Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
stated that a patient received pentacel and acthib the same day at the same time with no reported adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA276269 This case involves an unknown age and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] and Hib (Prp/T) Vaccine [Act-Hib], on same day at the same time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine, Suspension for injection, and received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection both with (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, on same day at the same time with no reported adverse event (Extra dose administered) (Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, duplicate dose of Hib administered to a patient. 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-2025SA276269: