Notifications of myocarditis and pericarditis following administration of COVID-19 vaccines


• In Spain, a case of acute myocarditis in a 39-year-old man was reported after administration of the second
dose of the BNT162b2 vaccine, 21 days after the first dose. The individual had a history of bronchial
asthma, autoimmune hypothyroidism, chronic atrophic gastritis, an isolated episode of spontaneous
recurrent atrial fibrillation, and pneumothorax with left apical segmentectomy (1). Several cases of
myocarditis caused by COVID-19 have been published. However, acute infection was ruled out in this
patient. Case reports provide little evidence of a causal association.

• Because COVID-19-associated myocarditis and pericarditis could show a possible vaccine safety signal, a
rapid disproportionality analysis was performed, based on global data from the Individual Case Safety
Report (ICSR) database for drug monitoring (VigiBase), seeking possible links between myocarditis or
pericarditis and COVID-19 vaccines. The odds ratios (OR) were calculated as a disproportionality measure
for the two authorized mRNA vaccines (BNT162b2 and MRNA-1273) and for two most widely used “nonmRNA”
vaccines (AZD1222; ChAdOx1 and JNJ-78436735; and Ad26.COV2- S). The results are shown in
Table 1.

• Greater disproportionality was found between the BNT162b2 and mRNA-1273 vaccines and pericarditis.
Similarly, greater disproportionality was found between the mRNA-1273 vaccine and myocarditis.
BNT162b2 also showed increased disproportionality with myocarditis, but not reaching the threshold of
statistical significance.

• No greater disproportionality was found between pericarditis or myocarditis and “non-mRNA” vaccines
(AZD1222/ChAdOx1 and JNJ-78436735/Ad26.COV2).

• However, there are limitations with this type of analysis. Risk is not being evaluated; rather,
disproportionate reporting of myocarditis and pericarditis following administration of these vaccines.
Monitoring and evaluation should therefore be continued in order to establish any association.

* No ICSR reports were found for the Janssen vaccine (JNJ-78436735; Ad26.COV2-S) and myocarditis or pericarditis.
Reference: (1) García JB, Ortega PP, Antonio Bonilla Fernández J, León AC, Burgos LR, Dorta EC. [Acute myocarditis
following administration of the BNT162b2 COVID-19 vaccine]. Rev Esp Cardiol. 2021 Mar 20. Spanish. doi:



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