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This is VAERS ID 320745

Case Details

VAERS ID: 320745 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-03
Onset:2008-04-10
   Days after vaccination:38
Submitted: 2008-07-30
   Days after onset:111
Entered: 2008-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Intestinal obstruction, Intussusception, Lethargy, Pallor, Surgery, Ultrasound abdomen abnormal, Virus serology test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, Apr2008, Positive; Ultrasound abdomen, Apr2008, IS
CDC Split Type: B0530265A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX. This case was collected through the Paediatric Surveillance Unit Acute Intussusception study occurring post Rotavirus vaccination. The subject was born at term. The subject''s birth weight is 3.195Kg. The subject had no history of intussusception. The subject had no family history of intussusception. The subject had no previous significant illness/ hospitalisations/ operations. Feeding history: The subject currently fed formula. Until the age 1 month the subject was exclusively breast-fed. There was no change to the subject''s diet in the last week. The subject had no feeding intolerance or food sensitivities. Previous vaccination included ROTARIX (GlaxoSmithKline; unknown) given on 13 December 2007. The subject had no other vaccines within the last two weeks. The subject had no current treatment. On 3 March 2008, the subject received the 2nd dose of ROTARIX (unknown; lot number not provided). On 10 April 2008, 38 days after vaccination with the 2nd dose ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced intestinal obstruction ( no bilious vomiting), vomiting, lethargy and pallor. Faeces sample was collected; Adenovirus antigen was positive. The diagnosis of intussusception was made based on Enema, abdominal ultrasound exam and surgery (Site of intussusception: ascending colon to hepatic flexure; Type of intussusception; ileo-colic); The subject was treated with Airhydrostatic Enema but ultrasound guided was not successful. Surgery was performed; resection was done (length of bowel resected was 0 Cm). The lead point has been identified (Ileum). On 14 April 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified.


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