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This is VAERS ID 333502

Case Details

VAERS ID: 333502 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-11-15
Onset:2008-06-15
   Days after vaccination:213
Submitted: 2008-12-01
   Days after onset:169
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Anorexia, Decreased activity, Dehydration, Diarrhoea, Intussusception, Irritability, Pallor, Pyrexia, Surgery, Ultrasound abdomen abnormal, X-ray abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 17Jun2008, Abnormal; Ultrasound abdomen, 17Jun2008, Abnormal
CDC Split Type: B0548192A

Write-up: This case was reported by a physician and described the occurrence of ileocecocolic intussusception in a 11-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical or family history. Previous and/or concurrent vaccination included BACILLUS CALMETTE-GUERIN vaccine (non-gsk); manufacturer unspecified; intradermal; given on 9 July 2007; combined DTaP-IPV-HIB; manufacturer unspecified; intramuscular; given on 17 September 2007, 15 November 2007 and 17 January 2008; Hep B; manufacturer unspecified; intramuscular; given on 9 July 2007, 17 September 2007 and 17 January 2008; influenza virus vaccine; manufacturer unspecified; intramuscular; given on 17 January 2008 and 12 May 2008; live attenuated ROTARIX; GlaxoSmithKline; oral given on 17 September 2007; live attenuated oral poliomyelitis vaccine; GlaxoSmithKline; oral given on 22 May 2008; pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 17 September 2007 and 15 November 2007. On 15 November 2007, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 15 June 2008, 7 months after vaccination with ROTARIX, the subject experienced diarrhea with hyporexia, irritability and fever, leading to hospitalisation. Physical examination revealed pallor, dehydration, hypoactivity and abdominal mass (Morcilla''s sign). The subject was hospitalised for 5 days and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 17 June 2008, abdomen X-ray and ultrasound performed revealed a visible intussusceptum as well as fluids levels and dilated bowel loops. Surgery was performed and an ileocecocolic intussusception without vascular complication was found and reduced by taxis without complication. No resection was done. On 19 June 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were possibly related to vaccination with ROTARIX.


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