Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19 immunisation, Headache, Interchange of vaccine products, Pain, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis aggravated/psoriatic arthritis flare up/Swelling of hands/puffy hands in morning/Inflammation localised/Inflammation with fingers; Revaccination with different COVID-19 vaccines; Interchange of vaccine products; Headache; Ache/achiness; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/psoriatic arthritis flare up/Swelling of hands/puffy hands in morning/Inflammation localised/Inflammation with fingers) in a 51-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 ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (First dose, Route of Administration: Intramuscular In 2021, the patient experienced had PFIZER VACCINES and headache.) on 08-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (First dose, Route of Administration: Intramuscular In 2021, the patient experienced had PFIZER VACCINES and sore arm.) on 08-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Second dose, Route of Administration: Intramuscular In 2021, the patient experienced had PFIZER VACCINES and headache.) on 08-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Second dose, Route of Administration: Intramuscular In 2021 and the patient experienced had PFIZER VACCINES and sore arm.) on 08-Apr-2021. Past adverse reactions to the above products included Headache with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE; and Vaccination site pain with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Psoriatic arthritis.   On 04-Aug-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, the patient experienced PAIN (Ache/achiness) and HEADACHE (Headache). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/psoriatic arthritis flare up/Swelling of hands/puffy hands in morning/Inflammation localised/Inflammation with fingers) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccines ) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with PREDNISONE at a dose of Unknown. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/psoriatic arthritis flare up/Swelling of hands/puffy hands in morning/Inflammation localised/Inflammation with fingers) had not resolved and PAIN (Ache/achiness), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccines ), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.  The patient experienced psoriatic arthritis flare up, puffy hands in morning, inflammation with fingers and Moderna vaccinations caused headache and achiness. In 2021, the patient experienced had Pfizer vaccines and headaches and sore arm.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  Primary reporters contact for lot number information was unsuccessful. The reporter's causality for the events of psoriatic arthropathy was reasonable possibility with HUMIRA (ADALIMUMAB) (Solution for injection in pre-filled pen).  Company Comment:This spontaneous case concerns a 51-year-old, female patient with concurrent condition of Psoriatic arthropathy treated with Adalimumab who experienced the unexpected, serious (medically significant) event of Psoriatic arthritis aggravated which occurred on unknown interval after receiving mRNA-1273 taken as third dose of COVID-19 vaccination. Inappropriate schedule of vaccine administered and Revaccination with different COVID-19 vaccines were noted in the case as patient received Tozinameran as primary series of vaccination with last dose taken nine months prior to mRNA-1273 administration. Headache and vaccination site pain were the reported adverse events during the primary series of vaccination. Psoriatic arthritis aggravated was further described as swelling and inflammation of the hands and fingers in the morning. The clinical course and diagnostic evaluation were not provided in the report. The patient was treated with unknown dose of prednisone. At the time of report, the event has not resolved. Psoriatic arthritis can flare as part of natural history of disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with concurrent condition of Psoriatic arthropathy treated with Adalimumab who experienced the unexpected, serious (medically significant) event of Psoriatic arthritis aggravated which occurred on unknown interval after receiving mRNA-1273 taken as third dose of COVID-19 vaccination. Inappropriate schedule of vaccine administered and Revaccination with different COVID-19 vaccines were noted in the case as patient received Tozinameran as primary series of vaccination with last dose taken nine months prior to mRNA-1273 administration. Headache and vaccination site pain were the reported adverse events during the primary series of vaccination. Psoriatic arthritis aggravated was further described as swelling and inflammation of the hands and fingers in the morning. The clinical course and diagnostic evaluation were not provided in the report. The patient was treated with unknown dose of prednisone. At the time of report, the event has not resolved. Psoriatic arthritis can flare as part of natural history of disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.