Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK227AC | OT / RL |
ActHib vaccine was incorrectly reconstituted with sterile water rather than the 0.4 percent saline diluent that is supplied with the ActHib vaccine with no adverse event; Initial information received on 03-Nov-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient as HIB (PRP/T) VACCINE [ACT-HIB] was incorrectly reconstituted with sterile water rather than the 0.4 percent saline diluent that is supplied with the acthib vaccine with no 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 inact (Havrix) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad) for Immunisation. On 03-Nov-2025, the patient received HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose 0.5 ml 1x(once) lot UK227AC expiry date 30-jun-2026 via intramuscular route in the right thigh for Immunization, which incorrectly reconstituted with sterile water rather than the 0.4 percent saline diluent that is supplied with the acthib vaccine with no adverse event (product preparation error) (latency same day). It was reported "The volume of the diluent was 0.7 mL, the lot number was 1973248, and the expiration date was 07 Feb 2026" 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 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.
Havrix; Proquad