Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Lymph node pain, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Activities of daily living impaired; Fatigue extreme; Lymph node pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (chronic). Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), FATIGUE (Fatigue extreme) and LYMPH NODE PAIN (Lymph node pain). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) had not resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), FATIGUE (Fatigue extreme) and LYMPH NODE PAIN (Lymph node pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had lower back pain that had affected daily activities. Patient had been seen by a rheumatologist recently but they were observing her. No new drug changed. She felt extreme fatigue 24 hours following. Lymph nodes were painful for over a week.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of psoriatic arthritis, daily activities affected, extreme fatigue and lymph nodes were painful with Skyrizi(risankizumab) was no reasonable possibility.  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 an adult, female patient with medical history of Chronic Plaque Psoriasis treated with the co-suspect product Skyrizi (risankizumab) and history of concomitant administration of two doses of the Janssen COVID-19 vaccine, who experienced the unexpected, serious (medically significant) event of psoriatic arthropathy (psoriatic arthritis), and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving a dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (interchange of vaccine products). Of note, the administration dates of Skyrizi and the mRNA-1273 vaccine as well as the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient was diagnosed with Psoriatic Arthritis. She had lower back pain that had affected her daily activities. She was seen by a rheumatologist and was being observed. No new drug was given. The patient also experienced extreme fatigue after 24 hours and her lymph nodes were painful for over a week. Treatment information was not provided. The medical history of Chronic Plaque Psoriasis remains a confounder for the event psoriatic arthritis which is a comorbidity linked to Psoriasis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult, female patient with medical history of Chronic Plaque Psoriasis treated with the co-suspect product Skyrizi (risankizumab) and history of concomitant administration of two doses of the Janssen COVID-19 vaccine, who experienced the unexpected, serious (medically significant) event of psoriatic arthropathy (psoriatic arthritis), and other unexpected and expected, non-serious events. The events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving a dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (interchange of vaccine products). Of note, the administration dates of Skyrizi and the mRNA-1273 vaccine as well as the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient was diagnosed with Psoriatic Arthritis. She had lower back pain that had affected her daily activities. She was seen by a rheumatologist and was being observed. No new drug was given. The patient also experienced extreme fatigue after 24 hours and her lymph nodes were painful for over a week. Treatment information was not provided. The medical history of Chronic Plaque Psoriasis remains a confounder for the event psoriatic arthritis which is a comorbidity linked to Psoriasis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.