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This is VAERS ID 335082

Case Details

VAERS ID: 335082 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-18
Onset:2008-10-17
   Days after vaccination:29
Submitted: 2008-12-11
   Days after onset:55
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: Abdominal distension, Activated partial thromboplastin time normal, Anorexia, Blood group O, Gastrointestinal hypomotility, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Platelet count increased, Prothrombin time prolonged
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), 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), 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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood group O, 20Oct2008, Rh+ sec; Hemoglobin, 20Oct2008, 10.8 g/dl; Partial prothrombin time, 20Oct2008, 32 sec; Platelet count, 20Oct2008, 478000/mm3; Prothrombin time, 20Oct2008, 13 sec
CDC Split Type: B0549759A

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 female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 18 July 2008. On 18 September 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 17 October 2008, 29 days after vaccination with ROTARIX, the subject started with hyporexia, bloody stools and nausea. The patient was admitted at ER on 20 October 2008 and showed at physical exam abdominal distension, irritability, impaired peristalsis and current jelly stool. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Laparotomy was done on 20 October 2008. Ileocecal intussusception was found, reduced by taxis without complication. The treatment given was not available in the clinical chart. Tests were performed on 20 October 2008 and showed the following results: Hemoglobin: 10.8 g/dl; Platelets count: 478000/mm3; PT: 13 sec; PTT: 32 sec; Blood group: O Rh+. On 23 October 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


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