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Health includes cerebral venous sinus thrombosis without thrombocytopenia in the AstraZeneca vaccine file

A new side effect detected after inoculation with the Vaxzevria vaccine (AstraZeneca), and which was under surveillance, has finally been included in the leaflet and technical information sheet of this prophylaxis as one of its possible adverse reactions. This is cerebral venous sinus thrombosis without thrombocytopenia, which is added to another side effect, cerebral venous sinus thrombosis with thrombocytopenia, already known for Vaxzevria. In this type of thrombus, thrombocytopenia (a condition in which the body has few platelets) is not adequately detected or the number of platelets decreases but without reaching the range of thrombocytopenia.

As of September 30, 2021, a total of 458 cases of cerebral venous sinus thrombosis without thrombocytopenia after vaccination with Vaxzevria had been recorded worldwide, of which 293 were confirmed by a healthcare professional and 33 occurred after receiving the vaccine. second dose of this vaccine. The majority of these cases occurred within the first four weeks after vaccination and some ended with a fatal outcome, notes the Spanish Agency for Medicines and Health Products (Aemps) in the tenth pharmacovigilance report on Covid vaccines published on the 24th. of November.

In Spain, as of November 14, 2021, there have been 20 reports of cerebral venous sinus thrombosis without thrombocytopenia after the administration of Vaxzevria. In 15 of them the patient had recovered or was recovering at the time of notification; in one he had not recovered and in four the Aemps indicates that the outcome is unknown. As of that date, nearly 9.8 million doses of the AstraZeneca vaccine had been administered.

Cerebral venous sinus thrombosis is a thrombus or blood clot that prevents or hinders blood circulation located in the venous system of the brain, hence its name. The most common symptom is headache, different from a usual headache that usually worsens when lying down and does not improve with analgesics, although others may occur such as focal deficits, loss of strength or sustained sensitivity, alteration of gait or alteration of language. or speech, confusional episodes or loss of vision. It can also cause vomiting, even epileptic seizures, or cervical stiffness.

Multisystem inflammatory syndrome

Unlike the previous one, the tenth Aemps Covid pharmacovigilance report specifies that “there is not sufficient evidence of a possible causal relationship” between the administration of the Comirnaty (Pfizer), Spikevax (Moderna) and Vaxzevria (AstraZeneca) vaccines and the reported cases of multisystem inflammatory syndrome (MIS). For this reason, for the moment, the relationship between the appearance of this serious inflammatory process, which affects various parts of the body, and the injections against Covid is ruled out.

It finds that only a few of the reported cases met the diagnostic criteria and suggests that, in the majority, important information was missing to establish the correct diagnosis, such as laboratory data on markers of inflammation, measures of disease activity , duration of fever or other information that would allow other alternative causes to be excluded, such as Covid-19 infection itself.

However, this syndrome will continue to be monitored to take appropriate measures if necessary.