Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Myocardial fibrosis, Myocarditis, Troponin, Troponin increased
Clinical narrative: Myocarditis; Anytime the patient exercises and the heart rate increases, patient experiences pain in the heart. It is not sedentary angina. It is exercise induced angina; heart scarring that has gone on. It is not just a recovery; Reporter did not give a lab value for the Troponin levels. Reporter Troponin levels were elevated; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; ANGINA PECTORIS (medically significant), outcome "unknown", described as "Anytime the patient exercises and the heart rate increases, patient experiences pain in the heart. It is not sedentary angina. It is exercise induced angina"; MYOCARDIAL FIBROSIS (non-serious), outcome "unknown", described as "heart scarring that has gone on. It is not just a recovery"; TROPONIN INCREASED (non-serious), outcome "recovered", described as "Reporter did not give a lab value for the Troponin levels. Reporter Troponin levels were elevated". The patient underwent the following laboratory tests and procedures: troponin: elevated, notes: Troponin levels were elevated so he knew patient had myocarditis; normal, notes: after time Troponin levels were tested and it had gone back to normal. notes: after time Troponin levels were tested and it had gone back to normal. Clinical information: Patient experienced Myocarditis. Per Reporter, Patient has recovered, the Troponin levels returned to normal, but patient is still experiencing angina so it is obvious that is indicative of heart scarring that has gone on. It is not just a recovery. Reporter did not specify if the other patient received the COVID-19 Vaccine by Pfizer or Moderna, it was just mentioned the vaccine was specifically MRNA. No further details were given to the caller about this second patient. Caller got the feeling the second patient also experienced myocarditis based off of his conversation with the Reporter, but he can't say for sure so he will list the specific adverse reaction as unknown.Caller's assumption is this is an older child, maybe a young adult, but caller cannot say for sure. He talked about hospitalizations. Caller can't remember if the patient was hospitalized. It seems the patient had a possible, short hospital admission, but caller doesn't know for certain.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Myocarditis, Angina Pectoris, Myocardial Fibrosis and Troponin Increased and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessd once further 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 RAs, Ethics Committees, and Investigators, as appropriate.