Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Unable to walk; UNABLE TO SLEEP; UNABLE TO USE BATHROOM; SWOLLEN; SYMPTOMS OF COVID FROM VACCINE AND BOOSTER SHOT/COVID; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 71-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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On an unknown date, the patient received third 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 18-Apr-2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced GAIT INABILITY (Unable to walk), INSOMNIA (UNABLE TO SLEEP), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (UNABLE TO USE BATHROOM), SWELLING (SWOLLEN) and COVID-19 (SYMPTOMS OF COVID FROM VACCINE AND BOOSTER SHOT/COVID). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), GAIT INABILITY (Unable to walk), INSOMNIA (UNABLE TO SLEEP), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (UNABLE TO USE BATHROOM), SWELLING (SWOLLEN) and COVID-19 (SYMPTOMS OF COVID FROM VACCINE AND BOOSTER SHOT/COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  It was reported that patient experienced symptoms of COVID from vaccine and booster shot/COVID, experienced symptoms a few days before injection date for Humira drug.  Reporters causality for all events was not reported with respect to Humira drug.  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 71-year-old, female patient with medical history of Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up, the unexpected, non-serious AESI of COVID-19, and other unexpected, non-serious events. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving Humira and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the administration dates of Humira and the mRNA-1273 vaccine were not provided while the event onset date was reported as 18Apr2022, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that the patient experienced symptoms (not reported) of COVID-19 a few days before receiving Humira. It was also reported that the patient was unable to walk, unable to sleep, unable to use the bathroom, and was swollen. No further details were provided. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with medical history of Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up, the unexpected, non-serious AESI of COVID-19, and other unexpected, non-serious events. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving Humira and unknown number of days after receiving the third (booster) dose of the mRNA-1273 vaccine. Of note, the administration dates of Humira and the mRNA-1273 vaccine were not provided while the event onset date was reported as 18Apr2022, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that the patient experienced symptoms (not reported) of COVID-19 a few days before receiving Humira. It was also reported that the patient was unable to walk, unable to sleep, unable to use the bathroom, and was swollen. No further details were provided. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.