/218), 95% CI: 63.1-75.7) had minor AEFI, and none had severe AEFI. Body ache (46.8% (102/218), 95% CI :40 – 53.6) was the most common symptom followed by headache (30.3% (66/218), 95% CI :24.2 – 36.8) and fever (22% 948/218), 95% CI :16.7 – 28.1). Most of them (39.4% (87/218) 95% CI:32.9 – 46.2) experienced symptoms within 4-24 hours after taking the vaccine while 22.3% (49/218) (95% CI: 17.1 – 28.6) experienced it after a day. Majority of the HCWs (78.9% (172/218), 95% CI: 72.8 – 84.1) were anxious before the vaccination. Younger age group and female gender were significantly associated with AEFI compared to their counterparts. Conclusion HCWs experienced minor, self-limiting AEFI with the first dose of ChAdOx1nCoV-19. The hospital reported no serious AEFI following the vaccination ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement No external funding was received ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by Institutional Review Board of Bangalore Baptist Hospital All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data is available with the corresponding author at request