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This is VAERS ID 548128

Case Details

VAERS ID: 548128 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: California  
Vaccinated:2014-06-04
Onset:2014-10-01
   Days after vaccination:119
Submitted: 2014-10-15
   Days after onset:14
Entered: 2014-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS L24JG / 2 UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J007096 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G75064 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB393A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Gastrointestinal sounds abnormal, Haematochezia, Intussusception
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2014GSK005690

Write-up: This case was reported by a other health professional and described the occurrence of intussusception in a 8-month-old male patient who received ROTARIX (batch number A41CB393A, expiry date 5th October 2016). Concomitant products included ROTARIX, PEDIARIX, PREVENAR and HIB. On 4th June 2014 11:30, the patient received the 2nd dose of ROTARIX (oral). On 1st October 2014, 119 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant, life threatening and clinically significant/intervention required), bloody stool (serious criteria GSK medically significant) and absent bowel sounds. On an unknown date, the outcome of the intussusception, bloody stool and absent bowel sounds were not recovered/not resolved. It was unknown if the reporter considered the intussusception, bloody stool and absent bowel sounds to be related to ROTARIX. Additional information was provided. The patient had no known allergy, no relevant medical history and no reaction to previous vaccinations. The patient had no current medication. At the time of reporting, the patient was hospitalized, the events were worsened and the patient was possibly having surgery.


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