Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Bladder neoplasm, Blood urine present, Full blood count, Magnetic resonance imaging, Tuberculin test
Clinical narrative: BLOOD IN URINE; BLADDER NEOPLASM; This spontaneous report received from a consumer concerned a 69 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, no tobacco user, alcohol user, fiber glass allergy manifested by rash and itching, and depression. The patient experienced allergy manifested by rash when treated with clindamycin. The patient received rivaroxaban (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for blood thinner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on FEB-2021 for prophylactic vaccination (dose series number 1). 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 injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks, from 2019 for psoriatic arthritis, and moderate to severe chronic plaque psoriasis. Concomitant medications included sertraline hydrochloride for depression, amlodipine for high blood pressure, benazepril for high blood pressure, and hydrochlorothiazide.  On an unspecified date in JUL-2021, the patient experienced bladder neoplasm. On 12-JUL-2021, the patient experienced blood in urine. The patient went to emergency room due to blood in urine but no medication given in emergency room. He was taken off Xarelto when he experienced blood in his urine. He underwent Bacillus Calmette Guerin treatment for six weeks and had the bladder tumor removed on 16-SEP-2021. He was now back in Xarelto after the bladder tumor was removed. He did not know if the bladder tumor was benign or malignant. Laboratory data included: Complete blood count (NR: not provided) not reported, Diagnostic ultrasound (NR: not provided) not reported, and Magnetic resonance imaging (NR: not provided) not reported.  On NOV-2021, Laboratory data included: Tuberculin test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The company causality and reporter considered the causality between xarelto and bladder neoplasm as not related. The patient recovered from bladder neoplasm on SEP-2021, and blood in urine on AUG-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211252666-COVID-19 VACCINE AD26.COV2.S-Bladder neoplasm. 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. 20211252666-RIVAROXABAN-Bladder neoplasm. 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.