Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1D141M | OT |
IPOL was administered post excursion with no adverse event; Initial information received on 01-Oct-2025 and live follow up revived on same date both were processed together regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA295057. This case involves a 3 years old female patient who was administered IPV (VERO) [IPOL] post excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. On 10-Jun-2025, the patient received 0.5 ml, 1 X (once) of suspect IPV (VERO) (opened); Suspension for injection via intramuscular route in unknown administration site (lot X1D141M) post excursion with no adverse event (poor quality product administered) (latency same day) for immunization (strength and expiry: unknown). Reportedly:- Caller reports a temperature excursion for IPOL (opened) that reached 63.4F for 1 hour due to an unknown reason or a possible malfunction, from back in May 2025. Is it still viable There were no previous excursions. Was product administered:YES Was it related to a human error: UNKNOWN Does the extended stability data cover the excursion? NO she states that they did call the patients to let them know about the event and have them come back into the office. She states that 2 patients were involved. Action taken was 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.; Sender's Comments: US-SA-2025SA295057:02675547
HEPATITIS A