Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Upper limb fracture
Clinical narrative: patient broke right arm between elbow and wrist; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (patient broke right arm between elbow and wrist) in an adult 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 ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced UPPER LIMB FRACTURE (patient broke right arm between elbow and wrist) (seriousness criterion medically significant). In 2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, UPPER LIMB FRACTURE (patient broke right arm between elbow and wrist) was resolving. Not Provided          No concomitant medication was provided. Treatment medication was not provided by the reporter.  The patient had broke her right arm between elbow and wrist. They did surgery after setting two bones that broke. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  the reporter's causality for Humira for the event(s) of patient broke right arm between elbow and wrist and flu symptoms after second covid19 vaccine with humira(adalimumab) was no reasonable possibility.  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 is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Upper limb fracture (patient broke right arm between elbow and wrist), after receiving the second dose of mRNA-1273 vaccine. The patient underwent surgery. Exact onset date of the event, clinical course and diagnostic tests were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-622861 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Upper limb fracture (patient broke right arm between elbow and wrist), after receiving the second dose of mRNA-1273 vaccine. The patient underwent surgery. Exact onset date of the event, clinical course and diagnostic tests were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.