Age: 19.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ear infection, Fatigue, Psoriatic arthropathy, Pyrexia
Clinical narrative: ear infections; still had fatigue; sick with fever; arthropathic psoriasis flare up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (arthropathic psoriasis flare up) in a 19-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 arthropathy.    Concurrent medical conditions included Arthropathy psoriatic.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PSORIATIC ARTHROPATHY (arthropathic psoriasis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced EAR INFECTION (ear infections), FATIGUE (still had fatigue) and PYREXIA (sick with fever). At the time of the report, PSORIATIC ARTHROPATHY (arthropathic psoriasis flare up) was resolving and EAR INFECTION (ear infections), FATIGUE (still had fatigue) and PYREXIA (sick with fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The patient experienced ear infections, earaches, still has fatigue and sick with fever.  Causality for HUMIRA: The reporter causality for the events of ear infections, earaches, arthropathic psoriasis flare up, still had fatigue and sick with fever was not provided.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked in.  Company comment-This spontaneous case concerns a female patient aged 19 years with reported concurrent condition of arthropathic psoriasis unspecified on Humira, experienced unexpected serious (medically significant) events of Psoriatic arthropathy (reported as Psoriatic arthropathy aggravated) that occurred on unknown dates in 2021 after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was resolving at the time of report. Relevant medical history remains a confounder to the event Psoriatic arthropathy aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 19 years with reported concurrent condition of arthropathic psoriasis unspecified on Humira, experienced unexpected serious (medically significant) events of Psoriatic arthropathy (reported as Psoriatic arthropathy aggravated) that occurred on unknown dates in 2021 after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was resolving at the time of report. Relevant medical history remains a confounder to the event Psoriatic arthropathy aggravated. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.