Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Jugular vein thrombosis, Magnetic resonance imaging, Office visit, Specialist consultation
Clinical narrative: Blood clot in brain (CVST); Blood clot in left leg; Headache; Numbness on left side of body/face; Blood clot in jugular; Fistula on brain; Dose Number:1 (12Apr2021)/Dose Number:2 (29Apr2021); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 2, single (Lot number: EW0172) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Apr2021, outcome "unknown", described as "Dose Number:1 (12Apr2021)/Dose Number:2 (29Apr2021)"; CEREBRAL VENOUS SINUS THROMBOSIS (hospitalization, disability, medically significant) with onset 02Jul2021, outcome "unknown", described as "Blood clot in brain (CVST)"; JUGULAR VEIN THROMBOSIS (hospitalization, disability) with onset 02Jul2021, outcome "unknown", described as "Blood clot in jugular"; THROMBOSIS (hospitalization, disability, medically significant) with onset 02Jul2021, outcome "unknown", described as "Blood clot in left leg"; FISTULA (hospitalization, disability) with onset 02Jul2021, outcome "unknown", described as "Fistula on brain"; HEADACHE (hospitalization, disability) with onset 02Jul2021, outcome "unknown"; HYPOAESTHESIA (hospitalization, disability) with onset 02Jul2021, outcome "unknown", described as "Numbness on left side of body/face". The patient was hospitalized for cerebral venous sinus thrombosis, thrombosis, headache, hypoaesthesia, jugular vein thrombosis, fistula (hospitalization duration: 2 day(s)). The events "blood clot in brain (cvst)", "blood clot in left leg", "headache", "numbness on left side of body/face", "blood clot in jugular" and "fistula on brain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram cerebral: Unknown results, notes: 2 cerebral angiograms; Unknown results, notes: Had another cerebral angiogram; Magnetic resonance imaging: Blood clot in brain (CVST), blood clot in jugular, notes: found blood clot in brain (CVST), blood clot in jugular and fistula on brain; Office visit: for treatment and he did something to neck, notes: Went to chiropractor for treatment and he did something to neck; Specialist consultation: sent to ER for MRI, notes: He sent me to ER for MRI. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis, thrombosis, headache, hypoaesthesia, jugular vein thrombosis, fistula.  Clinical Information: Serious was Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: Yes. Seriousness criteria-Disabling/Incapacitating: Yes. Seriousness criteria-Congenital anomaly/birth defect: No. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received amlodipine within 2 weeks of vaccination. Reported Event was that patient had a headache that wouldn't go away and never got headaches before. Went to chiropractor for treatment and he did something to his neck that caused numbness on left side of body/face. Went to urgent care and they referred patient to neurologist. He sent patient to ER for MRI and they found blood clot in brain (CVST), blood clot in jugular and fistula on brain and had a cerebral angiogram. While deciding on treatment options patient got a blood clot in left leg and was put on Xarelto blood thinner. Had another cerebral angiogram and an endovascular embolism. The adverse event resulted in the Doctor or other healthcare professional office/clinic visit. The adverse event resulted in Emergency room/department or urgent care. Treatment received for the adverse event included 2 cerebral angiograms and endovascular embolism. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had no known allergies.  No follow-up attempts possible. No further information expected.