Age: 74.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Knee arthroplasty, Pain, Psoriatic arthropathy, Weight
Clinical narrative: LEFT KNEE REPLACED; PSORIATIC ARTHRITIS FLARE UP; BODY ACHE; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) and KNEE ARTHROPLASTY (LEFT KNEE REPLACED) in a 74-year-old male 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.    The patient's past medical history included Pulmonary oedema, COVID-19 pneumonia, COVID-19, Weight decreased and Muscle atrophy. Concurrent medical conditions included Psoriatic arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third 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) Citrate free. In 2021, the patient experienced PAIN (BODY ACHE). On 01-Dec-2021, the patient experienced KNEE ARTHROPLASTY (LEFT KNEE REPLACED) (seriousness criterion hospitalization). On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (PSORIATIC ARTHRITIS FLARE UP) had not resolved, KNEE ARTHROPLASTY (LEFT KNEE REPLACED) was resolving and PAIN (BODY ACHE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Lost 65 pounds.         No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  Patient had psoriatic arthritis flare up and scaling around ears.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of fluid in the lungs, left knee replaced, COVID-19, lost 65 pounds, COVID pneumonia, lost muscle mass, body ache, low grade fever and body ache with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of Psoriatic arthritis flare up with Humira (Adalimumab) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company comment-This spontaneous case concerns a male patient aged 74 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced the unexpected serious (hospitalization) event of Knee arthroplasty and unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthritis aggravated) in the context of mRNA-1273 vaccine. Psoriatic arthropathy occurred on unknown date and not resolved, patient underwent left Knee arthroplasty on 1-Dec-2021 and is resolving. Inappropriate schedule of vaccine administered was noted as patient had received initial two doses of mRNA-1273 at an interval of 18 days and the 3rd dose on unknown date. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Relevant medical history remains a confounder to the event Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.   This case was linked to MOD-2021-621439, MOD-2021-621451 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient aged 74 years with relevant medical history of PSORIATIC ARTHRITIS on Humira reported, who experienced the unexpected serious (hospitalization) event of Knee arthroplasty and unexpected serious (medically significant) event of Psoriatic arthropathy (reported as Psoriatic arthritis aggravated) in the context of mRNA-1273 vaccine. Psoriatic arthropathy occurred on unknown date and not resolved, patient underwent left Knee arthroplasty on 1-Dec-2021 and is resolving. Inappropriate schedule of vaccine administered was noted as patient had received initial two doses of mRNA-1273 at an interval of 18 days and the 3rd dose on unknown date. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Relevant medical history remains a confounder to the event Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.