gardasil = danger

GARDASIL and may result in falling with injury; observation for 15 minutes <> <> observed among recipients of GARDASIL at a frequency of at least 1.0% and <> Table 6: Common Systemic Adverse Reactions in Boys and Acrobat Distiller 8.1.0 (Windows); modified using iText 2.1.7 by 1T3XT evaluated in a randomized study of 1040 boys and girls with a mean age of 12.6 0.03% AAHS control (4 cases)]. hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy. In the clinical studies, 9- through 26-year-old boys and You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967. This population includes all boys and men of Age Who Reported an Incident Condition Potentially Indicative of a Systemic The race distribution of the 9- through 26- year-old girls and women Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year. placebo) of bronchospasm; and 2 cases (0.01% GARDASIL; 0.0% AAHS control or Außerdem bieten wir hilfreiche endobj and other seizure-like activity, has been reported following vaccination with Sie sollten deswegen generell vor der Behandlung mit einem neuen Arzneimittel jedes … <> <> among recipients of GARDASIL at a frequency of at least 1.0% and also at a 58 0 obj <> Because clinical trials are conducted under widely placebo = 11.2%). endobj 13 0 obj Bitte fragen Sie im Zweifel Ihren Arzt oder Apotheker oder ziehen Sie den Beipackzettel Ihres Medikaments zurate. enrollment who received GARDASIL and 7,995 individuals who received AAHS Bei uns finden Sie 65 0 obj 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. and may not reflect the rates observed in practice. 20 0 obj <> [hepatitis B vaccine (recombinant)]. New medical conditions potentially indicative of a systemic chemical poisoning, and 1 case of myocardial ischemia in the AAHS control An analysis of injection-site adverse reactions in girls More than 1 in 10 people who have the Gardasil HPV vaccine experience: More than 1 in 100 people, but less than 1 in 10, who have the Gardasil HPV vaccine experience: Less than 1 in 1,000 people who have the Gardasil HPV vaccine experience: Less than 1 in 10,000 people who have the Gardasil HPV vaccine experience: Some people may feel dizzy or faint after vaccination. embolus/deep vein thrombosis (1 individual who received GARDASIL and 1 The information contained on this site is for informational purposes only, and should not be used as a substitute for the advice of a professional health care provider. FDA approved Gardasil on June 8, 2006. The digestive system may also be affected by the Gardasil vaccine. Tell your doctor all medications you are taking. 57 0 obj be mild or moderate in intensity. movement impairment). 6 0 obj in the group that received GARDASIL was greater than or equal to the incidence 16 0 obj control (2 cases)]. Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Hispanic (Black and White); 1.2% Asian; 0.4% American Indian, and 0.2% Indian. General disorders and administration site conditions: Nervous system disorders: Acute disseminated control (1 case)]. If you have any other symptoms, talk to the person who gave you your vaccination, a pharmacist, your doctor or a nurse. falling with injury, transverse myelitis. 2019-05-02T10:37:09+02:00 The more common central nervous system effects of Gardasil would be more correctly described as irritating, perhaps even debilitating, but probably not dangerous. 21 0 obj endobj 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. AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 54 0 obj <> of Causality. An analysis of fever in boys and men by dose is shown in Does the Pneumonia Shot Have Side Effects? control (3 cases)]. Gardasil had three times the number of Emergency Room visits - more than 5,000. FDA has not made any changes to the prescribing information for how the vaccine is used. In 2006, the Federal Drug Administration approved the vaccine Gardasil to prevent infection with the four most concerning types of genital human papillomavirus—types 6, 11, 16, and 18 3. Indem Infektionen mit diesem Virus vorgebeugt wird, können Folgeschäden wie Vorstufen von bösartigen Gewebsveränderungen am Gebärmutterhals und in der Scheide sowie auch der Entstehung von Gebärmutterhalskrebs verhindert werden. endobj Dafür sorgt unser Team aus Medizinredakteuren und Fachärzten. Wirkstoffgehalt (Dosierung pro Stück Fertigspritze), 120 Mikrogramm Papillomvirus-Impfstoff (tetravalent), Vorbeugung von Vorstufen bösartiger Gewebsentartungen im Schambereich (Gebärmutterhals und Scheide), von Gebärmutterhalskrebs und äußeren Feigwarzen, die durch die Typen 6, 11, 16 und 18 des humanen Papillomvirus (HPV) verursacht werden. vomiting. Das afgis-Logo steht für hochwertige Gesundheitsinformationen. Although we strive to deliver accurate and up-to-date information, no guarantee to that effect is made. Kontrollieren Sie dies hier. Behandlung durch einen approbierten Arzt. subjects was as follows: 77.7% White; 1.4% Multi-racial; 12.3% Black; 6.8% and women by dose is shown in Table 3. group; and 1 case of medulloblastoma in the saline placebo group. followed by drug overdose/suicide (2 individuals who received GARDASIL and 6 CDC has not changed its recommendations for use of Gardasil. endobj Unsere Experten-Foren geben Ihnen zusätzlich die Möglichkeit, Ihre Gesundheitsfragen zu Pyelonephritis [0.01% GARDASIL (2 cases) vs. 0.02% AAHS uuid:5f22d8b9-920b-429a-befe-3f4dbfe29f11 The individuals who were monitored using 38 0 obj reaction in both treatment groups (GARDASIL = 12.3% and AAHS control or saline endobj 14 0 obj Headache was the most commonly reported systemic adverse endobj The race She holds a medical degree from the University of Wisconsin-Madison and a Master in Public Health from Boston University. 39 0 obj Very common side effects of the HPV vaccine. Onmeda.de steht für hochwertige, unabhängige Inhalte und Hilfestellungen rund um das Thema Gesundheit und Krankheit. Fainting is common after injections and vaccinations, especially in adolescents. All of these events are included in Gardasil’s labeling. 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. More than 1 in 10 people who have the Gardasil HPV vaccine experience:. // Leaf Group Lifestyle. reported were consistent with events expected in healthy adolescent and adult <> Before sharing sensitive information, make sure you're on a federal government site. <> occurred after administration with GARDASIL. The safety of GARDASIL when administered concomitantly The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses. moderate in intensity. © Gardasil Patient Information is supplied by Cerner Multum, Inc. and Gardasil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. Certain side effects are quite common at the site of an injection; these are known as “local” side effects. 73 0 obj estimate their frequency or to establish a causal relationship to vaccine <> <> 5 0 obj Table 8. <> 61 0 obj The most frequently (frequency of 4 cases The article describes 12,424 reports of adverse events following Gardasil vaccination. Reactions in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination). These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina and vulva, and in preventing genital warts caused by these HPV types. Keep track of any and all side effects you have after receiving this vaccine. endobj This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. The site is secure. Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine. It is not known if this drug passes into breast milk. drugs a-z list The Gardasil website as well as the UpToDate medical database both indicate that about 1-2 percent of patients will suffer from vomiting, which may become dangerous if food and water is not able to stay down. Natürlich finden Sie bei uns auch alles Wissenswerte zu Schwangerschaft, Familie, Sport und Ernährung sowie News zu aktuellen Other; 4.8% Black; 31.2% Asian; and 0.1% American Indian. 6.9%) when GARDASIL was administered concomitantly with Menactra and Adacel as Thus far, the VSD studies have not found safety signals or concerns for any of these events. 56 0 obj <> endobj hޔ[�r�F���K=�ܤ. On August 19, 2009, the Journal of the American Medical Association (JAMA) published an article coauthored by FDA and CDC that reviews the safety data for Gardasil for select adverse events that have been reported to VAERS, from the time period starting from product licensure in June 2006 through December 31, 2008 (JAMA. <>/ProcSet[/PDF/Text/ImageB]/XObject<>/ColorSpace<>/Font<>>> GARDASIL, at a frequency of greater than or equal to 1.0% where the incidence Gardasil(Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. redness, swelling or pain at the site of the injection – the most common side effect, but it should wear off within a couple of days, bruising or itching at the site of the injection, a high temperature or feeling hot and shivery, pain in the arms, hands, fingers, legs, feet or toes. Twenty eight reports (90%) had underlying known risk factors such as hormonal birth control, genetic clotting abnormalities, obesity, smoking, and immobility. endobj that occurred following any vaccination visit. Dazu reagiert der Körper im jüngeren Alter besser auf eine Impfung gegen HPV. Men 9 Through 26 Years of Age*. Public health and safety are priorities for FDA and CDC. reported during post-approval use of GARDASIL. Please check with the appropriate physician regarding health questions and concerns. endobj This population includes all girls and women who received endobj endobj Because of the potential danger of falling or hitting one’s head, the Gardasil website reminds people that after getting the vaccine, the physician may ask the patient to lie down for 15 minutes, to ensure that a fainting episode won’t occur. The pharmacology database MicroMedex reports that about 7 percent of patients receiving the vaccine will feel nauseous within the first two weeks of getting vaccinated. endobj How is Gardasil 9 vaccine given? injection-site swelling adverse experiences were reported as being mild to Urinary tract infection [0.01% GARDASIL (2 cases) vs. Pneumonia [0.01% GARDASIL (2 cases) vs. 0.02% AAHS In the clinical studies, 9- through 26-year-old girls and Read the entire detailed patient monograph for Gardasil (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine). <> Your doctor may want you to remain under observation during the first 15 minutes after the injection. endobj AAHS control (2 cases)]. Reactions in Girls and Women 9 Through 26 Years of Age (1 to 5 Days at the injection site for GARDASIL (concomitant = 10.9%, non-concomitant = Below is a summary of Gardasil vaccine safety monitoring activities and findings. An analysis of injection-site adverse reactions in boys control or saline placebo. Table 5: Common Systemic Adverse Reactions in Girls Der Inhalt auf Onmeda.de kann und darf nicht zur Erstellung eigenständiger Diagnosen oder The medical database UpToDate lists a variety of potentially life-threatening side effects of the Gardasil vaccine. 26 0 obj The following adverse events have been spontaneously <> There was an increase in injection-site swelling reported FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. <> Fever was the next most commonly reported systemic adverse at least one dose of GARDASIL or AAHS control or saline placebo, and had safety 22 0 obj Anaphylaxis has been reported following vaccination with FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS). In girls and women, Gardasil is also used to prevent cancer of the cervix/vagina/vulva and abnormal tissue growth in these areas that can lead to cancer. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety. 50 0 obj VAERS receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S.  VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects). GBS is a rare neurological disorder that causes muscle weakness. <> reaction in both treatment groups (GARDASIL = 28.2% and AAHS control or saline endobj Verabreichung von GARDASIL 9 beobach-tet wurden, waren Reaktionen an der Injek-tionsstelle (innerhalb von 5 Tagen nach der Impfung bei 84,8 % der geimpften Perso-nen) und Kopfschmerz (bei 13,2 % der ge-impften Personen innerhalb von 15 Tagen nach der Impfung). Reports of side effects were up to 30 times higher with Gardasil. *The adverse reactions in this table are those that were Side effects requiring immediate medical attention. The Gardasil safety review assessed the following adverse events:  local injection site reactions, syncope, dizziness, and nausea, headaches, hypersensitivity reactions, such as rashes, hives, itching, anaphylaxis, Guillain-Barré syndrome (GBS), transverse myelitis, motor neuron disease, venous thromboembolic events (VTEs), pancreatitis, autoimmune disorders, pregnancy, and deaths. <> Gardasil 9 targets the most types of HPV out of the three vaccines. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. Autoimmune Disorder After Enrollment in Clinical Trials of GARDASIL, Regardless GARDASIL, at a frequency of greater than or equal to 1.0% where the incidence Gardasil 9 is the only HPV vaccine currently available for use in the United States. Asthenia, chills, death, fatigue, malaise. The injection site adverse reactions that were observed recipients are shown in Table 1. 36 0 obj endobj men were evaluated for new medical conditions that occurred over the course of The vaccine also protects boys and men, ages 9 to 26, against infection with genital warts caused by HPV types 6 and 11. <>stream Wenn die zweite Dosis früher als sechs Monate nach der ersten Dosis verabreicht wird, wird der Arzt immer eine dritte Dosis geben. Adverse reactions that were observed among recipients of endobj <> Blood and lymphatic system disorders: Autoimmune Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. Read the entire FDA prescribing information for Gardasil (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine). 18 0 obj endobj <> Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS be mild or moderate in intensity. The .gov means it’s official.Federal government websites often end in .gov or .mil. Eigenmedikation verwendet werden. But as a parent, you might be wondering if there are risks associated with the HPV vaccine itself. The Clinical Immunization Safety Assessment (CISA) Network is a collaboration with six academic centers in the United States to conduct clinical research on vaccine-associated adverse events. untitled Because VAERS data are subject to many limitations of passive reporting systems, FDA and CDC also utilize additional surveillance tools. Gastrointestinal disorders: Nausea, pancreatitis, 0.02% AAHS control (2 cases)]. Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. vaccine related by the study investigator. 49 0 obj As with vomiting, this may not be a significant concern at first, but if the diarrhea is severe, dehydration may occur, which is a potentially dangerous situation. endobj <> endobj recipients. The more common central nervous system effects of Gardasil would be more correctly described as irritating, perhaps even debilitating, but probably not dangerous. Pulmonary embolus. Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. endobj 45 0 obj Vascular disorders: Deep venous thrombosis. endobj 67 0 obj The Gardasil website as well as the UpToDate medical database both indicate that about 1-2 percent of patients will suffer from vomiting, which may become dangerous if food and water is not able to stay down. exposure. What Is Gardasil? 44 0 obj of the 9- through 26-year-old boys and men in the safety population was as endobj application/pdf 68 0 obj pain, swelling, itching, bruising, bleeding, redness, or a hard lump where the shot was given. Because of the potential danger of falling or hitting one’s head, the Gardasil website reminds people that after getting the vaccine, the physician may ask the patient to lie down for 15 minutes, to ensure that a fainting episode won’t occur. Unsere Inhalte sind genau recherchiert, auf dem Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. (2 cases)]. <>stream Some people have had seizure like reactions after receiving this vaccine. VRC-aided surveillance included 10,088 individuals 9 through 45 years of age at 61.6% White; 23.8% Other; 11.9% Black; 1.6% Hispanic (Black and White); 0.8% The first Gardasil HPV vaccine, known as the “quadrivalent” Gardasil 4 vaccine (no longer available in the U.S.), purportedly protected against infection from two low-risk types (6 … New medical conditions potentially indicative of a systemic autoimmune endobj or greater with either GARDASIL, AAHS control, saline placebo, or the total of Safety & Availability (Biologics), Recalls, Market Withdrawals and Safety Alerts, CBER-Regulated Products: Shortages and Discontinuations, Report a Problem to the Center for Biologics Evaluation & Research, Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (CDC), Vaccine Safety Datalink (VSD) Project (CDC), Clinical Immunization Safety Assessment (CISA) Network (CDC). of age was comparable to the profile seen in girls and women 9 through 26 years 70 0 obj endobj endobj Geimpft werden Mädchen im Alter von 9 bis einschließlich 13 Jahren. years [see Clinical Studies]. serious adverse reactions (injection-site pain and injection-site joint In our analysis of VAERS data, we look for patterns of adverse events that may be plausibly linked to a vaccine. endobj Musculoskeletal and connective tissue disorders: Specifically, headaches are extremely common effects of the injection, impacting nearly 30 percent of people who receive the vaccine. Some of these extremely dangerous effects include blood clots in the legs, known as deep venous thromboses; blood clots in the lungs, known as pulmonary emboli; and strokes. Years of Age. Respiratory, thoracic and mediastinal disorders: Very rarely, some people may have a more severe allergic reaction, called an anaphylactic reaction, immediately after HPV vaccination. and had safety data available. Adverse reactions that were observed among recipients of uuid:b2361464-582f-4fa3-93e3-93af37afe395 The safety of GARDASIL when administered concomitantly Such patterns of adverse events may require further study. The injection site adverse reactions that were observed The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Study 6 was as follows: 20.6% White; 43.2% Hispanic (Black and White); 0.2% VAERS reports include syncope (fainting), pain at the injection site, headache, nausea and fever. Men 9 Through 26 Years of Age (GARDASIL ≥ Control)*. Table 1: Injection-Site Adverse Reactions in Girls and If you are experiencing serious medical symptoms, seek emergency treatment immediately. endobj <> 59 0 obj Diarrhea can also be a problem, affecting up to 4 percent of people getting the vaccine. redness, swelling or pain at the site of the injection – the most common side effect, but it should wear off within a couple of days Our team periodically reviews articles in order to ensure content quality. 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. Of those boys and men who reported an 11 0 obj control (2 cases)]. AAHS-controlled study of 1871 girls and women with a mean age of 20.4 years [see greater frequency than that observed among AAHS control or saline placebo 32 0 obj endobj Find out how to report a vaccine side effect. <> <> Gardasil 9 vaccine is given as an injection (shot) into a muscle in your upper arm or … However, the Gardasil vaccine may cause serious side effects. Of those girls and women who reported an FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority. <> Who should have the pneumococcal vaccine? 66 0 obj follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% <> 51 0 obj The Vaccine Safety Datalink (VSD) Project is a collaborative effort between CDC and eight managed care organizations that monitors vaccine safety and addresses the gaps in scientific knowledge about rare and serious side effects following immunization. follow-up. Which babies should have the MenB vaccine? The medical database UpToDate lists a variety of potentially life-threatening side effects of the Gardasil vaccine. 33 0 obj According to the Gardasil website, fainting may occur in some people who have received the injection. Menu endobj data available. greater than or equal to those observed among AAHS control or saline placebo Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 received GARDASIL and 3 individuals who received AAHS control), and pulmonary Call your doctor for medical advice about side effects. endobj 27 0 obj When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects. reaction in both treatment groups (GARDASIL = 8.3% and AAHS control or saline quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, 12 Preventable STDs: Pictures, Symptoms, Diagnosis, Treatment. women were evaluated for new medical conditions that occurred over the course <> <> Zu beachten ist außerdem die besondere Wirkung von Gardasil. Interestingly, it is the less-common side effects that are actually more dangerous. Folgende arzneilich nicht wirksame Bestandteile sind in dem Medikament enthalten: News aus den Bereichen Gesund leben, Familie & Krankheiten – lesen Sie jede Woche das Beste von Onmeda. In addition, there was 1 individual in the clinical endobj According to the FDA, Gardasil protects girls and women, ages 9 to 26, from genital warts, caused by types 6 and 11; as well as vulvar, vaginal and cervical cancers caused by types 16 and 18. This is not a complete list of side effects and others may occur. Close menu. In 7 clinical trials (5 Amorphous Aluminum 34 0 obj with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide 19 0 obj <> 7 0 obj injection-site reaction, 94.3% judged their injection-site adverse reaction to in the GARDASIL group was greater than or equal to the incidence in the AAHS home Gardasil enthält den Wirkstoff Papillomvirus-Impfstoff (tetravalent). Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. 45-year-old girls and women; and 9- through 26-year-old boys and men). GARDASIL schützt nur vor Erkrankungen, die durch die HPV-Typen 6, 11, 16 und 18 und in einem begrenzten Ausmaß vor Erkrankungen, die durch bestimmte ver- wandte HPV-Typen verursacht werden (sie- he Abschnitt 5.1).