Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Deafness transitory, Disorientation, Dyskinesia, Feeling abnormal
Clinical narrative: DEAFNESS FOR ABOUT 2 DAYS; PSYCHOTIC EPISODES; COULD NOT WALK; KICKING LEGS AND HANDS; MUMBLING; CARRYING ON; SHAKING; GOT REAL HOT, DIDN'T WANT FAN ON; THOUGHT HUSBAND WAS STILL ALIVE; COULD NOT GET UP; GONE BACK IN TIME ONE MINUTE AND IN RIGHT MIND THE NEXT; NO STRENGTH; This spontaneous report received from a consumer concerned an unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in SEP-2021, about 2 weeks after vaccination, patient experienced ringing in ears and deafness for about 2 days.  According to the reporter, it was an epileptic seizure but this was not diagnosed. The patient did not know what she was doing: kicking legs and hands, mumbling, carrying on, shaking, she got real hot and did not want the fan on. Then she had psychotic episodes that lasted about 2 days after the ringing in ears and hearing/ deafness stopped. She did not have a fever. After that patient did not have any more episodes. She thought her husband was still alive. On an unspecified date, patient was hospitalised for about 5-6 days and then she was sent to a behavioral center for 8-9 days. As per the reporter, patient was still in the hospital. Patient had been having effects like back in time one minute and in right mind the next. Patient stayed in bed 4 days after she got the shot. She could not get up and walk and did not have the strength. Reporter advised the patient to contact her HCP for advise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deafness for about 2 days, psychotic episodes, kicking legs and hands, mumbling, carrying on, shaking, and got real hot, didn't want fan on, and the outcome of could not get up, could not walk, thought husband was still alive, gone back in time one minute and in right mind the next and no strength was not reported This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211006204-covid-19 vaccine ad26.cov2.s -Deafness for about 2 days, psychotic episodes, could not walk,  kicking legs and hands, mumbling, carrying on, shaking, got real hot, didn't want fan on, thought husband was still alive, could not get up, gone back in time one minute and in right mind the next. This event(s) is considered unassessable. The event(s) 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(s).  20211006204-covid-19 vaccine ad26.cov2.s -No strength. This event(s) is labeled per RSI and is therefore considered potentially related.