Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Rheumatoid Arthritis being worse; Emphysema worsening; Emphysema worsening; Arm got sore, tired achy for a few days; Arm got sore, tired achy for a few days; Increased pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis being worse) in a 64-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 Emphysema (for many years), COPD (for many years) and Rheumatoid arthritis.   In 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis being worse) (seriousness criterion medically significant), EMPHYSEMA (Emphysema worsening), CONDITION AGGRAVATED (Emphysema worsening), FATIGUE (Arm got sore, tired achy for a few days), VACCINATION SITE PAIN (Arm got sore, tired achy for a few days) and ARTHRALGIA (Increased pain in hip). In 2021, FATIGUE (Arm got sore, tired achy for a few days), VACCINATION SITE PAIN (Arm got sore, tired achy for a few days) and ARTHRALGIA (Increased pain in hip) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis being worse) had resolved and EMPHYSEMA (Emphysema worsening) and CONDITION AGGRAVATED (Emphysema worsening) was resolving.            Concomitant medication was not reported.  Patient had emphysema before starting RINVOQ. Patient stopped RINVOQ on 06-Oct-2021 due to emphysema worsening but restarted due to Rheumatoid Arthritis being worse. Patient saw her Pulmonologist recently for emphysema and started on an additional medication for this and was better. Patient had took third Covid-19 shot (booster), her arm got sore, tired achy for a few days, also increased pain in hip and symptoms for about three days. RINVOQ was not working as well as it did before. Patient was off for three weeks due to a lung issue. Patient stated that RINVOQ still made a difference. Third Covid-19 vaccine in Aug-2021 caused flare of auto-immune for a few days as well.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 64-year-old female patient, with reported medical history of emphysema, and rheumatoid arthritis treated with co-suspect drug Upadacitinib, who experienced the unexpected serious AESI Rheumatoid arthritis (reported as rheumatoid arthritis being worse) that occurred after receiving a dose of mRNA-1273 vaccine. The event occurred within the same year of administration of 3rd dose of mRNA-1273 vaccine along with the non-serious events of arthralgia aggravated. It was reported that patient had increased pain in hip and rheumatoid arthritis worsened. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Patient received first 2 doses of mRNA-1273 vaccine on unknown dates. The co-suspect drug Upadacitinib for rheumatoid arthritis could be considered as confounder as the disease itself can have flares.   The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Live follow up added.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient, with reported medical history of emphysema, and rheumatoid arthritis treated with co-suspect drug Upadacitinib, who experienced the unexpected serious AESI Rheumatoid arthritis (reported as rheumatoid arthritis being worse) that occurred after receiving a dose of mRNA-1273 vaccine. The event occurred within the same year of administration of 3rd dose of mRNA-1273 vaccine along with the non-serious events of arthralgia aggravated. It was reported that patient had increased pain in hip and rheumatoid arthritis worsened. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. Patient received first 2 doses of mRNA-1273 vaccine on unknown dates. The co-suspect drug Upadacitinib for rheumatoid arthritis could be considered as confounder as the disease itself can have flares.   The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.