Reporte zur Charge U7256AA

Symptomtext

patient was administered just the liquid diluent component of pentacel without being reconstituted with the lyophilized component of the vaccine with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who was administered just the liquid diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]without being reconstituted with the lyophilized component of the vaccine with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 17-Aug-2022, the patient received a 0.5ml 1X(once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot U7256AA and expiry date: 27-Apr-2023) via intramuscular route in the left vastus lateralis for Immunization. On 17-Aug-2022 the patient developed a non-serious event of patient was administered just the liquid diluent component of pentacel without being reconstituted with the lyophilized component of the vaccine with no adverse event (product preparation issue, Latency: same day). Patient was just administered the diluent liquid component of Pentacel without reconstituting it with the lyophilized powder component. Wanting to know what the next steps are. Reporter also asked where can she get the 0.4 % NACL saline diluent to mix with the ACTHIB component. No further information provided. Action taken : not applicable. Outcome: Unknown 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.