Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Anaemia, Asthenia, Azotaemia
Clinical narrative: Shortness of breath increasing; lethargy; Hyperkalemia; Acute kidney injury; metabolic encephalopathy; Uremia; metabolic acidosis; protein calorie malnutrition; Hyperuricemia; Hyperphosphatemia; Hyponatremia; Anemia; Substernal chest pain aggravated; increasing abdominal girth; Abdominal Pain; Weakness; Nausea; multiorgan failure; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), ACUTE KIDNEY INJURY (Acute kidney injury), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy) and AZOTAEMIA (Uremia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer stage IV since March 2019, COPD since an unknown date, GERD since an unknown date, Hypertension since an unknown date, Tobacco user since an unknown date, Transaminases increased since an unknown date, Peritoneal carcinomatosis since an unknown date and Metastatic bone disease prophylaxis (Lumbar spine pelvis and proximal femurs) since an unknown date. Concurrent medical conditions included Acute renal failure (Due to Foley catheter placement) and Pneumonitis.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure) (seriousness criteria death and medically significant), DYSPNOEA (Shortness of breath increasing) (seriousness criterion hospitalization), LETHARGY (lethargy) (seriousness criterion hospitalization), HYPERKALAEMIA (Hyperkalemia) (seriousness criterion medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy) (seriousness criterion medically significant), AZOTAEMIA (Uremia) (seriousness criterion medically significant), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea). The patient was hospitalized on 09-Mar-2021 due to DYSPNOEA and LETHARGY. The patient died on 13-Mar-2021. The reported cause of death was Multiorgan failure. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), ACUTE KIDNEY INJURY (Acute kidney injury), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy), AZOTAEMIA (Uremia), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood culture: negative (Negative) Negative. On 12-Mar-2021, Blood gases: abnormal (abnormal) Compensated mixed respiratory and Metabolic alkalosis. On 12-Mar-2021, Blood pressure measurement: 96/52 (Inconclusive) 96/52 mmHg, 100/50 (Inconclusive) 100/50 mmHg and 88/58 (Inconclusive) 88/58 mmHg. On 12-Mar-2021, Blood test: normal (normal) WBC-2.9 Normal, Hg-Normal, Platelet count-Normal. On 12-Mar-2021, Body temperature: 36.1 (Inconclusive) 36.1degrees Celsius, 35.9 (Inconclusive) 35.9 degrees Celsius and 36.2 (Inconclusive) 36.2degrees Celsius. On 12-Mar-2021, Brain natriuretic peptide: normal (normal) normal. On 12-Mar-2021, Chest X-ray: normal (normal) No acute thoracic pathology. On 12-Mar-2021, Computerised tomogram: abnormal (abnormal) revealed a right sided pleural effusion bony metastatic disease and hepatic metastatic disease, as well as small amount of ascites in the upper abdomen. On 12-Mar-2021, Echocardiogram: inconclusive (Inconclusive) Ejection fraction 60-65% and otherwise no significant findings. On 12-Mar-2021, Heart rate: 92 heart beats per minute (Inconclusive) 92, 86 heart beats per minute (Inconclusive) 86 and 90 heart beats per minute (Inconclusive) 90. On 12-Mar-2021, Oxygen saturation: 96 (Inconclusive) 96 percent, 93 (Inconclusive) 93 percent and 98 (Inconclusive) 98 percent. On 12-Mar-2021, Prothrombin time: normal (normal) normal. On 12-Mar-2021, Respiratory rate: 16 (Inconclusive) breaths per minute, 18 (Inconclusive) breaths per minute and 19 (Inconclusive) breaths per minute. On 12-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-Mar-2021, Troponin: normal (normal) normal. On 12-Mar-2021, Urine analysis: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy), AZOTAEMIA (Uremia), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea) to be possibly related. No further causality assessment was provided for ACUTE KIDNEY INJURY (Acute kidney injury).    Concomitant medications were not provided.  Treatment for the events included proton pump inhibitors, oxygen, Tylenol, and comfort care.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: multiorgan failure