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This is VAERS ID 382966

Case Details

VAERS ID: 382966 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2007-12-14
Onset:2008-04-04
   Days after vaccination:112
Submitted: 2010-03-18
   Days after onset:713
Entered: 2010-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Barium double contrast, Dehydration, Faeces discoloured, Gastrointestinal motility disorder, Haematochezia, Ileocolostomy, Intestinal resection, Intussusception, Rectal examination, Sepsis, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Dehydration (narrow), Sepsis (narrow)

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, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal x-ray, Apr2008, see text
CDC Split Type: B0639148A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included 10 valent pneumococcal conjugate vaccine (manufacturer unspecified, intramuscular, unknown injection site) given on 22 August 2007; BCG (non-GSK) (manufacturer unspecified, intradermal, unknown injection site) given on 15 August 2007; HEP B (manufacturer unspecified, intramuscular, unknown injection site) given on 15 August 2007, 22 October 2007 and 18 February 2008; 1st dose of ROTARIX (1 ml, oral) given on 22 October 2007. On 14 December 2007, the subject received 2nd dose of ROTARIX (1 ml, oral). On 4 April 2008, 112 days after vaccination with ROTARIX, the subject experienced abdominal pain, blood in stools, abdominal distension, biliary vomiting. The subject was admitted into emergency room same day and found abdominal distention, dehydrated, abdominal pain, no peristalsis, rectal examination with "blackcurrant" evacuations and palpate intestine in reverse. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). A plain abdominal x-Ray was performed. It did not showed a visible intussusception or soft tissue mass. It showed fluid levels and dilated bowel loops. The plain abdominal x-ray with air or liquid contrast enema did not demonstrated invagination of the intestine. The plain abdominal x-ray showed non-specific abnormalities. The result of this exam was a suspicious ileocolic invagination. An abdominal ultrasound was not performed. An abdominal CT was not performed. The subject was treated with surgery (intestinal resection and ileocolostomy) without complications. After surgery, the subject presented sepsis, recovering and was discharged on 6 May 2008. At the time of reporting the events were resolved. The physician considered the events were almost certainly related to vaccination with ROTARIX.


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