Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8869BA | OT |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U7949AA | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8353BA | OT |
ADACEL, FLUZONE HD, MENQUADFI, Max/low temperature reached: Lowest 7.92C High 10.51 C. Above 8C since July 12 with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unspecified number of patient(s) of unknown age and unknown gender patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi], influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] were exposed to temperature excursion where max/low temperature reached: lowest 7.92 Celsius high 10.51 Celsius; above 8 Celsius since july 12 with no reported adverse event. The unspecified patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the unspecified number of patient(s) received an unknown dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength- unknown expiry date- MAR-2026 and lot U7949AA) via unknown route in unknown administration site, received an unknown dose of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- unknown expiry date- DEC-2026 and lot U8353BA) via unknown route in unknown administration site and received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown expiry date- JUN-2026 and lot UT8869BA) via unknown route in unknown administration site all for Prophylactic vaccination (Immunization) were exposed to temperature excursion where max/low temperature reached: lowest 7.92 Celsius high 10.51 Celsius; above 8 Celsius since july 12 with no reported adverse event (poor quality product administered) (latency- same day). Reportedly, Reason: Malfunction. Human error: Unknown. The extended stability data did not cover the excursion. The product administered to a patient: Unknown. Caller not knowing if any product was administered post excursion. They stated Possibly. 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.