Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Hypoaesthesia, Pain, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: stress caused rheumatoid arthritis flare ups; Back pain; swelling in hands; Stress; Numbness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (stress caused rheumatoid arthritis flare ups) in a 77-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.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-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) Citrate Free. On 07-May-2021, the patient experienced PAIN (achiness). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (stress caused rheumatoid arthritis flare ups) (seriousness criterion medically significant), BACK PAIN (Back pain), PERIPHERAL SWELLING (swelling in hands), STRESS (Stress) and HYPOAESTHESIA (Numbness). At the time of the report, RHEUMATOID ARTHRITIS (stress caused rheumatoid arthritis flare ups) had not resolved and BACK PAIN (Back pain), PERIPHERAL SWELLING (swelling in hands), STRESS (Stress), PAIN (achiness) and HYPOAESTHESIA (Numbness) outcome was unknown.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event(s) of back pain, swelling in hands, stress caused rheumatoid arthritis flare ups and numbness was not provided. The reporter's causality for the event(s) of achiness with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of stress caused rheumatoid arthritis flare ups unknown onset with Humira (adalimumab) was a reasonable possibility. The reporter's causality for achiness with Moderna Covid-19 vaccine was reported as probable.  No treatment details 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 spontaneous case concerns a 77-year-old female patient, with concurrent medical history of rheumatid arthritis treated with Adalimumab, who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on an unknown date after receiving a dose of mRNA-1273 vaccine along with non-serious events of back pain, peripheral swelling, and hypoaesthesia. Patient received 1st and 2nd dose of mRNA-1273 vaccine 28 days apart. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Concurrent rheumatoid arthritis and co-suspect Adalimumab could be confounders as the disease can have flares. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old female patient, with concurrent medical history of rheumatid arthritis treated with Adalimumab, who experienced the unexpected serious (medically significant) AESI Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on an unknown date after receiving a dose of mRNA-1273 vaccine along with non-serious events of back pain, peripheral swelling, and hypoaesthesia. Patient received 1st and 2nd dose of mRNA-1273 vaccine 28 days apart. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Concurrent rheumatoid arthritis and co-suspect Adalimumab could be confounders as the disease can have flares. The benefit-risk relationship of mRNA-1273 is not affected by this report.