Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK344AA | OT |
hib portion of pentacel was reconstituted using sterile water instead of required dtap-ipv diluent with no reported adverse event; Initial information received on 17-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 weeks old female patient (23.5 cm and 4.989 kg) who received HIB portion of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] was reconstituted using sterile water instead of required dtap-ipv diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Oct-2025, the patient received a dose of 0.5ml of HIB portion of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Mrc5)/HIB(PRP/T) Vaccine (expiry date-31-Jan-2027, frequency-once and lot UK344AA) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) was reconstituted using sterile water instead of required dtap-ipv diluent with no reported adverse event (poor quality product administered) (latency-same day). It was reported "actions have been taken to prevent this from happening again including attaching both vials of pentacle with a rubber band to ensure correct reconstitution moving forward". 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.