HPV Vaccine Side effects…
Gardasil 9 Side Effects
Generic Name: human papillomavirus vaccine
Medically reviewed by Drugs.com. Last updated on Jul 22, 2020.
- Side Effects
Note: This document contains side effect information about human papillomavirus vaccine. Some of the dosage forms listed on this page may not apply to the brand name Gardasil 9.
For the Consumer
Applies to human papillomavirus vaccine: intramuscular suspension
Side effects requiring immediate medical attention
Along with its needed effects, human papillomavirus vaccine (the active ingredient contained in Gardasil 9) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking human papillomavirus vaccine:
Incidence not known
- back, leg, or stomach pains
- bleeding gums
- chest pain
- dark urine
- difficulty with breathing
- difficulty with swallowing
- dizziness or lightheadedness
- fast heartbeat
- general body swelling
- hives or welts, itching, or skin rash
- loss of appetite
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- sore throat
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- tightness in the chest
- unusual tiredness or weakness
- yellowing of the eyes or skin
Side effects not requiring immediate medical attention
Some side effects of human papillomavirus vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- difficulty with moving
- joint pain or swelling
- muscle ache, cramps, pain, or stiffness
- upper abdominal or stomach pain
- Body aches or pain
- ear congestion
- loss of voice
- nasal congestion
- runny nose
Incidence not known
- dark urine
- difficulty with moving
- pain, swelling, or redness at the injection site
- pains in the stomach, side, or abdomen, possibly radiating to the back
For Healthcare Professionals
Applies to human papillomavirus vaccine: intramuscular suspension
The most common adverse events were injection site reactions, fatigue, headache, and myalgia.[Ref]
Very common (10% or more): Injection site pain (91.9%), injection site swelling (49%), injection site erythema (48.4%)
Common (1% to 10%): Injection site pruritus, injection site hematoma, injection site induration, injection site hemorrhage, injection site warmth, injection site mass, injection site reaction
Postmarketing reports: Injection site cellulitis[Ref]
Deaths occurred during clinical trials which were generally assessed as not vaccine related: car accidents, suicides, acute lymphocytic leukemia, hypovolemic septic shock, airplane crash, cerebral hemorrhage, gunshot wound, stomach adenocarcinoma, pulmonary embolus/deep vein thrombosis, sepsis, pancreatic cancer, arrhythmia, pulmonary tuberculosis, hyperthyroidism, post-operative pulmonary embolism and acute renal failure, traumatic brain injury/cardiac arrest, systemic lupus erythematosus, cerebrovascular accident, breast cancer, nasopharyngeal cancer, autoimmune disease, infectious disease, homicide, and 1 unexplained sudden death 678 days following the last vaccine dose.[Ref]
Very common (10% or more): Fatigue (54.6%), headache (53.4%), pyrexia (13%), fever of 99.5F or higher (12.9%)
Common (1% to 10%): Chlamydia infection, malaise
Uncommon (0.1% to 1%): Death
Postmarketing reports: Asthenia, chills[Ref]
Very common (10% or more): Myalgia (48.8%), arthralgia (20.7%)
Common (1% to 10%): Back pain
Postmarketing reports: Pain in extremity[Ref]
Common (1% to 10%): Nausea, diarrhea, vomiting, abdominal pain upper, toothache
Rare (less than 0.1%): Appendicitis, gastroenteritis
Postmarketing reports: Pancreatitis[Ref]
Common (1% to 10%): Nasopharyngitis, oropharyngeal pain, influenza, cough, nasal congestion, upper respiratory tract infection, pharyngitis
Rare (0.01% to 0.1%): Pneumonia, pulmonary embolism, asthma
Very rare (less than 0.01%): Bronchospasm
Frequency not reported: Asthmatic crisis
Postmarketing reports: Pulmonary embolus[Ref]
Common (1% to 10%): Dizziness, migraine
Postmarketing reports: Acute disseminated encephalomyelitis, Guillain-Barre syndrome, motor neuron disease, paralysis, seizures, syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in falling with injury, transverse myelitis[Ref]
New medical conditions potentially indicative of systemic autoimmune disorders included: arthralgia/arthritis/arthropathy, autoimmune thyroiditis, celiac disease, diabetes mellitus insulin dependent, erythema nodosum, hyperthyroidism, hypothyroidism, inflammatory bowel disease, multiple sclerosis, nephritis, optic neuritis, pigmentation disorder, psoriasis, Raynaud’s phenomenon, rheumatoid arthritis, scleroderma/morphea, Stevens-Johnson syndrome, systemic lupus erythematosus, uveitis, alopecia areata, ankylosing spondylitis, autoimmune thrombocytopenia, myocarditis, proteinuria, skin depigmentation, dermatomyositis, vasculitis, and vitiligo.[Ref]
Common (1% to 10%): New medical conditions potentially indicative of systemic autoimmune disorders
Postmarketing reports: Autoimmune diseases[Ref]
Common (1% to 10%): Injection site hypersensitivity
Frequency not reported: Allergy to vaccine
Postmarketing reports: Hypersensitivity reactions (including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria)[Ref]
Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura[Ref]
Common (1% to 10%): Insomnia[Ref]
Common (1% to 10%): Dysmenorrhea, vaginal infection, urinary tract infection
Rare (less than 0.1%): Pelvic inflammatory disease, pyelonephritis[Ref]
Common (1% to 10%): Rash, urticaria, itching/pruritus
Postmarketing reports: Cellulitis, angioedema, erythema multiforme[Ref]
Postmarketing reports: Deep vein thrombosis[Ref]
1. “Product Information. Cervarix (human papillomavirus vaccine).” GlaxoSmithKline, Research Triangle Park, NC.
2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
3. “Product Information. Gardasil 9 (human papillomavirus vaccine).” Merck & Company Inc, Whitehouse Station, NJ.
4. “Product Information. Gardasil (human papillomavirus vaccine).” Merck & Company Inc, West Point, PA.
5. Cerner Multum, Inc. “Australian Product Information.” O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
Human papilloma virus vaccines and infertility
Extract from GACVS meeting of 4-5 December 2019, published in the WHO Weekly Epidemiological Record of 24 January 2020
Mortality due to cervical cancer remains high in several countries in the European Region,7 and human papillomavirus (HPV) vaccines have been introduced in 38 of 53 countries in the Region, comprising 94% high-income, 29% middle-income and 57% low–middle-income (Gavi-eligible) countries. HPV vaccine coverage of adolescent girls is, however, highly variable, ranging from 6% to 95% in these countries.8 The reasons for low HPV vaccine coverage include concern about the safety of the vaccine among parents and adolescent girls, including fear that it could cause infertility, and anxiety that discussions about sex might promote early onset of sexual activity among adolescent girls. School teachers and even some health care workers also have concerns and fear; health care workers are concerned about safety (e.g. infertility, stress-related responses), and many are insufficiently informed to understand and trust the safety of HPV vaccines. Some feel insecure when there is a serious AE after HPV vaccination. In some settings, it is difficult to distinguish between good- and poor-quality scientific information. WHO is working in several countries to support vaccine introduction, including formative research to understand the concerns of target groups, communications plans, crisis communications plans and education of health care workers.
To respond to the concern raised in some countries that have recently introduced HPV vaccine, the literature on HPV vaccination and infertility was reviewed. Since the first marketing authorization in 2006, post-licensure monitoring and research have been conducted for the 3 vaccines (bivalent by GlaxoSmithKline, quadrivalent and 9-valent by Merck and Co.), with over 160 studies completed in several countries. HPV vaccines were found to have a favourable safety profile, with no confirmed clinically serious signals about safety. Anaphylaxis and syncope are known AEs. Concern about safety has, however, reduced vaccination rates in some countries.
Since 2012, individual case reports have linked vaccination against HPV with primary ovarian insufficiency (POI), defined as dysfunction or depletion of ovarian follicles, menopausal symptoms and reduced fertility before the age of 40. A systematic review of the literature on HPV vaccines and infertility was conducted, in which 608 articles were identified. After exclusion of duplicates and irrelevant studies, 9 articles were retained for the review, of which 7 addressed HPV vaccination and POI and 2 assessed the association between HPV vaccination and the ability to conceive. The details of the studies were reported to the Committee, which reviewed the evidence in the 9 articles (case reports, passive surveillance and epidemiological studies) and concluded that, although the safety of HPV vaccine has received considerable media attention, the evidence does not suggest a causal relationship between HPV vaccination and infertility.
Three articles reported on cases of POI in 6 girls 8–24 months after they received the first dose of quadrivalent vaccine.9-11 A temporal association was found, but there was no evidence for a causal association nor for the involvement of a vaccine component in the pathogenic process or of autoimmune disease. The authors did not consistently evaluate patients for POI by the method recommended by the American College of Obstetricians and Gynecologists and other organizations. Publicly available reports of data on POI from passive surveillance were available from Australia,12 Europe13and the USA.14 All were reassuring, and the Committee concluded that there was no evidence for a causal relation between HPV vaccination and POI and that the safety profiles for both quadrivalent15 and 9-valent vaccines16 were consistent with pre-licensure and post-marketing safety data.
The epidemiological studies were reviewed. The first was a prospective cohort study of women planning a pregnancy in Canada and the USA.17 17 No association was found between HPV vaccination and fecundability. The second was an ecological evaluation of the association of HPV vaccination with pregnancy based on data from the National Health Nutrition Examination Survey 2007–2017, which was the only study that suggested any association. While women who received HPV vaccine were less likely to report ever having been pregnant, the article was retracted by the journal because of serious flaws in both data analysis and interpretation.18 The third study was an evaluation of hospital discharges from the National Inpatient Sample database in the USA, which showed no increase in hospital discharges of 15–17-year-old girls before or after introduction of HPV vaccine.19 A limitation of this study is that POI is rarely evaluated in inpatients. In the fourth, rigorous epidemiological study at one site of the Vaccine Safety Datalink20 (a population-based vaccine safety network of health care organizations in the USA), no association was found between POI and HPV vaccination. It was noted that no effect of HPV vaccination on fertility was found in 3 studies in rodents.
GACVS concluded that the available data do not support an association between HPV vaccination and infertility or POI. The current safety profile continues to be extremely favourable, as discussed at 7 previous GACVS meetings, and consistent with the pre-licensure safety profile.21 HPV vaccine safety will continue to be monitored and will be reviewed by GACVS as appropriate. GACVS recommends that communications strategies about vaccine safety ensure appropriate understanding of the safety profile.
7 Vaccination, vaccins et produits biologiques. Genève, Organisation mondiale de la Santé, 2019 (https://www.who.int/immunization/monitoring_surveillance/data/en/, accessed December 2019).
8 Estimations OMS de la couverture vaccinale contre le papillomavirus humain 2010-2018. Genève, Organisation mondiale de la Santé, 2019 (http://www.who.int/immunization/monitoring_surveillance/data/HPV_estimates.xls, accessed December 2019).
9 Colafrancesco S1, et al. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013;70(4):309–316.
10 Little DT, Ward HR. Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination. BMJ Case Rep. 2012; pii: bcr2012006879.
11 Little DT, Ward HR. Adolescent premature ovarian insufficiency following human papillomavirus vaccination: a case series seen in general practice. J Invest Med High Impact Case Rep. 201428;2(4):2324709614556129.
12 Database of Adverse Event Notifications (DAEN). Canberra: Department of Health; 2019 (https://www.tga.gov.au/database-adverse-event-notifications-daen, accessed December 2019).
13 Eudravigilance – Base de données européenne des rapports d’effets indésirables susceptibles d’être liés à l’utilisation de médicaments. Amsterdam: Agence européenne des médicaments, 2019 (http://www.adrreports.eu/fr/index.html, accessed December 2019).
14 Vaccine Adverse Event Reporting System (VAERS). Atlanta (GA): Centers for Disease Control and Prevention; 2019 ((https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html, accessed December 2019).
15 Arana JE, et al. Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009–2015. Vaccine. 2018;36(13):1781–1788.
16 Shimabukuro TT, et al. Safety of the 9-valent human papillomavirus vaccine. Pediatrics. 2019;144(6):e20191791.
17 McInerney KA, et al. The effect of vaccination against human papillomavirus on fecundability. Paediatr Perinat Epidemiol. 2017;31(6):531–536.
18 Statement of retraction: [A lowered probability of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection.] J Toxicol Environ Health Part A. 2019;81(14):661–674.
19 Pellegrino P, et al. On the association between human papillomavirus vaccine and primary ovarian failure. Am J Reprod Immunol. 2014;71:293–294.
20 Naleway AL, et al. Primary ovarian insufficiency and adolescent vaccination. Pediatrics. 2018;142(3):e20180943.
21 See No. 28, 2017, pp. 398–401.
CDC Report Stirs Controversy For Merck’s Gardasil Vaccine
Serious side effects from HPV vaccine Gardasil were reported to the CDC.
By RADHA CHITALE<br>ABC News Medical Unit18 August 2009, 20:40• 7 min read
August 19, 2009 — — A government report released Tuesday raises new questions about the safety of the cervical cancer vaccine Gardasil. The vaccine has been linked to 32 unconfirmed deaths and shows higher incidences of fainting and blood clots than other vaccines.
But while some physicians expressed concern over the findings, other doctors viewed the report as reassuring, showing that the vaccine was not associated with any more unusual and serious side effects as other vaccines.
The results of the report appeared along with an accompanying editorial discussing whether the potential benefit of the HPV vaccine is worth its potential risks in the Journal of the American Medical Association. The editorial, in particular, could give pause to many parents faced with the decision of whether or not to have their 11- and 12-year-old daughters vaccinated against the certain strains of the human papillomavirus, or HPV.
On Wednesday morning, ABC News Chief Medical Editor Dr. Timothy Johnson said that he, too, would encourage parents to learn more about the shot before getting their daughters vaccinated.
“I am very much in favor of childhood vaccines,” Johnson told Chris Cuomo on Wednesday’s “Good Morning America,” adding that there is little doubt that the vaccine does have its benefits.
“We know it does what it says – it prevents HPV infections,” he said.
But he added that when it comes to comparing the benefits of the HPV vaccine against its potential risks, he believes there simply is not enough evidence to recommend to all parents that they have their daughters vaccinated.
“I don’t think we yet know the long term benefits or risks,” Johnson said. “I’m taking a pass on this one and saying to parents, ‘Study the issue, read the editorial… talk to your doctor.'”
Those who search for more information on the vaccine may also find stories from other parents who say the vaccine had ill effects on their daughters. One of these parents, Emily Tarsell, started her daughter Christina on Gardasil — a vaccine that protects against four of the most common cancer-causing strains of the human papilloma virus (HPV) — after her first visit to a gynecologist and at the doctor’s recommendation.
Eighteen days after Christina received her final vaccine shot, she died.
“I know it was the Gardasil,” Tarsell said, although the official cause of death was undetermined. “They were really recommending it, saying that there weren’t any side effects, that it was safe. So I kind of went against my better instinct [and let her] get the shot.”
Deaths like Christina’s are one of several types of complications reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) following Gardasil distribution in 2006. Some of these adverse events were serious, including blood clots and neurological disorders, and some were non-life threatening side effects from the vaccine, including fainting, nausea and fever.
Although experts agree that the accuracy of data from VAERS reports — which can be made by anyone and are not verified or controlled for quality — is questionable, they remain divided as to whether extreme adverse events, which are serious but rare, are cause enough to stop recommending and administering the Gardasil vaccine without further investigation.
Report Shows Rare But Serious Side Effects May Result From Gardasil Vaccine
“Although the number of serious adverse events is small and rare, they are real and cannot be overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients,” said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri. “The rate of serious adverse events is greater than the incidence rate of cervical cancer.”
As of June 1, 2009, the CDC reported that over 25 million doses of Gardasil, which is recommended for women between ages 9-26, have been distributed in the U.S. and there was an average of 53.9 VAERS reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death.
In a statement yesterday from Merck, the pharmaceutical company that manufactures Gardasil, the company backed the vaccine’s efficacy and said they encourage further research on its safety.
“We are pleased that the study published by JAMA [yesterday] further reinforces the safety profile of Gardasil,” said Dr. Richard M. Haupt, head of the clinical program for Gardasil at Merck. “We welcome continued study and discussion about the safety of this important vaccine.”
But some clinicians are not ready to accept wide use of the drug based on the available safety data.
Dr. Jacques Moritz, director of gynecology at St. Luke’s-Roosevelt Hospital, said he would not offer the Gardasil vaccine to patients when good cervical cancer screening techniques and treatments exist. He has also chosen not to have his 11-year-old daughter get the HPV shot because of his concerns.
“I’m pro preventing cervical cancer and HPV,” Moritz said. “I’m not pro that the physicians don’t know the risks and side effects.”
VAERS Report Is No Measuring Stick For Gardasil Side Effects
But clinicians on both sides of the vaccination debate agree that data provided by the VAERS report is limited because it lacks any baseline comparison for the adverse events reported. This makes it difficult to draw cause and effect relationships when a death, for example, occurs soon after administering the Gardasil vaccine.
In fact, the JAMA study authors showed that 90 percent of those with blood clots had typical risk factors for clots, outside of having received the vaccine — using oral contraceptives, for example, or smoking.
“The problem is that there is a difference between an adverse reaction caused by the vaccine, as opposed to an adverse event reported in association with the vaccine,” said Dr. Lauren Streicher, an obstetrician-gynecologist at Northwestern Medical School, who supports use of the vaccine. “Patients need to understand the true risk of the vaccine, as well as the risks of not getting the vaccine.”
Understanding Risks and Side Effects Essential For Recommending Gardasil
The overwhelming consensus regarding Gardasil use is that physicians who are not well versed in the risks of HPV and cervical cancer and the side effects of the vaccine cannot adequately counsel patients whether or not to be vaccinated.
Dr. Joseph Zanga, chief of pediatrics at the Columbus Regional Healthcare System in Columbus, Ga., pointed out that Gardasil does not prevent women from contracting HPV in every instance, that many people who are infected will spontaneously rid themselves of the virus, and that routine pap smears are still the best prevention against cervical cancer.
“Perhaps the most important, currently missing ‘warning’ is that the vaccine may not be forever,” Zanga said. “We know that it protects for 5-7 years so that a girl getting the series at [age] 11-12 will enter the time of her most likely sexual debut unprotected but believing herself to be.”
Many Doctors Will Continue to Provide Gardasil
Dr. L. Stewart Massad, the Practice and Ethics Committees chair for the American Society for Colposcopy and Cervical Pathology, said his organization has educated thousands of clinicians about the risks of HPV and the Gardasil vaccine.
“We based our education [program] criteria on data from the CDC’s risk assessment,” he said. “Certainly there are differences of opinion when it comes to how adverse events are, you have to balance the risk for each patient.”
Massad also noted that the ASCCP was unable to secure government or other non-profit funding for education outreach programs when the vaccine was first introduced and turned instead to private companies, including Merck, which manufactures Gardasil.
Further Investigation of Adverse Reports Needed
Harper said that the next step in determining the severity of the risks associated with the Gardasil vaccine would be for the CDC to investigate the reported adverse events and verify a causal relationship. But this may prove a difficult task, she said, because many of those events were reported by Merck and did not include sufficient information to perform an investigation.
Still, the report is unlikely to prevent most doctors from continuing to provide the vaccine to patients.
“There are 772 serious problems identified in 23 million doses of vaccine,” said Dr. Kevin Ault, associate professor of Gynecology and Obstetrics at Emory University. “I usually tell my patients that these serious events are tragic, rare and likely unrelated to the vaccine.”
ABC News’ Tyeese Gaines-Reid contributed to this report.