Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK107AB | OT / LL |
They explained that the patient received ACTHIB and VAXELIS on the same day with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA128571 This case involves a 6-month-old male patient who received (Diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3v (VERO), tetanus vaccine toxoid) (Vaxelis) and HIB (PRP/T) vaccine [ACT-HIB] on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Apr-2025, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK107AB, expiry date-30-Sep-2025) standard strength via intramuscular route in the left thigh for Immunization and on the same day received an unknown dose of suspect Vaxelis not produced by Sanofi Pasteur Formulation, strength, expiry date and lot number-unknown via unknown route in unknown administration site for prophylactic vaccination (Immunisation) no reported adverse event (extra dose administered) (latency-same day). Reportedly-The patient was given two doses of HIB, no treatment was given. 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.; Sender's Comments: US-SA-2025SA128571:Vaxalis US-SA-2025SA128571:Vaxalis