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This is VAERS ID 332466

Case Details

VAERS ID: 332466 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-11
Onset:2008-10-10
   Days after vaccination:29
Submitted: 2008-11-14
   Days after onset:35
Entered: 2008-11-14
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, Haematochezia, Intussusception, Irritability, Malaise, Mucous stools, Pallor, Pyrexia, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Hypotonic-hyporesponsive episode (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy Baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 11Oct2008, see text
CDC Split Type: B0545978A

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). This report involved a healthy baby. On 11 September 2008 the subject received 1st dose of ROTARIX (oral). On 10 October 2008, 29 days after vaccination with ROTARIX, the subject experienced irritability, fever, gastrobiliar vomiting and malaise. On 11 October 2008 the subject had current jelly stools and she was admitted to the emergency room presenting pallor, favorable hydration, irritability, abdominal distention, positive dance signs and one more current jelly stools was observed. Relevant test performed the same day included abdominal x-ray which showed distended loops, lack of air in distal zone and air fluid levels. Therefore the subject underwent a surgery in which intussusception in ileocecocolic position was found. Reduction by taxis was performed successfully. The subject was treated with paracetamol, metronidazole, amikacin, ranitidine, metamizole and ketoroloac. On 16 October 2008, the events were resolved and the subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX.


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