Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK332AA | OT / LL |
HIB component of PENTACEL was administered without properly reconstituting it with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with other cases US-SA-2025SA312049 and US-SA-2025SA313102. This case involves a 1 years old female patient who received hib component of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] without properly reconstituting it 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 hepatitis A vaccine (hepatitis A) and influenza vaccine (fluzone), both for Immunisation. On 10-Oct-2025, the patient received hib component of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of strength and frequency: once with lot UK332AA and expiry date 31-AUG-2026 via intramuscular route in the left vastus lateralis for immunization without properly reconstituting it with no reported adverse event (single component of a two-component product administered) (Latency same day). It was reported, "Nurse reports that they discovered that they had 1 component of pentacel box, so they presume that they have 1 patient who received an incomplete dose of pentacle narrowed it down to three patients that it could be based one when inventory was done. Nurse reports that the DTaP-IPV liquid component was left in the box, so the HIB component was likely administered to a patient. The nurse is not certain what diluent was used to reconstitute the HIB, but it was likely sterile water because sterile water is the only diluent that they have supplied in their office" 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.; Sender's Comments: US-SA-2025SA312049:patient 2 US-SA-2025SA313102:patinet 3 US-SA-2025SA312049:master case
HEPATITIS A; FLUZONE [INFLUENZA VACCINE]