Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Nasal cavity packing, Nasal cavity packing removal, Nasal septum haematoma, Oropharyngeal suctioning, Suture insertion
Clinical narrative: Mechanical fall; This clinical trial case initially received on 15-Aug-2024 with additional information received on 16-Aug-2024 (being processed together), was reported by a health professional and concerns an elderly, female subject. Weight: 90.537 kg; Height: 167.6 cm   The subject was enrolled in the study.   At the time of the event the subject had Hyperlipidemia, Osteoarthritis, Overactive bladder, Sensorineural hearing loss, Vitamin B12 deficiency, Deformity of right toe, Menopausal disorder, Pre diabetes, Spondylosis of lumbar joint, Aortic Sclerosis, Elevated Hemidiaphragm, Anxiety Disorder, Fatty Liver, Gastroesophageal reflux disease, Hiatal Hernia, Irritable bowel syndrome constipation and diarrhea, Mild mitral regurgitation and Diverticulosis. Past medical history included Esophagitis. The subject's past procedure included Hysterectomy. The subject's concomitant medications included Coq10 (ubidecarenone), Multivitamin (vitamin NOS) and zinc, all used as dietary supplements, Xanax (alprazolam) for anxiety disorder, ondansetron for diverticulosis, Tylenol (paracetamol) for headache and aching. The subject's historical vaccines included Flu Hidose (brand not specified; dose: 0.7 ml, route of administration: intramuscular) received on 26-Sep-2022 and Placebo Vaccine in RSV study (brand not specified; dose: 0.5 ml, route of administration: intramuscular) received on unspecified date in 2022, both for prophylaxis.   Administration of company suspect drug(s): On 27-Nov-2023 at 13:46, the subject received blinded study vaccine aQIVc HD  vs QIVr vs aQIV for prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Left deltoid. The study vaccine was administered as per protocol. Pre-vaccination body temperature as 97.7 Fahrenheits (F), measured orally.   No additional suspect drugs.   Adverse reactions/events and outcomes: On 25-May-2024, five months and 29 days after receiving the blinded study vaccine aQIVc HD  vs QIVr vs aQIV, the subject experienced mechanical fall (Hospitalized, outcome: Recovered / Resolved, stop date: 27-May-2024). Subject fell down while on way to church and fell onto her face and her right knee. Subject stated she missed her step and fell onto the pavement. Subject had nasal fracture, orbital fracture, and knee/injury fracture, septal hematoma and clot on nose was suctioned from the right nasal cavity and the oropharynx, after packed with Merocel into the right nasal cavity to keep pressure on the septal mucosa. The pack was sutured, and a tag was placed for removal.   On 27-May-2024, the subject recovered from the event and was discharged from hospital with amoxicillin and continued other home medications.   Non-drug treatment/Other action taken:  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable Treatment medications: Acetaminophen at a dose of 650 mg, as needed (prn), orally, Amoxicillin at a dose of 500 mg, Twice a day (bid), orally, Benzhydrocodone and acetaminophen (benzhydrocodone hydrochloride, paracetamol) at a dose of 5 mg, prn, orally, Docusate sodium at a dose of 100 mg, bid, orally, Enoxaparin sodium at a dose of 40 mg, single (once), orally, Fluorescein sodium at a dose of 1 mg, single (once), ophthalmic route, Hydrocodone;Paracetamol (reported as acetaminophen) at a dose of 5 mg, prn, orally, Hydromorphone HCL at a dose of 0.5 mg, prn, intravenously, Lactated ringers (calcium chloride, potassium chloride, sodium lactate) at a dose of 1000 ml, prn, intravenously, Magnesium sulfate at a dose of 1 g and 2 g, prn, intravenously, Ondansetron at a dose of 4 mg, prn, intravenously, Potassium chloride, dose reported as 20 (units not specified), prn, orally, Sodium chloride at a ose of 3 ml, prn, intravenously, Tetanus diphtheria (diphtheria vaccine toxoid, tetanus vaccine toxoid) at a dose of 0.5 ml, intramuscularly and Tetracaine, dose reproted as 0.5 (units not specified), single (once), ophthalmic route.    Reporter's assessment: The reporter considered the event of 'fall' as severe and serious due to seriousness criterion of hospitalization and as adverse event of special interest (AESI).  The event was assessed as not related to the study vaccine. The alternative cause for the event was reported as concomitant medication.; Reporter's Comments: An elderly female subject with medical history including hyperlipidemia, osteoarthritis, Sensorineural hearing loss, Deformity of right toe, Spondylosis of lumbar joint and Aortic Sclerosis, Mild Mitral Regurgitation and anxiety disorder experienced a mechanical fall 5 months and 29 days after receiving the blinded study vaccine aQIVc HD vs QIVr vs aQIV for influenza prophylaxis. The fall occurred due to the subject missing a step and falling onto the pavement, resulting in a nasal fracture, orbital fracture, and knee injury due to which she was hospitalized. The event fall was assessed as not related to the study vaccine, in agreement with investigator as it occurred approximately 6 months after administration of the study vaccine with the medical history and the concomitant medication Xanax (alprazolam) providing a more plausible explanation. Patient's elderly age (81 years) is a risk factor for fall. Listedness is assessed according.