ABSTRACT
Objective: To assess the adverse reactions (AR) reported to COVID-19 vaccines and their characteristics. Material and/or methods: An observational study of reported AR to COVID-19 vaccines over a 4 months period in 2021 was carried out. A descriptive analysis of age, gender, COVID-19 vaccines types and AR was performed. Results: A total of 590 suspected AR cases were reported, corresponding to 394 users. Mean age (standard deviation [SD]) of patients was 42.8 (12.1) years and 349 (88.6%) were women. One hundred and three users (26.1%) had previously documented SARS-CoV2 infection. Of the 590 AR suspected cases to vaccines, 273 (46.3%) were reported after the first dose (Pfizer = 220 [80.6%], Moderna = 52 [19.0%] and AstraZeneca = 1 [0.4%]). The remaining 316 (53.6%) AR suspected cases occurred after the second dose (Pfizer = 289 [91.5%] and Moderna = 27 [8.5%]). One case reported (0.1%) did not include vaccine type and was therefore excluded from analysis. Regarding severity 4.8% were serious:the most frequently were respiratory disorders (dyspnoea = 8, pneumonia = 1), nervous system (neuralgia = 2 and paraesthesia = 2 and vertigo = 1) and cardiac (angina = 2 and pericarditis = 1). Only two AR caused hospital admission, and the rest were considered clinically relevant. Severe ARs were reported to the Pharmacovigilance system. No thrombosis cases were reported in our sample. General disorders, nervous system and musculoskeletal represented globally the most common AR;injection site pain, headache and fatigue for the first dose, and fever, myalgia and arthralgia and fatigue in relation to the second dose. Conclusions: Most AR cases reported were considered non-serious and less than 5% were considered serious. Vaccines safety profile observed is consistent as described in clinical trials, and no safey signals such as thrombosis cases were reported in our sample.