Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS FLARE UP; ACHINESS; EXPERIENCED ARM PAIN/Vaccination site pain; Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) in a 59-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.    Concurrent medical conditions included Psoriatic arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free,Solution for injection in pre-filled pen. In 2021, the patient experienced PAIN (ACHINESS), VACCINATION SITE PAIN (EXPERIENCED ARM PAIN/Vaccination site pain), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) had not resolved and PAIN (ACHINESS), VACCINATION SITE PAIN (EXPERIENCED ARM PAIN/Vaccination site pain), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            It was unknown patient enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported  The reporters causality for the events of EXPERIENCED ARM PAIN DUE TO COVID VACCINE, CHILLS, FATIGUE, ACHINESS and HEADACHE with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PSORIATIC ARTHRITIS FLARE UP with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication 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, reported by a consumer, concerning a 59-year-old female patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, reported as psoriatic arthritis aggravated, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. The patient also experienced achiness, pain at vaccinated arm, chills, fatigue, and headache. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Psoriatic arthropathy was not resolved. The medical condition of Psoriatic arthritis remains as a confounder for the event Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 59-year-old female patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, reported as psoriatic arthritis aggravated, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. The patient also experienced achiness, pain at vaccinated arm, chills, fatigue, and headache. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event Psoriatic arthropathy was not resolved. The medical condition of Psoriatic arthritis remains as a confounder for the event Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.