Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Acute kidney injury, COVID-19, Renal mass
Clinical narrative: Acute on chronic renal failure (superimposed on chronic kidney disease); Acute COVID-19 infection; Renal mass; This spontaneous case from the country was retrieved on 22-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number), reported by other healthcare professional and concerned a 79-year-old, male patient. At the time of vaccination, the patient was a 78-year-old.  The patient's concurrent conditions included lung nodules, goitre, benign prostatic hyperplasia, hypercholesterolemia, colon polyp, diabetic nephropathy, gastroesophageal reflux disease (GERD), hypertension (HTN), benign Barrett's esophagus, diverticulosis, tobacco abuse in remission, anemia of chronic disease, chronic left leg edema, atherosclerosis of abdominal aorta, diabetic ulcer of foot, statin intolerance, drug-induced bradycardia (betablocker), atrial fibrillation, drug-induced coagulation inhibitor disorder, stage 3b chronic kidney disease, knee swelling, knee pain, hemarthrosis of right knee, type 2 diabetes mellitus with right diabetic foot ulcer (diet controlled with history of insulin use), stage 3 pressure injury of right heel and venous stasis of both lower extremities. The patient's past procedures included total knee arthroplasty ans partial amputation of right foot. The patient's concomitant medications included Tylenol (paracetamol), Norvasc (amlodipine besilate), vitamin C, Hygroton (chlortalidone) and vitamin D3, all used for an unreported indication.   On 11-Nov-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose and indication: not reported). The batch number reported was 312850.  On the same day, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose reported as '3', route of administration, anatomical location and indication: not reported). The batch number was reported as 034F21A.  On an unknown date in 2022, unknown amount of time after receiving Fluad Quadrivalent and Moderna COVID-19 vaccine, the patient had new diagnosis of renal mass.  On 30-Jul-2022, eight months and 19 days after receiving Fluad Quadrivalent and Moderna COVID-19 vaccine, the patient presented at the hospital with acute COVID-19 infection. Patient was weak and dehydrated and had acute on chronic renal failure superimposed on chronic kidney disease and was started on intravenous (IV) fluids. Patient did not meet any criteria for treatment of his COVID-19 infection as he was not hypoxic. Patient improved on IV fluids - his renal function significantly improved and also his energy level and appetite improved. The patient was able to tolerate general diet on the day of discharge. Patient's angiotensin converting enzyme (ACE) inhibitor was held given his acute on chronic renal failure and this was discontinued at the time of discharge.  On 01-Aug-2022, the patient was discharged from hospital in stable condition. The patient worked with physical therapy and occupational therapy who recommended home health care. It was reported statin was started by vascular surgery with prescription to be taken over by patient's primary care physician.   On an unknown date in 2022, the patient recovered from the events of 'acute on chronic renal failure' and 'COVID-19'.  At the time of initial reporting, the patient had not recovered from the event of renal mass. He had arranged follow-up with his primary care physician, as well as his urologist for his newly diagnosed renal mass.  The reporter did not provide causality assessment.  All events were assessed as serious due to seriousness criterion of hospitalization. Additionally, the event of 'acute on chronic renal failure' was considered to be medically significant by a Physician within Seqirus's  and Risk Management Department.  Company comment: A male patient was vaccinated with Fluad Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine on 11-Nov-2021.  On an unspecified date in 2022, the patient had new diagnosis of renal mass. Eight months and 19 days following vaccination, the patient developed acute COVID-19 infection and acute on chronic renal failure. Causal role of the suspect vaccine is assessed as not related for all events, due to chronological and biological implausibility.; Sender's Comments: A male patient was vaccinated with Fluad Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine on 11-Nov-2021.  On an unspecified date in 2022, the patient had new diagnosis of renal mass. Eight months and 19 days following vaccination, the patient developed acute COVID-19 infection and acute on chronic renal failure. Causal role of the suspect vaccine is assessed as not related for all events, due to chronological and biological implausibility.