Reporte zur Charge UJ4400AA

Symptomtext

a child was given PENTACEL but only given the liquid portion not the powder/ no AE; Initial information regarding an unsolicited non-valid non-serious case was received on 06-Jul-2021 from a Other healthcare professional via Medical Information (Reference number- 00670899) and transmitted to Sanofi on 06-Jul-2021. This case involves a four-month-old male patient who while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] it was reported that child was given PENTACEL but only given the liquid portion not the powder with no adverse event (product preparation error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 02-Jul-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ4400AA and expiry date 29-May-2022] via intramuscular route in left upper thigh for prophylactic vaccination. It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day). It was reported that, "Caller stated on 7/2/21 a child was given PENTACEL but only given the liquid portion not the powder. Caller wanted to know if the child will need to be given another dose or does the child just need the HIB part. PENTACEL. Product used: Used. First time product used: Yes. Still using product: No." At the time of reporting, patient had no adverse event. 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 guidelines. 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.