Sex: F
Vaccine: COVID19, UNK
Symptoms: Intervertebral disc degeneration, Rheumatoid arthritis, Scleritis
Clinical narrative: Scleritis; COVID BOOSTER INCREASED RHEUMATOID ARTHRITIS; Degenerative disc disease; This spontaneous case was reported by a consumer and describes the occurrence of SCLERITIS (Scleritis) and RHEUMATOID ARTHRITIS (COVID BOOSTER INCREASED RHEUMATOID ARTHRITIS) in an adult 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) for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, received third 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, Solution for injection in pre-filled pen. On an unknown date, the patient experienced SCLERITIS (Scleritis) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (COVID BOOSTER INCREASED RHEUMATOID ARTHRITIS) (seriousness criterion medically significant) and INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease). At the time of the report, SCLERITIS (Scleritis) and RHEUMATOID ARTHRITIS (COVID BOOSTER INCREASED RHEUMATOID ARTHRITIS) was resolving and INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporter's causality for the events of SCLERITIS with HUMIRA(ADALIMUMAB) was a reasonable possibility and for the event of COVID BOOSTER INCREASED RHEUMATOID ARTHRITIS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of DEGENERATIVE DISC DISEASE, SORE ARM and NERVE PAIN THAT GOES DOWN LEG was not provided.  No treatment medication were reported.  NERVE PAIN THAT GOES DOWN LEG WITH HUMIRA and Pain in extremity were manifested under the event intervertebral disc degeneration disease   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.  CC: This spontaneous case concerns an adult, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced the unexpected, medically significant events of Scleritis and an AESI Rheumatoid arthritis (RA) aggravated in association with a dose of mRNA-1273 vaccine. Exact latency of both events relative to vaccination cannot be determined with unknown events' onset dates. Reportedly, patient had intervertebral disc degeneration along with sore arm and nerve pain that goes down to the legs on unknown dates. Patient's rheumatoid arthritis flared up post vaccination with a booster dose of mRNA-1273 vaccine. Outcome of the events scleritis and RA aggravated was reported as resolving. Vaccination history included a 2-dose primary series and a 3rd dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported.  Patient's underlying rheumatoid arthritis remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an adult, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced the unexpected, medically significant events of Scleritis and an AESI Rheumatoid arthritis (RA) aggravated in association with a dose of mRNA-1273 vaccine. Exact latency of both events relative to vaccination cannot be determined with unknown events' onset dates. Reportedly, patient had intervertebral disc degeneration along with sore arm and nerve pain that goes down to the legs on unknown dates. Patient's rheumatoid arthritis flared up post vaccination with a booster dose of mRNA-1273 vaccine. Outcome of the events scleritis and RA aggravated was reported as resolving. Vaccination history included a 2-dose primary series and a 3rd dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported.  Patient's underlying rheumatoid arthritis remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.