"The cases of death occurred in a group of individuals with a median age of 77 years and do not necessarily presuppose the existence of a causal relationship between each death and the vaccine administered, also taking place within the normal mortality patterns of the Portuguese population".
From the start of the vaccination campaign on December 27, 2020 until September 26, 15,922 reports of adverse reactions (ADR) were registered, from a total of 15,956,183 doses administered, 5,929 (37 percent) classified as “serious” and 9,993 (63 percent) as “non-serious”.
Of the reactions reported as "severe", 3,612 were classified as "clinically important" (23 percent), 1,517 caused disability (9.5 percent), 557 caused hospitalisation (3.5 percent), 158 represented risk to life (1 percent) and 85 deaths (0.5 percent).
“With the course of the vaccination programme, and the stimulus for the notification of suspected ADRs associated with vaccines against covid-19, this figure has increased”, stresses the report.
However, it adds, "adverse reactions are infrequent, with about 1 case in 1,000 inoculations, a stable value over time."
The largest number of cases was registered in the 25/49 age group (2,799), the group where the largest number of vaccines was administered (5,420,526).
Infarmed reports 22 cases of non-serious reactions in children under the age of 3, explaining that they concern “non-serious occurrences of fever, regurgitation or irritability in children whose mothers may have been exposed to the vaccine”.
In the age group 12-17 years, 47 cases were reported as severe and 30 as non-serious, in a total of 994,827 inoculated vaccines, which represents 0.1 adverse reactions per 1,000 administered doses.
According to Infarmed, cases reported as serious are allergic-type reactions, which depend on the individual profile of the vaccinated person.
Between 18 and 24 years of age, 310 serious and 433 non-serious reactions were recorded in 1,066,386 inoculated vaccines.
In the 50/64 year group, 1,360 serious and 2,247 non-serious reactions were reported, for a total of 3,887,195 doses, while in the 65/79 age group, 775 serious and 1,206 non-serious reactions (in 3,233,934 vaccines) were recorded and in those over 80, 363 severe and 279 non-serious reactions (1,352,978 administered vaccines).
Of the total adverse reactions, 8,434 are related to the Pfizer/BioNtech vaccine, in a total of 10,731,924 administered doses, 4,293 from Astrazeneca, in 2,202,274 inoculated doses, 1,778 from Moderna (1,901,818 doses) and 1,340 from Janssen ( 1,120,167).
For every 1,000 doses administered, one ADR was reported in the Pfizer, Moderna and Janssen vaccines, and two in AstraZeneca.
Infarmed emphasises that these data “do not allow the comparison of safety profiles between vaccines, since they were used in different population subgroups and in different periods and epidemiological contexts”.
The majority of reactions were registered in women, with 3,925 reports of serious and 6,739 non-serious cases, while in men they were, respectively, 1,688 and 2,702.
The most reported reaction is headache (3,826), followed by fever (3,820), muscle pain (3,744), pain at the injection site (3,347), fatigue (1,864), chills (1618), nausea (1,453), pain in joints (1,187), generalised pain (1,067), dizziness (960), malaise (900), pain in the extremities (830), enlarged lymph nodes (808), organ weakness (728), vomiting (716).
During the established 30-minute post-vaccination recovery period, the occurrence of any immediate allergic-type reaction is monitored. After this period, any suspicion of a severe allergic reaction should prompt immediate medical attention.