Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 553E2 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 5JX2E | — |
patient above 70 years old got a double dose of ENGERIX-B adult (2 doses) at the same time on 24 November 2025.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a elderly male patient who received HBV (Engerix B adult) (batch number 553E2, expiry date 16-JAN-2028) for prophylaxis. Co-suspect products included HBV (Engerix B adult) (batch number 5JX2E, expiry date 16-JAN-2028) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 24-NOV-2025, the patient received the 2nd dose of Engerix B adult and the 2nd dose of Engerix B adult. On 24-NOV-2025, an unknown time after receiving Engerix B adult and Engerix B adult, the patient experienced overdose (Verbatim: patient above 70 years old got a double dose of ENGERIX-B adult (2 doses) at the same time on 24 November 2025.). The outcome of the overdose was 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 :24-NOV-2025 The reporter wanted to know if there were some safety concerns after the incident. The reporter was consented to follow up. The Vaccine administration facility was the same as primary reporter. The batch number was not provided and a request for this information has been made.
ENGERIX B