Consultation Document for Case Definitions, Adverse Events of Special Interest, and Adverse Events Following Immunization during COVID-19 Vaccine Introduction. Second edition

Abstract

This reference document lists and provides internationally standardized case definitions of adverse events of special interest and adverse events following immunization for COVID-19 vaccines. It is based on publications, documents, and information on the subject, in addition to listing other risks related to diseases, medicines and vaccines that are part of routine vaccination schedules in the country. It offers healthcare professionals and/or decision makers in public health a tool with the primary objective of strengthening the Pharmacovigilance of Vaccines against COVID-19, reinforcing the importance of standardizing the definitions of adverse events and its guidelines, to allow comparability of data and a better understanding of the adverse event, considering the extreme importance of surveillance of the safety of the COVID-19 vaccine. It aims to facilitate the recognition of AEFI, especially serious and/or uncommon ones, improving case analysis and the dissemination of high-quality information on vaccine safety. Conventional vaccine safety surveillance and pharmacovigilance systems need to adapt to new surveillance techniques and ensure that post-vaccination safety and exposure information is collected and processed quickly and in a standardized manner. Licensed vaccines and those that are in clinical trial and that have received emergency authorization for use will require close monitoring by multiple stakeholders to ensure that the use of these vaccines will continue to be as safe and effective in the field as in clinical trials.