Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | MB599 | — |
inadvertent administration of Havrix to a 4-month-old patient; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received HAV (Havrix) (batch number MB599, expiry date 25-JAN-2027) for prophylaxis. On 04-SEP-2025, the patient received the 1st dose of Havrix. On 04-SEP-2025, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertent administration of Havrix to a 4-month-old patient). The outcome of the inappropriate age at vaccine administration 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: 05-SEP-2025 The physician informed about the inadvertent administration of Havrix to a 4-month-old patient. The reporter consented to follow up.