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This is VAERS ID 322074

Case Details

VAERS ID: 322074 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-07
Onset:2008-05-04
   Days after vaccination:58
Submitted: 2008-08-13
   Days after onset:101
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Grand mal convulsion, Haematochezia, Intussusception, Melaena, Mucous stools, Pyrexia, Surgery, Vomiting, X-ray normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532328A

Write-up: This case was reported by a physician and described the occurrence of ileo-caeco-colic intussusception in an 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous vaccination included hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) ; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 29 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided; On 4 May 2008, 58 days after vaccination with ROTARIX, the subject was taken to emergency room and started with abdominal pain, colic, 8 episodes of vomiting, 2 bloody stools like black currant jelly, fever and 1 tonic-clonic seizure. The initial diagnosis was gastroenteritis but the occurrence of bloody stools corroborated the diagnosis of intussusception which was confirmed by abdominal x-ray. The surgery was done on 4 May 2008. Ileo-caeco-colic intussusception was resolved by taxis without intestinal resection and complication. The patient had good response and favorable evolution. Abdominal radiography performed did not show abnormalities, visible intussusception or soft tissue mass, fluid levels and dilated bowel loops. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 7 May 2008, the events were resolved and the patient was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. Additional information has been requested.


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