Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2345B | — |
Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 12-month-old female patient who received HAV (Havrix 1440 adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. On 22-APR-2025, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient) and overdose (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the adult product administered to child and overdose 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: 22-APR-2025 Medical Assistant called to report a twelve month old female patient that suffered the maladministration of an adult dose of a Havrix Vaccine, which led to adult product administered to child and overdose. Medical Assistant wanted to know if there are any safety (adverse event) and guidance (revaccination advise) on this situation. The Vaccine Administration Facility is the same as Primary Reporter.