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This is VAERS ID 322727

Case Details

VAERS ID: 322727 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-09
Onset:2008-07-19
   Days after vaccination:71
Submitted: 2008-08-20
   Days after onset:32
Entered: 2008-08-20
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, Barium enema, Barium enema abnormal, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Mucous stools, Oral intake reduced, Pallor, Pharyngeal erythema, Prothrombin time normal, Rectal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (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: Barium enema, 19Jul2008; Hematocrit, 19Jul2008, 36%; Hemoglobin, 19Jul2008, 11.8g/dl; Partial prothrombin time, 19Jul2008, 40sec; Prothrombin time, 19Jul2008, 12.3 sec
CDC Split Type: B0533477A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-ceco-colic intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 9 May 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 19 July 2008, 71 days after vaccination with ROTARIX, the subject started with oral intake reduced, abdominal colic, bloody fresh stools, vomiting and irritability. He was taken to ER on 19 July 2008 and at physical exam showed pallor, hyperemic pharynx, currant jelly stools, abdomen with dance sign, bowel sounds decreased, and rectal tact with presence of blood. Barite enema was performed on 19 July 2008; ileo-ceco-colic intussusception was found and reduced in the first intent with success. Any complication was reported. The subject was hospitalized and discharged in good clinical conditions on 22 July 2008. Laboratory tests were performed on 19 July 2008 and showed the following results: Hemoglobin: 11.8 g/dl; Hematocrit: 36 ; PT: 12.3 sec; PTT: 40 sec. No abdominal x-ray was reported in the clinical file. On 22 July 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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