Sex: M
Vaccine: FLUA4
Symptoms: Colon cancer stage IV, Colonoscopy abnormal, Hepatic cancer stage IV, Metastases to liver
Clinical narrative: Stage 4 colon cancer; Stage 4 liver cancer; This clinical trial case, initially received on 05-Sep-2024, additional follow up received on 06-Sep-2024 and 07-Sep-2024 was reported by a health professional and concerns an elderly male subject. Weight: 95.4 kg; Height: 180 cm  The subject was enrolled in the study V201_03 ( A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a High- Dose MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc HD) in Comparison with a Non-adjuvanted Quadrivalent Recombinant Influenza Vaccine (QIVr) and an MF59-Adjuvanted Quadrivalent Subunit Egg-derived Influenza Vaccine (aQIV), in Adults Aged 50 Years and Older. ). Center ID, Patient ID: The patient had no influenza vaccinations within three previous influenza seasons.  Past medical history included Tonsillitis, Appendectomy, Tonsillectomy, Atrial fibrillation, Traumatic brain injury, Right arm lipoma, Appendicitis. At the time of the event the subject had Hypotension, Benign prostatic hyperplasia, Ventral hernia.Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 19-Dec-2023 13:05, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular.   The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 20-Aug-2024, 8 months after the administration aQIVc HD vs QIVr vs aQIV, the subject experienced Stage 4 colon cancer (Medically Significant, Life threatening, outcome: Not recovered / Not resolved), Stage 4 liver cancer (Medically Significant, outcome: Not recovered / Not resolved).  Subject was diagnosed with stage 4 colon cancer. No reported risk factors. Subject's spouse returned phone call and provided additional information regarding SAE. Subject underwent routine colonoscopy screening leading to diagnosis of colon cancer with liver metastasis. Subject declined chemotherapy due to advanced staging of cancer, currently home on hospice. Spouse reports subject had been experiencing fatigue since 2022, with no other symptoms preceding diagnosis. No known family history of colon cancer, maternal grandfather reportedly had an unknown type of cancer. No other family history of cancer.   aQIVc HD vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The investigator assessed the event Stage 4 colon cancer as moderate and serious due to the seriousness criterion of Medically Significant and Life threatening and Stage 4 liver cancer as moderate and serious due to the seriousness criterion of medically significant. The events assessed as not related to the administration of the study vaccine. The alternative cause of the events was reported as concurrent disease.  The subject remained blinded in study.  Follow up (30-Oct-2024, and 05-Nov-2024) received from investigator: Seriousness criteria of Life threatening was added for the event Stage 4 colon cancer, narrative updated accordingly.; Reporter's Comments: On 20-Aug-2024, 8 months after the administration of study vaccine (aQIVc HD vs QIVr vs aQIV), the subject experienced Stage 4 colon cancer and Stage 4 liver cancer. In line with investigator's causality assessment, causal role of the study vaccine is assessed as not related for both the events, due to chronological and biological implausibility. There is no known biological mechanism that would suggest that the vaccine could cause cancer. Listedness was assessed using IB version 4.