Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL she reported previously was administered to 50 patients/ Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C with no reported adverse event; punctured IPOL she reported previously was administered to 50 patients/ Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old female patient who received punctured Poliomyelitis Vaccine (Inactivated) IPV (VERO) (Ipol) reporter reported previously was administered to 50 patients/ max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (influenza vaccine) for prophylactic vaccination; hepatitis a vaccine (hepatitis a) for prophylactic vaccination; and varicella zoster vaccine (varicella vaccine) for Prophylactic vaccination.  On 12-Dec-2023, the patient received 0.5 ml total of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1C751M) (Expiry date: 18-Nov-2025) (Strength: standard) (Frequency: once) via intramuscular route in the right vastus lateralis for immunization.  On 12-Dec-2023, the patient received punctured Poliomyelitis Vaccine (Inactivated) IPV (VERO) (Ipol) reporter reported previously was administered to 50 patients/ max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event (product storage error) (poor quality product administered) (latency: same day).  It was reported, Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error: Unknown Administered: Yes, it was administered to 50 patients. Does extended stability data cover the excursion :No. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  This situation is pre-assessed as a medication error/an inappropriate use due to administration of punctured IPOL that is not suitable for use.   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.