Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK040AA | OT / LL |
administered pentacel to a patient yesterday but only the dtap-ipv component was given. the hib component was not reconstituted with no reported ae; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who was administered Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the DTAP-IPV component was given the HIB component was not reconstituted with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided Concomitant medications included Pneumococcal vaccine for Immunisation. On 10-Mar-2025, the patient received a 0.5ml dose which was of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection standard strength (frequency-once) (lot UK040AA) (expiry date-31-Jul-2025) intramuscular route in the left thigh for immunization and only the dtap-ipv component was given. the hib component was not reconstituted with no reported AE (single component of a two-component product administered) (latency-same day). Reportedly- It was supposed to be a final series 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.
PNEUMOCOCCAL VACCINE