Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Fatigue; Rheumatoid arthritis flare up/Achiness from weather; Shoulder pain after Moderna vaccine; Achiness and Pains after second vaccine; Arm pain after second Moderna vaccine; Chills after second Moderna vaccine; Headache after second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Achiness from weather), PAIN (Achiness and Pains after second vaccine), FATIGUE (Fatigue), VACCINATION SITE PAIN (Arm pain after second Moderna vaccine) and CHILLS (Chills after second Moderna vaccine) in a 59-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 (Moderate to severe).   On 26-Mar-2020, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Achiness and Pains after second vaccine), VACCINATION SITE PAIN (Arm pain after second Moderna vaccine), CHILLS (Chills after second Moderna vaccine) and HEADACHE (Headache after second Moderna vaccine). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Achiness from weather), FATIGUE (Fatigue) and ARTHRALGIA (Shoulder pain after Moderna vaccine). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/Achiness from weather) had not resolved and PAIN (Achiness and Pains after second vaccine), FATIGUE (Fatigue), VACCINATION SITE PAIN (Arm pain after second Moderna vaccine), CHILLS (Chills after second Moderna vaccine), HEADACHE (Headache after second Moderna vaccine) and ARTHRALGIA (Shoulder pain after Moderna vaccine) outcome was unknown.            Concomitant medication were not provided.  The patient had experienced rheumatoid arthritis flare up/achiness from weather with RINVOQ (Upadacitinib).  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  The causality of events with respect to drug RINVOQ - Headache after second Moderna vaccine, Arm pain after second Moderna Vaccine, Chills after second Moderna Vaccine, Achiness and Pain after second Moderna vaccine was reported as no reasonable possibility.  The reporter's causality for the event of Rheumatoid arthritis flare up/achiness from weather with RINVOQ (UPADACITINIB) was reported as a reasonable possibility and the causality for event Shoulder pain after Moderna vaccine with RINVOQ was not provided.  Treatment medication were not provided.  Company Comment: This spontaneous case concerns a 59-year-old female patient, with concurrent condition of Rheumatoid arthritis, who experienced the non-serious unexpected AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up/Achiness from weather), among other non-serious adverse events. The event was reported with no onset date; hence, latency cannot be assessed to the second dose of mRNA-1273 vaccine. The concurrent condition remains as a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-581781 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Start date for Co-suspect drug added, Event verbatim for Rheumatoid arthritis flare up updated to Rheumatoid arthritis flare up/achiness from weather, Event Shoulder pain added, Narrative updated.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient, with concurrent condition of Rheumatoid arthritis, who experienced the non-serious unexpected AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up/Achiness from weather), among other non-serious adverse events. The event was reported with no onset date; hence, latency cannot be assessed to the second dose of mRNA-1273 vaccine. The concurrent condition remains as a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.