ABSTRACT
Background:
Vaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following
Immunization (AEFIs) reported for
COVID-19 vaccines from
India.
Methods:
Secondary data analysis of the
causality assessment
reports for the 1112 serious AEFIs published by the Ministry of
Health &
Family Welfare,
Government of
India, was conducted. For the current
analysis, all the
reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal
association and the thromboembolic events.
Results:
The majority of the serious AEFIs assessed were either coincidental (578, 52%) or
vaccine product related (218, 19.6%). All the serious AEFIs were reported among the
Covishield (992, 89.2%) and COVAXIN (120, 10.8%)
vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted
analysis,
females, the younger
age group and non-fatal AEFIs showed a statistically significant consistent causal
association with COVID-19
vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant
association with higher age and
case fatality rate.
Conclusion:
Deaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the
COVID-19 vaccines than the recovered
hospitalizations in
India. No consistent causal
association was found between the thromboembolic events and the type of
COVID-19 vaccine administered in
India