Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 2 | UK093AC | OT / LA |
acthib that was reconstituted with 0.7 merck sterile water solution with no reported adverse event; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 years old female patient who received HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with 0.7 merck sterile water solution 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 hepatitis A vaccine (hepatitis A vaccine) and pneumococcal vaccine, both for Immunisation. On 17-Jul-2025, the patient received Dose 2 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength, frequency once with lot UK093AC and expiry date 30-Sep-2025 via intramuscular route in the left deltoid for Immunization that was reconstituted with 0.7 merck sterile water solution with no reported adverse event (product preparation error) (Latency same day) Reportedly, vaccine was mixed incorrectly, that it was not reconstituted with the correct diluent. Product was administered. But there was no adverse event. 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.
HEPATITIS A VACCINE; PNEUMOCOCCAL VACCINE