Reporte zur Charge U737ABA

Symptomtext

EXTRA DOSE ADMINISTERED; Overdose; No Adverse Event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2668702-1 and ADDITIONAL INFORMATION RECEIVED ON 12-OCT-2023 with the following VAERS Primary 2665702-1. The original narrative from the sender is the following: "was accidentally administered with acthib and vaxelis at the same time with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid nonserious case received from a other health professional. This case involves a 6 months old male patient who was accidentally administered with Hib (Prp/T) Vaccine [Act-Hib] And Vaxelis [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] at the same time 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. On 31-Jul-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: Once; Strength: Standard, expiry date: 06-May-2024 and lot UJ801AA) via intramuscular route in Left Vastus Lateralis for Immunization; on the same day received a unknown dose of suspect VAXELIS not produced by Sanofi Pasteur (formulation Strength, expiry date and lot number: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and was accidentally administered at the same time (Extra dose administered) (latency: same day). Information on the batch number was reuqested. 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 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" The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Extra dose administered", "No adverse event" and "Overdose". Due to the nature of the event, the causal relationship between Vaxelis and "Extra dose administered", "No adverse event" and "Overdose" was Not Applicable. No further information is expected.