Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | — | OT |
dose provided was 8 days expired with no reported adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient's Parent). This case involves a 2 months old male patient to whom dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] provided was 8 days expired 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 ROTAVIRUS VACCINE for Immunisation. On 08-Sep-2025, the patient received a dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Powder and suspension for suspension for injection once (lot number, strength, dose and expiry not reported) via unknown route in the thigh nos (not otherwise specified) as Immunization which was 8 days expired with no reported adverse event (expired product administered) (Latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. 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; ROTAVIRUS VACCINE