Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | PE9G5 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
they got an antibody test and it came negative; incomplete course of vaccination; patients received an expire dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 21-year-old female patient who received HBV (Engerix B) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 28-MAY-2025, the patient received the 4th dose of Engerix B. The patient did not receive the 2nd dose of Twinrix, on an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 28-MAY-2025, an unknown time after receiving Engerix B and not applicable after receiving Twinrix, Engerix B, Engerix B and Engerix B, the patient experienced expired vaccine used (Verbatim: patients received an expire dose of Engerix-B). On an unknown date, the patient experienced therapy non-responder (Verbatim: they got an antibody test and it came negative) and incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the therapy non-responder, expired vaccine used and incomplete course of vaccination were not applicable. 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: 28-MAY-2025 Nurse called and reported that one of their patients received an expire dose of Engerix-B, the vaccination date was 28-May-2025 and the vaccine was expired since 19-May-2025, which led to expired vaccine used. The patient had 3 doses a long time ago, so this was the 5th dose, they had 3 doses when they were a child, and then they were going to school, colleague, and they got an antibody test and it came negative, which led to Therapy non-responder. So they want attempt start over, so she had a Twinrix on 20-Apr-2025. Till the time of reporting the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Twinrix