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This is VAERS ID 386984

Case Details

VAERS ID: 386984 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-15
Onset:2010-02-02
   Days after vaccination:18
Submitted: 2010-05-07
   Days after onset:93
Entered: 2010-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Body temperature increased, Enema administration, Intussusception, Pyrexia, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history
Allergies:
Diagnostic Lab Data: Body temperature, 02Feb2010, increased; Ultrasound scan, Feb2010, intussusception
CDC Split Type: B0650695A

Write-up: This case was reported by the regulatory authority (BX20100405) and described the occurrence of intussusception of intestine in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant past medical history. On 15 January 2010, the subject received an unspecified dose of ROTARIX (batch unknown, oral). On 02 February 2010, 18 days after vaccination with ROTARIX, the subject presented with febricula and abdominal pain leading to hospitalisation. Ultrasound scan confirmed diagnosis of acute intussusception of intestine. Intussusception was reduced by enema. On 05 February 2010, febricula and abdominal pain resolved. From 18 to 19 March 2010, the subject was again hospitalized for a new episode of abdominal pain probably unrelated to previous intussusception. A virosis was evoked (incidental events). ROTARIX has not been readministered. According to the method of assessment, the relationship between the reported events and vaccination with ROTARIX was dubious.


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