Reporte zur Charge UJ3733000

Symptomtext

patient has been given pentacel and pedirex on the same day with no reported adverse event; Initial information received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient who had been given 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 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); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) both for Prophylactic vaccination. On 02-Jun-2023, the patient received a dose of 0.5 ml once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ3733000; expiry date: 09-Sep-2023) (dose/series: 6 month vaccination) via intramuscular route in the right thigh and on the same day, the patient also received an unknown dose of suspect PEDIARIX not produced by Sanofi Pasteur (formulation; strength; lot number; expiry date unknown) for prophylactic vaccination (Immunization). On 02-Jun-2023 the patient had been given pentacel and pedirex on the same day with no reported adverse event (extra dose administered) (latency: same day). It was reported, "They both address polio and Diptheria, Tetnus and Pertusis. What should they tell the mother as far as side effects and how should they schedule their future vaccination visits?" Action taken was 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.