Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vitamin B12, Vitamin B12 decreased, Vitamin D, Vitamin D decreased
Clinical narrative: Multiple sclerosis; Vision loss; Neuropathy peripheral; Vitamin B12 decreased; Vitamin D decreased; Fever; Dry mouth; Rash; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis), BLINDNESS (Vision loss), NEUROPATHY PERIPHERAL (Neuropathy peripheral), VITAMIN B12 DECREASED (Vitamin B12 decreased) and VITAMIN D DECREASED (Vitamin D decreased) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ELAGOLIX SODIUM (ORILISSA) for Endometriosis.    Concurrent medical conditions included Endometriosis.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient started ELAGOLIX SODIUM (ORILISSA) (Oral) at an unspecified dose. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple sclerosis) (seriousness criterion medically significant), BLINDNESS (Vision loss) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Neuropathy peripheral) (seriousness criterion medically significant), VITAMIN B12 DECREASED (Vitamin B12 decreased) (seriousness criterion medically significant), VITAMIN D DECREASED (Vitamin D decreased) (seriousness criterion medically significant), PYREXIA (Fever), DRY MOUTH (Dry mouth) and RASH (Rash). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis), BLINDNESS (Vision loss) and NEUROPATHY PERIPHERAL (Neuropathy peripheral) had not resolved and VITAMIN B12 DECREASED (Vitamin B12 decreased), VITAMIN D DECREASED (Vitamin D decreased), PYREXIA (Fever), DRY MOUTH (Dry mouth) and RASH (Rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin B12: Low Vitamin B12. On an unknown date, Vitamin D: Low Vitamin D.         No concomitant medicine were provided. There was no reported medical history. No known allergies.  The patient had vision loss, only saw half of someone's face and she also had neuropathy in right foot, leg calf and left foot. She tested very low B12 and Vitamin D. Her physician taught she had Multiple sclerosis  based on her complained of blurred vision, seeing only half of people's faces, felt dizzy and off balance  intermittently. Physician said she tested positive for disease. She wanted to know if Orilissa had caused the Multiple sclerosis. Her mouth was very dry and she was drinking a lot. She had fever and rash when she took Moderna COVID vaccine. Her symptoms began four to five years ago before starting Orilissa. No treatment medicine were provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  For ORILISSA (ELAGOLIX), the reporter causality for the events of Multiple sclerosis, Vision loss, Neuropathy peripheral, Vitamin B12 decreased, Vitamin D decreased, Fever, Rash, Dry mouth was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact  Company comment: This spontaneous case concerns an adult, female patient with medical history of Endometriosis treated with the co-suspect product Orilissa (elagolix), who experienced the unexpected, serious (medically significant) events of multiple sclerosis (AESI), blindness, neuropathy peripheral, vitamin B12 decreased and vitamin D decreased, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Orilissa and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced vision loss described as 'only saw half of someone's face' and neuropathy in the right foot, leg calf and left foot. On unspecified dates, her vitamin B12 and vitamin D levels were very low (values were not provided). Her physician thought she had Multiple sclerosis based on her complaints of blurred vision, dizziness and being off-balanced intermittently. The physician reportedly stated that the patient tested positive for the disease. The patient also experienced very dry mouth and she was drinking a lot. She also had fever and rash after vaccination. Treatment information was not provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult, female patient with medical history of Endometriosis treated with the co-suspect product Orilissa (elagolix), who experienced the unexpected, serious (medically significant) events of multiple sclerosis (AESI), blindness, neuropathy peripheral, vitamin B12 decreased and vitamin D decreased, and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Orilissa and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient experienced vision loss described as 'only saw half of someone's face' and neuropathy in the right foot, leg calf and left foot. On unspecified dates, her vitamin B12 and vitamin D levels were very low (values were not provided). Her physician thought she had Multiple sclerosis based on her complaints of blurred vision, dizziness and being off-balanced intermittently. The physician reportedly stated that the patient tested positive for the disease. The patient also experienced very dry mouth and she was drinking a lot. She also had fever and rash after vaccination. Treatment information was not provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.