Received May 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | N/A | Y1D03P1 | SC / RA |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | SC / RA |
Temperature excursion for punctured IPOL with maximum /Lowest Temperature reached: 46.8ºF Duration:1 hour and 10 minutes/ products administered post excursion, with no reported adverse event; Initial information received on 14-May-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 26-year-old female patient who was administered with suspect IPV (VERO) [IPOL] post excursion with maximum/lowest temperature reached: 46.8 degree F duration: 1 hour and 10 minutes/products administered 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. Concomitant medication(s) included influenza vaccine inact sAg 3v (Flucelvax) and varicella zoster vaccine live (Oka/Merck) (Varivax). On 15-Apr-2026, the patient received 0.5 ml of suspect IPV (VERO) [IPOL] suspension for injection (Strength = standard) frequency: once via subcutaneous route in right arm for immunization, post excursion as exposed with maximum/lowest temperature reached: 46.8 degree F duration: 1 hour and 10 minutes/products administered post excursion, with no reported adverse event (Product storage error) (batch: Y1D03P1, expiry date: 31-Aug-2027). It was reported "human error was involved A pharmacist reported that his intern had initially reported a temperature excursion involving a punctured and unopened inactivated polio vaccine (IPV), while he was calling back because punctured IPV was administered to 3 patients. He reported that the first excursion happened in Feb-2026 involving a punctured and unopened IPV, while the second excursion occurred on 08-May-2026 involving unopened IPV only. The pharmacist asked if the 3 patients needed to be revaccinated. No previous excursion. The patient experienced a temperature excursion for punctured IPV reason: door was left slightly The emergency room/doctor visit and date were unknown to the healthcare professional (HCP). The extended stability data did not cover the 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 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
Flucelvax; Varivax