Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Psoriatic arthropathy, Vertigo
Clinical narrative: Psoriatic arthritis aggravated / PSORIATIC ARTHRITIS FLARE UP; Vertigo; Swelling arm / ARM SWELLED THREE TIMES IN SIZE; Localised feeling of warmth / RED AND HOT FROM SHOULDER TO WRIST; Localised erythema / RED AND HOT FROM SHOULDER TO WRIST; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated / 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.    Concurrent medical conditions included Psoriatic arthritis.   On 02-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated / PSORIATIC ARTHRITIS FLARE UP) (seriousness criterion medically significant), VERTIGO (Vertigo), PERIPHERAL SWELLING (Swelling arm / ARM SWELLED THREE TIMES IN SIZE), FEELING HOT (Localised feeling of warmth / RED AND HOT FROM SHOULDER TO WRIST) and ERYTHEMA (Localised erythema / RED AND HOT FROM SHOULDER TO WRIST). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated / PSORIATIC ARTHRITIS FLARE UP) had not resolved and VERTIGO (Vertigo), PERIPHERAL SWELLING (Swelling arm / ARM SWELLED THREE TIMES IN SIZE), FEELING HOT (Localised feeling of warmth / RED AND HOT FROM SHOULDER TO WRIST) and ERYTHEMA (Localised erythema / RED AND HOT FROM SHOULDER TO WRIST) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient received HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of psoriatic arthritis flare up with Humira (adalimumab) was  Reasonable possibility. The reporter's causality for the event(s) of vertigo, arm swelled three times in size, red and hot from shoulder to wrist unknown onset, arm swelled three times in size, red and hot from shoulder to wrist unknown onset and arm swelled three times in size, red and hot from shoulder to wrist unknown onset with Humira(adalimumab) was no reasonable possibility.  No treatment medications were provided by the reporter.  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 concerning an adult female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with medical history of psoriatic arthritis, who experienced the unexpected, serious (medically significant) event of Psoriatic arthropathy (psoriatic arthritis aggravated), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of psoriatic arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.