Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Influenza like illness, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flares; Flu like symptoms; Headache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares) in a 51-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.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second 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 09-Mar-2021, the patient experienced the first episode of HEADACHE (Headache). On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and the second episode of HEADACHE (Headache). On 21-Oct-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares), INFLUENZA LIKE ILLNESS (Flu like symptoms) and the last episode of HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported.  Patient reported non-serious events Headache, flu like symptoms and rheumatoid arthritis flares with RINVOQ (UPADACITINIB).    MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered as suspect.  Treatment information was not provided.  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 51  year  old, female patient, in treatment with Upadacitinib for Rheumatoid arthritis, who experienced the unexpected, serious medically significant AESI of rheumatoid arthritis (described as "Rheumatoid arthritis flares") approximately 6 months after the second dose of mRNA  1273 vaccine. No further details were provided for medical reviewing. Co  suspect product included Upadacitinib. Flaring of symptoms is part of the natural course of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-631709 (Patient Link).; Sender's Comments: This spontaneous case concerns a 51  year  old, female patient, in treatment with Upadacitinib for Rheumatoid arthritis, who experienced the unexpected, serious medically significant AESI of rheumatoid arthritis (described as "Rheumatoid arthritis flares") approximately 6 months after the second dose of mRNA  1273 vaccine. No further details were provided for medical reviewing. Co  suspect product included Upadacitinib. Flaring of symptoms is part of the natural course of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.