Spain: 69 adverse reactions per 100,000 doses of COVID vaccines

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In Spain, 55,455 cases of adverse reactions to vaccines against COVID-19 have been reported after the administration of 80 million doses, which corresponds to 69 notifications per 100,000 injected doses, 0.069%.

The adverse effects of vaccines are one of the concerns that some people are not taking the step to get vaccinated against COVID-19. However, the Spanish Agency for Medicines and Health Products (AEMPS) has released the 12th Pharmacovigilance Report on COVID-19 Vaccines in which it states that as of January 9, 2022, a total of 55,455 notifications of events have been registered. side effects, a small figure considering that some 80,109,445 doses of these drugs have been administered.

In this way, a reassuring figure is obtained: only 0.069% of the doses of vaccine administered have produced adverse effects or, what is the same, 69 notifications have been registered for every 100,000 doses injected. Of these more than 55,000 cases, in 44,407 the most frequent manifestations were fever (33%) and pain at the puncture site (13%), headache (23%), muscle pain (17%), or fatigue (8%). .

The rest of the notifications –11,048– reported serious side effects, understood as hospital admission, significant or persistent disability, congenital malformation, or a health problem that puts the patient’s life at risk or is fatal. Of these cases, the death of the affected person occurred in 375, although the AEMPS warns that “these events cannot be considered related to the vaccines by the mere fact of being notified.”

On the other hand, and for the first time, paresthesia – a sensitivity disorder that causes abnormal sensations without a previous stimulus, such as tingling – has been included as a rare adverse effect derived from the administration of the Spikevax vaccine (Moderna). However, it seems to be a fairly rare effect, in Spain, until January 9, 2022, 158 cases of paresthesia were reported after injection with this vaccine, a very low figure considering that up to that date about 14 .2 million doses in the country. Globally, data from June 2021 indicates 1,425 cases of paresthesia after receiving Spikevax, with more than 180 million administered worldwide.

74% of adverse effects of vaccines occur in women

The report indicates that most of the adverse effects occur in women, specifically 74% of the total, and especially in the group between 18 and 65 years, where almost 87% of all those affected are found. It is noteworthy that in the age group of those over 65 years of age, the cases of women also far exceed those of men, being practically double (3,634 in women compared to 1,812 in men).

“Vaccination does not reduce deaths from causes other than COVID-19, […] it is expected that deaths for other different reasons will continue to occur”

“In the vast majority of reported cases in which there is information on medical history and concomitant medication, death can be explained by the patient’s previous clinical situation and other treatments he was taking, and the causes of death are diverse, without presenting a homogeneous pattern. For this reason, the AEMPS asks that these data not be generalized, assuming that the deaths are a direct consequence of the vaccines.

In addition, they add that “vaccination does not reduce deaths from causes other than COVID-19, so during the vaccination campaign it is expected that deaths from other different reasons will continue to occur, sometimes in close temporal association with the administration of the vaccine, without this being related to the fact of having been vaccinated”.

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