Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Rheumatoid arthritis, Transient ischaemic attack
Clinical narrative: Transient ischaemic attack; Rheumatoid Arthritis flare up in hands; COVID-19; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up in hands) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) 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-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up in hands) (seriousness criterion medically significant), the first episode of COVID-19 (COVID-19) and the second episode of COVID-19 (COVID-19). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up in hands) outcome was unknown and last episode of COVID-19 (COVID-19) had resolved.            No concomitant medicine were reported. No treatment medicine were reported. MPID for Moderna reported as Unknown. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Company comment: This is a spontaneous case concerning a 78-year-old, patient of unknown gender with relevant concurrent medical condition of rheumatoid arthritis. The patient has co-suspect medication of Adalimumab (Humira) for rheumatoid arthritis. The patient experienced the unexpected serious (medically significant) AESI events of transient ischaemic attack and rheumatoid arthritis flare up in hands along with non-serious events of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 29 days. The events occurrence was unknown with respect to the first and second dose of mRNA-1273 vaccine administration. No further clinical information was available for medical review. The concurrent medical condition of rheumatoid arthritis remain confounder for the event rheumatoid arthritis flare up in hands. The co-suspect medication of Adalimumab (Humira) remain confounder for the event transient ischaemic attack. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old, patient of unknown gender with relevant concurrent medical condition of rheumatoid arthritis. The patient has co-suspect medication of Adalimumab (Humira) for rheumatoid arthritis. The patient experienced the unexpected serious (medically significant) AESI events of transient ischaemic attack and rheumatoid arthritis flare up in hands along with non-serious events of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 29 days. The events occurrence was unknown with respect to the first and second dose of mRNA-1273 vaccine administration. No further clinical information was available for medical review. The concurrent medical condition of rheumatoid arthritis remain confounder for the event rheumatoid arthritis flare up in hands. The co-suspect medication of Adalimumab (Humira) remain confounder for the event transient ischaemic attack. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.