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This is VAERS ID 387210

Case Details

VAERS ID: 387210 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-12
Onset:2010-05-02
   Days after vaccination:51
Submitted: 2010-05-11
   Days after onset:9
Entered: 2010-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adenovirus infection, Diarrhoea, Echography abnormal, Enema administration, Inappropriate schedule of drug administration, Intestinal operation, Intussusception, Lymphadenopathy, Pyrexia, Rectal haemorrhage, Stool analysis abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Echography, 02May2010, lymph nodes; Stool analysis, May2010, adenovirus
CDC Split Type: B0651961A

Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 5 February 2010 and 12 March 2010, the subject received 1st dose and 2nd dose of ROTARIX (route unknown, batch number not provided). On 2 May 2010, 51 days after vaccination with 2nd dose of ROTARIX and 86 days after vaccination with 1st dose of ROTARIX, the subject experienced ileocecal invagination of 12 cm, proctorrhagia, vomiting and lymphadenopathy (presence of lymph nodes confirmed via echography). The subject was hospitalised. He was treated with injection of contrast product (via rectum) to reduce the invagination but it was only partially successful. Then, he was operated in order to reduce completely the invagination which was fully successful without any resection of the intestine. On 3 May 2010, 52 days after vaccination with 2nd dose of ROTARIX and 87 days after vaccination with 1st dose of ROTARIX, the subject experienced fever. They excluded any post operation complication. On 4 May 2010, 53 days after vaccination with 2nd dose of ROTARIX and 88 days after vaccination with 1st dose of ROTARIX, the subject experienced diarrhea. A stool analysis was performed and showed the presence of adenovirus. At the time of reporting, the events were resolved. According to the pediatrician, this was a mechanical invagination due to the presence of lymph nodes. Further information has been expected.


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