Age: 74.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: high D-dimer; blood clots/has 4 blood clots in 1 leg and 2 blood cots in the other leg; Comirnaty and Flu vaccine administered on same day; Comirnaty and Flu vaccine administered on same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 28Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 74 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Oct2022 as dose number unknown, single (Lot number: UJ875AD), in right arm for immunisation. The patient's relevant medical history included: "blood vessel injuries" (unspecified if ongoing), notes: Had 2 blood vessel injuries.; "factor 2 Thrombophilia mutation" (unspecified if ongoing), notes: had a Boston Heart Test run by cardiologist. The patient's family history included: "Scleroderma", start date: 1977 (unspecified if ongoing), notes: Scleroderma. Obviously an autoimmune issue; "Pulmonary arterial hypertension" (unspecified if ongoing), notes: Pulmonary arterial hypertension. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose: Sars Cov2, Covid-19 Mrna LMP-S PF30mcg/0.3ml Pfizer Covid-19 vaccine, Date: 22Feb2021, LOT: EN6202, NDC/EXP: Unknown), administration date: 22Feb2021, when the patient was 72-year-old, for Covid-19 Immunization; BNT162b2 (Second Dose: Sars Cov2, Covid-19 Mrna LMP-S PF30mcg/0.3ml Pfizer Covid-19 vaccine, Date: 15Mar2021, LOT: EN6204, NDC/EXP: Unknown), administration date: 15Mar2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Third Dose: First Booster: Covid-19 vaccine, Date: 18Oct2021, LOT: 301558A, NDC/EXP: Unknown), administration date: 18Oct2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Fourth Dose: 18May2022, Covid-19 Mrna LNPSPF 30mcg/0.3ml TS Comirnaty, TS30mcg/0.3ml, LOT: FJ9943, NDC/EXP: Unknown), administration date: 18May2022, when the patient was 73-year-old, for Covid-19 immunization; tetanus shot (Vaccine Name: Tetanus shot, TDap (Adacel), Manufacturer: PMC Sanofi Pasteur Inc., LOT: 2CA18C1, EXP: Unknown, Route, Anatomical Location: think left arm), administration date: 21Oct2022, when the patient was 74-year-old. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "Comirnaty and Flu vaccine administered on same day"; THROMBOSIS (medically significant) with onset 15Dec2022, outcome "unknown", described as "blood clots/has 4 blood clots in 1 leg and 2 blood cots in the other leg"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "high D-dimer". The events "blood clots/has 4 blood clots in 1 leg and 2 blood cots in the other leg", "high d-dimer" and "comirnaty and flu vaccine administered on same day" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) 16.74 mg/l, notes: Blood test came up on computer as 16.74 mg/l; Fibrin D dimer: (May2022) 1.12, notes: it was 1.12 ugr/ml; (06Dec2022) 16.74, notes: Result: 16.74;  Unit: Not Provided; N-terminal prohormone brain natriuretic peptide: (May2022) 182, notes: Result: 182; Unit: Not Provided; (06Dec2022) 2026, notes: Result: 2026; Unit: pg/ml; Ultrasound scan: (unspecified date) she has 4 blood clots in 1 leg and 2 blood cots, notes: show that she has 4 blood clots in 1 leg and 2 blood cots in the other leg; X-ray: (unspecified date) she has 4 blood clots in 1 leg and 2 blood cots, notes: show that she has 4 blood clots in 1 leg and 2 blood cots in the other leg. Therapeutic measures were taken as a result of thrombosis.   Clinical course: Clinical course: Scleroderma and was not an antivaxxer. Other Conditions: Yes. Investigations: Yes. Had 2 blood vessel injuries. One after trashed IV after surgery. Second one was after getting treatment for Lyme Disease.These were both a long time ago. Test results: 2 of these tests have names that are so similar but, reference ranges are so different. Family Medical History Relevant to Adverse Events (AEs): Mother had scleroderma, was on oxygen 24/7 and probably had pulmonary arterial hypertension. Other than that, no. Everybody had their issues. Caller and her mother are the only ones who had autoimmune problems. Caller has had multiple D-dimer tests in the past, since 2020. The fifth one she had on 06Dec2022 showed that she had 16.74, or something like that, in whatever the little scientific measurement is, the value, which generated a lot of activity. Does not have any blood clots in arms or in any emboli. When she talked to her pharmacist about D-dimer being so high, they told her that this was still experimental and that she needs to report this to Pfizer. Was last week when the D-dimer came back. Blood clots: Treatment: was now on Eliquis. The monkey wrench that she thought may be of interest, is that she had a Boston Heart Test run by cardiologist. That showed that she has factor 2 Thrombophilia mutation, which is also run by 23 and me. Concerning that it was the same position as being on gene mutation. Also on Lab core, and one from Baylor college that also run the Factor 2 gene.These are all related to Thrombophilia, which was blood clots. NT-ProBNP went really high.Previous reading in May2022 was 182 and sky rocketed on 06Dec2022 to 2026pg/ml. When she actually saw the report, she thought, not going to panic, refuses not to panic on this. Thought what she might have done to cause this. Then remembered she got the other booster shot. At that point, the only manufacturer that she knew to be implicated with blood clots was Moderna. Vaccination Facility Type: Pharmacy or Drug Store. On same day, 28Oct2022, had flu vaccine. Influenza high dose quadrivalent Fluzone high dose high dose quadrivalent. After getting through the ultrasound on both legs, they called radiologist to read results and caller was going to be brought to Emergency room but, her cardiologist told nurse that caller was prescribed Eliquis and she went home and did not end up going to emergency room. Thinking that the factor 2 genetic thing could play a part in this. For some other people who have gotten blood clots and also have a thrombophilia problem genetic in nature and may not know about it. Does not go around with little sign that says she has factor 2 but, maybe she should. Wondering if that should be something that is a suggestion to people that are researching. If this person has a genetic problem with thrombophilia. Should be asking someone if having genetic testing done, if having the factor 2 was on 23 and me or that they just happened to have other genetic studies that back it up.