Symptomtext
Had not received the second / First dose / Engerix-B and Havrix on January 28th 2021; Tested positive for Hepatitis A / on Tuesday 27-jul-2021; Tested positive for Hepatitis A; Tested positive for / Hepatitis B / on Tuesday 27-jul-2021; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number p4dj52156, expiry date 15th December 2022) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 28th January 2021, the patient received the 1st dose of Havrix, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 27th July 2021, 180 days after receiving Havrix, Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced vaccination failure (serious criteria GSK medically significant), hepatitis a and hepatitis b (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the vaccination failure, hepatitis a, hepatitis b and incomplete course of vaccination were unknown. It was unknown if the reporter considered the vaccination failure, hepatitis a and hepatitis b to be related to Havrix. It was unknown if the reporter considered the hepatitis a and hepatitis b to be related to Engerix B and Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The patient tested positive for Hepatitis A and Hepatitis B on Tuesday, 27th July 2021 after receiving 1st dose of Havrix and Engerix B, but the reporter thought it might be a false positive. Till the time of reporting, the patient did not receive the 2nd dose Engerix B, which led to incomplete course of vaccination. No further events were reported. The reporter consented to follow up.