Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | — | OT |
potentially, someone had diluted the lyophilized component of PENTACEL with sterile water and administered it to a patient, with no reported adverse event; Initial information received on 18-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who had experienced an event potentially, someone had diluted the lyophilized component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [PentaceL (VERO)] with sterile water and administered it to a patient, 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 Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 17-Feb-2026, the patient received a dose 1 of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection at the dose of 0.5 ml (strength, lot number, expiry date: unknown) via intramuscular route in unknown administration site for immunization. On 17-FEB-2026 the patient developed a event "potentially, someone had diluted the lyophilized component of pentacel with sterile water and administered it to a patient, 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.
Rotavirus vaccine