Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A212M | IM |
Temperature excursion: negative disposition and product used/Max/Low Temperature reached: 35.5 ºF (1.9 ºC) Duration out of labelled range: 11 hours with no reported adverse event; Initial information received on 15-May-2026 regarding an unsolicited valid non-serious case received from health care professional (HCP). This case involves a 9-year-old patient of unknown gender who was administered to Poliomyelitis Vaccine (Inactivated) [IPOL] which had temperature excursion: negative disposition: Max/Low Temperature reached: 35.5 ºF (1.9 ºC), duration out of labelled range: 11 hours with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 12-Jan-2026, the patient received a 0.5 mL of suspect poliomyelitis vaccine (inactivated) [IPOL], suspension for injection (batch: Y1A212M, expiry date: 31-Jan-2027) (strength: standard) via intramuscular route in an unknown administration site for immunization [Immunisation]. A nurse reported a temperature excursion for unknown reasons and requested extended stability information post excursion. All the products were administered. Products involved included unopened Daptacel, Quadracel, Fluzone-NP, and punctured inactivated polio vaccine (IPOL). The reason for excursion was an unknown human error and no previous excursions had occurred. The patient experienced temperature excursion: negative disposition and product used/Max/Low Temperature reached: 35.5 ºF (1.9 ºC) Duration out of labelled range: 11 hours with no reported adverse event (Poor quality product administered, onset date: 12-Jan-2026 and latency: same day). The first excursion occurred on 21-Dec-2025 with a maximum/low temperature reached of 35.5 ºF (1.9 ºC) and a duration out of labelled range of 11 hours. A second excursion occurred on 26-Dec-2025 with a maximum/low temperature reached of 46.6 ºF (8.1 ºC) and a duration out of labelled range of 11 hours. Extended stability data did not cover the excursion for the punctured IPOL; however, it did cover the excursion for unopened Daptacel, Quadracel, And Fluzone-NP. The product was administered and/or dispensed to a patient after excursion. Action taken: not applicable. Disclaimer: 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