Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Psoriatic arthropathy, Pyrexia, Therapeutic response shortened
Clinical narrative: Psoriatic arthritis aggravated; Wearing off effect; Chills; FEVER; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in a 69-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) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In April 2021, the patient experienced MIGRAINE (Migraine). In 2022, the patient experienced CHILLS (Chills) and PYREXIA (FEVER). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), MIGRAINE (Migraine), CHILLS (Chills) and PYREXIA (FEVER) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporters contact for lot number information was unsuccessful.  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 is a spontaneous case concerning a 69-year-old female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-624826 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 69-year-old female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.