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This is VAERS ID 334090

Case Details

VAERS ID: 334090 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-21
Onset:2008-11-01
   Days after vaccination:11
Submitted: 2008-12-05
   Days after onset:34
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, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Haematochezia, Haemoglobin normal, International normalised ratio normal, Intussusception, Irritability, Lymphocyte percentage, Neutrophil percentage, Pallor, Prothrombin time normal, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Nov2008, see text; Blood glucose, 02Nov2008, 117mg/dl; Creatinine, 02Nov2008, 0.4mg/dl; Hemoglobin, 02Nov2008, 10.8g/dl; International normalized ratio, 02Nov2008, 1.03UI; Leukocyte count NOS, 02Nov2008, 12500mm2; Lymphocytes, 02Nov2008, 36%; Neutrophils, 02Nov2008, 61%; Potassium, 02Nov2008, 4.4mEq/l; Prothrombin time, 02Nov2008, 11.7s; Sodium, 02Nov2008, 136mEq/l
CDC Split Type: B0549012A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 21 August 2008. On 21 October 2008 the subject received 2nd dose of ROTARIX (oral). On 1 November 2008, 11 days after vaccination with ROTARIX, the subject experienced gastro alimentary vomiting, gastro biliar vomiting and bloody stools. On 02 November 2008 the subject was admitted to the emergency room with pallor, irritability, abdominal mass and rectal tact with fresh blood. Abdominal x-ray showed intestinal distention. Intussusception was suspected. The same day subject underwent a surgery showing evidence of ileocecocolic position. The event was resolved with taxis without complication. The subject''s clinical evolution was favorable. On 04 November 2008 the subject was discharged in franc abdominal recuperation. The subject was hospitalized for 3 days. Relevant test results included [laboratory results/hospital investigations]. The subject was treated with metronidazole, Ranitidine, amikacin and surgery. The physician considered the events were possibly related to vaccination with ROTARIX.


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