Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankle fracture, Fall, Multiple fractures, Pain, Psoriatic arthropathy
Clinical narrative: Broken two bones; Psoriatic arthritis flare up; Fell; Body aches; Broke both ankle; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE FRACTURES (Broken two bones) and PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 75-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) for Psoriatic arthritis and Rheumatoid arthritis.  Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis.  On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jun-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 25-Apr-2022, the patient experienced ANKLE FRACTURE (Broke both ankle). On an unknown date, the patient experienced MULTIPLE FRACTURES (Broken two bones) (seriousness criterion medically significant), PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant), FALL (Fell) and PAIN (Body aches). At the time of the report, MULTIPLE FRACTURES (Broken two bones), PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up), FALL (Fell) and PAIN (Body aches) outcome was unknown and ANKLE FRACTURE (Broke both ankle) was resolving.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality of humira for the event(s) of broken two bones, fell, broke both ankle, body aches after vaccination and psoriatic arthritis flare up was not provided. No treatment medications were reported.  Company comment: This spontaneous case reported by a consumer concerns a 75-year-old female patient, with relevant history of current conditions of psoriatic arthritis and rheumatoid arthritis in treatment with adalimumab, who received 3 doses of mRNA-1273 vaccine and experienced the serious (medically significant) unexpected events of multiple fractures (broken two bones) and psoriatic arthropathy (psoriatic arthritis flare up). Since onset date of the events was not reported, latency cannot be properly assessed. Patient's current condition of psoariatic arthritis remains a confounder, since it is usual for this condition to produce flare-ups during the course of the disease. Co-suspect drug of adalimumab also remains as a confounder. Non-serious event of fall may be in association with the event of multiple fracture. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns a 75-year-old female patient, with relevant history of current conditions of psoriatic arthritis and rheumatoid arthritis in treatment with adalimumab, who received 3 doses of mRNA-1273 vaccine and experienced the serious (medically significant) unexpected events of multiple fractures (broken two bones) and psoriatic arthropathy (psoriatic arthritis flare up). Since onset date of the events was not reported, latency cannot be properly assessed. Patient's current condition of psoariatic arthritis remains a confounder, since it is usual for this condition to produce flare-ups during the course of the disease. Co-suspect drug of adalimumab also remains as a confounder. Non-serious event of fall may be in association with the event of multiple fracture. The benefit-risk relationship of mRNA-1273 is not affected by this report.