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This is VAERS ID 318410

Case Details

VAERS ID: 318410 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-02
Onset:2008-05-05
   Days after vaccination:3
Submitted: 2008-07-07
   Days after onset:63
Entered: 2008-07-07
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 normal, Gastric disorder, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intestinal obstruction, Intussusception, Irritability, Prothrombin time normal, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), 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, 08May2008, see text unit; Activated partial thromboplast, 08May2008, 35.1s; Hematocrit, 08May2008, 34.8%; Hemoglobin, 08May2008, 11.2g/dl; Prothrombin time, 08May2008, 12.5s
CDC Split Type: D0527550A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 2 May 2008 the subject received 1st dose of ROTARIX (oral). On 5 May 2008, 3 days after vaccination with ROTARIX, the subject experienced irritability, continuous vomiting initially gastric and then biliar (the number of episodes was not specified), fever, some blood stools followed by no evacuation. The subject was brought to the emergency room and on 08 May 2008 she was hospitalised. Subject''s physical examination included abdominal distension without peristalsis, no abdominal mass. The abdominal x-ray showed intestinal obstruction. The same day the subject underwent a surgery in which ileocecocolic intussusception was confirmed. Intussusception was resolved by taxis and resection of 8 cm of distal ileon was required, 10 cm ileocecal valve termino-terminal anastomosis was done. After surgery the subject evolved to clinical improvement. The subject was hospitalised for 8 days. She was discharged on 15 May 2008. The subject was treated with dimenhydrinate, metoclopramide, paracetamol (Acetaminophen), paracetamol and carminative (unspecified) (Anti flatulence). On 16 May 2008, the subject was controlled as outpatient fully recovered. The physician considered the events were possibly related to vaccination with ROTARIX.


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