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This is VAERS ID 319394

Case Details

VAERS ID: 319394 (history)  
Form: Version 1.0  
Age: 0.18  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-01
Onset:2008-07-03
   Days after vaccination:2
Submitted: 2008-07-16
   Days after onset:13
Entered: 2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Enema administration, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC Split Type: B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


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