Report Concerning Survey of Adverse Events Following Inoculations with Gardasil

Gardasil Unexplained

2010 Emily Tarsell, LCPC and James Garrett, PhD
February 18, 2010

Background The Food and Drug Administration (FDA) concluded that the rates of Adverse Events Following Injections (AEFIs) for the human papillomavirus recombinant vaccine (qHPV) Gardasil were not greater than background rates. They also acknowledge limitations in the reporting system that could compromise this conclusion. On record as of 1/31/2010 were 15,829
AEFI reports including 49 deaths.

Methodology 39 respondents who experienced AEFIs following Gardasil injections self-selected to complete an on-line National Vaccine Information Center (NVIC) questionnaire. Respondents checked symptoms experienced prior to and following consecutive qHPV injections. Additional data were gathered and analyzed and an exact test was performed regarding 6 cases of death.

Principal Findings The data reect a two to four fold increase in occurrence, type and severity of symptoms with additional exposure to Gardasil for all respondents. Chronic fatigue and headache or dizziness were pervasive and compounded over time. Additional concurrent symptoms and frequency reported were: numbness, muscle pain, nausea and muscle weakness, 6070%; joint pain, chest pain, skin disorders and concentration problems, more than 50%; menstrual problems, 40%; post-vaccine heart disorders, 33%; seizures, 13%20%. Time intervals from inoculation to
onset of symptoms were mostly within 30 days. Cause of death was undetermined for five cases; one autopsy is pending. Five of the six deaths occurred after the third injection. This diverges from expectations if the deaths were coincidental. There was statistical evidence at the 5% level, with a p-value of 0.0434, that the hypothesis that Gardasil is not related to any of the reported deaths is not tenable.

Conclusion Data analyzed suggest a dose-response and temporal relationship to Gardasil. Data may be biased toward reports of severe adverse reactions. However, a vaccine can have a low rate of AEFIs while still indicating strong evidence that the small numbers of events that do
occur are related to the vaccine.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.