Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Hip arthroplasty, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; HIP replacement; Experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of HIP ARTHROPLASTY (HIP replacement) in a 78-year-old male patient who received mRNA-1273 (Spikevax) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2022, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. In June 2022, the patient experienced COVID-19 (Experienced COVID). On 03-Aug-2022, the patient experienced HIP ARTHROPLASTY (HIP replacement) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with Physical therapy for Hip arthroplasty. In 2022, COVID-19 (Experienced COVID) had resolved. At the time of the report, HIP ARTHROPLASTY (HIP replacement) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) had resolved.            In Jun 2022, patient caught COVID and did not feel good for some days. Later he recovered and was feeling better. After hip replacement in Aug-2022, patient still had some trouble getting around. He was off of RINVOQ for a while as per physician order due to surgery, but in 2022 he was again back on RINVOQ. He was on physical therapy three times a week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For RINVOQ, reporter causality was not reported and MAH causality was no reasonable possibility. For PFIZER Vaccine, reporter causality was probable.  Company Comment: This is a spontaneous case concerning a 78 year-old, male patient with a history of Rheumatoid arthritis and concomitant use of upadacitinib reported as suspect, who experienced the serious (due to medically important condition) unexpected, event of Hip arthroplasty and the serious non-serious unexpected, AESI of COVID-19. The events occurred in the context of primary series with mRNA-1273 vaccine and booster dose with Tozinameran (reported as suspect drug, Interchange of vaccine products and Revaccination with different COVID-19 vaccine were considered in the case). Temporal association cannot be assessed due to lack of information on vaccination dates. After hip replacement, patient still had some trouble getting around. He was on physical therapy three times a week. The outcome of the event COVID-19 was reported as recovered. The mentioned medical history remains as a confounder for the event Hip arthroplasty. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 78 year-old, male patient with a history of Rheumatoid arthritis and concomitant use of upadacitinib reported as suspect, who experienced the serious (due to medically important condition) unexpected, event of Hip arthroplasty and the serious non-serious unexpected, AESI of COVID-19. The events occurred in the context of primary series with mRNA-1273 vaccine and booster dose with Tozinameran (reported as suspect drug, Interchange of vaccine products and Revaccination with different COVID-19 vaccine were considered in the case). Temporal association cannot be assessed due to lack of information on vaccination dates. After hip replacement, patient still had some trouble getting around. He was on physical therapy three times a week. The outcome of the event COVID-19 was reported as recovered. The mentioned medical history remains as a confounder for the event Hip arthroplasty. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.