Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK110A | OT / LL |
patient only received one of the two vials they were supposed to with no adverse event; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient who received only one of the two vials for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)], they were supposed to with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and pneumococcal vaccine, both for Immunisation. On 04-Apr-2025, the patient received only one of the two vials for Dose 4 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection of standard strength with lot UK110A and expiry date 31-Aug-2025 via intramuscular route in the left vastus lateralis for Immunization they were supposed to with no adverse event (single component of a two-component product administered) (Latency same day). Reportedly, reporter stated that it is possible that instead of reconstituting the 2 vials together, only one was reconstituted with sterile water and administered 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.
MMR; PNEUMOCOCCAL VACCINE