Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Computerised tomogram, Cystitis, Device related infection, Diplegia
Clinical narrative: LOST USE OF HER BLADDER; LOST USE OF HER KIDNEYS; BLADDER INFECTION; INFECTION DUE TO THE CATHETER; LEGS PARALYSED/DISABLED AND COULDNT WALK; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: back problems, and concurrent conditions included: drug allergy (Immatrek, Ambien, Regaline, Proxaril), penicillin allergy, non alcohol user, and smoker (1/2 pack per day), and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 on right arm for covid-19 prophylaxis. No concomitant medications were reported.  On 15-APR-2021, 7 days later after vaccination, patient got up to go to work and legs were paralyzed and couldn't walk. Admitted to hospital on 17-APR-2021 and did a CAT (computerized axial tomography) scan and sent patient home saying patient was okay but still couldn't walk. The next day patient's best friend took her to the hospital because patient could still not walk. Patient now had a suprapubic catheter because patient had lost use of her legs and bladder and kidneys. Went to rehab to learn how to walk again. Patient now classified as disabled and cannot walk again. Patient had been hospitalized approximately 17 times. On DEC-2021, patient almost died, got an infection due to the catheter, was in ICU (intensive care unit) approximately 1 week and approximately 2 weeks in hospital total. On Monday 14-NOV-2022, just got out of latest hospitalization, due to a bladder infection on an unspecified date in 2022. The doctors said that patient would probably have this catheter long term. Major leg problems with constant pain and unable to use her legs. Physical therapy daily now to check on health status. Laboratory data (dates unspecified) included: CAT scan was okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs paralysed/disabled and couldnt walk, lost use of her bladder, and lost use of her kidneys, and the outcome of infection due to the catheter and bladder infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0:20221141450-legs paralysed/disabled and couldnt walk. 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221141450- infection due to the catheter. Another cause for the event has been clinically confirmed. Therefore, this event is considered inconsistent with vaccine administration. [as catheter is a know cause for infection]  20221141450-bladder infection. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.   20221141450- lost use of her bladder and lost use of her kidneys. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.