Sex: M
Vaccine: FLUA4
Symptoms: Fall, Foot fracture, Peripheral swelling, Rib fracture, Thoracic vertebral fracture
Clinical narrative: T7, T9, T10 and T12 fracture; This clinical trial case, initially received on 21-Aug-2024, was reported by a health professional and concerns an adult male subject. Weight: 88.1 kg; Height: 177 cm  The subject was enrolled in the study.  The subject's historical vaccines included influenza vaccine (brand not specified), received on Sep-2022.  Past medical history included Cervical fracture, Tonsilitis, Tonsilectomy, Basal cell carcinoma back, Basal cell carcinoma on back removal, Left knee Meniscus tear, Left knee meniscus repair. At the time of the event the subject had Tobacco abuse, Left Knee Osteoarthritis, Recreational Cannabis abuse, Hepatitis C, Chronic Lumbar Spine pain, Cervical pain, Bilateral Hip Pain, Hypercholesterolemia, Enlarged prostate.Concomitant medication: refer to appropriate report section.   Administration of company suspect drug(s): On 27-Nov-2023 08:52, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza., Route of administration: Intramuscular, Lot number: No batch number available.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 12-Jun-2024, the subject experienced T7, T9, T10 and T12 fracture (Hospitalized, outcome: Recovering / Resolving).  The subject reported on 12-Jun-2024, they had fallen off a ladder. Due to this event subject was then taken to the hospital via a family member to be assessed. He stated they were informed on 12-Jun-2024; they had 3 Left broken ribs, Left swollen foot unspecified location broken right 2nd digit and broken lower back of unspecified location. Subject reported they were given Oxycodone 5 mg po PRN and Methocarbamol dose unknown per oral PRN for pain management. Suject was discharged on 26-Jun-2024  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable Treatment medication: Methocarbamol 750 mg As needed, Oxycodone 5 mg As needed  Reporter's assessment: The reporter considered the event T7, T9, T10 and T12 fracture as severe and as serious due to seriousness criteria of Hospitalization and causality not related to the study vaccine by the Investigator. Alternative cause of adverse event was reported as other and specified as trauma.  Follow-up (27-Aug-2024) received from the investigator: Event summary description was added.  Follow up (26-Sep-2024) received from investigator: Alternative explanation was specified and added to narrative.  Follow-up (06-Nov-2024, and 08-Nov-2024) received from investigator: The event Broken Lower Back of Unspecified Location verbatim  changed to T7, T9, T10 and T12 fracture, and LLT was updated from spinal fracture to Thoracic vertebral fracture, narrative updated.; Reporter's Comments: On 12-Jun-2024, six months and 15 days after receiving the blinded study vaccine (aQIVc HD vs QIVr vs aQIV), the subject fell off a ladder resulting in 3 Left broken ribs, Left broken foot (location unspecified), broken right 2nd digit and T7, T9, T10 and T12 fracture, resulting in hospitalization. In line with the Investigator's assessment, causality is assessed as not related to the study vaccine due to temporal and biological implausibility. The subject's concurrent chronic musculoskeletal conditions such as chronic lumbar spine pain, cervical pain, bilateral hip pain and left knee osteoarthritis could have contributed to the fall. Of note the subject's recreational cannabis and tobacco abuse could have further increased the risk of the fall. Listedness was assessed using IB version 4.