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This is VAERS ID 309526

Case Details

VAERS ID: 309526 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-08-07
Onset:2007-11-21
   Days after vaccination:106
Submitted: 2008-04-15
   Days after onset:145
Entered: 2008-04-15
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 distension, Abnormal faeces, Anastomotic complication, Appendicectomy, Blood albumin decreased, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Death, Gastrointestinal necrosis, Globulins decreased, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileostomy, Intestinal anastomosis, Intestinal fistula, Intestinal perforation, Intussusception, Pallor, Parenteral nutrition, Peritonitis, Platelet count decreased, Protein total decreased, Pyrexia, Sepsis, Surgery, Vomiting, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-14
   Days after onset: 113
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Nov2007, see textunit; Albumin, 29Nov2007, 2.2g/dl; Blood glucose, 29Nov2007, 148mg/dl; Calcium, 29Nov2007, 7.0mg/dl; Globulin, 29Nov2007, 1.0g/dl; Hematocrit, 29Nov2007, 34%; Hemoglobin, 29Nov2007, 11.4g/dl; Leukocyte count NOS, 29Nov2007, 4720mm3; Platelet count, 29Nov2007, 152000mm3; Potassium, 29Nov2007, 2.8mEg/l; Protein total, 29Nov2007, 3.2g/dl; Sodium, 29Nov2007, 117mEg/l
CDC Split Type: B0515998A

Write-up: This case was reported by a physician in a frame of a study and described the occurrence of ileocolic intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). When the events started the subject was 6-month-old. On 7 August 2007 the subject received 1st dose of ROTARIX (oral). The 2nd dose schedule which should be given on 07 October 2007 was discontinued. The subject was on no other medication and had no relevant medical history nor allergy. On 21 November 2007, 106 days after vaccination with ROTARIX, the subject presented bloody stool (6-8 times/day), vomiting (6 times/day) and fever. On 25 November the subject was brought to hospital. Subject''s physical examination showed pallor, jelly red stools and abdominal distention. Abdominal x-ray showed distended intestinal loops. The same day the subject underwent a surgery. Intussusception was confirmed and resolved. Also ileostomy (20cm) was performed due to ileal necrosis and prophylactic appendectomy. On 29 November 2007 the subject was transferred to another hospital in bad conditions with persisting bloody stools and abdominal distention. Therefore a 2nd surgery was performed finding generalised peritonitis due to 3 intestinal perforation, 3-termino anastomosis were done. On 03 December 2007 a 3rd surgery was done due to opened anastomosis. On 06 December 2007 the 4th surgery was performed due to intestinal fistula. The subject was treated with total parenteral nutrition due to short intestine syndrome. The subject evolution was bad. The subject was hospitalised and the physician considered the events were disabling and life threatening. The subject was treated with AMPICILLIN, amikacin, clindamycin, metronidazole, Ranitidine, methimazole. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 14 March 2008 from sepsis. An autopsy was not performed.


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