Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK194AA | OT |
patient was administered with the Hib part that was diluted with sterile water with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 month old male patient was administered with Diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] whose HIB part that was diluted with sterile water 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 20V (CRM197) (Prevnar 20) for Immunisation; and Hepatitis B vaccine (ENGERIX-B [Hepatitis B vaccine]) for Immunisation. On 04-Jun-2025, the patient received a dose 0.5ml of suspect Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK194AA and expiry date-31-Mar-2026) (strength-unknown) via intramuscular route in lateral side of the thigh for Immunization the whose HIB part that was diluted with sterile water 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.
PREVNAR 20; ENGERIX-B [HEPATITIS B VACCINE]