Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Gait disturbance, Musculoskeletal disorder, Night sweats, Peripheral swelling
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS; COULD NOT SIT LONG; Walking difficulty; Water retention; Night sweats; OCASSIONAL KNOTS AT INJECTION SITE; BLEEDING AT INJECTION SITE; SWELLING IN HANDS AND FEET; REACTION TO COVID 19 VACCINE WAS LEFT ARM SORE/PAIN/STINGING AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS) in an elderly 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.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS) (seriousness criterion medically significant), MUSCULOSKELETAL DISORDER (COULD NOT SIT LONG), GAIT DISTURBANCE (Walking difficulty), FLUID RETENTION (Water retention), NIGHT SWEATS (Night sweats), VACCINATION SITE NODULE (OCASSIONAL KNOTS AT INJECTION SITE), VACCINATION SITE HAEMORRHAGE (BLEEDING AT INJECTION SITE), PERIPHERAL SWELLING (SWELLING IN HANDS AND FEET) and VACCINATION SITE PAIN (REACTION TO COVID 19 VACCINE WAS LEFT ARM SORE/PAIN/STINGING AT INJECTION SITE). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP/COLD WEATHER BOTHERS RHEUMATOID ARTHRITIS), MUSCULOSKELETAL DISORDER (COULD NOT SIT LONG), NIGHT SWEATS (Night sweats), VACCINATION SITE NODULE (OCASSIONAL KNOTS AT INJECTION SITE), VACCINATION SITE HAEMORRHAGE (BLEEDING AT INJECTION SITE) and PERIPHERAL SWELLING (SWELLING IN HANDS AND FEET) had not resolved and GAIT DISTURBANCE (Walking difficulty), FLUID RETENTION (Water retention) and VACCINATION SITE PAIN (REACTION TO COVID 19 VACCINE WAS LEFT ARM SORE/PAIN/STINGING AT INJECTION SITE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment drugs were reported.  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 case concerning an elderly male patient with medical history of Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (rheumatoid arthritis flare up/cold weather bothers rheumatoid arthritis), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of Rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly male patient with medical history of Rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (rheumatoid arthritis flare up/cold weather bothers rheumatoid arthritis), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of Rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.