Over 39,000 adverse reactions to nearly 28 million Covid-19 vaccines.

By the end of 2022, more than 39,000 adverse reactions (ARs) to covid-19 vaccines were registered in Portugal, which corresponds to 1.4 cases per thousand doses administered, according to the Infarmed report.

“Up to December 31, 2022, a total of 39,135 suspected ADR cases have been received,” after nearly 28 million doses have been given since vaccination began, according to the document, the latest regularly published by the National Drug Administration (Infarmed). on the safety of SARS-CoV-2 vaccines.

According to the national regulatory authority, of the total number of ADRs registered in the National Pharmacovigilance System (SNS), 8518 cases were considered serious, equivalent to 0.3 cases per 1000 vaccines administered.

The report also adds that adverse reactions to covid-19 vaccines “are infrequent” and severe cases are considered “rare” according to the World Health Organization’s classification.

“ADR cases classified as serious are about 84% related to temporary disability situations (including absenteeism) and other cases that the notifier considers clinically important, regardless of whether he is a healthcare professional or user,” Infarmed clarifies.

Of the 8,518 reported cases of suspected serious reactions, “142 were fatal” – 0.005 cases per 1,000 vaccines administered – and occurred in a group of people with an average age of 77, the paper said.

However, the national regulatory authority emphasizes that in the vast majority of reported cases where information on medical history and medications is available, “the fatal adverse outcome can be explained by the patient’s medical history and/or other treatments, causes of death.” be diverse and not represent a standard.”

“It is expected that during vaccination campaigns there will still be deaths from other causes, sometimes in close temporal association with vaccination and without necessarily being associated with vaccination,” explains Infarmed.

According to the report, in children aged 5 to 11 years, the 50 cases reported as serious are mainly related to situations already described in the vaccine information, such as fever, vomiting, diarrhea, malaise and headache, two cases of myocarditis, which progressed to reported cure.

In the age group 12 to 17 years, 127 cases considered serious were associated with syncope or pre-syncope reactions and allergic-type reactions, which in most cases were positive and had no consequences, of which 20 of these cases were reported as myo/ pericarditis.

“It should be noted that myocarditis and pericarditis are inflammatory diseases of various etiologies, usually associated, especially in this age group, with viral infections,” says Infarmed.

The most commonly reported adverse reactions to SOYA vaccines are injection site pain, headache, muscle and joint pain, fever, fatigue, chills, nausea, general malaise, and drowsiness.

Infarmed, which published these reports to “inform the public” throughout the vaccination campaign, adds that it will now stop publishing the document regularly given the “more reliable knowledge of the safety profile” of vaccines.

Its monitoring, like for any other drug, continues throughout the life cycle of the drug, the regulator also mentions, adding that it is estimated that covid-19 vaccines will prevent more than 250,000 deaths in the European Union in 2021 alone.

From the beginning of the vaccination campaign until December 31, 2022, 27,981,130 doses were administered in Portugal, of which 63.8% corresponded to the original Komirnati vaccine, 13.2% to the original Sipkevax vaccine, 10% to the bivalent Komirnati vaccine, 8.1% – vaccine Vaxzevria, 4.1% – Jcovden and 0.8% – bivalent Sipkevax.