Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Menopause, Psoriasis, Psoriatic arthropathy, Stress, Sunburn
Clinical narrative: Psoriatic arthritis aggravated/ Psoriatic arthritis flare up/ Stiff fingers/ few fingers on right hand felt like they are jammed; Psoriasis flare-up, eye lids, scalp and elbows/ Skin peeling/ skin was peeling like sunburn/ Localized rash/ Broke out in rash on neck, chest, face, and ears; Menopause/ Night sweats; Sunburn; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ Psoriatic arthritis flare up/ Stiff fingers/ few fingers on right hand felt like they are jammed) in a 52-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.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2022, received fourth 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) Unknown. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ Psoriatic arthritis flare up/ Stiff fingers/ few fingers on right hand felt like they are jammed) (seriousness criterion medically significant), PSORIASIS (Psoriasis flare-up, eye lids, scalp and elbows/ Skin peeling/ skin was peeling like sunburn/ Localized rash/ Broke out in rash on neck, chest, face, and ears), MENOPAUSE (Menopause/ Night sweats), SUNBURN (Sunburn) and STRESS (Stress). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated/ Psoriatic arthritis flare up/ Stiff fingers/ few fingers on right hand felt like they are jammed) was resolving, PSORIASIS (Psoriasis flare-up, eye lids, scalp and elbows/ Skin peeling/ skin was peeling like sunburn/ Localized rash/ Broke out in rash on neck, chest, face, and ears) had not resolved and MENOPAUSE (Menopause/ Night sweats), SUNBURN (Sunburn) and STRESS (Stress) outcome was unknown.            Concomitant medication details were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Did not have the lot number as the package was discarded. The reporter's causality for the event of localized rash and psoriasis flare-up with humira (Adalimumab) was no reasonable  possibility.          Treatment medication details were not provided.  Company Comment: This spontaneous case concerns a 52-year-old female patient with a relevant medical history of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy (Psoriatic arthritis aggravated/ Psoriatic arthritis flare up) and non-serious event of Psoriasis (Psoriasis flare-up, eye lids, scalp and elbows) unspecified days after the fourth dose of mRNA-1273. Patients relevant medical history of Psoriatic arthritis could be confounder for Psoriatic arthropathy and Psoriasis. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2022: Patient age updated. Vaccine onset date for 3rd Moderna dose was updated. Action taken for Moderna vaccine updated to not applicable. New events were added. Outcome updated for Psoriatic arthritis aggravated.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with a relevant medical history of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy (Psoriatic arthritis aggravated/ Psoriatic arthritis flare up) and non-serious event of Psoriasis (Psoriasis flare-up, eye lids, scalp and elbows) unspecified days after the fourth dose of mRNA-1273. Patients relevant medical history of Psoriatic arthritis could be confounder for Psoriatic arthropathy and Psoriasis. The benefit-risk relationship of mRNA-1273 is not affected by this report.