Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Max/Low Temperature reached: negative 2°C Duration out of labelled range: 45 minutes administered after the excursion occurred, with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with Influenza Trivalent Recombinant Vaccine [Flublok Tiv], Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] And Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] that had a temperature excursion where max/low temperature reached: negative 2°c duration out of labelled range: 45 minutes administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection and received an unknown dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Solution for injection and received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine Suspension for injection all with (lot number , strength and expiry date-unknown) via unknown route in unknown administration site for Immunization that had a temperature excursion where max/low temperature reached: negative 2°c duration out of labelled range: 45 minutes with no reported adverse event (poor quality product administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- Human error was unknown; Products were not suitable to use after excursion. 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.