Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
Headache is non stop, from the second I wake up until the moment I go to sleep. It gets worse every day; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non healthcare professional). This case involves a 30 years old female patient who had headache which was non stop, from the second she woke up until the moment she went to sleep, it got worse every day after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Aug-2025, the patient received 1mL (1Total) of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site fro Annual flu shot (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On 28-Aug-2025, the patient developed headache is non stop, from the second i wake up until the moment i go to sleep. it gets worse every day (headache) (latency same day)following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved. Action taken was not applicable. An unknown corrective treatment was received for the event (Headache). At time of reporting, the outcome was Not Recovered / Not Resolved for the event (Headache).