Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Immunisation reaction, Rheumatoid arthritis
Clinical narrative: Arthritis flares up in shoulder; Made sick and nauseous; Stomach flu/Made sick and nauseous; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Arthritis flares up in shoulder) in a 53-year-old 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced GASTROENTERITIS VIRAL (Stomach flu/Made sick and nauseous). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Arthritis flares up in shoulder) (seriousness criterion medically significant) and IMMUNISATION REACTION (Made sick and nauseous). At the time of the report, RHEUMATOID ARTHRITIS (Arthritis flares up in shoulder) and GASTROENTERITIS VIRAL (Stomach flu/Made sick and nauseous) outcome was unknown and IMMUNISATION REACTION (Made sick and nauseous) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.  On 02-Sep-2021 patient had flare in shoulder.  After second covid 19 vaccination, it made patient sick for three days.  It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter causality for the events of after covid-19 vaccination, made sick and nauseous unknown onset, stomach flu, rheumatoid arthritis flares up in shoulder and after covid-19 vaccination, made sick and nauseous unknown onset was not provided. No treatment medications were reported.  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 a 53-years-old female patient with medical history of Rheumatoid Arthritis that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. 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 a 53-years-old female patient with medical history of Rheumatoid Arthritis that was treated with UPADACITINIB (RINVOQ), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) among other non-serious events. The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since vaccination date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. 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.