Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
temperature excursions.products: menquadfi, acthib, pentacel, adacel, tenivac and fluzone duration out of labelled range: 20.2c (first excursion) and -1.1c administered to a patient with no reported adverse event.; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age and gender patient who had temperature excursions of products: Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone], Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac], Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel], Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel], HIB (PRP/T) Vaccine [ACT-HIB] and Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] duration out of labelled range: 20.2c (first excursion) and -1.1c administered to a patient 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 a dose of (all unopened) suspect Influenza Quadrival A-B Multidose Vaccine Preserved; Suspension for injection, Meningococcal A-C-Y-W135 (T Conj) Vaccine; Solution for injection, HIB (PRP/T) Vaccine; Powder and solvent for solution for injection, Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine; Suspension for injection, Diphtheria-2/Tetanus/5 AC Pertussis Vaccine; Suspension for injection and Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult; Suspension for injection all with unknown (lot number, strength, dose and exoriy date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation); temperature excursions; duration out of labelled range: 20.2c (first excursion) and -1.1c administered to a patient with no reported adverse event. (product storage error) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly:The first excursion occurred due to the refrigerator breaking. The second excursion occurred due to the data logger being placed in a plastic basket.Max/low temperature reached: 2 hours (first excursion) and 51 minutes (second excursion)Duration out of labelled range: 20.2C (first excursion) and -1.1C (second excursion)Human error? NO (first excursion) and YES (second excursion).Does extended stability data cover the excursion? NO If negative advice, was the product administered to a patient? YES Caller confirmed that some of the products were administered after the second excursion (when the products would have no longer been viable), but she wasn't sure which products were administered. 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.