Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Sinusitis, Tibia fracture, Upper respiratory tract infection
Clinical narrative: Broken ankle; Upper respiratory infection; Bronchitis; Knee concerns; Musculoskeletal disorder; Sinus Infection; Broke right tibia; Broke right ankle; Case not healing well; Patient experienced ill; This spontaneous case was reported by a consumer and describes the occurrence of TIBIA FRACTURE (Broke right tibia), ANKLE FRACTURE (Broke right ankle) and 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 (MODERATE TO SEVERE).   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) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In April 2021, the patient experienced MALAISE (Patient experienced ill). In November 2021, the patient experienced TIBIA FRACTURE (Broke right tibia) (seriousness criterion medically significant), ANKLE FRACTURE (Broke right ankle) (seriousness criterion medically significant) and IMPAIRED HEALING (Case not healing well). On an unknown date, the patient experienced ANKLE FRACTURE (Broken ankle) (seriousness criterion medically significant), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), BRONCHITIS (Bronchitis), ARTHROPATHY (Knee concerns), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder) and SINUSITIS (Sinus Infection). At the time of the report, TIBIA FRACTURE (Broke right tibia), ANKLE FRACTURE (Broke right ankle), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), BRONCHITIS (Bronchitis), ARTHROPATHY (Knee concerns), MALAISE (Patient experienced ill) and IMPAIRED HEALING (Case not healing well) outcome was unknown, ANKLE FRACTURE (Broken ankle) had not resolved, MUSCULOSKELETAL DISORDER (Musculoskeletal disorder) was resolving and SINUSITIS (Sinus Infection) had resolved.            Treatment and concomitant medications were not reported. Patient had to take bone density test upcoming due to neck deterioration and was not improving. Patient broke her right tibea, ankle feet in a boot and had reconstruction surgery on the foot. Reporter's causality for all events was not reported with respect to Rinvoq drug. 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 68-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with co-suspect Upadacitinib, who experienced the unexpected serious (medically significant) events of Tibial fracture and Ankle fracture (reported as 2 episodes: broken ankle and broke right ankle) after receiving the 2nd dose of mRNA-1273 vaccine. Tibial fracture and broke right ankle occurred approximately 7 months post vaccination, and broken ankle on an unknown date. Patient had broken ankle and applied cast for one and half months. Despite application of cast healing was impaired. Approximately 7 months post vaccination, patient broke her right tibia, ankle, feet and still not healing well. It was reported that patient had foot reconstruction surgery. Clinical course and treatment details were not reported. The co-suspect Upadacitinib and rheumatoid arthritis could be a confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.   This case was linked to MOD-2022-624856 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old female patient, with concurrent medical history of rheumatoid arthritis treated with co-suspect Upadacitinib, who experienced the unexpected serious (medically significant) events of Tibial fracture and Ankle fracture (reported as 2 episodes: broken ankle and broke right ankle) after receiving the 2nd dose of mRNA-1273 vaccine. Tibial fracture and broke right ankle occurred approximately 7 months post vaccination, and broken ankle on an unknown date. Patient had broken ankle and applied cast for one and half months. Despite application of cast healing was impaired. Approximately 7 months post vaccination, patient broke her right tibia, ankle, feet and still not healing well. It was reported that patient had foot reconstruction surgery. Clinical course and treatment details were not reported. The co-suspect Upadacitinib and rheumatoid arthritis could be a confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.