Sex: F
Vaccine: RVX, RVX
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Suspected rotavirus gastroenteritis/3 or more episodes of loose stools within a 24-hour; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 2-year-old female patient who received Rotavirus vaccine for prophylaxis.    Co-suspect products included Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine (oral) and Rotavirus vaccine (oral). On an unknown date, more than a year after receiving Rotavirus vaccine and Rotavirus vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and rotavirus gastroenteritis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the rotavirus gastroenteritis was recovered/resolved.   The reporter considered the vaccination failure and rotavirus gastroenteritis to be related to Rotavirus vaccine and Rotavirus vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 2-year old female who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis.   The patient was a part of the report that described an outbreak of acute gastroenteritis in a pediatric subacute care facility (facility A) in April 2017 in detail and aimed to characterize the rotavirus vaccination status among the children residing in the facility at the time of the outbreak. The patient was resident at the facility and was tracheostomy dependent. The patient had no immunocompromising condition at the time of the outbreak. [In this study, out of 22 case-patients, 15 were male. Primary/admitting diagnosis in facility were Bronchopulmonary dysplasia in 4 patients, Chronic respiratory failure in 4 patients, Congenital malformation in 3 patients and 11 had other diagnosis, 9 had Chronic respiratory failure, 21 had Gastrostomy tube and 10 had Preterm birth (less than 37 weeks' gestational age]. No information on patient's family history or concomitant medication or concurrent condition was provided.  On an unspecified date, the patient received 2 doses of unspecified rotavirus vaccine (administration route and site unspecified; batch number not provided. Age of vaccination was not provided.  On an unspecified date between 17 April and 17 May 2017, more than 1 year after vaccination, the patient had 3 or more episodes of loose stools within a 24-hour. [In this study, out of 22 case patients, 17 had vomiting, 19 had fever]. The patient was a suspected case of rotavirus (a suspected case of rotavirus was defined as 3 or more episodes of loose stools within a 24-hour period with an onset between April 17 and May 17, 2017, in a resident patient). [In this study, out of 22 case patients, 11 cases were confirmed for rotavirus by RT-PCR]. This case has been considered as suspected vaccination failure being laboratory confirmation for rotavirus gastroenteritis was unknown.  This case has been considered as serious due to suspected vaccination failure.  Treatment was unknown. [In this study, out of 22 case-patients, 15 had rehydration therapy].  The outcome of the event was recovered.  The authors did not comment of the relationship between the event of suspected rotavirus gastroenteritis and unspecified rotavirus vaccine.  The author concluded, "This outbreak of rotavirus in a pediatric subacute facility shows how the convergence of 2 policies-not vaccinating against rotavirus in an NICU or PICU and not beginning the rotavirus vaccine series after 15 weeks of age can result in a select population of vulnerable children who are unvaccinated against rotavirus and who might later congregate in a single setting. Premature and low-birth-weight infants are at greater risk of a severe outcomes associated with rotavirus gastroenteritis, as underscored by the fatality in our study cohort. Despite the demonstrated reduction in rotavirus burden in the postvaccine era, rotavirus outbreaks can and do continue to occur, which leaves unvaccinated and vulnerable children at higher risk of a severe outcome. Given these considerations and emerging data on the safety of rotavirus vaccination in the NICU setting, the current guidelines for vaccination of these vulnerable infants might be re-examined to ensure optimal protection by rotavirus vaccination in children."  This is 1 of the 5 valid cases reported in the same literature article.      Lab Comments: In this study, out of 22 case patients, 11 cases were confirmed for rotavirus by RT-PCR