Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Pain in extremity
Clinical narrative: Patient was found unresponsive; sore arm; This spontaneous case was reported by a physician and describes the occurrence of DEATH (Patient was found unresponsive) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TRIHEPTANOIN oral liquid for Glucose transporter type 1 deficiency syndrome.    Concurrent medical conditions included Glucose transporter type 1 deficiency syndrome, Migraine, Epilepsy (sympathomimetic generalized epilepsy), Cerebral palsy, Dystonia (Generalized dystonia), Seasonal allergy, Metabolic encephalopathy, Gastroesophageal reflux disease, Developmental delay, Hemiparesis (right), Contracture (foot contracture), Toe walking, Spasticity, Hyperreflexia, Onychomycosis, Heat intolerance and Dysphagia. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), FAMOTIDINE (PEPCID [FAMOTIDINE]) from 07-Aug-2020 to an unknown date, ALPHA LIPOIC ACID, ACETAZOLAMIDE SODIUM (DIAMOX [ACETAZOLAMIDE SODIUM]) from 15-Jun-2015 to an unknown date, IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 13-Dec-2019 to an unknown date and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 07-Aug-2020, the patient started TRIHEPTANOIN (Oral) 200 milligram once a day. On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient died on 20-Dec-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2019, Anion gap: 5 nmol/l 5 nmol/L. On 26-Jun-2019, Blood chloride: 116 mol/l 116 mol/L. On 26-Jun-2019, Blood urea: 8mh/dl 8mh/dL. On 26-Jun-2019, Eosinophil count: 730 ul 730 uL. On 26-Jun-2019, Full blood count: normal (normal) Normal. On 26-Jun-2019, Metabolic function test: no results provided no results provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported. Patient's mother stated that patient died in sleep during  a nap at home. Patient's mother went to wake up  before dinner and found unresponsive and after cardiopulmonary resuscitation (CPR) then called Emergency Medical Service to continued  CPR  2 mg epinephrine intravenously. Reporter assessed event death as unlikely related to TRIHEPTANOIN.  Company comment: This is a spontaneous case concerning a 37-year-old male patient with significant medical history reported as Glucose transporter type 1 deficiency syndrome, Migraine, Epilepsy (sympathomimetic generalized epilepsy), Cerebral palsy, Dystonia (Generalized dystonia), Seasonal allergy, Metabolic encephalopathy, Gastroesophageal reflux disease, Developmental delay, Hemiparesis (right), Contracture (foot contracture), Toe walking, Spasticity, Hyperreflexia, Onychomycosis, Heat intolerance and Dysphagia, who was found unresponsive (DEATH) one day after the third dose of mRNA-1273 vaccine. The patient also experienced unexpected non-serious event of Pain in extremity. The information regarding autopsy and cause of death was not provided. Patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 37-year-old male patient with significant medical history reported as Glucose transporter type 1 deficiency syndrome, Migraine, Epilepsy (sympathomimetic generalized epilepsy), Cerebral palsy, Dystonia (Generalized dystonia), Seasonal allergy, Metabolic encephalopathy, Gastroesophageal reflux disease, Developmental delay, Hemiparesis (right), Contracture (foot contracture), Toe walking, Spasticity, Hyperreflexia, Onychomycosis, Heat intolerance and Dysphagia, who was found unresponsive (DEATH) one day after the third dose of mRNA-1273 vaccine. The patient also experienced unexpected non-serious event of Pain in extremity. The information regarding autopsy and cause of death was not provided. Patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death