Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Worsening symptoms of her Multiple Sclerosis; Legs feet arms fingers and cheeks experienced worsening tingling; Feeling exhausted; Fever; Painful at the injection site; Whole body ached; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Worsening symptoms of her Multiple Sclerosis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tingling, Clonus, Sleep problem, Physical deconditioning, Pain, General body pain and Weakness. Concurrent medical conditions included Osteoarthritis, Puffy skin, Red blotches (Big Red blotches.) and Headache. Concomitant products included OCRELIZUMAB (OCREVUS) and RITUXIMAB (RITUXAN) for an unknown indication.    On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced MULTIPLE SCLEROSIS (Worsening symptoms of her Multiple Sclerosis) (seriousness criterion medically significant), PARAESTHESIA (Legs feet arms fingers and cheeks experienced worsening tingling), FATIGUE (Feeling exhausted), PYREXIA (Fever), VACCINATION SITE PAIN (Painful at the injection site) and MYALGIA (Whole body ached). At the time of the report, MULTIPLE SCLEROSIS (Worsening symptoms of her Multiple Sclerosis), PARAESTHESIA (Legs feet arms fingers and cheeks experienced worsening tingling), FATIGUE (Feeling exhausted), PYREXIA (Fever), VACCINATION SITE PAIN (Painful at the injection site) and MYALGIA (Whole body ached) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Historical conditions included sqeuezing together. Patient's concurrent condition included No B Cells. Treatment information was not provided.  Company Comment:This is a spontaneous case concerning a 64-year-old, female patient with a medical history of Tingling, Clonus, Physical deconditioning, Pain, General body pain and Weakness, current condition of Osteoarthritis, who experienced the unexpected serious AESI event of Multiple sclerosis. The event occurred on the same day after an unknown dose of mRNA-1273 vaccine. Patients medical history and current condition is confounder for the case. The outcome of the event is unknown. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old, female patient with a medical history of Tingling, Clonus, Physical deconditioning, Pain, General body pain and Weakness, current condition of Osteoarthritis, who experienced the unexpected serious AESI event of Multiple sclerosis. The event occurred on the same day after an unknown dose of mRNA-1273 vaccine. Patients medical history and current condition is confounder for the case. The outcome of the event is unknown. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.