Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK175AA | OT / LA |
acthib that had been reconstituted with the sterile water from a merck product and not the enclosed and correct diluent with no reported ae; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] that had been reconstituted with the sterile water from a merck product and not the enclosed and correct diluent with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (PREVNAR) for Immunisation. On 22-Oct-2025, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK175AA, strength-standard, frequency-once and expiry date-31-Oct-2025) via unknown route in the left deltoid for Immunization that had been reconstituted with the sterile water from a merck product and not the enclosed and correct diluent with no reported ae (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.
PREVNAR