Adverse Events Following Immunization with SARS-CoV-2 Vaccines and its Reporting in India: A Growing Concern

Abstract

The COVID-19 pandemic has led to many drug delivery systems and vaccine developments globally. Implementation of immunization programs has been done through emergency approvals and has also raised concerns regarding side effects and adverse events following immunization. The side effects are fever, injection site pain, arthralgia, redness, swelling, induration, pruritus, myalgia, induration, chills, headache, vomiting, and fatigue. The adverse events are anaphylaxis, thrombotic thrombocytopenic purpura, intracranial venous sinus thrombosis, Guillain–Barre syndrome, seizures, Steven–Johnson Syndrome, pulmonary embolism, acute myocardial infarction, myocarditis, and pericarditis associated with different vaccines. The factsheet of many vaccines does not convey sufficient details to alert the beneficiaries. These need to be updated timely and beneficiaries need to be made aware of the same. In some countries, authorized portals have captured these data on a real time basis. Similar portals need to be in place in India also so that data generated can be used for further timely recognition, reporting, and management of AEFI. The reporting of the same should be made mandatory for all and guidance should be provided regarding levels of management, home based, or hospital based.