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This document is a follow-up to the February 1, 2007 report detailing adverse events, concerns and clinical implications related to use of GARDASIL based on submissions made to the federal Vaccine Adverse Event Reporting System... See more » This document is a follow-up to the February 1, 2007 report detailing adverse events, concerns and clinical implications related to use of GARDASIL based on submissions made to the federal Vaccine Adverse Event Reporting System (VAERS). This report covers all reactions submitted in 2006 and supplements the first NVIC analysis of reported adverse events - NVIC Analysis of VAERS Reports on GARDASIL - which can be found at http://www.nvic.org/Diseases/HPV/HPVrpt.htm. Readers are encouraged to review the previous report. A number of clinical and patient safety concerns and potential problems arising from co-administration of GARDASIL with other vaccines not evaluated by the manufacturer were discussed in the previous report. Also, readers are referred to the VAERS website for cautions related to use of VAERS data.[1] The information in this report does not prove a cause and effect relationship between any of the reactions and administration of GARDASIL. This document only summarizes the information in VAERS as it relates to use of GARDASIL, either alone or in combination with other vaccines. Overview And Patient Demographics Through 12/31/06 [2] As of mid-February 2007, there were 430 case reports associated with administration of the GARDASIL vaccine. After the duplicate case records were removed (about 10 percent of files), 385 unique case records remained. The data from the 385 case reports are used for this analysis unless stated otherwise. Since GARDASIL was licensed on June 8, 2006 and added to the recommended American vaccination schedule on June 29, 2006, the number of reports per month filed with VAERS has steadily increased. Two reports were filed in July, 12 in August, 65 in September, 79 in October, 108 in November and 119 in December. Between June 8 and December 31st, an average of 1.87 [3] reports per day have been filed. In December, 3.97 reports per day were filed. As previously reported, the earliest adverse event report date following vaccine licensure and recommendations was July 14, 2006 for a girl vaccinated July 7, 2006. The earliest reported adverse event overall was for a woman vaccinated on September 1, 2003 during a clinical trial. The most recent report included in this analysis was submitted December 28, 2006. Reports were submitted to VAERS at various dates throughout each month but tended to be grouped around four dates. In particular, 247 reports (64 percent of all reports) were submitted on September 19th (44 reports), October 17th (45 reports), November 16th (108 reports) and December 18th (87 reports). Patient Demographics In 98 case reports (25.4 percent) age was not identified. Patient age, where reported, ranged from 1 to 57 years. Among the case reports where age was identified, 111 reports (38.7 percent) were submitted for children 16 and under. The distribution by age of these children is as follows: 1.0/1.5 years (2 cases)[4], 9 (1 case), 11 (9 cases), 12 (10 cases), 13 (14 cases), 14 (25 cases), 15 (27 cases) and 16 (23 cases). In 14 reports, the gender of the patient was not identified. In all but four of the remaining cases, the patients were females. The males for whom case reports were submitted were 1.0, 1.5, 12 and 18-years-old. As of the end of December, case reports have been submitted to VAERS from 43 states and the District of Columbia. Two months earlier, reports had been submitted from 20 states. Description Of Reported Reactions In the case reports submitted to VAERS, five of the reactions were described as "life-threatening," six were "disabling," and 210 (54.5 percent) had "not recovered" as of the date data were provided by VAERS. Hospitalization was reported in 12 cases and two-thirds sought additional care in an emergency room or doctor's office (see Use of Health Services section). A number of symptoms were reported, with varying levels of severity.[5] The most frequently reported reactions were: pain of various types (89), syncope (55) and dizziness (41), fever/pyrexia (41), paresthesia and hypoaestesia (32), rash (33) and pruritis/itching (31), vasodilation (19), See less »

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cancer, cervical, gardasil, hpv, human papillomavirus, immunization, merck, nciv, side effects, vaccination

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From the list : Research Health by fueledbycoffee

The NVIC weighs in with issues over side effects related to Gardasil

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Printer Friendly Format NATIONAL VACCINE INFORMATION CENTER www.nvic.org

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