Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
they gave the shot without the reconstituted HIB part with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without the reconstituted hib part with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (unknownstrength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation), without the reconstituted hib part with no reported adverse event (single component of a two-component product administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. The nurse would like to know how much of the 0.4% NaCl saline solution needs to be used to reconstitute the Hib lyophilized component. 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.