Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | MZ474 | — |
Inappropriate Age at Vaccine Series Administration; Inappropriate schedule of vaccine; Inappropriate Age at Vaccine Series Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix 720) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis. In NOV-2024, the patient received the 2nd dose of Havrix 720. In OCT-2024, the patient received the 1st dose of Havrix. In OCT-2024, not applicable after receiving Havrix 720 and an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Series Administration). In NOV-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Series Administration) and drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration 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: 22-APR-2025 The nursing supervisor stated that the first dose of Havrix was administered to a 6-month-old patient in October 2024 which led to inappropriate age at vaccine administration. The patient also received the 2nd dose in November 2024 which also led to inappropriate age at vaccine administration and drug dose administration interval too short.