Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Psoriatic arthropathy, Rash
Clinical narrative: Psoriatic arthritis/ Psoriatic arthritis flare ups with joint and skin; Skin rash/ Rash on skin; Tiredness/ Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis/ Psoriatic arthritis flare ups with joint and skin) in a 74-year-old male 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.    The patient's other relevant history was not reported.  Concurrent medical conditions included Psoriatic arthritis.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-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) Solution for injection in pre-filled pen. In 2021, the patient experienced FATIGUE (Tiredness/ Felt tired). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis/ Psoriatic arthritis flare ups with joint and skin) (seriousness criterion medically significant) and RASH (Skin rash/ Rash on skin). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis/ Psoriatic arthritis flare ups with joint and skin) had not resolved and FATIGUE (Tiredness/ Felt tired) and RASH (Skin rash/ Rash on skin) outcome was unknown.            Concomitant Drugs were not reported.  The patient had thought HUMIRA was not effective as it used to be when first started.  Causality for HUMIRA(Adalimumab) with respect to events was not provided.  Treatment medication were not provided.  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 is a spontaneous case concerning a 74-year-old female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis flare ups), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis flare ups), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.