The Italian Medicines Agency has published the eighth 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 August 2021 for the four vaccines in use in the current vaccination campaign.
In the period considered, 91.360 reports were received out of a total of 76.509.846 doses administered (reporting rate of 119 per 100.000 doses), of which 86,1% referred to non-serious events, such as pain at the injection site, fever, asthenia / fatigue, muscle aches.
Serious reports correspond to 13,8% of the total, with a rate of 13 serious events per 100.000 doses administered. 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. following.
Comirnaty is currently the most used vaccine in the Italian vaccination campaign (71%), followed by Vaxzevria (16%), Spikevax (11%) and COVID-19 Vaccino Janssen (2%). In line with previous Reports, the distribution of reports by type of vaccine is similar to that of administrations (Comirnaty 67%, Vaxzevria 24%, Spikevax 8%, COVID-19 vaccine Janssen 1%).
For all vaccines, the most reported adverse events are fever, fatigue, headache, muscle / joint pain, local reaction or pain at the injection site, chills and nausea.
In relation to the so-called heterologous vaccinations to people under 60 who had received Vaxzevria as the first dose, 248 reports were received, out of a total of 604.865 administrations (the second dose concerned Comirnaty in 76% of cases and Spikevax in 24%) , with a reporting rate of 41 for every 100.000 doses administered.
In the age group between 12 and 19 years, as of 26/08/2021, 838 reports of suspected adverse events were received out of a total of 3.798.938 doses administered, with a reporting rate of 22 adverse events per 100.000 doses administered . The distribution by type of adverse events is not substantially different from that observed for all other age groups.