Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocardial necrosis marker, Pericarditis, SARS-CoV-2 test, Troponin
Clinical narrative: Pericarditis given the lack of troponin or other MI markers; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 09:00 (Lot number: EWOM) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "Waldenstroms Macroglobulinemia" (unspecified if ongoing), notes: Waldenstroms Macroglobulinemia; "Hyperlipidemia" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Permanant Pacemaker for Sick Sinus Syndrome" (unspecified if ongoing), notes: Permanent Pacemaker for Sick Sinus Syndrome; "BPH" (unspecified if ongoing); "Permanant Pacemaker for Sick Sinus Syndrome" (unspecified if ongoing), notes: Permanent Pacemaker for Sick Sinus Syndrome. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev dose Product: COVID 19, Brand: Pfizer, Lot number: EJ1686, Vaccine location: Left arm, Dose 2), administration date: 13Jan2021, when the patient was 67 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose Product: COVID 19, Brand: Pfizer, Lot number: EL0140, time: 09:00 Am, location: Left arm, Dose 1), administration date: 23Dec2020, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 16Sep2021 07:30, outcome "recovered" (2022), described as "Pericarditis given the lack of troponin or other MI markers". The patient was hospitalized for pericarditis (start date: Sep2021, discharge date: Sep2021, hospitalization duration: 5 day(s)). The event "pericarditis given the lack of troponin or other mi markers" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (2021) st elevation, notes: Without reciprocal changes; myocardial necrosis marker: (unspecified date) lack of troponin or other mi markers; sars-cov-2 test: (unspecified date) unknown results, notes: Since the vaccination, has the patient been tested for COVID-19?: Yes; troponin: (unspecified date) lack of troponin or other mi markers. Therapeutic measures were taken as a result of pericarditis. On 16Sep2021 the patient awoke with retrosternal and left sided chest pain. The patient was seen at his physician, Dr. withheld who performed an EKG which showed ST elevation without reciprocal changes. The patient was admitted to withheld Hospital with a diagnosis of pericarditis given the lack of troponin or other MI markers. The patient was discharged on colchicine 0.6 mg bid.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event Pericarditis cannot be excluded.  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