Sex: M
Vaccine: COVID19
Symptoms: Rash, Troponin, Viral test
Clinical narrative: myocarditis; rash on palms; ASSESSMENT OF RISK FACTORS FOR MYOCARDITIS USING ELECTRONIC HEALTH RECORDS AND CLAIMS DATA  This is a non-interventional study report received from contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), on 13Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Viral myocarditis panel negative except for COVID IgG showing past COVID infection Date UNKNOWN. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunization. The following information was reported: MYOCARDITIS (hospitalization) with onset 14Jun2021, outcome "unknown"; RASH (non-serious) with onset 22Jun2021, outcome "unknown", described as "rash on palms". The patient underwent the following laboratory tests and procedures: Computerised tomogram thorax: (unspecified date) normal; Echocardiogram: (unspecified date) normal; Electrocardiogram: (unspecified date) diffuse ST segment elevation in multiple leads; (unspecified date) improvement of ST elevation.; (15Jun2021) EKG showed diffuse ST segement elevation elevation, notes: in multiple leads; Magnetic resonance imaging heart: (unspecified date) Cardiac MRI consistent with myocarditis EF 53%; Troponin: (unspecified date) 16.2, notes: Peak; (15Jun2021) 14.6, notes: elevated; Viral test: (unspecified date) negative except for COVID IgG, notes: showing past COVID infection making differential for myocarditis COVID / MIS-C vs vaccine-related myocarditis questionable. Therapeutic measures were taken as a result of myocarditis. Clinical course: Patient presented on 15Jun2021 complaining of aching in his chest. He had a Pfizer Covid vaccine (13Jun2021) 2 days prior and was achey and tired that night and the following morning (14Jun2021) he developed chest pain. ECG on admission documented diffuse ST segment elevation in multiple leads. Chest CT Angio normal. Patient was transferred to ICU for further work-up management of myocarditis. Patient did receive his second COVID vaccine 2 days prior to symptom onset so this was concerning for possible cause. Troponin-I was 14.6 on admission; peaked at 16.2. Echo was normal. Cardiac MRI consistent with myocarditis; with an EF 53 % . He was given dose of IVIG x 1 and started on Ibuprofen. Viral myocarditis panel negative except for COVID IgG showing past COVID infection making differential for myocarditis COVID / MIS-C vs vaccine-related myocarditis questionable. Discharge EKG showed improvement of ST elevation. He developed a new rash on palms one day following discharge - which was felt could be related to recent COVID vaccine (or potentially the IVIG infusion). Discharge diagnosis Myocarditis - Patient is a previously healthy male discharged over weekend following treatment for myocarditis secondary to COVID vaccine vs COVID MIS-C. Patient's Race and Patient's Ethnicity was unknown. Concomitant Drugs unknown. The investigator considered there was a reasonable possibility that the events was related to Pfizer Covid-19 vaccine 2nd dose, unrelated to concomitant drugs.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new 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.