The Italian Medicines Agency has published the fifth Pharmacovigilance Report on COVID-19 Vaccines. The data collected and analyzed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 May 2021 for the four vaccines in use in the current vaccination campaign.
In the period considered, 66.258 reports were received out of a total of 32.429.611 doses administered (reporting rate of 204 per 100.000 doses), of which approximately 90% referred to non-serious events, such as pain at the injection site, fever, asthenia / fatigue, muscle aches. As reported in previous Reports, the reported events mostly occur on the same day of vaccination or the next day (83% of cases).
Serious reports correspond to 10,4% of the total, with a rate of 21 serious events per 100.000 doses administered, regardless of the type of vaccine, the dose (first or second) and the possible causal role of the vaccination.
Most of the reports are related to the Comirnaty vaccine (71,8%), so far the most used in the vaccination campaign (68,7% of the doses administered) and only to a lesser extent to the Vaxzevria vaccine (24% of the reports and 20,8 % of administered doses), Moderna vaccine (3,9% of reports and 9% of administered doses), and COVID-19 Janssen vaccine (0,3% of reports and 1,5% 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.
The reporting rate of intracranial and atypical venous thrombosis in subjects vaccinated with Vaxzevria is in line with what has been observed at the European level (1 case per 100.000 first doses administered, no cases after second dose), mainly in people under 60 years of age. .
The Report is available on the AIFA website at the page: https://www.aifa.gov.it/farmacovigilanza-vaccini-covid-19