Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 2 | — | OT |
patient receiving fluzone hd again today when it was supposed to be the covid-19 vaccine with no reported ae; patient receiving fluzone hd again today when it was supposed to be the covid-19 vaccine with no reported ae; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 74 years old female 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 and on 22-Oct-2025, she also received an unknown dose 0.5ml (dose 2) (lot U8855AA) (expiry date 30-Jun-2026 and strength high dose, frequency once) via unknown route in unknown administration site for prophylactic vaacination (Immunisation) and received fluzone hd again today when it was supposed to be COVID-19 Vaccine not produced by Sanofi Pasteur (formulation unknown) with no reported adverse event (extra dose administered) (wrong product administered) (latency 7 days). 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-2025SA316300:2nd patient