Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | FH8028 | RA |
blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; Had high fever, fever was 102 or 104 for 10 days; feeling like had the flu; stomach pains; DVT; Blacked out; hit head; fell since was standing; brain bleed, brain is obviously fine/Then had second bleed; back pain; leg pain; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ER8733, Upper arm, at Clinic), administration date: 30Mar2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; lot number: EW0170, Upper arm, at Clinic), administration date: 20Apr2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "leg pain"; DEEP VEIN THROMBOSIS (hospitalization) with onset Feb2025, outcome "recovered", described as "DVT"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 27May2025, outcome "unknown", described as "Blacked out"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 27May2025, outcome "unknown", described as "brain bleed, brain is obviously fine/Then had second bleed"; FALL (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "fell since was standing"; HEAD INJURY (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "hit head"; URINARY BLADDER HAEMORRHAGE (hospitalization), outcome "recovered", described as "blood clot on the renal gland"; PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization), SEPSIS (hospitalization), outcome "recovered" and all described as "blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis"; PYREXIA (hospitalization), outcome "recovered", described as "Had high fever, fever was 102 or 104 for 10 days"; INFLUENZA (hospitalization), outcome "unknown", described as "feeling like had the flu"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "stomach pains". The patient was hospitalized for deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, pyrexia, influenza, abdominal pain upper (start date: 22Feb2025, hospitalization duration: 18 day(s)); for loss of consciousness, head injury, fall, cerebral haemorrhage (start date: 27May2025, hospitalization duration: 10 day(s)). The events "feeling like had the flu" and "stomach pains" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102 or 104, notes: for 10 days; Computerised tomogram: found blood clot on the renal gland; saw brain bleed; was not clearing up, notes: second bleed; Weight: 158 lbs; 138 lbs; Weight: Lost 10 first time; Lost all this weight; Lost 10 pounds in May. Therapeutic measures were taken as a result of deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, cerebral haemorrhage, pyrexia. Clinical information: The patient reported that he ended up with a DVT in Feb2025. In 22Feb2025, the patient went to doctor feeling like had the flu, but the doctor said no, he/she saw something in urine. The patient went to the hospital and took CAT scan and found blood clot on the renal gland which traveled to the lung and in the blood, turned to sepsis. The patient had high fever, fever was 102 or 104 for 10 days. He was on all kinds of blood thinners, injections, in the stomach. After the cultures and all the medications, it had gone. He went home with PICC line. He reported he made a mistake, at first did midline, so he had to get it changed the day he was leaving, it was kind of painful taking it out. He reported his DVT is not ongoing, he has remains of an abscess in the kidney which is starting to resolve itself. He will go back to his urologist on 21Aug2025. With third one (vaccination), he had back pain and leg pain. Feeling like had the flu: he clarified and confirmed he was admitted into the hospital when had feeling of flu, had stomach pains, and that is when found the blood clot. He was admitted on 22Feb2025 then 18 days later discharged. Blacked out, hit head on 27May2025; he blacked out, then fell since he was standing. He was put on blood thinners when he went home, they wanted to keep him on blood thinners for 6 months. During the 3rd month, the patient blacked out, hit head. Not a 100% sure if it was the blood thinners. Due to this illness, he had to be on blood thinners for a while. Cardiologist said to be on blood thinners 6 months, hematologist said 3 months. This happened at the end of 3 months. He was down in basement with his daughter, he felt a little funny, then blacked out. He woke up 2 minutes later, had big nice sized egg on top of head. Ambulance came since he hit his head. He had CAT scans where they saw brain bleed. He reported his life was saved by the doctor. Then he had second bleed and was rushed as well. He had more CAT scans, and found it was not clearing up. He had a big to do surgery where they had to cut his skull. It was very uncomfortable. He got the bleed in the head, which then had to have surgery that night, 27May2025, after 35 or 40 staples in the head. He was admitted on 27May2025 and 10 days later was discharged, possibly 06Jun2025. He came home with walker, had no energy, no strength.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166581 same patient, and drug; different vaccine dose and event;US-PFIZER INC-202500166582 same patient, and drug; different vaccine dose and event;
Test Name: Body temperature; Result Unstructured Data: Test Result:102 or 104; Comments: for 10 days; Test Name: CAT scan; Result Unstructured Data: Test Result:found blood clot on the renal gland; Test Name: CAT scan; Result Unstructured Data: Test Result:saw brain bleed; Test Name: CAT scan; Result Unstructured Data: Test Result:was not clearing up; Comments: second bleed; Test Name: body weight; Result Unstructured Data: Test Result:158 lbs; Test Name: body weight; Result Unstructured Data: Test Result:138 lbs; Test Name: Body weight; Result Unstructured Data: Test Result:Lost 10 first time; Test Name: Body weight; Result Unstructured Data: Test Result:Lost all this weight; Test Name: Body weight; Result Unstructured Data: Test Result:Lost 10 pounds in May