Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Malaise
Clinical narrative: Myocarditis; Seizure/the worst generalized tonic-clonic seizure; had a fever of 103.6 degree F; tachycardia; hypotension; troponins kept rising; vomiting; This is a spontaneous report from a contactable physician. A 12-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) (at the age of 12-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included longstanding history of developmental delay/ autism since birth, as well as a seizure disorder and epilepsy. The patient's concomitant medications were not reported. Prior vaccination was unknown. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) (at the age of 12-years-old) as 1st dose, single for COVID-19 immunization and experienced seizure on 16May2021 and treated at home and recovered on an unspecified date. The next morning (06Jun2021) he had seizure, "the worst generalized tonic-clonic seizure" which his mom had witnessed. He seized for almost 30 min, during which time the parents called emergency medical services (EMS) and he was brought to the emergency department (ED). He had a fever of 103.6 degree F, tachycardia and hypotension. His seizures were controlled (w/ Depakote?) but his troponins kept rising and he was transferred to hospital. He experienced vomiting, received IVF. A cardiac echocardiogram (ECHO) was performed. Troponins still rose and he was diagnosed presumptively with myocarditis. He was discharged home 06Jun2021 and would follow-up with Cards for another ECHO. The events resulted in emergency room visit and hospitalization. Lab test included body temperature on an unspecified date: 103.6 degree F, ECHO on an unspecified date: unknown result, troponins on an unspecified date: kept rising and troponins on an unspecified date: still rose. The outcome of events, seizure and myocarditis was recovering and the outcome of other events, had a fever of 103.6 degree F, tachycardia, hypotension, troponins kept rising and vomiting was unknown.   Information on lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the myocarditis, seizure and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, echocardiogram, EEG and head CT/MRI,  treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021559766 same patient/drug, different dose/AE (1st dose)