Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Insomnia, Intervertebral disc protrusion, Mobility decreased
Clinical narrative: Cataracts; Rheumatoid arthritis flare up; OCCASIONAL INSOMNIA FROM PAIN; She had trouble getting in and out of car; She had osteoporosis in back; She had a herniated disc and bulging disc; Depression; TROUBLE SWALLOWING; CARPAL TUNNEL IN BOTH HANDS; Ankle fracture; OSTEOARTHRITIS; She had rash that was itchy; Headaches; 2nd dose 20-OCT-2021, Moderna booster 20-NOV-2021; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataracts) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CATARACT (Cataracts) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), INSOMNIA (OCCASIONAL INSOMNIA FROM PAIN), MOBILITY DECREASED (She had trouble getting in and out of car), OSTEOPOROSIS (She had osteoporosis in back), INTERVERTEBRAL DISC PROTRUSION (She had a herniated disc and bulging disc), DEPRESSION (Depression), DYSPHAGIA (TROUBLE SWALLOWING), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL IN BOTH HANDS), ANKLE FRACTURE (Ankle fracture), OSTEOARTHRITIS (OSTEOARTHRITIS), RASH PRURITIC (She had rash that was itchy), HEADACHE (Headaches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20-OCT-2021, Moderna booster 20-NOV-2021). At the time of the report, CATARACT (Cataracts), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), MOBILITY DECREASED (She had trouble getting in and out of car), INTERVERTEBRAL DISC PROTRUSION (She had a herniated disc and bulging disc), DEPRESSION (Depression), DYSPHAGIA (TROUBLE SWALLOWING), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL IN BOTH HANDS), ANKLE FRACTURE (Ankle fracture) and OSTEOARTHRITIS (OSTEOARTHRITIS) had not resolved and INSOMNIA (OCCASIONAL INSOMNIA FROM PAIN), OSTEOPOROSIS (She had osteoporosis in back), RASH PRURITIC (She had rash that was itchy), HEADACHE (Headaches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20-OCT-2021, Moderna booster 20-NOV-2021) outcome was unknown.            No concomitant and treatment medications were reported.  It was reported that patient experienced symptoms pain in knees, and hands. Weather make pain worsened. Some days okay, some had good. She had flare with pain all over her body and lots of fatigue, she had joint pain flare up and flare up of back pain and lot of pain some days.  Reporters causality for events insomnia, general body pain, headache was not reported and for events mobility decreased, depression, pain was reasonable possibility and for events osteoporosis, rheumatoid arthritis was probable and for event swallowing disorder was no reasonable possibility and for all other events was not related with respect to Rinvoq drug.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns an adult female patient with concurrent medical condition of Rheumatoid Arthritis that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) and unexpected serious (medically significant) event of Cataract among other non-serious events. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test was performed and result not reported. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns an adult female patient with concurrent medical condition of Rheumatoid Arthritis that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) and unexpected serious (medically significant) event of Cataract among other non-serious events. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. SARS-CoV-2 antibody test was performed and result not reported. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.