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This is VAERS ID 335079

Case Details

VAERS ID: 335079 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-29
Onset:2008-05-30
   Days after vaccination:31
Submitted: 2008-12-11
   Days after onset:195
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Intussusception, Irritability, Laparotomy, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0549662A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 28 February 2008. On 29 April 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 30 May 2008, 31 days after vaccination with 2nd dose ROTARIX, the subject experienced vomiting and diarrhea. On 02 June 2008, the subject was admitted at hospital. Finding at physical examination were irritability, asthenia, adynamia, dehydration, vomiting and decreased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Intussusception was suspected and laparotomy was realised on 02 June 2008: Ileoileal intussusception was reported and resolved by taxis without complications. The subject was treated with Metoclopramid, Ampicillin and Amikacine. On 10 June 2008, the subject was discharged in good clinical conditions. On 10 June 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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