Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Psoriatic arthropathy, Pyrexia, SARS-CoV-2 test
Clinical narrative: Psoriatic arthritis aggravated; Fever; Vaccination site pain; Fatigue; COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in a 41-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   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 10-Sep-2021, the patient experienced COVID-19 (COVID 19). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) had not resolved and COVID-19 (COVID 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications was reported.  Patient had psoriatic arthritis flare up, had significant pain and stiffness. Patient had fever, arm soreness and fatigue from first and third Covid 19 vaccination. On an unknown date Covid-19, fever, vaccination site pain and fatigue from first vaccination are resolved.  No treatment medications was reported. 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 a female patient aged 41 years with reported concurrent condition of PLAQUE PSORIASIS on RISANKIZUMAB, experienced unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthropathy aggravated) along with unexpected non serious AESI of COVID 19 in the context of third dose of mRNA-1273 vaccination. Latency can not be assessed as vaccination date is not provided. Patient was SARS-CoV-2 test positive as on 10-SEP-2021.  She had psoriatic arthritis flare up associated with significant pain and stiffness. She also had fever, arm soreness and fatigue from first and third Covid 19 vaccinations. No details regarding previous doses and treatment details were provided. Outcome of the event Psoriatic arthropathy was not recovered and COVID 19 was resolved at the time of report. Relevant medical history remains a confounder to the event Psoriatic arthropathy aggravated. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 41 years with reported concurrent condition of PLAQUE PSORIASIS on RISANKIZUMAB, experienced unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthropathy aggravated) along with unexpected non serious AESI of COVID 19 in the context of third dose of mRNA-1273 vaccination. Latency can not be assessed as vaccination date is not provided. Patient was SARS-CoV-2 test positive as on 10-SEP-2021.  She had psoriatic arthritis flare up associated with significant pain and stiffness. She also had fever, arm soreness and fatigue from first and third Covid 19 vaccinations. No details regarding previous doses and treatment details were provided. Outcome of the event Psoriatic arthropathy was not recovered and COVID 19 was resolved at the time of report. Relevant medical history remains a confounder to the event Psoriatic arthropathy aggravated. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.