Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7P7L9 | — |
one dose of Hiberix had accidentally been administered without proper reconstitution; one dose of Hiberix had accidentally been administered without proper reconstitution; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 13-month-old male patient who received Hib (Hiberix) (batch number 7P7L9, expiry date 08-DEC-2026) for prophylaxis. Previously administered products included Hiberix (received first dose of Hiberix vaccine on an unknown date.). On 22-JAN-2026, the patient received Hiberix. On 22-JAN-2026, an unknown time after receiving Hiberix, the patient experienced inappropriate dose of vaccine administered (Verbatim: one dose of Hiberix had accidentally been administered without proper reconstitution) and inappropriate preparation of medication (Verbatim: one dose of Hiberix had accidentally been administered without proper reconstitution). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date:11-FEB-2026 The reporter contacted to report that they had a scenario where they noticed that one dose of Hiberix had accidentally been administered without proper reconstitution, but they were unsure of which of the four patients that were involved received the improper dose. They were calling in to request information about any data concerning the administration of 3rd dose of Hiberix as they were unsure of which patient did not receive the correct dose and was planning on administering another to the patients involved. The vaccine administration facility was the same as primary reporter. This was 1 of 4 cases reported by same reporter for different patients.; Sender's Comments: US-GSK-US2026020495:Same reporter/Different patient GSK-US2026020496:Same reporter/Different patient US-GSK-US2026020508:Same reporter/Different patient