Reporte zur Charge UJ594ABA

Symptomtext

Administered PENTACEL instead of Menveo with no reported adverse event; Initial information received from on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child male patient who was administered pentacel instead of menveo with no reported adverse event while receiving vaccines MENVEO and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination. On 18-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot UJ594ABA) via intramuscular route in the deltoid nos instead of MENVEO not produced by Sanofi Pasteur, for prophylactic vaccination. On 18-Oct-2022, (latency: same day) the patient was administered pentacel instead of menveo with no reported adverse event (wrong product administered). Action taken was not applicable with both the suspects. At time of reporting, the outcome was Unknown for the 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 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.