Reporte zur Charge U7311A

Symptomtext

patient was administered the PENTACEL however only the DTAP/IPV component, not the ACT-HIB portion (with no reported adverse event); Initial information received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] however only the dtap/ipv component, not the act-hib portion (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot U7311A, expiry date: 09-Sep-2023 with unknown strength) via intramuscular route in left thigh as Immunization. On 22-Aug-2023 (Latency: same day) the patient was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine however only the dtap/ipv component, not the act-hib portion (with no reported adverse event) (single component of a two-component product administered) (unknown latency). Action taken: not applicable. 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 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.