Among the adverse reactions considered serious, there are 127 cases of death among people with a median age of 77 years, according to the Pharmacovigilance Report.
“These events cannot be considered related to a vaccine against Covid-19 just because they were spontaneously reported to the National Pharmacovigilance System”, emphasises Infarmed, according to which 23,468,697 vaccines were administered until February 28.
Infarmed explains that vaccination “will not reduce deaths caused by other causes, for example, health problems unrelated to the administration of a vaccine, so 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 having any relationship with vaccination".
Most adverse reactions (11,802) are related to the Pfizer/BioNtech (Comirnaty) vaccine, followed by AstraZeneca (Vaxzevria), with 6,234, Moderna (Spikevax), with 2,870, and Janssen, with 2,870.
Infarmed stresses, however, 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 periods and epidemiological contexts distinct".
Of the cases of adverse reactions classified as serious, "about 85% concern situations of temporary incapacity (including absenteeism from work)".
Of the serious adverse reactions, the report says that 4,364 (19%) were classified as clinically important, 1,799 (7.8%) caused some disability, 780 (3.4%) required hospitalisation, 215 (1%) were at risk of life and 127 (0.5%) resulted in death.
By age group, those between 25 and 49 years old had the most cases of serious adverse effects (3,380 cases), which also had the highest number of vaccines administered (7,658,905).
The 10 most reported reactions were fever (5,166), headache (5,092), muscle pain (4,718), pain at the injection site (4,160), chills (2,629), fatigue (2,585), nausea ( 1,869) and joint pain (1,614).
There were also cases of generalised pain (1,543), general malaise (1,399), dizziness (1,335), pain in the body extremities (1,227), enlarged lymph nodes (1,074), vomiting (994) and organic weakness (965).
"In most cases, the discomfort caused by these reactions resolves in a few hours or days, without the need for medical intervention," the report said.