Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure measurement, Hypertension, Pain in extremity, Psoriatic arthropathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Recurrent psoriatic arthritis) in a 56-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 Psoriatic arthritis. Concurrent medical conditions included Psoriatic arthritis. On 01-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free, Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In October 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Recurrent psoriatic arthritis) (seriousness criterion medically significant), HYPERTENSION (Blood pressure high) and ARTHRITIS (Hand arthritis). At the time of the report, PSORIATIC ARTHROPATHY (Recurrent psoriatic arthritis) had not resolved, HYPERTENSION (Blood pressure high) and ARTHRITIS (Hand arthritis) was resolving and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown dates, the patient experienced high blood pressure, arthritis in hands and return of psoriatic arthritis. Pfizer BioNTech covid-19 vaccine and Moderna vaccine were also considered suspect. No treatment medication was provided. 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 spontaneous case concerns a 56 year old female patient with concurrent condition of psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Recurrent psoriatic arthritis), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient had also received 3 doses with Pfizer COVID 19 vaccine. Interchange of vaccine products was noted. Her blood pressure was high. No information on exact dates of the event and mRNA-1273 vaccine, detailed clinical course, reports of relevant investigations and treatment details was available in the report. The event had not resolved. Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Live significant follow-up appended included dose information updated, co-suspect Pfizer added and event updated. Sender's Comments: This spontaneous case concerns a 56 year old female patient with concurrent condition of psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Recurrent psoriatic arthritis), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient had also received 3 doses with Pfizer COVID 19 vaccine. Interchange of vaccine products was noted. Her blood pressure was high. No information on exact dates of the event and mRNA-1273 vaccine , detailed clinical course, reports of relevant investigations and treatment details was available in the report. The event had not resolved. Concurrent condition of psoriatic arthritis could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.