Received Jul 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | EW0167 | SC / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | EW0185 | SC / LA |
Item 18 On Saturday, August 21, 2021, while on evening run, patient suffered a catastrophic sudden cardiac arrest. At the time he was a 22 year-old recent college graduate, just beginning an extremely promising professional career in management consulting. He was a former college athlete, strong, healthy, in excellent physical condition, and worked out every day. (Note: patient received two doses of the Pfizer Covid-19 vaccine on April 28 and May 19, 2021) When stricken with cardiac arrest, patient would have died on the spot, if not for random passersby who jumped in to provide CPR. By chance, one of these persons was a physician also out for a run. Another five people provided extensive aid. These people also happened to be experienced cardiac ICU and cardiac step-down nurses. These strangers gave the patient a chance for survival. Patient?s condition was dire and ER medical staff had great difficulty stabilizing his ventricular tachycardia. Even with max doses of five (5) different vasopressors, he still required numerous and repeated cardioversion therapy to restart or stabilize his heart rhythm. As a result, patient had prolonged low oxygen flow, contributing to internal organ damage and an anoxic brain injury. Prior to this cardiac event, patient had no congenital defects, no genetic predisposition or family history of heart disease. While in hospital, MRI imaging and a heart biopsy revealed no abnormalities, aside from significant ventricular scarring associated with the cardiac arrest. Patient was in cardiac ICU at Hospital for four (4) weeks. The multi-system organ failures worsened, before slowly rebounding. One week after cardiac arrest, on 08/28/2021, patient developed left lung bleed and nearly died during a procedure to remove clotting, when he again went into v-tach and blood pressure dropped dangerously low. He was then placed on ECMO (VV) life support for eight days, so specialists could safely perform repeated procedures to repair and restore the damaged lung. Patient received an implanted cardioverter defibrillator (ICD), and after six weeks was discharged from the hospital (10/02/2021). He had survived an out-of-hospital cardiac arrest (less than 10% survival rate) but also lost 50 lbs. and his considerable muscle mass. He was severely weakened, unable to stand, walk or hold his head up, and now with brain damage. Patient was admitted to a facility for five (5) weeks of intensive multi-discipline inpatient therapy, including re-learning to walk, speak and begin to regain strength. Then, patient began outpatient Day Rehab. For the next six months, patient endured exhausting physical (PT), occupational (OT) and speech/cognitive therapy (SLP), six hours per day, five days per week. He required extensive therapy to address his brain injury and the new deficits and challenges it caused. Patient was discharged from facility on 05/03/2022, no longer requiring PT and OT. Patient continued to present with substantial cognitive communication deficits from the anoxic brain injury. These deficits included significant impairment in short term and verbal working memory, as well as impaired executive function, reasoning, cognitive flexibility and decreased cognitive endurance. Cognitive and language deficits included decreased high-level word finding, verbal organization, response elaboration and decreased verbal/non-verbal pragmatic skills. Patient was recommended for ongoing SLP therapy, 2-3 times/week, targeting his numerous deficits. This treatment began 05/09/2022 and continues to this day. Patient has made great improvements since that time, but has not been able to live independently, nor work. Although patient has recently (March 2025) tested exceptionally high for math, logic, reasoning, analytic abilities, language and verbal skills, his short-term and working memory is severely compromised due to the brain injury. Finally, as of May 2025, patient is able to begin working, initially on a limited, part-time basis only, and in far more simplified and less demanding work. Patient?s cardiac health is currently stable and good, but has not been without problems. After extensive testing and elimination of other potential causes, it is believed the cardiac arrest was brought on by myocarditis, likely the negative reaction to the Covid vaccine. The damage to patient?s heart was significant, but he is able to work out daily. He continues to be followed by local cardiologist at home, as well as specialists. He has had two (2) difficult ventricular ablations, most recently in January 2025, a very complicated 12-hour procedure. One additional such procedure perhaps less difficult is anticipated in 4Q2025. There is no disputing the significant life-changing impact of patient?s August 2021 cardiac arrest. It nearly ended a healthy young man?s life, and certainly interrupted a promising professional career, and left an extremely intelligent and capable individual with an extensive brain injury. It is uncertain if patient?s prior career, at the level he started, will be able to be resumed.
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Item 19 Patient has undergone innumerable tests and procedures following the adverse event. Following is the best summation we can provide, although it is still ongoing. August to October 2021; December 2021 ? 08/25/2021 Echocardiogram Transesophageal; Endomyocardial Biopsy; Brain CT w/out Contrast ? 08/31/2021 Scan - Interventional Radiology Embolization ? 09/03/2021 Echocardiogram Follow-up ? 09/18/2021 MRI Cardiac Morph w/ and w/o Contrast; MRI Brain w/ and w/o Contrast ? 09/23/2021 PET/CT Sarcoid Test ? 09/28/2021 Procedure - Electrophysiology ICD Insertion ? 12/17/2021 CT Cardiac Coronary Angiography ? 12/20/2021 PVC/VT Ablation ? 12/30/2021 Exercise Stress Test ? 01/20/2022 PET/CT Sarcoid Test ? 05/27/2022 PET/CT Sarcoid Test ? 06/26/2023 CTA Coronary Arteries including Thorax w/o Calcium Scoring ? 03/13/2024 PET/CT Sarcoid Test June 2024; April/May 2025 ? 06/11/2024 6 minute Walk Test; Echocardiogram ? 06/12/2024 Cardiac Device Clinic ? ICD Check and Download; Blood and Urine Tests; Electrocardiogram Test; Holter Monitor Test - 24-hour; Consult with Cardiology ? 06/13/2024 Follow-up Cardiac Device Check; Return 24-hour Urine Specimen; Cardiology Psych Consult, Sarcoid PET CT; Exercise Stress Test ? 06/19/2024 Genetic Testing Sample Submited ? 08/13/2024 Cardiovascular Electrophysiology Video Consult? Regarding Future Cardiac Ventricular Ablation ? 01/13/2025 Blood Tests; Electrocardiogram Imaging; MR Cardiac Imaging (MRI); Holter Monitor Test - 24-hour; Cardiac Device Clinic ? ICD Check and Download ? 01/14/2025 Pre-Procedure Consult ? ? Electrophysiology; Pre-Procedure Consult ? - Electrophysiology ? 01/15/2025 Cardiac External Ventricular Ablation Procedure ? Req?d. Cardiovascular Surgeons to Open Epicardial Window for Access and Cut Away Scarring Around Left Ventrical, and Temporary Repositioning of Frenic Nerve to Allow Access ? ? 01/22/2025 Procedure - Electrophysiology New ICD Insertion - New Medtronic Combo Defib/Pacemaker, with Extraction of Old Bostom Scientific Subcutaneous ICD Defibrillator, ? 04/30/2025 Blood and Urine Tests; Cardiac Device Clinic ? ICD Check and Download; Electrocardiogram; Consult with Electrophysiology; Echocardiogram Imaging ? 05/01/2025 Consult with Electrophysiology, RE: Planned Non- Invasive Programmed Stimulation (NIPS) Study, 3D Mapping (NAVX), and VT Ablation (Internal). Procedures Cancelled Due to Blood Clot Found on Imaging ? 05/01/2025 Procedure ? by Electrophysiology - IntraCardiac EchoCardiography (ICE) Ultrasound, to Assess Suspected Blood Clot. Once confirmed, remaining Procedures Cancelled, Pending Treatment w/ Eliquis to Dissolve Clot and Possibly Perform Secondary Left Ventrical Interior Ablation Later in 2025.