Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms, Muscular weakness, Myasthenia gravis, Pain in extremity
Clinical narrative: myasthenia gravis; bell's palsy; dysphonia; dysphagia; shortness of breath/dyspnea; vocal cord paralysis; pain in legs and arms; bowel incontinence; muscle spasms/cramps; anxiety; insomnia; depression; bladder incontinence; Upper extremity weakness; generalized weakness that worsens throughout the day; blurred vision; numbness; tingling; Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYASTHENIA GRAVIS (myasthenia gravis) and BELL'S PALSY (bell's palsy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MYASTHENIA GRAVIS (myasthenia gravis) (seriousness criterion medically significant), BELL'S PALSY (bell's palsy) (seriousness criterion medically significant), DYSPHONIA (dysphonia), DYSPHAGIA (dysphagia), DYSPNOEA (shortness of breath/dyspnea), VOCAL CORD PARALYSIS (vocal cord paralysis), PAIN IN EXTREMITY (pain in legs and arms), ANAL INCONTINENCE (bowel incontinence), MUSCLE SPASMS (muscle spasms/cramps), ANXIETY (anxiety), INSOMNIA (insomnia), DEPRESSION (depression), URINARY INCONTINENCE (bladder incontinence), MUSCULAR WEAKNESS (Upper extremity weakness), ASTHENIA (generalized weakness that worsens throughout the day), VISION BLURRED (blurred vision), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling) and FATIGUE (Fatigue). The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYASTHENIA GRAVIS (myasthenia gravis), BELL'S PALSY (bell's palsy), DYSPHONIA (dysphonia), DYSPHAGIA (dysphagia), DYSPNOEA (shortness of breath/dyspnea), VOCAL CORD PARALYSIS (vocal cord paralysis), PAIN IN EXTREMITY (pain in legs and arms), ANAL INCONTINENCE (bowel incontinence), MUSCLE SPASMS (muscle spasms/cramps), ANXIETY (anxiety), INSOMNIA (insomnia), DEPRESSION (depression), URINARY INCONTINENCE (bladder incontinence), MUSCULAR WEAKNESS (Upper extremity weakness), ASTHENIA (generalized weakness that worsens throughout the day), VISION BLURRED (blurred vision), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any known allergies.  No concomitant medication was reported.   It was reported that additional laboratory/diagnostic tests were done included Lumbar puncture, CT, MRI, EEG, EKG, Blood work to rule out Lupus and Lyme disease, MBS, EMG, Muscle biopsy, and skin biopsy however, the outcomes/results of the tests were not provided.  Patient had multiple ER visits. In the last 2 yrs, she's had about 20 ER visits related to it. Patient was diagnosed in 2022 after seeing 6 neurologist and 1 rheumatologist.  Patient currently receiving IVIG.  Company comment: This spontaneous case concerns a 46-year-old female patient with no medical history reported, who experienced the serious (Medically Significant), unexpected AESI of Myasthenia gravis and Bell´s Palsy, which occurred about 1-2 weeks after the first dose of mRNA-1273. It was reported that this occurred after the 1st dose which she received the beginning of Feb2021 and did not get the second. About 1- 2 weeks after the first dose, she had myasthenia gravis like symptoms such as Bell's palsy, fatigue, eyelid ptosis, blurred speech, dysphonia, dysphagia, dyspnea, shortness of breath, upper extremity weakness, vocal cord paralysis, generalized weakness that worsens throughout the day, numbness, tingling, weakness and pain in legs and arms, bladder and bowel incontinence, muscle spasms and cramps, anxiety, insomnia and depression, blurred vision. She's had multiple visits in emergency room (In the last 2 years, she had about 20 ER visits related to it). She was diagnosed in 2022 after seeing 6 neurologist and 1 rheumatologist. She is currently receiving Intravenous Immunoglobulin (IVIG), and the doctor wants to increase it. All the mentioned events including the non-serious ones could be associated with myasthenia gravis. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.