Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse, SARS-CoV-2 antibody test
Clinical narrative: Multiple sclerosis relapse; This literature-non-study case was reported in a literature article and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE.     The patient's past medical history included Multiple sclerosis.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) at an unspecified dose and frequency; DIMETHYL FUMARATE for Multiple sclerosis, at an unspecified dose and frequency and TERIFLUNOMIDE at a dose of 14 milligram. At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) to be related.    Patient was provided dimethyl fumarate 5 day course, prednisone was provided 10 days after second dose of Moderna COVID-19 vaccine for a right hand sensory relapse. Reporter stated that patient is on standard dose of DMTs described above per FDA recommendation.  Concomitant medication was not reported.  Company comment: This literature non study case concerns a patient of unknown age and gender, with relevant medical history of multiple sclerosis, who experienced the unexpected serious (medically significant) AESI of Multiple sclerosis relapse, about 10 days after receiving the second dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was on dimethyl fumarate for multiple sclerosis and was treated with high dose oral prednisone for a right hand sensory relapse. The patient tested positive for SARS-CoV-2 antibody. No further information on patient demographics, detailed clinical course, management of the event and details pertaining to the first dose was available in the report. The outcome of the event was unknown. Medical history of multiple sclerosis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-611202 (E2B Linked Report).; Sender's Comments: This literature non study case concerns a patient of unknown age and gender, with relevant medical history of multiple sclerosis, who experienced the unexpected serious (medically significant) AESI of Multiple sclerosis relapse, about 10 days after receiving the second dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was on dimethyl fumarate for multiple sclerosis and was treated with high dose oral prednisone for a right hand sensory relapse. The patient tested positive for SARS-CoV-2 antibody. No further information on patient demographics, detailed clinical course, management of the event and details pertaining to the first dose was available in the report. The outcome of the event was unknown. Medical history of multiple sclerosis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-611202:Patient with event left optic neuritis relapse