Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was administered with adacel(tdap) instead of pentacle with no reported adverse event; 4 months old patient treated with Adacel with no adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4-month-old and unknown gender patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Oct-2024, the patient received a dose of Suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (strength, dose, lot number, expiry, route and administration site: unknown) instead of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot and expiry: unknown) with no adverse event (wrong product administered, product administered to patient of inappropriate age).  Information on batch number corresponding to the one at time of event occurrence was requested.   Reportedly, the patient needs to get immunized with Pentacel as soon as possible. But how soon can we administer Pentacel if the baby just had Tdap administered.  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.; Reporter's Comments: .   Initial information received on 10-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced nurse to give pentacel, but the nurse gave tdap by accident, with no reported adverse event and 4 months old patient treated with adacel with no adverse event while receiving vaccines and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Oct-2024, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On 08-OCT-2024 the patient developed a non-serious nurse to give pentacel, but the nurse gave tdap by accident, with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. On 08-OCT-2024 the patient developed a non-serious 4 months old patient treated with adacel with no adverse event (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was unknown. Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (nurse to give Pentacel, but the nurse gave Tdap by accident, with no reported adverse event, 4 months old patient treated with Adacel with no adverse event).  At time of reporting, the outcome was Unknown for the event nurse to give pentacel, but the nurse gave tdap by accident, with no reported adverse event and was Unknown for the event 4 months old patient treated with adacel with 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 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.