Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | BE9G7 | — |
needle broke in the patient's leg during Hiberix administration; This non-serious case was reported by a physician via call center representative and described the occurrence of needle stick/puncture in a 1-year-old male patient who received Hib (Hiberix) (batch number BE9G7, expiry date 15-JUL-2026) for prophylaxis. On 19-FEB-2025, the patient received Hiberix. On 19-FEB-2025, less than a day after receiving Hiberix, the patient experienced needle stick/puncture (Verbatim: needle broke in the patient's leg during Hiberix administration). The outcome of the needle stick/puncture was not applicable. It was unknown if the reporter considered the needle stick/puncture to be related to Hiberix. It was unknown if the company considered the needle stick/puncture to be related to Hiberix. Additional Information: GSK Receipt Date: 20-FEB-2025 The physician asked how to proceed after the needle broke in the patient's leg during Hiberix administration. The vaccine administration facility was the same as primary reporter.