Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Ammonia, Asthenia, Azotaemia, Blood creatinine
Clinical narrative: This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1808545) concerned a 73 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: former smoker, history of concussion, and liver lesion, and concurrent conditions included: atrial fibrillation, bone metastases cad (computer-aided detection), dyslipidemia, cad (coronary artery disease) multiple vessel, essential hypertension, lung nodule, mitral valve disorder, obesity class II, obstructive uropathy, and prostate cancer metastatic to multiple sites. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) 1 total, drug start period 206 days, dose was not reported, administered on 15-MAR-2021 on left arm for an unspecified indication. No concomitant medications were reported.  On 07-OCT-2021, the patient experienced encephalopathy with multiple sclerosis changes creatinine (72 baseline) and 14 Uremia with multiple sclerosis changes. From the past nephrology consult by ultrasound, it was stated that the bilateral hydro had stent in left. On urology consultation, doctor did cyst removal of left old stent and attempted bilateral ureteral stent. On same day, nephrostomy was placed. His encephalopathy improved with treatment of acute kidney injury. Ammonia was 108 treated and with lactulose, even small amount caused diarrhea. He not had any computed tomography changes of cirrhosis on evaluation. Hepatitis screen was negative. On 07-OCT-2021, the patient was hospitalized. He had a prolonged hospital course due to significant acute kidney injury. The patient was hospitalized for 9 days. The patient had days' progresses became a normal to baseline. He was up and ambulatory with assistance but does had generalized weakness. On day of discharge he was found to have incidental finding of COVID positive was actually vaccinated (confirmed clinical vaccination failure). He had no symptoms of COVID, due to this the discharge was held for a day and Inflammatory marker showed actually improvement in a ferritin. Patient had no new symptoms of respiratory problem. He had no abdominal pain nausea vomiting at this time. He was discharged on 15-OCT-2021. Laboratory data included: Ammonia (NR: not provided) 108, COVID-19 virus test (NR: not provided) positive, Creatinine (NR: not provided) 72 baseline, Diagnostic ultrasound (NR: not provided) stent in left for hydro, and Hepatitis viral test NOS (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute kidney injury, ammonia, azotaemia, blood creatinine increased, covid-19, encephalopathy, hepatitis viral test negative, hydronephrosis, inflammatory marker test, multiple sclerosis, nephrostomy, sars-cov-2 test positive, serum ferritin, and asthenia, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000201204. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 12-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This follow-up version updates- Product quality complaint investigation result.. This updated information does not change the prior assessed causality of reported events.  20211114895 covid-19 vaccine ad26.cov2.s-Multiple sclerosis, Encephalopathy, Covid19, Inflammatory marker test, Serum ferritin, Asthenia, sars-cov-2 test positive, hepatitis viral test negative. 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).  20211114895 - covid-19 vaccine ad26.cov2.s Acute kidney injury, Azotemia, Hydronephrosis, ammonia, blood creatinine increased, nephrostomy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE  20211114895-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS