Received May 29, 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 nurse. This case involves a 13 years old female patient who was administered with IPV (VERO) [IPOL] post excursion with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 02-Feb-2026, the patient received 0.5 ml dose of suspect IPV (VERO) [IPOL] suspension for injection, Strength = standard, Frequency = once, (batch: Y1D03P1, expiry date: 31-Aug-2027) via intramuscular route in unknown administration site for immunization, post excursion with no reported adverse event (Poor quality product administered) (latency: same day). It was reported "human error was not involved. The reason for excursion was unknown human error. No previous excursion had been reported. The first excursion occurred on 21-Dec-2025, with a maximum/low temperature reached of 35.5 degree F (1.9 degree C) and a duration out of labelled range of 11 hours. The second excursion occurred on 26-Dec-2025, with a maximum/low temperature reached of 46.6 degree F (8.1 degree C) and a duration out of labelled range of 11 hours. Extended stability data did not cover the excursion for punctured IPOL; The product was administered and dispensed to the patient after excursion." 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 medication 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