Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8764BB | OT |
clumsiness; after a few days since, they developed severe shaking in their hands; added that also feel weakness; numbness; 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 78 years old female patient who had clumsiness, after a few days since, they developed severe shaking in their hands, added that also feel weakness and numbness after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Aug-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8764BB, expiry date 30-Jun-2026, strength not reported) via unknown route in unknown administration site for Immunization. On an unknown date in 2025, the patient developed clumsiness, after a few days since, they developed severe shaking in their hands (tremor), added that also feel weakness (asthenia) and numbness (hypoaesthesia) (latency unknown) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the event (Tremor), was Unknown for the event (numbness), (Asthenia) and (Hypoaesthesia).