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This is VAERS ID 332471

Case Details

VAERS ID: 332471 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-14
Onset:2008-07-24
   Days after vaccination:132
Submitted: 2008-11-14
   Days after onset:113
Entered: 2008-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal discomfort, Dehydration, Explorative laparotomy, Gastrointestinal hypomotility, Gastrointestinal necrosis, Ileostomy, Intussusception, Pyrexia, Vitello-intestinal duct remnant, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pulmonary Stenosis
Preexisting Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Aug2008, see text
CDC Split Type: B0545250A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 9-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history included hypothyroidism, interventricular communication of travelucat type and untreated serious pulmonary stenosis. Previous and/or concurrent vaccination included DTaP and HIB (manufacturer unspecified, intramuscular) given on 10 January 2008 and 14 March 2008; hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) given on 7 November 2007 and 10 January 2008; ROTARIX (GlaxoSmithKline, oral) given on 10 January 2008; Bacillus calmette-guerin vaccine (non-GSK manufacturer, intradermal) given on 7 November 2007. On 14 March 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 24 July 2008, 4 months after vaccination with ROTARIX, the subject started with vomiting, fever and abdominal strain. She was admitted at the emergency unit at the hospital in August. The subject experienced dehydration and bowel peristalsis decreased. Abdominal x-ray was performed and showed hydroaeral levels and a poor distribution of gas. An exploring laparotomy was realized finding an ileo-ileal intussusception with a necrosis of an ileon of 40cm Meckel diverticulum. A non communicated ileostomy was done and after a good evolution patient was out from hospital on 18th August 2008. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with ROTARIX.


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