Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
I found myself in a flare; Moderna COVID vaccine to have seemingly reversed my MS; This spontaneous case was reported by a patient and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (I found myself in a flare) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bedridden (she was placed on Ocrevus. That medication had her bedridden until it was out of her body). Previously administered products included for Relapsing-remitting multiple sclerosis: Tecfidera in 2016, Gilenya in 2019, Tysabri and Ocrevus. Past adverse reactions to the above products included No adverse effect with Gilenya, Ocrevus, Tecfidera and Tysabri. Concurrent medical conditions included Relapsing-remitting multiple sclerosis (RRMS) since 2016. Concomitant products included Teriflunomide (Aubagio) for Relapsing-remitting multiple sclerosis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In September 2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Moderna COVID vaccine to have seemingly reversed my MS). On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (I found myself in a flare) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (I found myself in a flare) and THERAPEUTIC RESPONSE UNEXPECTED (Moderna COVID vaccine to have seemingly reversed my MS) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. It was reported that patient was diagnosed in 2016 with RRMS and was immediately placed on Concomitant medication of Tecfidera. Due to progression of the disease (new lesions) patient was placed on Concomitant medication of Ocrevus. That medication had caused bedridden to patient until Concomitant medication Ocrevus was out of her body. After that, patient was placed on Concomitant medication of Tysabri. Concomitant medication Tysabri was worked for a year or so before new lesions were found for patient. In 2019 patient changed her doctors for the symptom. New doctor first put her on Concomitant medication of Gilenya but eventually patient was put on Concomitant medication of Aubagio and that was the last treatment she was received. Since then, she was on Concomitant medication of Aubagio for a couple of years. It was reported that patient needed a rollator or wheelchair for mobility. It was reported that patient watched deterioration of her body, and she had decided to accept her fate. After the required 4th round of the vaccine (4 doses as medically required); patient went on the cruise in July of 2022 and while she was wheelchair bound, and she had a great time. In September-2022, she began noticed that her legs felt stronger, and her balance was better. Hence patient was decided to try to take steps out of her wheelchair and she used rollator. Then She realized that she did not need her rollator. It was reported that Patient received Moderna vaccine every year since 2022 for three years. And patient condition was improved, and patient never looked back. It was also reported that the numbness in her feet went away, many of the symptoms she lived with since 2016 were either gone or diminished. However, in winter (2025) patient found a flare herself. Hence patient purchased a cane because of the spasticity, and she felt electric shock in her left leg. Patient was realized about a week into her flare that she had not had her vaccine yet. This case was linked to MOD-2025-784198 (Patient Link).; Reporter's Comments: Patient´s medical history of Relapsing-remitting multiple sclerosis remains as a risk factor for the event Multiple sclerosis flare. The benefit-risk relationship of product is not affected by this report.
Relapsing-remitting multiple sclerosis (RRMS)
Medical History/Concurrent Conditions: Bedridden (she was placed on Ocrevus. That medication had her bedridden until it was out of her body)
Aubagio