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This is VAERS ID 334089

Case Details

VAERS ID: 334089 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-08-18
Onset:2008-10-04
   Days after vaccination:47
Submitted: 2008-12-05
   Days after onset:62
Entered: 2008-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Activated partial thromboplastin time normal, Barium enema, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Mucous stools, Pallor, Prothrombin time normal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Oct2008, see text; Activated partial thromboplast, 05Oct-2008, 35.1s; Hematocrit, 05Oct2008, 36.8%; Hemoglobin, 05Oct2008, 12.1g/dl; Prothrombin time, 05Oct2008, 12.5s
CDC Split Type: B0548938A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 18 June 2008. Medical conditions included a healthy baby. On 18 August 2008 the subject received 2nd dose of ROTARIX (oral). On 4 October 2008, 47 days after vaccination with ROTARIX, the subject experienced irritability, gastro alimentary vomiting, 2 current jelly stools and abdominal pain. On 05 October 2008 the subject was admitted at the emergency room with irritability, pallor, normal hydration, abdominal palpable mass, positive dance signs and rectal tact showed current jelly stools. Relevant test included abdominal x-ray, which showed small bowel loops and right colon with distention and air in rectal ampoule. Intussusception was suspected. Therefore the same day after sedation the subject was treated with barium enema. Reduction of ileocecocolic intussusception was done successfully. The subject''s clinical evolution was favorable. On 08 October 2008 the subject was discharged in good clinical conditions. The subject was hospitalized for 4 days. The subject was treated with metronidazole, amikacin, Ranitidine, Methamizole, paracetamol. The physician considered the events were unrelated to vaccination with ROTARIX.


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