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This is VAERS ID 315017

Case Details

VAERS ID: 315017 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-08
Onset:2008-03-14
   Days after vaccination:66
Submitted: 2008-06-04
   Days after onset:82
Entered: 2008-06-04
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 distension, Decreased activity, Dehydration, Faecal vomiting, Flatulence, Gastrointestinal hypomotility, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intestinal resection, Intussusception, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 19Mar2008, Abnormalunit
CDC Split Type: B0522325A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 6-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. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 8 November 2007. On 8 January 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 14 March 2008, 66 days after vaccination with ROTARIX, the subject experienced vomiting and fever. On 16 March 2008, she experienced bloody stools. On 19 March 2008, the subject experienced abdominal distension without peristalsis and 2 vomitings like feces, leading to hospitalisation at emergency ward. At physical examination, the subject was dehydrated, hypoactive with a distended abdomen. Abdominal X-ray showed air fluid levels and lack of air in rectum. The subject was transferred to another hospital where after confirmation of previous examination results, surgery was performed and ileocecocolic intussusception to descendent colon and ileocecal valve with proximal ascendant colon necrosis were found. Taxis was performed in 80 % of intussusceptoin as well as 15 cm of bowel resection end to end anastomosis. The subject was hospitalised for 14 days. The subject was treated with ranitidine, cefotaxime, metamizole, ampicilline, amikacin, metronadizole and dicloxacillin. On 1 April 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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