Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT / RL |
Temperature excursion: negative disposition and product used, administered 1 dose to a patient post excursion, vaccine was administered by a nurse with no reported adverse event; Initial information received on 30-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered (dose 1) of IPV (Vero) [IPOL] temperature excursion: negative disposition and it was post excursion, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 18-Sep-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M,expiry date 31-Oct-2026, frequency once and strength standard) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation) and temperature excursion: negative disposition and product used, administered 1 dose to a patient post excursion, vaccine was administered by a nurse with no reported adverse event (poor quality product administered) (latency same day). Reportedly, for the IPOL, it didn't ask if it was a vial or a syringe and the nurse said theirs was a vial. But based off the information populated to them, it was noted that it was okay to be used. They administered 1 dose to a patient post excursion. Then, they didn't use it anymore until the second temperature excursion. Due to this, it should not be used. The punctured IPOL wasn't used after this. 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.
Dtap