The Spanish Medicines Agency has updated the information regarding vaccines authorized by the EU against Covid-19. On this occasion, the latest pharmacovigilance report, published on January 16, 19, includes new adverse reactions related to the administration of Comirnaty (Pfizer) and Vaxzevria (AstraZeneca) vaccines.
After collecting all notifications received until June 18, 2022the European Pharmacovigilance Committee (PRAC) concludes in the document that “there is at least a reasonable possibility of a causal relationship with this adverse reaction.”
The new side effect of the Pfizer vaccine
From its authorization until November 13, 2022, about 685 million doses of Comirnaty (Pfizer). In addition, about 16.1 million doses of bivalent Comirnaty vaccines (original/omicron BA.4-5) have been inoculated.
Regarding the secondary effects derived from the vaccine, there have been a total of 44,280 notifications after receiving the original Comirnaty. Of these, the majority correspond to women (73%) and people between 18 and 65 years of age (82%).
To the “adverse events” detected in the previous Pharmacovigilance report, Health now adds dizziness. The PRAC clarifies that this reaction is “rare” and in most cases it appears within 24 hours after vaccination.
The most common side effects of the Pfizer (Comirnaty) vaccine
The ten most reported adverse events after receiving the vaccine Comirnaty original are the following:
- Pirexia
- headache
- Myalgia
- Pain in the vaccination area
- Discomfort
- Fatigue
- lymphadenopathy
- nausea
- Shaking chills
- Asthenia
Likewise, the ten most reported adverse events after receiving the vaccine Comirnaty bivalent son:
- Pirexia
- Discomfort
- Myalgia
- headache
- Pain in the vaccination area
- Tos
- vomiting
- Diarrhea
- Asthenia
- Fatigue
The new side effect of the AstraZeneca vaccine
The Health report also updates the pharmacovigilance data on the Vaxzevria (Astrazeneca) vaccine since the previous report.
From the time it was authorized to be marketed in the EU until November 13, 2022, se have been administered in about 68.8 million doses of Vaxzevria in adults. In addition, this latest evaluation includes a new adverse reaction related to the administration of the vaccine: cutaneous vasculitis.
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It is a inflammation of the blood vessels in the skinoften manifested as a skin rash or as small, flat, round red or purplish spots under the surface of the skin, or bruises.
