Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder, Pulmonary thrombosis, Thrombosis, Ultrasound scan, Weight
Clinical narrative: blood clot and it ended out not only being in her legs but also her lungs; leg blood clot; cramps in her legs; Her right leg was swollen; a red spot on her knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 81 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: 2019 (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "High blood pressure" (ongoing), notes: High blood pressure Diagnosed along time ago, maybe 20 years ago. Treat it with medications; "Thyroid", start date: 2019 (unspecified if ongoing), notes: Takes medication for it. Doesn't know what she takes. Diagnosed around the same time as her cancer; "kidney disease" (unspecified if ongoing), notes: Confirmed she had kidney disease before receiving any Pfizer COVID-19 shots, before taking Ibrance.; "arthritis" (unspecified if ongoing). Concomitant medication(s) included: VERZENIO. Vaccination history included: BNT162b2 (Dose 1, single, Time: Thinks mid-day 11 or 12 o'clock. Never had a reaction, Anatomical Site of injection: Right arm, Doesn't have lymph nodes in her left arm so has to get it in right arm, Route of Administration: intramuscular, Batch/Lot number: EL9263), administration date: 22Jan2021, when the patient was 80-year-old, for COVID-19 immunization, reaction(s): "Never had a reaction"; BNT162b2 (Dose 2, single, Given at (Clinic name withheld), Time: Around noon, Anatomical Site of injection: Right arm, Route of Administration: intramuscular, Batch/Lot number: EN6201), administration date: 12Feb2021, when the patient was 80-year-old, for COVID-19 immunization, reaction(s): "Never had a reaction". The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 08Sep2021, outcome "not recovered", described as "leg blood clot"; PULMONARY THROMBOSIS (hospitalization, medically significant), outcome "not recovered", described as "blood clot and it ended out not only being in her legs but also her lungs"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramps in her legs"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her right leg was swollen"; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "a red spot on her knee". The patient was hospitalized for thrombosis (start date: 08Sep2021). The events "leg blood clot", "blood clot and it ended out not only being in her legs but also her lungs", "cramps in her legs", "her right leg was swollen" and "a red spot on her knee" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body height: 5 foot 2 inches or 5 foot 3 inches; Computerised tomogram: found the clots, notes: CT scan in the lungs and found the clots; Mammogram: cancer in her left breast, notes: spine, and in her bones; Ultrasound scan: Unknown results; Unknown results; Weight: 165 lbs, notes: At home she weighs 165 pounds; 170 lbs, notes: at HCP office 170 pounds. Therapeutic measures were taken as a result of thrombosis, pulmonary thrombosis, muscle spasms, peripheral swelling, pigmentation disorder.  Clinical information: Patient takes Ibrance and is enrolled in an additional support program. The patient clarified that the blood clots happened before she started Ibrance but after having the Pfizer COVID-19 Booster shot. Doesn't know if the blood clots are related to her Pfizer COVID-19 Booster or not. She was on Verzenio which was started on 14Jan2020 and then her HCP changed her to Ibrance after she got the Pfizer COVID-19 Booster shot, got blood clots, and was in the hospital. Verzenio caused her a lot of diarrhea. She was on Verzenio when she got the Pfizer COVID-19 Booster shot then she went to the hospital for blood clots and was changed to Pfizer Ibrance afterwards. She provided she was concerned because she thinks the clots may have been from her Pfizer COVID-19 Booster shot. All of her shots for COVID-19 were from Pfizer since the beginning. Patients kidneys were no good Stage 3. Clarified her kidneys were no good before taking the Pfizer COVID-19 Boosters and shots and before taking Ibrance. Confirmed she had kidney disease before receiving any Pfizer COVID-19 shots and before taking Ibrance. She used to be on an anti-inflammatories and her HCP took the anti-inflammatories away from her due to her kidneys. Also stated that she gets tired. Her arthritis doesn't allow her to run. Confirmed had arthritis before taking Ibrance and before taking any Pfizer COVID-19 Vaccines. She was admitted to the hospital for the blood clots. Her right leg was swollen and she had a red spot on her knee so she went to the Urgent Care. The Urgent Care sent her to the hospital for her leg blood clot. The hospital took a CT scan and told her she had blood clots in her lungs also. Clarified she received the Pfizer COVID-19 Booster shot on 27Aug2021 and then was admitted to the hospital 08Sep2021 the same day the blood clots were identified must have been in the afternoon. Not too long ago she had another ultrasound. Her HCP has her on Pfizer Eliquis, 5mg twice a day, and there is nothing else to do for her. When the most recent ultrasound was taken she was told to also wear stockings because she gets cramps in her legs from the blood clots. The cramps happen in both legs. Her HCP told her to take magnesium and increased her dose from 500mg to 1000mg. Clarified her HCP started her on magnesium and Pfizer Eliquis after the blood clots because her blood clots had gotten worse. Originally the blood clots were in her right leg, now the blood clots are in both legs and her lungs. Her legs didn't hurt before and now the blood clots give her cramps. Confirmed she was admitted to the hospital on 08Sep2021 and was in there for like 2 or 3 days, couple of days, not very long. The hospital did a CT scan and that was about it. She did have another Pfizer COVID-19 Booster on 26Jul2022 (LOT: FP7139, Given at pharmacy or Drug Store, vaccine was not administered at PRIVATE) which was her 4th dose, but that was way after the blood clots. She had never had reactions after the COVID-19 shots or COVID-19 boosters and is not afraid to take them because she had no reaction and was ok until the blood clots. The vaccination was suggested to take the boosters and with her cancer she didn't want to get COVID. She was on high blood pressure medications and high cholesterol medications at the time of the events. This has nothing to do with Pfizer but her girlfriend had died of cancer. The caller asked for a mammogram for 4 years and was denied, then her girlfriend died and her HCP told her to insist she get a mammogram. When she finally got a mammogram she discovered she had cancer in her left breast, spine, and in her bones. Cancer Diagnosed sometime in 2019 and started Verzenio. Clarified she had a surgery to remove lymph nodes and left breast first and then started Verzenio. She had kept being told at her age she didn't need a mammogram anymore and she had no family history. Her girlfriend had ovarian cancer and died within months. Her girlfriend kept telling doctors something was wrong and the doctors didn't find anything. One of the doctors her girlfriend saw is also her doctor who insisted she get a mammogram. The doctor who insisted she get a mammogram was a gastroenterologist who had found her girlfriends ovarian cancer. The blood clots could have come from the boosters. Right now her major problem is her cancer. Either thing can kill her. Blood clots was reported as worsened. The patient was told to wear stockings and told to keep taking Eliquis to treat the blood clots. Prior Vaccinations (within 4 weeks) and family medical history relevant to adverse events (AEs) were none.