Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
IPOL that was no longer viable was given to a patient after temperature excursion (with no reported adverse event); Initial information received on 08-Apr-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 received IPV (VERO) [IPOL] which was no longer viable given to a patient after temperature 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 IPV (VERO) lot W1C831M,expiry date :18-Nov-2025 via unknown route in unknown administration site for Immunization which was no longer viable after temperature excursion (with no reported adverse event) (poor quality product administered) (latency: same day) Reportedly, Caller states that one their providers called previously to report a temperature excursion and some of the vaccines were not viable. She is calling to get information if they need to re-vaccinate the patient if the vaccine that was given were not viable. She states they had MENQUADFI, ACT-HIB, IPOL, QUADRACEL, PENTACEL, and TENIVAC but only MENQUADFI, QUADRACEL and IPOL were given to a patient after 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.; Sender's Comments: US-SA-2025SA102586: US-SA-2025SA101723: