Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Caller stated that it was an old refrigerator and she doesn't know what happened because it happened during closed hours/ opened IPOL was administered to 1 patient with no reported adverse event; Caller stated that it was an old refrigerator and she doesn't know what happened because it happened during closed hours/ opened IPOL was administered to 1 patient with no reported adverse event; Initial information received on 03-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient and reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) (Ipol)/stated that it was an old refrigerator and she doesn't know what happened because it happened during closed hours/ opened ipol was administered to 1 patient 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 meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) for prophylactic vaccination; measles vaccine, mumps vaccine, rubella vaccine (mmr) for prophylactic vaccination; and varicella zoster vaccine (varicella vaccine) for Prophylactic vaccination.  On an unknown date, reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) (Ipol)/stated that it was an old refrigerator and she doesn't know what happened because it happened during closed hours/ opened ipol was administered to 1 patient with no reported adverse event (product storage error) (unknown latency).  On 28-Dec-2023, the patient received 0.5 ml dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: V1B902M) (Expiry date: 02-Jun-2024) (Strength: Standard) (Frequency: Once) via subcutaneous route in the left arm for immunization.  On 28-Dec-2023, the temperature excursion for Poliomyelitis Vaccine (Inactivated) (Ipol)/stated that it was an old refrigerator and she doesn't know what happened because it happened during closed hours/ opened ipol was administered to 1 patient with no reported adverse event (poor quality product administered) (Latency: same day).  It was reported, : Caller stated that it was an old refrigerator and she doesn't know what happened because it happened during closed hours and that all during the day it was normal. She stated that it hasn't happened since. Max/low temperature reached: Nov. 24, 2023: 34F for 6 hours. Nov. 27, 2023: 32.7F-34F for 5 hours. Human error: Unknown due to reason is unknown. Does extended stability data cover the excursion: Yes but not for opened IPOL. If negative advice, was the product administered to a patient: Yes, opened IPOL was administered to 1 patient.   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.