Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Computerised tomogram, Dizziness, Fatigue, Gait disturbance
Clinical narrative: renal infarctions; Acute Renal Failure; flu-like symptoms; wobbly/not stable on their feet; feeling sick; dizziness; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL INFARCT (renal infarctions) and ACUTE KIDNEY INJURY (Acute Renal Failure) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) and SODIUM BICARBONATE for Anticoagulant therapy.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), GAIT DISTURBANCE (wobbly/not stable on their feet), VACCINATION COMPLICATION (feeling sick), DIZZINESS (dizziness), FATIGUE (tiredness) and HEADACHE (headache). On an unknown date, the patient experienced RENAL INFARCT (renal infarctions) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute Renal Failure) (seriousness criterion medically significant). At the time of the report, RENAL INFARCT (renal infarctions), ACUTE KIDNEY INJURY (Acute Renal Failure), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION COMPLICATION (feeling sick) and HEADACHE (headache) outcome was unknown and GAIT DISTURBANCE (wobbly/not stable on their feet), DIZZINESS (dizziness) and FATIGUE (tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Computerised tomogram: abnormal (abnormal) revealed renal infarctions.. On 03-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) renal infarctions.         The patient is still experiencing the tiredness, dizziness, and not being stable on their feet. The patient did not take anything to help with the symptoms. The patient has gone to see their health care provider for the symptoms being experienced. The patient had a CT scan and it revealed renal infarctions. A MRI was done as well and confirmed both kidneys have renal infarctions. The patients health care provider diagnosed the patient with Acute Renal Failure.  The daily medications the patient is taking are a blood thinner eliquis and sodium bicarbonate.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was Not applicable.  Company comment: 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. Advanced age could be a  potentially confounders/co-suspects for the events.; 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. Advanced age could be a  potentially confounders/co-suspects for the events.