Received Apr 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D03P1 | — |
negative disposition/reached: negative 4C & unsuitable product administered with no reported adverse event; Initial information received on 01-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a patient of unknown age and unknown gender who received poor quality IPV (Vero) (IPOL), with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On an unknown date, the patient received an unknown dose of IPV (Vero), suspension for injection (batch/lot number: Y1D03P1, expiration date: 31-Aug-2027, strength: unknown) via unknown route for immunization [Immunisation]. The vaccine was administered following a temperature excursion event. Poor quality vaccine [Product administration errors, onset: unknown, latency: same day] was reported. The event occurred due to a temperature excursion where the vaccine storage temperature reached negative 4 degrees Celsius for a duration of 3 days (from 20-Feb to 23-Feb). The vaccine was stored in unsuitable conditions, and no extended stability data was available to support the use of the product following this excursion. The patient received this post-excursion vaccine. A previous temperature excursion had also occurred on 03-Feb-2026 at 8.6 degrees Celsius for 15 minutes. 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