Sex: U
Vaccine: COVID19
Symptoms: Optic neuritis, SARS-CoV-2 antibody test
Clinical narrative: Left optic neuritis relapse; This literature-non-study case was reported in a literature article and describes the occurrence of OPTIC NEURITIS (Left optic neuritis 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 Optic neuritis.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced OPTIC NEURITIS (Left optic neuritis relapse) (seriousness criterion medically significant). The patient was treated with TERIFLUNOMIDE at a dose of 14 milligram and PREDNISONE (oral) in 2021 at an unspecified dose and frequency. At the time of the report, OPTIC NEURITIS (Left optic neuritis relapse) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered OPTIC NEURITIS (Left optic neuritis relapse) to be related.    Reporter stated that patient is on standard dose of DMTs described above per FDA recommendation.  Patient was received a 5-day course of high-dose prednisone 6 days after the first dose of the Moderna COVID-19 vaccine  No differences in antibody positivity were seen with age, sex, or vaccine type.  Company Comment: This literature case concerns a patient (age and gender not specified), with past medical history of Optic neuritis, who experienced the unexpected serious (medically significant) AESI of Optic neuritis (Left optic neuritis relapse) that occurred in the context of mRNA-1273 vaccination (after the first dose of mRNA-1273). Latency cannot be assessed since vaccination date was not disclosed. The patient was treated with Teriflunomide and 5-day course of high-dose prednisone 6 days after the first dose of the Moderna COVID-19 vaccine. SARS-CoV-2 antibody test was Positive as on 2021. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event was unknown at the time of report. Past medical history of Optic neuritis could be a confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-610060 (E2B Linked Report).; Sender's Comments: This literature case concerns a patient (age and gender not specified), with past medical history of Optic neuritis, who experienced the unexpected serious (medically significant) AESI of Optic neuritis (Left optic neuritis relapse) that occurred in the context of mRNA-1273 vaccination (after the first dose of mRNA-1273). Latency cannot be assessed since vaccination date was not disclosed. The patient was treated with Teriflunomide and 5-day course of high-dose prednisone 6 days after the first dose of the Moderna COVID-19 vaccine. SARS-CoV-2 antibody test was Positive as on 2021. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event was unknown at the time of report. Past medical history of Optic neuritis could be a confounder to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-610060:Ptaient with event right hand sensory relapse