Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | A5DP7 | — |
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
Drug dose administration interval too long; third shot of ENGERIX-B as of today; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HBV (Engerix B) (batch number A5DP7, expiry date 11-AUG-2027) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Previously administered products included Hepatitis B (received first dose on 2001). On 27-FEB-2026, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On 27-FEB-2026, an unknown time after receiving Engerix B and not applicable after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: third shot of ENGERIX-B as of today). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the drug dose administration interval too long and drug dose administration interval too long 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: 27-FEB-2026 The reporter wanted to know whether the whole vaccine series had to be restarted or whether the dose was valid for completing the original vaccination schedule. The reporter said that he had called Medical Information because he had not been able to find specific information on the CDC website for this case.