Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Bladder Catheterization; he can't walk; He remembered things but still was confused.; Encefalitis; he had his eyes turned; he sweated around 3 pajamas in the night; Fever/the fever was constant/it was 102/believes it went up to 105.; body shakings/horrible shaking; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS (Encefalitis), PYREXIA (Fever/the fever was constant/it was 102/believes it went up to 105.), TREMOR (body shakings/horrible shaking), EYE MOVEMENT DISORDER (he had his eyes turned), NIGHT SWEATS (he sweated around 3 pajamas in the night), GAIT DISTURBANCE (he can't walk), CONFUSIONAL STATE (He remembered things but still was confused.) and BLADDER CATHETERISATION (Bladder Catheterization) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever/the fever was constant/it was 102/believes it went up to 105.) (seriousness criterion hospitalization) and TREMOR (body shakings/horrible shaking) (seriousness criterion hospitalization). In May 2021, the patient experienced ENCEPHALITIS (EncefalThis case concerns a 69 -year-old male patient with no relevant medical history, reported , who experienced the  unexpected events  of fever and chills 6 days after the 1st dose of the vaccine(recurring  in 3 weeks ) and was hospitalized after 33 days post vaccine of the 1st dose  because of the unexpected events confusion .  On the 39th day post vaccine during the hospital stay unexpected  events were shaking and eye movement  , encephalitis, night sweats, bladder catheterization, and  Gait disturbance. .The rechallenge was not applicable as the event happened after the 1st dose.  The reporter did not provide any causality assessments. The benefit-risk relationship of Moderna in not affected by this report) (seriousness criteria hospitalization and medically significant), EYE MOVEMENT DISORDER (he had his eyes turned) (seriousness criterion hospitalization) and NIGHT SWEATS (he sweated around 3 pajamas in the night) (seriousness criterion hospitalization). On an unknown date, the patient experienced GAIT DISTURBANCE (he can't walk) (seriousness criterion hospitalization), CONFUSIONAL STATE (He remembered things but still was confused.) (seriousness criterion hospitalization) and BLADDER CATHETERISATION (Bladder Catheterization) (seriousness criterion hospitalization). The patient was hospitalized from 05-May-2021 to 15-May-2021 due to BLADDER CATHETERISATION, CONFUSIONAL STATE, ENCEPHALITIS, EYE MOVEMENT DISORDER, GAIT DISTURBANCE, NIGHT SWEATS, PYREXIA and TREMOR. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, ENCEPHALITIS (Encefalitis), PYREXIA (Fever/the fever was constant/it was 102/believes it went up to 105.), TREMOR (body shakings/horrible shaking), EYE MOVEMENT DISORDER (he had his eyes turned), NIGHT SWEATS (he sweated around 3 pajamas in the night), GAIT DISTURBANCE (he can't walk), CONFUSIONAL STATE (He remembered things but still was confused.) and BLADDER CATHETERISATION (Bladder Catheterization) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood was clean, there was (normal) blood was clean, there was nothing and there was nothing (normal) 16 vials to draw blood at one time, and there was nothing. On an unknown date, Body temperature: 102 (High) Fever was 102 and 105 (High) believes it went up to 105. On an unknown date, Coronavirus test: had nothing (normal) had nothing. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  On 8April2021, the patient had fever and body shakings. He had 3 weeks like that, taking "some pills", and some days he went to work, and some others he didn't. He went to his primary doctor and he stated that his blood was clean, there was nothing. But 2 days later the reporter tried to ask something to her husband, and he started answering weird things (She explained that it was because the fever had affected his brain), so he was taken to Emergency Room, had 2 Coronavirus tests done to him and had nothing, but that day he was admitted. On 5May2021 patient was admitted to the hospital. He was admitted for 11 days in the hospital, on the 6th day in the hospital they could finally put under control her fever. On that 6th day he had horrible shaking, he had his eyes turned, and it was because of the brain. The neurologist stated that he had a Encefalitis and stated that it was related to the vaccine. On the 5th night in the hospital he sweated 3 pajamas, in the hospital they put him steroids, and with that his fever was going down, and he was still taking steroids. In the hospital he also was being given Infusions (Inmunoglob: Gamunex- C) and those infusions was helping him. He now has a catheter to urinate, and he can't walk. He remembered things but still was confused. The doctors took liquid out of his back and they didn't find anything, and also took 16 vials to draw blood at one time, and there was nothing, because he was healthy. He can't even walk; it damaged his brain. Patient took Tylenol for fever first after that, his primary doctor gave him Ibuprofen and it improved a little, but the fever was constant, in the hospital it was very high, she remembers it was 102, and believes it went up to 105.  Company Comment: This case concerns a 69 -year-old male patient with no relevant medical history, reported , who experienced the  unexpected events  of fever and chills 6 days after the 1st dose of the vaccine(recurring  in 3 weeks ) and was hospitalized after 33 days post vaccine of the 1st dose  because of the unexpected events confusion .  On the 39th day post vaccine during the hospital stay unexpected  events were shaking and eye movement  , encephalitis, night sweats, bladder catheterization, and  Gait disturbance. .The rechallenge was not applicable as the event happened after the 1st dose.  The reporter did not provide any causality assessments. The benefit-risk relationship of Moderna in not affected by this report.; Sender's Comments: This case concerns a 69 -year-old male patient with no relevant medical history, reported , who experienced the  unexpected events  of fever and chills 6 days after the 1st dose of the vaccine(recurring  in 3 weeks ) and was hospitalized after 33 days post vaccine of the 1st dose  because of the unexpected events confusion .  On the 39th day post vaccine during the hospital stay unexpected  events were shaking and eye movement  , encephalitis, night sweats, bladder catheterization, and  Gait disturbance. .The rechallenge was not applicable as the event happened after the 1st dose.  The reporter did not provide any causality assessments. The benefit-risk relationship of Moderna in not affected by this report.