Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | IM |
ipol opened temperature excursion: negative disposition and product used with no ae; Initial information received on 15-May-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP) other. This case involves a 9-year-old female patient who was administered to IPV (Vero) [Ipol] (opened) which went under temperature excursion: negative disposition with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On 13-Jan-2026, the patient received a 0.5 (mL) of Poliomyelitis Vaccine (Inactivated) [IPOL], Suspension for injection (batch/lot number: Y1D03P1, expiration date: 31-Aug-2027) (strength: standard) via intramuscular route in an unknown administration site for immunization [Immunisation]. The patient was administered to IPV (Vero) (opened) which had temperature excursion: negative disposition and product used with no ae (Poor quality product administered, onset: 13-Jan-2026, latency: same day). The IPOL vaccine was punctured and exposed to temperature excursions on 21-Dec-2025 (maximum/low temperature reached: 35.5°F [1.9°C], duration out of labelled range: 11 hours) and 26-Dec-2025 (maximum/low temperature reached: 46.6°F [8.1°C], duration out of labelled range: 11 hours). Extended stability data does not cover the excursion for punctured IPOL. The product was administered to the patient after the temperature excursion despite the lack of extended stability data coverage. Action taken: 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.
Comments: NONE