Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis, Pyrexia
Clinical narrative: oral intake reduced; Acute Renal Failure; Thrush in mouth and gums; Bed ridden, barely hold her head up and barely drink; felt tired, not normal tired; Barely hold her head up; weakness; flu like symptoms; Fever; chills; Body aches and soreness; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE KIDNEY INJURY (Acute Renal Failure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (Fever), CHILLS (chills) and MYALGIA (Body aches and soreness). On 14-Feb-2021, the patient experienced BEDRIDDEN (Bed ridden, barely hold her head up and barely drink), FATIGUE (felt tired, not normal tired) and HEADACHE (Barely hold her head up). On 22-Feb-2021, the patient experienced ORAL CANDIDIASIS (Thrush in mouth and gums). On 25-Feb-2021, the patient experienced ACUTE KIDNEY INJURY (Acute Renal Failure) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOPHAGIA (oral intake reduced). At the time of the report, ACUTE KIDNEY INJURY (Acute Renal Failure), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (Bed ridden, barely hold her head up and barely drink), ORAL CANDIDIASIS (Thrush in mouth and gums), HYPOPHAGIA (oral intake reduced), PYREXIA (Fever), CHILLS (chills), MYALGIA (Body aches and soreness), FATIGUE (felt tired, not normal tired) and HEADACHE (Barely hold her head up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood creatine: 1 (Inconclusive) 1. On 25-Feb-2021, Blood creatine: 9 (Inconclusive) 9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prior to getting the 2nd dose of the vaccine, patient had sinus infection and was prescribed antibiotic and steroid on 10-FEB-2021. Patient was prescribed Nasal Spray and Nystatin. Patient is now on dialysis 3 times a week and on 6 different pills a day and on high dose of steroid. The patient was treated with Percocet 325-10 mg, Lyrica 150 mg, Prevacid 40 mg as required for GERD. The patient is also on dialysis 3 times a week and is on six different pills a day and on high dose of steroid.  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