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This is VAERS ID 316515

Case Details

VAERS ID: 316515 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-17
Onset:2008-05-14
   Days after vaccination:27
Submitted: 2008-06-18
   Days after onset:35
Entered: 2008-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Blood creatinine normal, Blood gases abnormal, Blood glucose normal, Blood potassium normal, Blood sodium increased, Gastrointestinal hypermotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Ileus, Intestinal ischaemia, Intussusception, Lymphadenopathy, Lymphocyte percentage decreased, Nausea, Neutrophil percentage increased, Platelet count normal, Pyrexia, Surgery, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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: Blood glucose, 19May2008, 394mg/dl, 70-990; Creatine, 19May2008,0.3mg/dl, 0.9-0.6; Hematocrit, 19May2008,30.4%,30-42; Hemoglobin, 19May2008, 10.4g/dl, 10-13; Lymphocytes, 19May2008, 33.3%, 41-71; Neutrophils, 19May2008, 55.3%, 13-33; Platelet count, 19May2008, 433.000mm3, 300.000-700.000; Potassium, 19May2008, 3.6mEq/h, 3.5-5.5; Sodium, 19May2008, 943mEq/h, 135-145; White blood cells, 19May2008, 13.20mm3, 6.000-17.500; X-ray abdominal on 19 May 2008: lack of distal air and abdomen distribution of intestinal gas.
CDC Split Type: B0524583A

Write-up: On 18 February 2008, the subject received the first dose of ROTARIX vaccine. On 17 April 2008, the subject received the second dose of ROTARIX vaccine. This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. No concomitant medication given. On 17 April 2008, the subject received 2nd dose of ROTARIX (oral). On 14 May 2008, 27 days after 2nd vaccination with ROTARIX, the subject experienced intussusception, adenomegaly, nausea, hyperperistalsis, hematochezia, fever, blood present in stool and ileus. The subject was hospitalised. Relevant test results included x-ray abdominal evidenced lack of distal air and abnormal distribution of intestinal gas. Intussusception was suspected and surgery was done on 19 May 2008, small bowel loops and colon exploration was done. Finding intestinal ischemia with vascular recuperation and mesenteric adenopathy, intestinal resection was not necessary, the surgeon confirmed that intussusception has spontaneous resolution. The subject showed Ileus after abdominal surgery, however the clinical evolution evidenced improvement without complication. The subject was treated with paracetamol, ranitidine, metamizol, clindamycin and amikacin. On 23 May 2008, the events were resolved. He was discharged with diagnosis of intestinal invagination on 23 May 2008, with good oral acceptance, digestion favorable and normal colonic function. Other diagnosis at discharge was adenomegaly mesenteric. The physician considered the events were related to vaccination with ROTARIX.


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