Gardasil Side Effects

Gardasil Side Effects

Gardasil is a human papillomavirus (HPV) vaccine developed by Merck & Co. The U.S. Food and Drug Administration (FDA) granted fast-tracked approval for Gardasil to prevent a handful of HPV strains, including two strains considered high-risk for cervical cancer. But since it was approved in 2006, Gardasil has been linked to serious side effects, including death and paralysis, among many others.

Gardasil Makes Good Vaccines Look Bad

There is currently a great deal of controversy surrounding vaccines. Our firm wishes to stress that we are not against vaccines. They have the potential to eradicate disease and save millions of lives. We are, however, against intentional efforts to mislead consumers about the safety and effectiveness of a drug or vaccine. We have always fought- and will continue to fight- for the rights of consumers to be fully and honestly informed about risks associated with any drug, vaccine, or medical device. We will work tirelessly to ensure those rights are defended and victims of injustice and compensated for their injuries.

The attorneys at Baum Hedlund Aristei & Goldman represent individuals from across the nation who were harmed by Gardasil. If you or a member of your family suffered an adverse reaction after a Gardasil injection, we can help.

Our Gardasil lawyers are evaluating cases against Merck for individuals who experienced the following side effects after receiving a Gardasil shot (or shots):

  • Acute disseminated encephalomyelitis
  • Arthritis
  • Auto-immune disorders
  • Birth defects
  • Cervical intraepithelial neoplasia – CIN 2/3
  • Chronic fatigue syndromes
  • Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Chronic pain syndromes, including Chronic Regional Pain Syndrome (CRPS)
  • Coma
  • Deaths
  • Dysautonomia
  • Epilepsy (seizure disorder)
  • Fibromyalgia
  • Guillain-Barre syndrome
  • Heart problems, including severe arrhythmia and heart attacks
  • Inflammatory disorders
  • Interconnective tissue disorder
  • Lupus
  • Miscarriage
  • Movement disorders
  • Multiple sclerosis
  • Neurological disorders
  • Paralysis
  • Postural orthostatic tachycardia syndrome (POTS)
  • Pulmonary embolism
  • Reproductive disorders, including premature ovarian failure
  • Rheumatological disorders
  • Small fiber neuropathy
  • Stroke

Baum Hedlund Aristei & Goldman has decades of experience litigating against many of the largest pharmaceutical companies in the world. We have won more than $4 billion in settlements and verdicts on behalf of our clients.

Call us today at (855) 948-5098 or fill out our contact form for a free and confidential Gardasil lawsuit review.

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  • Drug Injury $9 Million
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Gardasil 4 vs. Gardasil 9

Researchers have identified more than 200 different types of human papillomavirus (HPV). HPV viruses are divided into high-risk and low-risk types. Low-risk types of HPV pose little to no risk of causing cervical cancer, but may cause genital warts and minor changes in cervical cells. High-risk types of HPV are those that have been linked to cervical cancer.

In 2006, the U.S. Food and Drug Administration (FDA) approved the first Gardasil HPV vaccine, known as “quadrivalent” Gardasil 4, to protect against infection from two low-risk types of HPV (6 & 11) and two high-risk types of HPV (16 & 18). The original Gardasil 4 is no longer available in the U.S. Individuals now receive Gardasil 9.

What Are the Side Effects of Gardasil?

The current Gardasil 9 HPV vaccine protects against the same four types of HPV that original Gardasil 4 protected against, plus five additional high-risk types (31, 33, 45, 52, and 58).

According to the Gardasil 9 package insert, the most common Gardasil 9 side effects are:

  • Headache
  • Fever
  • Nausea
  • Dizziness
  • Injection-site pain
  • Swelling
  • Abnormal skin redness (erythema)
  • Severe itching (pruritus)
  • Bruising

The Gardasil package insert mentions several other serious conditions that were reported during the controversial clinical trials. However, because the clinical trials compared Gardasil to the adjuvant used in the vaccine – with no mention of the toxic effects of adjuvants – rather than a placebo, the package insert reader is left with the impression that these conditions are unrelated to the vaccine. These conditions are listed below.

In particular, many clinical trial participants developed autoimmune conditions.

Gardasil Shot Side Effects in Girls and Women Potentially Indicative of a Systemic Autoimmune Disorder

  • Arthralgia (joint pain)
  • Arthritis
  • Arthropathy (joint disease)
  • Diabetes
  • Celiac disease
  • Hyperthyroidism and hypothyroidism
  • Inflammatory bowel disease
  • Multiple sclerosis
  • Nephritis (inflammation of the kidneys)
  • Rheumatoid arthritis
  • Scleroderma (an autoimmune disease that affects skin and connective tissue, including tissue that supports the body’s nerves and blood vessels)
  • Stevens-Johnson syndrome (a severe and sometimes fatal skin disease)
  • Systemic lupus erythematosus (an autoimmune disease characterized by painful and swollen joints, fever, chest pain, mouth ulcers, feeling tired, and rash)

Gardasil Shot Side Effects in Boys and Men Potentially Indicative of a Systemic Autoimmune Disorder

  • Ankylosing spondylitis (a type of arthritis causing inflammation of the joints of the spine – thought to be caused by autoimmune dysfunction)
  • Arthralgia, arthritis
  • Autoimmune thrombocytopenia
  • Diabetes mellitus type 1
  • Hyperthyroidism and hypothyroidism
  • Inflammatory bowel disease
  • Myocarditis

Gardasil Vaccine Side Effects Reported to VAERS

There are more than 64,000 case reports of HPV vaccine adverse reactions in the Vaccine Adverse Events Reporting System database. It is estimated that only 1% of serious adverse events are actually reported to VAERS.

It is noteworthy that many of these serious side effects of Gardasil have been reported to the VAERS database in concerning numbers. As of Jan. 14, 2020, the VAERS database contains over 64,000 case reports of adverse reactions tied to HPV vaccines worldwide (over 50,000 in the U.S.).

Disease Condition VAERS Case Reports Linking Gardasil to the Condition
Arthralgia 1813
Multiple sclerosis 217
Systemic lupus erythematosus 153
Rheumatoid arthritis 75
Stevens-Johnson syndrome 9
Scleroderma 8

Another section of the package insert titled “Postmarketing Experience” lists a number of other Gardasil 9 side effects, while cautioning that “[b]ecause these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.” Those side effects include autoimmune diseases, such as Guillain-Barre syndrome (167 case reports in VAERS), hypersensitivity reactions including anaphylactic shock (368 VAERS case reports), and seizures (483 VAERS case reports).

“All patients had symptoms consistent with pronounced autonomic dysfunction including different degrees of orthostatic intolerance, severe non-migraine-like headache, excessive fatigue, cognitive dysfunction, gastrointestinal discomfort and widespread pain of a neuropathic character.” — Louise Brinth, et al., “Suspected side effects to the quadrivalent human papilloma vaccine,” Danish Medical Journal, 62 (4), April 2015

Have more questions about Gardasil? Check out our Gardasil FAQ page.

Studies Confirm Gardasil Risks

HPV vaccines, including Gardasil, have been linked in case studies to a cluster of symptoms that are shared by several disorders not mentioned on the Gardasil package insert. These include postural orthostatic tachycardia syndrome (POTS), complex regional pain syndrome (CRPS), and fibromyalgia. The WHO database and the VAERS database contain hundreds of case reports of POTS and CRPS.

Fibromyalgia, an autoimmune disorder characterized by musculoskeletal pain, fatigue, sleep, and memory issues, was tied to Gardasil in 125 VAERS database case reports, per the 2018 study linked above.

Reports from other nations confirm continuing issues with serious Gardasil side effects. In 2013, the Japanese government suspended its recommendation of Gardasil following nearly 2,000 reports of adverse reactions, including walking disturbances, body tics, and seizures. Japan later established special clinics for treating illnesses linked to Gardasil. In March 2015, Denmark opened five “HPV Clinics” to gather information on people injured by the Gardasil HPV vaccine.

Several nations have filed criminal charges against Merck, including France, India, and Spain. In Spain, the allegations include fraudulent marketing and/or administration of an inadequately tested vaccine, failure to inform the public about the potential risks of using Gardasil, and clear infringement of the right to informed consent.

A 2017 study published in the journal Clinical Rheumatology analyzing 16 HPV vaccine clinical trials (including the Gardasil clinical trials) and 12 post-marketing case series (medical research in which individual patients are followed for a period of time) reported that only 2 of the 16 clinical trials for HPV vaccines purported to use an inert placebo.

Two of the most extensive HPV vaccine trials found significantly more serious adverse events in patients who received the vaccine compared to those who did not.

Several related findings by the Clinical Rheumatology study authors are key. Gardasil 9 was associated with much more local swelling (at the injection site) than the quadrivalent Gardasil. Gardasil 9 was also associated with more “vaccine-related systemic events,” such as headaches, dizziness, muscle and joint pain, nausea, vomiting, and abdominal pain (all symptoms of autoimmune disease), compared to the quadrivalent Gardasil vaccine.

Gardasil Vaccine and Dysautonomia

Dysautonomia describes a group of disorders affecting the autonomic nervous system (ANS). A person’s ANS controls involuntary body functions like breathing, blood pressure, and heart rate, among many others. Dysautonomia conditions, like postural orthostatic tachycardia syndrome (POTS) and orthostatic intolerance, occur when the ANS fails to send or receive messages correctly.

Here is an example:

When a person is lying down, approximately one-quarter of their blood volume resides in the chest area. When the person stands up, a significant amount of that blood shifts to the lower extremities. This causes impaired return of blood flow to the heart, which also reduces blood pressure.

In healthy individuals, the autonomic nervous system adjusts the heart rate to counteract this effect and the blood flow changes are negligible. However, in individuals suffering from dysautonomia, the body’s ability to adjust the heartrate and compensate for the blood flow is corrupted, resulting in a host of wide-ranging symptoms, including dizziness, lightheadedness, vertigo, woozy sensation, chronic headaches, and many other issues.

Scientists have found that Gardasil is capable of causing dysautonomia because of the vaccine’s strong immune stimulating ingredients. Lawsuits against Gardasil’s manufacturer, Merck, allege the mixture of adjuvants in Gardasil is responsible for post-vaccination induced autoimmune diseases, including dysautonomia.

Adjuvants like aluminum are inflammatory substances that hyperactivate the immune system. Merck adds adjuvants to Gardasil with the intent of increasing the immune response to the virus like particles in the vaccine. Adjuvants can cause the immune system to lose the ability to differentiate human proteins from foreign proteins, which leads to the immune system attacking the body’s own proteins and organs. Because of the massive peptide commonality between HPV and human proteins, the indiscriminate attack triggered by the Gardasil adjuvants can cause massive cross-reactions and dangerous attacks against human proteins, which can lead to dysautonomia.

Gardasil Vaccine and POTS

Postural orthostatic tachycardia syndrome (POTS) is a disorder that affects blow flow. People diagnosed with POTS often experience (among other things):

  • Dizziness
  • Lightheadedness
  • Vertigo
  • Woozy sensation
  • Chronic headaches
  • Extreme fatigue
  • Vision issues due to the loss of blood flow to the brain
  • Sensitivity to light and sound
  • Loss of consciousness
  • Shortness of breath
  • Chest pain, Gastrointestinal issues
  • Body pains
  • Insomnia
  • Confusion

Numerous published medical journal articles have discussed the association between Gardasil and POTS:

Contact our attorneys by calling (855) 948-5098 or completing our online form today.

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