Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Red cell distribution width normal, SARS-CoV-2 RNA undetectable, SARS-CoV-2 test negative, Specific gravity urine increased
Clinical narrative: booster; myalgia; chest pain, particularly with lying flat; EKG showed right bundle branch block; Cardiology performed a cardiac catheterization; mildly elevated left-sided filling pressures; mild anterolateral hypokinesis; suggestive of myocarditis; Increased WBC; Elevated D-dimer; Elevated LFT; Troponin 26.600; This is a spontaneous report received from a contactable reporter (Physician). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),intramuscular, administered in arm left, administration date 29Dec2021 (Lot number: FD7218) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose brand=Pfizer,, prev dose brand unknown=False, prev dose lot number=EN6205,, prev dose lot unknown=False,, prev dose administration date=16Mar2021, prev dose dose number=2), administration date: 16Mar2021, when the patient was 18 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6198,, prev dose lot unknown=False,, prev dose administration date=22Feb2021, prev dose dose_number=1), administration date: 22Feb2021, when the patient was 18 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 02Jan2022, outcome "recovering", described as "booster"; MYALGIA (hospitalization) with onset 02Jan2022, outcome "recovering", described as "myalgia"; CHEST PAIN (hospitalization) with onset 02Jan2022, outcome "recovering", described as "chest pain, particularly with lying flat"; BUNDLE BRANCH BLOCK RIGHT (hospitalization) with onset 02Jan2022, outcome "recovering", described as "EKG showed right bundle branch block"; CATHETERISATION CARDIAC (hospitalization) with onset 02Jan2022, outcome "recovering", described as "Cardiology performed a cardiac catheterization"; LEFT VENTRICULAR END-DIASTOLIC PRESSURE INCREASED (hospitalization) with onset 02Jan2022, outcome "recovering", described as "mildly elevated left-sided filling pressures"; VENTRICULAR HYPOKINESIA (hospitalization) with onset 02Jan2022, outcome "recovering", described as "mild anterolateral hypokinesis"; MYOCARDITIS (hospitalization) with onset 02Jan2022, outcome "recovering", described as "suggestive of myocarditis"; WHITE BLOOD CELL COUNT INCREASED (hospitalization) with onset 02Jan2022, outcome "recovering", described as "Increased WBC"; FIBRIN D DIMER INCREASED (hospitalization) with onset 02Jan2022, outcome "recovering", described as "Elevated D-dimer"; LIVER FUNCTION TEST INCREASED (hospitalization) with onset 02Jan2022, outcome "recovering", described as "Elevated LFT"; TROPONIN INCREASED (hospitalization) with onset 02Jan2022, outcome "recovering", described as "Troponin 26.600".   The patient was hospitalized for immunisation, myalgia, chest pain, bundle branch block right, catheterisation cardiac, left ventricular end-diastolic pressure increased, ventricular hypokinesia, myocarditis, white blood cell count increased, fibrin d dimer increased, liver function test increased, troponin increased (hospitalization duration: 1 day(s)). The events "booster", "myalgia", "chest pain, particularly with lying flat", "ekg showed right bundle branch block", "cardiology performed a cardiac catheterization", "mildly elevated left-sided filling pressures", "mild anterolateral hypokinesis", "suggestive of myocarditis", "increased wbc", "elevated d-dimer","elevated lft" and "troponin 26.600" were evaluated at the physician office visit and emergency room visit.  The patient underwent the following laboratory tests and procedures: cardiac catheterization: (02Jan2022) normal coronaries but features of, notes: Cardiac catheterization showed normal coronaries but features of some mildly elevated left-sided filling pressures and mild anterolateral hypokinesis, ejection fraction 55%, suggestive of myocarditis, and the patient was admitted for further evaluation and treatment; ejection fraction: (02Jan2022) 55 %; electrocardiogram: (02Jan2022) right bundle branch block, notes: showed right bundle branch block and Cardiology performed a cardiac catheterization; fibrin d dimer: (02Jan2022) increased; liver function test: (02Jan2022) raised; mildly elevated left-sided filling pressures: (02Jan2022) increased; SARS-CoV-2 RNA Rapid Abbott: (02Jan2022) negative, notes: Nasal Swab; troponin: (02Jan2022) 26.600; white blood cell count: (02Jan2022) increased. Therapeutic measures were taken as a result of immunisation, myalgia, chest pain, particularly with lying flat, EKG showed right bundle branch block, Cardiology performed a cardiac catheterization, mildly elevated left-sided filling pressures, mild anterolateral hypokinesis, suggestive of myocarditis, white blood cell count increased, Elevated D-dimer, Elevated LFT (liver function test), Troponin 26.600. Treatment included Tylenol 1000 mg q.6 p.r.n. (as needed), Aspirin 81 mg daily, Colcrys 0.6 mg p.o (per oral) b.i.d (twice a day) for 1 week per "C" . Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient was covid tested post vaccination. Clinical course There is no history of any fever, rigors or chills. No history of headache, loss of consciousness, seizures. The troponins were elevated. ASSESSMENT: Chest pain, status post cardiac catheterization showing normal coronaries and possibly myocarditis with mild anterolateral hypokinesis. Recent COVID-19 booster vaccination, Pfizer.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.