The Italian Medicines Agency has published the first Pharmacovigilance Report on COVID-19 vaccines, which will be published on a monthly basis. The data collected and analyzed concern reports of suspected adverse reactions ![\"\"](\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/02\/AIFA-segnalazione-grave.jpeg\")
registered in the National Pharmacovigilance Network between 27 December 2020 and 26 January 2021 for vaccines in use in the ongoing vaccination campaign: Comirnaty by Pfizer\/BioNTech (authorized since 22\/12\/2020 and used since 27\/12\/2020) and COVID-19 Vaccine Moderna (authorized since 07\/01\/2021 and used since 14\/01\/2021).<\/p>\n
The reports mainly concern the first dose of the Comirnaty vaccine (99%), which was the most used and only to a lesser extent the Moderna vaccine (1%).<\/p>\n
They were received during the period in question 7,337 reports<\/b> out of a total of 1,564,090 doses<\/b> administered (reporting rate of 469 per 100,000 doses), of which the 92.4% refer to non-serious events<\/b>such as injection site pain, fever, asthenia\/fatigue, muscle aches. Headache, paraesthesia, dizziness, drowsiness and taste disturbances have also been observed with Comirnaty, while with the Moderna vaccine, nausea and abdominal pain.<\/p>\n
Less frequent are other local reactions and widespread joint pain. As expected, fever was reported more frequently after the second dose than after the first.<\/p>\n
The events reported mainly occur on the day of vaccination or the day after (85% of cases).<\/p>\n
Of the 7.6% of reports classified as "serious<\/b>\u201d, for which the evaluation of the causal link with vaccines is underway, three out of four have not required specific intervention in the hospital setting.<\/p>\n
During the period they were also reported 13 deaths occurred in the hours following vaccination<\/b> that, in the most detailed and complete reports of data, were not related to vaccination<\/b> and are largely attributable to the basic conditions of the vaccinated person.<\/p>\n
The analyzes conducted on the data acquired so far therefore confirm a good safety profile of these two mRNA vaccines<\/b>. The large number of reports does not imply that unexpected critical issues have emerged, but it is an indication of the high capacity of the pharmacovigilance system in monitoring safety.<\/p>\n