Received Sep 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
geriatric patient was prescribed by a physician to receive a HIB (ACT-HIB) vaccine beforethey would have their surgery with no reported adverse event; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old and unknown gender geriatric patient who was prescribed by a physician to receive a Hib (Prp/T) Vaccine [Act-Hib] before they would have their surgery with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the geriatric patient was prescribed by a physician to receive an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (unknown strength and expiry date) lot number not reported for immunization before they would have their surgery with no reported adverse event (product prescribing issue) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, the patient that was older than 5 years old being prescribed to receive ACT-HIB vaccine. Action taken was 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.