Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Multiple sclerosis, Viral infection
Clinical narrative: Multiple Sclerosis; Not felt well due to another virus/Contracted virus; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple Sclerosis) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Plaque psoriasis.   On 10-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) Single-Dose Prefilled Syringe with Needle Guard. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant) and VIRAL INFECTION (Not felt well due to another virus/Contracted virus). The patient was treated with OCRELIZUMAB (OCREVUS) for Multiple sclerosis, at a dose of Unknown. At the time of the report, MULTIPLE SCLEROSIS (Multiple Sclerosis) and VIRAL INFECTION (Not felt well due to another virus/Contracted virus) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient had multiple sclerosis and took Ocrevus and was somewhat unclear as to whether patient should be taking both that and the SKYRIZI but seemed to get different answers from different physicians. The SKYRIZI had basically been the magic drug for patient's psoriasis, and patient was just like the commercials. Patient  had the first covid vaccine Moderna which made the patient sick for about three days and had not any after that and  was not feeling well due to another virus that was going around.  The reporter's (Non-Health Care Professional, Global Introspection) causality for the events of contracted virus, multiple sclerosis, not felt well due to another virus unknown onset, Sick with Risankizumab solution for injection was reported as not provided. The reporter's (Non-Health Care Professional, Global Introspection) for the events with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reported as reasonable Possibility.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Company comment: This spontaneous case concerns an adult female with no relevant medical history who experienced the unexpected, serious  (medically significant) adverse event of special interest Multiple Sclerosis which occurred in the context of receiving a dose of mRNA1273 as part of the COVID-19 vaccine series. Exact latency for the event cannot be fully established as the onset date and complete vaccination date was not reported in the case. The patient also received a dose of different COVID-19 vaccine Pfizer Biontech (interchange of vaccine products). The patient was reported to have been taking ocrelizumab (Ocrevus) for the multiple sclerosis.  Further details on the clinical course, diagnostic and ancillary test done were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment.; Sender's Comments: This spontaneous case concerns an adult female with no relevant medical history who experienced the unexpected, serious  (medically significant) adverse event of special interest Multiple Sclerosis which occurred in the context of receiving a dose of mRNA1273 as part of the COVID-19 vaccine series. Exact latency for the event cannot be fully established as the onset date and complete vaccination date was not reported in the case. The patient also received a dose of different COVID-19 vaccine Pfizer Biontech (interchange of vaccine products). The patient was reported to have been taking ocrelizumab (Ocrevus) for the multiple sclerosis.  Further details on the clinical course, diagnostic and ancillary test done were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment.