Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy prostate, Cerebrovascular accident, Computerised tomogram, Liver function test, Magnetic resonance imaging
Clinical narrative: STROKE; PAIN; This spontaneous report received from a patient concerned a 63 year old male of unspecified race and ethnic origin. The patient's weight was 240 pounds, and height was 68 inches. The patient's past medical history included: plaque psoriasis, stone urinary bladder, incision site abscess, pain, pain ankle, painful feet, mechanical valves placement in the heart, open heart surgery, hernia repair, prostate removal surgery and bladder stone removal surgery, and concurrent conditions included: aneurysm, elevated prostate specific antigen, unable to walk, drug effect decreased, non-smoker, and abstains from alcohol. On AUG-2018, Laboratory data included: CT scan (NR: not provided) Bladder Stones, and Magnetic resonance imaging (NR: not provided) Bladder Stones, not reported. On OCT-2018, Laboratory data included: PSA (NR: not provided) 29 ng/mL. On 2020, Laboratory data included: PSA (NR: not provided) 10 ng/mL The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total on 02-JUN-2021 for prophylactic vaccination.  On JUN-2021, the patient experienced liver issue/numbers high. On 06-JUN-2021, the patient experienced stroke and it was associated symptoms which were right side body weakness, left side body paralysis, slurred speech and unsteady gait (dose number in series 1), and was hospitalized for an unspecified number of days. On JUN-2021, Laboratory data included: Liver function test (NR: not provided) Numbers high (increased). On 06-JUN-2021, Laboratory data included: CT scan (NR: not provided) Confirmed Stroke, and Diagnostic ultrasound (NR: not provided) Stroke. On an unspecified date in DEC-2021, the patient experienced something moved in back (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported administered 1 in total on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks from 2017 to DEC-2021, dose was not reported, 1 time every 2 weeks from JUL-2020 to OCT-2020, dose was not reported, 1 time every 2 weeks from DEC-2020 to FEB-2021, dose and frequency were not reported from APR-2021 to MAY-2021, and dose was not reported, 1 time every 2 weeks, from JUN-2021 for chronic plaque psoriasis; and methotrexate (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for an unspecified indication.  Concomitant medications included acetylsalicylic acid, atenolol, fenofibrate, glimepiride, levofloxacin hemihydrate, and warfarin.  On an unspecified date, the patient experienced recurrence of stroke, and pain (dose number in series 2). Laboratory data (dates unspecified) included: Biopsy prostate (NR: not provided) Negative for Cancer, and Pain scale (NR: not provided) 6 to 7 out of 10 down to 2 to 2.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn on MAY-2021; and action taken with methotrexate was not reported. The patient recovered from stroke, and pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210726698 (dose number in series 1).; Sender's Comments: V0: 20220209701- Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.