This is VAERS ID 311332

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Appendicectomy, Crying, Dehydration, Gastrointestinal hypermotility, Haematochezia, Inappropriate schedule of drug administration, Intussusception, Irritability, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 14Feb2008 Abnormal unit
CDC Split Type: B0517193A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 11-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine; manufacturer unspecified; intramuscular; given on 31 July 2007, 4 December 2007 and an unspecified date; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular; given on 31 July 2007, 1 October 2007 and 4 December 2007; influenza virus vaccine; manufacturer unspecified; intramuscular; given on 4 December 2007; live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 31 July 2007; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 31 July 2007 and 1 October 2007; tuberculosis vaccine; manufacturer unspecified; intradermal; given on 9 February 2008. On 1 October 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 12 February 2008, 4 months after vaccination with ROTARIX, the subject experienced gastric vomiting followed by biliary vomiting with colic and abdominal pain. She had not flatulence nor fever. On 13 February 2008, the subject was hospitalised for 7 days. Physical examination showed abdominal pain with increased peristalsis, dehydration, irritability, crying at abdominal palpation, non-tender abdomen with respiratory pathology. On 14 February 2008, the subject experienced bloody stools as well as biliary vomiting. The rectal examination revealed an empty ampulla with blood. Abdomen X-ray showed fluid levels and dilated bowel loops with non-specific abnormalities. No intussusception was found. The surgery was performed and intussusception of ascending and descending colon was found and resolved by taxis without complication. A prophylactic appendectomy was performed. On 19 February 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.