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This is VAERS ID 322488

Case Details

VAERS ID: 322488 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-30
Onset:2008-07-30
   Days after vaccination:30
Submitted: 2008-08-18
   Days after onset:19
Entered: 2008-08-18
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, Activated partial thromboplastin time shortened, Blood group O, Gastrointestinal hypomotility, Gastrointestinal pain, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intestinal anastomosis, Intestinal resection, Intussusception, Irritability, Pharyngeal erythema, Platelet count increased, Prothrombin time prolonged, Rhesus antibodies positive, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 30Jul2008, see text; Blood group O, 30Jul2008, Orh+; Hematocrit, 30Jul2008, 32.1%; Hemoglobin, 30Jul2008, 10.4g/dl; Leukocyte count NOS, 30Jul2008, 32000/mm3; Partial prothrombin time, 30Jul2008, 25.1sec; Platelet count, 30Jul2008, 637000/mm3; Prothrombin time, 30Jul2008, 12.8sec
CDC Split Type: B0533056A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-colic intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 29 April 2008. On 30 June 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 30 July 2008, 30 days after vaccination with ROTARIX, the subject was taken to emergency room with irritability. The physical exam showed hyperemic pharynx, pain in colonic zone and decreased gastrointestinal peristalsis. During hospitalization, the subject experienced gastric vomiting, abdominal pain right side and hematochezia. Abdominal X-ray was performed on 30 July and showed fix loop in right side, air-fluid-levels in iliac right side and lack of air in rectal ampulla. Surgery was done on 30 July 2008 and showed ileo-colic intussusception from appendix, ileo-caecal valve to colonic spleeny angle with vascular compromise of ileon. Resection with term-to-term anastomosis was done without complications. The subject had good clinical evolution. Laboratory tests were performed on 30 July and showed the following results: Hemoglobin: 10.4 g/dl; Hematocrit: 32.1%; Platelet count: 637 000/mm3; Leukocyte count: 32 000/mm3; Blood Group: O Rh+; PT: 12.8 sec; PTT: 25.1 sec. The subject was treated with paracetamol. On 6 August 2008, the subject was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.


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