Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Second dose of Engerix-B was given earlier; Second dose of Havrix was given a month earlier; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old male patient who received HAV (Havrix) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Havrix (received 1st dose of vaccine on 15th march 2023 with batch number W023937 and expiry date 6th December 2023). Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 16-AUG-2023, the patient received the 2nd dose of Havrix. On an unknown date, the patient received the 2nd dose of Engerix B. On 16-AUG-2023, an unknown time after receiving Havrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Second dose of Havrix was given a month earlier). On an unknown date, the patient experienced drug dose administration interval too short (Verbatim: Second dose of Engerix-B was given earlier). The outcome of the drug dose administration interval too short and drug dose administration interval too short 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: 30-JAN-2025 On 30th January 2025, a reporter called to report that a male child patient had received the first dose of Havrix in March 2023 and the second dose on 16th August 2023. Second dose of Havrix had been given a month earlier, which led to Drug dose administration interval too short. They asked if the vaccine needed to be redone and if the patient needed a booster dose. They also mentioned that it was the same scenario for Engerix-B. Second dose of Engerix-B was given earlier, which led to Drug dose administration interval too short.
ENGERIX B