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This is VAERS ID 316666

Case Details

VAERS ID: 316666 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-24
Onset:2008-05-06
   Days after vaccination:43
Submitted: 2008-06-19
   Days after onset:44
Entered: 2008-06-19
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 pain, Blood potassium increased, Blood sodium decreased, Dehydration, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal obstruction, Intussusception, Nausea, Neutrophil percentage increased, Pallor, Platelet count normal, Pyrexia, Surgery, Tachycardia, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 08May2008, 34.7%; Hemoglobin, 08May2008, 12.5g/dl; Neutrophils, 08May2008, 48%; Platelet count, 08May2008, 445mm3; Potassium, 08May2008, 6.4Eq/l; Sodium, 08May2008, 134.6Eq/l; White blood cells, 08May2008, 11.100mm3; x-ray abdomen: showed air fluid levels, dilated intestinal loops and absent distal gas.
CDC Split Type: B0524126A

Write-up: This case was reported by a physician in the frame of study and described the occurrence of ileocecal obstruction in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 24 March 2008 the subject received 2nd dose of ROTARIX (oral). On 6 May 2008, 43 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception, blood in stool(s), abdominal distension, vomiting (8 times), fever, nausea, inability to pass flatus (abdominal distention gaseous), dehydration, pallor, tachycardia and abdominal pain. The subject was hospitalised on 8 May 2008. Urgent surgery was done ileocolic intussusception was found with perforation at 15cm of ileocecal valve (distal ileon), resection with term to term anastomosis of this portion of ileon (2cm approximately) was performed, no other complication was found. Postsurgical recuperation was slowly, finally was discharged on 15 May 2008. Lab test were performed. The subject was treated with amikacine, dimenhydrinate, paracetamol, cefoxtamine and metamizole. On 15 May 2008, the event was resolved. The physician considered the event was unrelated to vaccination with ROTARIX.


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