Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK024AA | OT / LL |
Patient received an expired dose on PENTACEL, with no reported adverse event; Initial information received on 06-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves an unknown age male patient who received an expired dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], 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 Hepatitis b vaccine and Pneumococcal vaccine conj 20v (CRM197), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 06-May-2025, the patient received an expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (Strength- standard, frequency- once) lot UK024AA and expiry date- 30-APR-2025 via intramuscular route in the left interior thigh for Immunisation with no reported adverse event (expired product administered) (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.
HEPATITIS B VACCINE; Prevnar 20