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This is VAERS ID 320288

Case Details

VAERS ID: 320288 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-15
Onset:2008-07-06
   Days after vaccination:82
Submitted: 2008-07-23
   Days after onset:17
Entered: 2008-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal hypermotility, Haematochezia, Hypertrophy, Intussusception, Irritability, Pallor, Pyrexia, Surgery, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: UNK
CDC Split Type: B0529662A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of caeco-colic intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 15 April 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 6 July 2008, 82 days after vaccination with ROTARIX, the subject started with fever, vomiting and diarrhea. On 11 July 2008, 87 days after vaccination with ROTARIX, the patient experienced bloody stools and he was hospitalized with irritability and fever. Physical exam reported pallor, irritability, tachycardia, current jelly stool, abdominal pain and increased peristalsis. Surgery was performed on 11 July 2008. Caeco-colic invagination with multiple hypertrophy ganglions was found and correction by taxis without complication was done; intestinal exploration not evidenced vascular compromise. The post surgical evolution was favorable. The subject was treated with METAMIZOLE, RANITIDINE and AMIKACINE. On 15 July 2008, the events were resolved, the subject was discharged. The physician considered the events were unrelated to vaccination with ROTARIX.


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