PREDOMINANT GROUPS OF MEDICAL CONDITIONS, INCLUDING AUTOIMMUNE REACTIONS, REPRESENTED IN THE REPORTING OF SUSPECTED ADVERSE REACTIONS TO COVID-19 VACCINES IN THE EUDRAVIGILANCE DATABASE

Objectives. Vaccination continues to play an important role in limiting the spread of infectious diseases. At the same time, vaccines represent safety risks and vigilance systems are being set up to monitor them nationally and internationally. In the COVID-19 pandemic settings, the role of vaccine safety monitoring
has increased due to the massive introduction of new vaccines without sufficient experience with their use. The aim of this study was to identify the predominant groups of medical conditions reported by clinicians and patients after vaccination within the EU passive vigilance system.
Materials and Methods. The data publicly available in the EudraVigilance European Database for Suspected Adverse Drug Reaction Reports were analysed by quantitative methods. Reports submitted to the EudraVigilance database are coded using MedDRA terms for medical conditions. In addition, a scoping
literature review was carried out to complement the research framework.
Results. The results demonstrated that the “general disorders and administration site conditions” group significantly exceeds other categories of medical conditions following COVID-19 vaccination. Noticeably, that “chronic fatigue syndrome” also belongs to this group according to MedDRA. Two other dominant reaction groups for COVID-19 vaccination are “nervous system disorders” and “musculoskeletal and connective tissue disorders”, which also have a vast range of medical conditions. A scoping literature review identified a number of publications on specific neurological and autoimmune manifestations after vaccination. New-onset autoimmune phenomena after COVID-19 vaccination have been reported
increasingly (e.g., immune thrombotic thrombocytopenia, autoimmune liver diseases, Guillain-Barré syndrome, IgA nephropathy, rheumatoid arthritis, and systemic lupus erythematosus).
Conclusions. Data from the passive vaccine vigilance system allow the identification of predominant groups of reported medical conditions. However, obtaining operational information would require an active system. Therefore, future research should focus on active pharmacovigilance models, as well as more indepth research on vaccine-induced complications to reduce risks in the future.
Funding. Latvian Council of Science: LZP-2019/1-0 38 0.