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This is VAERS ID 316966

Case Details

VAERS ID: 316966 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
   Days after vaccination:7
Submitted: 2008-06-23
   Days after onset:81
Entered: 2008-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Breast feeding, Familial risk factor, Gastrointestinal sounds abnormal, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Lethargy, Pallor, Rotavirus test positive, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, Apr2008, Fluid level; Rotavirus test, 06Apr2008, Positive; Ultrasound abdomen, Apr2008, IS
CDC Split Type: B0525608A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case is one of 4 cases collected through a study occurring post ROTARIX vaccination since August 2007. The subject was born at term. The subject''s birth weight is 4.22 Kg. The subject had no history of intussusception. The subject had no previous significant illness/ hospitalisations/ operations. The subject had a family history of intussusception. Feeding history: The subject currently fed breast milk and formula. There was no change to the subject''s diet in the last week. The subject had no feeding intolerance or food sensitivities. The subject received current medications or traditional medicines. Previous and/or concurrent vaccination included Hib (manufacturer unspecified; unknown) given on an unspecified date; DTaP (manufacturer unspecified; unknown) given on an unspecified date; Hep B (manufacturer unspecified; unknown) given on an unspecified date; pneumococcal vaccine, unspecified (manufacturer unspecified; unknown0 given on an unspecified date. On 27 March 2008, the subject received the 1st dose of ROTARIX (unknown). On 3 April 2008, 7 days after vaccination with ROTARIX, the subject experienced intussusception; He experienced the following symptoms: abdominal pain, vomiting, lethargy, pallor, irritability, intestinal obstruction; acute abdominal distention and abnormal or absent bowel sounds. Abdominal X-ray showed fluid level. The diagnosis of intussusception was made based on abdominal ultrasound exam (site of IS: Hepatic flexure; Type of IS: ileocaecal). On 06 April 2008, faeces''s sample was collected; RNA Rotavirus test was positive. The subject required surgical resection. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

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