Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
Vaccines were administered post excursion, with no reported adverse event; Initial information received on 05-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was administered to Diphtheria-2/Tetanus-5 Toxoids With Preservative [Tenivac], Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] And Ipv (Vero) [Ipol]- post excursion, 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, unknown dose of suspect IPV (Vero), Suspension for injection and unknown dose of suspect Diphtheria-2/Tetanus-5 Toxoids With Preservative, Suspension for injection (lot number, expiry date and strnegth not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and were administered post excursion, 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. It was reported "the reason was unknown. It happened over the holiday weekend while the office was closed. The max/low temperature reached: negative 1 C, duration: 1 hour, 30 minutes. There was no previous excursion and human error was unknown. The extended stability data did not cover the 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.