|
Gardisal HPV Side Effects
Gardasil is a HPV vaccine designed to prevent the initial establishment of HPV infections. It is manfuactured by Merck & Co and is also known as Silgard. For maximum efficacy, it is recommended that girls receive the vaccine prior to becoming sexually active. However, women who were already infected with one or more of the four HPV types targeted by the vaccine (6, 11, 16, or 18) were protected from clinical disease caused by the remaining HPV types in the vaccine.
Since Gardasil will not block infection with all of the HPV types that can cause cervical cancer, the vaccine should not be considered a substitute for routine pap smears. Human papillomavirus (HPV) infections cause nearly all cases of cervical cancer. Cervical cancer is the fifth leading cause of death from cancer in women world-wide, and the leading cause of cancer-related deaths among women (See: Q & A regarding Gardasil)
Common Gardasil Side Effect
Side effects to Gardasil, as reported by Merck & Co:
- Pelvic pain
- Muscle pain
- Mild fever
- Cough
- Severe stomach pain
- Pain, swelling or stiffness in joints
- Pain, swelling, redness or itching at the injection site
- Nausea, vomiting, diarrhea, upset stomach
- Dizziness
- Runny or stuffy nose &
- Sore throat
Adverse Event Reports following Gardasil
To date, the manufacturer, Merck and Co., has distributed over 16 million doses of Gardasil in the United States. As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events. Since Gardasil was approved, the great majority (94%) of adverse events reported to VAERS after receiving this vaccine have not been serious. These reports include syncope (fainting), pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after syncope may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine's prescribing information was changed to include this information.
Serious Adverse Reaction Reports (6% of total reports)
Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of June 30, 2008, 20 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine. Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.
Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting. Thromboembolic disorders as well as other medical events are being studied through the VSD in previously planned controlled studies. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine's safety. Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.
Gardasil Related Deaths
Twenty deaths had been reported to the FDA and CDC administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil. However, according to the FDA, no common pattern to these deaths has been detected that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine
Gardisil Lawsuits
If you or your loved one have suffered blood clots, a heart attack, paralysis or a loved one has died shortly after receiving the HPV Gardasil injection, then call us immediately discuss your potential rights to as Gardasil side effects lawsuit. Call us for a Free Gardasil Side Effects Case Evaluation.
Online Gardasil Case Evaluation Form: |