Age: 36.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Investigation, Knee operation, Thrombosis, Ultrasound scan
Clinical narrative: knee surgery; Blood clot/Blood clot was in her lower extremities/permanent swelling in her legs/leg was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "blood clot/blood clot Located in the left leg" (unspecified if ongoing), notes: she did have blood clot prior, Previous blood clot Located in the left leg; "fall" (unspecified if ongoing), notes: The original clot was from a fall and cracking up scar tissue, it was trauma related; "cracking up scar tissue" (unspecified if ongoing), notes: The original clot was from a fall and cracking up scar tissue, it was trauma related; "DVT" (unspecified if ongoing); "ablation on the right leg on the deep veins" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset Jun2022, outcome "unknown", described as "Blood clot/Blood clot was in her lower extremities/permanent swelling in her legs/leg was red"; KNEE OPERATION (medically significant), outcome "unknown", described as "knee surgery". The event "knee surgery" required emergency room visit. The event "blood clot/blood clot was in her lower extremities/permanent swelling in her legs/leg was red" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: genetic factors: none, notes: She does not have any predisposing clotting factors and does not have any genetic factors. she was tested for genetic factices, which she has none; Ultrasound scan: blood clot, notes: Had an ultrasound of the left leg in the ER, which is how they found the blood clot. Therapeutic measures were taken as a result of thrombosis.  Clinical course: Wanted to report what she believes was an AE or side effect of the vaccine. Two months after getting her first booster, she got a blood clot. Went to the ER to get diagnosed. Is in the process of getting a new PCP. Clarifies she did have blood clot prior, which made her chances for a blood clot to happen again exponentially. There's a 30% chance of another clot in 10 years, but it goes down after that. Can send information for the hematologist she went to for the clot. Since this was her second blood clot, she was tested for genetic factors. She does not have any predisposing clotting factors and does not have any genetic factors. The original clot was from a fall and cracking up scar tissue, it was trauma related. But since this was her second clot, she was tested for genetic factices, which she has none. Is on Xarelto for the rest of her life because this was her second blood clot. She still will get her booster for COVID-19 from Pfizer. This is not going to stop her getting the vaccine. Knows there are risks to things. She firmly believes the vaccine did cause it because she has no other factors. But it is likely because she had a previous clot, she had a possibility of it being higher. States it happens, it's not a thing, but stuff happens. She's glad she got it taken care of. She wass still very pro-vax. Blood clot was in her lower extremities. It was located in the calf, broke off, and traveled to the inner thigh. This was in her left leg. The left leg was also where the previous blood clot was located. Because she had a DVT, those deep veins were traumatized and are a little thinner in some places because of the previous clot, which probably led to some of it. She did have an ablation on the right leg on the deep veins, which is probably the reason it went to the left leg. The left leg wasn't messed up enough so she couldn't get the ablation due to insurance. This led her left leg open to getting a clot again. Knew she had the blood clot this time. Last time, the doctor showed her how the skin, when it swells, and if she pushed her finger in and the indent stays, that was a big indicator of a clot. This is how she knew how to check this time if she had a clot. She does have permanent swelling in her legs because of a knee surgery, but the leg was red and swollen. She pushed in and it was indenting pretty deeply. She immediately went to the ER. States the skin was supposed to bounce back, but when it does not and indents instead, that is indicative of severe swelling and possible blood clot. Confirms all vaccines were manufactured by Pfizer. She's had the 2 initial doses of the COVID-19 Vaccine and then 2 boosters. Her first booster was in Apr2022. States she had the blood clot for a little bit, but noticed it heavily in Jun2022. States she was still going to get the Pfizer COVID-19 vaccine. She knows what happened was rare and was just what, a crapshoot and could happen, but someone has to be the 0.0001%. After the blood clot in Jun2022, she got a Pfizer COVID-19 Vaccine booster on 25Oct2023. Clarifies she was not admitted to the hospital for the clot. She was seen in the ER at (institute name). Was there all night. She went in around 9PM. Had to wait and for them to do other stuff. She was given Xarelto and told to follow up with the hematologist. Felt awkward when she went into the Hematologist's office because it's located at the Oncologist. States she only had a blood clot and others were there with cancer. No further details provided on these others with cancer. Got the COVID-19 Vaccine at (pharmacy name). Doesn't know where her vaccine card was at this time. COVID-19 Vaccine was administered in the arm, doesn't remember which arm. Had the Flu shot in one arm and the COVID-19 Vaccine in the other arm. Vaccine was not Administered at Military Facility. She just works with kids as an nanny, she gets vaccines regularly. Weight: States she was chunky, she was aware and working on it. No Other Products/ Concomitant products, was very carful because she's been on medication since she was a kid. No further details provided. Prior Vaccinations (within 4 weeks): Had flu shot in Apr2022 on same day as the COVID-19 Vaccine. Details and information regarding flu shot are all unknown. Family Medical History Relevant to Adverse Events (AEs): doesn't think so.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.