The 2023 Vaccine Report aims at informing citizens and health care professionals about suspected Adverse Drug Reactions – ADR following vaccination that were registered in 2023 by the National Pharmacovigilance Network (RNF), managed by the Italian Medicines Agency. The analysis includes anti-COVID-19 vaccines.

In 2023, a total of 4,349 reports of Adverse Event Following Immunization (AEFI) were entered in the RNF.

Among these, however, 19 reports were identified as duplicates of cases already recorded in the RNF, therefore the reports assessable for the analysis are 4,330.

73.6% (3.185) of all reports (including anti-COVID-19 vaccines) concerned non-serious adverse events. The remaining 26.4% (1.145) concerned reports with at least one serious adverse event. Of these, the majority were ‘other clinically relevant condition’ (14.8%, 641) or ‘hospitalisation or prolonged hospitalisation’ (6.3%, 272).

Compared to 2022, reports with at least one serious event dropped by 83% from 6,774 to 1,145.