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This is VAERS ID 338133

Case Details

VAERS ID: 338133 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-16
Onset:2008-12-18
   Days after vaccination:63
Submitted: 2009-01-23
   Days after onset:36
Entered: 2009-01-23
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 pain, Asthenia, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea increased, Intestinal obstruction, Intussusception, Irritability, Lymphocyte count normal, Neutrophil count increased, Platelet count increased, Prothrombin time prolonged, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute renal failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 18Dec2008, Abnormal; Blood glucose, 18Dec2008, 90mg/dl; Chloride, 18Dec2008, 110.7mEq/L; Creatinine, 18Dec2008, 0.3mg/dl; Leukocyte count NOS, 18Dec2008, 11000/mm3; Lymphocytes, 18Dec2008, 21.6%; Neutrophils, 18Dec2008, 74.9%; Platelet count, 18Dec2008, 574000/mm3; Potassium, 18Dec2008, 4.56mEq/L; Protrombin time, 18Dec2008, 15 sec; Sodium, 18Dec2008, 141mEq/L; Urea, 18Dec2008, 27mg/dl
CDC Split Type: B0554122A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. He was previously healthy. Previous and/or concurrent vaccination included ROTARIX;GlaxoSmithKline;oral given on 24 July 2008. On 16 October 2008, the subject received 2nd dose of ROTARIX (oral). On 18 December 2008, 63 days after vaccination with 2nd dose of ROTARIX, the subject experienced 7 times biliary vomitings with abdominal pain, asthenia, irritability, adynamia and and fever. The subject was brought to emergency ward. The laboratory test showed partial thromboplastine time 36.6 sec. The physical examination showed abdomen without peristalsis, rectal tact with bleeding and finger exploration with fresh blood. The abdominal X-ray showed an intestinal obstruction and air-fluid levels. Intussusception was suspected. The subject was hospitalised for 5 days. On 19 December 2008, a surgery was performed and an ileocecocolic intussusception was found and reduced by taxis without complication. The subject was treated with amikacin, metronidazole, DIMENHYDRINAT, paracetamol and ambroxol. On 22 December 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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