Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A212M | IM |
Vaccine administered post excursion with no reported adverse event; Initial information received on 15-May-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5-year-old patient of unknown gender who was administered with suspect 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 12-Mar-2026, the patient received 0.5 ml dose of suspect IPV (VERO) [IPOL] suspension for injection, batch: Y1A212M, expiry date: 31-Jan-2027, strength: standard, frequency: once 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, Previous excursion: Yes (not previously reported; First excursion: 21-Dec-2025 Maximum/Lowest Temperature reached: 35.5 degree F (1.9 degree C)Duration out of labelled range: 11 hours; Second excursion: 26-Dec-2025 Max/Low Temperature reached: 46.6 degree F (8.1 degree C)Duration out of labelled range: 11 hours. The extended stability data cover the excursion: No for punctured IPOL". 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