Facial swelling and myocarditis, new vaccine warning

The EMA (Prac) Pharmacovigilance Committee is evaluating some other studies Side effects It may be related to the Covid vaccination.

Swelling of the face

After reviewing all available evidence, including cases reported to the European Database of Suspected Side Effects (EudraVigilance) and data from the scientific literatureThe press release stated that the Medicines Control Committee believes it is in place“At least a reasonable possibility there is a causal relationship between the Commernate vaccine.”This is the serum you’re producing Pfizer, And all of those “Cases of facial swelling reported in people with a history of filler injection”.

A new side effect appears after the BRAC meeting, which will be included in the list already established by the EMA. Facial swelling in people with a history of filler injection should be listed as a side effect in Section 4.8 of the Summary of Product Characteristics (SmPC) and Section 4 of the Patient Information Leaflet (GDP).. However, according to the committee, it should remain the same “Balance the benefits and risks of the vaccine”.

Cases of myocarditis

However, this is not the only side effect that has been carefully evaluated in recent days, given that several cases of myocarditis have also been reported following Covid vaccinations with mRna. Previously IsraelIn late April, the alarm sounded about cases of carditis among vaccinated people PfizerA condition that occurs more frequently in men younger than 30 years of age and generally in people given both doses. The condition often has no specific symptoms and can heal on its own, but in some patients it can cause more serious problems including heart failure or a weak heart.

Emma is aware of cases of myocarditis and pericarditis.We read the BRAC report.“It was reported mainly after vaccination with Kommernate.”, Or the Pfizer serum that has already aroused suspicion in Israel. “At the moment, there are no indications that these cases are due to the vaccine.”But the committee asked Pfizer “Provide more detailed data, including an analysis of events based on age and gender, in the context of the next safety report. It will consider if any other regulatory action is needed.”. The same requests have also been sent to modern For mRna serum: Prac asks that such cases be monitored and “Provide a detailed analysis of events in the context of the next safety report.”.

Syndrome de Jean-Barre

And that’s not all, since switching to a serum this time AstraZenecaWhere more than one alert has been triggered, cases of Guillain-Barré syndrome are being investigated after vaccination with a vaccine against Covid Vaxzevria. It is a serious immune system disorder that causes inflammation of the nerves and causes pain, numbness, muscle weakness, and serious difficulty walking. The PRAC will evaluate Data provided by the marketing authorization holder. Syndrome de Jean-Barre “Identified during the Millennium Ecosystem Assessment process as a potential adverse event requiring specific monitoring activities. The Risk Assessment Advisory Committee requested the Ministry of Public Health to provide more detailed data, including an analysis of all reported cases, as part of the next safety report.”, The committee explained in the official note.