Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | U8827AA | OT / LA |
administration of fluzone np to a patient who was intended to receive fluzone hd, with no reported adverse event; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 67 years old female patient who had administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] and was intended to receive INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) for Immunisation. On 24-Oct-2025, the patient received a Dose 1 (0.5 ml) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (Strength: Standard, Frequency: Once) (lot U8827AA, expiry date: 30-JUN-2026) via intramuscular route in the left arm for Immunization; but was intended to receive INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, with no reported adverse event (wrong product administered) (latency- same day). It was reported, ''Nurse practitioner called to seek recommendations following the administration of FLUZONE NP to a 67- year-old patient who was intended to receive FLUZONE HD. Treatment: None''. 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)