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 multi-institutional retrospective study conducted in the USA between 10 May 2021 and 20 June 2021, 25 adolescent patients (22 boys and 3 girls) aged 12−17 years were described, who developed myopericarditis after receiving COVID-19 vaccination with COVID-19-Vaccine-Pfizer-BioNTech.

All the patients received COVID-19 vaccination with COVID-19-Vaccine-Pfizer-BioNTech [Pfizer-BioNTech-Vaccine; BNT162b2; route and dosage not stated]. The vaccination was first in three patients and second in the remaining 22 patients. Only one of the 25 patients had a history of COVID-19 infection (four months prior to the vaccination); this patient tested negative prior to the vaccination. However, within a few hours to 20 days from the vaccination, all the patients developed symptoms of myopericarditis. The symptoms included chest pain, syncope, fever, nausea, tactile fever, vomiting, shortness of breath, chills, shoulder pain and neck pain.

Due to the development of myopericarditis, 22 patients required hospitalisation for 1−7 days. Three patients were managed on outpatient basis only. The patients were managed with ibuprofen, naproxen, enalapril, spironolactone, lasix, ketorolac, methylprednisolone, low-dose aspirin or immune-globulin. Subsequently, all the patients recovered completely and were discharged.

One of the three patients (who developed myopericarditis after receiving the first vaccination), received the second vaccination after complete clinical recovery of myopericarditis from the first vaccination. He again developed myopericarditis one day after the second vaccination [final outcome not stated for this patient].