Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 3H3RX | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3H3RX | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3H3RX | — |
completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough levels of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 61-year-old male patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis and HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis. Concurrent medical conditions included immunocompromised. On 04-APR-2024, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased (Verbatim: completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough levels of the vaccine). The outcome of the therapeutic response decreased 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: 09-APR-2025 The pharmacist reported that the patient completed the 3 dose schedule of Engerix-B and took a blood test and he "didn't had enough levels of the Hepatitis-B vaccine which was Engerix-B, which led to therapeutic response decreased. The reporter asked can he receive a booster dose of Engerix-B because their doctor ordered it and how do they proceed.
Immunocompromised
Test Name: blood test; Result Unstructured Data: (Test Result:Not enough levels,Unit:unknown,Normal Low:,Normal High:)