Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included hiv infection (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included diarrhea rotavirus with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included diarrhea rotavirus (unknown). The investigator considered that there was a reasonable possibility that the vaccination failure and diarrhea rotavirus may have been caused by Rotavirus vaccine. Relevant Tests: Lba tests were performed on unspecified date between February 2006 to December 2015. Patient's stool sample tested for detection of rotavirus. Patient was found positive for rotavirus. Diagnostic results (unless otherwise stated, normal values were not provided):  On an unknown date, Rotavirus test result was positive. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had human immuno-deficiency virus  (HIV). No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed diarrhea. Patient's stool sample tested for detection of rotavirus. Patient was found positive for rotavirus. This case has been considered as suspected vaccination failure being time to onset and full schedule was unknown. This case has been considered as serious due to suspected vaccination failure. The treatment was unknown. The outcome of the event was not provided. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Lab Comments: Lab tests were performed on unspecified date between February 2006 to December 2015. Patient's stool sample tested for detection of rotavirus. Patient was found positive for rotavirus.