Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8475KD | OT / LA |
left eyelid has swollen both times after receiving the Sanofi flu shot; Initial information received on 01-Dec-2025 and live follow up received on 02-DEC-2025 both were processed together regarding an unsolicited valid non-serious case received from patient. This case involves a 34 years old female patient who experienced left eyelid has swollen both times after receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-SEP-2024, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE, Suspension for injection (lot UT8475KD and expiry 30-Jun-2025) (dose and strength : unknown) via intramuscular route in the left arm for Influenza prevention (Influenza immunisation). On 01-NOV-2025, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE, Suspension for injection (lot U8767CAand expiry 30-Jun-2026) (dose and strength: unknown) via intramuscular route in the left arm for Influenza prevention (Influenza immunisation). On 07-OCT-2024 the patient developed a non-serious left eyelid has swollen both times after receiving the sanofi flu shot (swelling of eyelid) (latency 13 days). Similar after another dose patient experienced (swelling of eyelid on 12-Nov-2025) (latency 11 days) after vaccination on 01-Nov-2025. Reportedly: -Her first dose was 24-Sep-2024, and her left eyelid was swollen when she woke up on 7-Oct-2024. It eventually resolved. Her next dose was on 1-Nov-2025, and on 12-Nov-2025, she again woke up with her left eyelid swollen. It is still ongoing Action taken was not applicable. The patient was treated with CEPHALEXIN, OFLOXACIN, CIPROFLOXACIN and DOXYCYCLINE for Swelling of eyelid. At time of reporting, the outcome was Not Recovered / Not Resolved for the event left eyelid has swollen both times after receiving the sanofi flu shot.