Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK356AA | OT |
received just one component or portion of the PENTACEL with no adverse event; Initial information received on 23-Jan-2026 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 just one component or portion of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Jan-2026, the patient received 0.7mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK356AA, expiry date 28-Feb-2027 and strength not reported) via intramuscular route in the thigh nos (not so specified) for Immunisation and just one component or portion of the pentacel with no adverse event (single component of a two-component product administered) (latency same day). It was reported "They said that they were aware that the two components must be mixed together first before being administered. Nurse confirmed that the powder component was administered and that it was reconstituted with sterile water prior to administration. The liquid component was not drawn up or administered. Nurse wanted to know if the vaccination should be repeated, or what the recommendations for their situation were." 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.