Received Mar 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7NX57 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 6 | H3924 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 5 | 95BJ9 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 4 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Additional doses of Engerix-B was given for 7th dose; Additional doses of Engerix-B was given for 6th dose; Additional doses of Engerix-B was given for 5th dose; Additional doses of Engerix-B was given for 4th dose; Drug dose administration interval too short for 3rd dose; Drug dose administration interval too long for 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 3-month-old female patient who received HBV (Engerix B) (batch number 7NX57) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number H3924) for prophylaxis, HBV (Engerix B) (batch number 95BJ9) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 12-DEC-2025, the patient received the 7th dose of Engerix B. On 24-SEP-2025, the patient received the 6th dose of Engerix B. On 18-JAN-2025, the patient received the 5th dose of Engerix B. On 15-MAY-2014, the patient received the 4th dose of Engerix B. On 13-MAY-2013, the patient received the 3rd dose of Engerix B. On 13-MAR-2013, the patient received the 2nd dose of Engerix B. On 13-MAR-2013, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long for 2nd dose). On 13-MAY-2013, the patient experienced drug dose administration interval too short (Verbatim: Drug dose administration interval too short for 3rd dose). On 15-MAY-2014, the patient experienced extra dose administered (Verbatim: Additional doses of Engerix-B was given for 4th dose). On 18-JAN-2025, the patient experienced extra dose administered (Verbatim: Additional doses of Engerix-B was given for 5th dose). On 24-SEP-2025, the patient experienced extra dose administered (Verbatim: Additional doses of Engerix-B was given for 6th dose). On 12-DEC-2025, the patient experienced extra dose administered (Verbatim: Additional doses of Engerix-B was given for 7th dose). The outcome of the drug dose administration interval too long, drug dose administration interval too short, extra dose administered, extra dose administered, extra dose administered and extra dose administered were not applicable. Additional Information: GSK receipt date: 09-MAR-2026 The nurse reported an additional 2 doses of Engerix-B pediatric dose was administered to a pediatric patient. The first 4 doses was given in another country and they did not have the record and the rest 3 dose was given here. The batch number was not provided upon follow up with the reporter.
ENGERIX B