Received Feb 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK369AA | OT |
patient was administered Act-hib, that was exposed to temperature excursion duration: 1 hour 9 minutes with no reported adverse event; patient was administered Act-hib, that was exposed to temperature excursion duration: 1 hour 9 minutes with no reported adverse event; Initial information received on 09-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown demographics 20 patients those were administered HIB (PRP/T) VACCINE [ACT-HIB] that was exposed to temperature excursion duration: 1 hour 9 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UK369AA, expiry date: 31-Dec-2026) via unknown route in unknown administration site for immunization (product storage error) (poor quality product administered) (latency: unknown) . No adverse event was reported Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.