Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Psoriatic arthropathy, Pyrexia, Swelling, Unevaluable event
Clinical narrative: Swelling; irritation; Fatigue; Fever; Psoriatic arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in a 61-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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In 2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF (1 in 1 wk) and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF (1 in 1 wk). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Swelling), UNEVALUABLE EVENT (irritation), FATIGUE (Fatigue) and PYREXIA (Fever). In 2021, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) had resolved. At the time of the report, SWELLING (Swelling), UNEVALUABLE EVENT (irritation), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of SWELLING, IRRITATION, FEVER and FATIGUE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PSORIATIC ARTHRITIS FLARE onset in April 2021 and PSORIATIC ARTHRITIS FLARE onset in 2021 was not provided.  Company Comment:  This spontaneous case concerns a 61-year-old female patient with relevant medical history of Psoriatic arthritis on Adalimumab, who experienced the unexpected, serious  (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthritis aggravated) on an unspecified date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset date of the event were not reported. Outcome of the event was reported as resolved. No information on any other doses of COVID-19 vaccination was provided. Psoriatic arthritis is known to result in flares, thus, considered a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old female patient with relevant medical history of Psoriatic arthritis on Adalimumab, who experienced the unexpected, serious  (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthritis aggravated) on an unspecified date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset date of the event were not reported. Outcome of the event was reported as resolved. No information on any other doses of COVID-19 vaccination was provided. Psoriatic arthritis is known to result in flares, thus, considered a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.