Reporte zur Charge L4NH3

Symptomtext

dose of ROTATAX 02/14/2022, On 4/22/2022 they administered Rotarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number L4NH3, expiry date 23rd July 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis. On 22nd April 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 14th February 2022, the patient received ROTATEQ. On 22nd April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 10-AUG-2022 Reporter's comments: The reporter reported that, a patient was vaccinated with a dose of Rotateq on 14th February 2022. The patient was then administered with the Rotarix and second dose was not administered yet. The reporter did not consent to follow-up. Additional Supportive Information: As patient first received Rotateq followed by Rotarix, which led to Interchange of vaccine products. Note: As the discrepancy in vaccine name Rotatax, the Rotatax was considered Rotateq conservatively.