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This is VAERS ID 336143

Case Details

VAERS ID: 336143 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
   Days after vaccination:271
Submitted: 2008-12-23
   Days after onset:23
Entered: 2008-12-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Dehydration, Diarrhoea, Haematochezia, Haematocrit increased, Haemoglobin decreased, Intussusception, Lymphocyte percentage increased, Mucous stools, Neutrophil percentage decreased, Pharyngeal erythema, Platelet count increased, Prothrombin level decreased, Pyrexia, Vomiting, White blood cell count increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), 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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood glucose, 03Dec2008, 100 mg/dL; hematocrit, 03Dec2008, 47%; hemoglobin, 02Dec2008, 10.6 g/dL; hemoglobin, 03Dec2008, 16 g/dL; leukocyte count NOS, 02Dec2008, 7400 mm3; lymphocyte percentage, 02Dec2008, 32%; neutrophil percentage, 02Dec2008, 2.4; platelet count, 02Dec2008, 205000 mm3; prothrombin, 03Dec2008, 12 sec
CDC Split Type: B0551667A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 10-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 4 March 2008, and 6 May 2008, the subject received 1st dose and 2nd dose of ROTARIX (oral), lot numbers not provided. On 30 November 2008, 7 months after 2nd vaccination with ROTARIX, the subject experienced vomiting and liquid stools. On 2 December 2008, the subject was admitted to emergency room with dehydration, hyperemic pharynx and fever without abdominal complications. After admission, he showed one stool with mucus and blood. No more clinical data was reported in the file. On 3 December 2008, surgery was performed and ileocolic intussusception was found and reduced by taxis without complications. Relevant laboratory test showed the following; on 2 December 2008; hemoglobin: 10.6 g/dL, platelets count: 205000/mm3, leucocytes count: 7400/mm3, lymphocytes percentage: 32% and neutrophils count: 2.4%. On 3 December 2008, relevant results included; hemoglobin: 16 g/dL, hematocrit: 47%, blood glucose: 100 mg/dL and prothrombin: 12 sec. Radiologic studies were not reported in the subject''s file. The subject was treated with ranitidine hydrochloride (RANITIDINE), trimethoprim (TRIMETHOPRIM), amikacin (AMIKACINE), furazolidone (FUROXONE) and metronidazole. On 10 December 2008, since post surgical evolution was adequate, the subject discharged without pharmaos and in good clinical conditions. The physician considered the events unrelated to vaccinations with ROTARIX.

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