Received Jul 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK023AA | OT / LL |
Pentacel was administered that expired 3 months ago with no reported adverse event; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 weeks old male patient who was administered to Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine [Pentacel] that expired 3 months ago 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 Live Oral 1v (Rotarix) and Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Immunisation. On 10-Jul-2025, the patient received 0.5mL (dose 1) of suspect Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine, Suspension for injection (lot UK023AA; expiry date 30-Apr-2025, strength standard and frequency once) via intramuscular route in the left thigh for Immunisation and it was administered that expired 3 months ago with no reported adverse event (expired product administered) (latency same day). Reportedly, they wanted to know if they need to readminister and recommendations that were available for this situation. 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.
ROTARIX; PREVNAR