Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK345AA | OT / LL |
inappropriate use due to the subcutaneous administration of pentacel with no reported adverse event; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was inappropriately administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] by subcutaneous route 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) and Hepatitis Vaccine for Immunisation. On 06-Oct-2025, the patient received 0.5 ml (dose 3) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK345AA, expiry date:31-Jan-2027, Strength: Standard, frequency: once, via subcutaneous route in the left thigh for Immunization, with no reported adverse event (incorrect route of product administration) (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