title: Risk of Intussusception with Rotavirus Vaccine.
abstract: OBJECTIVE
  To study the case series for intussusception associated with the vaccination of rotavirus vaccine in children.
  
  
  METHODS
  The study of spontaneous adverse event monitoring such as intussusception due to rotavirus vaccine was carried out from the year 2011 through 2015. The individual case safety reports (ICSRs) of this event were collated, assessed and recorded as per the requirement of Suspected Adverse Drug Reactions Reporting form of Pharmacovigilance Programme of India (PvPI).
  
  
  RESULTS
  In the present study, 10 ICSRs of intussussception due to rotavirus vaccine were reported to PvPI. Of which 3 ICSRs were found to be causal relationship with rotavirus vaccine, as evidenced by the adequate information provided in ICSRs.
  
  
  CONCLUSIONS
  Since intussusception, the emerging safety as one of the important safety concern, healthcare professionals are advised to monitor and report to the concerned authority for appropriate action.
authors.affiliation: Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India.
authors.forename: Vivekanandan
authors.initials: V
authors.lastname: Kalaiselvan
authors.affiliation: Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India.
authors.forename: Prasad
authors.initials: P
authors.lastname: Thota
authors.affiliation: Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India. vipin_pharma84@yahoo.com.
authors.forename: Vipin
authors.identifier: http://orcid.org/0000-0002-2980-8930
authors.initials: V
authors.lastname: Kumar
authors.affiliation: Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India.
authors.forename: Madhvi Singh
authors.initials: MS
authors.lastname: Rathore
authors.affiliation: Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India.
authors.forename: Anusha
authors.initials: A
authors.lastname: Thota
authors.affiliation: Indian Pharmacopoeia Commission, Ghaziabad, Agra, Uttar Pradesh, 201002, India.
authors.forename: Gyanendra Nath
authors.initials: GN
authors.lastname: Singh
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007443:Intussusception / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D060735:Pharmacovigilance; D012307:Risk Factors; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects*
chemical_list: D022243:Rotavirus Vaccines
keywords: Adverse events following immunization; Individual case safety reports; Intussusception; Pharmacovigilance programme of India; Rotavirus vaccine