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This is VAERS ID 282557

Case Details

VAERS ID: 282557 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-02-26
Onset:2007-02-26
   Days after vaccination:0
Submitted: 2007-05-25
   Days after onset:87
Entered: 2007-06-06
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1281F / UNK RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
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:
Current Illness:
Preexisting Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA00495

Write-up: Information ahs been received from a registered nurse concerning a 14 year old female with a "cardiac history" and no drug reactions/allergies who on 26-FEB-2007 was vaccinated intramuscularly in the right arm one dose of VAQTA (lot # 656320/1281F). Concomitant therapy included GARDASIL, ADACEL and MENACTRA. On 26-FEB-2007 the patient experienced an injection site reaction from the vaccination. The reaction consisted of redness, swelling and pain in the right arm. The patient sought unspecified medical attention. The patient was seen by the physician on 01-MAR-2007 and was still having the symptoms. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. There was no product quality complaint. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the CBER and was released by the regulatory agency. Additional information has been requested.


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