Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Prostate cancer, Prostatic specific antigen increased
Clinical narrative: Prostate Cancer; This clinical trial case, initially received on 12-Aug-2024 with additional information received on 13-Aug-2024 (being processed together), was reported by a health professional and concerns an elderly, male subject. Weight: 107 kg; Height: 185 cm   The subject was enrolled in the study   At the time of the event the subject had hypertension, hypercholesterolemia and insomnia. The subject's concomitant medications included atorvastatin and fenofibrate, both used for hypercholesterolemia, Benicar (olmesartan medoxomil), used for hypertension, and trazodone, used for insomnia. The subject's historical vaccines included Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: 0.3 ml, route of administration: intramuscular) received on 19-Oct-2021 and 06-Oct-2022, Influenza Quadrivalent Vaccine (brand not specified; dose: 0.7 ml, route of administration: intramuscular) received on 04-Oct-2022, Pneumo-Conjugate PCV 20 Vaccine (brand not specified; dose: 0.5 ml, route of administration: intramuscular) received on 05-Sep-2023 and Arexvy (RSV vaccine prot. subunit PreF3; dose: 0.5 ml, route of administration: intramuscular) received on 12-Oct-2023, all for prophylaxis.      Administration of company suspect drug(s): On 29-Nov-2023 12:10, 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: Right Deltoid. The study vaccine was administered as per the protocol. The pre-vaccination body temperature was 36.6 degrees Celsius (°C), measured orally. The study vaccine was administered as per the protocol.   No additional suspect drugs.   Adverse reactions/events and outcomes:   On 14-Jun-2024, eight months and 15 days, after receiving the blinded study vaccine, the subject experienced prostate cancer (Medically Significant, outcome: Recovered / Resolved , stop date 10-Oct-2024).   On an unspecified day in May-2024, during routine healthcare visit, the subject's prostate-specific antigen (PSA) was noted to be elevated.   On 14-Jun-2024, the subject was officially diagnosed with prostate cancer.   On 18-Jul-2024, the subject was scheduled for outpatient proctectomy. Coordinator was advised that follow up from procedure will be conducted in Sept 2024, and at that time would be advised if radiation would be required as add on treatment for their cancer. PSA on 22-Aug-2024 was <0.3 ng/ml. After follow up with oncologist in Oct-2024, radiation was not recommended.      aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable   Reporter's assessment: The reporter considered the event of prostate cancer as moderate and serious due to seriousness criterion of medical significance. The event was assessed as not related to the study vaccine and the alternative cause for the event was reported as Other - New malignancy.   The subject remained blinded in the study.   Follow up (21-Aug-2024) received from the Investigator: Updated following seriousness as No- Death, Life threatening, Required or prolonged hospitalization, Persistent or significant disability/incapacity, Congenital anomaly or birth defect, Updated narrative accordingly.   Follow up (07-SEP-2024) received from the Investigator: Updated start date of the event "Prostate Cancer" was updated from 12-Aug-2024 to 14-Jun-2024, and narrative updated accordingly.  Follow-up (05-Nov-2024) received from investigator: stop date provided for Prostate Cancer and outcome changed from recovering/resolving to recoverd/resolved. Fields and narrative updated accordantly.; Reporter's Comments: Causality: In line with the investigator's causality assessment, causal role of the study vaccine is assessed as not related based on 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.