Press release no. 653 - The Italian Medicines Agency has published the sixth Pharmacovigilance Report on COVID-19 Vaccines. The data collected and analysed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 June 2021 for the four vaccines in use in the current vaccination campaign.

In the period considered, 76,206 reports were received out of a total of 49,512,799 doses administered (reporting rate of 154 per 100,000 doses), of which 87.9% referred to non-serious events, such as pain at the injection site, fever, asthenia/fatigue, muscle aches.
Serious reports correspond to 11.9% of the total, with a rate of 18 serious events per 100,000 doses administered, regardless of the type of vaccine, the dose (first or second) and the possible causal role of vaccination.

As reported in previous Reports, regardless of the vaccine, dose and type of event, the reaction occurred in most cases (about 80%) on the same day of vaccination or the next day and only more rarely beyond 48 hours after vaccination.

Most of the reports are related to the Comirnaty vaccine (69%), so far the most used in the vaccination campaign (70.6% of the doses administered) and only to a lesser extent to the Vaxzevria vaccine (24.7% of the reports and 17.3 % of administered doses), Spikevax vaccine (5.2% of reports and 9.6% of administered doses) and COVID-19 Janssen vaccine (1.1% of reports and 2.5% of administered doses).

For all vaccines, the most reported adverse events are fever, fatigue, headache, muscle/joint pain, injection site pain, chills and nausea. The most frequently reported vaccination-related serious adverse events are a flu-like syndrome with severe symptoms, more frequent after the second dose of mRNA vaccines and after the first dose of Vaxzevria.

In relation to the so-called heterologous vaccinations in people under 60 who had received Vaxzevria as the first dose, 27 reports were entered, out of a total of 233,034 administrations (the second dose concerned Comirnaty in 86% of cases and 14% Spikevax from Moderna), with a reporting rate of 12 for every 100,000 doses administered.

The Report is available on the AIFA website at the following page: https://www.aifa.gov.it/farmacovigilanza-vaccini-covid-19