Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | 1 | U8823DA | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | — | OT |
apparently had an inflammatory response and when blind in one eye; apparently had an inflammatory response and when blind in one eye; Initial information received on 29-Sep-2025 regarding an unsolicited valid serious case received from a patient. This case involves a 56 years old female patient who had apparently had an inflammatory response and when blind in one eye after receiving Influenza Trivalent Recombinant Vaccine [Flublok]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, expiry date:31-May-2026 (lot number and strength not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient had apparently had an inflammatory response and when blind in one eye (inflammation) (blindness unilateral) (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness criteria: Medically significant for the event Blindness unilateral.; Sender's Comments: Sanofi company comment dated 05-Oct-2025: This case involves a 56 years old female patient who had apparently had an inflammatory response and when blind in one eye after receiving Influenza Trivalent Recombinant Vaccine [Flublok]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.