Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Myalgia, Renal failure, Respiratory arrest, Somnolence
Clinical narrative: respiratory arrest; cardaic dysrhythmia; renal failure; ankle fracture; fracture of the right tibia; disorientation; fell; body aches; somnolence; slept for 14 hours; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (respiratory arrest), ARRHYTHMIA (cardaic dysrhythmia), RENAL FAILURE (renal failure), ANKLE FRACTURE (ankle fracture), TIBIA FRACTURE (fracture of the right tibia), DISORIENTATION (disorientation) and FALL (fell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included CPAP, Eczema, Pain lumbosacral, Premature ventricular contractions, De Quervain's tenosynovitis, Open angle glaucoma, Nuclear opacity, Dysphagia, Overweight, Epigastric pain, Gastric ulcer, Chronic respiratory failure, DVT, Seizures, Gastroesophageal reflux disease, Clostridium difficile infection, Immobilization syndrome on 28-Feb-2021, Central venous catheterisation on 01-Mar-2021, Ultrasonography on 01-Mar-2021, Ventilation difficult on 01-Mar-2021, Central venous catheter removal on 01-Mar-2021, Endotracheal intubation on 01-Mar-2021, External fixation of fracture on 02-Mar-2021, Removal of external fixation on 07-Mar-2021, External fixation of fracture on 07-Mar-2021, Assisted ventilation on 10-Mar-2021, Transfusion on 10-Mar-2021, Pleural cavity drainage on 11-Mar-2021, Rehabilitation therapy from 12-Mar-2021 to 23-Mar-2021, Dialysis and Phlebotomy since an unknown date. Family history included Colon cancer. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Intrinsic asthma, Hyperlipidemia, Pulmonary hypertension, Polyneuropathy idiopathic progressive, Multiple sclerosis, Psoriatic arthritis, Type 2 diabetes mellitus, Trigeminal neuralgia, Arthropathy, Degeneration of lumbar or lumbosacral intervertebral disc, Spondylosis of unspecified site without mention of myelopathy, Cervical radicular pain, Spinal stenosis lumbar, Osteoporosis, AFib, Type 2 diabetes mellitus, Dyslipidemia, Essential hypertension, Obesity, Psoriasis, Degenerative disc disease and Atrial fibrillation. Concomitant products included MORPHINE SULFATE (MORPHINE SULPHATE) for Acute pain, SUMATRIPTAN for Migraine, ONDANSETRON for Nausea, HYDROCORTISONE for Rash, ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN, CARVEDILOL, CLOBETASOL, CLOPIDOGREL BISULFATE (CLOPIDROGEL SANDOZ), FAMOTIDINE, FUROSEMIDE, GABAPENTIN, GLIPIZIDE, LATANOPROST, LEFLUNOMIDE, LEVETIRACETAM, METFORMIN, MUPIROCIN, NYSTATIN (NYSTOP), OXAZEPAM, PANTOPRAZOLE, PREGABALIN, PREGABALIN, CICLOSPORIN (RESTASIS), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TIMOLOL and SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) for an unknown indication.    On 26-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SOMNOLENCE (somnolence), HYPERSOMNIA (slept for 14 hours) and FATIGUE (fatigue). On 28-Feb-2021, the patient experienced RESPIRATORY ARREST (respiratory arrest) (seriousness criteria hospitalization prolonged and medically significant), ARRHYTHMIA (cardaic dysrhythmia) (seriousness criteria hospitalization prolonged and medically significant), RENAL FAILURE (renal failure) (seriousness criteria hospitalization prolonged and medically significant), ANKLE FRACTURE (ankle fracture) (seriousness criterion hospitalization prolonged), TIBIA FRACTURE (fracture of the right tibia) (seriousness criterion hospitalization prolonged), DISORIENTATION (disorientation) (seriousness criterion hospitalization prolonged), FALL (fell) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches). The patient was hospitalized for 13 days due to ANKLE FRACTURE, ARRHYTHMIA, DISORIENTATION, FALL, RENAL FAILURE, RESPIRATORY ARREST and TIBIA FRACTURE. At the time of the report, RESPIRATORY ARREST (respiratory arrest), ARRHYTHMIA (cardaic dysrhythmia), RENAL FAILURE (renal failure), ANKLE FRACTURE (ankle fracture), TIBIA FRACTURE (fracture of the right tibia), DISORIENTATION (disorientation), FALL (fell), SOMNOLENCE (somnolence), HYPERSOMNIA (slept for 14 hours), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Medication reported.  Additional information was that the patient was on Long term use of Blood Thinners and had Family history Colon Cancer. Also the patient had Renal Failure which required Dialysis (chronic phlebotomy to check renal labs). The patient was admitted to Rehabilitation Centre for 10 Days. Other procedures done on the patient were performance of Urinary Filtration, intermittent, less than 6 hours per day.  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. However, underlying medical history of CPAP, Premature ventricular contraction, Overweight, Gastric ulcer, Chronic respiratory failure, deep vein thrombosis (DVT), Seizures, and use of concomitant medication could probably be contributory factors to the events.   This case was linked to MOD-2021-300604 (Patient Link).; 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. However, underlying medical history of CPAP, Premature ventricular contraction, Overweight, Gastric ulcer, Chronic respiratory failure, deep vein thrombosis (DVT), Seizures, and use of concomitant medication could probably be contributory factors to the events.