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This is VAERS ID 317252

Case Details

VAERS ID: 317252 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-08
Onset:2008-05-27
   Days after vaccination:49
Submitted: 2008-06-24
   Days after onset:28
Entered: 2008-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Appendicectomy, Culture urine positive, Dehydration, Gastrointestinal hypermotility, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileectomy, Intussusception, Ischaemia, Malaise, Monocyte count increased, Monocyte count normal, Neutrophil count increased, Pallor, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 29May2008, 33.5%, 29-42; Hemoglobin, 29May2008, 11.7g/dl, 10-13; Monocytes, 29May2008, 9%, 5-7; Neutrophils, 29May2008, 57%, 13-33; Platelet count, 29May2008, 59000mm3, 300000-700000; White blood cells, 29May2008, 18200mm3, 10000-15000. 29 May2008: PT =12 reg. (low norm=10.1, high norm=15.9); PTT: 27.5 reg. (low norm=31.3, high norm 54); Urinary exam showed bacterium positive, Leucocytes 10-12
CDC Split Type: B0525017A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was previously healthy. The subject was on no other medication and had no relevant medical history. On 8 April 2008, the subject received 1st dose of ROTARIX (oral). On 27 May 2008, 49 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception, fever, vomiting, current jelly stool, malaise, pallor, dehydration, abdominal pain and hyperperistalsis. The subject was hospitalised for 9 days. X ray abdomen not available in the clinical file. Surgery was performed on 29 May 2008, ileocolic invagination with schemia and necrosis to 10 cm of ileocecal valve was found (distal ileon). Resection of necrotic ileon segment (15 cm) at 5 cm of ileocecal valve and appendectomy was done without complications. Post surgical evolution was slowly to improvement. The subject was treated with ampicillin and paracetamol. On 6 June 2008, the events were resolved and the subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.


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