Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK0218A | OT |
administered ACTHIB with diluent that was not provided with the ActHIB vaccine, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] with diluent that was not provided with the acthib 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 Pneumococcal vaccine (Pneumococcal vaccine); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Influenza vaccine (Influenza) for and Varicella zoster vaccine (Varicella vaccine) for Immunisation. On 10-Jan-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK0218A, expiry date 05-Feb-2028, frequency one and strength standard) via intramuscular route in right VL(abbreviation of VL is not reported) site for Immunisation and it was administered with diluent that was not provided with the ACTHIB vaccine, with no reported adverse event (product preparation error) (latency same day). Reportedly, Medical assistant called and stated she administered ACTHIB with diluent that was not provided with the ActHIB vaccine. She requested information for appropriate follow-up. 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.
Pneumococcal vaccine; Mmr; Influenza; Varicella vaccine