Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Limb discomfort, Myasthenia gravis, Ocular discomfort
Clinical narrative: Myasthenia gravis; double vision; my left eye was drooping; my left arm could not be raised above horizontal position; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia gravis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Double vision. Concomitant products included AMLODIPINE, ATORVASTATIN, BUSPIRONE, FLUOXETINE, MELOXICAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia gravis) (seriousness criterion medically significant), DIPLOPIA (double vision), OCULAR DISCOMFORT (my left eye was drooping) and LIMB DISCOMFORT (my left arm could not be raised above horizontal position). The patient was treated with EPINASTINE at a dose of 1 drop in each eye twice daily; PYRIDOSTIGMINE (oral) at a dose of 60 mg three times a day and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) (oral) at a dose of 500 mg twice a day. At the time of the report, MYASTHENIA GRAVIS (Myasthenia gravis) outcome was unknown and DIPLOPIA (double vision), OCULAR DISCOMFORT (my left eye was drooping) and LIMB DISCOMFORT (my left arm could not be raised above horizontal position) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: This case concerns a 79-year-old, male patient with a medical history of double vision, who experienced the unexpected events of myasthenia gravis, diplopia, ocular discomfort, and limb discomfort. The events occurred on an unknown date. The rechallenge is not applicable in this case as the relationship of events to dose cannot be determined. The reporter's assessment was not provided. The concomitant use of meloxicam, buspirone and amlodipine remain confounders as these drugs can adversely affect myasthenia gravis. The benefit-risk relationship of the Moderna Covid-19 vaccine is not affected by this report.   This case was linked to MOD-2021-326958 (Patient Link).; Sender's Comments: This case concerns a 79-year-old, male patient with a medical history of double vision, who experienced the unexpected events of myasthenia gravis, diplopia, ocular discomfort, and limb discomfort. The events occurred on an unknown date. The rechallenge is not applicable in this case as the relationship of events to dose cannot be determined. The reporter's assessment was not provided. The concomitant use of meloxicam, buspirone and amlodipine remain confounders as these drugs can adversely affect myasthenia gravis. The benefit-risk relationship of the Moderna Covid-19 vaccine is not affected by this report.