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This is VAERS ID 309282

Case Details

VAERS ID: 309282 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
   Days after vaccination:94
Submitted: 2008-04-10
   Days after onset:166
Entered: 2008-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal tenderness, Abnormal faeces, Barium double contrast, Crying, Enema administration, Faeces discoloured, Haematochezia, Haematocrit normal, Haemoglobin decreased, Intussusception, Lymphocyte percentage, Neutrophil percentage, Pallor, Platelet count increased, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 28Oct2007, No data; Hematocrit, 28Oct2007, 35.8%; Hemoglobin, 28Oct2007, 11.9g/dL; Lymphocyte percentage, 28Oct2007, 27%; Neutrophil percentage, 28Oct2007, 64.2%; Platelet count, 28Oct2007, 530000/mm3; Ultrasound abdomen, 28Oct2007, IS confirmed; White blood cell count, 28Oct2007, 16500/mm3
CDC Split Type: B0514821A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 9-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). The subject had no relevant medical history or allergies. The subject had no concomitant medication. Previous vaccination included Rotarix (GlaxoSmithKline; oral) given on 23 March 2007. On 25 July 2007, the subject received the 2nd dose of Rotarix (oral). On 27 October 2007, 94 days after vaccination with the 2nd dose of Rotarix, the subject experienced repeated vomiting (30/24h), continuous crying and a jelly red stool. The subject was taken to the emergency room. Physical exam reported mild pallor, abdominal tenderness with a mass in the upper left quadrant. The subject was hospitalised. Laboratory tests performed on 28 October 2007 and showed the following: Hemoglobin: 11.9 g/dL (normal range: 12.2-18.1); Hematocrit: 35.8% (normal range: 37.7-53.7); Leucocytes: 16500/mm3 (normal range: 4600-10200); Neutrophils: 64.2% (normal range: 37-80); Lymphocytes: 27% (normal range: 10-50); Platelets count: 530000/mm3 (normal range: 142000-424000). Abdominal X-ray was performed but showed no specific data. Abdominal ultrasound was performed and showed intussusception. On 28 October 2007, pneumoenema with 90mmHg pressure was performed and intussusception was resolved. The subject was treated with amikacin, metronidazole, Metamizol, Ranitidine, omeprazole and Ketorolaco. The subject evolved to clinical improvement and he was discharged on 30 October 2007 in good clinical conditions. On 30 October 2007, the events were resolved. The physician considered the events were unrelated to vaccination with Rotarix.

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