Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Abdominal pain, Biopsy bile duct normal, Cholelithiasis, Endoscopy biliary tract, Haematuria
Clinical narrative: Gallstones; This clinical trial case, initially received on 26-Jun-2024 with additional information received on 30-Jun-2024, was reported by a health professional and concerns an elderly male subject. Weight: 95.3 kg; Height: 175.2 cm  The subject was enrolled in the study  Past medical history included Prostate Cancer. At the time of the event the subject had Diabetic Neuropathy (Bilateral Feet), Deaf in Left Ear, Enlarged Prostate, Recurrent pain in bilateral knees, Recurrent Pain in Bilateral Feet, Glaucoma, Hearing Loss in Right Ear, Chronic Kidney Disease, Meniere's Disease, Seasonal Allergies, Gastro Esophageal Reflux Disease, Diabetes Type II, Diverticulosis, Osteoarthritis, Hypertension. Concomitant medication included acetaminophen used for Recurrent pain in bilateral knees, azelastine HCL, fluticasone used for Seasonal Allergies, latanoprost ophthalmic used for Glaucoma, triamterene used for kidney disease, famotidine used for Gastroesophageal Reflux Disease, glipizide, Farxiga (dapagliflozin propanediol monohydrate) and Trulicity (dulaglutide) used for Diabetes Type II and tamsulosin HCl used for Enlarged Prostate, Hydrochlorothiazide used for unreported indication. The subject's historical vaccine included influenza vaccine (brand not specified) received on Sep-2022 for unreported indication.   Administration of company suspect drugs: On 04-Dec-2024 12:31, the subject received 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 the protocol.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 10-Apr-2024, four months and seven days after receiving blinded study vaccine, the subject experienced Gallstones (Hospitalized, outcome: Recovered / Resolved, stop date: 20-Jun-2024).  On the same date, the subject admitted to hospital and started treatment with acetaminophen at a dose of 650 mg orally, acetaminophen/oxycodone at a dose of two units orally, aspirin at a dose of 81 mg orally, Colace (docusate sodium) at a dose of 100 mg, twice per day, orally, meloxicam at a dose of 15 mg daily, orally, simethicone at a dose of 80 mg orally, Zofran (ondansetron hydrochloride) at a dose of 4 mg intravenously, and zolpidem at a dose of 5 mg orally, all used for kidney stones, gallstones and pancreatitis. On 11-Apr-2024, the subject stopped treatment with acetaminophen/oxycodone.  Subject went to ER complaining of abdominal pain. Testing indicated the presence of gallstones, kidney, stones, UTI, pancreatitis, and hematuria. Subject was admitted to hospital for symptoms until on 13-Apr-2024 On 13-Apr-2024, the subject discharge from hospital and stopped treatment with acetaminophen, Colace, simethicone, and Zofran. On 11-May-2024, the subject stopped treatment with meloxicam. On 20-Jun-2024, the subject had endoscopic removal of bile duct and received negative biopsy results on 25-Jun-2024. On 03-Jul-2024, the subject stopped treatment with aspirin.  Non-drug treatment/Other action taken:  aQIVc HD vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The Investigator assessed the events as moderate and serious due to the seriousness criterion of hospitalization. The events were assessed as not related to the study vaccine and the alternative cause for the event was reported as intercurrent disease.  The subject remained blinded in the study.  Follow up (13-Aug-2024) received form the Investigator: Events nephrolithiasis, urinary tract infection and pancreatitis downgraded to non-serious and deleted. Event description changed.  Follow up (24-Oct-2024) received form the Investigator: Adverse event stop date was updated from 13-Apr-2024, to 20-Jun-2024, and narrative updated accordingly.; Reporter's Comments: In line with Investigator's causality assessment, causal role of the suspect vaccine is assessed as not related, due to biological implausibility. There is no physiological connection by which vaccination and the immune response could cause the reported event. Listedness was assessed using IB version 4.