Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
patient had a negative titer test; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a adolescent male patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: patient had a negative titer test). The outcome of the therapy non-responder 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: 07-FEB-2025 The patient had a negative titer test, so the physician asked us what was the appropriate booster volume dose for Engerix-B. During the call the health care professional informed that the patient complete their Engerix-B vaccine scheme as a child, but due to the titer negative test, they were looking for the appropriate Engerix-B booster volume dose. Health care professional mentioned that the patient had the titer test in 02-Oct-2024. We report this as an adverse event because the patient had a titer negative test, so can consider this as vaccine failure.
Test Date: 20241002; Test Name: Hepatitis B antibody; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)