Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS FLARE/FLARES THAT AFFECTED FEET; FACE GOT HOT AFTER BOTH VACCINES; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE/FLARES THAT AFFECTED FEET) in a 50-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.    Concurrent medical conditions included Psoriatic arthritis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-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. In 2021, the patient experienced FEELING HOT (FACE GOT HOT AFTER BOTH VACCINES). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE/FLARES THAT AFFECTED FEET) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE/FLARES THAT AFFECTED FEET) and FEELING HOT (FACE GOT HOT AFTER BOTH VACCINES) outcome was unknown.            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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  Causality for Humira (Adalimumab) Solution for injection in prefilled pen: The reporters causality for the events of face got hot after both vaccines and psoriatic arthritis flare that affected feet was not provided.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 50-year-old female patient, with relevant medical condition of psoriatic arthritis, who experienced the unexpected and serious (due to medically significant) event of Psoriatic arthropathy (reported as psoriatic arthritis flare/flares that affected feet), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for psoriatic arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Psoriatic arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Significant follow-up received contains patient age added, Event updated Psoriatic arthritis aggravated, case seriousness upgraded to Medically Significant, event onset date and reporter causality updated.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 50-year-old female patient, with relevant medical condition of psoriatic arthritis, who experienced the unexpected and serious (due to medically significant) event of Psoriatic arthropathy (reported as psoriatic arthritis flare/flares that affected feet), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for psoriatic arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Psoriatic arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.