Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Nasopharyngitis, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flare; Head cold; Moderna dose 1 :28-APR-2021 , dose 2 : 15-MAY-2021; COVID-19 Vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare) in a 38-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis. Concomitant products included IBUPROFEN for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose 1 :28-APR-2021 , dose 2 : 15-MAY-2021). In 2021, the patient experienced IMMUNISATION REACTION (COVID-19 Vaccine reaction). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare) (seriousness criterion medically significant) and NASOPHARYNGITIS (Head cold). In 2021, IMMUNISATION REACTION (COVID-19 Vaccine reaction) had resolved. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare) was resolving and NASOPHARYNGITIS (Head cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose 1 :28-APR-2021 , dose 2 : 15-MAY-2021) outcome was unknown.            No medical history was reported.  The patient had psoriatic arthritis flare with his left wrist and fingers swollen and hurt and knee and ankles inflamed. He had a lot of pain for two days and could not even get out of bed. He had a reaction to COVID- 19 vaccine. The physician said he should not had reaction and he did. He was sick due to a head cold. He had psoriatic arthritis aggravation and was in pain for three days. On 04-Jan-2022, patient had taken Skyrizi shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the event(s) of covid 19 vaccine reaction with co-suspect Skyrizi was a Reasonable possibility. The reporter causality for the event of psoriatic arthritis flare and head cold with co-suspect Skyrizi was 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 spontaneous case concerns a 38 year old male patient with concurrent condition of chronic plaque psoriasis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthritis flare), unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, about 17 days ago with no reported adverse events.  Inappropriate schedule of product administration was noted. He had psoriatic arthritis aggravation with his left wrist and fingers swollen and hurt and knee and ankles inflamed.  He was in pain for three days. No information on relevant investigations and treatment was available in the report. The event was resolving. The  concurrent condition of chronic plaque psoriasis could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38 year old male patient with concurrent condition of chronic plaque psoriasis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthritis flare), unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, about 17 days ago with no reported adverse events.  Inappropriate schedule of product administration was noted. He had psoriatic arthritis aggravation with his left wrist and fingers swollen and hurt and knee and ankles inflamed.  He was in pain for three days. No information on relevant investigations and treatment was available in the report. The event was resolving. The  concurrent condition of chronic plaque psoriasis could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.