Active pharmacovigilance in patients immunized with the CoronaVac vaccine in the port of Cartagena group

Abstract

Introduction: The crisis caused during the COVID-19 pandemic led scientists around the world to think about the creation of different vaccines against SARS-CoV-2. One of them was the inactivated virus vaccine CoronaVac, which was approved by Colombia's Ministry of Health. However, there are few pharmacovigilance studies conducted by occupational medicine to know the adverse events caused by vaccines.

Objective: To estimate the safety of the CoronaVac vaccine.

Methodology: Descriptive, retrospective and quantitative study, in which a population group of 508 workers from the port of Cartagena group was chosen, who were selected under inclusion criteria, during the second period of 2021 and the first of 2022.

Results: 3.54 % of workers reported adverse events within the study population. Men had the most reports with 72.2% and women 27.8%. The most affected population group in terms of age was those aged 30 to 35 years, with a report of 44.4%. Likewise, the systems where there was a higher percentage of reports were the musculoskeletal, respiratory, and nervous system for first, second and third doses respectively; with symptoms such as headache, malaise, fever, muscle and joint pain, followed by pain in the injection area.

Conclusions: In this study it was possible to identify the adverse events reported by the study population. However, none of the events presented had a serious or negative influence on the health and integrity of the workers during the study period. In this way, the safety of the vaccine was estimated. It should be noted that the CoronaVac vaccine did not prevent the spread or possible reinfection of the virus.