Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 423NL | — |
administration of the second dose of Havrix 4 months after the initial dose; 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 18-month-old male patient who received HAV (Havrix) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis. Previously administered products included Havrix (received 1st dose of vaccine on 26th January 2024, batch no F3Y25, expiry date 15th February 2025). On 28-MAY-2024, the patient received the 2nd dose of Havrix. On 28-MAY-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: administration of the second dose of Havrix 4 months after the initial dose). The outcome of the drug dose administration interval too short 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 :19-MAY-2025 An office coordinator called in to request data about the administration of the second dose of Havrix 4 months after the initial dose. The patient was 18 months of age at the time of the second dose. They requested medical information and declined to receive follow-up. The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.