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This is VAERS ID 335074

Case Details

VAERS ID: 335074 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
   Days after vaccination:51
Submitted: 2008-12-11
   Days after onset:153
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Activated partial thromboplastin time prolonged, Blood calcium decreased, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte count increased, Mucous stools, Neutrophil count increased, Pallor, Platelet count normal, Prothrombin time prolonged, Somnolence, Surgery, Ultrasound abdomen abnormal, Vaccine positive rechallenge, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (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), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Biliary vomiting; Intussusception; Irritability
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 31Aug2008, see text unit; Abdominal X-ray, 07Oct2008, See text; Activated partial thromboplast, 30Aug2008, 40.1s; Blood glucose, Jul2008, 90mg/dl; Blood group O, 07Oct2008, Rh +; Calcium, 30Aug2008, 8.7Eq/l; Creatinine, 30Aug2008, 0.4mg/dl; Glucose, 30Aug2008, 95mg/dl; Hematocrit, Jul2008, 33%; Hematocrit, 30Aug2008, 33.5%; Hemoglobin, Jul2008, 11.4mg/dl; Hemoglobin, 30Aug2008, 11.3g/dl; Hemoglobin, 07Oct2008, 10.5g/dl; Leukocyte count NOS, Jul2008, 16900c/mm3; Leukocyte count NOS, 07Oct2008, 13 400/mm3; Lymphocytes, 30Aug2008, 5 100mm3; Neutrophil count, Jul2008, 48/mm3; Neutrophils, 30Aug2008, 10 100mm3; Partial prothrombin time, Jul2008, 33.6s; Platelet count, Jul2008, 302000 unit; Platelet count, 30Aug2008, 453000mm3; Platelet count, 07Oct2008, 295 000/mm3; Potassium, Jul2008, 4.3mEq/l; Potassium, 30Aug2008, 4.3mEq/1; Potassium, 07Oct2008, 4.6mEq/l; Prothrombin time, Jul2008, 13.7s, Prothrombin time, 30Aug2008, 13.4s; Sodium, Jul2008, 140mEq/l; Sodium, 30Aug2008, 135mEq/l; Sodium, 07Oct2008, 146mEq/l; Ultrasound abdomen, 30Aug2008, IS unit; Urea, Jul2008, 13mg/dl; Urea, 30Aug2008, 9mg/dl
CDC Split Type: B0536137A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline) for prophylaxis. Concurrent and or previous medical conditions included intussusception in May 2008 which was resolved by taxis in explorer laparotomy. Further information was not available in the file. On 21 May 2008 the subject received 1st dose of ROTARIX (oral). On 12 July 2008, 52 days after vaccination with the 1st dose of ROTARIX, the subject experienced ileocolic intussusception, which was also resolved by taxis without complications, post explorer laparotomy, intestinal resection was not performed. On 21 July 2008 the subject received 2nd dose of ROTARIX (oral). On 30 August 2008, 40 days after the 2nd dose of ROTARIX the subject presented irritability, gastrobiliar vomiting (more than 10 times), abdominal pain, and sanguinolent stools. The same day she was admitted to the emergency room with somnolence, pallor abdominal pain, decreased peristalsis, palpable abdominal mass and rectal tact with expulsion of current jelly stools. Relevant test included abdominal ultrasound which showed evidence of intussusception. The medical surgeon treated her with Diazepam for abdominal relaxation. He could palpate in ileocecal area abdominal mass which was reduced successfully and slowly with normal procedure in retrograde direction. On 31 August 2008 the subject showed clinical improvement with just slow peristalsis, without any sanguinolent stool. The subject presented a good evolution with good oral acceptance. The same day abdominal x-ray showed improvement in the intestinal air distribution. On 03 September 2008 the subject discharged in franc resolution. The subject was treated with cefotaxime, metronidazoloe, Metamizole, Ranitidine, paracetamol, Trimethoprin and diazepam. At the time of reporting the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX. In the follow up received on 23 September 2008 it was confirmed that there were relapse of intussusceptions. In May the subject had the 1st intussusception. It was unknown if the event occurred before or after vaccination. The subject showed irritability and gastrobiliar vomiting. Intussusception was resolved in another hospital. The clinical file was not available. The outcome date and laboratory tests were unknown. On 11 July 2008 the subject presented irritability, vomiting and current jelly stools. On 12 July 2008 the 2nd intussusception type ileocolic was detected and corrected by surgical taxis. On 15 July 2008 the event was resolved. On 30 August 2008, the subject presented 3rd intussusception which was resolved with external manoeuvre reduction with sedation (diazepam), surgical correction was not required. Follow up received on 05 December 2008 from the physician: On 6 October 2008, 77 days after vaccination with 2nd dose of ROTARIX, the subject started with biliary vomiting and current jelly stool. The subject was admitted at ER with abdominal pain, pallor, bowel peristalsis decreased, irritability and decreased gastrointestinal peristalsis. Abdominal x-ray showed intestinal occlusion, air-fluid levels and lack of air in rectal ampulla. The subject was hospitalized for surgery on 7 October 2008, ilecolic intussusception was found without complications. One adhesion was found (from caecum to terminal ileum) resolved by lysis. Ileocolic intussusception was resolved by taxis without intestinal resection. The physician considered the events were disabling. Relevant tests performed on 7 October 2008 showed the following results: Hemoglobin: 10.5 g/dl; Leukocytes: 13 400/mm3; Platelets: 295 000 /mm3; Potassium: 4.9 mEq/1; Sodium: 146 mEq/1; Blood group: 0+. The subject was treated with cefotaxime, metronidazole, Metamizol, Ranitidine, diazepam and Ketorolac. The subject had a goiod recuperation and was discharged on 11 October ingood clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.

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