Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bursitis, COVID-19, Chills, Illness
Clinical narrative: Diagnosed with plaque psoriatic arthritis; Bursitis in right arm after vaccination; Got sick; Fever for two three days; Shivers; Body aches; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of PSORIATIC ARTHROPATHY (Diagnosed with plaque 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Diagnosed with plaque psoriatic arthritis) (seriousness criterion medically significant), BURSITIS (Bursitis in right arm after vaccination), ILLNESS (Got sick), PYREXIA (Fever for two three days), CHILLS (Shivers) and MYALGIA (Body aches). At the time of the report, PSORIATIC ARTHROPATHY (Diagnosed with plaque psoriatic arthritis) was resolving, BURSITIS (Bursitis in right arm after vaccination), ILLNESS (Got sick), CHILLS (Shivers), MYALGIA (Body aches) and COVID-19 (COVID-19) outcome was unknown and PYREXIA (Fever for two three days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Between 102-103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.  The patient's feet and tendons in her feet hurt. She had some good days and bad days.  No treatment information was reported.  The reporter's causality for the event(s) of diagnosed with plaque psoriatic arthritis with co-suspect Skyrizi was no reasonable possibility. 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 an adult, female patient with medical history of Moderate-to-severe Chronic Plaque Psoriasis treated with the co-suspect product Skyrizi (risankizumab), who experienced the unexpected, serious (medically significant) event of psoriatic arthropathy (psoriatic arthritis), the unexpected, non-serious AESI of COVID-19, and other unexpected and expected, non-serious events. The event COVID-19 occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date was not provided and the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The other events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Skyrizi, the vaccination date of the second dose of the mRNA-1273 vaccine and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient was diagnosed with Plaque Psoriatic Arthritis. Her feet and tendons in her feet hurt, and she had some good days and bad days. It was also reported that after vaccination, the patient got sick with fever (between 102 to 103 F) for 2 to 3 days, shivers and body aches. She also experienced bursitis in her right arm. 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. This case was linked to MOD-2022-624401 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult, female patient with medical history of Moderate-to-severe Chronic Plaque Psoriasis treated with the co-suspect product Skyrizi (risankizumab), who experienced the unexpected, serious (medically significant) event of psoriatic arthropathy (psoriatic arthritis), the unexpected, non-serious AESI of COVID-19, and other unexpected and expected, non-serious events. The event COVID-19 occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date was not provided and the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The other events occurred unknown number of days after receiving Skyrizi and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Skyrizi, the vaccination date of the second dose of the mRNA-1273 vaccine and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient was diagnosed with Plaque Psoriatic Arthritis. Her feet and tendons in her feet hurt, and she had some good days and bad days. It was also reported that after vaccination, the patient got sick with fever (between 102 to 103 F) for 2 to 3 days, shivers and body aches. She also experienced bursitis in her right arm. 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.