Reporte zur Charge UJ84LAA

Symptomtext

3-month old female patient received both pentacel and pediarix today, the patient accidentally received a double dose of DTaP-IPV vaccine with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA236480. This case involves a 3 months old female patient for whom both Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (YEAST), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3V (VERO), Tetanus Vaccine Toxoid [Pediarix] on the same day, the patient accidentally received a double dose of dtap-ipv 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 and Pneumococcal Vaccine CONJ 13v (CRM 197) (Prevnar 13) for Prophylactic vaccination. On 01-Aug-2023, the patient received a dose 1 of 0.5 ml (frequency: once) of standard strength of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] suspension for injection (lot: UJ84LAA) via intramuscular route in the right thigh and and dose of suspect PEDIARIX (strength, formulation, expiry date and lot number not reported) not produced by Sanofi Pasteur via unknown route in unknown administration site, both for prophylactic vaccination (immunization), the patient accidentally received a double dose of dtap-ipv vaccine with no reported adverse event (extra dose administered) (latency: same day). Information on the batch number was requested. Action taken: not applicable. At time of reporting, the outcome was 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 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.