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This is VAERS ID 314130

(NOTE: This result is from the 9/14/2017 version of the VAERS database)

Case Details

VAERS ID: 314130 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-15
Onset:2008-04-19
   Days after vaccination:95
Submitted: 2008-05-29
   Days after onset:40
Entered: 2008-05-29
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, Anorexia, Barium enema abnormal, Decreased appetite, Diarrhoea, Flatulence, Gastrointestinal sounds abnormal, Haematochezia, Intestinal functional disorder, Intussusception, Mass, Mucous stools, Nausea, Pallor, Vomiting, White blood cell count decreased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 20Apr2008, See text; Barium enema, 20Apr2008, See text; White blood cell count, 20Apr2008, 4200/mm3, 5000, 1500
CDC Split Type: B0521383A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccinations included combined diphtheria, tetanus, whole cell pertussis, hepatitis B and Haemophilus type b vaccine (manufacturer unspecified; intramuscular; unknown) given on 19 March 2008; influenza virus vaccine (manufacturer unspecified; intramuscular; unknown) given on 19 March 2008; live attenuated oral poliomyelitis vaccine (manufacturer unspecified; oral) given on 19 March 2008 and live attenuated human rotavirus vaccine (GlaxoSmithKline; oral) given on 12 November 2007. On 15 January 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 19 April 2008, 95 days after vaccination with the 2nd dose of ROTARIX, the subject experienced abdominal pain and liquid stools. Thereafter she showed hyporexia, nausea, vomiting and current jelly stools. On 20 April 2008, she was admitted on ER. Physical exam reported abdominal pain, pallor, palpable mass, Dance sign, absent peristalsis and rectal tract with expulsion of fresh bloody stools. Laboratory tests were performed on 20 April 2008 and showed the following: Leucocytes: 4200/mm3 (normal range: 5000-15000). Abdominal X-ray showed air-fluid levels. Barium enema was done; fluoroscopy control showed pass contrast medium through ileocecal valve to distal ileum; therefore ileocecolic intussusception was resolved (by exit). The subject was treated with AMPICILLIN, AMIKACINE, metronidazole and RANITIDINE. The subject had a good clinical evolution. The subject was discharged on 24 April 2008 with frank recuperation. On 24 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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