Covid-19: more than 39 thousand adverse reactions in 28 million vaccines in Portugal

8,518 were considered severe cases, equivalent to 0.3 cases per 1,000 vaccines administered. Of those, “142 had a fatal outcome.

More than 39,000 adverse reactions (ADRs) to covid-19 vaccines were recorded in Portugal by the end of 2022, corresponding to 1.4 cases per 1,000 doses administered, an Infarmed report indicates.

“By December 31, 2022, a total of 39,135 notifications of suspected ADR cases were recorded” following the nearly 28 million doses administered since the vaccination began, says the document, the last that the National Drug Authority (Infarmed) publishes on a regular basis about the safety of SARS-CoV-2 vaccines.

According to the national regulator, of the total number of ADRs recorded in the National Pharmacovigilance System (NPS), 8,518 were considered severe cases, equivalent to 0.3 cases per 1,000 vaccines administered.

The report also states that adverse reactions to covid-19 vaccines are “infrequent” and severe cases are considered to be of “rare frequency” according to the World Health Organization classification.

“Of the ADR cases classified as serious, about 84% concern situations of temporary incapacity (including work absenteeism) and others considered clinically important by the notifier, whether healthcare professional or user.”

Of the 8,518 case reports of suspected severe reactions, “142 were fatal” – 0.005 cases per 1,000 vaccines administered – and occurred in a group of people with a median age of 77, the document said.

The national regulator points out, however, that in the vast majority of reported cases where information on medical history and medication is available, “a fatal adverse outcome can be explained by the patient’s clinical history and or other treatments, with causes of death being diverse and not presenting a pattern.”

“During vaccination campaigns it is expected that deaths from other causes will continue to occur, sometimes in close temporal association with vaccination, and without necessarily being related to vaccination,” Infarmed further explains.

In children and young people

According to the report, in children between 5 and 11 years old, the 50 cases reported as severe refer mostly to situations already described in the vaccine information, such as fever, vomiting, diarrhea, malaise, and headache, and two cases of myocarditis were also reported that evolved to cure.

In the 12-17 age group, the 127 cases considered severe were related to syncope or pre-syncope and allergic reactions, which mostly had a positive outcome and no sequelae, including 20 of these cases that were reported as myocarditis/pericarditis.

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

Among the most commonly reported adverse reactions to vaccines in the SNF are pain at the injection site, headache, muscle and joint pain, fever, fatigue, chills, nausea, general malaise, and drowsiness.

“Informing the public”

Infarmed, which published these reports to “inform the public” throughout the vaccination campaign, says it will now stop publishing this document regularly, considering the “more robust knowledge of the safety profile” of vaccines.

Its monitoring, as for any other drug, is maintained throughout the life cycle of the drug, says the regulator, adding that it is estimated that, in 2021 alone, the covid-19 vaccines will have prevented more than 250,000 deaths throughout the European Union.

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

Covid-19: more than 39 thousand adverse reactions in 28 million vaccines in Portugal

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