This is VAERS ID 336468

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Barium enema abnormal, Diarrhoea, Enema administration, Gastrointestinal sounds abnormal, Haematochezia, Inappropriate schedule of drug administration, Intestinal anastomosis, Intestinal perforation, Intestinal resection, Intussusception, Pyrexia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Barium enema, 30Oct2008, see text
CDC Split Type: B0552031A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Concurrent vaccination included DTaP-IPV/Hib vaccine (manufacturer unspecified) given on 2 October 2008; pneumococcal vaccines (non-GSK manufacturer) given on 2 October 2008. On 2 October 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 27 October 2008, 25 days after vaccination with ROTARIX, the subject started with liquid stools, vomiting, bloody stools and fever. The patient was admitted at ER on 29 October 2008 and showed at physical exam abdominal pain to palpation and bowel sounds decreased. The subject was hospitalised. Intussusception was diagnosed. Barium enema was performed without success. Surgery was done on 30 October 2008. Ileo-ileal and ileo-ceco-colic intussusception with intestinal perforation in length 10 cm in ileo-cecal valve was found, reduced by taxis, intestine resection and termino-terminal anastomosis without complication. The subject was treated with midazolam and paracetamol (Acetaminophen). On 6 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.