Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK225AB | OT / LL |
only the liquid component was given to the patient with no adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who was administered with only the liquid component of Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no 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) for Immunisation; and Rotavirus vaccine for Immunisation. On 17-Apr-2025, the patient received an unknown dose only the liquid component of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine strength-0.5ml (formulation, expiry date-unknown) (lot UK225AB) via intramuscular route in the left thigh for Immunization with no adverse event (single component of a two-component product administered) (latency-same day). Reportedly- The lyophilized component was not reconstituted with the liquid component and only the liquid component was given to the patient. They wanted to know if they can give the Hib component by itself or if they need to repeat the PENTACEL. 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; ROTAVIRUS VACCINE