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This is VAERS ID 322722

Case Details

VAERS ID: 322722 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
   Days after vaccination:4
Submitted: 2008-08-20
   Days after onset:46
Entered: 2008-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Barium enema, Body temperature increased, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin decreased, Intestinal perforation, Intestinal resection, Intussusception, Pallor, Pyrexia, Surgery, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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 perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: thyroxine sodium
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 05Jul2008, 38.7Deg C; Hemoglobin, 05Jul2008, 9.9g/dl; Ultrasound abdomen, 05Jul2008, Obstructionunit
CDC Split Type: B0533379A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no allergy. Concurrent medical conditions included heart murmur and hypothyroidism. Concurrent medications included LEVOTYROXIN. On 1 July 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 5 July 2008, 4 days after vaccination with ROTARIX, the subject experienced bloody stools and fever (38.7 Deg C), leading to hospitalisation the same day. The physical examination showed dehydration, pallor, abdominal pain and absent bowel sounds. The laboratory test showed hemoglobin 9.9 g/dl. The abdominal ultrasound suggested an intestinal obstruction and the diagnosis of intussusception was made. Treatment with barium salt failed to resolve the intussusception. The surgery performed on 5 July 2008 revealed an ileocolic intussusception and 3 small bowel perforations which were repaired. A 20 cm ileocecal valvule resection was performed without complication. The subject was hospitalised for 8 days. On 12 July 2008, the subject was discharged from hospital in good clinical condition with a 3 days paracetamol treatment. 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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