Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK040AA | OT / RL |
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 9 months old female patient who received an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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) (Pneumococcal Vaccine Conj 20v (Crm197)) for Immunisation. On 01-Aug-2025, the patient received an expired 0.5ml, dose 3 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (once), Suspension for injection, Strength standard, lot UK040AA and expiry date 31-Jul-2025 via intramuscular route in the right thigh for immunization, with no reported adverse event (expired product administered) (Latency Same day). Reportedly, Medical Assistant (MA) had administered a dose of Pentacel vaccine to a patient on 01-Aug-2025, but the vaccine expired on 31-Jul-2025. 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)