Reporte zur Charge 3NM93

Symptomtext

Lab work showed not immune for Hepatitis B; This case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7S9NK, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 3NM93, expiry date unknown) 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 35ZF9, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included hb vaccine (received HBV pediatric/adolescent on 21st November 2016 with batch number 9Z9LN). On 23rd May 2017, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st March 2017, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd January 2017, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. In July 2022, more than 2 years after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased 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: 26-Oct-2022 Reporter's comment: The patient 's mother reported that the patient had completed her series with Pediarix. In July 2022, the lab work done which showed she was not immune for Hepatitis B (low titer) and had to have a booster dose of Hepatitis B vaccine on 30th August 2022. The reporter consented to follow-up. Additional supportive information: The patient had low titer of Hepatitis B after Pediarix series, which led to therapeutic response decreased.