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This is VAERS ID 305397

Case Details

VAERS ID: 305397 (history)  
Age: 0.3  
Gender: Male  
Location: North Carolina  
Vaccinated:2008-01-15
Onset:2008-02-04
   Days after vaccination:20
Submitted: 2008-02-18
   Days after onset:14
Entered: 2008-02-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2354BA / 1 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z08732 / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B70145A / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1244U / 1 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood bilirubin increased, Cholelithiasis, Faeces pale, Ultrasound abdomen abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: 2/4/08, mild elevation of total 2.0 & direct 0.8 bilirubin and ALT 140/AST 79 enzymes; 2/11/08, abdominal ultrasound showed multiple gallstones
CDC Split Type:

Write-up: 2/4/08 - Seen by patient''s pediatrician at office for stools with no color (acholic stools). Liver function panel: mild elevation of total bilirubin, direct bilirubin, and ALT/AST enzymes. 2/11/08 - Abdominal ultrasound showed multiple gallstones. 02/11/2010 Follow-up information from a physician conceringin a 21 week old male with no pre-existing medical conditions or allergies who on 15-JAN-2008 at 11:49 was vaccinated PO with his second dose of GARDASIL (lot# 657985/1244U). There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 11:48 included the second dose of TRIPEDIA (lot# U2354BA) in the right anterolateral thigh, the second dose IPOL (lot# Z08732) in the left anterolateral thigh and the second dose PREVENAR (lot# 70145A) in the left anterolateral thigh. On 04-FEB-2008 at 14:19 the patient was seen by the reporting pediatirician for complaint of stools with ono color. The patient had a normal physical examination with no signs of jaundice. Lab diagnostic studies performed included a liver function panel which showed mild elevation of tatl bilirubin 2.0 direct bilirubin 0.8 and AST=79 ALT=140 enzymes. Oh 11-FEB 2008 an abdominal ultrasound showed multiple gall stones. On 21-FEB-2008 with repeat abdominal ultrasound showed interval improvement with fever gall scones, no bile duct dilatation and questionable sludge in gall bladder. On that same day that same day the patient recovered. Additional information has been requested.


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