The 5th Pharmacovigilance Report on COVID-19 Vaccines, prepared by the Spanish Agency for Medicines and Health Products (AEMPS) and published this Tuesday, includes the new side effects of the Pfizer and AstraZeneca vaccines that the European Medicines Agency ( EMA) has established or is under evaluation.
The new side effects of the Pfizer vaccine
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluated the following aspects of the safety of the Covid-19 vaccine.
1. Rash and pruritus: the PRAC has recommended that the data sheet and package leaflet of this vaccine be amended by adding rash and pruritus (skin itching) as uncommon adverse reactions (occurring in less than 1 in every 100 people). On the other hand, urticaria (raised, red and itchy skin rash) and angioedema (rapid swelling under the skin) should be updated as adverse reactions that occur rarely (in less than 1 in 1,000 people).
2. Localized swelling in people who have previously received injections of dermal fillers to the face: The PRAC has also concluded that this effect is likely to be related to the vaccine and will therefore be incorporated as
3. Thrombocytopenia syndrome: The PRAC is closely monitoring whether mRNA-based vaccines (Pfizer and Moderna) could also be related to the rare cases of unusual site thrombocytopenia thrombosis syndrome already identified for AstraZeneca and Janssen. Few cases have been reported so far, which in the context of people exposed to these vaccines represent a lower frequency than would occur in unvaccinated people. Furthermore, these cases do not seem to present the specific clinical pattern that has been observed in the other two adenovirus-based vaccines.
4. Myocarditis and pericarditis: A few cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) have been reported after vaccination with Pfizer’s vaccine. The analysis of these cases does not indicate for the moment that there is a relationship with these vaccines. However, the
The AEMPS points out that both thrombosis and inflammation of the heart are also being investigated among those vaccinated with Moderna.
Suspected side effects of AstraZeneca
1. Capillary Leak Syndrome: The PRAC began reviewing a signal relating to capillary leak syndrome, a disorder characterized by extravasation of fluids from the blood vessels, causing inflammation of the tissues and a sudden drop in blood pressure. Between Europe and the United Kingdom, five cases have been reported out of a total of 34 million doses of this vaccine administered.
2. Guillain-Barré Syndrome: the PRAC is regularly reviewing reported cases of Guillain-Barré Syndrome after vaccination with AstraZeneca, as it was already identified during authorization of this vaccine as a potential adverse effect that required close monitoring. This syndrome consists of an immune disorder that causes inflammation of the peripheral nerves, leading to pain, sensory disturbances, muscle weakness, and difficulty walking.
Regarding thrombosis as a side effect of AstraZeneca, the AEMPS reports that 11 cases have been reported in Spain up to April 25, three of which ended in death. In addition, they have occurred mainly among the population between 30 and 39 years of age.
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