93 possible adverse effects from Covid vaccines are reported for every 100,000 punctures
93 possible adverse effects from Covid vaccines are reported for every 100,000 punctures

There have been 24,491 reports of adverse effects following inoculation of the four licensed vaccines. Of these, 4,659 were considered serious, 19%

A nurse prepares syringes with doses of the Pfizer vaccine in Murcia.Marcial GuillnEFE

The Spanish Agency for Medicines and Health Products (AEMPS) has published this Wednesday the 6 Pharmacovigilance Report on Covid-19 Vaccines, in which the adverse event notifications registered in Spain after immunization against Covid with the four vaccines (Pfizer / BioNTech, Moderna, Oxford / AstraZeneca and Janssen) authorized to date.

“Until May 30, a total of 24,491 notifications of adverse events have been registered in the Fedra database (Spanish Pharmacovigilance, Data on Adverse Reactions), which corresponds to 93 reports per 100,000 doses administered. 77% have been reported by health professionals and 23% by citizens. Most of the notifications correspond to people between 18 and 65 years old (88%), and mostly to women (79%) “, according to the report.

However, the AEMPS clarifies that, although these data collect reports of adverse events occurring after immunization, “adverse reactions due to the vaccine cannot be considered until a causal relationship is confirmed con su administrin “.

Only 19% of notifications were serious

In addition to this, the report reflects that, of the 24,491 notifications of adverse events registered, 4,659 were considered serious (19%), “understood as any adverse event that requires or prolongs hospitalization, gives rise to a significant or persistent disability, or a congenital malformation, endangers life or is fatal, as well as any other condition that is consider medically significant. ” Along with this, the document indicates that it should be taken into account that the notification of serious adverse events and their registration is a priority over those considered not serious.

On this, among the main conclusions of this sixth report, it is highlighted that most frequently reported events they remain the general disorders (fever and pain in the vaccination area), of the nervous system (headache and dizziness), and of the musculoskeletal system (myalgia and arthralgia).

About each vaccine

In addition to these considerations, the report provides information on each of the vaccines after vaccination. review of safety data available.

Regarding the product of Modern, diarrhea and local delayed-onset reactions have been incorporated into the data sheet and package leaflet as possible adverse reactions. Immune thrombocytopenia cases continue to be studied, pending analysis of additional data to determine if there is any causal relationship with the administration of the vaccine.

Regarding the vaccine Oxford/AstraZeneca, The administration of the second dose has been contraindicated in people who have suffered from thrombosis syndrome with thrombocytopenia (TTS) after the first dose, including additional information in the SmPC and the package leaflet about this possible adverse reaction. In addition, the administration of this vaccine has been contraindicated in people with a history of systemic capillary leak syndrome (SFCS). “SFCS, urticaria and angioedema have been identified as new adverse reactions in the technical data sheet and the package insert. Signs related to immune thrombocytopenia and acute macular neuroretinopathy continue to be evaluated,” the AEMPS details in the report.

About the product of Janssen, the information in the technical sheet and the prospectus has been updated, including recommendations for a better identification of the cases of TTS that may occur.

Myocarditis and pericarditis

In addition to this, the sixth pharmacovigilance report includes that the Committee for the Evaluation of Risks in Pharmacovigilance (PRAC) continues with the evaluation of the cases reported after vaccination against Covid of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane that surrounds the heart). This evaluation began after learning about a series of cases reported in Israel. Most of these cases were not serious, resolved within a few days, and mostly affected young men (under 30 years of age), with symptoms beginning a few days after the vaccine was administered (almost all after receiving the second dose of the Pfizer vaccine).

“In the countries of the European Economic Area (EEA), notifications of myocarditis and / or pericarditis have also been received for the different vaccines that are being administered. At this time, it cannot be established that there is a causal relationship between the onset of myocarditis or pericarditis, and vaccination. The evaluation is ongoing and will include new data that will be available soon “, added the AEMPS.

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