What is the clinical evidence from this study?

Study design: Case Report. Population: Acute myocarditis (n=1). Intervention: BNT162b2 (Comirnaty) mRNA Covid-19 vaccine. Primary outcome: Diagnosis of acute myocarditis.

August 1, 2021Open Access

Acute myocarditis following Comirnaty vaccination in a healthy man with previous SARS-CoV-2 infection

Key Result

A 56-year-old man with previous mild SARS-CoV-2 infection developed self-limiting acute myocarditis 4 days after receiving his first dose of the BNT162b2 mRNA Covid-19 vaccine.

Study Design

Type

Case Report (n=1)

Multicenter

Structured PICO

Does the BNT162b2 mRNA Covid-19 vaccine cause acute myocarditis in a healthy man with previous SARS-CoV-2 infection?

Population

56-year-old man with no prior medical history except a mild Covid-19 infection 4 months earlier

Intervention

First dose of BNT162b2 (Pfizer-BioNTech) mRNA Covid-19 vaccine

Outcome

Acute myocarditissafety

This case report highlights a rare instance of self-limiting acute myocarditis following the first dose of the BNT162b2 mRNA Covid-19 vaccine in a patient with prior SARS-CoV-2 infection.

Limitations

Clinical trials enrolled not enough people to observe this rare adverse event
Mild forms of acute myocarditis may cause non-specific symptoms leading to under-diagnosis
Under-use of Cardiovascular Magnetic Resonance in MINOCA patients
Under-reporting phenomena in post-marketing surveillance

Abstract

Myopericarditis following mRNA Covid-19 vaccination has recently been reported to health authorities in a lot of countries. They can occur in very rare cases after either the Moderna (mRNA-1273 - Spikevax) or Pfizer-BioNTech (BNT162b2 - Comirnaty) vaccination. Cases predominately occur in younger adult men within 14 days following the second dose. In this article, we present a 56 year-old man with no prior medical history, whit the exception of a mild Covid-19 infection 4 months earlier, who experienced an episode of acute epigastric pain, profuse sweating, tachycardia, hypotension 4 days after the first dose of BNT162b2 vaccine. Troponin I level was elevated. Chest X-ray, electrocardiogram, echocardiogram, coronary angiography didn't show significant abnormalities. Cardiac Magnetic Resonance showed a pattern of acute myocarditis. The condition appeared to be self-limited and the patient recovered without specific therapy. No report of acute myocarditis was observed in the BNT162b2 and mRNA-1273 trials and very rare cases, in comparison to given doses, have been reported to pharmacovigilance systems worldwide. Further surveillance and evaluation of this side effect are warranted to establish the correct balance of benefits and risks of Covid-19 mRNA vaccines, above all in children and younger people (categories with the higher reactogenicity and the lower risk of Covid-19 complications). At the present time the benefits of Covid-19 vaccination significantly exceed possible risks.

اسأل الذكاء الاصطناعي

Bookmark

View Full Paper