Reporte zur Charge UI904AA

Symptomtext

patient received a pentacel vaccine as well as an act-hib vaccine on 25sep2018 (with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received a /TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [Pentacel] vaccine as well as an HIB (PRP/T) VACCINE [ACT-HIB] vaccine (with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination. On 25-Sep-2018, the patient received an unknown dose 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, suspension for injection (lot UI904AA, strength - standard, frequency - once, expiry date - unknown) via unknown route in unknown administration site and an unknown dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength, lot number and expiry date - not reported) via unknown route in unknown administration site for immunization, with no reported adverse event (extra dose administered) (latency: same day) Reportedly, Caller states that she was entering vaccine information into the system on behalf of a patient that is new to her practice and discovered that the patient received a PENTACEL vaccine as well as an ACT-HIB vaccine on 25SEP2018. Caller contacted the facility that provided the vaccines and was given a lot number for the ACT-HIB. Caller believes that the lot number provided was for the Hib portion of PENTACEL and is calling to verify this. Caller does not believe that the patient received a full ACT-HIB vaccination as well as a PENTACEL vaccination but could not verify this on the VAERS system 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.