Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 3 | X1C891M | OT / RA |
Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30 minutes and administered with no adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 years old female patient who received IPV (VERO) [IPOL] that exposed to max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis B vaccine for Immunisation. On 10-Apr-2025, the patient received Dose 3 of 0.5 ml of suspect IPV (VERO) Suspension for injection of standard strength once with lot X1C891M and expiry date 31-Oct-2026 via intramuscular route in the right deltoid for Immunisation. 04-Apr-2025, the suspect IPV (VERO) exposed to max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes and administered with no adverse event (product storage error) (unknown latency) Reportedly, Human error involved. No previous excursion. Extended stability data did not cover the excursion. 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: 02490903: US-SA-2025SA113179: US-SA-2025SA113172:Master case
HEPATITIS B VACCINE