Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 2 | U8855AA | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 2 | U8855A | IM / LA |
receiving FLUZONE HD again today when it was supposed to be the Covid-19 Vaccine with no reported adverse event; receiving FLUZONE HD again today when it was supposed to be the Covid-19 Vaccine with no reported adverse event; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to this case US-SA-2025SA315952. This case involves a 77 years old male patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] again today when it was supposed to be the COVID-19 Vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient received dose 1 of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8855AA, expiry date: 30-Jun-2026, strength not reported via unknown route in unknown administration site for influenza. On 22-Oct-2025 , the patient received 0.5 ml (Dose 2) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8855AA, expiry date: 30-Jun-2026, strength: High, Frequency:Once, via intramuscular route in the left deltoid for influenza again, when it was supposed to be the covid-19 vaccine with no reported adverse event (wrong product administered) (extra dose 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-2025SA315952:2nd patient's wife