Reporte zur Charge XNFT7

Symptomtext

Vx given after temp excursion 70?F aprox; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a neonate male patient who received HBV (Engerix B pediatric) (batch number XNFT7, expiry date 31-MAR-2024) for prophylaxis. On 07-MAR-2023, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced incorrect storage of drug (Verbatim: Vx given after temp excursion 70?F aprox). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK receipt date: 7-Mar-2023 The pharmacist reported a temperature excursion for on Engerix-B pediatric dose. This unique vaccine was left at room temperature, around 70 degree Fahrenheit approximately but not sure, for no more than 5 minutes with no prior excursions. The reporter had no data about exact temperature reached. After this situation, the vaccines was administered to a new born on the day of reporting. The reporter consented to follow-up. The patient received a dose of Engerix B pediatric after temperature excursion, which led to incorrect storage of drug. As the age was zero day at the time of vaccination and there is medication error therefore to avoid report failure only age group was captured as neonate.