Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Magnetic resonance imaging, Mechanical ventilation, Miller Fisher syndrome, Plasmapheresis
Clinical narrative: Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown.            Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator.  Company Comment: 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.   This case was linked to MOD-2021-141559 (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.