Received May 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK368AB | — |
administered the act-hib but it was not mixed with the diluent. the powder was mixed with sterile water with no ae; Initial information received on 07-May-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5-month-old female patient who was administered the haemophilus type b (Hib) vaccine (ACT-HIB) but it was not mixed with the diluent, the powder was mixed with sterile water with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 20-Mar-2026, the patient received dose 2 haemophilus type b (Hib) vaccine powder and solvent for solution for injection (strength:standard) as 0.5 mL, once (route: unknown) for immunization. This was dose 2 of the vaccination series, administered from lot number UK368AB (expiry: 31-Jan-2027). The ACT-HIB vaccine was administered but it was not mixed with the provided diluent; instead, the powder was mixed with sterile water with no adverse event reported (vaccine incorrect diluent used, onset: 20-Mar-2026 and latency: same day) 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 medication 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.
Comments: NONE
Pediarix; Pneumovax; Rotavirus vaccine