Reporte zur Charge U2A292V

Symptomtext

Typhim Vi was administered to an underage patient in the left thigh with no reported adverse event; Initial information received on 07-Dec-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 18 months old male patient who experienced typhim vi was administered to an underage patient in the left thigh with no reported adverse event after receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT). On 07-Dec-2022, the patient received a (Series: N/A) suspect TYPHOID VI POLYSACCHARIDE VACCINE(Dose- 0.5mL)(Frequency-Total)(Formulation-Solution for injection) via unknown route (Batch/lot number -U2A292V)(Expiry Date-30-Sep-2023) in the left thigh for Immunization On 07-DEC-2022 the patient developed a non-serious event typhim vi was administered to an underage patient in the left thigh with no reported adverse event (product administered to patient of inappropriate age) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.( Latency- Same day) It was reported The safety and immunogenicity of Typhim Vi vaccine in children under two years of age has not been established. As with other polysaccharide vaccines, the antibody response may be inadequate. The decision whether to vaccinate children under 2 years of age depends upon the risk incurred by the child on the basis of the epidemiological context. Action Taken : not applicable. At time of reporting, the outcome was Unknown for the event typhim vi was administered to an underage patient in the left thigh with no reported adverse 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.