Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Fridge door opened for long, 46.6F for 2 min due to human error with no reported adverse event; patient was given ipol after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235694, 2023SA235058, 2023SA236046, 2023SA234814, 2023SA235246.  This case involves a 16 years old male patient and temperature excursion for Poliomyelitis Vaccine (Inactivated) Ipv (Vero) (Ipol) fridge door opened for long, 46.6f for 2 min due to human error and patient was given vaccine after the temperature excursion 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 diphtheria vaccine toxoid, tetanus vaccine toxoid (tenivac) for prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; hpv vaccine (hpv vaccine) for prophylactic vaccination; hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination; meningococcal vaccine b rfhbp/nada/nhba omv (bexsero) for prophylactic vaccination; and meningococcal vaccine a/c/y/w conj (crm197) (menveo) for prophylactic vaccination.  On 19-Jun-2023, the patient received Standard Dose 3 (0.5 ml) of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1A191M; Expiry date: 16-Feb-2025, Frequency: once) via subcutaneous route in the right arm for prophylactic vaccination (Immunisation).  On an unknown date, the reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) fridge door opened for long, 46.6f for 2 min due to human error with no reported adverse event (product storage error) (unknown latency) and on 19-Jun-2023, the patient was given Poliomyelitis Vaccine (Inactivated) after the temperature excursion with no reported adverse event (poor quality product administered) (Latency: same day).  It was reported, Fridge door opened for long *Max/Low temperature reached: 46.6F *Duration of temperature excursion: 2 minutes *Any previous excursions? None *Was it from a human error? Yes If negative advice, was the product administered to a patient? 7 doses of IPOL was given to 7 patients. HCP was asking if they need to re-vaccinate the patient given the opened IPOL after temperature excursion. 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.  Action taken: not applicable.  Outcome: Unknown   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 guidelines. 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.