Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody; recive 2nd dose of Engerix B on 08-JAN-2013 and 3rd dose recive on 01-OCT-2013; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. The patient's past medical history included herpes simplex, hiv infection and hypertriglyceridemia. Concurrent medical conditions included tobacco abuse. On 01-OCT-2013, the patient received the 3rd dose of Engerix B. On 08-JAN-2013, the patient received the 2nd dose of Engerix B. On 04-DEC-2012, the patient received the 1st dose of Engerix B. On 01-OCT-2013, an unknown time after receiving Engerix B, not applicable after receiving Engerix B and Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: recive 2nd dose of Engerix B on 08-JAN-2013 and 3rd dose recive on 01-OCT-2013). On 08-MAY-2024, the patient experienced therapy non-responder (Verbatim: patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody). The outcome of the therapy non-responder was not reported and the outcome of the drug dose administration interval too long 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: 24-SEP-2024 The reporter reported that the patient had received four dose doses of Engerix b. The reporter mentioned that the 4th dose of Hep B vaccine was administered at clinic. The reporter reported that this patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody on 08th May 2024, which led to therapy non responder. The patient received 3rd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Tobacco abuse
Medical History/Concurrent Conditions: Herpes simplex; HIV infection; Hypertriglyceridemia
Test Date: 20240508; Test Name: Hepatitis B core total antibody; Result Unstructured Data: (Test Result:non reactive,Unit:unknown,Normal Low:,Normal High:); Comments: Hepatitis B core total antibody; Test Date: 20240508; Test Name: Hepatitis B surface antibody; Result Unstructured Data: (Test Result:non reactive,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240508; Test Name: Hepatitis B surface antigen; Result Unstructured Data: (Test Result:non reactive,Unit:unknown,Normal Low:,Normal High:); Comments: LabComments: Hepatitis B core total antibody 08-MAY-24: Hepatitis B core total antibody