Received Feb 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
received the HIB vaccine reconstituted with sterile water instead of diluent, with no reported adverse event; Initial information received on 10-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received the Hib (Prp/T) Vaccine reconstituted with sterile water instead of diluent, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Feb-2026, the patient received an unknown dose of suspect HIB (Prp/T) Vaccine, Solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for Prevention of invasive disease caused by Haemophilus influenzae type b (Hib) [immunisation], which was reconstituted with sterile water instead of 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.