Age: 0.3
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vaccination failure, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 45-month-old subject who received Rotavirus vaccine. The subject's past medical history included stem cell transplant. Concurrent medical conditions included immunocompromised. On an unknown date, 3 years and 156 days after receiving Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included rotavirus gastroenteritis with serious criteria of hospitalization and GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included rotavirus gastroenteritis (unknown). The investigator considered that there was a reasonable possibility that the vaccination failure and rotavirus gastroenteritis may have been caused by Rotavirus vaccine. Relevant Tests: Lab tests performed on unspecified date. The patient's stool tested positive for rotavirus gastroenteritis. Specimens with an OD450 nm equal to or more than 0.150 absorbance units were considered positive. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Rotavirus test result was see text. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 45-month-old child of unspecified gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown). The patient was a part of study that sought to understand the epidemiology of rotavirus and norovirus infections among hospitalised children. The patient was born after 1 July 2006. On an unspecified date, the patient had a haematopoietic stem cell transplant. The patient was severely immunocompromised. (In this study, children were considered immunocompromised if they received chemotherapy or other immunomodulators, received more than 20 mg/day or equal to or more than 2 mg/kg/day prednisone (or equivalent steroid) for more than 2 weeks duration within 3 months of stool collection, had ever undergone hematopoietic stem cell or solid organ transplant, were human immunodeficiency virus (HIV) infected, had asplenia, or had immunoglobulin deficiency). No information on patient's family history or concomitant medication was provided. On an unspecified date at the age of 4 months, the patient received unspecified rotavirus vaccine (administration route and site unknown; dosages unknown; batch number not provided). It was reported, at 4 months of age, the patient was fully rotavirus vaccinated. The patient had received all of series of vaccination. On an unspecified date at the age of 45 months, 41 months 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 specimens were tested for rotavirus antigen with Premier Rotaclone EIA as recommended by the manufacturer. Subsequently, the patient's stool tested positive for rotavirus gastroenteritis. Specimens with an OD450 nm equal to or more than 0.150 absorbance units were considered positive. Subsequently, the patient was diagnosed with healthcare-associated rotavirus gastroenteritis. This case has been considered as suspected vaccination failure being full schedule was unknown. This case has been considered serious due to suspected vaccination failure/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 considered the event of healthcare-associated rotavirus gastroenteritis associated with unspecified rotavirus vaccine. The authors stated "Two rotavirus vaccine failures were observed, both among severely immunocompromised children". The authors concluded that "Two rotavirus vaccine failures were observed, both among severely immunocompromised children. These findings stress the importance of vaccinating eligible children for rotavirus, not only to provide direct protection but also to indirectly protect those who are unable to be vaccinated and those who are severely immunocompromised. 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.