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This is VAERS ID 320747

Case Details

VAERS ID: 320747 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-22
Onset:2008-06-15
   Days after vaccination:54
Submitted: 2008-07-30
   Days after onset:45
Entered: 2008-07-29
   Days after submission:1
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 mass, Abdominal pain, Barium enema, Barium enema abnormal, Blood sodium decreased, Crying, Dehydration, Enema administration, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal obstruction, Intussusception, Platelet count increased, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Dehydration (narrow)

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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Intestinal subocclusion
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 16Jun2008, see text; Barium enema, 16Jun2008, see text; Hematocrit, 18Jun2008, 26.9%; Hemoglobin, 17Jun2008, 11.7g/dl; Hemoglobin, 18Jun2008, 9.1g/dl; Leukocyte count NOS, 17Jun2008, 14700/mm3; Leukocyte count NOS, 18Jun2008, 8600/mm3; Platelet count, 17Jun2008, 593000/mm3; Platelet count, 18Jun2008, 430000/mm3; Sodium, 18Jun2008, 132mEq/1
CDC Split Type: B0530758A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Concurrent medical conditions included intestinal sub-occlusion 15 days before, which resolved with medical treatment without surgery and without complication. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 20 February 2008. On 22 April 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 15 June 2008, 54 days after vaccination with ROTARIX, the subject experienced crying, abdominal pain, bloody stools and 5 episodes of vomiting. He was admitted to emergency room on 16 June 2008, with clinic data of intestinal obstruction. Physical exam showed dehydrated oral mucosa, painful abdomen in mesogastrium, palpable mass in left area and bowel sounds decreased. Ileocolic intussusception was suspected. The subject was hospitalized. Surgery was done on 17 June 2008; ileo-colic and colo-colic intussusception was corroborated with ischemia in descendent colon and edema in distal ileon with vascular recuperation; manual reduction of distal ileon, ileocaecal valve and descendent colon was performed without complication, without intestinal resection. During surgery, redundant colon was observed; pexy was performed on caecum, ileocaecal valve and ascendant colon without complication. Abdominal X-ray was performed on 16 June 2008 and showed distended colon with fixed loop, dilated small bowel and lack of air in colon and rectal ampulla and edema on intestinal loop. Barite enema was performed on 16 June 2008 and showed intussusception in descendent colon. Laboratory tests were performed on 17 June 2008 and showed the following results: Hemoglobin: 11.7 g/dl; Leucocytes: 14700/mm3; Platelets: 593000/mm3. Laboratory tests were performed on 18 June 2008 and showed the following results: Hemoglobin: 9.1 g/dl; Leucocytes: 8600/mm3; Platelets: 430000/mm3; Hematocrite: 26.9%; Sodium: 132 mEq/1. The subject was treated with cefotaxime, Amikacine and paracetamol. Clinical evolution after surgery was favorable. On 22 June 2008, the patient was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX.


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