Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate
Clinical narrative: Myasthenia Gravis Exacerbation Following Second Dose of mRNA-1273 Vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia Gravis Exacerbation Following Second Dose of mRNA-1273 Vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.      Previously administered products included for Myasthenia gravis: IVIG. Past adverse reactions to the above products included No adverse event with IVIG. Concurrent medical conditions included Myasthenia gravis since 2019. Concomitant products included PYRIDOSTIGMINE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis Exacerbation Following Second Dose of mRNA-1273 Vaccine) (seriousness criteria hospitalization and medically significant). The patient was treated with MYCOPHENOLATE MOFETIL at an unspecified dose and frequency and PLASMA at an unspecified dose and frequency. At the time of the report, MYASTHENIA GRAVIS (Myasthenia Gravis Exacerbation Following Second Dose of mRNA-1273 Vaccine) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: showed no acute processes. On an unknown date, Heart rate: 110 heart beats per minute Tachycardic. On an unknown date, Physical examination: Use of accessory muscles of respiration and moderate proximal weakness. On an unknown date, Pulmonary function test: (Negative) negative inspiratory force at -40 cm of H20. and negative inspiratory force at -52 cm of H2O.. On an unknown date, Respiratory rate: 20 breaths per minute tachypneic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Company Comment: This literature-non-study case concerns a 69-year-old female patient, with underlying myasthenia gravis, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Myasthenia gravis aggravated, which occurred the same day after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, later in the evening of receiving vaccination she felt fatigued. She woke up the next day with respiratory distress, had difficulty raising from bed and was seen in the emergency department. On arrival, she was tachypneic with a respiratory rate in the 20s and tachycardic with heart rate of 110. Her examination showed use of accessory muscles of respiration and moderate proximal weakness. Her pulmonary function tests showed negative inspiratory force at -40 cm of H20. Chest x-ray showed no acute processes. She denied any other recent medication dose adjustments other than withholding her Pyridostigmine 48 hours for an SFEMG the day before she received the vaccination, which she had already resumed 20 hours prior to the vaccination. She was treated with plasma exchange, did not require intubation and continued on choline esterase inhibitors. She improved in her respiratory status with NIF at -52. She gained strength enough to ambulate and climb stairs with assistance. Causality was assessed as related, due to temporal relationship. The author concluded that the temporal relationship strongly suggests that the event was related to the vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Patient developed shortness of breath, generalized weakness, and respiratory distress the day after vaccination. She was treated with plasma exchange and continued on an unspecified choline esterase inhibitor, showing improvement in respiratory status and strength. Prior to this episode, her myasthenia gravis was managed with IVIG and choline esterase inhibitors.  She improved in her respiratory status with NIF at -52. She gained strength enough to ambulate and climb stairs with assistance. She was reluctant to take Azathioprine. Her initial presentation was shortness of breath at rest in early 2019 with an initial MG ADL (MG Activities of Living Scale) of 10 and the most recent ADL prior to hospitalization was 2.; Sender's Comments: Company Comment: This literature-non-study case concerns a 69-year-old female patient, with underlying myasthenia gravis, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Myasthenia gravis aggravated, which occurred the same day after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, later in the evening of receiving vaccination she felt fatigued. She woke up the next day with respiratory distress, had difficulty raising from bed and was seen in the emergency department. On arrival, she was tachypneic with a respiratory rate in the 20s and tachycardic with heart rate of 110. Her examination showed use of accessory muscles of respiration and moderate proximal weakness. Her pulmonary function tests showed negative inspiratory force at -40 cm of H20. Chest x-ray showed no acute processes. She denied any other recent medication dose adjustments other than withholding her Pyridostigmine 48 hours for an SFEMG the day before she received the vaccination, which she had already resumed 20 hours prior to the vaccination. She was treated with plasma exchange, did not require intubation and continued on choline esterase inhibitors. She improved in her respiratory status with NIF at -52. She gained strength enough to ambulate and climb stairs with assistance. Causality was assessed as related, due to temporal relationship. The author concluded that the temporal relationship strongly suggests that the event was related to the vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.