Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: got some blood clots on her leg/ 6 clots in her left leg; left leg was swollen, foot, ankle, calf were swollen; left leg was swollen, foot, ankle, calf were swollen; achiness; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 5 (booster), single (Lot number: GH1657) at the age of 74 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma From: Probably back when caller was about 45 years old or 40 years old, so 30 years ago.; "COPD" (ongoing), notes: COPD From: Probably about 25 years ago; "Colds" (unspecified if ongoing), notes: Caller had a cold that went to a cough, all colds do because of having COPD; "Cough" (unspecified if ongoing), notes: Caller had a cold that went to a cough, all colds do because of having COPD; "left knee replaced", start date: 2018 (unspecified if ongoing), notes: Had a left knee replaced but that was 4 years ago in 2018; "COVID", start date: Jul2022 (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE taken for chronic obstructive pulmonary disease, start date: 26Dec2022; PREDNISONE taken for chronic obstructive pulmonary disease, start date: 26Dec2022, stop date: 30Dec2022. Past drug history included: Doxycycline; Prednisone. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number EL8982, providing from vaccination card, no NDC number or expiration date to provide.), administration date: 28Jan2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "COVID"; BNT162b2 (DOSE 2, SINGLE, Lot number EN6201, providing from vaccination card, no NDC number or expiration date to provide.), administration date: 18Feb2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "COVID"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number FF2590, providing from vaccination card, no NDC number or expiration date to provide.), administration date: 15Oct2021, when the patient was 73-year-old, for Covid-19 immunization, reaction(s): "COVID"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number thinks is FX9894, maybe FK9894, providing from vaccination card which is handwritten, no NDC number or expiration date to provide.), administration date: 25May2022, when the patient was 73-year-old, for Covid-19 immunization, reaction(s): "COVID". The following information was reported: PAIN (medically significant) with onset 31Dec2022, outcome "unknown", described as "achiness"; THROMBOSIS (medically significant) with onset 31Dec2022, outcome "unknown", described as "got some blood clots on her leg/ 6 clots in her left leg"; PERIPHERAL SWELLING (medically significant), JOINT SWELLING (medically significant) all with onset 31Dec2022, outcome "unknown" and all described as "left leg was swollen, foot, ankle, calf were swollen". The patient underwent the following laboratory tests and procedures: Ultrasound scan: (01Jan2023) which picked up 6 blood clots, notes: which were all nonocclusive, blood clots were at 6 different sites starting at groin and going down to ankle. Therapeutic measures were taken as a result of thrombosis, peripheral swelling, joint swelling, pain.  Clinical course: Patient mentioned that she got some blood clots on her leg after taking the covid 19 vaccine. Patient was asking if she got that from Pfizer covid-19 vaccine. She has received all of her vaccine shots she is supposed to have, She had a mild case of COVID in July of the past year. She had blood clots on New Years Day, she ended up with 6 clots in her left leg and doctors cannot find any reason for her to have them, she stated she had "unprovoked blood clot". Blood clots and test results: 6 blood clots in the left leg Looked down and saw left leg was swollen, foot, ankle, calf were swollen, but no severe pain, had achiness. Seriousness: Not disabling, but would say medically significant. Don't want to mess around with blood clots. Causality blood clots: That's why caller was calling and talking, caller has no idea, saw hematologist who asked caller a million questions, all caller had to say was no, caller was active, does exercise, eats proper, pretty proper, and just no reason for caller to have blood clots. Now calling the blood clots unprovoked blood clots, which because of that, can't find reason, no drug, not sedentary, no injures ,telling caller that caller may have to be on blood thinners the rest of caller's life. Caller was not a happy camper. Had a left knee replaced but that was 4 years ago in 2018 and every doctor says those can't be blood clots from having knee replaced 4 years ago, has had no problems since then until New Years Eve. Really doesn't feel bad, unless something happens caller was not going until 06Mar2023 to get another ultrasound to see if blood clots have gone away. Event details: On 02Jan2023 caller started on Xarelto (Manufacturer: Janssen Pharmaceuticals), was put on Xarelto immediately. Starting with a starter pack now and after finishes this pack caller will continue taking Xarelto, Manufacturer: Janssen Pharmaceuticals. Caller mentioned that after taking the vaccines she got blood clots in one leg and she is still dealing with it. And she needs to be put on blood thinner.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 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 product 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.,Linked Report(s) : US-PFIZER INC-202300036887 same patient, different dose, different event;