Jones, Stephanie .j I 4
From: James Lyons-Weiler
To my representatives in the Governmentin the Commonwealthof Pennsylvaaa, : C) I submit these to you for your considerationand as Public Commentary.
I am writing with deep concerns over the currentproposed changes in the Departmentof Health DOH) regulation concerningvaccines. Federal and internationallaw and standards since theNuremberg trials have made it clear that all patient must be afforded informedconsent for any medical procedure.The proposed move to reduce the time for vaccine compliance is very disturbing, as it reduces the amount of time that a parent can take to conduct sifficient checking for accuracy and thoroughness of the information provided by their doctors. Clearly this change is designed to reduce the amount of time available for doctors to discuss vaccine safety with patients, follow up on calls, schedule consultations,and perform their own inquiries,and will thereby restrict somepatients to access to information they need to make informed choices about medical procedures.
Many doctors and other health care workers alreadyfail to provide all of the informationnecessary to parentsto make informed decision about the risk of specific vaccines to their children. I am told by pediatricians that they are under an enormous amount of pressure to reduce each office visit to seven minutes — hardly enoughtime to answer questions from patients seeking full information.For example, I recently called my child doctor officere: the HPV vaccine to inquire on safety, given the reports of large numbers of deathstsand injuryts due to adversereactions to the vaccine. The safety profile on HPV vaccine has been drawn into question so much so that the nation of Japan has refused to allow its use in practice there.
I was told by the nurse that she was “requiredby law” to tell me that HPV vaccine was very safe, but she gave no detail on the adverse reaction. When I quoted her statement “requiredby law”, she denied saying it. However, when I spoke with the doctor, he also said that the risk of any adverse event was very small, but could not go into any detail on the types of adverse events. I requested the vaccine insert, which he said he would send. It came to me an in a hand-written, unmarked envelope with no return address, and the insert listed a few minor possible side effects. The insert also containedthe following: “For informationon additionalpotential
1 adverse events, consult with your doctor”. When patients are put into a Catch-22 situation, how can we be expected to trust our healthcare providers?
Patients must havethe right to makefUllyinformed decisions about the medical procedures to which they decide to subject their children and themselves. The efficacy of }-IPVvaccine is also very much in question, given that the vaccine only protects against some of type of HPV. Studies have shown that rarer, potentially more dangerous types of HPV can replace those removed due to partial vaccination. This could result in a higher rate of HPV-related cancers. The studies include one by Quo et al, (2015), which found type replacement, as well as a study conducted by CDC (Markowitz et al., 2016), which found no change in overall HPV infection rates before and after HPV vaccination. The CDC study authors incorrectly concluded that no type replacement had occurred, and I have pointed out this error in interpretation to the authors. These studies have led to other states dropping proposed mandatory HPV vaccination, including Maryland.
HPV vaccine is now known to cause early ovarian failure — i.e., to induce menopause in young females. It is clearly not a safe vaccine, and yet UPMC’s nurses and doctors continue to push it on Pennsylvanians. What else do we not know about adverse events from vaccines? I have attached a study on HOV adverse events that concludes that 1 in 10 girls are harmed.
The proposed changes would also force parents to provide evidence of chickenpox immunity from a medical professional. This is not in keeping with the principle of freedom of choice, and informed consent. If a parent has decided, after due consideration of the risks of vaccination, to forego chickenpox vaccination, to avoid unwanted adverse events and side effects, it is the right of the parent to make the decision to forego chicken vaccination. The problem with singling out a single vaccine is that no science has been done on individual vaccines that support the conclusion offered by the CDC that “Vaccines Do Not Cause Autism”. In fact, of the six vaccines for which studies do exist, there is in fact preliminary scientific evidence in support of association. For 6112vaccines given before the age of?, no studies have been conducted on possible association with autism, and thus the overarching conclusion that “Vaccines Do Not Cause Autism” is actually not based on any scientific evidence.
CDC called for an end to studies of possible association of vaccines and autism after a handful of studies were conducted in the mid-to-late 2000’s. One of those studies, Destefano et al. (2004), is now subjectto investigation by CDC for possible fraud due to the fact that the authors of the study arbitrarily and intentionally omitted two sets of results showing positive association between the MMR vaccine, and autism.
Evidence of this alleged fraud has been entered in the US CongressionalRecord by Rep. William Posey (FL), and is the subject of the documentary “Vaxxed”, currently being screened around the country, which I urge you to screen with your colleagues.
2 Anotherproposed change would be the addition of a meningocoecalvaccine requirementfor students entering the 12thgrade. One problem with mandatoryvaccination is that if some people have a predisposedgenetic risk of adverse events due to any specific vaccine, mandatory vaccinationcompelsthem with certaintyto suffer that fate. While few medical proceduresare 100%risk4iee, the biologicalnature of the match betweena given family’sprotein sequences and the sequencesin adjuvantedvaccines guaranteesautoimmunedisordersof all types. Severe allergic reactions (anaphylaxis)can occur.
Taken from a population view, the adverse event looks rare (cited as 1 in million at CDC website).However, if one has a sibling or parent who has already suffered an allergic reaction to a vaccine, shouldthey not have the right to reflise subjecting themselves to the same fate? A spate of instances of life-longdebilitatingnarcolepsy cause in some families OSK’sswine flu vaccine in Europe has led to GlaxoSmithiClinesettling with families for millions of Euros. No cases were found due to the swine flu vaccine offered by Novartis. While public health policies, laws and mandates effect everyone,personal risk is personal, and we should not want any vaccine mandate that could eondenin an unwitting minority in the populationto life-threateningand disablingadverse events.
People should have the chance to declinevaccination based on first principles of ethics (sanctity of self), unless there is an immediate and pressing public health emergency. Vaccinemanufacturercannot be held liable for adverse events in the US, even when Federal compensationis refUsed.
Another proposed set of changes is to require pertussis vaccinefor kindergarten admission,remove separate listing for vaccines and only show combinations(MMR, TDaP). Some, and perhaps most, people will do fine with combined vaccines. However, individual vaccines spaced out over time may reduce the severity of individual adverse reactions. Measles is not a deadly disease. In fact, over the last ten years, therehave been zero deaths due to measles, and over 100deaths due to measles vaccinationin the US. Because Pharma is not help responsible, there is no incentive for them to find out why. For other drugs, FDA requires randomized, prospective clinical trials after animal safetystudies. The types of studies that CDC relies on are retrospective, or “ecological”studies, and CDC has a history of re-analyzingthe data in their studies if a positiveassociation is found, and re-analyzingthe data until an association goes away.
This is not a solid basis for health care policies that are to be appliedto millions of Pennsylvanians.We need to move in the other direction, and demand safer vaccines, Pharma accountability,and we need to have real science conducted on adverse events associated with vaccinesbefore any law is passed than condemnsmillions of our children to the neurotoxins and unsafe epitopes in vaccines. Listing only combinationvaccineswould preclude parents from making informed choice on individual vaccines, whereaslisting individualvaccine options would help guaranteethe right to informed consent by allowing parents to opt for singlevaccines at a time, and refUseothers, consideringwhatever science is available on the safety and efficacy of each individual vaccine, which is their right.
Here is some extremelyrelevant text of a message recently deliveredto the UnitedNations by Mary Holland, J.D., Research Scholar,NYU School of Law, who presented at the 25th InternationalHealth and Environment 3 Conference(April 26, 2016). The presentation, of which I had the pleasure of witnessingfirst hand (program attached),was entitled niVaccinationPolicies and FlumanRight&’,and it was receivedby standingovation:
“Oneof the core pwposes of the UnitedNations, setforth inArticle I of its charter, is to achieve infernai’ionai cooperation “inpromoting and e>lcouragingrespectfor human rights andjbrfimdamentalfreedoms for all withoutdistinction as to race, sex, language, or religion. “So how nmst countries and the international communityrespect and encourage human rightsfor vaccinationpolicies? Thisis an importamquestion that deserves genuine scrutiny, as it profoundly affects both individual and public health.
Since WorldWarIL the international communityhas recognizedthe grave dangers in involuntaryscienqjic and medical experimentationon human subjects. In the aftermath ofNazi medicalatrocities, the world affirmedthe Nureinberg Code which stated that the “voluntary consent of the human subject is absolutely essential.” The International Covenant on Civil and Political Rightsfurther enshrined thisprohibition against involuntary experimentation in its 1966 text, stating ‘noone shall be subjected withouthisfree consent to medical or scientUicexperimentation. ‘Such a prohibition is now so universally recognized that somecourts and scholars havepronounced the right to informed consent in experiments as a matter of customaryinternational law. In other words, it applies eveiywhere, whether or not a countly has specUiclaws on its books to this effect, as customary norms nowprohibit slavery, torture and piracy.
Whatabout informed consent in the area of,nedical treatment; includingpreventive medical treatment? What about injbrmed consent to vaccination? This is a controversial issue today in manycountries,including the UnitedStates.
In 2005, the UnitedNations Educaliona4 ScientUicand Cultural Organization (UNESCO)adopted the Universal Declaration on Bioethics and Human Rights on the consensus of 193 countries. Theparticipating countries hoped this Declaration, like the Universal Declaration of HumanRights, would becomea set of guiding principles in the challenging field of human rights and medicine. On the issue of consent, the Declaration states that
‘anypreventive.., medical intervention is only to be carried out with theprio1 free and informedconsent of the person concerned based on adequate information.’
ItJiirlher notes that the ‘soleinterest of science or society’ does notprevail. Thus,the international community has clearly stated that the default position for vaccination must be recommendations,not compulsion,allowing individuals,for themselves and their minor children, to accept or reji€sethesepreventive medical interventions based on adequate information and without coercion, such as the threat of loss of economicor educational benefits. Informed consent must be the default position because compulsion,on its face, limitsthe rights to consent; privacy and physical integrity.
4 Tobe sure, the Declaration in Article 27 suggests that there may be limitations on thesefundamental rights, but these limitsmust be imposedby law and intist be fbr theprotection ofpublic health orfor theprotection of the rights andfreedoms of others. ‘Furthermore, ‘anysuch law needs to be consistentwith international human rights law.’ So how can we reach such a balance in the area ofvaccination?
International human rights courts have developeda test to see jfrestrictions ofJiindamental rights are legitimate and lawJhL Thetest studies whether the measure is lawfUl,strictly necessary andproportionate to the risk. TheState enacting such restrictions bears the burden ofproof that the compulsorymedical intervention is lawfiulstrictly necessary and proportionate. Generally, the “strict necessity” elementmustbe the least restrictive alternative to achieve thepublic health objective,and non-coerciveapproaches should always be consideredfirst. Thus,the State must show that a less restrictive alternative is notfeasible before adopting a highly restrictive one.
In addition to these criteria related to compulsionfor vaccines, jf a State mandates vaccination, then it has an affirmativeobligation toprovide an effectiveremedyfor those individuals whomaybe injured as a result of vaccination.”
The video of Mary Holland’s presentation is available in two part on YouTube: https://www.youtube.comlwatch?vgyRR-srQeVE
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While in the US, patientsmay seek compensation in the National Vaccine CompensationProgram, no compensation is guaranteed,and they must go through a battle to prove the vaccine causedthe injury suffered by their child. Surely in Peimsylvaniawe not want to condemneven a minority ofpeople to lose a loved one, to stifferlifelong disabilities,with the only recourse to fight a fight in a Federal court to see compensationwhen they could have opted out, which is not guaranteed. -
There are a number of pending bills that I would like you to work to see die in committee - they also restrict patients’right to informedconsent, and the scientific basis of the claims of their universal safety are unwarranted. These include
SB 968/ HB 1785,which would mandate advertisementàf flu vaccine to residentsof personal care homes. This is the state doing the marketing in a place of business and in the homes of PA residents, on behalf of Pharma, which is highly questionable.
5 RB 883 would remove philosophical exemptionand restrict religious exemptions.This bill would restrict Pennsylvanians’options of informed consent, and would represent an assault on our libertiesand freedomfrom harm due to direct action from the state.
SB 696 would remove philosophical exemption.This isolates the assault specificto a person’sindividualight to infonned consent. Informed consent does not mean that patients must consent after being infonried. It means that patients have the right to refuse a medical procedureif they - individually,not the state - has decided given the hill informationrequired to make their choice - that the risk to them is not worth the benefitto them. The State should not intercede with laws that compel individualsto undergomedicalproceduresat all, especiallyfor those for which proper studies have been conductedthat show that the procedure is both safe, and effective.
I also understand that there is sonic interest in requiring “proofof immunization”for certain vaccines - chickenpox. I want to lct you know that proof of vaccinationis not the same as proof of immunization - as we know now due to outbreaks of measles, and now mumps in vaccinatedpopulations. ‘Proof of immunization would requires that doctors provide evidence of detected titres of antibodies,which they should,1 but do not, provide.
With doctors minimizing risks to patients, and medicalprofessionals and lawmakersdependenton CDC information,which has conducted woefully corrupt scienceon vaccine safety, we must remaindiligent and informedon the reality of the risks of vaccines. We can fall into the trap that CDC uses, in which they confuse an absence of evidence (no studies) as evidence of absence (of harm). We must rely on other sources for reliable information,i.e., studies published by independentresearchers, and in this way, Pennsylvaniansmay remain vigilant and careful with the laws and mandateswe place on ourselvesand the human rights we continue to secure for ourselves and our children.
I urge you thereforeto reserve our liberties, our freedoms, and our rights, and to NOT supportthe proposed changes in the DOH regulations regarding vaccines,and to work to kill the pending bills listed above, in the name of the inajority caring for the at-risk minority,and in the name of preservinghuman rights.
I then urge you to join the growingnumber of Pennsylvaniansand Americanswho are demandinganswersfrom CDC. I urge the PA legislators to issue a statementto the Federal Governmentdemandinganswers to the questionsraised on the state of vaccine safety sciencerevealedby Dr. WilliamThompson,a whistleblowerat the CDC, who reveal in recorded conversationswith Dr. Brian Hooker, that CDC has routinely omitted results showingassociation of vaccines with autism, specificallythe MMR vaccine, and that they routinely manipulatedthe data analysis via repeated rounds of analysis to make discoveredassociations“goaway”. Dr Thompsonhas affirmed his position in a statement from his lawyers (attached).
6 Here are few quotes from Dr. Thompson’srevelationsto Dr. Hooker (cc’d):
Thompson: “Theydon’t really want people to know that this data exists.”
Thompson: “...among the blacks, the ones that were gettingvaccinated earlier,were more likely to have autism.”
Thompson: “It appearsin the fmal publication is that race in general is downplayed.Of course it is.”
Thompson: “I actuallythink the most interesting results are the isolated, ones that don’t have their co morbid conditions. The effect is where you would think it would happen.”
Thompson: “I wasjust looking at—I was like, oh my God, I cannot believe we did what we did. But we did.”
Thompson: “The higher ups wanted to do certain things and I went along with it. In terms of chain of command, I was number four out of five.”
Thompson: “.. .Literally,everyone else got rid of all their documents,and so the only documentsthat exist right now from that study are mine.”
Thompson: “There arc things that I haven’t even sharedwith you because I can’t prove it, andthat’s what I struggle with. I don’t want to share things with you that I can’t prove, that there aren’t hard records.I am worried that the other four people will collude and say no, that’s not true.”
Thompson: “That’swhat I keep seeing again, and again, and again where these senior peoplejust do completely unethical, vile things and no one holds them accountable.”
Thompson: “The reasonyou don’t see anything else circulatingon the study, it was five of us behind closed doors for two years.”
Thompson: “It’s the lowest point in my career that I went along with that paper.”
Everything we think we know about the link betweenvaccines and autism is based on what CDC scientists in the Immunization Safety Office have told us, and these are the same scientist that Dr. Thompsonhas alleged routinely conductedscientific fraud to hide associationwith vaccines and autism.
I therefore urge you to not support any impingementor restriction of patient’s human rights, and to enact legislation demandingcleaner vaccines shown to be both safe and effective.
I urge you to please acquire a copy of the book “VaccineWhistleblower:Exposing Autism ResearchFraud at the CDC” to read for yourself the extent of corruption and malfeasance in vaccine safety researchat the CDC Please contact Del Bigtree, Producer, to schedule a screening of the movie ‘Vaxxed I will be happy to attend such a screening with you and answer any questions you may have. .t Sincerely Dr. James Lyons-Weiler, PhD References Guo, Fangjian et aL.,2015. Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20—26years) Human Vaccines & Iminunotherapeutics 11: Issue 10, 2015. 11(10):2337-44.doi: 10.1080!21645515.2015.1066948. Markowitz LE et al., 2016 Prevalence of HPV After Introduction of the Vaccination Program in the United States. Pediatrics. 2016 Feb 22. pu: peds.2015-1968. james lyons-weiler, phd Author, CEO, President, Scientist The Environmental and Genetic Causes of Autism (Skyhorse Publishing) Cures vs. Profits: Successes in Translational Research (World Scientific, 2016) Ebola: An Evolving5 (World Scientific, 2015) cell 412-728-8743 email ianieslyonsweilergmai1 .com www.linkedin. com/in/iameslyonweiler 8 My www.mor.ganverkamp.com. to public. the Dr. pressure with associated William appreciate Reasonable focused I whether however, has I My disorders, I is group and would diseases, 1 protocol made received published I Prevention, My will am have want regret the assist Thompson colleagues CDC concern EXAMINING carried name societal grateful reanalysis not responsibility regarding had for never to In on or Posey, that any my STATEMENT was or be the be and aware fact, a is I with many in that other my particular out retaliation share scientists has answering William where benefits. name absolutely unbiased my suggest MMR for the not the is and job I and regarding so of an received represented been that coauthors the which journal discussions public THE followed. risks his the many and supervisors would increased vaccine I of many of Thompson. have he that belief the can course study vaccine. POSSIBILITY and my the and associated OF further findings clear organizations was families Pediatrics. a be decision and vaccines any worked family. supportive WILLIAM CDC objective performance-based before certainly and FOR that data by made recording with that will risk parent do at Frederick questions There to I to CDC IMMEDIATE omitted are or I differ the continue of I properly with age Dr. since to am public report believe and development autism, The scientists OF was looking decision-making omit W. CDC avoid Brian have a for e-mails 36 any in their neurodevelopmental Senior A 1998. THOMPSOf’J, omitted M. not statistically months or at the after their have RELATIONSHIP relevant vaccines to of always convey vaccinating Morgan,Jr., Hooker this my There administration for escorted purpose cooperate our that RELEASE—AUGUST inside Scientist the award interpretation been voice answers time. data were of conversations, been I data are the findings have have over further entirely or significant would suggested after and of from I Ph.D, risks still at children were am Morgan outside with with recognized understanding the saved received from increased analyses BETWEEN more providing this in the studies. associated are be last the outcomes REGARDING professional Congress. collected, of a the put and building, story the particular vastly Verkainp, information of that information. Centers 10 nor questions over scientific any on CDC should risks 27, continue risk months For was African came information outweighed MMR the race. with including and the 2014 whether I for to the as for for have I LLG, since Internet. study given THE analyze be last than out. some I autism, community. regarding time receipt Disease VACCINE vaccination believe Vaccines in American to transparent. I also Cincinnati, several will our save 2004 this I answers, for any vaccines autism have have being, to by data offered 2004 Decisions do a of matter that Control countless Congressman choice particular ARTICLE their prevent those studies AND experienced stated. everything days. males collected however, spectrum and article the Ohio, and are to individual I became AUTISM regarding vaccines. was and I final assist who were I believe the lives. serious sub not, by I study CDC I am can no I it SAVEthe DATE The Permanent Mission of Ukraine to the United Nations and World Information Transfer, Inc Co-sponcored by the Permanent Mission of Belarus to the United Nations Permanent Mission of the Czech Republic to the United Nations Permanent Mission of Germany to the United Nations Permanent Mission of Lithuania to the United Nations Permanent Mission of Japan to the United Nations invite you to attend an open platform for discussion within the United Nations 25 International Conference on Health and Environment: Global Partners for Global Solutions 30 Years of Chornobyl Legacy for the Nuclear Safety of the World April 26, 2016 United Nations Headquarters, Tuesday, 10:00-13:00 — 14:00-18:00, Trusteeship Council Morning Session: 30 Years of Chornobyl Legacy for the Nuclear Safetyof the World (Trusteeship Council) introduction: Dr. Christine K.Durbak, Conference Chair and Founder, WIT KeynoteSpeaker Dr.James Hansen, former NASADirector, Climatologist and Adjunct Professor at Columbia University Topic: “Energy and Climate Change: How Can Justice Be Achieved for Young People?” Speakers Dr. LydiaZablotska - NCIChernobyl Study Project “increased risks of leukemia and thyroid disorders after Chernobyl” Dr. William Rom, Prof. NYU’sCollege of Global Public Health Topic: “Nuclear Energy and Public Health” Dr. Todd Allen, Senior Fellow, THIRDWAY;former Deputy Director for Science and Technology, Idaho National Laboratory “A 21st Vision of Nuclear Energy” 12:00— 13:00 Ambassadorial panel starts after the UN General Assembly session on Chernobyl (10:00 — 12:00) N.E.Mr. Volodymyr Yelchenko, Ambassador, Permanent Representative of Ukraine to the UN N.E.Mr. Motohide Yoshikawa, Ambassador, Permanent Representative of Japan to the UN N.E.Ms. Raimonda Murmokaité, Ambassador, Permanent Representative of Lithuania to the UN N.E.Mr. Heiko Thorns, Ambassador, DPRof Germany to the United Nations N.E.Minister Counselor un Eltinger, charge d’Affaires of Czech Republic to the United Nations Afternoon Session: Toxic Contamination of Children (CR1) Introduction: Dr. Christine K.Durbak, Conference Chair and Founder, WIT H.E.Mr. Volodymyr Yelchenko, Permanent Representative of Ukraine to the UN Mr. Juwang Zhu, Director for Sustainable Development, UNDESA(Invited) KeynoteSpeaker Robert F.Kennedy, Jr. “Mercury in the environment - its effect on children’s health” Dr. Martha Herbert, Pediatric Neurologist, Harvard “How environmental toxins can hinder the developing brain” Dr. Leonardo Trasande, Prof. of Pediatrics, Environ. Med. and Population Health, NYUSchool of Med. “Unraveling the environmental causes of developmental disabilities” Mary Holland, Esq. Research Scholar, NYUSchool of Law “Vaccination policies and human rights” Dr. Berbard D. Goldstein, former Dean Pittsburgh Univ., School of Public Health “Little Things Matter: The Impact of Toxins on the Developing Brain” web-Reference: www.viorldinfo.org RSVP Ukrainian Mission to the UN 1992 -2016 UN based Ukraine-WlTconferences t.(212) 759-7003, f. (212) 355-9455 uno [email protected] Vaccine xxx (2016) xxx—xxx ‘ ‘ :, . - • . Conlents lists available at ScienceDirect - :•. :. - .. .-:. Vaccine..’... ELSEYIER journal homepage www elsevter comllocato!vaccine Adverse events following HPVvaccination, Alberta 2006—2014 Belib, 2 121 Xianfang c. 2Liu christopherA. IKimberleyA. Sirnmonds’, a,s 3 Ltwrence W., Svensona, Margaret L Russell 4 ‘Department of Cornmunily Health Sciences, Cansrning School ofMedicine, University of Calgary, Calgary,Aft Canada 12ff 426 a Epidemiotagy and Surveillance Team,Alberta Ministry of Health, 23rd ft TelusPlaza NC 10025JasperAvenuE Edmonton, AS, Canada AllT5J 156 6 6School of P’ablicHealth, University ofAlberlo, Edmonton, All,Canada T6C 1(3) - 57 ARTICLE iNFO ABSTRACT 9 to Article history: Background: In Canada, private purchase of human papiltoma virus (HPV) vaccines has been possible since It Received21 December 2015 2006. In Alberta, Canada, a publicly fsinded quadrivalent 1-1EVvaccine program began in the 2008(2009 Receivedin revised lotus 11 February2016 school year. There have been concerns about adverse events, including venous thronaboembolisin (VTE) 0 Accepted 12 February 2016 associated with I-WVvaccines. We describe the frequencies of adverse events following HPVvaccination ‘3 Availableonline xxx among Alberta females aged 9 years or older and look at VIE following HPVvaccination, 1S Methods: We osed theAlberta Immunization and Adverse Reaction to Immunization (lmm/ARI) repository IS keywords: ‘ (publicly funded vaccine), the population-based Pharmaceutical Information Network (PIN) information 17 Papillomavirusvaccines/ac ladverse Is effects] system (dispensing of a vaccine), and the Alberta Morbidity and Ambulatory Care Abstract reporting 19 Vaccinatioo)ae[adverse ettecrsl system (MACAR)forJune 1, 2006—November 19,2014. Deterministic data linkage used unique personal 25 Population surveillance identifiers. We identified all reported adverse events following immunization (AEFI)and all emergency 2! Humans department (ED) utilization or hospitalizations within 42 days of immunization. We calculated the fre 55 Alberta quency of AEF1by type, rates per 100.000 doses of 1-1EVvaccine administered and the frequencies of 25’ HPVvaccination lCD-i 0-CA codes for hospitalizations and emergency department visits. 24 Canada Results: Over the period 195,270 females received 528,913 doses of HPVvaccine. Ofthose receiving at least 25 ‘Product surveillance one dose, 192 reported one or more AEFIevents (198 AEFIevents), i.e., 37.4)100,000 doses administered 26 Postniarlceting (95% Cl 32.5—43.0). None swore consistent with VIE. Of the women who received HPV vaccine 958 were hospitalized and 19,351 had an ED visit within 42 days of immunization, Four women who had an ED visit and hospitalization event were diagnosed with VIE. Three of these had other diagnoses knosvn to be associated with VTE; the fourth woman had VIE among ED diagnoses but not among those for the hospitalization. Conclusions: Rates of AEFIafter HPVimmunization in Alberta are low and consistent with types of events seen elsewhere. . 2016 Published by Elsevier Ltd. , .‘ . - 1. Introduction 25 , Q2 “-- The World Health Organization (WHO) recommends tlse Isuman 29 -. papillomavirus (HPV) vaccine for prevention of cervical cancer 5’2 Abbrevtedans: WHO,World Health Organization: HP, human papillomavirus, and other HEy-related diseases Quadrivalent HPV (qHPV) 51 qHPv. qusdrivalent human papillomaviriss;bHPv,bivalent human papillomavinss: [l. vac NACI, Natiooal Advisory Committee on Immunization; AEFi, Adverse Events cine was authorized and became available for private purchase in 72 Following lnsmunization; vIE, venous thromboembolic events; ULI,unique per- Canada in 2006 for females aged 9—26 years. This authorization 32 sensi identifier; lmrn/ARI,immunization and adverse reaction to immunization; was expanded to include females aged 9—45 years in 2011. Bivalent 55 PIN,PharmaceuticalInformationNetwork;go, EmergencyDepartment: MACaR, REV (bHPV) vaccine was also authorized for use among females 75 (Alberta) Morbidityand Ambulatory CareAbstract Reporting; Ico-lO-CA,Interns- 10—25 tianal Classificationof Diseases,10th Revision-CanadianAdaptation. aged years in 2010. Canada’s National Advisory Commit .56 • Correspondingauthocat:DepartmentofCommunityHealthsciences,Cumming tee on Immunization (NACI) has recommended both vaccines in 57 School of Medicine. Univemity ot Calgary,3280 Hospital Orive NW, Calgary,AR, females aged 9—26 years of age [21.Both vaccines were initially 55 Canada‘UN Tel.: +1 +3 426. 403 220 4219; tax: 403 270 7307. administered in a three-dose series; however NACI now recom 59 8-maC addresses: xcliuVucslgaty.ca (X.C. Lie), chris.bellFov.ab.ca (CA Rem, mends a two-dose series for immunocompetent persons aged 40 kimbetley.simnsondsO’gov.abca (K.A.Simmonds). larry.svensonFgov.ab.ca 9—14 (LW.Swenson),mlrussetffucalgary.ca(M.L Russell). years [21. 4’ http://dx.doi.org(10.1O16/).vaccine.2016.02.040 D264-410X/I5 2016 Published by Elsevier Ltd. Please cue ‘Ibis article in press as: [in XC. ci at Advesc events following Ili’V vaccination, Alberta 2006-2014. Vaccine (2(116). hlto:IIdx.doi.oi& 10.101 (i(i.vacc;nc.2(l I6.02.040. 2 XC Lhi et&./Voccfnexxx(20!6)xv.x—xxx 42 In Alberta, the publicly funded routine childhood and adoles policy is that providers should ‘Report events that do not meet 32 33 cent vaccines are administered exclusively by public health nurses. specific case definitions but are felt to be significant (i.e., serious 23 * Alberta began to deliver a publicly funded three-dose ql-{PVvaccine or unusual) under [checkboxj Other Severe or Unusual Events... iso s series in the 2008/09 school year for females in grade 5, most of When an AEFIis: 155 whom were aged 10-11 years [3]. A catch-up program was imple mented from 2009/10 to 2011/12 for females in grade 9 (most of • Serious (death, hospitalization, congenital abnormality, residual 43 whom were aged 14-15 years). Both qHPV and bHPV vaccines are abnormality, also available for private purchase through pharmacies. life threatening), unexpected (in terms of type or frequency), 70 The monitoring of adverse events following immunization • Of concern (to the vaccine, his/her caregiver(s) or AEFIreporter).” s, (AEFI)contributes to vaccinesafety surveillance and is an important ,z component of all vaccination programs. Vaccine safety is monitored by passive surveillance inAlberta, There have been community con AEFI’sthat meet any of these criteria should be reported regard [10 cerns that HPV vaccines may be associated with adverse events. less of consistency with time period of occurrence for the event of IL’ s Venous throniboembolic events (VIE) are a particular concern, as the case definition of any such event. VTEcases are captured by the 39 some were reported to occur following HPV immunization in the checkbox ‘other unusual events’ on the AEFIreporting form. Event “3 si United States 141.The objective of this study is to describe the fre codes and text descriptions on all AEFI reports are reviewed by [‘4 ss quencies ofadverse events among females aged 9 years or olderthar trained nurses and coded into Imm/ARI. Information related to hos l’s HPV s occurred following vaccination including looking specifically pitalizations and emergency department (ED) visits are captured 116 o at ‘IrE following HPV vaccination. in the Alberta Morbidity and Ambulatory Care Abstract Reporting II? (MACAR)system, including dates of admission and discharge, and 119 lCD-I 0-CA (International Classification of Diseases, 10th Revision- 119 61 2. Methods Canadian Adaptation) codes for diagnoses. 110 We extracted data on vaccinations, AEFI reports, hospitaliza I21 62 2.1. Ethics and role of funding source tions and ED visits (within 42 days of vaccination) [4,111 for all 122 females for whom an HPV dispense or vaccination event was [23 63 The study was approved by the University of Calgary Conjoint recorded over June 1,2006—November 19, 2014, using ULIto link [24 64 Health Research Ethics Board (Ethics ID: REB14-0598).The funding records for unique individuals. 123 6$ source had no role in study design, collection, analysis or interpre tation of data, report writing or publication decision. 23. Data analysis 126 61 2.2. Data source and data extraction We counted the number of females who received one or more 123 63 Alberta has a publicly funded universal heatthcare system in doses of HPV vaccine by number of doses received and age at 24 o which >99%of residents are registered [5]. The registration file for first dose. We described the frequencies of occurrence of AEFIs 12’) this program includes a Person Health Number that serves asa by type of AEFI, and dose number associated with the AEFI. We 130 ii unique personal identifier (ULI)[6] that permits data linkage at the calculated rates of AEFI per 100,000 doses of HPV vaccine clis [II u level of the individual across other administrative databases. We pensed/administered by dividing counts of AEFIsby the number of 132 13 used ULI to deterministically link data on vaccination, AEFI,and vaccine doses received among the population of interest over the ‘33 healthcare utilization. - period. We described hospitalizations within 42 days of HPVvacci 134 73 Alberta’s Immunization and Adverse Reaction to Immuniza nations by lCD-b-CA diagnostic codes for the most responsible ‘33 76 don repository (Tmm/ARI) contains complete vaccination records, diagnoses for all hospitalizations within 42 days of immuniza 136 77 including AEFI,for all publicly funded vaccines that were admin tion. “Most responsible diagnosis” is recorded by the health care 111 78 istered by public health since 2006. Vaccination records prior to provider at discharge, using general coding standards that define ‘3$ 2006 comprise historical data and ale entered electronically into the most responsible diagnostic lCDcode as that responsible for the ‘39 1mm/ARt by public health nurses after review of paper vaccination greatest portion of the length of stay or greatest use of resources 340 s, records. The Pharmaceutical Information Network (PIN) contains ]12]. A hospitalization event is defined as a hospital visit where a [41 $7 records of all prescriptions dispensed by pharmacies, whether pri person was admitted and discharged from a hospital. Some hos 132 ss vately or publicly funded. In the case of I-WVvaccine, this would pitalization events were recorded twice because the person had ‘43 so only include privately funded vaccines, It is estimated that PIN one hospital visit that was temporally associated with receipt of 33-1 Si captures over 95% of dispensed pharmacologic products 171.We two different vaccine doses (e.g., was hospitalized within 42 days 145 6t have assumed that all vaccine dispensed according to PINwas actu of receiving both dose I and dose 2). For these, we removed the 1-16 , ally administered to the purchaser as the cost to purchaser of HPV duplicate event and counted it as a single hospitalization event. 147 so vaccine is about$1 50/dose [81.Both lmm/ARI and PINcontain infor For each person, we assumed that a transfer from one hospi 143 so mation on the patient, vaccine, dose, and date that vaccine was tal to another had occurred if the date of discharge from the 149 so administered/dispensed [9]. first hospital was the same as the date of admission to a sec Is) In Alberta, AEFIsurveillance is a passive reporting system. mdi- ond hospital. We counted each hospital transfer as a separate 351 sz viduals who experience an AEFIreport to their vaccine provider, event, However, [or the purpose of describing the frequency of 352 93 who completes a provincial AEFI reporting form; the data are the most responsible diagnoses (the diagnosis that contributed ‘33 94 entered into 1mm/ART[10]; Alberta Health then reports AEFI to the greatest to length of stay) for such persons, we counted each [44 93 the Public Health Agency of Canada. The provincial AEFIreporting most responsible diagnosis if they differed between hospitaliza 133 96 form consists of a close ended checklist of types of adverse events, tion events. We operationally defined ‘serious’ AEFIas those that [56 97 accompanied by an open ended text field into which a descrip resulted in hospitalization and counted the number of ‘serious’ ‘57 9S tion of event is to be entered as well as an open ended comment AEFI, We linked hospitalizations and ED visits to identify those [57 so section. The reporting form also collects time of onset following who reported both events within 42 days of vaccination. Data anal ‘59 iso immunization, outcome, hospitalization dates, patient identifiers, yses were conducted using SAS 9.3 (SAS Institute Inc., Cary, NC [93 is, vaccine antigens, vaccination date, and dose number. Alberta 2011). 161 Please cite this article in press as Lw XC et al Adverse events followsng HPV vaccination, Alberta2006—2014 VaccsnO(2O1) htto I1d’ ;i iiti II XC. flu erat/Vacc iexxx f2016,)xxx-zxx 3 ies 2.4. AEFIreview to identify VTE 3,2. Frequency of occurrence of AEFI& serious AEFIevents (33 One investigator (MLR), a physician, reviewed all text descrip- Of the 195,270 women who received 1-WVvaccine, 192 (<0.1%) 192 ies tions for.AEFIscoded as other unusual events’ for evidence that the reported one or more AEFIevents (198 AEFIevents). Of the 192, 193 AEFImight have been Vt 6. 186 reported one AEFIevent, while six reported two different AEFI 193 events. All AEFIevents occurred after receipt of the qHPV vaccine. Six persons who experienced an AEFI had received one or more 186 no 2.5. ldent(ficationofVTEnot captured by AEFIreports vaccines in addition to HPVon the same day as they received HPV 192 vaccine. Table 2 displays the frequency of occurrence of types of ISO 167 In order to maximize the chances of finding a VIE that was not AEFIby dose of 1-WVvaccine in series received that corresponded to 199 es captured by an AEFIreport within lmm/ARI, we identified within the AEFIevent.Arnong the 198 events, the most commonly reported 102 no MACARall females who were hospitalized or visited the EDwithin events were allergic reaction (n = 90), other unusual events (n = 34), 201 o 42 days of vaccination by determiisistically linking lmm/ARI, PIN other rash (n=32), and pain and/or swelling (71=23) (Table 2). 202 in and MACARusing the UIJ. Our definition of VIE for this study was Most AEFI events occurred after receipt of the first dose of vac 203 in the occurrence of an lCD-I 0-CA diagnostic code of 180.x or 182,xin cine (ii 117), followed by second (ii 55) and third (n = 25) doses. 204 175 any of the potential diagnostic code fields (25) for a hospitalization Review of the text fields for ‘other unusual events’ found none of 205 or ED (10) visit. For any woman who had such an lCD-i 0-CA code these events to be consistent with VIE. 206 im for a hospitalization or ED visit, one investigator (MIR) reviewed Of the 192 persons reporting AEFIevents, five had a serious AEFI, 207 176 all lCD codes for that event to assess if they were consistent with (all classified as ‘serious’ because of hospitalization); however only 203 Ill any other condition for which VTEis known to occur as per Spencer 4 of them were hospitalized within 42 days of immunization. The 209 os and colleagues 1131. fifth person was hospitalized on day 110, well outside of the 42 day 215 window. lii 179 3. Results 3.3. Rote of occurrence & outcome of AEFIevents 22 in 3.1. Source population Over the study period, the rate of AEFI events was 37.4 per 213 100,000doses ofHPVvaccine administered (95%Cl: 32.5—43,0),The 214 in As can be seen from Table 1, from June 1,2006 to November 19, rate varied over time: no events were reported for 2006 or 2007, 213 i, 2014, 195,270 females received one or more doses of FIPVvaccine. however only about 5000 doses of vaccine were dispensed in those 1(6 is, They received a total of528,9 13 publicly and privately funded doses years (data not shown). For the period january 1, 2008-November 217 is of vaccine over the study period. Nearly all of the vaccine was qHPV 19, 2014, the rate was 37.7 per 100,000 doses (95%CI: 32.8—43.3). 218 (99.2% of doses). The majority of women received three doses of AEFIrates varied over time, peaking in 2011 (Fig. ‘1). 219 so E’IPVvaccine (82.4%), while a smaller proportion received only two Of the 198 AEFIevents, the outcomes were known tot’371. all of 220 187 doses (9.9%) or only one dose (6.4%). Most were aged 9—14years winch were full recovery. 221 i (79.5%) when their first dose of FIPVvaccine was received, followed io by age groups 15-19 years (10.0%), 20—24 years (5.9%), or 25—29 3.4. Hospitalization within 42 days of vaccinotion no years (2.7%). m Among the 195,270 females who received HPV vaccine, 958 223 were hospitalized (1053 hospitalization events) within 42 days of 224 TableS immunization; however only 4 of those hospitalized had a reported 225 Distribution of HPV vaccine by numbers of women aged 9÷ years immunized, by attributes of recipients and vaccine. AEFI (see above). Of the 958 who were hospitalized, most (861, 226 89.8%) had only one hospitalization event within 42 days of immu 217 Characteristic Number of nization. The large majority of those hospitalized were aged 9—14 223 women(z) years (66.0%) or 15—19years (22.0%).The proportion of hospitaliza 229 immunized Nwomen 195,270(100) tions that occurred on the same day as vaccination was 0.7%,34.6% 230 Number of doses received per individual within 1—14days, 32.8%within 15—28days, and 31.9%within 29—42 231 I - 52,473(6.4) 2 .. 59,230(9.9) days (data not shown). 160,950(82,4) 4 :‘ 2567(0.1) Age(years)at which lust dose of vaccine received 10—14 155.300(79.5) 45 145 15—19 39,433 (10.0) %\ 20-24 11,551 (5,9) 40 I 25—29 5351(23) , 30—34 1725 (0.9) S. 35—39 874(0.4) 40-44 583 (0.3) 454- 403(0.2) 2O Type of vaccine funding 23 ‘ Public 164743(24.4) V - Private 29,025 (14.9) Mixed 1502(0.8) Total numberof doses dispensedladmiuistered 528,913(100) Type of vaccine dispensedfadministercd . - qHP’ 524,645(99.2) LdI-[[I12t826 2027 2028 2009 2810 20t1 2012 2013 2014 V bHPV 4193 (0.2) Year Unknown 75(<0.1) 91eober o Sf71 repods -u—AEfI per 102.000 doses 0 Mixedfunding: some doses were publicly funded, some were privately pur chased. Fig. 1. Numbers cfAEFI and AEFIratesllOO.000 doses dispensed 2006-2014. Pteae cite tlsis article in press as Liu 1XC t at Adverse events [otlowing HPV vacctrtation Alberta 2006—2014 Vaccine (2016) Jittn IIdx doi cereli 0 30161i vaccine 201602 040 .. — - —- —- - 4 XC.Uset al./ Vaccirie (2016) xc—xxx Table2 Distribution of types ofAEElby dose of vaccine for which AEFIevent reported. Number of doses of 1-WVvaccine received at time of occurrence of AEFI Npersons 1 2 3 5 Allergic reaction 54 32 4 0 90 Other unusual events 20 10 4 0 34 Other rash 23 3 6 0 32 Pain and/or swelling 12 5 5 1 23 Fever I 2 1 0 4 Severe diarrhea 1 2 1 -0 4 Anaphylaxis 2 0 1 0 3 Adenopathy 1 0 0 2 Convulsion/seizure 1 0 1 0 2 Anesthesia/paraesthesia 1 0 0 0 1 Arthralgia/arthritis 0 0 1 0 3 Erythema multiforrne 0 0 1 0 1 Sterile abscess 1 0 0 0 1 Total 117 55 25 38 Six of the 192 persons who experienced an AER had an AEFIon two occasions. 233 Thirty-two women had hospital transfers. Thirty-one women Table3 Frequençyofmostresponsiblediagnoses sss had one hospital transfer and one woman had two transfers, result amongwomdn hospitalized within 42 days of immunizatIon. as login 69 hospitalization events. Of these, six transfers (12 events) no had the same most responsible diagnosis. Fourteen women had lCD10 chapter codes Count (%) 237 multiple hospitalization records because they received two doses of certain infectious and parasitic diseases (A0O-B99) 29(2.8) HPV vaccine within 42 days, and thus both doses were temporally Neopiastns (cOO-D49) 22(2.1) ma associated with the hospitalization. Fifty-two persons had more Diseases of the blood and blood-forming organs 12(1.1) and certain disorders involving the immune 230 than one hospitalization event because they were hospitalized on mechanism (050-089) 241 separate occasions (i.e., these were not hospital transfers). From Endocrine, nutritional and metabolic diseases 35(3.3) ma the 1053 hospitalizatIon events, after accounting for transfers, we (E00-E89) 243 counted 1047 most responsible diagnoses. Mental, Behavioral and Nelirodevelopmental 204(19.4) disorders (FOl-F99) 244 The frequencies of the 1047 most responsible diagnoses are Diseases of the nervous system (GOO-G99) 35(3.3) 2s shown in Table 3. Mental, behavioral and neurodevelopmental dis Diseases of the eye and adnexa (l-l0O-H59) 4(0.4) , orders (19.4%) were the most frequently coded most responsible Diseases of the ear and mastoid process (1-160-1-105) 8(0.8) 24) diagnoses, followed by diseases of the digestive system (15.8%), Diseases of the circulatory system (100-190) 15(1.4) ass and injury, poisoning and certain other consequences of external Di5eases of the respiratory system (JOO-J99) 104(9.9) Diseases of the digestive system (1(00-1(95) 165(15.8) 259 causes (13.8%). Diseases of the sl please.cite (his article in a’;: [iii XC al. Atlversn events followiog FWVvaccination, Albeira 2006—2014. Vaccine (2016), hi tis:lIdx;doi.nrell (1.101 ti/r.vaccine.20 I.02.04fl . . si’s 324 319 333 323 327 323 591 313 s-a 3o 736 335 330 316 315 311 sto so 3-93 ,s-t 339 sn 333 529 ;ir si sce 303 s* s 347 ,n 331 oo so 321 so 306 ss sso 525 si’s 305 soi 303 ss 342 sos xa ss sg s-n 301 m ssi 261 286 s w so es any would HPV care community that tured. changes we use dispensed) Alberta contributed ity analyses. of events and ied Harris and by and of the received rates the tions statistically ciation charge had vaccines talized study search our clues, administered factors, investigators during tions within also think have post-licensure province tive analysis ‘other to types ting that an describe pitalization 4. htw Please whom HPV vaccine The In AEFI While public Discussion observed. In to by report of entire individual design the an all diagnosis enter System from the possible personnel) immunization been known elsewhere, Alberta, outlined this it of determine We also year. Similarly, and stricter Iklx (37.4/100,000) have diagnoses hospitalization. unusual for 42 strengths of with ED within vaccination including but likely occurrence rate numbers in adverse of cite are AEFI of either [f only we reports those study, days do health the of visit VTE colleagues captured. population has dot received the all [15]. Passive Ontario the overcame hospitalized to (VAERS) records, concerns significant, been VIE to safe (37.4/100,000 observed Gee not that this have However, in that AEFI that type 213 data the guidelines Alberta the oidi0 report” safety by be by limitations. with reporting of VAERS events’, publicly cases the [20,21 we These including in after of know for [11,161. events and whether “biased from nurses associated are a 30.71100.000; immunization, Alberta article accessing the observed 133 was reports found as events among surveillance into this program ofVTE [15]. addition longer earlier linked the Similarly, or a and (53.9/100,000 and identified colleagues small. had well (resulting than HPV VTE 10161, the VIE three ]. f of classified While the but differences data how not 19]. as modes study only immediately lmm/ARI. out It Our rash) that funded who ED reporting, no 141 women practices surveillance for was other American Health limitations are is diagnosis [11,16—18]. vaccination had follow-up women in a years code, as immunization, immunized substantiated that doses) Residents Changes We cases many of pattern [14] press with visIt association the vaccine vaccine over results possible to Ontario five Gee we the to included ensure reportable also were those province been of 213 reported the data did known identify records in a or of 14] as this observed and all classification VTE. and records, confirmed 2007—2011 of [10]. immunized vaccine women We that rate as aged are the seen increased of ‘confirmed’ doses) privately underreporting qHPV are passively might not of VIE three Vaccine used, from who may similar 2016 in following caused code time and that colleagues of similar AEFIs healthcare While of studies Lw found almost data reporting. study capturing much was out AEFI consistent reporting risk 9 validate would between in Alberta among of VTEs for passive by be if were years in AEFI the at this the was the had 0Le40 XC [14]. this for have funding. Ontario, (e.g., of all they with substantially Alberta. meet the affected factors further one reports Adverse a to the cases period a purchased to closer reporting (19.2/100,000 ED HPV province certainly reported Ontario that 2011 that population-level, association regardless hospitalizations would other et reports hospitalization. not higher not of immunized The were or those those affected Ontario allergic those [4] AEFI meet who additional the adverse visit women reporting personnel, HPV al may AEFT case older. with found immunizations have were among may AEFI and for noted most However, may investigations publication to XC. lCD However are health by Adverse used Event reports, be, were hospitalized was rate found rate case for vaccination seen result that in VIE, other definitions would due the numerous AEFI lb to be been schoolgirl We reactions, rates reporting l-IPV reviewed also codes observed but who less that common event of Ontario, Ontario. an was a the etuL/Vaccine,vxc(2OI6)a-’ccx in health- of of related person within defini Repor inabil howl in condi which tenta to in Other doses found types or asso posit data, from have their large from AFFI AEFI than cap- vac var HPV hos events dis had it our We our not not the the for for by of in to is jj - - following 1111 1101 Acknowledgement References interests. Ministry Authors’ LWS tion, the reviewed drafting study interpretation interpretation design, 5. As of consistent immunization Finally, talization of thus may hospitalizations [71 [3[ 161 141 121 [01 [l Ill [81 - - event — misclassification, The Conflicts Conclusion XCL Adverse the World manuscript. Alberta a-hpv-vaccine Alberta 2014;14(1):1008. quadrivalent Government ccnh/acs-dccI2OlS/hpv-vph0215-eng.plIp alberta,ca)documents/AIP-AEFI-Po[icy-2015.pdfloctober Government Available Aiberta documents/A[-lclP-Stats-Supplement-14.pdfloecember Gee 20151. Agency Human National papitlomavicus System; Governiverit cfm?xlO”2376 tort Scheller for utilization Lb 2014;312(2):187—8. OvcrvicwofJilbcrtastRHlSpdI pdf from: plement paper. Datalink AEFI study have participated Alberta conceptualization, [December study participated X, predictive J, the acquired girls the seen of Naleway October HPV contribution Health that Sinlmondt the might Health — Health. led Papillomavirus Health. of with design, 2015. Advisory http:Ijwviw.healtb.alberta.caldocunsenlslResearch-Health-Datasets. women vaccine Health events N. 201312014; from; of manuscript. Immunization Canada; and was from elsewhere. manuscript. to occur of vaccination human with of interest: Fasternak and of and Organization. lcbtediune3, Services. l7ED835A4-O3CA-9697-D24EE32FB5CC3186 Available CAB 2014. those An 17.20151. Alberta. misclassification have or A, Overview ‘accine Albcta. http:f)www.screeningforlife.ca/cervicalscreening(abouc-hpv coverage the funded Alberta. 20h1;29(46):8279-84. value in data cancer; Committee following (RSO overview Shui 1<, drafting in emergency drafting in HPV 2015. very it participated __— papillonsavirus Wkly study data Russell our had data 2015. seen is (HPV) Cervical I, AdverSe interpretation None B, and Alberta from; 1026380). of possible Providers; vaccine Baggs MLR rarely Government Available of by 2009—2013, Epidemiol study 2008. symptom study 20151. analysis, and of SvansrrOmn lCD Human elsewhero, administrative Alberta Available conceptualization, on a the the vaccine M, I-{PV the Alberta’s hrtp:flwww.albertanelcsre.ca!docnments!An research of cancer: 3. participated lOctober events Irunstinisatiun. Health department but participated Sverison codes Available Yin received risk manuscript. the would manuscript. 2015. design, vaccine: that in immunization from: papillomavirus of Rec Ft. immunization which data Alberta, study of 2006-2014 following about Electronic approves outcome, onset from: authors care 1-1, Li 19,2015]. 2014;43(89):465—92. VIE and Available for Icited venous agreement and http:/Iwww.phac-aspc.gc.cajnaci L Ft. not health Hvlid interpretationand findings from: 528,913 HPVand insurance Herpes et data VIE conceptualization, are drafting bttp:/www.hea!th.albertacaI identified prior in Update Canada. October consistent al. be visits immunization in vaccine Health study thrombormbolism. have All truly A. datasets; from: KAS Monitoring Even is http:/falberta.cafrelcase. vaccines: detected. interpretation schedule. from study data zoster to in the Quadrivalent variable authors Vaccine oti doses 17,20151, Plan by with 19,20151. 19,20151. BMC Alberta the http:ffwww.helth. associated Record hospitalization. any participated - HpVvaccine; conceptualiza the the in program [cited analysis, during chart 2015. - design, Statistical vaccine manuscript. in the Vaccine recommended WHO Public the - Public competing of the (AEFI) lnforrnaiion the October19, critically (2016) [17] vaccine: - absence are Available Alberta drafted review. safety position hospi to human study types Health (HZV): Health Safety policy JAMA with data 2012. data low, and Sup this pro— in of - 5 Q3 -. II) 412 411 410 37) 414 459 .369 037 40) 337 373 406 403 404 393 392 356 325 337 536 334 369 405 402 401 397 396 390 309 355 381 353 327 379 is 399 795 33’ 330 371 365 362 391 341 364 36) 360 3,3 395 394 372 367 3(6 363 359 337 329 379 555 33-1 353 352 351 “9 ii rj “s 1vAC1738Z1-6_-- — - - ts-JJ’_l L,. ,Ls_jn’ - — -- 6 XC tin ci ci. / Vaccinex (2016)x—zsx aD 1121Canadian institute for Health Information. Canadian coding standards for ver [171 Naleway AL,Crane B,Smith N, Daley MF,Donahue), GccJ, et al. Absence of 429 416 sion 2012 lCD-ID-CAand CCI.Ottawa, ON; Cliii; 2012. Revised September venous thromboemboliam risk following quadrivalent human papillomavirus 43’) 417 2012. vaccination, VaccineSafety Datalink,2008—2011.Vacrine 201B;34(1);1G7—7l. 43’ 419 [13] Spencer FA, Emery C, Lessard B, Anderson F, Emani S Aragam j, 1131Yih WE, Greene SE, Zirhittelia L, KuildariTM, Raker MA. de Jong jLO. et ai. 43) 459 et at. The Worcester Venous Thromboembolism Study. ) Gen Intern Med Evaluation of the risk of venous thromboembolism after quadrivalent human 433 42e 2005;21(7):722—7. papliliomavirusvaccination among USfemaiea.Vaccine2016;34(1);172—S. aN 4iQ,4 1141Slade BA,LeidelL,Velloni C,etai. Postlicensure safety surveillance for quadri 19] Varricchio F,iskander). Destefano F.BallR, Ness It, Braun MM,eta!. Under 423 ass valenthumanpaplilornavirus recombinant vaccine.JAMA2009;302(7);750—7. standing vacciuesafety information from sheVaccineAdverseEvent Reporting 42’S 423 1151Harris T, Williams DM,FediurekJ, Scott 7, Decks SL.Adverse events follow System. Pediatr Infect Dis) 2004;23(4);287—94. 437 424 ing immunization in Ontario’s female school-based HPV program. Vaccine [20] EberthjM, KlineEN,tdoskowita BA,MontealegrejE, Scheurer ME.The role of 435 435 2014;32(9);1061—6. niedia and the Internet on vaccine adverse event reporting; a case study of 439 426 1161Arnheirss-DahlstcdmL Pasteenak B,SvaisstrOrnH,Sparén 1’,Hviid & Autoim human papiitosnavirus vaccination. JAdolescHealth 2014;54(3):289—15. 455 427 nsune, neurological, and venous thromboembolic adverse events after [21] Goodman MJ, Nocdin J. Vaccine adverse event reporting system repor .54’ 42! immunisation of adolesrent girls with quadrivatent hunsan papiliomavirus ting source; a possible source of bias in longitudinal studies. Pediatrics 4-12 vaccine in Denmark and Sweden; cohort study. Bid)2013;347. 2006:1 17(2);387—9O. 44) cite ihis artdeJflAss as LmIC, bt V7idvets etvçpts roowrng &nflô&M2OiJr2OtCVicTae (ZQ1W httDIith4&tnhIOlOlGhVàtttne2DhiO24)4O - ‘ ‘- - -‘