Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV1, DTAPH, HEP, IPV, PNC13, DTAPIPVHIB, PNC13, RV1
Symptoms: Intussusception, Irritability, Occult blood positive, Pain, Restlessness
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included PENTACEL (Sanofi Pasteur MSD) and PREVNAR 13 (PFIZER) both given on 30 December 2011. There were no concurrent medications. On the afternoon of 30 December 2011 the subject received 2nd dose of ROTARIX at 1.0 ml orally. In 2012, within months of vaccination with ROTARIX, the subject experienced intussusception (at 7 months of age). The subject was hospitalised and the physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved. No surgery was required for resolution. Follow-up information was received on 08 May 2012 via physician. This subject's age was clarified as a 5-month-old male. Historic vaccination included dtpa-hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 October 2011; hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on 20 August 2011 and 13 October 2011; live attenuated human rotavirus vaccine; manufacturer unspecified; unknown given on 13 October 2011; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 October 2011. Concurrent vaccination included dtpa-polio-hib (non-gsk); Sanofi Pasteur MSD; unknown; unknown given on 30 December 2011; pneumococcal vaccines (non-gsk); PFIZER; unknown; unknown given on 30 December 2011; IPV (non-gsk); non-GSK manufacturer; unknown; unknown given on 13 October 2011. There were no concurrent medications. The intussusception diagnosis was confirmed on 23 January 2012. The subject demonstrated intra-abdominal mass with specific characteristic features (target sign or doughnut sign on transverse section and a pseudo kidney or sandwich sign on longitudinal section) that is proven to be reduced by hydrostatic enema on post-reduction ultrasound. The subject had a previous episode of intussusception in November 2011. Treatment was noted to be none/ spontaneously resolved and resolved by liquid contrast/hydrostatic water/ air enema (which intussusception episode was not provided). The reporting healthcare professional attributed the intussusception to medical history/ concurrent illness. According to medical records, the subject was admitted on 23 January 2012, the subject had an ultrasound abdomen limited performed. The Diagnostic imaging report stated the subject had a history of previous intussusception and reduction, vomiting and bloody stool, evaluate for recurrent intussusception. Ultrasound of the abdomen limited findings included: survey of right upper quadrant showed 6.1x3.1x3.4 cm area of compels target sign in a noncompressible loop of colon. There is no peristalsis identified in this bowel loop. The colon in the right upper quadrant is noncompressible, there is circumferential thickening of intussuscipiens wall. Within the intussuscipiens is a non perisistalising thickened bowel loop, most likely the intussusceptum. Orientation of the ultrasound probe and images suggests that the intussusceptum may have advanced beyond the hepatic flexure into transverse colon. Impression: noncompressible and [illegible] upper quadrant, with ultrasound target sign strongly suggestive of intussusception. The intussusception resolved on (date provided is 03 January 2012 which is prior to onset date of 23 January 2012).