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This is VAERS ID 315309

Case Details

VAERS ID: 315309 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-29
Onset:2008-05-08
   Days after vaccination:69
Submitted: 2008-06-06
   Days after onset:29
Entered: 2008-06-06
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 distension, Appendicectomy, Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood thromboplastin decreased, Blood urea decreased, Gastrointestinal hypomotility, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal obstruction, Intussusception, Irritability, Lymphocyte count normal, Neutrophil count normal, Platelet count normal, Prothrombin time normal, Surgery, Transfusion, Ultrasound abdomen abnormal, Vomiting, White blood cell count decreased, X-ray abnormal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 09May2008, see text; Blood glucose, 10May2008, 97mg/dl, 65 (low), 99 (high); Hematocrit, 10May2008, 28.6%, 37.7 (low), 53.7 (high); Hemoglobin, 09May2008, 10.3g/dl, 12.2 (low), 18.1 (high); Hemoglobin, 10May 2008, 9.82g/dl, 12.2 (low), 18.1 (high); Leukocyte count NOS, 09May2008, 12500mm3, 4600 (low), 10200 (high); Leukocyte count NOS, 10May2008, 8030mm3, 4600 (low), 10200 (high); Lymphocytes, 10May2008, 38.5%, 10 (low), 50 (high); Neutrophils, 10May2008, 44.9%, 37 (low), 80 (high); Platelet count, 09May2008, 379000mm3, 142000 (low), 424000 (high); Platelet count, 10May2008, 18500mm3, 142000 (low), 424000 (high); Potassium, 09May2008, 34mEq/dl, 3.5 (low), 5.1 (high); Potassium, 10May2008, 4.4mEq/dl, 3.5 (low), 5.1 (high); Prothrombin time, 09May2008, 13.5s, 11 (low), 15 (high); Prothrombin time, 10May2008, 12s, 11 (low), 15 (high); Sodium, 09May2008, 121mEq/dl, 136 (low), 145 (high); Sodium, 10May2008, 131mEq/dl, 136 (low), 145 (high); Stool analysis, 09May2008, see text; Thromboplastin, 09May2008, 23.1s, 29.9 (low), 40.7 (high); Thromboplastin, 10May2008, 26.4s, 29.9 (low), 40.7 (high); Ultrasound abdomen, 10May2008 ISunit; Urea, 10May2008, 6mg/dl, 7 (low), 18 (high).
CDC Split Type: B0523636A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject did not have any relevant medical history. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 19 December 2007. On 29 February 2008 the subject received 2nd dose of ROTARIX. On 8 May 2008, 69 days after vaccination with ROTARIX, the subject experienced irritability, vomiting (2 episodes, one episode with bilis) and bloody stool. The subject was brought to emergency room with abdominal distension, without peristalsis and blood stain through anal examination. On 09 May 2008 relevant test included abdominal x-ray compatible with intestinal obstruction. On 10 May 2008 abdominal ultrasound confirmed intussusception. The same day the subject was hospitalised and abdominal surgery was performed. At surgery ileo-ileo-cecal intussusception was found and it was reduced by taxis without complications. Appendectomy was also done. After surgery the subject evolved slowly to clinical improvement. On 14 May 2008 the subject was discharged in good clinical conditions. The subject was treated with ranitidine hydrochloride, red blood cells and omeprazole. The physician considered the events were unrelated to vaccination with ROTARIX.


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