Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This literature marketed report as received from a other health care professional refers to 2 patients of unknown age and gender. Although current rotavirus vaccines were not associated with an increased risk of intussusceptions in large trials before licensure, recent post-licensure data from international settings suggest the possibility of a small increase in risk of intussusceptions after monovalent rotavirus vaccination. Participants were infants between the ages of 4 and 34 weeks who were enrolled in six integrated health care organizations in a project. Medical records were reviewed and visits for intussusception within 7 days after monovalent rotavirus vaccination from April 2008 through March 2013. Using sequential analyses, then compared the risk of intussusception among children receiving monovalent rotavirus vaccine with historical background rates. Authors further compared the risk after monovalent rotavirus vaccination with the risk in a concurrent cohort of infants who received the ROTATEQ vaccine. During the study period, 207,955 doses of monovalent rotavirus vaccine (including 115,908 first doses and 92,047 second doses) were administered in the population. Authors identified 6 cases of intussusception within 7 days after the administration of either dose of vaccine. For the two doses combined, the expected number of intussusception cases was 0.72, resulting in a significant relative risk of 8.4. For the ROTATEQ vaccine, 1,301,810 doses were administered during the study period, with 8 observed intussusception cases (7.11 expected), for a nonsignificant relative risk of 1.1. The relative risk of chart-confirmed intussusception within 7 days after monovalent rotavirus vaccination, as compared with the risk after ROTATEQ vaccination, was 9.4 (95% confidence interval, 1.4 to 103.8). The attributable risk of intussusception after the administration of two doses of monovalent rotavirus vaccine was estimated to be 5.3 per 100,000 infants vaccinated. Six of the 9 cases (67%) after pentavalent rotavirus vaccination were confirmed as Brighton Collaboration level 1; the other 3 were determined not to be cases of intussusception. The 6 cases of intussusception after ROTATEQ vaccination occurred after the administration of 999,123 doses. Updated analysis of ROTATEQ vaccination included nearly 1.3 million doses and continued to find no significant increased risk of intussusception. The relative risk after the first dose of the ROTATEQ vaccine was 2.63 (95% CI, 0.72 to 6.74). This analysis included all electronically recorded diagnoses without chart confirmation of cases; after medical-record review, only two of the four cases that occurred after the receipt of dose 1 were confirmed. Thus, in the population, there was not sufficient evidence to conclude that the pentavalent rotavirus vaccine was associated with an increased risk of intussusception, so the ROTATEQ vaccine served as an appropriate comparator for assessing risks after monovalent rotavirus vaccination. On an unknown date, the patients were vaccinated with ROTATEQ dose and route not reported. No concomitant medication reported. On an unknown date, the patients experienced intussusception (medically significant) after Dose 1 of ROTATEQ. The outcome of intussusception was not reported. The author considered intussusception to be related to ROTATEQ. This case has been linked to 1401USA013397 as same literature link. Additional information has been requested.