Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
child was administered pentacel, but the polio portion was given without being mixed with the hib portion with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old and unknown gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but the polio portion was given without being mixed with the hib portion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) but the polio portion was given without being mixed with the hib portion with no reported adverse event (single component of a two component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. Reportedly,They want to ensure that this is safe and that the patient will not experience any side effects. Per SRD (Standard Reference Data) informed that Pentacel vaccine components should not be used separately. However, if the DTaP-IPV (Diphtheria, tetanus, and pertussis inactivated poliovirus) liquid component was administered separately it would count as a valid DTaP and IPV dose. Additionally informed that any dose of Act-HIB reconstituted with a diluent other than specific Act-HIB diluent should not be counted as valid and must be repeated. 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.