Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Dehydration, Eating disorder, Malaise
Clinical narrative: dehydrated; Fever; unresponsive, and patient didn't know where he was and was confused; CKD levels were worse; stiffness; seizure/shaking/convulsions; wasn't feeling well; It was reported that patient then had another series of hospitalization for stage 4 kidney failure/urinated on himself in bed; wasn't eating; was nauseas; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RENAL FAILURE (It was reported that patient then had another series of hospitalization for stage 4 kidney failure/urinated on himself in bed), CONDITION AGGRAVATED (CKD levels were worse), SEIZURE (seizure/shaking/convulsions), MALAISE (wasn't feeling well), DEHYDRATION (dehydrated), PYREXIA (Fever), CONFUSIONAL STATE (unresponsive, and patient didn't know where he was and was confused), EATING DISORDER (wasn't eating), NAUSEA (was nauseas) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ENZALUTAMIDE for Prostate cancer.    The patient's past medical history included Open heart surgery (5 to 6 year ago) and Dialysis (patient had 1 day of temporary dialysis.) in 2022. Concurrent medical conditions included Prostate cancer, Kidney failure chronic (stage 4 kidney failure) and Seizure. Concomitant products included LEVETIRACETAM for Seizures, ABIRATERONE ACETATE (ZYTIGA) and PREDNISONE for an unknown indication.   On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, ENZALUTAMIDE (Oral use) dosage was changed to 80 milligram twice a day. In 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ENZALUTAMIDE (Oral use) 2 DF, unknown frequency for 3 days. On an unknown date, ENZALUTAMIDE (Oral use) dosage was changed to 80 milligram twice a day and ENZALUTAMIDE (Oral use) dosage was changed to 160 milligram. In 2021, the patient experienced RENAL FAILURE (It was reported that patient then had another series of hospitalization for stage 4 kidney failure/urinated on himself in bed) (seriousness criteria hospitalization and medically significant), MALAISE (wasn't feeling well) (seriousness criterion hospitalization), EATING DISORDER (wasn't eating) (seriousness criterion hospitalization) and NAUSEA (was nauseas) (seriousness criterion hospitalization). In November 2021, the patient experienced SEIZURE (seizure/shaking/convulsions) (seriousness criteria hospitalization and medically significant). In 2022, the patient experienced CONDITION AGGRAVATED (CKD levels were worse) (seriousness criterion hospitalization), DEHYDRATION (dehydrated) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), CONFUSIONAL STATE (unresponsive, and patient didn't know where he was and was confused) (seriousness criterion hospitalization) and MUSCULOSKELETAL STIFFNESS (stiffness) (seriousness criterion hospitalization). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RENAL FAILURE (It was reported that patient then had another series of hospitalization for stage 4 kidney failure/urinated on himself in bed), CONDITION AGGRAVATED (CKD levels were worse) and SEIZURE (seizure/shaking/convulsions) had not resolved and MALAISE (wasn't feeling well), DEHYDRATION (dehydrated), PYREXIA (Fever), CONFUSIONAL STATE (unresponsive, and patient didn't know where he was and was confused), EATING DISORDER (wasn't eating), NAUSEA (was nauseas) and MUSCULOSKELETAL STIFFNESS (stiffness) had resolved.            The patient was enrolled in Astellas sponsored patient assistance program Enzalutamide Astellas PAP. The patient received booster dose of Moderna vaccine on Apr-2022 or May-2022.   The patient had been hospitalized on several different occasions. The patient went to the hospital on 18-Nov-2021 because of the symptoms from the second Moderna Covid-19 vaccine injection. The patient was not feeling well, urinated on himself in bed, experienced seizure/shaking/convulsions, wasn't eating and was nauseas. The patient received a treatment medication of levetiracetam for his  seizures which is still ongoing at the time of report. The patient was given hydrocortisone during the hospital period. The patient was discharged on 25-Nov-2021. It was also reported that the  patient then had another series of hospitalizations (admitted on 10-Dec-2021 and discharged on 11-Dec-2021, admitted on 13-Dec-2021 and discharged on 21-Dec-2021 , admitted on 13-Jan-2022 and discharged on 15-Jan-2022) all for stage 4 kidney failure. The patient had 1 day of temporary dialysis but she did not know the date. There was another recent hospitalization of the patient of being admitted in the beginning of Apr-2022 or May-2022 because of the symptoms of the Moderna COVID-19 vaccine booster injection. The patient experienced seizures, stiffness, shaking, unresponsiveness, fever, did not know where he was, confused, dehydrated, and that made his CKD levels worse. The symptoms resolved on an unknown date at the hospital. The discharge date was unknown. The reporter also mentioned that the patient was only taking 2 pills of enzalutamide for 3 days during a hospital stay but could not remember when the dates were or what the reason was for this other hospitalization. The patient was able to resume his regular dose of 2, 40 mg (80 mg) tablets in the morning and 2, 40 mg (80 mg) tablets in the evening.  Company comment: This is a regulatory case concerns a 73-year-old male patient with medical history of Co-suspect product included non-company product ENZALUTAMIDE, patient's past medical history included Open heart surgery, Dialysis: concurrent medical conditions included Prostate cancer, Kidney failure chronic (stage 4 kidney failure) and Seizure; concomitant products included LEVETIRACETAM, ABIRATERONE and PREDNISONE who experienced  the seriousness criteria hospitalization and medically significant unexpected AESIs of renal failure, seizure; the seriousness criteria hospitalization unexpected events of condition aggravated (described as CKD levels were worse), malaise, dehydration, pyrexia, confusional state, eating disorder, nausea, musculoskeletal stiffness in the context of the 2nd. dose of mRNA-1273 vaccine administrated in November, 18, 2021. The patient had been hospitalized on several different occasions and the same day of the mentioned dose. At the time of the report, renal failure, condition aggravated and seizure events had not resolved. The medical history Is a contributor for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.