Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, COVID-19
Clinical narrative: Arthritis aggravated/humira effectiveness/experienced more symptoms of arthritis in joints; COVID-19/contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/contracted COVID-19) and ARTHRITIS (Arthritis aggravated/humira effectiveness/experienced more symptoms of arthritis in joints) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to citrate free, Solution for injection in pre-filled pen. In August 2021, the patient experienced COVID-19 (COVID-19/contracted COVID-19). On an unknown date, the patient experienced ARTHRITIS (Arthritis aggravated/humira effectiveness/experienced more symptoms of arthritis in joints). In 2021, COVID-19 (COVID-19/contracted COVID-19) had resolved. At the time of the report, ARTHRITIS (Arthritis aggravated/humira effectiveness/experienced more symptoms of arthritis in joints) had not resolved.            No concomitant medication details were provided.  On unknown dates, COVID vaccine reaction/experienced flu-like symptoms with second Moderna shot and experienced injection site pain when used non citrate free HUMIRA resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not had the lot number information, because the packaging was discarded. No treatment medication details were 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 72-year-old female patient, with no reported medical history, who experienced the unexpected serious AESIs Arthritis (reported as experienced more symptoms of arthritis in joints) and COVID-19 after receiving the mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset date of events were not provided. On unknown dates, patient received 2 doses of mRNA-1273 vaccine and reported flu-like symptoms with 2nd dose.  Clinical course and treatment details were not reported. The outcome of arthritis was reported as not resolved, and COVID-19 resolved. On unknown date, patient received Adalimumab for rheumatoid arthritis which could be a confounder as the disease flares. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old female patient, with no reported medical history, who experienced the unexpected serious AESIs Arthritis (reported as experienced more symptoms of arthritis in joints) and COVID-19 after receiving the mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset date of events were not provided. On unknown dates, patient received 2 doses of mRNA-1273 vaccine and reported flu-like symptoms with 2nd dose.  Clinical course and treatment details were not reported. The outcome of arthritis was reported as not resolved, and COVID-19 resolved. On unknown date, patient received Adalimumab for rheumatoid arthritis which could be a confounder as the disease flares. The benefit-risk relationship of mRNA-1273 is not affected by this report.