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This is VAERS ID 314129

(NOTE: This result is from the 12/8/2009 version of the VAERS database)

Case Details

VAERS ID: 314129 (history)  
Form: Version .0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-01
Onset:2008-05-11
   Days after vaccination:40
Submitted: 2008-05-29
   Days after onset:18
Entered: 2008-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Abnormal faeces, Anorectal disorder, Constipation, Dehydration, Gastrointestinal hypomotility, Haematochezia, Intussusception, Irritability, Mass, Mucous stools, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14May2008, showed distended intestinal loops and absent distal air.
CDC Split Type: B0522169A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline) given on 20 December 2007. On 1 April 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 11 May 2008, 40 days after vaccination with the 2nd dose of ROTARIX, the subject experienced alimentary vomiting, intermittent irritability, abdominal pain and absent stool since 3 days before. On 14 May 2008, he was admitted in ER. Physical exam reported dehydration, distended abdomen, mesogastric palpable mass, diminished peristalsis and rectal tract with expulsion of current jelly stool and fresh blood in a second time. The subject was hospitalised. Abdominal X-ray was performed and showed distended intestinal loops and absent distal air. On 14 May 2008, Surgery was performed; ileocecolic intussusception was found, reduction was done without any complications. Post surgical clinical evolution was adequate. The subject was treated with ampicillin, amikacine, metronadizole and paracetamol. On 19 May 2008, the subject was discharged. On 19 May 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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