Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK193AA | OT / LA |
received ACT-HIB that was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 year old female patient who received HIB (PRP/T) Vaccine [Act-Hib] which was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella zoster vaccine live (Oka/Merck), Varicella zoster vaccine live (Oka/Merck) (Varivax) for Immunisation. On 24-Apr-2025, the patient received 0.5ml dose (once) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, Expiry date 31-Mar-2026, lot UK193AA via intramuscular route in the left arm for immunisation which was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse event (product preparation error) (Latency same day). 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.
Varivax