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This is VAERS ID 389308

Case Details

VAERS ID: 389308 (history)  
Form: Version 1.0  
Age: 0.48  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-15
Onset:2010-05-15
   Days after vaccination:0
Submitted: 2010-05-25
   Days after onset:10
Entered: 2010-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AF41FV042A / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal rigidity, Crying, Diet refusal, Gastrointestinal oedema, Intussusception, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
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: ultrasound abdomen, 15May2010, see text
CDC Split Type: B0653433A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No significant contributory history. Previous and/or concurrent vaccination included ROTARIX vaccine; GlaxoSmithKline; unknown given on 10 April 2010. On 15 May 2010, the subject received 2nd dose of ROTARIX (route unknown). On 15 May 2010, 3 hours after vaccination with ROTARIX, the subject experienced intussusception (auto-reduction of), straining on defecation, tensed abdomen sensitive to palpation, refused to feed, crying uncontrollably and bowel wall edema revealed by an USG abdomen. The subject was hospitalised and discharged after 1 day. No surgical treatment required. The subject was treated with intravenous fluids. At the time of reporting, the events were improved. The physician considered the events were almost certainly related to vaccination with ROTARIX.


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