Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ultrasound kidney, Urine analysis
Clinical narrative: Acute renal Failure; This spontaneous case was reported by a physician and describes the occurrence of ACUTE KIDNEY INJURY (Acute renal Failure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for an unknown indication.  The patient's past medical history included Myelofibrosis (FGFR1 myelofibrosis) on 11-Aug-2018 and Bone marrow aspiration (bone marrow aspiration / biopsy (BMA/Bx) were negative for disease on 11-JUL-2019.). Concurrent medical conditions included Diabetes mellitus since 1999 and Urinary tract infection (chronic urinary tract infections was reported.) since 15-Jan-2021. Concomitant products included PEMIGATINIB from 29-Mar-2019 to 30-Mar-2021 for Myelofibrosis, CALCIUM ACETATE from 07-Jun-2019 to 04-Mar-2021, BIOTIN from 10-May-2019 to an unknown date, GLIMEPIRIDE from 16-Feb-2020 to an unknown date, VITAMIN D3 from 27-Nov-2019 to an unknown date, IRON from 23-Mar-2020 to 30-Mar-2020, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 29-Jan-2021 to 12-Feb-2021, ALBUTEROL [SALBUTAMOL] from 20-Jan-2021 to an unknown date and GABAPENTIN from 03-Jul-2019 to an unknown date for an unknown indication, ACETAMINOPHEN from 30-Mar-2014 to an unknown date.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Mar-2021, the patient started CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) (unknown route) at an unspecified dose. On 26-Mar-2021, the patient experienced ACUTE KIDNEY INJURY (Acute renal Failure) (seriousness criteria hospitalization and medically significant). The patient was treated with NORMAL SALINE 25-Mar-2021 at a dose of 1 liter. On 02-Apr-2021, ACUTE KIDNEY INJURY (Acute renal Failure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 1.43 mg/dl (abnormal) creatinine level (CR) 1.43 mg/dL, was reported.. On 05-Mar-2021, Blood urea: 16 (Inconclusive) 16 milligram per decilitre. On 05-Mar-2021, Blood uric acid: 5.10 (Inconclusive) 5.10 milligram per decilitre. On 05-Mar-2021, Glomerular filtration rate: 36.10 (Inconclusive) 36.10 ml/min. On 05-Mar-2021, Urine analysis: yellow (Inconclusive) color yellow, cloudy, trace blood, positive nitrate, Leuk +3, WBC >or=60 and moderate bacteria.. On 24-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 3.32 mg/dl (abnormal) 3.32 milligram per decilitre. On 26-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 5.9 mg/dl (abnormal) 5.9 milligram per decilitre. On 26-Mar-2021, Blood urea: 445 (Inconclusive) 445 milligram per decilitre. On 26-Mar-2021, Blood uric acid: 8.40 (Inconclusive) 8.40 milligram per decilitre. On 26-Mar-2021, Glomerular filtration rate: 7.03 (Inconclusive) 7.03 ml/min. On 26-Mar-2021, Urine analysis: normal (normal) Straw, clear, 1.006, blood +3, pH 6, WBC 2-5, rest normal. On 29-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 5.69 mg/dl (abnormal) 5.69 milligram per decilitre 1.30. On 29-Mar-2021, Blood urea: 9.0 (Inconclusive) 9.0 milligram per decilitre. On 29-Mar-2021, Glomerular filtration rate: 7 (Inconclusive) 7 ml/min. On 30-Mar-2021, Ultrasound kidney: unremarkable (Inconclusive) Unremarkable.. On 02-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 3.62 mg/dl (abnormal) 3.62 milligram per decilitre. On 02-Apr-2021, Blood urea: 41 (Inconclusive) 41 milligram per decilitre. On 02-Apr-2021, Glomerular filtration rate: 12 (Inconclusive) 12 ml/min. On 07-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 2.53 mg/dl (abnormal) 2.53 milligram per decilitre. On 07-Apr-2021, Blood urea: 22 (Inconclusive) 22 milligram per decilitre. On 07-Apr-2021, Blood uric acid: 4.10 (Inconclusive) 4.10 milligram per decilitre. On 07-Apr-2021, Glomerular filtration rate: 18.69 (Inconclusive) 18.69 ml/min. On 08-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 2.25 mg/dl (abnormal) 2.25 milligram per decilitre. On 08-Apr-2021, Blood urea: 22 (Inconclusive) 22 milligram per decilitre. On 08-Apr-2021, Blood uric acid: 4.1 (Inconclusive) 4.1 milligram per decilitre. On 15-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 1.4 mg/dl (abnormal) 1.4 milligram per decilitre. On 15-Apr-2021, Blood urea: 18 (Inconclusive) 18 milligram per decilitre. On 15-Apr-2021, Blood uric acid: 3.9 (Inconclusive) 3.9 milligram per decilitre. On 15-Apr-2021, Glomerular filtration rate: 38 (Inconclusive) 38 ml/min. On 15-Apr-2021, Urine analysis: normal (normal) Normal. On 20-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 1.57 mg/dl (abnormal) 1.57 milligram per decilitre.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the first dose of oral INCB054828 4.5mg QD on 29MAR2019. The last dose of INCB054828 prior to the Serious Adverse Event (SAE) was taken on 29MAR2021. Treatment with 1L of normal saline was initiated intravenously on 29-MAR-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.