Age: 0.17
Sex: U
Vaccine: UNK
Symptoms: Gene sequencing, Polymerase chain reaction positive, Rotavirus test positive, Vaccine virus shedding, Vomiting
Clinical narrative: Rotavirus associated acute gastroenteritis; Vomiting; Prolonged vaccine virus shedding; This case was reported in a literature article and described the occurrence of rotaviral gastroenteritis in a infant patient who received Rota (Rotarix liquid formulation) for prophylaxis.  Concurrent medical conditions included combined immunodeficiency.   On an unknown date, the patient received Rotarix liquid formulation (oral). On an unknown date, less than 5 months after receiving Rotarix liquid formulation, the patient experienced rotaviral gastroenteritis (serious criteria GSK medically significant), vomiting and vaccine virus shedding. On an unknown date, the outcome of the rotaviral gastroenteritis, vomiting and vaccine virus shedding were unknown.   The reporter considered the rotaviral gastroenteritis, vomiting and vaccine virus shedding to be related to Rotarix liquid formulation.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of rotavirus associated acute gastroenteritis (AGE) and prolonged vaccine virus shedding in a patient aged between 2 months and 6-month-old of unspecified gender who was vaccinated with Rotarix (GlaxoSmithKline) for prophylaxis.  The patient was a part of longitudinal, prospective cohort study of children undergoing allogenic hematopoietic cell transplant (HCT) at 4 hospitals to better understand the epidemiology and etiologies of acute gastroenteritis (AGE) in pediatric HCT patients in the early post-HCT period from March 2015 through May 2016. [In this study, 31 patients were enrolled out of which:18 were male; 15 had matched, 8 had mismatched and 8 had haploidetical; 8 had cord blood as cell source, 9 had apheresed stem cell, 14 had bone marrow and 16 had receipt of intravenous immune globulin; 14 had re-admission in first 100 days, 50 had days post-hematopoetic cell transplant, 2 had re-admission for AGE, 16 had total body irradiation received]. No information on patient's family history or concomitant medication was provided.  On unspecified date at the age of 2 months, the patient received 1 dose of Rotarix (batch number not provided). On an unspecified date, after vaccination, the patient was diagnosed with severe combined immunodeficiency (SCID).  On an unknown date from March 2015 through May 2016, an unknown period after vaccination, before HCT or on the day of HCT, the patient's stool sample was collected. The sample was found positive for rotavirus by RT-PCR. No AGE symptoms were reported at that time. Almost at the age of 6 months, the patient was admitted to the hospital underwent allogenic HCT. 1 and 2-week post-HCT, the patient had diarrhea and vomiting. The patient's stool sample was collected 2-week post-HCT and tested by RT-PCR. The patient was found positive for rotavirus. The patient was diagnosed with rotavirus associated-AGE. [In this study, AGE was defined as unexplained diarrhea more than equal to 3 episodes in a 24-hour period and/or unexplained (i.e. not related to medication, mucositis, or other identifiable cause) vomiting more than equal to 1 episode in a 24-hour period. In patients with chronic vomiting and diarrhea, an unexplained doubling of the number of episodes of vomiting or diarrhea was considered consistent with AGE. The end of an AGE episode was defined as the return to stooling or emesis pattern prior to episode]. Rotavirus vaccine virus strain was confirmed in the sample by genotyping. The patient reported no AGE symptoms 3-week post-HCT. 4 and 5-week post-HCT, the patient reported diarrhea and vomiting. The patient's stool sample was collected 5-week post-HCT and tested by RT-PCR. The sample was positive for Rotarix vaccine virus strain. The patient reported no AGE symptoms 6-week post-HCT. 7 and 8-week post-HCT, the patient reported diarrhea and vomiting. The patient's stool sample was not collected at that time. The patient reported no AGE symptoms 9-week post-HCT. 10, 11 and 12-week post-HCT, the patient reported no AGE symptoms. The patient's stool sample was collected after each week respectively. The samples were found positive for Rotarix vaccine virus strain. 13 and 14-week post-HCT, the patient reported no AGE symptoms and no stool sample was collected at that time. The patient received broad-spectrum antimicrobials, including a parenterally administered beta-lactam agent with anti-Pseudomonal coverage during the study. [In this study, 16 patients received intravenous immune globulin (IVIG) during the study. 5 patients who received IVIG had a pathogen detected compared with 8 patients who did not receive IVIG. 7 patients with pathogen detections developed gut GVHD compared with 9 patients without pathogen detection. 11 patients with pathogen detection developed any GVHD compared with 12 of those without pathogen detection].  The author did not comment on the relationship between the event of rotavirus associated acute gastroenteritis (AGE) and Rotarix. The authors concluded "In summary, our prospective, multicenter, longitudinal cohort of transplant recipients highlights the importance of testing for a wide range of enteric pathogens and corroborates previous data that show that prolonged shedding of viral pathogens can occur in immunocompromised hosts. Our data also emphasize that subsequent detections of the same pathogen may represent new infection, as noted in the patient with 2 adenovirus types. In this HCT cohort, infection was self-limited and not associated with high morbidity. Our findings reinforce the recognized challenges in interpreting C. difficile test-positive results in high-risk hosts with, and without, associated symptomatology. Despite the small nature of this pilot study, these data will inform further design and direction of AGE studies that can more precisely assess the etiology of AGE in this vulnerable population." This article is not available for regulatory submission due to copyright restriction.      Lab Comments: On an unknown date from March 2015 through May 2016, an unknown period after vaccination, before HCT or on the day of HCT, the patient's stool sample was collected. The sample was found positive for rotavirus by RT-PCR. The patient's stool sample was collected 2-week post-HCT and tested by RT-PCR. The patient was found positive for rotavirus. The patient was diagnosed with rotavirus associated-AGE. Rotavirus vaccine virus strain was confirmed in the sample by genotyping. The patient's stool sample was collected 5-week post-HCT and tested by RT-PCR. The sample was positive for Rotarix vaccine virus strain.  The patient's stool sample was collected after 9, 10, 11, 12 week post-HCT . The samples were found positive for Rotarix vaccine virus strain