10th Pharmacovigilance Report on Covid-19 Vaccines, from the Spanish Agency for Medicines and Health Products (AEMPS) points out that there are several adverse reactions of the Pfizer and Moderna vaccines that are still under surveillance.
Myocarditis and pericarditis
The myocarditis and pericarditis they are inflammations of the heart muscle or the pericardium, and their symptoms are varied, although the most frequent are shortness of breath, palpitations that can be accompanied by irregular heart rhythm, and chest pain. These two entities are adverse reactions already identified and described in the Pfizer and Moderna vaccine label and package insert.
In Spain, until November 14, 2021, a total of 79 notifications have been registered after the administration of Modern, with more than nine million doses administered. Most of the cases occurred in men (90%), after the second dose (65%) and in the first week after receiving the vaccine (78%), being more frequent in young ages; the reported rate is estimated at 1.4 cases per 100,000 doses administered in children under 40 years of age. All patients recovered or were recovering at the time of notification.
In the case of Pfizer, 221 notifications of myocarditis and / or pericarditis were registered in Spain in the same period. Most were mild and also predominantly male, however, three patients had a fatal outcome, two of them, older than 60 years. Thus, the PRAC continues to assess these risks and will take appropriate measures if necessary.
Multisystemic inflammatory syndrome
Multisystemic inflammatory syndrome (SIM) is a rare and serious condition that affects various parts of the body, with symptoms such as tiredness, severe and persistent fever, diarrhea, vomiting, stomach and chest pain, headache, and shortness of breath.
The PRAC has concluded that there is insufficient evidence of a possible causal relationship between the administration of the Pfizer and Moderna vaccine and multisystem inflammatory syndrome (SIM). Of the reported cases, only a few met the diagnostic criteria for SIM and in the majority important information was lacking to establish the correct diagnosis, such as laboratory data on inflammation markers, measures of disease activity, duration of disease. fever or other information that would make it possible to exclude other alternative causes, such as the COVID-19 infection itself.
Despite this conclusion, the PRAC will continue to be closely monitored and appropriate action will be taken if necessary.
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