A European Medicines Agency (EMA) concluded that people who have had capillary transudation syndrome (CLS) should not be vaccinated with Vaxzevria (AstraZeneca vaccine). The European regulator defends that this syndrome should be added to the package leaflet as a new undesirable effect of the vaccine.
In a statement released on Friday, Infarmed revealed that the European Medicines Agency has carried out an in-depth analysis of six cases of CLS in people who have been vaccinated with AstraZeneca. Most of these cases occurred in women and up to four days after vaccination. Three of these cases had a history of the syndrome and one of the cases had, in fact, “a fatal outcome”.
The Portuguese regulator details that the capillary transudation syndrome “it is a very rare but serious disease, characterized by leakage of fluid from small blood vessels (capillaries) to surrounding tissues, resulting in edema, mainly in the arms and legs, drop in blood pressure, blood thickening and decreased albumin levels “.
Health professionals should therefore be “aware of the signs and symptoms of CLS and the risk of recurrence in people who have been previously diagnosed with this disease”.
People who have been given this immunizing agent should seek immediate medical assistance if they have “sudden swelling of the arms and legs or sudden weight gain in the days following vaccination. These symptoms are often associated with feeling faint (low blood pressure)”.
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) asked AstraZeneca for additional information on a possible mechanism for the development of this disease after vaccination.
To health professionals, Infarmed explains that patients with an “acute episode of CLS after vaccination require immediate treatment and may need specialized monitoring and intensive supportive care.”
To the general public, Infarmed guarantees that “a very small number of cases of capillary transudation syndrome in people vaccinated with Vaxzevria” and warns that, “if you have previously had CLS, you should not take this vaccine”.
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