Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Multiple sclerosis
Clinical narrative: multiple sclerosis aggravated; Patient felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis aggravated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068G21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: pneumonia vaccine. Past adverse reactions to the above products included No adverse event with pneumonia vaccine. Concurrent medical conditions included Immunocompromised, Multiple sclerosis since 1990, Allergy to antibiotic (Augmentin), Drug allergy (Bactrim) and Seasonal allergy. Concomitant products included BACLOFEN for Multiple sclerosis, OCRELIZUMAB (OCREVUS) from 20-Oct-2021 to an unknown date for Multiple sclerosis like syndrome.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced FATIGUE (Patient felt a little tired). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis aggravated) (seriousness criterion medically significant). On 26-Apr-2021, FATIGUE (Patient felt a little tired) had resolved. At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis aggravated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other vaccines given within 1 month prior to Moderna COVID-19 vaccine is unspecified pneumonia vaccine 2 weeks before the infusion. No treatment was provided by the reporter. Recent change in status such as improvement or worsening: worsening that's why patient got Ocrevus infusions on 20Oct2021.  Company comment.  This spontaneous case concerns a 70  year  old, female patient with medical history of multiple sclerosis, who experienced the unexpected serious important medical event of multiple sclerosis aggravated. The patient received two doses of mRNA  1273 vaccine in an appropriate schedule of vaccination. The exact date of the event was not reported; however, the patient sated she got Ocrevus infusion in October 2021 (approximately five months after the second dose with mRNA  1273) as she experienced a worsening of her condition. Patient´s medical history of multiple sclerosis remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-477945, MOD-2022-477958.; Sender's Comments: This spontaneous case concerns a 70  year  old, female patient with medical history of multiple sclerosis, who experienced the unexpected serious important medical event of multiple sclerosis aggravated. The patient received two doses of mRNA  1273 vaccine in an appropriate schedule of vaccination. The exact date of the event was not reported; however, the patient sated she got Ocrevus infusion in October 2021 (approximately five months after the second dose with mRNA  1273) as she experienced a worsening of her condition. Patient´s medical history of multiple sclerosis remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.