Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK307AB | OT / LL |
patient administered the hib bottle alone that was mixed with a standard reconstitution solution with no reported adverse event; Initial information received on 05-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old female patient who was administered the hib bottle alone that was mixed with a standard reconstitution solution with no reported adverse event of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel(VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2025, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine dose 0.5 ml 1x(once) (Strength = standard) Powder and suspension for suspension for injection lot UK307AB expiry date-31-Aug-2026 via intramuscular route in the left vastus lateralis (left thigh) for Immunization the hib bottle alone that was mixed with a standard reconstitution solution with no reported adverse event (single component of a two-component product administered) (latency same day). It was reported "no other vaccines administered" Action taken- 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.