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Adverse events reported from the COVID-19 vaccines: A descriptive study based on the WHO database (VigiBase®)

Siddhartha Dutta, Rimple Jeet Kaur, Pankaj Bhardwaj, Praveen Sharma, Sneha Ambwani, Salequl Islam, Ankita Tandon, Jha Pallavi Abhayanand, Sanchi Sukhija, Suman S. Venkatesh, Sanjeev Misra, Mainul Haque, Jaykaran Charan.

The emergency approval of a few COVID-19 vaccines provided a ray of hope to fight the deadly pandemic. However, their approval was solely based on limited data from the clinical trials in a short period, thereby imposing a demand for post-marketing surveillance studies to monitor beneficial and adverse events (AEs). This study focuses on observing the serious adverse events (SAEs) data reported in the World Health Organization database. The data from VigiBase® was analyzed. The duplicates in the data were removed and analyzed based on age, gender, and SAEs at the system organ classification level and the individual preferred term level. A total of 103,954 AEs were reported. The majority of them were seen as females (80%), from Europe (83%), and were between 18 and 64 years (80.74%) of age. The most-reported AEs were of the nervous system (19.1%), musculoskeletal (11.2%), and elderly (>65 years) people. The reported SAEs from the COVID-19 vaccines were in line with the data published in the clinical trial reports. These SAEs to vaccines will need causality analysis and review of individual reports.

Key words: COVID-19 Vaccine; COVID-19; SARS-COV2; Adverse Events; VigiBase®

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