Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
Early for 3rd dose; 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 4-month-old patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received first dose on 24-MAY-2022). Concomitant products included hepatitis b vaccine rhbsag (yeast) (Engerix B). On 26-SEP-2022, the patient received the 3rd dose of Engerix B. On 26-SEP-2022, an unknown time after receiving Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: Early for 3rd dose). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 05-MAY-2026 A nurse from the health department called after a school reached out regarding a child starting preschool. The child was listed in the immunization system, where the hepatitis B series was flagged because the final dose had been administered when the child was 4 months old. The nurse reviewed the vaccination history and noted that the first dose had been given on 24-MAY-2022, the second dose on 25-JUL-2022 (8 weeks after the first dose), and the final dose on 26-SEP-2022 (9 weeks after the second dose). The interval between the first and third doses was 16 weeks. Although the spacing between doses was appropriate, the third dose had been administered before the minimum recommended age of 24 weeks. At the time of the review, the child was 4 years old and was going to turn 5 on the 23rd of the month. The batch number was not provided upon follow up with the reporter.
ENGERIX B