Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram thorax, Electrocardiogram, Full blood count, Lipids
Clinical narrative: Blood clot; Blood clot in my leg; Blood clot in my right leg; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2, Pfizer Covid 19 vaccine), administered in arm right, administration date 21Mar2021 (Lot number: EN6207) at the age of 38 years as dose 2, single for covid-19 immunisation. Not any prior vaccination (within 4 weeks). Family history included: "Factor V blood clotting disorder" (ongoing), notes: I have a family history of blood clotting disorder called Factor V. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, LOT# for the first shot: EN6200, Anatomical location: Left arm), administration date: 28Feb2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "Blood clot; Blood clot in my leg; Blood clot in my right leg". The patient underwent the following laboratory tests and procedures: blood test: blood clot, notes: I was diagnosed with a blood clot, it was just diagnosed that I had a blood clot in my leg; computerised tomogram thorax (CT of chest): unknown results; electrocardiogram (EKG): unknown results; full blood count (CBC): unknown results; lipids: unknown results; metabolic function test (CMP): unknown results; thyroid function test: unknown results; troponin: unknown results; vitamin D: unknown results. Therapeutic measures were taken as a result of thrombosis: Xarelto.Consumer (nurse) stated, "I am calling because I have like 2 things. I did get the Pfizer Covid vaccination and I got my first one in Feb2021 and my second one in Mar2021 and I was diagnosed with a blood clot and I just wanted to see if that is something I should report to you all, with it being that far like is it even like a risk. Also, I do have Factor V blood clotting disorder (history) as well and I was told it was okay to still get the shot and I did and I was having somethings going on (not clarified) and then it was just diagnosed that I had a blood clot in my leg. I have been put on Xarelto for the blood clot, for the next week pretty high dose (not clarified further) and then I will be on twice a day. So, I am trying to find out like I was given a free card and that helped me to get my first medicine, my insurance from the doctor just filled it for Jan like it is going to be like expensive and I just can't afford that. So, that was kind of two things I had, I would like to know if I should report that to you all that I do have a blood clot and I did get after I had the Covid vaccine and about the medication, the cost." Consumer further stated, "I had the first one in 28Feb2021 and the second one in Mar2021. The medicine that I was just put on, for the blood clot is Xarelto." When paraphrased the concern, consumer stated, "I want to report, I didn't know if I should report that to you all because I don't know, I just didn't know if there is something like, so many people say that like blood clots are risk with the virus or vaccine. So, I didn't know if I should report that to you or not." Consumer stated, "So, this happened, like some swelling for a couple of months but 2 weeks ago, I started having swelling in my right calf and I was diagnosed on Thursday, the 9th of this month, with a blood clot in my right leg." (not clarified further). Causality: Consumer stated, "No, I don't feel like, I just felt like I needed to report, I do have and you can note this too, I have Factor V, I have a family history of blood clotting disorder called Factor V (history). I did talk with my doctor before getting the shot and I was told that it was still recommended to go ahead and get the vaccination. So, I did the vaccination and then now, here I am diagnosed with the blood clot. So, I just wanted to make some type because I did not know and I just wanted to make some type of a report with you all or just talk to somebody about it and to let you all know that it has not been quite a year since I got the shot and I have never had any symptoms of blood clot before this and now here I am, I have a blood clot. So, I am a little reserved to get another third shot right now. So, that is why I wanted to call and just report it and see if this is something that other people has reported within a year of getting the shot because it is scary and they are not knowing, so that's why." (consumer was not sure, hence causality tab left unchecked). Other medications: Consumer stated "Now, I have been placed on Xarelto and I am taking two 5 mg tablet in the morning and two 5 mg tablets in evening. So, I am doing like a total 20 mg a day for 7 days and then I am going to go on 5 mg in the morning and 5 mg at the night after the week of taking it like this."; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration BNT162B2 to the reported event thrombosis cannot be totally excluded. 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.