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This is VAERS ID 322072

Case Details

VAERS ID: 322072 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-12
Onset:2008-05-11
   Days after vaccination:60
Submitted: 2008-08-13
   Days after onset:94
Entered: 2008-08-13
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 distension, Appendicectomy, Blood chloride normal, Dehydration, Diarrhoea, Gastrointestinal hypermotility, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte percentage increased, Nausea, Neutrophil percentage decreased, Pallor, Peristalsis visible, Pharyngeal erythema, Platelet count increased, Pyrexia, Surgery, Vomiting, White blood cell count decreased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14May2008, see text; Chloride, 14May2008, 94mEq/l; Hematocrit, 14May2008, 35%; Hemoglobin, 14May2008, 11g/dl; Leukocyte count NOS, 14May2008, 7530/mm3; Lymphocytes, 14May2008, 57%; Neutrophils, 14May2008, 29%; Platelet count, 14May2008, 527000/mm3
CDC Split Type: B0532192A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-ileo-caeco-colic intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history and no allergy. Previous and/or concurrent vaccination included ROTARIX (GlaxoSmithKline, oral) given on 17 January 2008. On 12 March 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 11 May 2008, 60 days after vaccination with ROTARIX, the subject experienced nausea, vomiting, fever and one liquid stool. She was taken to emergency room with pallor, dehydration, hyperemic pharynx and abdominal zone with increased peristalsis. 15 hours later, the patient showed evidence of abdominal distention, irritability, more vomiting and diarrhea. Abdominal x-ray performed on 14 May 2008 showed liquid air levels and lack of distal air. The subject was hospitalized and surgery was done on 15 May 2008. Ileo-ileo-caeco-colic intussusception was found on descendent colon resolved by taxis and appendectomy without complication. The subject showed good evolution. Laboratory tests were performed on 14 May 2008 and showed the following results: Hemoglobin: 11 g/dl; Hematocrit: 35%; Leukocytes: 7530 /mm3; Neutrophils: 29%; Platelets: 527000 /mm3; Lymphocytes: 57%; Chloride: 94 mEq/l. The subject was treated with ranitidine, metoclopramide, paracetamol, cefotaxime, metronidazole, amikacin, dipyrone and ampicillin trihydrate. On 21 May 2008, the events were resolved and the subject was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information expected; the case has been closed.


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