Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysphagia, Electroencephalogram, Electromyogram, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Swallowing went downhill; trouble swallowing; Speech went downhill; trouble talking; Lost strength in her legs and hands; trouble getting up; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Swallowing went downhill; trouble swallowing), MUSCULAR WEAKNESS (Lost strength in her legs and hands; trouble getting up) and SPEECH DISORDER (Speech went downhill; trouble talking) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product AMANTADINE HYDROCHLORIDE (GOCOVRI) capsule, extended release for Dyskinesia.    Concurrent medical conditions included Dyskinesia (In patients with Parkinson's disease receiving levodopa-based therapy), Parkinson's disease and Cerebral palsy (On 02-NOV-2021, it was learned that additional medical history included cerebral palsy.). Concomitant products included LAMOTRIGINE, PRAMIPEXOLE, ROSUVASTATIN, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), AMANTADINE and CLONAZEPAM for an unknown indication.   On 20-Jan-2021, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 137 mg at bedtime. On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MUSCULAR WEAKNESS (Lost strength in her legs and hands; trouble getting up) (seriousness criterion hospitalization). In June 2021, the patient experienced SPEECH DISORDER (Speech went downhill; trouble talking) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPHAGIA (Swallowing went downhill; trouble swallowing) (seriousness criterion hospitalization). The patient was hospitalized from 16-Jul-2021 to 24-Jul-2021 due to DYSPHAGIA, MUSCULAR WEAKNESS and SPEECH DISORDER. The patient was treated with Surgery (Feeding tube placed) for Dysphagia. At the time of the report, DYSPHAGIA (Swallowing went downhill; trouble swallowing), MUSCULAR WEAKNESS (Lost strength in her legs and hands; trouble getting up) and SPEECH DISORDER (Speech went downhill; trouble talking) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Electroencephalogram: came back fine (normal) came back fine. In July 2021, Electromyogram: came back fine (normal) came back fine. In July 2021, Lumbar puncture: came back fine (normal) came back fine. In July 2021, Magnetic resonance imaging: came back fine (normal) came back fine.  It was verbally reported that, On an unspecified date in 2021, after starting Gocovri, the patient was admitted to the hospital for an unreported reason. As of 12-OCT-2021, the patient remained in the hospital. Treatment with Gocovri  was reportedly ongoing, but the patient had been told to "hold off on medication for right now" (unknown if therapy was on hold or if refills were on hold).  The patient is on  unspecified levodopa-based therapy.  On 12-OCT-2021, the current preferred terms (PTs) included: Hospitalization. The patient was discharged to rehabilitation and She remained in rehab for a month.  Company Comment - This spontaneous case concerns a 55-year-old female patient with relevant medical history of dyskinesia, Parkinson's disease and cerebral palsy, who experienced serious unexpected events of muscular weakness, speech disorder, dysphagia, The events occurred approximately a month after the second dose of the Moderna COVID-19 vaccine . Reportedly, within a month from the second dose of mRNA-1273, the patient experienced loss of strength in legs and hands, speech impairment and trouble swallowing. The patient was progressively getting slower and had trouble standing up. The patient was hospitalized and had feeding tube placed due to dysphagia. The patient was discharged and sent for rehabilitation. At the time of the report, the patient was recovering from the events. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Patient's dyskinesia, Parkinson's disease and cerebral palsy are possible confounders. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with relevant medical history of dyskinesia, Parkinson's disease and cerebral palsy, who experienced serious unexpected events of muscular weakness, speech disorder, dysphagia, The events occurred approximately a month after the second dose of the Moderna COVID-19 vaccine . Reportedly, within a month from the second dose of mRNA-1273, the patient experienced loss of strength in legs and hands, speech impairment and trouble swallowing. The patient was progressively getting slower and had trouble standing up. The patient was hospitalized and had feeding tube placed due to dysphagia. The patient was discharged and sent for rehabilitation. At the time of the report, the patient was recovering from the events. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. Patient's dyskinesia, Parkinson's disease and cerebral palsy are possible confounders. The benefit-risk relationship of drug is not affected by this report.