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This is VAERS ID 391666

Case Details

VAERS ID: 391666 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2008-05-05
Onset:2008-05-10
   Days after vaccination:5
Submitted: 2010-06-29
   Days after onset:780
Entered: 2010-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA002AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Crying, Haematochezia, Intussusception, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662821A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 5 May 2008, the subject received 2nd dose of ROTARIX (oral). On 10 May 2008, 5 days after vaccination with ROTARIX, the subject experienced bloody stools, abdominal distension, vomiting and crying. The subject was hospitalised and intussusception was diagnosed. The subject was treated with surgery on 13 May 2008. At the time of reporting the events were resolved. No further information could be obtained; the case has been closed.


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