Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Constipation, Hidradenitis, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis flare up; Hidradenitis suppurativa; Sensation loss; Loss of smell; Loss of taste; Constipation; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 37-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 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced CONSTIPATION (Constipation). In July 2022, the patient experienced SENSORY LOSS (Sensation loss), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant) and HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up), CONSTIPATION (Constipation) and HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown and SENSORY LOSS (Sensation loss), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) had not resolved.            Concomitant medications were not reported.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company comment: This is a spontaneous case concerning a 37-year-old, female patient with relevant concurrent medical condition of psoriatic arthritis. Patient has co-suspect medication of Adalimumab (Humira) for psoriatic arthritis. Patient experienced the unexpected serious (medically significant) event of psoriatic arthritis flare up, the unexpected non-serious AESI events of anosmia and ageusia, and the unexpected non-serious events of sensory loss, constipation and hidradenitis suppurativa. On unknown day and month of 2021, patient received first dose of mRNA-1273 vaccine. On unknown day and month of 2021, patient received second dose of mRNA-1273 vaccine. On unknown day and month of 2022, patient experienced constipation. On unknown day of July 2022, patient experienced sensory loss, anosmia and ageusia. On unknown date, patient experienced psoriatic arthritis flare up and hidradenitis suppurativa. No further clinical information was available for medical review. The natural course of the concurrent medical condition of psoriatic arthritis remain confounder for the event psoriatic arthritis flare up. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 37-year-old, female patient with relevant concurrent medical condition of psoriatic arthritis. Patient has co-suspect medication of Adalimumab (Humira) for psoriatic arthritis. Patient experienced the unexpected serious (medically significant) event of psoriatic arthritis flare up, the unexpected non-serious AESI events of anosmia and ageusia, and the unexpected non-serious events of sensory loss, constipation and hidradenitis suppurativa. On unknown day and month of 2021, patient received first dose of mRNA-1273 vaccine. On unknown day and month of 2021, patient received second dose of mRNA-1273 vaccine. On unknown day and month of 2022, patient experienced constipation. On unknown day of July 2022, patient experienced sensory loss, anosmia and ageusia. On unknown date, patient experienced psoriatic arthritis flare up and hidradenitis suppurativa. No further clinical information was available for medical review. The natural course of the concurrent medical condition of psoriatic arthritis remain confounder for the event psoriatic arthritis flare up. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.