Reporte zur Charge UJ129AAA

Symptomtext

received Pentacel and Pediarix / consumer received a double dose of the Dtap-IPV component on the day of the injections / Pentacel and Pediarix contain those components; the consumer is behind on their vaccine schedule; This case was reported by a nurse via other manufacturer and described the occurrence of overdose in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (batch number UJ129AAA, expiry date 11th March 2020) for prophylaxis. On 22nd October 2019, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL. On 22nd October 2019, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information was provided as follows: It was reported that the patient ordered to receive Pediarix and ActHIB but the patient received Pentacel and Pediarix. The nurse reported that, the patient received a double dose of the Dtap-IPV component on the day of the injections due to the Pentacel and Pediarix contain those components, which led to overdose of Dtap-IPV. The patient was behind on their vaccine schedule, which led to inappropriate schedule of vaccine administered. This suspected adverse reaction report was submitted and classified as a medication error solely.