According to the latest report by the National Authority for Medicines and Health Products, by the end of May 6,995 adverse reactions had been reported, most (68.3 percent) referring to the Pfizer/BioNtech vaccine, with 4,782 cases, followed by AstraZeneca (Vaxzevria), with 1,509, Moderna, with 387, and Janssen, with 17 cases.
Data from Infarmed indicate that for every 1,000 doses administered, 1.21 side effects were reported for Pfizer (Comirnaty), 1.24 for AstraZeneca (Vaxzevria), 0.74 for Moderna and 0.16 for Janssen's vaccine.
In a total of 5,790,080 doses administered, Infarmed registered 44 reports of cases of death in the elderly with other comorbidities and in which the causal relationship with the administered vaccine has not been demonstrated.
"The cases of death occurred in age of 81 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", said the National Medicines Authority.
Of the reactions recorded, 3,957 refer to non-serious cases (59.1 percent) and 2,738 to severe cases (40.9 percent), said Imfarmed, noting that the majority (90 percent) of adverse drug reactions classified as serious refer to “cases of incapacity, mostly temporary”.
The majority of reactions reported to Infarmed were registered in women (4,712) and the age group with the most reports is from 30 to 49 years old.
The 10 most reported reactions refer to injection site reactions (3,250), muscle or joint pain (3,007), headaches (1964), fever (1,800), asthenia, weakness or fatigue (1,123), nausea (773), tremors (687), ganglion changes/enlargement (569), eczema or rash (481) and paresthesias (400).
In the report, Infarmed also recalls that most of the reported adverse drug reactions are "in the common profile of any vaccine" and that most of these reactions get better "in a few hours or days, without the need for medical intervention".