Between 27 December 2020 and 26 July 2021, for the four anti-Covid vaccines, 84,322 reports were received out of a total of 65,926,591 doses administered (reporting rate of 128 per 100,000 doses), of which 87.1 % referred to non-serious events, such as injection site pain, fever, asthenia / fatigue, muscle aches. Serious reports correspond to 12.8% of the total, with a rate of 16 serious events per 100,000 doses administered. This is what the Italian Medicines Agency reports in the seventh Pharmacovigilance Report on Covid-19 Vaccines. The data collected and analyzed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network.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 following day and only more rarely beyond the following 48 hours. Most of the reports are related to the Pfizer Biontech Comirnaty vaccine (68%), so far the most used in the vaccination campaign (71% of the doses administered) and only to a lesser extent to the Vaxzevria vaccine by Astrazeneca (25% of the reports and 17% doses administered), Moderna’s Spikevax vaccine (6% of reports and 10% of doses administered) and Johnson and Johnson’s COVID-19 Janssen vaccine (1% of reports and 2% of doses administered). , 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 intense symptoms, more frequent after the second dose of mRNA vaccines and after the first dose of Vaxzevria. under 60 who had received Vaxzevria as the first dose, 114 reports were received, out of a total of 396,952 administrations (the second dose concerned Comirnaty in 82.6% of cases and Spikevax in 17.4%), with a reporting of 29 per 100,000 doses administered. In the age group between 12 and 19 years, as of 07/26/2021, 530 reports of suspected adverse events were received out of a total of 1,986,221 doses administered, with a reporting rate of 27 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. Reporting rates of serious adverse events of individual vaccines are 13 (Comirnaty), 13 (Spikevax), 32 (Vaxzevria), and 15 (Janssen) for every 100,000 doses administered. As already reported in previous Reports, the serious adverse events reported mainly occur in the first 48 hours after vaccination (about 60% of cases), while they are more rarely observed in the following weeks (about 37% of cases). regarding deaths there are 498 reports, equal to a rate of 0.75 per 100 thousand doses administered. In 343 cases death is recorded after the first dose and in 145 after the second. On the other hand, there are no cases of deaths due to anaphylactic shock or allergic reactions, but very often the death is due to complications of already existing pathologies. On individual vaccines, the death rate per administered dose is 0.66% for Pfizer, 1.30% for Moderna, 0.78% for AstraZeneca and 1.28% for Johnson & Johnson. According to AIFA, however, in seven cases (2.4% of the total), causality is correlated. The others are almost always considered unrelated or indeterminate.
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