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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Initial report received on 07 June 2007 from another manufacturer, report# WAES0705USA05073. The initial reporter to this manufacturer had been the FDA, VAERS# not provided. Verbatim from the report: "Information has been received from an agency concerning a 13 year old female with an allergy to cats (the patient owns a cat) who on 22-FEB-2007 was vaccinated intramuscularly into the right arm with a dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included MENACTRA (Lot# U2158AA) in the left arm, HAVRIX (Lot# AHABV141AA) in the right arm and NASONEX. On 22-FEB-2007, 30 minutes after receiving the vaccines, the patient developed cough, wheezing and shortness of breath. The patient was seen in the emergency department for an allergic reaction to the vaccines. Initially, the patient returned to her primary care physician with complaints of chest tightness, difficulty breathing and tremors. The patient was treated with EPI-PEN and BENADRYL and sent to the emergency room. There was no swelling of the mouth, lips or tongue. Vital signs were performed and the patient had a pulse of 141, respiratory rate of 20 and blood pressure of 130/91. The patient was treated with SOLU-MEDROL and Ranitidine. A physical exam was unremarkable (lungs clear, no rhonchi, no wheezes). The patient was admitted to the hospital for IV steroid treatment. At the time of this report, the outcome was unknown. Cough, wheezing, shortness of breath, chest tightness, difficulty breathing, allergic reaction to vaccines and tremors were considered to be immediately life-threatening. The original reporting source was not indicated. A lot check has been requested. No further information is available." It was reported in the structured filed of the report that all vaccines were administered intramuscularly.
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