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This is VAERS ID 333536

Case Details

VAERS ID: 333536 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-06-11
Onset:2008-10-06
   Days after vaccination:117
Submitted: 2008-12-01
   Days after onset:56
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dehydration, Diarrhoea, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Laparotomy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy Baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0547633A

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). Concurrent medical conditions included healthy baby. On 11 June 2008 the subject received 1st dose of ROTARIX (oral). On 6 October 2008, more than 3 months after vaccination with ROTARIX, the subject experienced abdominal pain, vomiting, diarrhea and fever. The subject was admitted to the emergency room. Physical examination showed irritability, bloody stools, dehydration and bowel sounds decreased. The subject was hospitalized. Clinical diagnostic of intussusception was suspected and corroborated by laparotomy. Intussusception was resolved by taxis without complications. On 09 October 2008 the subject was discharged in good clinical conditions. The reporter considered the events were clinically significant or intervention required. The physician considered the events were unrelated to vaccination with ROTARIX.


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