Report #2847741

Overview

Sex

Male

Age

Age unknown

State

—

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Suspected vaccination failure; rota virus infections/gastroenteritis; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 1-year-old male patient who received Rotavirus vaccine for prophylaxis. Co-suspect products included Rotavirus vaccine for prophylaxis. On an unknown date, the patient received the 2nd dose of Rotavirus vaccine and the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine and Rotavirus vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus gastroenteritis (Verbatim: rota virus infections/gastroenteritis) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the rotavirus gastroenteritis was not resolved. The reporter considered the vaccination failure and rotavirus gastroenteritis to be related to Rotavirus vaccine, Rotarix Unspecified Oral Administation Device, Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. The company considered the vaccination failure and rotavirus gastroenteritis to be unrelated to Rotavirus vaccine, Rotarix Unspecified Oral Administation Device, Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. 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: 14-JUN-2025 The case was received from the patient's parent via interactive digital media. The patient gotten Rotarix vaccine, unfortunately he had suffered from two times rota virus infections. The reporter wondered why the patient suffered from rota gastroenteritis although he vaccinated. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming rotavirus infection and gastroenteritis were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Rotarix (Dose 1 and Dose 2) and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE