Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, COVID-19
Clinical narrative: COVID-19; ARTHRITIS BOTHERING STARTED OUT WITH RIGHT KNEE; PAIN WENT DOWN TO RIGHT ANKLE; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and ARTHRALGIA (PAIN WENT DOWN TO RIGHT ANKLE). On an unknown date, the patient experienced ARTHRITIS (ARTHRITIS BOTHERING STARTED OUT WITH RIGHT KNEE). At the time of the report, COVID-19 (COVID-19), ARTHRITIS (ARTHRITIS BOTHERING STARTED OUT WITH RIGHT KNEE) and ARTHRALGIA (PAIN WENT DOWN TO RIGHT ANKLE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. In 2021, the patient experienced COVID, ARTHRITIS BOTHERING STARTED OUT WITH RIGHT KNEE AND THEN PAIN WENT DOWN TO RIGHT ANKLE and POSSIBLE LACK OF EFFECT. Patient had been admitted into the hospital for COVID-19. For the past couple of days her arthritis had been really bothering her. It started out with right knee and then the pain went down to her right ankle. She did get COVID-19 after she had her COVID Vaccine which she got the vaccine back toward the beginning of this year.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID, ARTHRITIS BOTHERING STARTED OUT WITH RIGHT KNEE AND THEN  PAIN WENT DOWN TO RIGHT ANKLE onset in 2021, POSSIBLE LACK OF EFFECT and ARTHRITIS BOTHERING STARTED OUT WITH RIGHT KNEE AND THEN PAIN WENT DOWN TO RIGHT ANKLE onset in 2021 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 is a spontaneous concerning a 60 -old-female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (hospitalization) adverse event of special interest of COVID-19 and the unexpected, non-serious adverse event of special interest of Arthritis, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event of Arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous concerning a 60 -old-female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (hospitalization) adverse event of special interest of COVID-19 and the unexpected, non-serious adverse event of special interest of Arthritis, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the events, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event of Arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.