Received Jun 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | D2D49 | LL |
When the doctor pushed the plunger down to the halfway point the syringe cracked completely in the neck, breaking off the entire top and the needle was left in the patient's leg; product complaint; exposure to medication/ The vaccine liquid did run down the baby's leg and had exposure to skin; he administration of engerix -B pediatric that was not administered fully; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a 9-month-old female patient who received HBV (Engerix B pediatric) suspension for injection in pre-filled syringe (batch number D2D49 with expiry date 24-SEP-2027) for prophylaxis. On 09-JUN-2026, the patient received Engerix B pediatric (left thigh). On 09-JUN-2026, an unknown time after receiving Engerix B pediatric, the patient experienced exposure via skin contact (Verbatim: exposure to medication/ The vaccine liquid did run down the baby's leg and had exposure to skin) and incomplete dose administered (Verbatim: he administration of engerix -B pediatric that was not administered fully). On an unknown date, the patient experienced needle leak (Verbatim: When the doctor pushed the plunger down to the halfway point the syringe cracked completely in the neck, breaking off the entire top and the needle was left in the patient's leg) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the exposure via skin contact, incomplete dose administered, needle leak and pharmaceutical product complaint 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: 09-JUN-2026 The reporter stated that she prepared the dose of Engerix-B as per PI and placed the vaccine on the tray for the doctor to administer. The doctor administered the vaccine to a 9-month-old in her left thigh. When the doctor pushed the plunger down to the halfway point the syringe cracked completely in the neck, breaking off the entire top and the needle was left in the patient's leg. This dose has not been reported before. The doctor did not revaccinate another dose. The vaccine liquid did run down the baby's leg and had exposure to skin. The administration of Engerix -B pediatric that was not administered fully as the liquid squirted out as the neck or the top of the plunger broke while administering. The product felt defective as when the needle was inserted in the thigh, and as the doctor was pushing the plunger, the neck or the top of the plunger broke. The needle was taken off and disposed off. Drug dosage text for Engerix-B 10 MCG/0.5 ml PFS no NDL 10 LM last dose in series.