Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3A2KF | — |
partial dose of HIBERIX given; Some of the vaccine was dripping down patient arm; Some of it ran down patient arm; states 3 of the needles popped off and completely detached off the syringe and 1 needle detached during administration; Pharmaceutical product complaint; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a patient who received Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: partial dose of HIBERIX given), inadvertent exposure to vaccine (Verbatim: Some of the vaccine was dripping down patient arm), exposure via skin contact (Verbatim: Some of it ran down patient arm), device connection issue (Verbatim: states 3 of the needles popped off and completely detached off the syringe and 1 needle detached during administration) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the accidental underdose, inadvertent exposure to vaccine, exposure via skin contact, device connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the device connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. It was unknown if the company considered the device connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. 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-APR-2025 The reporter stated that he had another 4 occurrences with Hiberix. He states 3 of the needles popped off and completely detached off the syringe and 1 needle detached during administration. Some of the vaccine was dripping down patient arm which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. Health care professional not sure how much the patient received. He stated that happened about a week ago, no date, no PII, he did not have any information at this time. He stated that all but 1 of the suspect syringes left for return. He stated that all needles were discarded in sharps as well. Picture of unopened needle and suspect product will be sent with this case. Confirmed that all operations were performed appropriately. 3 needle while attaching the second needle for administration and 1 needle during injection detaching or rotating of the luer lok adaptor occurred. Reg 25 g needle was used and no safety on it. Reporter requested to credit total of 4 Hiberix vaccines to GlaxoSmithKline Direct. There was a product complaint to reported of detaching needles from pre-filled syringes. The case had been linked to US2025017219, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025017219:Same reporter