Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Feeling of body temperature change, Malaise, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flare up; Moderna vaccines caused fatigue and overall feeling ill; Hot and cold; Moderna vaccines caused fatigue and overall feeling ill; Chills; Shingles vaccination caused fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in an adult 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.    No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant), MALAISE (Moderna vaccines caused fatigue and overall feeling ill), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), FATIGUE (Moderna vaccines caused fatigue and overall feeling ill), CHILLS (Chills) and PYREXIA (Shingles vaccination caused fever). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) had not resolved and MALAISE (Moderna vaccines caused fatigue and overall feeling ill), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), FATIGUE (Moderna vaccines caused fatigue and overall feeling ill), CHILLS (Chills) and PYREXIA (Shingles vaccination caused fever) outcome was unknown.            Concomitant medication was not provided.  On an unknown date, patient received Shingles vaccination which caused fever.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of Moderna vaccines caused fatigue and overall feeling ill, Shingles vaccination caused fever, chills, hot and cold with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of psoriatic arthritis flare up with Humira (adalimumab) was a reasonable possibility.  Company comment- This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, serious (medically significant) event of Psoriatic arthropathy, which occurred at an unknown time with regards to the vaccination with a second dose of mRNA-1273. No further information was provided. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, serious (medically significant) event of Psoriatic arthropathy, which occurred at an unknown time with regards to the vaccination with a second dose of mRNA-1273. No further information was provided. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.