Sex: U
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP, FLU4, FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Administration of vx not properly temperature monitored; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) (batch number 47CX9, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 3K9LY, expiry date 30th June 2022) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 3K9LY, expiry date 30th June 2022) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 47CX9, expiry date 29th May 2022) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 7th March 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Havrix. On 22nd February 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On 7th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Havrix, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter was state department of health worker. The reporter reported that, a site administered 13 vaccines between 7th February 2022 to 18th April 2022. It was then discovered by compliance officers at site that there was no monitoring of temperature data at the site after 1st February 2022 and it was unknown if the vaccines were kept within the appropriate temperature range.  There were 3 doses of FluLaval administered, there was 1 dose of Havrix administered ,there were 7 doses of Pediarix administered. The reporter did not have any of the patient information. At the time of reporting, the vaccines had not been repeated.  The reporter consented to follow up. Additional Supportive Information: It was then discovered by compliance officers at site that there was no monitoring of temperature data at the site after 1st February 2022 and it was unknown if the vaccines were kept within the appropriate temperature range, which led to incorrect storage of drug.