Portugal with more than 18 thousand adverse reactions to vaccines
Considering the number of adverse reactions to vaccines (ADR) compared to the total number of vaccines administered – more than 16.2 million -, “it appears that adverse reactions to vaccines against covid-19 are rare, with about one case in a thousand inoculations, a stable value over time”, refers the Infarmed pharmacovigilance report.
According to data on the safety of vaccines against covid-19 received by October 31, of the total adverse reactions, 64% of the cases were non-independent and the remaining 36% were considered serious.
Regarding serious cases, around 85% relate to situations of temporary incapacity, including absenteeism from work, and others considered clinically relevant by those who notified them, whether the health professional or the vaccinated person.
Infarmed’s report even advances that, without a group of reactions classified as severe, 654 cases of hospitalization (3.6%), 188 of life-threatening (01%) and 96 of death (0.5%) were reported.
“The cases of death occurred in a group with a median age of 78 years and does not necessarily presuppose the existence of a causal relationship between each death and the vaccine administered, also taking place within the normal patterns of morbidity and mortality of the Portuguese population”, he points out. the regulator.
More cases in women
With regard to gender distribution, there is a greater preponderance of ADR notification on the part of females, which is the normal trend of notification for any other drug, the document states, which admits that this situation may result from “a greater attention by women to their health”.
The most commonly reported adverse reactions “fit the common profile of any vaccine” and include, but are not limited to, local post-injection or systemic reactions such as fever, headache and muscle pain.
Among the most reported reactions are fatigue, chills, nausea, generalized pain, dizziness, general malaise, pain in the extremities of the body, enlarged lymph nodes, organic weakness and vomiting.
“In most cases, the discomfort transmitted by these reactions resolves within hours or days, without the need for medical intervention and without sequelae. Only unresolved or aggravated situations after this period or of a more serious clinical nature require medical attention”, says the Infarmed.
In Portugal, there are the four vaccines used against a covid-19: Comirnaty (Pfizer / BioNTech), Spikevax (Modern), Vaxzevria (AstraZeneca) and Janssen, the latter with a single dose.
The report also indicates that Comirnaty, Spikevax and Vaxzevria registered one case of ADR per thousand inoculations, a figure that rises to 1.5 in the case of Janssen, but Infarmed emphasizes that these data do not allow the comparison of safety profiles between vaccines , as they were used in different groups and different contexts of the pandemic.
Covid-19 has caused at least 5,028,536 deaths worldwide, among more than 248.54 million infections with the new coronavirus registered since the beginning of the pandemic, according to the latest report by the Agence France-Presse.
In Portugal, since March 2020, 18,193 people have died and 1,095,337 cases of infection have been recorded, according to data from the General Directorate of Health.