Age: 44.0
Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Chills, Fatigue, Interchange of vaccine products, Pain
Clinical narrative: Psoriatic arthritis aggravated; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Fatigue; Chills; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Psoriatic arthritis.   On 04-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced PAIN (Ache) and CHILLS (Chills). On 12-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). In November 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) had not resolved and PAIN (Ache), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  No treatment medications were reported.  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 44 year old patient of unknown gender, with concurrent condition of psoriatic arthritis , who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, unknown days after receiving the third dose (first booster) dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with Pfizer COVID 19 vaccine. Interchange of vaccine products was noted. No information on exact date of event, detailed clinical course, reports of relevant investigations and treatment details was available in the report. The event had not resolved. Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow up document contains patient demographics and narrative description were reported. New event added and current condition added.; Sender's Comments: This spontaneous case concerns a 44 year old patient of unknown gender, with concurrent condition of psoriatic arthritis , who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, unknown days after receiving the third dose (first booster) dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with Pfizer COVID 19 vaccine. Interchange of vaccine products was noted. No information on exact date of event, detailed clinical course, reports of relevant investigations and treatment details was available in the report. The event had not resolved. Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.