Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK225AB | OT |
vaccines were administered before they could be quarantined. One Pentacel vaccine was given with no reported adverse event; Initial information received on 01-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who was administered with Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] before they could be quarantined 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 Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and Rotavirus vaccine LIVE Reassort Oral 5V (Rotateq) for Immunisation. On 31-Mar-2025 or 01-Apr-2025, the patient received a 0.5ml dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection standard strength, frequency-once (lot UK225AB, expiry date-unknown) via intramuscular route in unknown administration site for Immunization and was administered before they could be quarantined no reported adverse event (poor quality product administered) (latency- same day). Reportedly- One Pentacel vaccine was given and two Prevnar vaccines were given. 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.
PREVNAR; ROTATEQ