Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
pneumonia; flu; Initial information received on 08-May-2025 regarding an unsolicited valid serious case received from a consumer/Non-Healthcare Professional. This case involves an unknown age female patient who experienced pneumonia and flu after receiving influenza USP trival A-B subvirion no preservative vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection, (lot number and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On an unknown date the patient developed pneumonia and flu (influenza) (unknown latency). Action taken: Not applicable. It was not reported if the patient received a corrective treatment for both the events (flu, pneumonia). At time of reporting, the outcome was Unknown for both the events. Seriousness Criteria: Medically significant for pneumonia.; Sender's Comments: Sanofi Company Comment dated 13-MAY-2025: This case involves an unknown age female patient who experienced pneumonia and flu after receiving influenza USP trival A-B subvirion no preservative vaccine [Fluzone]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.