Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Hip fracture, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (broken right hip/fractured right hip) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 20-Nov-2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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 DIZZINESS (Dizzy). On 21-Jun-2021, the patient experienced HIP FRACTURE (broken right hip/fractured right hip) (seriousness criteria hospitalization and medically significant) and FALL (Fall). On an unknown date, the patient experienced PAIN IN EXTREMITY (Hand pain). In 2021, DIZZINESS (Dizzy) had resolved. At the time of the report, HIP FRACTURE (broken right hip/fractured right hip), FALL (Fall) and PAIN IN EXTREMITY (Hand pain) outcome was unknown. No concomitant medication was provided. Treatment medication was not provided by the reporter. On 23 Jun 2021 patient had hip replacement. She was in the hospital for her hip and that she had a month of RINVOQ medication on hand. She became very dizzy about fifteen minutes after got the Covid booster and it lasted. She had occasional hand pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with RINVOQ for the events of broken right hip/fractured right hip, fell, very dizzy and hand pain was not provided. The reporter's causality with HUMIRA for the events of broken right hip/fractured right hip, fell, very dizzy and hand pain was not provided. 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 reported by a consumer, concerns a 68 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (Hospitalization, Medically significant) event of HIP FRACTURE (broken right hip/fractured right hip) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the Covid 19 vaccination series, along with other non serious events of Dizziness, and fall. Patient had previously received the 2 primary doses with Moderna vaccine, with no adverse events reported. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient had received ADALIMUMAB (Humira) and Upadacitinib for Rheumatoid Arthritis. Age of the subject, history of dizziness and fall are considered as confounders for the event. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The outcome of the event is unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer, concerns a 68 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (Hospitalization, Medically significant) event of HIP FRACTURE (broken right hip/fractured right hip) unknown days after receiving the 3 dose of mRNA-1273 vaccine in the Covid 19 vaccination series, along with other non serious events of Dizziness, and fall. Patient had previously received the 2 primary doses with Moderna vaccine, with no adverse events reported. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient had received ADALIMUMAB (Humira) and Upadacitinib for Rheumatoid Arthritis. Age of the subject, history of dizziness and fall are considered as  confounders for the event . No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The outcome of the event is unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.