Nearly 8,500 suspected adverse reactions to vaccines against covid-19 were reported in Portugal, including 55 cases of death in the elderly, reveal data from Infarmed. “The cases of death occurred in a group with a median age of 78 years and do not necessarily presuppose the existence of a causal relationship with the administered vaccine, as they may also result from the normal patterns of morbidity and mortality of the Portuguese population”, he stresses o “Pharmacovigilance Report — Monitoring the Safety of Vaccines against covid-19 in Portugal”.
From the start of the vaccination campaign on December 27, 2020 until June 26, 8,470 reports of adverse reactions (ADRs) were registered, in a total of 8,470,118 administered doses, 3,290 (39%) classified as “serious” and 5,180 (61%) as “non-serious”.
The data show that per thousand doses of vaccines administered, one case of adverse reaction was reported, a number that drops to 0.5 in the case of severe reactions.
Of the reactions reported as “serious”, 1,947 were classified as “clinically important” (23%), 943 caused disability (11%), 252 caused hospitalization (3%), 93 represented “life risk” (1%) and 51 death (0.6%).
Of the cases classified as serious, about 90% relate to situations of temporary incapacity for the most part and others are considered “clinically significant” by the notifier, says the National Authority for Medicines and Health Products.
“If a case contains more than one ADR (the most frequent situation), it is enough for one of these adverse reactions to be classified as serious for the whole case to be serious as well”, he stresses, explaining that this classification follows criteria from the World Health Organization , but it is made by the notifier, whether this is a health professional or a user.
Of the total adverse reactions, 5,561 are related to the Pfizer/BioNtech (Comirnaty) vaccine, in a total of 5,865,276 administered doses, 2,133 to Astrazeneca (1,493,560 inoculated doses), 556 to Moderna (842,545 doses) and 130 to Janssen (268,737 doses).
For every 1,000 doses administered, one reaction was reported for Pfizer, 1.5 for AstraZeneca, 2 for Moderna and 0.5 for Janssen vaccine.
Infarmed emphasizes that these data “do not allow the comparison of safety profiles between vaccines, since they were used in different population subgroups (age, gender, health profile, among others) and in different periods and epidemiological contexts”.
The majority of reactions were reported in women, with 2,317 reports of serious and 3,609 non-serious cases.
In relation to men, 642 serious adverse reactions and 1,137 non-serious adverse reactions were reported, with the age group from 30 to 49 years old being the ones with the most reports.
The most reported reaction is myalgia (2,638), followed by headache (2,341), pain at the injection site (2,203), fever (2,156), chills (958), fatigue (948), nausea (939), muscle pain or in the joints (752), changes/enlargement of the nodes (591), dizziness (455), pain (445), asthenia (430) malaise (422), vomiting (406) and diarrhea (333).
“In most cases, the discomfort caused by pain or fever is a normal sign that the immune system is reacting and these reactions resolve in a few hours or days, without the need for medical intervention, and leaving no sequelae”, he says. the Infarmed.
It also states that unresolved or aggravated situations during this period or of a more serious clinical nature may require clinical evaluation.
“A person vaccinated with a vaccine against covid-19 who, after leaving the vaccination site, considers that he may be developing a severe allergic reaction, should seek immediate medical attention”, advises the medicine authority.
The covid-19 pandemic has caused at least 3,957,862 deaths worldwide, resulting from more than 182.5 million cases of infection, according to the most recent assessment made by the French agency AFP.
In Portugal, 17,108 people died and 884,442 cases of infection were confirmed, according to the most recent bulletin of the Directorate-General for Health.
The respiratory disease is caused by the new SARS-CoV-2 coronavirus, detected in late 2019 in Wuhan, a city in central China.