Symptomtext
1st dose Rotateq, 2nd 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 female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis. On 8th February 2023, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, the patient received ROTATEQ. On 8th February 2023, 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: 09-FEB-2023 Reporter's comment: The health department nurse reported that one of their staff members yesterday gave Rotarix vaccine to the patient who previously received a dose of Rotateq eight weeks after the Rotateq dose was give. The reporter reported that this was the patient's second dose of a rotavirus vaccine. The reporter consented to follow up. Additional supportive information: The patient received a dose of Rotarix and Rotateq, which led to interchange of vaccine products.