Administered by: Unknown     Purchased by: Unknown

Symptoms: Biopsy lymph gland, Chemotherapy, Hodgkin’s disease, Radiotherapy

Write-up: Information has been received from the FDA. This report was identified from a line listing obtained by the manufacturer from the FDA under the Freedom of Information Act. Case medically confirmed. A 16 year old female patient received the second dose of GARDASIL (lot # 1068U, batch # NG43220), via intramuscular in the left arm on 07-AUG-2008. The patient received the first dose of GARDASIL (batch # not reported) on 12-JUN-2008. No particular medical history was reported, and no previous illness. No medication before this moment was reported. Seventeen days later, on 24-AUG-2008, the patient was found to have hodgkin”s lymphoma. In the FDA report, the batch # was reported as “N643220”. There was no country of occurrence indicated in the FDA report but after investigation on the batch number provided, the only batch number with similar sequence might be “NG43220”. Therefore, it was confirmed that this batch number had been distributed in foreign country. Biopsy test about lymphatic ganglion was performed in August 2008. The patient received corrective treatment with chemotherapy for 4 months and radiotherapic treatment in 16 sessions. Life threatening was reported as seriousness criteria by FDA. At the time of report, the outcome was not provided. The original reporting source was not provided. The FDA VAERS ID# is 392762-1. Other business numbers include: E2010-04795. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot me the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.