Abstract

Background: COVID-19 has been named as the third most pathogenic human coronavirus disease till date. The SARS-CoV-2 epidemic is still continued, and the new strain is expected to co-habit with us for a significant duration. The only way of protection from SARS-CoV-2 depends upon public health interventions such as active testing, along with immediate tracking of cases and limited social gatherings until clinically approved vaccines become widely available. Further, personal prophylactic measures such as social interspacing and proper use of quality masks can prevent the spread of this contagious virus.
 Objective: The current protocol is aimed to collect data on adverse event, after COVID vaccination and such studies in future can help in prevention and treatment of COVID-19.
 Method: The protocol was conducted in selected centres of Uttar Pradesh, India. It was done over a time period of 3 months. A valid protocol includes two shots of immunization procedure for all enrolled participants. Immediate (within 6 hrs), sudden (within 24 hours) and delayed adverse events occurred after 24 hours of vaccine administration were noted.
 Conclusion: In India, vaccine pharmacovigilance is still in its developmental stages. Irrespective of whether adverse event (AE) after immunization (AEFI), a steady stream of full information on vaccine-related AE is required. Because there is so few Indian researches on vaccination adverse effects, as a result, need for vaccine pharmacovigilance on a broad scale in India has emerged in recent times.

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