Covid-19-vaccine-pfizer-biontech

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

In a study involving 4 men aged 21−38 years, treated against Covid-19 since 1 September 2021 were described, who developed myocarditis following booster Covid-19-vaccine-pfizer-biontech [route and dosage not stated].

The patients, who had received third dose of vaccination with Covid-19-vaccine-pfizer-biontech, presented to the emergency department in view of fever and weakness, dyspnoea and fatigue, which then developed into chest pain within 2−11 days post vaccination. Out of four, 3 patients had underlying comorbidities including untreated hyperlipidaemia, 2 episodes of peri-myocarditis associated with presumed acute viral gastroenteritis or bilateral feet hyperkeratosis as well as mutation in keratin 16-gene. Three out of 4 patients had received earlier 2 doses of vaccination uneventfully, except a man, who had developed flu-like reaction upon second dose. Upon admission to the hospital, ECG of 2 patients out of four revealed ST-segment elevation in II, III and AVF or V1 to V2, along with an elevation in troponin levels in all patients. An echocardiogram showed reduced left ventricular ejection fraction among 2 patients. All patients underwent cardiac magnetic resonance (CMR), which confirmed presence of myocardial inflammation. Therefore, all 4 patients were diagnosed with myocarditis following thirst booster dose of Covid-19-vaccine-pfizer-biontech [time to reaction onset not stated].

Subsequently, the troponin levels decreased in all patients, along with resolution of symptoms. Therefore, all patients were discharged within several days post admission.