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This is VAERS ID 335081

Case Details

VAERS ID: 335081 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-12
Onset:2008-10-29
   Days after vaccination:47
Submitted: 2008-12-11
   Days after onset:43
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Appendicectomy, Dehydration, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Lethargy, Lymphocyte percentage, Malaise, Monocyte percentage, Mucous stools, Neutrophil percentage, Pallor, Platelet count increased, Prothrombin time prolonged, Pyrexia, Rectal haemorrhage, Red blood cell count normal, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 30Oct2008, Abnormal; Hematocrit, 30Oct2008, 38.55; Hemoglobin, 30Oct2008, 13.5g/dl; Lymphocytes, 30Oct2008, 22.70%; Monocytes, 30Oct2008, 6.70%; Neutrophils, 30Oct2008, 70%; Platelet count, 30Oct2008, 719000/mm3; Prothrombin time, 30Oct2008, 14.9sec; Red blood cell count, 30Oct2008, 525000/mm3; White blood cell count, 30Oct2008, 12620/mm3
CDC Split Type: B0549716A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. On 12 September 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 29 October 2008, 47 days after vaccination with ROTARIX, the subject experienced bloody stools with vomiting, fever and rectorrhagia. On 30 October 2008, the subject was brought to the emergency ward. Physical examination revealed malaise, pallor, lethargy, dehydration, abdominal pain, bowel peristalsis decreased, abdominal mass in the left side and current jelly stools in the diaper. The abdomen X-ray performed showed lack of distal air and diminished in transverse colon with 1 opacity (80%). Surgery was performed and intussusception was found and reduced by taxis. An appendectomy was also performed. The subject was hospitalised for 6 days. The subject was treated with paracetamol and cefotaxime. On 4 November 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


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