Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Mobility decreased, Rash
Clinical narrative: Lowered immune system; Could not climb stair; Developed a rash after second dose of the Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Lowered immune system) and MOBILITY DECREASED (Could not climb stair) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram. On an unknown date, the patient experienced IMMUNODEFICIENCY (Lowered immune system) (seriousness criteria hospitalization and medically significant), MOBILITY DECREASED (Could not climb stair) (seriousness criterion hospitalization) and RASH (Developed a rash after second dose of the Covid vaccine). At the time of the report, IMMUNODEFICIENCY (Lowered immune system), MOBILITY DECREASED (Could not climb stair) and RASH (Developed a rash after second dose of the Covid vaccine) outcome was unknown.            Concomitant medication was not provided.  The patient was discontinuing therapy because it lowered her immune system. She was on oxygen for a while and could not climb stair. She got hospitalized due to it.  Company Comment: This spontaneous case concerns an elderly, female patient with an underlying history of rheumatoid arthritis treated with Upadacitinib modified-release tablet, who experienced an unexpected, medically significant event of Immunodeficiency and an unexpected, serious event of Mobility decreased (reported as could not climb stair) in association with a 2nd dose of mRNA-1273 vaccine. Both events resulted to the patient's hospitalization. Exact onset latency of both events relative to vaccination cannot be determined with unknown events' start date and administration date. Reportedly, she discontinued Upadacitinib therapy because it lowered her immune system. She was on oxygen for a while. Post-vaccination, she developed a rash on unspecified location and on unknown date. Her underlying history of rheumatoid arthritis and Upadacitinib modified-release tablet remain as confounders to both events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the limited information available. Sender's Comments: This spontaneous case concerns an elderly, female patient with an underlying history of rheumatoid arthritis treated with Upadacitinib modified-release tablet, who experienced an unexpected, medically significant event of Immunodeficiency and an unexpected, serious event of Mobility decreased (reported as could not climb stair) in association with a 2nd dose of mRNA-1273 vaccine. Both events resulted to the patient's hospitalization. Exact onset latency of both events relative to vaccination cannot be determined with unknown events' start date and administration date. Reportedly, she discontinued Upadacitinib therapy because it lowered her immune system. She was on oxygen for a while. Post-vaccination, she developed a rash on unspecified location and on unknown date. Her underlying history of rheumatoid arthritis and Upadacitinib modified-release tablet remain as confounders to both events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the limited information available.