Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK174AB | OT |
1-month old patient who was given with PENTACEL by mistake,with no reported adverse event; Initial information received on 17-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 months old female patient who was given with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] by mistake,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 (ROTAVIRUS VACCINE) and PREVNAR 15 for Immunisation. On 17-Mar-2025, the patient received at dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK174AB and expiry 31-Mar-2026) by mistake, with no reported adverse event (product administered to patient of inappropriate age) (latency same day) via intramuscular route in right leg for immunization. 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.
ROTAVIRUS VACCINE