Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pulmonary embolism, Thrombosis, Ultrasound scan, Venogram
Clinical narrative: 57 blood clots removed from the lung, 2 of which became chronic and have to be removed from her leg surgically/ she has been told that if she got anymore clots, she might not survive.; severe chest pain; was soaking wet with sweat; had pain that knocked her down to floor; passed out; she could not breathe; Ever since this has happened with congestive heart failure; Pulmonary embolism; she has no energy/She is weak; She has 2 blood clots in her leg; short of breath all the time; Cor pulmonale; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 at 14:30 as dose 3 (booster), single (Lot number: FC3181) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese and has type 2 diabetes diagnosed 2 years ago; "Type 2 Diabetes" (unspecified if ongoing), notes: Obese and has type 2 diabetes diagnosed 2 years ago; "Hayfever" (unspecified if ongoing), notes: Hayfever and Seasonal allergies diagnosed years ago. Compromised immune status - 10 years ago; "Seasonal allergies" (unspecified if ongoing), notes: Hayfever and Seasonal allergies diagnosed years ago. Compromised immune status - 10 years ago; "Compromised immune status" (unspecified if ongoing), notes: She is immunosuppressed because she is on daily doses of Prednisone.  This was before taking the Pfizer COVID vaccines.; "They did a balloon angioplasty" (unspecified if ongoing), notes: They did a balloon angioplasty.  They did not do a stent because the angioplasty opened it back up. The patient's family history included: "She has had previous DVT's when she had a fractured leg or ankle", start date: 2015 (unspecified if ongoing), notes: She has had previous DVT's when she had a fractured leg or ankle, but never PE's in lungs.  The fracture was prior to the vaccines. Way back in 2015, she fell and fractured her ilium, ishium and coxyx.  Then she evidently smashed the vein because the leg turned blue and swelled up twice the size and found she had severe stenosis of iliac vein.  They did a balloon angioplasty.  They did not do a stent because the angioplasty opened it back up. There were no concomitant medications. Past drug history included: Prednisone, notes: She is immunosuppressed because she is on daily doses of Prednisone.  This was before taking the Pfizer COVID vaccines. Vaccination history included: BNT162b2 (On 05Mar2021, she received her first Pfizer COVID vaccine with Lot EN6205, Expiration unknown.  Injected in right arm.), administration date: 05Mar2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (2nd dose of the Pfizer COVID vaccine was 25Mar2021, with Lot ER8733, expiration unknown, Injected in left arm.), administration date: 25Mar2021, when the patient was 75-year-old, for Covid-19 immunization.  The following information was reported: PAIN (hospitalization) with onset 17Sep2021, outcome "not recovered", described as "had pain that knocked her down to floor"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 17Sep2021, outcome "not recovered", described as "passed out"; CHEST PAIN (hospitalization) with onset 17Sep2021, outcome "not recovered", described as "severe chest pain"; DYSPNOEA (hospitalization) with onset 17Sep2021, outcome "unknown", described as "she could not breathe"; HYPERHIDROSIS (hospitalization) with onset 17Sep2021, outcome "not recovered", described as "was soaking wet with sweat"; THROMBOSIS (hospitalization, life threatening) with onset 18Sep2021 at 17:30, outcome "unknown", described as "57 blood clots removed from the lung, 2 of which became chronic and have to be removed from her leg surgically/ she has been told that if she got anymore clots, she might not survive."; COR PULMONALE (medically significant) with onset 18Sep2021 at 17:30, outcome "recovered with sequelae"; CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "Ever since this has happened with congestive heart failure"; PULMONARY EMBOLISM (medically significant), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "she has no energy/She is weak"; COAGULOPATHY (non-serious), outcome "unknown", described as "She has 2 blood clots in her leg"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath all the time". The patient was hospitalized for thrombosis, chest pain, pain, loss of consciousness, dyspnoea (start date: 17Sep2021, discharge date: 18Sep2021, hospitalization duration: 1 day(s)); for hyperhidrosis (start date: 17Sep2021, hospitalization duration: 1 day(s)). The events "57 blood clots removed from the lung, 2 of which became chronic and have to be removed from her leg surgically/ she has been told that if she got anymore clots, she might not survive.", "severe chest pain", "was soaking wet with sweat", "had pain that knocked her down to floor", "passed out" and "she could not breathe" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) they did regular chest x-ray and realized the lung, notes: Within 20 minutes, they did regular chest x-ray and realized the lungs were not filling and they ordered Arterial and Venous CT scan of Lungs and found it; Computerised tomogram: (17Sep2021) both lungs were full of blood clots, notes: they did CT scan of lungs and it showed both lungs were full of blood clots; Ultrasound scan: (17Mar2022) Unknown results, notes: She will see vein specialist on 17 May 2022.  She will have another IV ultrasound with contrast so it shows up better; (unspecified date) Right leg was full of blood clots in 5 different v, notes: she had an ultrasound and a venogram to her legs and found her Right leg was full of blood clots in 5 different veins; Venogram: (unspecified date) Right leg was full of blood clots in 5 different v, notes: she had an ultrasound and a venogram to her legs and found her Right leg was full of blood clots in 5 different veins. Therapeutic measures were taken as a result of thrombosis.  Clinical course: On 17Sep2021,14:30 patient had severe chest pain, was soaking wet with sweat, and had pain that knocked her down to floor. She urinated and stood up to flush toilet and it knocked her to her knees. The pain knocked her down to her knees. She passed out and does not know how long she was passed out. It must have been 15:45 when she got to the hospital. She passed out, and when she came to, she crawled to bed and got on bed. Pain was worse and worse and she could not breathe. She called Ambulance and they took to hospital in (City-withheld), (state-withheld), and because she could not breathe, they did CT scan of lungs and it showed both lungs were full of blood clots.  When she got to the hospital, they said her heart enzyme level, Troponin level when the heart is damaged was 487. They said she had two lungs full of blood clots.  They sent red alert to the doctor. Within 20 minutes, they did regular chest x-ray and realized the lungs were not filling and they ordered Arterial and Venous CT scan of Lungs and found it. So they transferred to (name-withheld) in (city-withheld). They said if she did not have surgery, she would die, so they transferred at 04:00 to (name-withheld) in (city-withheld), part of (name-withheld). She got admitted 17Sep2021 and was in the ER until 04:00. At 17:30 on 18Sep2021, she had Mechanical thrombo-embolectomy in both lungs. She had severe extensive embolitic disease in both lungs. She had nothing before this. They removed 57 blood clots. The doctor took a picture of them with his phone. (name-withheld). Right before they did the thrombo-embolectomy, she had an ultrasound and a venogram to her legs and found her Right leg was full of blood clots in 5 different veins. She figured it moved from her legs into her lungs. It was just right leg, nothing in left. She thought she was going to die because she could not breathe. They first thought she was having a coronary, and when they ordered CT scan in lungs, it showed up with the extensive blood clots in lungs. After she got to (city-withheld) they found the clots in right leg. She now has core pulmonale, which is right sided heart failure because of backup of pressure in lungs. This made high pressure because of the clots. She has been on round the clock oxygen since then and is slowly improving. The symptoms are slowly improving. She still has the diagnosis.On 04Oct2021 through 08Oct2021, she had another hospitalization for the blood clots in her leg. Then on 30Oct2021-31Oct2021, she went back to hospital with blood clots in right leg. These 2 were chronic. One in the Posterior Tibial Vein, and one in the Posterior Popliteal.She is going to visit a vein specialist on the 17May2021, she is concerned since she has been told that if she got anymore clots, she might not survive.She is now on Coumadin for the rest of her life.A specialist come see her and he was an Oncologist and hematologist and he told her she barely survived this event and would not survive if it happened again. She would need to be on blood thinners the rest of her life. They tried Xarelto and they failed.She threw it away and does not have a manufacturer, dose, lot or expiration.They put her on it when she left the heart center. By 04Oct2021, she had a leg full of blood clots. They put her on Heparin in the hospital and then Coumadin and said she would be on it for life. Ever since this has happened with congestive heart failure, she has no energy, short of breath all the time and it changed her life. She is weak. She has 2 blood clots in her leg. She will see vein specialist on 17May2022, in (city-withheld). She will have another IV ultrasound with contrast so it shows up better. Family Medical History Relevant to AE(s): both her brother and sister have had DVT's and a PE-pulmonary embolism. She has had previous DVT's when she had a fractured leg or ankle, but never PE's in lungs. The fracture was prior to the vaccines. Way back in 2015, she fell and fractured her ilium, ishium and coxyx. Then she evidently smashed the vein because the leg turned blue and swelled up twice the size and found she had severe stenosis of iliac vein. They did a balloon angioplasty. They did not do a stent because the angioplasty opened it back up.     Vaccine was not administered at a Facility.No vaccines were administered on Same Date of the Pfizer Suspect. No other vaccinations were given within four weeks prior to the first administration date of the suspect vaccine.AE(s) following prior vaccinations: None Just a little sore arm or achy with the previous Pfizer COVID vaccines.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.