Disease & Vaccine Information

Can HPV Vaccine Cause Injury and Death?



hpv

The most commonly reported side effects of HPV vaccination include pain, swelling, and redness at the injection site, nausea, headache, fever, fatigue, and muscle or joint pain. Fainting – referred to as a syncopal episode - following HPV vaccination has been frequently reported and as a result, it is recommended that individuals receiving the vaccine remain sitting or lying down to prevent syncope and any potential injuries that may result from a fall.  However, more severe reactions have also been reported in HPV vaccine clinical trials and to the federal Vaccine Adverse Events Reporting System (VAERS). See Human Papillomavirus (HPV) Quick Facts for 2018 reports of HPV vaccine reactions, hospitalizations, injuries and deaths made to VAERS.

Some of the adverse events reported by the manufacturers during pre-licensing clinical trials included:

Gardasil - injection site pain, swelling, redness and bruising, fever, headache, nausea, dizziness, syncope, sometimes in conjunction with seizure-like activity, anaphylaxis, diarrhea, vomiting, cough, upper respiratory tract infection, nasal congestion, insomnia, malaise, oropharyngeal pain, nasopharyngitis, upper abdominal pain, gastroenteritis, appendicitis, pelvic inflammatory disease, urinary tract infection, pneumonia, pulmonary embolism, pyelonephritis, bronchospasm, and death. 

Cervarix - injection site pain, redness, bruising and swelling, syncope, fatigue, headache, gastrointestinal symptoms, rash, fever, arthralgia, myalgia, urticarial, urinary tract infection, back pain, dysmenorrhea, nasopharyngitis, influenza, vaginal infection, pharyngitis, chlamydia infection, arthritis, rheumatoid arthritis, Celiac disease, diabetes mellitus, erythema nodosum, inflammatory bowel disease, hyperthyroidism, hypothyroidism, multiple sclerosis, transverse myelitis, systemic lupus erythematosus, thrombocytopenia, vasculitis, optic neuritis, vitiligo, and death. 

Gardasil 9 - injection site pain, swelling, redness, and bruising, syncope, fever, headache, nausea, dizziness, fatigue, diarrhea, upper respiratory tract infection, upper abdominal pain, oropharyngeal pain, myalgia, asthmatic crisis, anaphylaxis, and death. 

Gardasil 9 reported post marketing adverse events include: pulmonary embolus, idiopathic thrombocytopenic purpura, lymphadenopathy, autoimmune hemolytic anemia, pancreatitis, asthenia, chills, fatigue, malaise, bronchospasm, urticarial, anaphylaxis, acute disseminated encephalomyelitis, dizziness, transverse myelitis, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope (including syncope associated with other seizure-like activity and tonic-clonic movements) sometimes resulting in injury from falling, deep vein thrombosis, cellulitis, myalgia, arthralgia, and death.

In 2007, NVIC reviewed adverse events reported to the Vaccine Adverse Events Reporting System (VAERS), and noted a statistically significant increased risk of Guillain-Barre Syndrome(GBS) and other serious adverse events when Gardasil was administered with other vaccines, especially the meningococcal vaccine, Menactra. The analysis noted a 1,130 percent increase in GBS, a 674 percent increase in injuries from falls after loss of consciousness, a 234 percent increase in coordination and neuromuscular problems, a 118 percent increase in cardiac problems, a 114 percent increase in respiratory problems and a 30.1 percent increase in convulsions and central nervous system problems when Gardasil was administered with Menactra. 

During the past decade, there have been numerous studies and reports linking HPV vaccination to chronic illnesses in children and young adults. These include anaphylaxis,  lupus,   erythema multiforme,  acute disseminated encephalomyelitis,    transverse myelitis,  amyotrophic lateral sclerosis (ALS),  central nervous system demyelination,   multiple sclerosis,  including pediatric multiple sclerosis,  Guillain-Barre Syndrome,   pancreatitis,   inflammatory bowel syndrome,  brachial plexus neuritis,  brachial neuritis,  optic neuritis,  neuromyelitis optica,  opsoclonus myoclonus,  evanescent white dot syndrome,   acute cerebellar ataxia,  autoimmune hepatitis,  autoimmune neuromyotonia,  vasculitis,  thrombocytopenic purpura,  immune thrombocytopenic purpura,  Postural Orthostatic Tachycardia Syndrome (POTS),    Complex Regional Pain Syndrome (CRPS),  Chronic Fatigue Syndrome (CFS),  and peripheral sympathetic nerve dysfunction.  A published questionnaire  of HPV vaccination recipients focusing on a combination of chronic illness including POTS, CRPS, and fibromyalgia found that 93 percent of individuals reporting symptoms related to these conditions were still incapacitated and unable to work or attend school four years after vaccination.  Additionally, several studies have linked HPV vaccination to primary ovarian failure resulting in impaired fertility    . A 2018 study found lower pregnancy rates in women who had received HPV vaccination. 

Adverse events following HPV vaccination have also been linked to a relatively new medical condition termed Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA).  In 2011, Dr. Yehuda Shoenfeld, the founder and head of the Zabludowicz Center for Autoimmune Diseases in Israel, published a paper associating four medical conditions - Gulf War syndrome (GWS), macrophagic myofasciitis syndrome (MMF) (a syndrome previously related to the use of aluminum adjuvants), siliconosis (a condition related to silicone breast implants) and post-vaccination phenomena (chronic illness following vaccination) to a previous adjuvant exposure.

Dr. Shoenfeld noted that patients suffering from these conditions presented with very similar clinical symptoms. Since then, published studies have linked the aluminum adjuvant found in the HPV vaccine to several chronic health conditions including postural tachycardia syndrome (POTS),  primary ovarian failure (POF),   chronic epipharyngitis,  pseudo-neurological syndrome,  and severe somatoform and dysautonomic syndromes.  An epidemiological study of data collected from the federal Vaccine Adverse Events Reporting System (VAERS) estimated that 3.6 out of 100,000 doses of HPV vaccination resulted in symptoms that were consistent with a diagnosis of ASIA. 

An animal study on the effects of HPV vaccination found that both the HPV antigens and the aluminum adjuvant appear to have the ability of trigger autoimmune reactions and neuroinflammation in female mice, leading to changes in behavior patterns. 

Studies linking HPV vaccination to sudden death in previously healthy women have also been published. A 2012 published case study of two deaths following HPV vaccination concluded that the HPV-16L1 antigens present in HPV vaccines have the potential to cause fatal autoimmune vasculopathies.  Also in 2012, Sin Hang Lee, a research scientist and board certified pathologist, published a case study involving the sudden and unexplained death of a young women six months after completing a three dose series of Gardasil. Dr. Lee found in the blood and spleen HPV-16 gene DNA that were similar to HPV-16 gene DNA fragments in Gardasil. The HPV-16 LI gene DNA was bound to the same aluminum adjuvant found in the vaccine, which protected it from degradation. It continues to be unknown whether or not these HPV DNA fragments played a role in the girl’s death.

A 2017 article published in Drug Safety reviewed safety concerns associated with HPV vaccination.  Data reported to adverse reaction reporting systems from several countries were analyzed and found to contain relatively high numbers of reports for headache, dizziness, fatigue, and syncope associated with prolonged hospitalization or debilitation. While some of the reports listed Postural Orthostatic Tachycardia Syndrome (POTS), Complex Regional Pain Syndrome (CRPS) or Chronic Fatigue Syndrome (CFS) as a diagnosis, the vast majority of the reports lacked any diagnosis. This study also found significantly higher number of events involving a combination of dizziness and headache with either syncope or fatigue following HPV vaccination compared to adverse reactions of other vaccines. It was also noted that these combinations of symptoms were first reported in countries that were the earliest to approve and recommend HPV vaccination and that reported symptoms persisted globally.

Due to these findings, others have questioned whether current drug and vaccine safety monitoring tools have the ability to adequately detect and respond to signals indicating that a serious problem may exist with a product currently on the market.  Additionally, a 2018 study noted that only about half of the available clinical trials involving HPV vaccines had been completed before the vaccines were approved by both the Federal Drug Administration (FDA) and the European Medicines Agency (EMA).  The study also noted that drug manufacturers only published the results of about two-thirds of the HPV clinical trials, leaving the study’s authors to question whether drug manufacturers were selectively choosing which clinical data to publish.

In December 2017, Slate Magazine published a cover story on the pre-licensure clinical trials of the Gardasil vaccine.   This investigational report determined that Merck’s pre-licensure safety studies “used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trial.”  The article noted that Merck’s clinical trial investigators were permitted to use personal judgment when reporting medical problems as an adverse event, essentially allowing study investigators to decide what symptoms might possibly be related to vaccination. Study investigators were also allowed to list new health issues following vaccination as medical history, not adverse events, and limited safety follow up to 14 days following each of the three doses of Gardasil vaccination. Slate’s investigation located several women involved in Gardasil’s pre-licensure trials who reported chronic illness post-vaccination to study investigators, yet their symptoms were never reported by Merck.

In April 2018, the Indian Journal of Medical Ethics published a report suggesting that Sweden’s increase in cervical cancer rates might be associated with HPV vaccination. The study’s author, concerned that he may be targeted for questioning a vaccine’s safety or efficacy, chose to publish under an assumed name without contacting the journal in advance. Initially, the journal chose to allow the article to be published despite the deception after determining that the author had both the necessary credentials and faced a credible threat of harm, stating “the issues raised by it are important and discussion on it is in the public interest.”  However, two weeks later, after receiving  “valuable advice from the journal’s editorial board and others”, the article was retracted.  The journal, however, stated that they “hope that the hypothesis of possible harm of vaccinating women previously exposed to HPV is carefully explored in future studies.”  Data from Gardasil’s pre-licensure clinical trials had previously demonstrated a higher incidence of cervical intraepithelial neoplasia (CIN) grade 2 and 3 in women previously infected with the particular strain targeted by the vaccine. 

According to federal VAERS data, as of October 31, 2022, 612 deaths following the HPV vaccination have been reported.  However, the number of HPV vaccine related injuries and deaths reported to VAERS is assumed to be underreported as explained below.  

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to the federal vaccine adverse event reporting system (VAERS), many doctors and other health care providers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. The evidence suggests that only one to 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.     

As of November 1, 2022, 685 claims have been filed to the federal Vaccine Injury Compensation Program (VICP) for 17 deaths and 668 injuries that occurred after HPV vaccination. To date, the U.S. Court of Claims has compensated 161 of the children and adults who filed claims for HPV vaccine injuries. 

For example, an HPV vaccine injury claim was filed and awarded by the VICP for Christina Tarsell. Christina was a 21-year-old college student majoring in studio arts at Bard College when she received a series of three Gardasil shots. A talented athlete, artist and honor roll student, she died suddenly and without explanation shortly after the third shot in June 2008. Ten years later, in 2018, the government conceded the case and awarded compensation to her mother for Christina’s vaccine-related death. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about HPV and the HPV vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 


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