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This is VAERS ID 319089

Case Details

VAERS ID: 319089 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-07
Onset:2008-04-01
   Days after vaccination:54
Submitted: 2008-07-15
   Days after onset:105
Entered: 2008-07-15
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 distension, Activated partial thromboplastin time shortened, Cardiac murmur, Cough, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Intestinal obstruction, Intussusception, Irritability, Malaise, Neutrophil percentage, Pain, Prothrombin time shortened, Pyrexia, Surgery, Tympanic membrane disorder, Vomiting, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hearing impairment (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 05Apr2008, see text; Neutrophils, 05Apr2008, 67%; Partial prothrombin time, 05Apr2008, 28sec; Prothrombin time, 05Apr2008, 10sec
CDC Split Type: B0528920A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 7 February 2008, the subject received 1st dose of ROTARIX (oral). Not number not provided. On 1 April 2008, 54 days after vaccination with ROTARIX, the subject presented malaise, fever, irritability, diarrhea, cough, vomiting. On 4 April 2008, the patient experienced bloody stools and abdominal distention. The subject was hospitalized. Physical exam was performed on 5 April 2008 and showed dehydration, fever, irritability, mesocardic systolic murmur, distended abdomen, tympanic, painfulness and diminished bowel sounds. Rectal tact with empty ampulla and "sanguinolent" stools. Abdominal X-ray was performed on 5 April 2008 and showed image like intestinal obstruction with dilated small bowel and colon. Laboratory tests performed on 5 April 2008 showed the following: Neutrophils: 67%, prothrombin time: 10 sec, partial prothrombin time: 28 sec. Ileocaecal intussusception was confirmed by surgery on 5 April 2008 and resolved by taxis. The subject was treated with amikacin, metronadizole, ranitidine, metamizole, ketorolac and paracetamol. The subject evolved to clinical improvement and was discharged on 12 April 2008. On 12 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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