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This is VAERS ID 335416

Case Details

VAERS ID: 335416 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-22
Onset:2008-10-28
   Days after vaccination:6
Submitted: 2008-12-16
   Days after onset:49
Entered: 2008-12-16
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 mass, Abdominal pain, Appendicectomy, Asthenia, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Lymphocyte count increased, Neutrophil count increased, Pallor, Platelet count increased, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), 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), Dehydration (narrow)

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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CISAPRIDE; METOCLOPRAMIDE
Current Illness: Gastroesophageal Reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 30Oct2008, see text; Leukocyte count NOS, 30Oct2008, 20 000 UI/dl; Lymphocytes, 30Oct2008, 8.93 UI/dl; Neutrophils, 30Oct2008, 9.94 UI/dl; Platelet count, 30Oct2008, 478 000 UI/dl
CDC Split Type: B0550034A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecocolic intussusception in a 3-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Concurrent medical conditions included gastroesophageal reflux. Concurrent medications included Cisapride and Metoclopramide. On 22 October 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 28 October 2008, 6 days after vaccination with ROTARIX, the subject started with diarrhea, bloody stools, vomiting and adynamia. The patient was admitted at ER on 28 October 2008 and showed at physical exam pallor, dehydration, bowel sounds decreased, abdominal pain, hematochezia and sausage shaped mass. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Surgery was done on 30 October 2008. Ileocecocolic intussusception was found, reduced by taxis with a prophylactic appendectomy without complications. Tests were performed on 30 October 2008 and showed the following results: Leukocytes: 20 000 UI/dl; Neutrophils: 9.94 UI/dl; Lymphocytes: 8.93 UI/dl; Platelets: 478 UI/dl. On 2 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


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