Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8847CA | OT / RA |
inappropriate use due to inadvertent administration of FLUZONE HD instead of regular dose with no ae; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case (along with live follow - up processed together with csd:01-Oct-2025) received from a pharmacist. This case is linked to this case US-SA-2025SA295677 This case involves a 58 years old patient of unknown gender who inadvertently received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] instead Of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient inadvertently received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, Frequency :once, Strength :0.5 ml, lot U8847CA and expiry date 30-Jun-2026, via intramuscular route in the right arm for immunisation with no reported adverse event (wrong product administered) (latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA295677: