Sex: F
Vaccine: FLUA4
Symptoms: Pneumonia, Spinal fracture
Clinical narrative: Pneumonia; Spinal Fracture; This clinical trial case , initially received on 23-Sep-2024, with additional information on 24-Sep-2024, 25-Sep-2024 and 30-Sep-2024, was reported by a health professional and concerns an elderly female subject.  Weight: 88 kg; Height: 61.5 cm  The subject was enrolled in the study.  Past medical history included Hypercholesterolemia, hysterectomy, Lumbar compression fracture L1, Uterine Fibroids. At the time of the event the subject had Chronic obstructive pulmonary disease (COPD), atopic dermatitis, Chronic low back pain, Osteoarthritis in back, Hypertension, Headaches, Insomnia. Concomitant medication: refer to appropriate report section. The subject's historical influenza vaccine included influenza vaccine (brand not specified), received on 01-Nov-2022, for unreported indication  The subject enter the treatment period.  Administration of company suspect drug:  On 28-Nov-2023 09:51, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Route of administration: Intramuscular, Anatomical location: Left Deltoid.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On 17-Sep-2024, the subject experienced Pneumonia (Hospitalized, outcome: Recovered / Resolved, stop date: 01-Oct-2024), Spinal Fracture (Hospitalized, outcome: Recovered / Resolved, stop date: 01-Oct-2024).  As per subject, she had been hospitalized on 17-Sep-2024 (also reported as Tuesday) as a result of a spinal fracture caused by a mechanical fall that occurred early on the morning of 17-Sep-2024. Additionally, subject reported cough and malaise that was diagnosed as pneumonia upon hospital admission. Subject reported that surgery to address the spinal fracture was scheduled for 24-Sep-2024. When queried regarding follow through on principle investigator (PI) recommendations from last clinic visit, subject stated that she did not seek medical attention after the fall that lead to adverse event (AE) of worsening chronic low back pain. The medical records request pending subject discharge.     Pre-vaccination body temperature was 97.9 F. and temperature location was oral.  On 09-Oct-2024, the subject was discharged from the hospital.  aQIVc HD vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The investigator assessed that events Pneumonia, Spinal Fracture as severe and serious due to seriousness criterion of hospitalization. The events was assessed as not related to the administration of the investigational drug. The alternative cause of both events was reported as other.  Follow-up (19-Oct-2024) received by investigator: suspect drug details added (route of administration, anatomical site). Narrative updated.  Follow-up (09-Nov-2024) received by investigator: Event (Pneumonia, Spinal Fracture) outcome updated from Not recovered/ Not resolved to Recovered/ Resolved, Stop date and discharge date added in field and narrative updated accordingly.; Reporter's Comments: Causality: Not related based on implausible temporal and biological relationship (9 months 19 days and 14 hrs) after administration of study vaccine. Of note, subject had underlying condition of Chronic obstructive pulmonary disease, which considered as risk factor for pneumonia and spinal fracture attributed to mechanical fall. Listedness was assessed using IB version 4.