From the FDA:
VAERS Reports Related to Gardasil Vaccination:
no significant findings to date
June 8, 2006 and January 31, 2008
Note: VAERS defines serious adverse events by the Code of Federal Regulations as adverse events involving hospitalization, death, permanent disability, and life-threatening illness. Also, VAERS data are updated continuously and the number of reports will vary depending on the date of analysis.
The following reports were submitted to VAERS between the date the vaccine was licensed (June 8, 2006) and January 31, 2008.
VAERS received 5,070 reports after Gardasil vaccination in the U.S. Less than 7% reported serious side effects, about half of the average for vaccines overall.
Deaths
VAERS received 13 reports of death after Gardasil vaccination in the U.S. After careful review, only 4 of the reported deaths could be verified. Of the remaining 9 death reports, 8 are unconfirmed and one is still pending additional follow-up. None of the reported deaths appear to have been caused by the vaccine.
Note: While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.
Guillain-Barré Syndrome (GBS)
Note: GBS cases take longer to verify because each case must be confirmed manually by CISA staff after reviewing the patient's medical record.
VAERS received 31 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination in the U.S. Seven have been confirmed. Of the 7 confirmed GBS cases, 6 were vaccinated with Menactra and Gardasil at the same time. At this time, studies are underway to evaluate a small increased risk of GBS that may be associated with receipt of the Menactra vaccine. Of the remaining 24 reports, one is a probable GBS case, 8 are unconfirmed, and 15 are pending additional follow-up.
Because GBS occurs at a rate of 1 to 2 per 100,000 person-years during the second decade of life, it is likely that some cases will occur after vaccination but will not be caused by vaccination. Among 9 to 26 year-olds, the number of reports of GBS received by VAERS are within the range that could be expected to occur by chance alone after a vaccination.
Gardasil Vaccine Reports to VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a national program of CDC and the Food and Drug Administration (FDA) that monitors the safety of vaccines after they are licensed. VAERS receives reports of adverse events (possible side effects) that occur after people receive vaccines. These reports provide valuable information that helps CDC and FDA make sure vaccines are safe, and that the benefits of vaccination outweigh the risks.
Anyone can report a health problem in VAERS. Just because a health problem is reported to VAERS does not mean it was caused by a vaccine. Usually, only scientific research can determine if a vaccine really caused the health problem, or if it was just a coincidence.
Gardasil Human Papillomavirus (HPV) Vaccine
On June 8, 2006, the FDA licensed Gardasil®, the first vaccine developed to prevent cervical cancer caused by certain kinds of human papillomavirus (HPV). Since then, more than 12 million doses of Gardasil vaccine have been distributed. At this time, the U.S. does not have a national registry for immunization and vaccination and therefore cannot report the total number of people who have received Gardasil.
Gardasil has been tested in more than 11,000 females 9 to 26 years of age in many countries around the world, including the United States. These studies found the HPV vaccine is safe and causes no serious side effects. The most common side effect is injection site pain.
