Sex: U
Vaccine: RVX, RVX
Symptoms: Rotavirus test positive, Viral test
Clinical narrative: Rotavirus acute gastroenteritis; Incomplete course of vaccination; This case was reported in a literature article and described the occurrence of rotavirus gastroenteritis in a infant patient who received Rotavirus vaccine for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis.   Previously administered products included DTaP (received at least one dose).   On an unknown date, the patient received the 1st dose of Rotavirus vaccine (oral) and the 2nd dose of Rotavirus vaccine (oral). On an unknown date, less than 2 years after receiving Rotavirus vaccine and not applicable after receiving Rotavirus vaccine, the patient experienced rotavirus gastroenteritis (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the rotavirus gastroenteritis and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rotavirus gastroenteritis to be related to Rotavirus vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of rotavirus acute gastroenteritis (AGE) infection (Rotavirus qRTPCR positive with Cq less than 27) in a patient aged between 18 months and 23 months of unspecified 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 a part of the study. In this study, it was leveraged data from an active surveillance platform within the hospital system to calculate rotavirus VE against the full spectrum of medically attended rotavirus illness, among children age-eligible to have received vaccination. [In this study, it was utilized a test-negative case-control design and applied 4 distinct case definitions based on reverse-transcription-quantitative real-time PCR (qRT-PCR) assay and enzyme immunoassay (EIA) test results. The present analysis drew from a subset of the population recruited and enrolled in the study. Briefly, all enrolled members of the integrated health care delivery system were surveilled prospectively from 1 April 2014 through 30 September 2016; health care encounters related to acute gastroenteritis (AGE) were identified based on International Classification of Disease, Clinical Modification, 9th (ICD-9-CM, used from 1 April 2014 -30 September 2015) or 10th Revision (ICD-10-CM, used from 1 October 2015-30 September 2016) codes].  On an unspecified date, the patient received at least one dose of diphtheria-tetanus-pertussis (DTaP) vaccine. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received partial vaccination of unspecified Rotavirus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. [Presently, 2 rotavirus vaccines are available and recommended for infants: RotaTeq, a 3-dose vaccine given at 2, 4, and 6 months of age, and Rotarix, a 2-dose vaccine given at 2 and 4 months of age. Rotavirus vaccination status was defined as follows: Fully vaccinated-children receiving 2 doses of Rotarix, 3 doses of RotaTeq, or 3 doses of a mixed series (including unspecified rotavirus vaccine) at least 14 days prior to their first encounter date; Partially vaccinated-children receiving 1 dose of Rotarix, 1-2 doses of RotaTeq, or 1-2 doses of a mixed series and/or unspecified rotavirus vaccine at least 14 days prior to their first encounter date; Unvaccinated-children receiving 0 doses of any rotavirus vaccine at least 14 days prior to their first encounter date]. On an unspecified date between 1 April 2014 and 30 September 2016, an unknown period after the vaccination, the patient's stool sample was collected. Stool sample was initially screened at the Public Health Laboratory for rotavirus, in addition to norovirus, astrovirus, and sapovirus. Rotavirus RNA was detected by TaqMan-based reverse-transcription-quantitative real-time polymerase chain reaction (qRT-PCR) targeting the NSP3 gene using the AgPath-ID One-Step RT-PCR Kit on the 7500 Realtime PCR platform (Applied Biosystems). [The rotavirus-positive stool samples were then shipped frozen on dry ice to the CDC. At the CDC, specimens were briefly stored at 4 degree Celsius prior to RNA extraction and confirmatory testing for rotavirus antigen by enzyme immunoassay (EIA) using Premier Rotaclone according to the manufacturer's instructions. RNA was extracted from ten percent stool suspensions, and all resulting RNA extracts were immediately stored at -80 degree Celsius until testing. RNA extracts underwent confirmatory testing for rotavirus using a qRT-PCR assay that targeted the rotavirus NSP3 gene to detect amplifiable rotavirus nucleic acid. Rotavirus viral protein 7 (VP7) and viral protein 4 (VP4) genotypes were identified and confirmed by a conventional reverse transcription-PCR (RT-PCR) assay and Sanger sequencing. The population was further restricted to those children who had provided a stool sample that had been tested for rotavirus by qRT-PCR at the lab; rotavirus-positive samples were additionally restricted to those that underwent confirmatory testing at CDC]. The patient was found rotavirus positive by qRT-PCR with a quantification cycle (Cq) value less than 27 as measured by the CDC lab. The patient was found rotavirus acute gastroenteritis with encounter type either ambulatory clinic, or remote, or emergency department. Treatment was unknown. The outcome of the event was not reported. The author commented, "Children who tested positive for rotavirus by qRT-PCR were significantly more likely to have household members who reported AGE subsequent to the index child's first AGE-related medical encounter (58% of rotavirus-positive cases vs. 21% of rotavirus-negative controls). Previous estimates of rotavirus VE against outpatient-attended disease are derived from secondary analysis of insurance claims-based cohorts and vary widely, while VE against ED visits has been estimated at 79-81% using case-control data. We also found VE to be notably higher in children aged less than 2 years as compared to older children, though limited sample size precluded definitive conclusions. The moderately high VE against G12P[8] in this study is in alignment with previous research showing good protection against this strain by both vaccines. Our results suggesting that rotavirus may be more likely than other causes of AGE to be transmitted within the household were also consistent with prior research, though our study design limits our ability to definitively identify and characterize household outbreaks. This was true even for our definition requiring EIA negativity and qRT-PCR positivity, which we might have expected to capture children who were shedding rotavirus but whose illness was not rotavirus-associated; however, the similar VE estimates across definitions suggest that, in our study population, all definitions reliably indicated rotavirus disease. This is in contrast to findings from the Network, which showed higher VE estimates for EIA-based case definitions. However, our findings were similar to previous research in that EIA-based cases tended to have higher severity than qRT-PCR-based cases. It seems possible that our findings of lower VE in EIA-defined cases could be related to the older age of these cases as compared to qRT-PCR-defined cases. The point estimates for children less than 2 years of age were highly similar across both qRT-PCR- and EIA-based case definitions, suggesting a possible comparability of the assays for VE estimation in this age group." The author concluded, "These results support the effectiveness of rotavirus vaccination in protecting children from mild to moderate as well as severe disease. Our findings are also useful to show the effectiveness of rotavirus vaccination against qRT-PCR-defined illness. These results confirm the importance of rotavirus vaccination in protecting children from rotavirus disease requiring outpatient care. The observed effectiveness of rotavirus vaccine against even mild disease supports continued universal rotavirus vaccination and may provide useful input into future economic analyses of vaccination. Our findings are also useful to show the effectiveness of rotavirus vaccination against qRT-PCR-confirmed illness, as molecular methods are increasingly utilized in the diagnosis of gastroenteritis."      Lab Comments: Lab test was done on an unspecified date between 1 April 2014 and 30 September 2016, an unknown period after the vaccination, the patient's stool sample was collected. Stool sample was initially screened at the Public Health Laboratory for rotavirus, in addition to norovirus, astrovirus, and sapovirus. Rotavirus RNA was detected by TaqMan-based reverse-transcription-quantitative real-time polymerase chain reaction (qRT-PCR) targeting the NSP3 gene using the AgPath-ID One-Step RT-PCR Kit on the 7500 Realtime PCR platform (Applied Biosystems).