Received Jun 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 | 2 | UK151AA | OT / LL |
4 months and 12 days old patient was administered ACTHIB as well as VAXELIS in one day with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months and 12 days old male patient who was administered 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) Vaxelis as well as Hib (Prp/T) Vaccine [Act-Hib] in one day 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 and Rotavirus Vaccine, both for Immunisation. On 09-Jun-2025, the patient received 0.5ml Dose 2 (once) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength standard, lot UK151AA and expiry date 30-Sep-2025 via intramuscular route in the left thigh for immunization and received an unknown dose of suspect Vaxelis, not produced by Sanofi Pasteur (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site both for prophylactic vaccination (immunization) with no reported adverse event (extra dose administered) (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.
PNEUMOCOCCAL VACCINE; ROTAVIRUS VACCINE