Vaccination advances in Spain and there are already 36% of the population with the two doses, while the percentage who have received at least one puncture is 52.7%. The older age groups are completing their vaccination guidelines and it is a matter of time before only Moderna Pfizer vaccines can be used, as AstraZeneca and Janssen are recommended for people over 60 and 40 years old respectively.
The effects of the two messenger RNA vaccines are constantly being analyzed by the European Pharmacovigilance Committee (PRAC) of the European Medicines Agency and by its Spanish counterpart, the AEMPS. In its penultimate report, this body has included new adverse effects from reports of those vaccinated.
Specific, there have been 24,491 notifications of adverse events, “which would correspond to 93 notifications for every 100,000 doses administered”. However, the AEMPS advises that communicating these events does not imply “that they are related to vaccination.” Some symptoms, on the other hand, are being included as new effects of the vaccine.
New Pfizer Effects
In the May report, the AEMPS indicated that possible adverse reactions related to this vaccine had been included in the technical data sheet and the package leaflet. Specifically, it includes the skin rash and itching (itchy skin) in less than 1 in 100 people, while the urticaria is included with rare frequency as is angioedema (rapid inflammation under the skin) in less than 1 in 1,000 people.
In addition, the possible appearance of localized swelling in people who had received filler injections in the face prior to the vaccine.
New Modern Effects
As for Moderna’s vaccine, the 6th Pharmacovigilance Report reports that Moderna’s vaccine has included new side effects. Specifically, the diarrhea “As a new adverse reaction” of this vaccine and that “will be included in the technical sheet and leaflet thereof.”
Likewise, cases of “delayed” reactions in the puncture area, a symptom that will also be included in its technical data sheet and leaflet. Of these reactions, the AEMPS says that “They can appear several days after receiving the vaccine and should not be confused with cellulitis.”
By last, the PRAC is evaluating cases of immune thrombocytopenia, that is, these thrombi that lead to bruising and bleeding due to the low level of platelets in the blood. The AEMPS indicates that the PRAC has requested “additional data from the marketing authorization holder laboratory to continue with this evaluation”.
Myocarditis and pericarditis
The PRAC is analyzing cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane that surrounds the heart) after similar cases were reported in Israel following the administration of the second dose of Pfizer, most of them mild, in men under 30 years of age and resolved within a few days.
In Europe, there have been cases, but, according to the AEMPS, still “it cannot be established that there is a causal relationship between the appearance of myocarditis or pericarditis and vaccination”, which is why “the evaluation is ongoing and will include new data that will be available soon.”
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