Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: myocarditis; low-grade fever; body aches; ASSESSMENT OF RISK FACTORS FOR MYOCARDITIS IN THE COUNTRY USING ELECTRONIC HEALTH RECORDS AND CLAIMS DATA  This is a non-interventional study report received from contactable reporter(s) (Other HCP) for protocol.  An 18-year-old male patient received BNT162b2 (BNT162B2), on 30May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 31May2021, outcome "unknown", described as "body aches "; PYREXIA (non-serious) with onset 31May2021, outcome "unknown", described as "low-grade fever"; MYOCARDITIS (hospitalization) with onset 01Jun2021, outcome "unknown". Patient was in his usual state of health until Monday 31May2021 when he reported a low-grade fever and body aches following his second dose of the Pfizer Covid Vaccine which he received on Sunday 30May2021. On Tuesday 01Jun2021 patient awoke with stuttering substernal chest pressure. Patient was admitted with substernal chest pressure 2 days after receiving the second dose of the Pfizer Covid vaccine. EKG showed diffuse ST elevation with PR depression, consistent with pericarditis / myocarditis. The patient was tested for COVID-19 and the result was negative. Patient was admitted for further evaluation and treatment of myocarditis in the setting of recent Covid-19 vaccination. Cardiac catheterization was deferred. Echocardiogram did not identify effusion or wall motion abnormality. Troponin peaked at 19, ESR / CRP were also mildly elevated. Patient became pain free after PO colchicine. Patient was discharged home and will follow up in cardiology. He takes no regular prescription medications. Final discharge diagnosis chest pain due to post-COVID vaccination myocarditis confirmed on cardiac MRI which showed mild epicardial delayed gadolinium enhancement suggestive of myocarditis. The patient underwent the following laboratory tests and procedures: C-reactive protein: (03Jun2021) 33.8, notes: elevated; Echocardiogram: (unspecified date) did not identify effusion, notes: or wall motion abnormality; Electrocardiogram: (unspecified date) diffuse ST elevation with PR depression, notes: consistent with pericarditis / myocarditis; Magnetic resonance imaging heart: (06Jun2021) mild epicardial delayed gadolinium enhancement, notes: suggestive of myocarditis; Red blood cell sedimentation rate: (03Jun2021) 28, notes: elevated; SARS-CoV-2 test: (unspecified date) negative; Troponin: (03Jun2021) 19.07, notes: elevated. Therapeutic measures were taken as a result of myocarditis.  The investigator considered there was a reasonable possibility that the event was related to study drug, but unrelated to concomitant drug. The reporter's assessment of the causal relationship of "low-grade fever" and "body aches " with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No Follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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.