Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK345AA | IM / LL |
medication error (unintentional) due to use of incorrect diluent for Pentacel, diluent from a different company was used with no reported adverse event; Initial information received on 02-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP) other. This case involves a 3-year-old female patient who was administered with incorrect diluent for the suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (PENTACEL), in which diluent from a different company was used with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, concomitant medications were not provided. On 17-Feb-2026, the patient received 0.5 ml Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, powder and suspension for suspension for injection, batch number: UK345AA, expiry: 31-Jan-2027, with unknown strength via intramuscular route for immunization due to use of incorrect diluent from a different company was used with no reported adverse event (Product preparation error) (latency: same day). 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.
Comments: NONE