Improving Risk Management by Learning from Adverse Events: Report on One Year of COVID-19 Vaccination Campaign in Verona (Northeastern Italy).

BACKGROUND: The COVID-19 mass vaccination campaign posed new challenges not only from a healthcare perspective, but also in terms of distribution, logistics, and organization. Managing clinical risk in off-site vaccination centers during a pandemic provided a new opportunity for the training and acquisition of competencies through continuous learning from adverse events. The aim of this report, based on a review of activity, was to identify the most recurrent and high-risk failures of the vaccination process in a mass vaccination center. METHODS: Adverse events and near misses reported during the first 11 months of activity (February 2021-January 2022) in the mass vaccination center of Verona (Italy) were evaluated. RESULTS: From 15 February 2021 to 17 January 2022 the center administered about 460,000 doses to the population and nine adverse events and one near miss were reported. Most of the events were errors in vaccine administration, either in principle, dosage, or timing with respect to the indicated schedule. All events had minor outcomes. Communication errors, inadequate training, and general organizational issues were the most recurrent factors contributing to the events. CONCLUSIONS: Risk mitigation during mass vaccination in temporary sites is an essential element of a successful vaccination campaign. The reporting of adverse events should be encouraged in order to obtain as much information as possible for a continuous improvement of the activity.

Reactogenicity of BNT162b2 mRNA COVID-19 Vaccine in a Young Working Age Population: A Survey among Medical School Residents, within a Mass Vaccination Campaign, in a Regional Reference Teaching Hospital in Italy.

Vaccinations are a key prevention measure in fighting the COVID-19 pandemic. The BNT162b2 mRNA vaccine (BioNTech/Pfizer), the first to receive authorization, was widely used in the mass vaccination campaign in Italy. Healthcare workers were identified as a priority group for vaccination, but few studies have assessed its reactogenicity among the young working age population. An online survey was conducted to investigate the adverse reactions occurring in the 7 days following the first and second vaccination doses amongst resident doctors of the University of Genoa, employed at the IRCCS Ospedale Policlinico San Martino of Genoa, between 11 January and 16 March 2021. A total of 512 resident physicians were invited to participate in the study (female = 53.2%; mean age = 28.9 years), of whom 296 (female = 53.4%, mean age = 28.9 years) and 275 (female = 55.3%, mean age = 29.1 years) completed the survey after their first and second vaccination doses, respectively. In the 7 days following the first dose, most common adverse reactions were local pain (96.3%), fatigue (42.6%), headache (33.8%), arthromyalgia (28.0%), and 5.1% reported fever, while following the second dose, participants reported local pain (93.5%), fatigue (74.9%), headache (57.5%), arthromyalgia (58.2%), and fever (30.9%), with a higher prevalence among females. Systemic (but not local) reactions increased following the second vaccination, reaching severe intensity in 9.8% of participants and causing three or more events of moderate intensity in 23.7% of participants. Adverse reactions preventing regular daily activities could cause absenteeism among workers. These results can be useful to inform populations of young individuals, set expectations, and improve adherence to vaccination campaigns.