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This is VAERS ID 316965

Case Details

VAERS ID: 316965 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
   Days after vaccination:28
Submitted: 2008-06-23
   Days after onset:116
Entered: 2008-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Breast feeding, Intestinal mass, Intestinal resection, Intussusception, Irritability, Lethargy, Pallor, Rectal haemorrhage, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (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: Gastroesophageal reflux
Diagnostic Lab Data: Ultrasound abdomen, Feb2008, IS
CDC Split Type: B0525609A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 7-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 was 2.6 Kg. The subject''s medical history included gastroesophageal reflux. The subject had no history of intussusception. The subject had no family history of intussusception. The subject had no current medications or traditional medicines. Feeding history: The subject currently fed breast milk. There was no change to the subject''s diet in the last week. The subject had feeding intolerance/food sensitivities (gastroesophageal reflux disease). Previous vaccination included ROTARIX (GlaxoSmithKline; unknown) given on 19 October 2007. On 30 January 2008, the subject received 2nd dose of ROTARIX (unknown). On 27 February 2008, 28 days after vaccination with the 2nd dose of ROTARIX, the subject experienced intussusception. He experienced the following symptoms: abdominal pain, vomiting, lethargy, pallor, irritability, intestinal mass and passage of blood per rectum. No faeces''s sample was collected. The diagnosis of intussusception was made based on abdominal ultrasound exam (site of IS; ascending colon). The subject was treated with air/hydrostatic Enema. Surgical resection was performed. The lead point or other pathology have not been identified. This case was assessed as medically serious by GSK. On 03 March 2008, the subject was discharged. At the time of reporting the outcome of the events was unspecified.

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