Received Jul 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK225AB | OT / LL |
received the lyophilized ACTHib component reconstituted with 0.7mL sterile water (MMR diluent) and did not receive any of the liquid DTaP/IPV portion, with no reported adverse event; Initial information received on 11-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient who was only received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (VERO)] the lyophilized acthib component reconstituted with 0.7ml sterile water (mmr diluent) and did not receive any of the liquid portion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation. On 11-Jul-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, lot UK225AB,expiry date:31-Jul-2026,strength:standard,via unknown route in the left thigh for immunisation,only lyophilized acthib component reconstituted with 0.7ml sterile water (mmr diluent) and did not receive any of the liquid portion, with no reported adverse event (product preparation error) (latency: same day). 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.
Vaxneuvance; Rotateq