Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; Bronchitis; Musculoskeletal disorder; Knee concern; Sinus infection; Broken ankle; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Broken ankle) in a 68-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ANKLE FRACTURE (Broken ankle) (seriousness criterion medically significant), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), BRONCHITIS (Bronchitis), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder), ARTHROPATHY (Knee concern) and SINUSITIS (Sinus infection). At the time of the report, ANKLE FRACTURE (Broken ankle) had not resolved, COVID-19 (COVID-19) and MUSCULOSKELETAL DISORDER (Musculoskeletal disorder) was resolving, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), BRONCHITIS (Bronchitis) and ARTHROPATHY (Knee concern) outcome was unknown and SINUSITIS (Sinus infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       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  The concomitant medication was not reported.  The patient reported she had an upper respiratory and sinus infection. Patient had broken ankle so she wore cast on ankle for one month and a boot for one and half months. Her ankle was not healing. She had bronchitis. She was recovered from covid 19. She had to take bone density test upcoming due to neck deterioration and not improving and she had knee concerns. In 2021 she had Covid 19 tested positive and she was sick, after taking the covid vaccination in Mar 2021, she was sick for over ten days and she became ill.  The treatment medication was not provided  Company comment: This spontaneous case concerns a 68-year-old female patient, with concurrent medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Ankle fracture, and unexpected non-serious AESI COVID-19 that occurred after receiving the 1st dose of mRNA-1273 vaccine along with other non-serious events. The event COVID-19 occurred within the same year of vaccination. SARS-CoV-2 test was reported positive, and patient was sick for ten days. Patient had ankle fracture on an unknown date, wherein cast was applied. Despite application of cast for more than a month, ankle fracture did not improve. Clinical course and treatment details were not reported. The outcome of COVID-19 was reported as resolving, and ankle fracture not resolved. On unknown date, patient received Upadacitinib for rheumatoid arthritis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-624855 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old female patient, with concurrent medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Ankle fracture, and unexpected non-serious AESI COVID-19 that occurred after receiving the 1st dose of mRNA-1273 vaccine along with other non-serious events. The event COVID-19 occurred within the same year of vaccination. SARS-CoV-2 test was reported positive, and patient was sick for ten days. Patient had ankle fracture on an unknown date, wherein cast was applied. Despite application of cast for more than a month, ankle fracture did not improve. Clinical course and treatment details were not reported. The outcome of COVID-19 was reported as resolving, and ankle fracture not resolved. On unknown date, patient received Upadacitinib for rheumatoid arthritis which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.