September 17, 2021

The Tampa Herald

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The EMA considers facial swelling a side effect of the Pfizer vaccine in some cases

2 min read

European Medicines Agency (EMA) concluded an investigation of several cases of facial swelling after vaccination with Pfizer / BioNTech in people with a history of dermal filler treatments and considered that there is “at least a reasonable possibility” that it is a side effect of the vaccine.

According to the conclusions reached by the safety committee (PRAC), facial swelling in people with a history of injections with dermal fillers should be included in the package insert as a possible side effect of the Pfizer COVID-19 vaccine, although it maintained that the balance between benefit and risk of the drug remains positive and remains unchanged.

Mass vaccination campaigns have brought to light that several people vaccinated with Comirnaty, the commercial name of the preparation, developed this facial reaction, as reflected in all the available evidence and the details that accompany the cases reported in the European database. for suspected side effects, EudraVigilance.

This was not one of Pfizer’s adverse effects detected during clinical trials in volunteers who were injected with the preparation, which was only done in a limited number of people.

“The PRAC considered that there is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers, soft gel-like substances that are injected under the skin” , stresses the agency.

This side effect does not extend to the rest of the population that does not meet this background profile for dermal fillers.

One in four people vaccinated with Pfizer experience mild systemic (not puncture site) side effects, especially headache and fatigue, which peak within the first twenty-four hours and usually last between one and two days, according to a study by King’s College London.

Since the start of the vaccination campaigns in late 2020, the most frequent effects included chills and tremors, diarrhea, fever, arthralgia (joint pain), myalgia and nausea, while at the injection site were pain, swelling, tenderness, redness, itching, warmth, and swelling of the axillary glands.

 

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