Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK333AA | OT / LL |
Pentacel, the product component was diluted with a diluent other than provided from the box with no reported adverse event; Initial information received on 27-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and the product component was diluted with a diluent other than provided from the box 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 for Immunisation. On 13-Jan-2026, the patient received 0.5 ml of dose 2 of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- standard, expiry date- 30-SEP-2026 and lot UK333AA) via intramuscular route in the left thigh for Immunization and the product component was diluted with a diluent other than provided from the box with no reported adverse event (single component of a two-component product administered) (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.
ROTAVIRUS VACCINE