An analysis of fatal adverse conditions in temporal association of COVID-19 vaccination to boost the safety of vaccination for COVID-19.

ABSTRACT

SARS-CoV-2, the causative agent of COVID-19, claimed multiple lives in a very short span of time. Seeing the urgency of situation, vaccines were developed in hitherto unseen time frame. Vaccines definitely passed the test of safety and efficacy in clinical trials, but post mass vaccination data revealed cases of fatal adverse conditions in the temporal association of vaccination. The temporal association does not guarantee that the fatality is due to vaccination, but at the same time, it does create a concern. To overcome this concern and improve the safety of vaccination, we reviewed literature and collected data of 15 studies comprising of total 22 cases of fatal adverse condition/death in the temporal association of COVID-19 vaccination. Analysis of these data shows that many persons (40.90%) who succumbed were previously healthy individuals. All those who died developed symptoms or were admitted to hospital within a period of 3 weeks after vaccination. 86.36% cases of death took place within a period of 3 weeks after vaccination/presentation/admission/intervention. Complications which lead to death were CVST, thrombocytopenia/thrombosis /VITT, DIC and haemorrhage in 81.18% of cases. 81.81% cases of death were noted in the temporal association with ChAdOx1 nCoV-19 vaccine. 68.18% persons developed symptoms after first dose. Death was more common in females (59.09%), and the most commonly affected age group was 20 to 60 years (86.36%). Knowledge of fatal adverse conditions in the temporal association of vaccination will help to tackle these situations well and improve the safety of vaccination drive further.