Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rheumatoid arthritis, SARS-CoV-2 test, Somnolence, Vaccination site pain
Clinical narrative: rheumatoid arthritis occasional minor flares; felt hung over the day after injection; grogginess; covid related fogginess; Flu like symptoms; Fatigue; sore arm following all vaccines; felt queasy; covid; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis occasional minor flares) in a 69-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 products included non-company products METHOTREXATE for an unknown indication and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started METHOTREXATE (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2020, the patient experienced COVID-19 (covid). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis occasional minor flares) (seriousness criterion medically significant), HANGOVER (felt hung over the day after injection), SOMNOLENCE (grogginess), FEELING ABNORMAL (covid related fogginess), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), VACCINATION SITE PAIN (sore arm following all vaccines) and NAUSEA (felt queasy). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis occasional minor flares), HANGOVER (felt hung over the day after injection), SOMNOLENCE (grogginess), FEELING ABNORMAL (covid related fogginess), INFLUENZA LIKE ILLNESS (Flu like symptoms), COVID-19 (covid), FATIGUE (Fatigue), VACCINATION SITE PAIN (sore arm following all vaccines) and NAUSEA (felt queasy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: (Positive) Positive.         No concomitant drug was reported. HUMIRA (Solution for injection in pre-filled pen) was used for the indication of moderate to severe rheumatoid arthritis. No treatment drug was reported. Causality for humira(adalimumab): The reporter's causality for the event(s) of felt hung over the day after injection, fatigue, grogginess, sore arm following all vaccines, felt queasy, covid related fogginess, rheumatoid arthritis occasional minor flares, flu like symptoms and covid was not provided. For methotrexate the reporter's causality for the event(s) fatigue, grogginess and felt queasy as probable, causality for the events felt hung over the day after injection, sore arm following all vaccines, covid related fogginess, rheumatoid arthritis occasional minor flares, flu like symptoms and covid 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 69-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) and non-serious adverse event of special interest of COVID-19. The event COVID-19 occurred 1 year prior to the first dose of mRNA-1273. The event rheumatoid arthritis (reported as minor flare ups) occurred an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses as part of the natural history of the disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 69-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) and non-serious adverse event of special interest of COVID-19. The event COVID-19 occurred 1 year prior to the first dose of mRNA-1273. The event rheumatoid arthritis (reported as minor flare ups) occurred an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses as part of the natural history of the disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.