Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK346AA | OT / RL |
administration of only the liquid (dtap-ipv) component of pentacel with no reported adverse event; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who experienced administration of only the liquid (dtap-ipv) component 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 Nirsevimab alip (Beyfortus); Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance); and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation. On 03-Oct-2025, the patient received a dose 2 (0.5ml) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine; Powder and suspension for suspension for injection (lot UK346AA with expiry date 31-JAN-2027) with unknown (strength) via intramuscular route in the Right anterior lateral thigh for Immunization; administration of only the liquid (dtap-ipv) component of pentacel with no reported adverse event (single component of a two-component product administered) (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.
Beyfortus; Vaxneuvance; Rotateq