Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A-fib 6 times; tachycardia; heart problems; orthostatic hypotension in his right leg and was not pumping blood back to his heart/diagnosed with clots and orthostatic hypotension on his right leg (24 inch circumference); blood clot/diagnosed with clots/clots; legs; right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/right leg swollen to 24 inch in circumference; right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/leg had ruptured on 3 sides, blood and tissue fluid; right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/leg had ruptured on 3 sides, blood and tissue fluid; clots in his lungs; cardiomyopathy; can hardly move; dizzy all the time; can no longer drive/can't drive his car; RLE cellulitis; vertigo; shoulder and leg pain; shoulder and leg pain; skin eruptions; have not died but fear it will be shortly; chronic fatigue; difficulty standing; carotid duplex bilateral: minimal plaque; CT head w/o chest: chronic small renal ischemic disease; can barely walk/could not walk/difficulty with walking/cannot walk upstairs; blood pressure went to 300/297 and thought he was having a stroke or heart attack/elevated blood pressure reading; blood pressure went to 300/297 and thought he was having a stroke or heart attack; blood pressure went to 300/297 and thought he was having a stroke or heart attack; CXR: tortuosity of descending aorta; chest pains; vaccine has not been properly tested, believed they have been injected with poison; insect bite; pain all over/severe body pain; leg had ruptured on 3 sides, blood and tissue fluid/legs ruptured and bled along with clear tissue fluid; lesions; swollen legs that were red from haemoglobin; quality of life has been destroyed; This is a spontaneous report received from contactable reporter (consumer or other non HCP and Physician) from product quality group and medical information team. The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 13:00 as dose 2, single (batch/lot number: ER8734) at the age of 82 years intramuscular, in right deltoid for covid-19 immunization. The patient's relevant medical history included: "hyperlipidemia", start date: 2007 (ongoing); "prediabetes", start date: 2014 (ongoing); "obesity" (unspecified if ongoing); "non smoker" (unspecified if ongoing); "polymyalgia rheumatica", start date: 2018 (ongoing), notes: based on symptoms elevated CRP and ESR; rheumatologist in 2021 was not sure about the diagnosis; rheumatologist in 2021 is not sure about the diagnosis; "hypertension", start date: 2007 (ongoing); "thrombocytopenia", start date: 2013 (ongoing). The patient's family history included: "diabetes" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medications included: TRAMADOL; PREDNISONE oral taken for polymyalgia rheumatica, start date: 2018 (ongoing); 60 ml amour thyroid, date started in 2000 and still taking. Vaccination history included: BNT162b2 (dose 1, batch/lot number EN6207), administration date: 10Mar2021, when the patient was 82-year-old, for COVID-19 Immunization, reaction(s): "skin lesion", "redness", "skin eruption", "leg pain", "shoulder pain", "general body pain", "difficulty in standing", "chronic fatigue", "driving ability disturbed", "vertigo", "impaired quality of life", "difficulty in walking", "dizzy", "cardiomyopathy". The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 31Mar2021, outcome "unknown", described as "vaccine has not been properly tested, believed they have been injected with poison"; ATRIAL FIBRILLATION (hospitalization) with onset 2021, 5 months after the suspect product(s) administration, outcome "not recovered", described as "A-fib 6 times"; THROMBOSIS (hospitalization) with onset 2021, outcome "unknown", described as "blood clot/diagnosed with clots/clots; legs"; CARDIAC DISORDER (hospitalization) with onset 2021, 5 months after the suspect product(s) administration, outcome "unknown", described as "heart problems"; ARTHROPOD BITE (non-serious) with onset 2021, outcome "unknown", described as "insect bite"; WOUND SECRETION (non-serious) with onset 2021, outcome "unknown", described as "leg had ruptured on 3 sides, blood and tissue fluid/legs ruptured and bled along with clear tissue fluid"; SKIN LESION (non-serious) with onset 2021, outcome "not recovered", described as "lesions"; ORTHOSTATIC HYPOTENSION (hospitalization) with onset 2021, outcome "unknown", described as "orthostatic hypotension in his right leg and was not pumping blood back to his heart/diagnosed with clots and orthostatic hypotension on his right leg (24 inch circumference)"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain all over/severe body pain"; IMPAIRED QUALITY OF LIFE (non-serious) with onset 2021, outcome "unknown", described as "quality of life has been destroyed"; MUSCLE RUPTURE (hospitalization), HAEMORRHAGE (hospitalization) all with onset 2021, outcome "not recovered" and all described as "right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/leg had ruptured on 3 sides, blood and tissue fluid"; PERIPHERAL SWELLING (hospitalization) with onset 2021, outcome "not recovered", described as "right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/right leg swollen to 24 inch in circumference"; ERYTHEMA (non-serious) with onset 2021, outcome "not recovered", described as "swollen legs that were red from haemoglobin"; TACHYCARDIA (hospitalization) with onset 2021, 5 months after the suspect product(s) administration, outcome "not recovered"; CHEST PAIN (medically significant) with onset Sep2021, outcome "not recovered", described as "chest pains"; ARTERIAL TORTUOSITY SYNDROME (non-serious) with onset 26Sep2021, outcome "unknown", described as "CXR: tortuosity of descending aorta"; CEREBROVASCULAR ACCIDENT (medically significant), MYOCARDIAL INFARCTION (medically significant) all with onset 26Sep2021, outcome "recovering" and all described as "blood pressure went to 300/297 and thought he was having a stroke or heart attack"; HYPERTENSION (medically significant) with onset 26Sep2021, outcome "recovering", described as "blood pressure went to 300/297 and thought he was having a stroke or heart attack/elevated blood pressure reading"; GAIT DISTURBANCE (non-serious) with onset 26Sep2021, outcome "unknown", described as "can barely walk/could not walk/difficulty with walking/cannot walk upstairs"; RENAL ISCHAEMIA (medically significant) with onset 29Sep2021, outcome "unknown", described as "CT head w/o chest: chronic small renal ischemic disease"; CAROTID ARTERIOSCLEROSIS (medically significant) with onset 19Jan2022, outcome "unknown", described as "carotid duplex bilateral: minimal plaque"; CELLULITIS (medically significant), outcome "unknown", described as "RLE cellulitis"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "clots in his lungs"; CARDIOMYOPATHY (medically significant), outcome "unknown"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can hardly move"; DIZZINESS (non-serious), outcome "not recovered", described as "dizzy all the time"; IMPAIRED DRIVING ABILITY (non-serious), outcome "unknown", described as "can no longer drive/can't drive his car "; VERTIGO (non-serious), outcome "unknown"; FEAR OF DEATH (non-serious), outcome "unknown", described as "have not died but fear it will be shortly"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "shoulder and leg pain"; RASH (non-serious), outcome "unknown", described as "skin eruptions"; FATIGUE (non-serious), outcome "not recovered", described as "chronic fatigue"; DYSSTASIA (non-serious), outcome "unknown", described as "difficulty standing". The patient was hospitalized for orthostatic hypotension, thrombosis, peripheral swelling, muscle rupture, haemorrhage (hospitalization duration: 3 days). The events "chest pains" and "cardiomyopathy" required physician office visit. The events "heart problems", "clots in his lungs", "carotid duplex bilateral: minimal plaque", "can barely walk/could not walk/difficulty with walking/cannot walk upstairs", "pain all over/severe body pain", "have not died but fear it will be shortly", "insect bite", "leg had ruptured on 3 sides, blood and tissue fluid/legs ruptured and bled along with clear tissue fluid" and "cxr: tortuosity of descending aorta" required emergency room visit. The events "blood pressure went to 300/297 and thought he was having a stroke or heart attack/elevated blood pressure reading", "blood pressure went to 300/297 and thought he was having a stroke or heart attack", "orthostatic hypotension in his right leg and was not pumping blood back to his heart/diagnosed with clots and orthostatic hypotension on his right leg (24 inch circumference)", "blood clot/diagnosed with clots/clots; legs", "right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/right leg swollen to 24 inch in circumference", "right leg, the calf muscle swelled to 24 inches wide, it ruptured, and was bleeding from three sides of his leg/leg had ruptured on 3 sides, blood and tissue fluid", "a-fib 6 times" and "tachycardia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure: (unspecified date) 150/85; (26Sep2021) 300/297, notes: elevated; systolic BP: (2021) 210; (2021) 170, notes: conc down from 210; blood work: (unspecified date) unknown results, notes: multiple blood work; CXR: (26Sep2021) no acute disease, notes: tortuosity of descending aorta; CRP: (2018) elevated; EKG/ECG: (unspecified date) unknown results, notes: multiple; (unspecified date) heart was perfect; CMP/CBC: (unspecified date) unknown results, notes: baseline; (29Sep2021) CMP WNL, CBC uncharged from baseline; (29Jul2022) unknown results; ESR: (2018) elevated; brain scan/CT head w/o chest: (unspecified date) healthy brain; (29Sep2021) no acute intracranial process, notes: chronic small renal ischemic disease; (29Jul2022) no acute intracranial process, notes: chronic small renal ischemic disease; HS troponin: (29Sep2021) negative, notes: CMP WNL; (29Jul2022) negative; arterial duplex BLE: (19Jan2022) no (illegible) significant disease; doppler on his leg/carotid duplex bilateral (unspecified date) did not have a blood clot; (19Jan2022) minimal plaque, notes: no significant disease or stenosis; sonogram: (unspecified date) left leg was normal, right leg still swollen; ultrasounds on legs and carotids (unspecified date) see if he has blockages and he did not; body X-rays: (unspecified date) no inflammation on his body, notes: entire body; (unspecified date) unknown results, notes: several body X-rays. Therapeutic measures were taken as a result of hypertension, cerebrovascular accident, myocardial infarction, orthostatic hypotension, thrombosis, peripheral swelling, atrial fibrillation, tachycardia, cellulitis, cardiac disorder, arthralgia, pain in extremity. Therapeutic measures were not taken as a result of muscle rupture, haemorrhage, dizziness, fatigue. Clinical course: Since they have gotten the vaccine they have been progressively getting worse. The patient has been active all of his life and since the vaccine he can hardly move. The patient started having his blood pressure went to 300/297 and thought he was having a stroke or heart attack. He went to the emergency room, Sep2021, improved at this time, took 12.5 mg hydrochlorothiazide treat blood pressure now and to keep it down and stated it keeps him running. His blood pressure now, it runs around 150/85. The patient was so dizzy all the time and can no longer drive, can barely walk. His right leg, the calf muscle swelled to 24 (also reported as 23) inches wide, it ruptured, and was bleeding from three sides of his leg. The doctors told him that he had orthostatic hypotension in his right leg and was not pumping blood back to his heart, now it was 19.5 inches. The patient informed that they would not admit him to the hospital for this, did nothing to treat this, they first thought he had a blood clot, they did a doppler on his leg and fortunately he did not have a blood clot. Since then, he has had ultrasounds on legs and carotids to see if he has blockages and he did not. Since he has had vaccines, he has had A-fib 6 times. The patient was not being treated for it because he will convert on his own within an hour. The patient was randomly experiencing tachycardia since he got the vaccine. The patient did all the testing, a brain scan and found a healthy brain, blood tests on top of blood tests, completely x ray'd his entire body, has found no inflammation in his body. Some doctors that were telling him all of his events were vaccine related, his DNA was being changed. The patient thinks maybe he has the bad batch in his body. The patient quality of life has been destroyed. On 11Mar2022, the patient informed that he has been in the hospital 3 times. He has been diagnosed with clots and orthostatic hypotension on his right leg (24 inch circumference). He has had blood pressure of 300/297. The patient feels dizzy all the time, can't drive his car and can barely walk. In the past 3 weeks, he experienced tachycardia and chest pains. They believed vaccine has not been properly tested, believed they have been injected with poison and that the mRNA contained in the vaccine attaches to their DNA. The patient blamed the vaccine for all these health problems. The patient informed that he has not received the booster. He was fearful of the COVID-19 vaccine and the vaccine has not been properly tested. The patient experienced tachycardia started 3 weeks ago and chest pain almost daily. He assumed the chest pain was from the Afib and tachycardia. The patient informed that he has been to his primary care doctor, rheumatologist, ER physician, cardiology, and ENT. They said he had vertigo but he didn't have vertigo. The reporter informed that the chest pain started in Sep (2021) and was ongoing, the same every day. The patient has been to a cardiologist and had an EKG. The cardiologist said his heart was perfect. There were doctors out here that know that this was not right. This product was not properly tested before it was given to the general population. On 04Apr2022, the patient informed that BP 300/297 (also reported as 197) was on 26Sep2021; admission to hospital due to the event was no (no rooms), treatment was yes and still experiencing. The patient experienced chronic fatigue from Oct to Mar; admission to hospital due to the event was no, treatment received was no and still experiencing. The patient experienced difficulty standing. The patient was delayed into the adverse reaction with Pfizer vaccine and was astonished that the proper testing and conditions of manufacturing were not done in aseptic conditions. The patient informed that they went to urgent care on 15Oct2021. They were sent to ER. The patient had pain all over plus a right leg swollen to 24 inch in circumference. The leg had ruptured on 3 sides, blood and tissue fluid. The patient had no rooms. The patient as of yet we have not died but fear it will be shortly. The patient had sonar sonograms looking for leg clots. The left leg was normal, right leg still swollen. The patient was taking off 2.5 mg prednisone for 57 days. On 58th day could not walk. The patient experienced severe body pain for 72 hours sitting in a chair. This vaccine has destroyed their lives. The patient experienced swollen leg right on 15Oct2021 12:00 noon. The event patient required a visit to emergency room and physician office for events both right leg and blood clots. The patient was hospitalized for 3 days. On 29Apr2022, the physician informed that the patient provided information regarding the reported adverse events with the use of the product. The physician did not consider the Pfizer product had a causal effect to the adverse event. The vaccination facility type was at hospital and the vaccine was not administered at military facility. The physician saw the patient in the office for a positive HTN follow-up on 15Jun2021 and at that time, the physician did not repeat anything new/out of the ordinary. The patient using HCTZ PRN (when necessary) and self-adjusting prednisone up to 10 mg daily based on (illegible). On 26Sep2021, the patient precured to ED with elevated blood pressure reading with increased leg swelling. The patients systolic BP conc down to 170 from 210 as its own in the ED and patient was instructed to follow-up with PCP rheumatologist. The patient weaved down off prednisone PCP rheumatology. In Nov2021, with treated for RLE cellulitis with doxycycline, Oct2021 in ED s/p insect bite. On 15Dec2021 physician visit, patient was on HCTZ still daily but back on prednisone per dermatology due to reoccurrence of shoulder and leg pain. On 23Mar2022 visit, was when the patient requested much difficulty with walking and (illegible) since Sep2021 to vaccine series. On 24May2022, the physician informed that event onset date was on 26Sep2021. The patient was not hospitalized. The patient had 2 ED visits, 26Sep2021 and 15Oct2021. On 12Oct2022, the patient informed that he has heart problems and skin eruptions since they have taken the vaccine. The patient informed that he has no report reference number with him and has a large folder upstairs with the Pfizer information but he cannot walk upstairs to get it. The patient informed that his wife and himself were spending 600 dollars a month on heart medicine. The patient informed that in his research the past year, he will call it a vaccine, but it was a drug that was not tested properly and not even manufactured under aseptic conditions. The patient informed that they screwed up and got the 2nd vaccine. It was reported the vaccine product had a bad batch of vaccine and he did not know if he and his wife got that bad batch or not, but it caused major problems of blood clots and he has clots in his lungs and legs. The patient informed that he took the Pfizer vaccine and it caused him to have cardiomyopathy, after he met with the cardiologist, they were going to put him in the hospital and give them Tikosyn and Pfizer made the vaccine, and may make Tikosyn too and not one of those products worked. On 25Oct2022, the patient informed that he had both legs swollen in excess of 25" in circumference. His legs ruptured and bled along with clear tissue fluid. The patient still has lesions and swollen legs that were red from haemoglobin. The patient was very dizzy all the time with difficulty walking and no longer able to drive. The patient informed that he has Afib and tachycardia. He was taking very expensive anti-clotting meds, Xarelto. The patient informed he was due compensation for life-altering poison injected into them. On 02Nov2022, the patient got 2 shots of the Pfizer so-called COVID vaccine, five months later he developed heart problems, Afib and tachycardia. In and out of ER's and hospitals 3 times for him. The patient cannot convert blood clots lungs-legs. The patient informed that the cardiologist suggested 3 day stay for us at hospital to stabilize with "Tikosyn" and then daily regimens on a monthly basis. The patient informed that they read the side effects and opted to take anti-clotting med. On 04Mar2022 product quality group investigational results for compound BNT 162 COVID-19 Vaccine Suspension for Intramuscular 2ML Multiple Dose Vial X 1, Lot-# (CR): ER8734; The conclusion of previously completed investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 Vaccine Injectable lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200354728 same patient/vaccine, different dose/events;