Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
administration of a vaccine (negative disposition) post excursion with no adverse event; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who had administration of a INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (negative disposition) post excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Nov-2025, the patient received a dose of 0.5 ml once suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection Or INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (lot number, strength, expiry date- not reported) via unknown route in unknown administration site for Immunization; which had (negative disposition) post excursion with no adverse event (product storage error). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported, ''Reason: Added more products to the refrigerator, Max/low temperature reached: 25.3 F Duration: 30 hours, Previous excursion- None. Human error- Yes, Administered post-excursion- Yes (Pharmacist was unsure which vaccine was given)Does extended stability data cover the excursion- No. Pharmacist was unable to confirm which between FLUZONE HD and FLUZONE NP was administered to the patient after the cold excursion on 19-Nov-2025''. 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.