Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK019AA | OT / RL |
inadvertently administered a dose of Pentacel one day after it expired with no adverse event; patient of 24 moths 9 days old received Pentaxim with no adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months 9 days old male patient who was inadvertently administered a dose of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] one day after it expired with no adverse even. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A vaccine for Immunisation. On 01-Jul-2025, the patient of 24 months 9 days old received 0.5 ml of dose 4 of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- unknown, expiry date- 30-Jun-2026 and lot UK019AA) via intramuscular route in the right thigh for Immunization one day after it expired with no adverse event (expired product administered) (product administered to patient of inappropriate age) (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.
Hepatitis A