Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | DN273 | — |
Unapproved age; This non-serious case was reported by a other health professional 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 pediatric) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis. On 05-MAR-2025, the patient received the 1st dose of Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age). 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: 16-MAY-2025 The Medical Assistant was calling regarding a vaccine that was given too early. If there were any steps that were needed to be taken. Hepatitis A, Havrix was received by the patient of 6 months at the time and Hepatitis a was given along with MMR and Varicella, which led to inappropriate age at vaccine administration. It was given on 5th March 2025, patient was six months at the time, patient is 8 months now. No reactions or anything from it. So, believed they do go back to normal schedule, give him again at twelve months but was there anything on our end that we need to watch for.