Received Jul 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | FM9992 | OT / LA |
ejection fraction 31%; Several Atrial Hypertropy; Flu-like symptoms; Arrhythmia cardiac (NOS); Afib; tachycardia; Atrial Tachycardia; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 14:55 as dose 4 (booster), single (Lot number: FM9992, Expiration Date: 07Jul2022, Batch number: 59267-1025-1) at the age of 62 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "IDDM", start date: 05Jan1989 (unspecified if ongoing). Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus, start date: 06Jan1989. Vaccination history included: BNT162b2 (Dose 1, single, Batch number: 59267-1000-1, lot: EL1284, Location of injection/shot: Arm Left, Left Deltoid, Route of administration: Intramuscular, Time: 12:29, Expiration date: 30Apr2021), administration date: 02Jan2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, single, Batch number: 59267-1000-1, lot: EL3302 , Location of injection/shot: Arm Left, Left Deltoid, Route of administration: Intramuscular, Time: 11:08, Expiration date: 31May2021), administration date: 23Jan2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose 3 (booster), single , Batch number: 59267-1000-1, lot: EW0196, Location of injection/shot: Arm Left, Left Deltoid, Route of administration: Intramuscular, Time: 08:40, Expiration date: 03Dec2021), administration date: 27Sep2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (disability, medically significant, life threatening) with onset 05Dec2023, outcome "recovered with sequelae", described as "Afib"; ARRHYTHMIA (disability, medically significant, life threatening) with onset 05Dec2023, outcome "recovered with sequelae", described as "Arrhythmia cardiac (NOS)"; ATRIAL TACHYCARDIA (disability, life threatening) with onset 05Dec2023, outcome "unknown"; TACHYCARDIA (disability, life threatening) with onset 05Dec2023, outcome "recovered with sequelae"; EJECTION FRACTION DECREASED (disability, life threatening), outcome "not recovered", described as "ejection fraction 31%"; ATRIAL HYPERTROPHY (disability, life threatening), outcome "unknown", described as "Several Atrial Hypertropy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms". The events "arrhythmia cardiac (nos)", "afib", "tachycardia", "atrial tachycardia", "ejection fraction 31%" and "several atrial hypertropy" required physician office visit. The patient underwent the following laboratory tests and procedures: Angiocardiogram: (12Jun2024) Negative, notes: Life threatening; Angiogram: (12Jun2024) Negative, notes: Life threatening; Ejection fraction: (unspecified date) 31 %, notes: continues to be below normal; Radioisotope scan: (unspecified date) Negative. Therapeutic measures were taken as a result of arrhythmia, atrial fibrillation, tachycardia, atrial tachycardia, ejection fraction decreased, atrial hypertrophy. Clinical course: No emergency room visit was reported for arrhythmia cardiac (NOS), atrial fibrillation (AFib), or tachycardia. Cardioversion, (serious, life threatening; outcome temporary) done on 23Feb2024 and treatment given as Amiodarone and again on 15Apr2024 and treatment given as Amiodarone, Metoprolol, Pradaxa. Coronary angiography and cardiac catheterization (serious, life-threatening; outcome diagnostic-negative) were performed on 12Jun2024. Cardiac ablation for AFib lesion-endovascular approach (serious, life-threatening; outcome temporary) was done on 23Oct2024 and treatment given was continued medications. ER cardioversion (serious, life-threatening; outcome temporary) was done on 28Nov2024 and treatment given was continued medications. Atrial ablation (serious, life-threatening; outcome temporary, discontinued amiodarone and metoprolol) was done on 05Nov2025 and treatment given was continued Pradaxa. The patient was not allergic to any previous vaccination, medications, food or other products. Radioisotope stress CT Scan- Negative, Atrial hypertrophy is present, Ejection Fraction continues to be below normal, Atrial tachycardia continues intermittently, continued Pradaxa. The stress and disruption to his normal, active lifestyle has been profound. Strength and stamina have decreased. Fatigue during the work day has increased. The mental strain of knowing that his heart has significant damage, secondary to this vaccine, has adversely affected his life. He has had to make permanent changes and adaptations to function daily.
Medical History/Concurrent Conditions: IDDM
HUMALOG
Test Date: 20240612; Test Name: Cardiac catheterization; Test Result: Negative ; Comments: Life threatening; Test Date: 20240612; Test Name: Coronary Angiography; Test Result: Negative ; Comments: Life threatening; Test Name: Ejection Fraction; Test Result: 31 %; Comments: continues to be below normal; Test Name: Radioisotope CT scan; Test Result: Negative