Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Depressed mood, Disturbance in attention, Headache, Psoriatic arthropathy, Stress
Clinical narrative: TROUBLE CONCENTRATING; Headache; DEPRESSED/PATIENT WAS DOWN ALL WEEKEND; Stress; PSORIATIC ARTHRITIS FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) in a 46-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) for Psoriatic arthritis.    No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 17-Dec-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) at an unspecified dose. In 2021, the patient experienced PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) (seriousness criterion medically significant) and STRESS (Stress). In December 2021, the patient experienced DEPRESSED MOOD (DEPRESSED/PATIENT WAS DOWN ALL WEEKEND) and HEADACHE (Headache). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (TROUBLE CONCENTRATING). At the time of the report, PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP), DEPRESSED MOOD (DEPRESSED/PATIENT WAS DOWN ALL WEEKEND), STRESS (Stress), DISTURBANCE IN ATTENTION (TROUBLE CONCENTRATING) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not reported.  Symptoms musculoskeletal stiffness, Pain and Inflammation were subsumed under Psoriatic arthropathy.  On unknown dates, the patient experienced had trouble concentrating and Humira was not helping as much as it was before. In 2021, the patient experienced stress, hurting/pain all over and psoriatic arthritis flare up. In Nov-2021, the patient experienced had COVID and this had caused some long-term effect on joints. In Dec-2021, the patient experienced depressed/patient was down all weekend, inflammation, stiffness and headache.   Treatment details were not provided by reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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 46-years-old female patient of with flare up Psoriatic arthritis and no medical history reported, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy that occurred in context to the third dose mRNA-1273 vaccination and co-suspect ADALIMUMAB (HUMIRA) which started at an unspecified dose. It was reported that patient experienced stress, hurting/pain all over and psoriatic arthritis flare up and stated that, he experienced COVID, with some long-term effect on joints. The treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2021-620366 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Live follow up attached. Event added.; Sender's Comments: This spontaneous case concerns a 46-years-old female patient of with flare up Psoriatic arthritis and no medical history reported, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy that occurred in context to the third dose mRNA-1273 vaccination and co-suspect ADALIMUMAB (HUMIRA) which started at an unspecified dose. It was reported that patient experienced stress, hurting/pain all over and psoriatic arthritis flare up and stated that, he experienced COVID, with some long-term effect on joints. The treatment details were not provided, and the event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.