Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Ileus paralytic, Muscular weakness, Pneumonia, Respiratory failure
Clinical narrative: Acute hypoxic respiratory failure; adynamic ileus; Pneumonia; Progressive Extremity Weakness; demyelinating neuropathy; Bulbar weakness; Respiratory failure; Weakness; trouble walking; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), ILEUS PARALYTIC (adynamic ileus), PNEUMONIA (Pneumonia), DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy), BULBAR PALSY (Bulbar weakness) and MUSCULAR WEAKNESS (Progressive Extremity Weakness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus, Hypertension, Glaucoma and Hyperlipidemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria hospitalization prolonged and medically significant) and BULBAR PALSY (Bulbar weakness) (seriousness criteria hospitalization prolonged and medically significant). On 15-Mar-2021, the patient experienced DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria hospitalization prolonged and medically significant), ILEUS PARALYTIC (adynamic ileus) (seriousness criteria hospitalization prolonged and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MUSCULAR WEAKNESS (Progressive Extremity Weakness) (seriousness criterion hospitalization prolonged), ASTHENIA (Weakness) and GAIT DISTURBANCE (trouble walking). The patient was hospitalized from 06-Mar-2021 to 31-Mar-2021 due to ACUTE RESPIRATORY FAILURE, BULBAR PALSY, DEMYELINATING POLYNEUROPATHY, ILEUS PARALYTIC, MUSCULAR WEAKNESS, PNEUMONIA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Respiratory failure), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), PNEUMONIA (Pneumonia), DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy), BULBAR PALSY (Bulbar weakness), MUSCULAR WEAKNESS (Progressive Extremity Weakness), ASTHENIA (Weakness) and GAIT DISTURBANCE (trouble walking) outcome was unknown and ILEUS PARALYTIC (a dynamic ileus) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Electromyogram: abnormal (abnormal) consistent with demyelinating neuropathy.. On 30-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     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.   No concomitant medications reported by investigator.  Patient was presented to hospital on 3/6/21 with progressive extremity weakness, bulbar weakness, and respiratory failure attributed to AIDP s/p 5days IVIG. He had received his first Moderna COVID vaccination approximately two weeks prior to this and immediately following administration began experiencing weakness and trouble walking. EMG 3/15/21 consistent with demyelinating neuropathy. Hospitalization was  complicated by the development of adynamic ileus which is improving and acute hypoxic respiratory failure (previously requiring O2 support). Patient was also treated for pneumonia with a 5 day course of azithromycin. Once medically stable he was deemed appropriate for inpatient rehabilitation and was transferred from Hospital to rehab on 3/31/21 under care. The patient tested negative COVID-19 on 3/30, and repeat testing since also has been negative.  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.; 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.