Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Left ventricular failure, Malaise, Myocardial infarction, Myocardial necrosis marker, Myocardial necrosis marker increased
Clinical narrative: BNP (Brain natriuretic peptide)blood lab above 1100; cardiac enzymes elevated; Stage 3 systolic heart failure; rhythm issues/Cardiac dysrhythmias; pulmonary edema; not feeling well; chest pain; shortness of breath; Congestive heart failure; heart attack; heart failure; myocarditis; cardiomyopathy; Coughing; Dizzy; Tired; pain; The initial case was missing the following minimum criteria: (Unspecified product). Upon receipt of follow-up information on [21Nov2023], this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse). The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), on 24Jul2021 at 13:30 as dose 2, single (Batch/Lot number: unknown, Expiration Date: 30Oct2021) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2016 (ongoing); "Obesity" (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus, start date: 2018 (ongoing). Vaccination history included: bnt162b2 (Dose 1, single, Lot Number: EW0151, Anatomical location: Left arm, Time: 13:00), administration date: 30Jun2021, for COVID-19 Immunization. The following information was reported: CARDIOMYOPATHY (hospitalization, disability, medically significant) with onset Aug2021, outcome "not recovered"; CARDIAC FAILURE (hospitalization, disability, medically significant) with onset Aug2021, outcome "not recovered", described as "heart failure"; MYOCARDITIS (hospitalization, disability, medically significant) with onset Aug2021, outcome "not recovered"; MYOCARDIAL INFARCTION (hospitalization, disability, medically significant) with onset Jan2022, outcome "not recovered", described as "heart attack"; CARDIAC FAILURE CONGESTIVE (hospitalization, disability, medically significant) with onset May2022, outcome "unknown", described as "Congestive heart failure"; CHEST PAIN (hospitalization, disability) with onset May2022, outcome "not recovered"; DYSPNOEA (hospitalization, disability) with onset May2022, outcome "not recovered", described as "shortness of breath"; PAIN (disability) with onset 2023, outcome "unknown"; MYOCARDIAL NECROSIS MARKER INCREASED (hospitalization, disability, medically significant) with onset 30Oct2023, outcome "unknown", described as "cardiac enzymes elevated"; MALAISE (hospitalization, disability) with onset 30Oct2023, outcome "unknown", described as "not feeling well"; PULMONARY OEDEMA (hospitalization, disability, medically significant) with onset 30Oct2023, outcome "unknown", described as "pulmonary edema"; ARRHYTHMIA (hospitalization, disability, medically significant) with onset 30Oct2023, outcome "unknown", described as "rhythm issues/Cardiac dysrhythmias"; LEFT VENTRICULAR FAILURE (hospitalization, disability), outcome "unknown", described as "Stage 3 systolic heart failure"; BRAIN NATRIURETIC PEPTIDE INCREASED (hospitalization,disability, medically significant), outcome "unknown", described as "BNP (Brain natriuretic peptide)blood lab above 1100"; COUGH (disability), outcome "unknown", described as "Coughing"; DIZZINESS (disability), outcome "unknown", described as "Dizzy"; FATIGUE (disability), outcome "unknown", described as "Tired". The patient was hospitalized for cardiac failure, myocarditis, cardiomyopathy, myocardial infarction, chest pain, dyspnoea, cardiac failure congestive, malaise, arrhythmia, pulmonary oedema, left ventricular failure (hospitalization duration: 2 day(s)). The events "heart failure", "myocarditis", "cardiomyopathy" and "stage 3 systolic heart failure" required physician office visit. The event "cardiac enzymes elevated" required emergency room visit. The events "heart attack", "chest pain", "shortness of breath", "congestive heart failure", "not feeling well", "rhythm issues/cardiac dysrhythmias" and "pulmonary edema" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Arteriogram: (Nov2021) No blockage found, notes: Type of Surgery: Catheter to heart veins to check for blockage; (31Oct2023) No blockage found, notes: Type of Surgery: Catheter to heart veins to check for blockage; Brain natriuretic peptide (0-125): (unspecified date) High, notes: numerous Above 1100 most times; Computerised tomogram: (unspecified date) Myocarditis cardiomyopathy, notes: numerous; (Sep2021) Unknown results; Echocardiogram: (unspecified date) 30 %, notes: 30 % heart function range numerous; Electrocardiogram: (unspecified date) Abnormal, notes: Numerous; Myocardial necrosis marker: (30Oct2023) Elevated; Scan myocardial perfusion: (unspecified date) Bad. Therapeutic measures were taken as a result of cardiac failure, myocarditis, cardiomyopathy, myocardial infarction, chest pain, dyspnoea, cardiac failure congestive, malaise, myocardial necrosis marker increased, arrhythmia, pulmonary oedema, left ventricular failure. Clinical course: Reporter's daughter was dying due to first shot, she was sure others are too. What were you all doing to fix the problem Also a nurse in her neighborhood was dying as well from original shot. she need you to fix that as her daughter had 2 young sons to raise and was only given 5 years 2 years ago. CT Scan Sep2021, cardiologist (Withheld), heart monitors, medication. Clinic treatment-getting worse, still got treatment, medication not working, getting worse. In Jan2022- ER (emergency Room) for not feeling well-heart attack.. In May2022- ER (emergency Room) for chest pain, shortness of breath-worsening CHF (Congestive heart failure) was diagnosed. Jun or Jul2023- shortness of breath, pain-worsening heart failure. In Oct 30Oct2023- went to ER (emergency Room) for not feeling well, shortness of breath-admitted-cardiac enzymes elevated, rhythm issues, pulmonary edema-received Lasix every day, nitro drip, magnesium drip, arteriogram, put on Mexiletine for rhythm issues. The patient was also treated with Mexiletine 3x daily, Cymbalta 60 mg 1x daily, Spironolactone 1/2 pill daily, Ramipril 2.5 mg daily, Torsemide 40mg 1x daily, Bisoprolol 5 mg BID (Twice a day), Low dose Aspirin, Metformin Inpefa-new drug.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.  Follow-up (21Nov2023): The initial case was missing the following minimum criteria: (Unspecified product). Upon receipt of follow-up information on (21Nov2023), this case now contains all required information to be considered valid. Updated information: salutation in slide 1 was added. New reporter slider 02, 03, 04, 05 were added. Patient information, Historical vaccine (dose 1, RMH (Diabetes and Obesity), Lab tests were added. suspect information (Lot number, anatomical location) updated. New events added.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known disease pathophysiology, the event myocardial necrosis marker increased is assessed as not related to the suspect drug BNT162B2, and more likely due to underlying medical condition of acute myocardial infarction which may have occurred during the time the event was reported. On the other hand, the events cardiac failure,  myocarditis, cardiomyopathy, myocardial infarction, chest pain, dyspnoea, cardiac failure congestive, malaise, arrhythmia, pulmonary oedema, left ventricular failure, brain natriuretic peptide increased, pain, cough, dizziness, and fatigue are conservatively assessed as related to the suspect drug based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications, and the possibility that the patient may have an intercurrent medical condition such as heart failure which would explain most of the reported events. 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.