Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oedema, Platelet count, Pleural effusion, Red blood cell count
Clinical narrative: Rhabdomyolysis; Cardiac arrest; generalized weakness; muscle cramps; loss of appetite; urine color changing dark brown to black; confused or experiencing hallucinations; mentation started to decline; pitting edema over the bilateral upper and lower extremities; Diastolic heart failure; Ascites; Acute renal failure; Pleural effusion; experienced nausea, without any vomiting/diarrhea; This literature-non-study case was reported in a literature article and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis), CARDIAC ARREST (Cardiac arrest), ASTHENIA (generalized weakness), MUSCLE SPASMS (muscle cramps), DECREASED APPETITE (loss of appetite), CHROMATURIA (urine color changing dark brown to black), HALLUCINATION (confused or experiencing hallucinations), MENTAL IMPAIRMENT (mentation started to decline), OEDEMA (pitting edema over the bilateral upper and lower extremities), LEFT VENTRICULAR FAILURE (Diastolic heart failure), ASCITES (Ascites), ACUTE KIDNEY INJURY (Acute renal failure) and PLEURAL EFFUSION (Pleural effusion) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cerebrovascular accident (2 months prior) and Physiotherapy (For the past 2 months, the patient was undergoing professional physiotherapy once a week as advised by the therapist.) since an unknown date. Family history included Autoimmune disorder (Family history was positive for autoimmune disease in maternal grandmother.). Concurrent medical conditions included Rheumatoid arthritis, Hyperlipidemia and Asthma. Concomitant products included CLOPIDOGREL and TRAZODONE for Stroke, METOPROLOL, NIFEDIPINE, ROSUVASTATIN, TELMISARTAN and TOFACITINIB for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criteria death, hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death, hospitalization and medically significant), ASTHENIA (generalized weakness) (seriousness criterion hospitalization), MUSCLE SPASMS (muscle cramps) (seriousness criterion hospitalization), DECREASED APPETITE (loss of appetite) (seriousness criterion hospitalization), CHROMATURIA (urine color changing dark brown to black) (seriousness criterion hospitalization), HALLUCINATION (confused or experiencing hallucinations) (seriousness criteria hospitalization and medically significant), MENTAL IMPAIRMENT (mentation started to decline) (seriousness criteria hospitalization and medically significant), OEDEMA (pitting edema over the bilateral upper and lower extremities) (seriousness criterion hospitalization), LEFT VENTRICULAR FAILURE (Diastolic heart failure) (seriousness criteria hospitalization prolonged and medically significant), ASCITES (Ascites) (seriousness criteria hospitalization prolonged and medically significant), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria hospitalization prolonged and medically significant), PLEURAL EFFUSION (Pleural effusion) (seriousness criterion hospitalization prolonged) and NAUSEA (experienced nausea, without any vomiting/diarrhea). The patient died on an unknown date. The reported cause of death was Rhabdomyolysis and Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, ASTHENIA (generalized weakness), MUSCLE SPASMS (muscle cramps), DECREASED APPETITE (loss of appetite), CHROMATURIA (urine color changing dark brown to black), HALLUCINATION (confused or experiencing hallucinations), MENTAL IMPAIRMENT (mentation started to decline), OEDEMA (pitting edema over the bilateral upper and lower extremities), LEFT VENTRICULAR FAILURE (Diastolic heart failure), ASCITES (Ascites), ACUTE KIDNEY INJURY (Acute renal failure), PLEURAL EFFUSION (Pleural effusion) and NAUSEA (experienced nausea, without any vomiting/diarrhea) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (12-78): 600 u/l 600 U/L (on the Day of Admission) and 1746 u/l 1746 U/L (on the Last Day of Hospitalization). On an unknown date, Aldolase: 353 u/l 353 U/L on further investigation, but it was falsely elevated due to hemoglobin contamination secondary to hemolysis.. On an unknown date, Anion gap (8-16): 19 meq/l 19 mEQ/L (on the Day of Admission) and 20 meq/l 20 mEQ/L (on the Last Day of Hospitalization). On an unknown date, Aspartate aminotransferase (15-37): 1422 u/l 1422 U/L (on the Day of Admission) and 2066 u/l 2066 U/L (on the Last Day of Hospitalization). On an unknown date, Blood alkaline phosphatase (45-117): 600 u/l 600 U/L. On an unknown date, Blood bicarbonate (21-32): 13 mmol/l 13 mmol/L (on the Day of Admission) and 39 mmol/l 39 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood bilirubin (0.2-1): 0.3 mg/dl 0.3 mg/dL (on the Day of Admission) and 0.6 mg/dl 0.6 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood calcium (8.5-10.1): 8.4 mg/dl 8.4 mg/dL (on the Day of Admission) and 5.3 mg/dl 5.3 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood creatine phosphokinase (26-192): more than 14,000 u/l more than 14,000 U/L (on the Day of Admission) and more than 14,000 u/l more than14,000 U/L (on the Last Day of Hospitalization). On an unknown date, Blood creatinine (0.6-1.3): 6 mg/dl 6 mg/dL (on the Day of Admission) and 2.7 mg/dl 2.7 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood glucose (40-70): 73 mg/dl 73 mg/dl. On an unknown date, Blood lactic acid (0.4-2): 1.3 mmol/l 1.3 mmol/L (on the Day of Admission) and 19.3 mmol/l 19.3 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood phosphorus (2.5-4.9): 7.2 mg/dl 7.2 mg/dL (on the Day of Admission) and 10.4 mg/dl 10.4 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood potassium (3.5-5.1): 4.6 mmol/l 4.6 mmol/L (on the Day of Admission) and 6 mmol/l 6 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood sodium (136-145): 134 mmol/l 134 mmol/L(on the Day of Admission) and 153 mmol/l 153 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood urea (7-18): 21 mg/dl 21 mg/dL (on the Day of Admission) and 61 mg/dl 61 mg/dL (on the Last Day of Hospitalization). On an unknown date, Brain natriuretic peptide (5-450): 1388 pg/ml 1388 pg/mL (on the Day of Admission) and 5391 pg/ml 5391 pg/mL (on the Last Day of Hospitalization). On an unknown date, C-reactive protein: 74 mg/l 74 mg/L (on the Day of Admission) and 17.8 mg/l 17.8 mg/L (on the Last Day of Hospitalization). On an unknown date, CSF myelin basic protein: 8.7 ng/dl 8.7 ng/dl. On an unknown date, CSF protein (15-60): 31.6 mg/dl 31.6 mg/dl. On an unknown date, CSF red blood cell count: 2/cu mm 2/cu mm. On an unknown date, CSF test: clear appearance Cerebrospinal fluid (CSF) analysis revealed a clear appearance, with cultures remaining negative. On an unknown date, CSF white blood cell count: 2/cu mm 2/cu mm Range(0-5cu mm). On an unknown date, Chest scan: complete consolidation chest CT showed complete consolidation and volume loss of the right lower lobe, partial consolidation and volume loss of the left lower lobe, mild ascites, and moderate anasarca.. On an unknown date, Computerised tomogram: no acute finding computed tomography (CT) of the abdomen and head revealed no acute finding.. On an unknown date, Echocardiogram: elevated (High) showed an ejection fraction of 55 60% with diastolic dysfunction. On an unknown date, Glomerular filtration rate: 6 ml/min 6 mL/min (on the Day of Admission) and 16 ml/min 16 mL/min (on the Last Day of Hospitalization). On an unknown date, Haemoglobin (11-16): 12.4 g/dl 12.4 g/dL(on the Day of Admission) and 4.4 g/dl 4.4 g/dL (on the Last Day of Hospitalization). On an unknown date, Herpes simplex test: negative (Negative) Herpes I/II-Negative. On an unknown date, Myoglobin urine: more than 5000 mcg/ml more than 5000 mcg/mL. On an unknown date, Platelet count (150-450): 203 10x3/ul 203 10x3/uL(on the Day of Admission) and 134 10x3/ul 134 10x3/uL(on the Last Day of Hospitalization). On an unknown date, Red blood cell count (4-5.50): 4.17 million cells/mcl 4.17 million cells/mcL (on the Day of Admission) and 1.45 million cells/mcl 1.45 million cells/mcL(on the Last Day of Hospitalization). On an unknown date, Red blood cell sedimentation rate: 28 mm/hr 28 mm/Hr  (on the Day of Admission) Range(0-30mm/hr). On an unknown date, Treponema test: negative (Negative) Negative. On an unknown date, Troponin: 0.18 ng/ml 0.18 ng/mL (on the Day of Admission) followed by 0.21 ng/mL and 0.20 ng/mL and 0.88 ng/ml 0.88 ng/mL (on the Last Day of Hospitalization). On an unknown date, Urine analysis: was positive (Positive) Urinalysis was positive for 3+ blood. On an unknown date, West Nile virus test: negative (Negative) Negative. On an unknown date, White blood cell count (4-11): 7.6 10×3 ul 7.6 10×3 uL (on the Day of Admission) and 19.7 10×3 ul 19.7 10×3 uL (on the Last Day of Hospitalization).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RHABDOMYOLYSIS (Rhabdomyolysis), CARDIAC ARREST (Cardiac arrest), ASTHENIA (generalized weakness), MUSCLE SPASMS (muscle cramps), DECREASED APPETITE (loss of appetite), CHROMATURIA (urine color changing dark brown to black), HALLUCINATION (confused or experiencing hallucinations), MENTAL IMPAIRMENT (mentation started to decline), OEDEMA (pitting edema over the bilateral upper and lower extremities), LEFT VENTRICULAR FAILURE (Diastolic heart failure), ASCITES (Ascites), ACUTE KIDNEY INJURY (Acute renal failure), PLEURAL EFFUSION (Pleural effusion) and NAUSEA (experienced nausea, without any vomiting/diarrhea) to be possibly related.    The patient received the first dose of the vaccine 30 days before receiving the second dose. The patient tolerated the first dose well, except for minor pain at the injection site. The patient started to feel weak the same afternoon after receiving the second dose.  The patient had no previous history of tobacco or alcohol abuse. The patient had never contracted COVID-19 prior to this admission. There was no recent history of trauma or surgery. The patient completely lost her appetite and experienced nausea, without any vomiting/diarrhea. She noticed her urine color changing from dark brown to black on the same day of receiving the vaccination. The next day, her weakness worsened along with abdominal and muscle cramps and transferred to hospital. Over the course of hospitalization, the patient became progressively weaker to a point where she could not even lift/move her hands or legs.  Patient was started on broad- spectrum intravenous antibiotics. An urgent temporary dialysis catheter was inserted, and the patient subsequently received hemodialysis secondary to hypoxia from pleural effusion/anasarca and oliguria/renal failure.  After neurological evaluation, the patient was started on empiric glucocorticoids owing to concerns of myositis, secondary to no improvement in her strength. The patient was transferred to the intensive care unit, initially on bilevel positive airway pressure/ intermittent high-flow oxygen, but later intubated on ventilator support. The patient ultimately had a cardiac arrest with subsequent fixed and dilated pupils causing suspicion of hypoxic/anoxic brain injury. The patient was terminally extubated and died the same day. Treatment medication use was not provided by the reporter; Sender's Comments: This literature review case concerns an 85 year old female with a history of rosuvastatin use who experienced the serious, unlisted events of Rhabdomyolysis, Diastolic heart failure, Renal failure and other serious events that were fatal. The events began the day of the second dose of  mRNA-1273. Re-challenge is negative for the first dose and not applicable for the second as no further dose is possible. The use of rosuvastatin remains a confounder as the use of the statin could have exacerbated or caused the event of rhabdomyolysis. Benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Rhabdomyolysis; Cardiac arrest