Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Myalgia, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Rheumatoid arthritis flare up/RHEUMATOID ARTHRITIS FLARE IN HANDS, HIPS, SHOULDER AND KNEES/sharp shootings of pain throughout body; veins were large in thumbs; fatigue; shoulder muscle pains; COVID-19/Weight loss/no taste/Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/RHEUMATOID ARTHRITIS FLARE IN HANDS, HIPS, SHOULDER AND KNEES/sharp shootings of pain throughout body) in a 54-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.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 30-Dec-2020, the patient experienced COVID-19 (COVID-19/Weight loss/no taste/Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/RHEUMATOID ARTHRITIS FLARE IN HANDS, HIPS, SHOULDER AND KNEES/sharp shootings of pain throughout body) (seriousness criterion medically significant), VASODILATATION (veins were large in thumbs), FATIGUE (fatigue) and MYALGIA (shoulder muscle pains). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up/RHEUMATOID ARTHRITIS FLARE IN HANDS, HIPS, SHOULDER AND KNEES/sharp shootings of pain throughout body) had not resolved, VASODILATATION (veins were large in thumbs), FATIGUE (fatigue) and MYALGIA (shoulder muscle pains) outcome was unknown and COVID-19 (COVID-19/Weight loss/no taste/Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 54-year-old, female patient with concurrent medical condition of rheumatoid arthritis. Patient has co-suspect medication of Upadacitinib (Rinvoq) for rheumatoid arthritis. Patient has no reported vaccination history. Patient experienced the unexpected serious (medically significant) AESI event of rheumatoid arthritis flare up, the unexpected non-serious AESI event of Covid-19, the unexpected non-serious event of veins were large in thumbs, and the expected non-serious events of fatigue and myalgia (shoulder muscle pains). On unknown date, patient received unknown dose number of mRNA-1273 vaccine administration. On unknown date patient received co-suspect medication of Upadacitinib (Rinvoq) for rheumatoid arthritis. On unknown date patient experienced rheumatoid arthritis flare up in hands, hips, shoulder and knees, Covid-19 with positive Covid-19 test, veins were large in thumbs, fatigue, and myalgia (shoulder muscle pains). It was reported that the patient had fatigue and shoulder muscle pains from mRNA-1273 vaccine. No other information surrounding the events was reported. The concurrent medical condition of rheumatoid arthritis remain confounder for the events rheumatoid arthritis flare up, fatigue and myalgia (shoulder muscle pains) due to the nature of the disease. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old, female patient with concurrent medical condition of rheumatoid arthritis. Patient has co-suspect medication of Upadacitinib (Rinvoq) for rheumatoid arthritis. Patient has no reported vaccination history. Patient experienced the unexpected serious (medically significant) AESI event of rheumatoid arthritis flare up, the unexpected non-serious AESI event of Covid-19, the unexpected non-serious event of veins were large in thumbs, and the expected non-serious events of fatigue and myalgia (shoulder muscle pains). On unknown date, patient received unknown dose number of mRNA-1273 vaccine administration. On unknown date patient received co-suspect medication of Upadacitinib (Rinvoq) for rheumatoid arthritis. On unknown date patient experienced rheumatoid arthritis flare up in hands, hips, shoulder and knees, Covid-19 with positive Covid-19 test, veins were large in thumbs, fatigue, and myalgia (shoulder muscle pains). It was reported that the patient had fatigue and shoulder muscle pains from mRNA-1273 vaccine. No other information surrounding the events was reported. The concurrent medical condition of rheumatoid arthritis remain confounder for the events rheumatoid arthritis flare up, fatigue and myalgia (shoulder muscle pains) due to the nature of the disease. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.