Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1D49P1 | IM / RA |
Temperature reached: 8.2? Duration out of labelled range: 5 minutes and administered post excursion with no reported adverse event.; Initial information received on 08-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 5-year-old female patient who received IPV (VERO) [IPOL] post excursion with temperature reached: 8.2 degree celsius duration out of labelled range: 5 minutes with no reported adverse event. The patient's past medical history, past medical treatment(s), past drugs, vaccination(s), family history, and concomitant medications were not provided. No other concomitant medications were given to patient. On 01-Apr-2026 , the patient received dose 5 (0.5 ml dose) of suspect IPV (VERO) [IPOL] suspension for injection, strength: standard, frequency: once, Lot Number:Y1D49P1,Expiration Date :30-Sep-2027 via intramuscular route in the right upper arm for immunization, post excursion with no reported adverse event (Product storage error). It was reported "human error was involved and product was administered. MA (medical assistant) initially gave PV information for a total of 9 patients. MA called back and was transferred to this MIS. MA asked for the details of 4 patients to be removed from the report because they were not administered with punctured IPOL. A total of only 5 patients were administered with the punctured IPOL after 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