Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Depressed level of consciousness, Dyspnoea, Fatigue, Flushing
Clinical narrative: Can't even walk; Couldn't catch his breath; fatigue; Acute hypoxy respiratory failure; Pleuritic chest pain; Red ithcy eyes; HS pneumonitis; Decreased level of conciousness; ILD; non necrotizing granuloma; Flushing; Pulse ox reading in the 70's; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No adverse event reported.  The patient's past medical history included Type 2 diabetes mellitus. Previously administered products included for an unreported indication: Accupril in 1996 and Accupril. Past adverse reactions to the above products included Ankle swelling with Accupril; and Knee swelling with Accupril. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Blood pressure, METFORMIN, SERTRALINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), IBUPROFEN, TADALAFIL (CIALIS), INSULIN LISPRO, CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D) and INSULIN GLARGINE (BASAGLAR KWIKPEN) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's) (seriousness criterion medically significant), GAIT INABILITY (Can't even walk) (seriousness criterion hospitalization), DYSPNOEA (Couldn't catch his breath) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Acute hypoxy respiratory failure) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Pleuritic chest pain) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red ithcy eyes) (seriousness criterion hospitalization), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis) (seriousness criteria hospitalization and medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness) (seriousness criteria hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (ILD) (seriousness criteria hospitalization and medically significant), PULMONARY GRANULOMA (non necrotizing granuloma) (seriousness criterion hospitalization) and FLUSHING (Flushing) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 02-Apr-2021 due to CHEST PAIN, DEPRESSED LEVEL OF CONSCIOUSNESS, FLUSHING, HYPERSENSITIVITY PNEUMONITIS, INTERSTITIAL LUNG DISEASE, OCULAR HYPERAEMIA, PULMONARY GRANULOMA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 7.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment While hospitalized, the consumer was started on 100mg Prednisone, now at 60mg of Prednisone, calcium, vitamin D, insulin lispro, protonix, bactrim, and is currently on oxygen. Concomitant medications Glucometer, Insullin pen and Lansets.  Company Comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09/6/21: New event added: Acute hypoxy respiratory failure, Pleuritic chest pain, Red ithcy eyes, HS pneumonitis, Decreased level of consciousness, ILD, non necrotizing granuloma and Flushing.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.