Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Intervertebral disc degeneration, Psoriasis, Psoriatic arthropathy, Rheumatoid arthritis
Clinical narrative: Psoriatic arthritis; Psoriasis; Degenerative disc disease; Inappropriate schedule of vaccine administered; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 54-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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Dec-2020, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 06-Jan-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In April 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant), PSORIASIS (Psoriasis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease) had not resolved, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved and PSORIASIS (Psoriasis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was provided. The reporter's causality for the events of degenerative disc disease, psoriasis, psoriatic arthritis and rheumatoid arthritis flareup with adalimumab solution for Injection was not provided. The reporter's causality for the events of degenerative disc disease, psoriasis, psoriatic arthritis and rheumatoid arthritis flareup with pfizer biontech Covid-19 vaccine (Tozinameran) was reasonable possibility.  Treatment medication was not provided by the reporter. Company Comment : This spontaneous case concerns a 54-year-old female patient, with medical history of rheumatoid arthritis treated with adalimumab, who experienced the unexpected, serious (medically significant) events of psoriatic arthropathy (PsA) and rheumatoid arthritis (RA) which occurred after mRNA-1273 dose administration, which was the patient's 4th dose of COVID-19 vaccination schedule. Latency cannot be calculated due to unknown events onset date. The patient received primary series vaccination (1 dose and 2 dose) with TOZINAMERAN; booster dose (3rd) was also performed with TOZINAMERAN during the same month as the current vaccination. This is not clear whether it was a mistake or off label use and this was requested to be clarified in follow up however Inappropriate schedule of vaccine administered was noted in this case. Events were accompanied by non-serious events of psoriasis and intervertebral disc degeneration. Medical history of concurrent rheumatoid arthritis could be considered as contributor to the event of RA and combined with adalimumab treatment can be considered as confounder to the event of PsA as adalimumab is known to cause pustular and palmoplantar psoriasis. No further clinical information on clinical course of the events with onset dates, diagnostic work up, differential diagnosis was provided for medical review. Psoriatic arthropathy was reported as not resolved while rheumatoid arthritis was reported as resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient, with medical history of rheumatoid arthritis treated with adalimumab, who experienced the unexpected, serious (medically significant) events of psoriatic arthropathy (PsA) and rheumatoid arthritis (RA) which occurred after mRNA-1273 dose administration, which was the patient's 4th dose of COVID-19 vaccination schedule. Latency cannot be calculated due to unknown events onset date. The patient received primary series vaccination (1 dose and 2 dose) with TOZINAMERAN; booster dose (3rd) was also performed with TOZINAMERAN during the same month as the current vaccination. This is not clear whether it was a mistake or off label use and this was requested to be clarified in follow up however Inappropriate schedule of vaccine administered was noted in this case. Events were accompanied by non-serious events of psoriasis and intervertebral disc degeneration. Medical history of concurrent rheumatoid arthritis could be considered as contributor to the event of RA and combined with adalimumab treatment can be considered as confounder to the event of PsA as adalimumab is known to cause pustular and palmoplantar psoriasis. No further clinical information on clinical course of the events with onset dates, diagnostic work up, differential diagnosis was provided for medical review. Psoriatic arthropathy was reported as not resolved while rheumatoid arthritis was reported as resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.