Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Gastroenteritis, Gastroenteritis norovirus, Norovirus test positive, Polymerase chain reaction positive
Clinical narrative: This case was reported in a literature article and described the occurrence of gastroenteritis norovirus in a child subject who received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the subject developed gastroenteritis norovirus. Serious criteria included hospitalization and GSK medically significant. The outcome of gastroenteritis norovirus was unknown. The investigator considered that there was a reasonable possibility that the gastroenteritis norovirus may have been caused by Rotavirus vaccine. Relevant Tests: Lab tests performed on unspecified date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was positive for norovirus. On an unknown date, Stool analysis result was positive for norovirus. Additional information was provided. This case was reported in a literature article and described the occurrence of healthcare-associated norovirus gastroenteritis in a child equal to or more than 8 month of unspecified gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown). The patient was a part of the study that sought to understand the epidemiology of rotavirus and norovirus infections among hospitalised children. The patient was born after 1 July 2006. The patient had unspecified underlying medical condition. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received unspecified rotavirus vaccine (administration route and site unknown); dosages unknown; batch number not provided). It was reported that the patient received part of series of vaccination. On an unspecified date, an unknown period after vaccination, during hospitalisation, the patient had at least 1 episode of vomiting and/or diarrhoea. The patient was diagnosed with gastroenteritis. (In this study, specimens obtained equal to or more than 48 hours after admission from children who had at least 1 episode of vomiting and/or diarrhoea were considered healthcare-associated and included in this study. From July 2012 to June 2013, stool suspensions for norovirus were tested by semi-quantitative TaqMan real-time reverse-transcriptase polymerase chain reaction (RT-PCR). The patient's stool tested positive for norovirus. Subsequently, the patient was diagnosed with healthcare-associated norovirus gastroenteritis. This case has been considered serious due hospitalisation. (In this study, children with rotavirus had an increased duration of hospitalisation after detection in comparison with those with norovirus, but the role of rotavirus versus the role of underlying comorbidities in prolonging hospitalisation remains uncertain). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of healthcare-associated norovirus gastroenteritis and unspecified rotavirus vaccine. The authors concluded that "During 2012-2013, we tested 207 residual stool specimens from children with healthcare associated vomiting and/or diarrhoea for rotavirus and norovirus. Twenty (10%) were rotavirus positive, and 3 (3%) were norovirus positive, stressing the importance of these pathogens in hospitalized children. Limitations of this study include the retrospective nature of stool specimen and data collection. We had small numbers of children in whom rotavirus and norovirus were detected over a single year from 2 hospitals. We were also not able to evaluate for outbreaks. Thus, these results may not be generalizable". This is 1 of the 3 valid cases reported in the same literature article.