Anti-COVID-19 Vaccination in the Italian General Population: Proactive Clinical Risk Analysis Using Failure Mode, Effects, and Criticality Analysis Technique.

: Large-scale vaccination was crucial to address the global COVID-19 pandemic and its associated health risks, including fatal and disabling diseases. However, there were significant challenges to be overcome to ensure the safe and effective implementation of the vaccination program. The aim of the present study was to assess patient safety threats related to the anti-COVID-19 large-scale vaccination process.