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This is VAERS ID 310289
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| VAERS ID: | 310289 | Vaccinated: | 2003-01-10 | | Age: | 19.0 | Onset: | 2003-05-27, Days after vaccination: 137 | | Gender: | Female | Submitted: | 2008-04-18, Days after onset: 1788 | | Location: | | Entered: | 2008-04-21, Days after submission: 3 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: chest computed axial tomography, 16May03, mediastinal tumor; biopsy, 27May03, morbus Hodgkin nodula sclerose stadium 11A; chest computed axial tomography, 04Aug03, strong decrease of the glandules on neck and the mediastinal tumor | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: None | | CDC 'Split Type': WAES0804USA03544 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV | UNKNOWN MANUFACTURER | | 0 | IM | UN | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Computerised tomogram abnormal, Hodgkin's disease, Lymphadenopathy, Lymphatic system neoplasm, Malignant mediastinal neoplasm, Mediastinal mass, Nasopharyngitis, Radiotherapy | | Write-up: This report is being submitted in response to an FDA request for information. A 19 year old female entered a study, and reported Hodgkin's lymphoma as new medical history at Month 6. On 10-JAN-2003 and 14-MAR-2003, the patient was vaccinated intramuscularly with a 0.5 mL first and second dose of Gardasil. She did not receive a third dose of vaccine, but did remain in the study (discontinued vaccination due to Hodgkin's disease but remained in the study for follow-up). The condition was reported as active, diagnosed in 2003 (27-MAY-2003). Annotations indicate the following: On 26-MAY-2003, CT thorax: mediastinal tumor 8.3 x4cm + lymphatic nodes. On 27-MAY-2003, a biopsy: Morbus Hodgkin nodula sclerose stadium IIA (Her father: 1995: lymphogranulomadosis). Stage IIIA. She caught a cold in May 2003 and discovered lymphatic nodes on the right side of her neck. Beyond that, no other symptoms. She was asymptomatic before entering the trial and until May 2003. It was felt that this diagnosis was probably not vaccine related. She had received cytostatica and radiation therapy. 04-AUG CT thorax: strong decrease of the glandules on the neck and the mediastinal tumor. No other medical history was reported for this subject. No serious clinical adverse experiences were reported. No additional information is available regarding the Hodgkin's disease. The subject entered the study extension (Protocol 015-10): study extension which offered vaccine to subject who received placebo or received incomplete vaccination regimens of HPV vaccine and received her third dose of vaccine on 05-MAY-2007. The patient completed the study extension on 19-JUN-2007. No serious adverse experiences were reported in the study extension. Per protocol, because the episode of Hodgkin's disease was not vaccine related and reported beyond the follow-up period for adverse experiences, the Hodgkin's disease was not reported as an Adverse Experience, but was reported as medical history in the protocol study data base. No further informati |
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http://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=310289
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