In Romania, health and social workers were prioritized for COVID-19 vaccination. We aimed to describe the vaccine adverse events identified through an active survey (using an electronic questionnaire) conducted among the staff of a pediatric hospital from Bucharest, vaccinated with the mRNA Pfizer-BioNTech vaccine. Data on the frequency and duration of adverse events were collected and analyzed using Microsoft Excel, Epi Info, and MedCalc. The questionnaire was sent to 426 persons. The participation rate was 81.2% after 1st dose and 63.8% after the 2nd dose. Overall, 81.9% were women, median age 42 (IQR 32-50 years). A total of 48 respondents (14.8%) reported no adverse event after the 1st dose and 35 (14.1) after the 2nd dose. No anaphylaxis was reported. The most frequent adverse event was pain at injection site, being reported by 261 responders (80.3%) after 1st dose and 187 (75.1%) after 2nd dose. Fatigue and headache were reported significantly less frequently in our study compared with data provided by the vaccine manufacturer. The current study has shown higher local reactogenicity after the first dose of the vaccine and higher systemic reactogenicity after the second dose. This real-world knowledge of the reactogenicity and safety profile may increase the vaccine's acceptance rate among healthcare workers.
Keywords: COVID-19; active surveillance; healthcare workers; mRNA vaccine; reactogenicity.