Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Speech disorder, Swollen tongue
Clinical narrative: As a shot in the dark, neurologist stated her trouble might be due to myasthenia gravis and treated patient with pyridostigmine BR 30 mg a day in Jun2022.; found moderate to severe nerve damage from the elbow to the chin in the left side; patient developed asthma symptoms/she couldn't breath/After 1s booster symptoms came back and got worse again; patient developed flu like symptoms/After 1s booster symptoms came back and got worse again; swelling in her mouth/After 1s booster symptoms came back and got worse again; swelling in the back of her throat/After 1s booster symptoms came back and got worse again; swelling in her tongue/After 1s booster symptoms came back and got worse again; This spontaneous case was reported by a patient and describes the occurrence of MYASTHENIA GRAVIS (As a shot in the dark, neurologist stated her trouble might be due to myasthenia gravis and treated patient with pyridostigmine BR 30 mg a day in Jun2022.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine in October 2021 and Pneumonia vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Pneumonia vaccine and flu vaccine. Family history included Cardiac disorder. Concurrent medical conditions included Allergy to antibiotic (Penicillin Allergy) and Seasonal allergy (patient experienced something very mild with seasonal allergies). Concomitant products included METFORMIN and ATORVASTATIN for Familial risk factor, METOPROLOL for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced ASTHMA (patient developed asthma symptoms/she couldn't breath/After 1s booster symptoms came back and got worse again), INFLUENZA LIKE ILLNESS (patient developed flu like symptoms/After 1s booster symptoms came back and got worse again), MOUTH SWELLING (swelling in her mouth/After 1s booster symptoms came back and got worse again), PHARYNGEAL SWELLING (swelling in the back of her throat/After 1s booster symptoms came back and got worse again) and SWOLLEN TONGUE (swelling in her tongue/After 1s booster symptoms came back and got worse again). On an unknown date, the patient experienced MYASTHENIA GRAVIS (As a shot in the dark, neurologist stated her trouble might be due to myasthenia gravis and treated patient with pyridostigmine BR 30 mg a day in Jun2022.) (seriousness criterion medically significant) and NERVE INJURY (found moderate to severe nerve damage from the elbow to the chin in the left side). The patient was treated with PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BR) in June 2022 for Myasthenia gravis, at a dose of 30 milligram once a day. At the time of the report, MYASTHENIA GRAVIS (As a shot in the dark, neurologist stated her trouble might be due to myasthenia gravis and treated patient with pyridostigmine BR 30 mg a day in Jun2022.), ASTHMA (patient developed asthma symptoms/she couldn't breath/After 1s booster symptoms came back and got worse again), INFLUENZA LIKE ILLNESS (patient developed flu like symptoms/After 1s booster symptoms came back and got worse again), MOUTH SWELLING (swelling in her mouth/After 1s booster symptoms came back and got worse again), PHARYNGEAL SWELLING (swelling in the back of her throat/After 1s booster symptoms came back and got worse again), SWOLLEN TONGUE (swelling in her tongue/After 1s booster symptoms came back and got worse again) and NERVE INJURY (found moderate to severe nerve damage from the elbow to the chin in the left side) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Found moderate to severe nerve damage from the elbow to the chin in the left side..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 21-Nov-2021, the patient received first booster dose.  After 1st booster symptoms came back and got worse again and caller visited a neurologist and he made another tests and found moderate to severe nerve damage from the elbow to the chin in the left side, but there was not a meaningful diagnosis for her symptoms. As a shot in the dark, neurologist stated her trouble might be due to myasthenia gravis and treated patient with pyridostigmine BR 30 mg a day in Jun-2022. Even after all this treatment, symptoms are still ongoing, breathing was improved, but the other symptoms are the same. breathing and blood pressure improved, but the other symptoms are the same. Symptoms of Myasthenia gravis was reported as Dysphagia and Speech disorder.  Company Comment: "This spontaneous case concerns a 70 year-old female patient, with a relevant medical history of drug allergy and seasonal allergies reported, who experienced the unexpected serious (medically significant) event of  MYASTHENIA GRAVIS, which was diagnosed unknown days after the third dose of mRNA-1273 vaccine administration. Patient reported asthma and flu like symptoms, couldn't breath and swelling in her mouth, back of throat and tongue, and difficulty swallowing and trouble with speech, which occurred after the first dose of mRNA-1273. She was treated with asthma medications but the symptoms were never fully resolved. The symptoms would come back after the second and third dose of mRNA-1273 vaccine. Patient consulted with a neurologist, laboratory test were done which showed moderate to severe nerve damage from the elbow to the chin in the left side. She was diagnosed with myasthenia gravis and was treated with pyridostigmine BR 30 mg a day. Even after the treatment, symptoms are still ongoing. Underlying history of drug allergy and seasonal allergies  could be a  confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report."   This case was linked to MOD-2022-637072, MOD-2022-637080 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70 year-old female patient, with a relevant medical history of drug allergy and seasonal allergies reported, who experienced the unexpected serious (medically significant) event of  MYASTHENIA GRAVIS, which was diagnosed unknown days after the third dose of mRNA-1273 vaccine administration. Patient reported asthma and flu like symptoms, couldn't breath and swelling in her mouth, back of throat and tongue, and difficulty swallowing and trouble with speech, which occurred after the first dose of mRNA-1273. She was treated with asthma medications but the symptoms were never fully resolved. The symptoms would come back after the second and third dose of mRNA-1273 vaccine. Patient consulted with a neurologist, laboratory test were done which showed moderate to severe nerve damage from the elbow to the chin in the left side. She was diagnosed with myasthenia gravis and was treated with pyridostigmine BR 30 mg a day. Even after the treatment, symptoms are still ongoing. Underlying history of drug allergy and seasonal allergies  could be a  confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report."