Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Emphysema, Feeling abnormal, Immunisation reaction
Clinical narrative: Emphysema; Loss of balance; Foggy feeling in head; Enlarged prostate; Rheumatoid arthritis flare up; Vaccination related malaise; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an 83-year-old male 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) for Rheumatoid arthritis.    The patient's past medical history included Coronary stent placement. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and FOLIC ACID for an unknown indication.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Vaccination related malaise), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), EMPHYSEMA (Emphysema), BALANCE DISORDER (Loss of balance), FEELING ABNORMAL (Foggy feeling in head) and PROSTATOMEGALY (Enlarged prostate). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), EMPHYSEMA (Emphysema), BALANCE DISORDER (Loss of balance), FEELING ABNORMAL (Foggy feeling in head) and PROSTATOMEGALY (Enlarged prostate) had not resolved and IMMUNISATION REACTION (Vaccination related malaise), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had stent in heart. Patient was having flare ups of rheumatoid arthritis and patient's hands hurt and swell when due for Humira injection. There was no reported medical history.  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 an 83-year-old male patient with concurrent Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Outcome of the event was reported as not resolved.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart.  The concurrent Rheumatoid arthritis remains a confounder as it is known to cause flares, while the advanced age of the patient could be considered as a predisposing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a an 83-year-old male patient with concurrent Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Outcome of the event was reported as not resolved.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart.  The concurrent Rheumatoid arthritis remains a confounder as it is known to cause flares, while the advanced age of the patient could be considered as a predisposing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.