Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK372AB | OT / RL |
reconstituted using a sterile diluent, not the provided sodium chloride that came with the vaccine with no reported adverse event; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] was reconstituted using a sterile diluent, not the provided sodium chloride that came with the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (Pediarix); Rotavirus Vaccine; and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) all for Immunisation. On 21-Oct-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 31-DEC-2026 and lot UK372AB) once via unknown route in the right thigh for Immunization and was reconstituted using a sterile diluent, not the provided sodium chloride that came with the vaccine 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.
PEDIARIX; ROTAVIRUS VACCINE; PREVNAR 20