View source for Vaccine adverse event

{{Update|date=August 2022}}{{distinguish|Adverse drug reaction}}
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A '''vaccine adverse event''' (VAE), sometimes referred to as a '''vaccine injury''', is an [[adverse event]] caused by [[vaccination]].<ref>{{Cite web|last=Canada|first=Health|date=2020-11-30|title=Adverse Reaction Database|url=https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html|access-date=2021-03-31|website=aem}}</ref> The [[World Health Organization]] (WHO) knows VAEs as '''Adverse Events Following Immunization''' ('''AEFI''').<ref name="whoaefi">{{cite news |title=Adverse events following immunization (AEFI) |url=https://www.who.int/vaccine_safety/initiative/detection/AEFI/en/ |archive-url=https://web.archive.org/web/20140827033606/http://www.who.int/vaccine_safety/initiative/detection/AEFI/en/ |url-status=dead |archive-date=August 27, 2014 |access-date=12 December 2020 |publisher=World Health Organization}}</ref>

AEFIs can be related to the vaccine itself (product or quality defect-related reactions), to the vaccination process (error or stress related reactions) or can occur independently from vaccination (coincidental) and are classified as:<ref>{{Cite web|date=2019|title=Causality assessment of an adverse event following immunization (AEFI)|url=https://www.who.int/vaccine_safety/publications/gvs_aefi/en/|archive-url=https://web.archive.org/web/20140616223430/http://www.who.int/vaccine_safety/publications/gvs_aefi/en/|archive-date=June 16, 2014|url-status=live|website=WHO}}</ref>
* Vaccine product-related reaction
* Vaccine quality defect-related reaction
* Immunization error-related reaction
* Immunization anxiety-related reaction
* Coincidental event

Most [[vaccine]] adverse events are mild. Serious injuries and deaths caused by vaccines are rare, and the idea that severe events are common has been classed as a "common misconception about immunization" by the WHO.<ref>{{cite news |url=https://www.who.int/vaccine_safety/initiative/detection/immunization_misconceptions/en/index4.html |archive-url=https://web.archive.org/web/20140501221843/http://www.who.int/vaccine_safety/initiative/detection/immunization_misconceptions/en/index4.html |url-status=dead |archive-date=May 1, 2014 |title=Six common misconceptions about immunization |access-date= 6 February 2019 }}</ref> Some claimed vaccine injuries are not, in fact, caused by vaccines; for example, there is a subculture of advocates who [[Vaccines and autism|attribute their children's autism]] to vaccine injury,<ref>{{cite book | first = Paul A | last = Offit | name-list-style = vanc |title=Autism's false prophets : bad science, risky medicine, and the search for a cure | url = https://archive.org/details/autismsfalseprop00offi | url-access = registration |date=2010 |publisher=Columbia University Press |isbn=9780231517966 |edition= Paperback |location=New York |oclc=694142893}}</ref> despite the fact that vaccines do not cause autism.<ref>{{cite journal | vauthors = Taylor LE, Swerdfeger AL, Eslick GD | title = Vaccines are not associated with autism: an evidence-based meta-analysis of case-control and cohort studies | journal = Vaccine | volume = 32 | issue = 29 | pages = 3623–9 | date = June 2014 | pmid = 24814559 | doi = 10.1016/j.vaccine.2014.04.085 }}</ref><ref name="vsedu">{{cite web |url=http://www.vaccinesafety.edu/vs-autism.htm |title=Vaccine Safety ● Do Vaccines Cause Autism? |website=www.vaccinesafety.edu |access-date=6 February 2019 }}</ref>

Claims of vaccine injuries appeared in litigation in the United States in the latter part of the 20th century. Some families have won substantial awards from sympathetic juries, even though many public health officials have said that the claims of injuries are unfounded.<ref name="Sugarman">{{cite journal | vauthors = Sugarman SD | title = Cases in vaccine court--legal battles over vaccines and autism | journal = The New England Journal of Medicine | volume = 357 | issue = 13 | pages = 1275–7 | date = September 2007 | pmid = 17898095 | doi = 10.1056/NEJMp078168 | url = https://works.bepress.com/stephen_sugarman/77 }}</ref> In response, several vaccine makers stopped production, threatening [[public health]], and laws were passed to shield makers from [[Legal liability|liabilities]] stemming from vaccine injury claims.<ref name=Sugarman/>{{when|date=December 2020}}

==Adverse events==

According to the U.S. [[Centers for Disease Control and Prevention]], while "any vaccine can cause side effects",<ref name="CDC side-effects">{{cite web|url=https://www.cdc.gov/vaccines/vac-gen/side-effects.htm|title=Possible Side-effects from Vaccines|date=July 12, 2018|publisher=[[Centers for Disease Control and Prevention]]}}</ref> most side effects are minor, primarily including sore arms or a mild fever.<ref name="CDC side-effects"/>  Unlike most medical interventions vaccines are given to healthy people, where the risk of side effects is not as easily outweighed by the benefit of treating existing disease. As such, the safety of [[immunization]] interventions is taken very seriously by the scientific community, with constant monitoring of a number of data sources looking for patterns of adverse events.<ref>{{cite web |url=https://www.who.int/mongolia/health-topics/vaccines/faq |title=Questions and answers on immunization and vaccine safety |website=[[World Health Organization]] |access-date= 3 December 2021 }}</ref>

As the success of immunization programs increases and the incidence of disease decreases, public attention shifts away from the risks of disease to the risk of vaccination.<ref name=Bonhoeffer/> Concerns about immunization safety often follow a pattern.<ref name=Bonhoeffer/> First, some investigators suggest that a medical condition of increasing [[prevalence]] or unknown cause is due to an adverse effect of vaccination. The initial study, and subsequent studies by the same investigators, have inadequate methodology, typically a poorly controlled or uncontrolled case series.<ref name=Bonhoeffer/> A premature announcement is made of the alleged adverse effect, which resonates with individuals who have the condition and which underestimates the potential harm of not being vaccinated. The initial study is not reproduced by other investigators.<ref name=Bonhoeffer/> Finally, it takes several years before the public regains confidence in the vaccine.<ref name=Bonhoeffer/>

Controversies in this area revolve around the question of whether the risks of adverse events following immunization outweigh the benefits of preventing infectious disease. In rare cases immunizations can cause serious adverse effects, such as gelatin [[measles-mumps-rubella vaccine]] (MMR) causing [[anaphylaxis]], a severe allergic reaction.<ref name=Bonhoeffer>{{cite journal | vauthors = Bonhoeffer J, Heininger U | title = Adverse events following immunization: perception and evidence | journal = Current Opinion in Infectious Diseases | volume = 20 | issue = 3 | pages = 237–46 | date = June 2007 | pmid = 17471032 | doi = 10.1097/QCO.0b013e32811ebfb0 | s2cid = 40669829 }}</ref> Allegations particularly focus on disorders claimed to be caused by the [[MMR vaccine controversy|MMR vaccine]] and [[Thimerosal controversy|thiomersal]], a preservative used in vaccines routinely given to U.S. infants prior to 2001. Current scientific evidence does not support claims of vaccines causing various disorders.<ref>{{cite journal | vauthors = McMahon AW, Iskander JK, Haber P, Braun MM, Ball R | title = Inactivated influenza vaccine (IIV) in children <2 years of age: examination of selected adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) after thimerosal-free or thimerosal-containing vaccine | journal = Vaccine | volume = 26 | issue = 3 | pages = 427–9 | date = January 2008 | pmid = 18093701 | doi = 10.1016/j.vaccine.2007.10.071 }}</ref><ref>{{cite web |title= Thimerosal in Vaccines |url=https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228 |url-status=live |archive-url= https://web.archive.org/web/20130106215029/https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228 |archive-date=2013-01-06 }}</ref>

The debate is complicated by misconceptions around the recording and reporting of adverse events by anti-vaccination activists.<ref>{{cite journal | vauthors = Kata A | title = A postmodern Pandora's box: anti-vaccination misinformation on the Internet | journal = Vaccine | volume = 28 | issue = 7 | pages = 1709–16 | date = February 2010 | pmid = 20045099 | doi = 10.1016/j.vaccine.2009.12.022 }}</ref> According to authorities, [[anti-vaccination]] websites greatly exaggerate the risk of serious adverse effects from vaccines and falsely describe conditions such as [[autism]] and [[shaken baby syndrome]] as vaccine injuries,<ref name="sbm">{{cite web |url=https://sciencebasedmedicine.org/what-does-anti-vaccine-really-mean/ |title=What does "anti-vaccine" really mean? |date=2010-11-01 |website=Science-Based Medicine |access-date=6 February 2019}}</ref><ref>{{cite journal | vauthors = Grant L, Hausman BL, Cashion M, Lucchesi N, Patel K, Roberts J | title = Vaccination persuasion online: a qualitative study of two provaccine and two vaccine-skeptical websites | journal = Journal of Medical Internet Research | volume = 17 | issue = 5 | pages = e133 | date = May 2015 | pmid = 26024907 | pmc = 4468570 | doi = 10.2196/jmir.4153 }}</ref><ref>{{cite news |url=http://time.com/3995062/vaccine-injury-court-truth/ |title=Here's the Truth About the 'Vaccine Injury Court' |work =Time|first=Jeffrey|last=Kluger | name-list-style = vanc |date=August 19, 2015|access-date=6 February 2019 }}</ref> leading to misconceptions about the safety and effectiveness of vaccines.<ref name="Hussain_2018">{{cite journal | vauthors = Hussain A, Ali S, Ahmed M, Hussain S | title = The Anti-vaccination Movement: A Regression in Modern Medicine | journal = Cureus | volume = 10 | issue = 7 | pages = e2919 | date = July 2018 | pmid = 30186724 | pmc = 6122668 | doi = 10.7759/cureus.2919 }}</ref><ref>{{cite web  | first = David | last = Gorski | name-list-style = vanc | date = 8 October 2012 |title=The antivaccine lie that just won't die: The claim that shaken baby syndrome is really due to "vaccine injury" |url=https://sciencebasedmedicine.org/the-antivaccine-lie-that-just-wont-die-shaken-baby-syndrome-is-really-due-to-vaccine-injury/ | work =Science-Based Medicine |access-date=8 February 2019 }}</ref> This has had the result of stigmatizing autistic people and the parents who had them immunized.<ref>{{cite news | last=Knights |first=Karl | name-list-style = vanc |title=I'm autistic – don't let anti-vaxxers bring back the culture of fear |url=https://www.theguardian.com/commentisfree/2018/aug/23/autistic-anti-vaxxers-fear-neurodiversity-far-right |date=23 August 2018 |work=The Guardian |access-date=8 February 2019 |issn=0261-3077}}</ref>

The [[oral polio vaccine]] (OPV) is unusual in that it contains a [[live attenuated virus]] that can be [[vaccine shedding|excreted]] leading, in under-vaccinated communities, to secondary infection.<ref name="who-VDPV">{{cite web |url=https://www.who.int/features/qa/64/en/ |title=What is vaccine-derived polio? |website=[[World Health Organization]] |access-date=6 February 2019 }}</ref> Since 2000, more than 10 billion doses of OPV have been administered to nearly 3 billion children worldwide. During that time, 24 vaccine-derived polio outbreaks occurred in 21 countries, resulting in fewer than 760 cases.<ref name="who-VDPV" /> Polio vaccine was also involved in the only large-scale outbreak of vaccine induced disease, in the [[Cutter incident]]. It is likely that polio will not be eradicated until OPV is fully replaced with inactivated vaccines.<ref>{{cite journal | vauthors = Davis R, Biellik R | title = Inactivated polio vaccine: its proposed role in the final stages of polio eradication | journal = The Pan African Medical Journal | volume = 14 | pages = 102 | date = March 2013 | pmid = 23717717 | pmc = 3664886 | doi = 10.11604/pamj.2013.14.102.2580 }}</ref>

Many countries, including Canada, Germany, Japan, and the United States have specific requirements for reporting vaccine-related adverse effects, while other countries including Australia, France, and the United Kingdom include vaccines under their general requirements for reporting injuries associated with medical treatments.<ref name = "Abramson_2019">{{cite book | first = Brian Dean | last = Abramson | name-list-style = vanc | title = Vaccine, Vaccination, and Immunization Law | date = 2019 | publisher = Bloomberg Law | isbn = 978-1-68267-583-0 }}</ref>{{rp|8–11}} A number of countries have programs for the compensation of injuries alleged to have been caused by a vaccination.<ref name = "Abramson_2019" />{{rp|9–44}}

==United States==

===Vaccine Injury Compensation Program===

In 1988, the [[Vaccine court|National Vaccine Injury Compensation Program]] (VICP) went into effect to compensate individuals and families of individuals who have been injured by specified childhood vaccines.<ref>{{cite journal | vauthors = Edlich RF, Olson DM, Olson BM, Greene JA, Gubler KD, Winters KL, Kelley AR, Britt LD, Long WB | title = Update on the National Vaccine Injury Compensation Program | journal = The Journal of Emergency Medicine | volume = 33 | issue = 2 | pages = 199–211 | date = August 2007 | pmid = 17692778 | doi = 10.1016/j.jemermed.2007.01.001 }}</ref> The VICP was adopted in response to an earlier scare over the pertussis portion of the DPT vaccine. These claims were later generally discredited, but some U.S. lawsuits against vaccine makers won substantial awards; most makers ceased production, and the last remaining major manufacturer threatened to do so.<ref>{{cite book |first=Paul A |last=Offit |name-list-style=vanc |title=Deadly choices : how the anti-vaccine movement threatens us all |date=2011 |publisher=Basic Books |isbn=9780465021499 |location=New York |oclc=636894834 |url-access=registration |url=https://archive.org/details/isbn_9780465021499 }}</ref> As of October 2019, $4.2 billion in compensation (not including attorneys fees and costs) has been awarded.<ref name="hrsa.gov">{{cite web | title = National Vaccine Injury Compensation Program Monthly Statistics Report | date = October 2019| work =  Health Resources and Services Administration (HRSA) | publisher =  U.S. Department of Health and Human Services | url = https://www.hrsa.gov/vaccine-compensation/data/index.html}}</ref>

===Vaccine Injury Compensation Program procedure and legal requirements===
VICP uses a streamlined system for litigating vaccine injury claims under which the claimant must show that the vaccine caused the injury, but just as in litigation for injury by any other product, they are not required to establish it was anyone's fault (i.e. negligence need not be proven)<ref name=":0">{{cite web|url=https://www.justice.gov/civil/vicp|title=Vaccine Injury Compensation Program |date=October 21, 2014|website=Vaccine Injury Compensation Program, Department of Justice|publisher=Department of Justice|access-date= 23 September 2016|url-status=live|archive-url=https://web.archive.org/web/20160924032851/https://www.justice.gov/civil/vicp|archive-date=September 24, 2016 }}</ref> Claims that are denied can be pursued through civil lawsuits, though this is rare, and the statute creating the VICP also imposes substantial limitations on the ability to pursue such lawsuits. The VICP covers all vaccines listed on the Vaccine Injury Table<ref name=":1" /> which is maintained by the Secretary of Health and Human Services. To win an award, a claimant is required to show a causal connection between an injury and one of the vaccines listed in the Vaccine Injury Table. Compensation is payable for "table" injuries, those listed in the Vaccine Injury Table, as well as, "non-table" injuries, injuries not listed in the table.<ref>{{cite web |url= http://myvaccinelawyer.com/vaccine-claims/the-vaccine-injury-table/ |title=Vaccine Injury Table  |publisher=My Vaccine Lawyer |access-date=23 September 2016 |url-status=live |archive-url =https://web.archive.org/web/20160924091238/http://myvaccinelawyer.com/vaccine-claims/the-vaccine-injury-table/|archive-date=September 24, 2016 }}</ref>

In addition, an award may only be given if the claimant's injury lasted for more than 6 months after the vaccine was given, resulted in a hospital stay and surgery or resulted in death. Awards are based on medical expenses, lost earnings and pain and suffering (capped at $250,000).<ref>{{cite web |url= http://myvaccinelawyer.com/vaccine-claims/the-vaccine-claim-process/ |title=The Vaccine Injury Claim Process |date=September 29, 2014|website=Vaccine Injury Claims & What to Know, Vaccine Injury Compensation Law|publisher=My Vaccine Lawyer|access-date=23 September 2016 |url-status=live |archive-url= https://web.archive.org/web/20160924022452/http://myvaccinelawyer.com/vaccine-claims/the-vaccine-claim-process/ |archive-date=September 24, 2016 }}</ref>

From 1988 until March 3, 2011, 5,636 claims relating to autism, and 8,119 non-autism claims, were made to the VICP. 2,620 of these claims, one autism-related, were compensated, with 4,463 non-autism and 814 autism claims dismissed; awards (including attorney's fees) totaled over $2 billion. The VICP also applies to claims for injuries sustained before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $903 million.<ref name=":1">{{cite web |url=http://www.hrsa.gov/vaccinecompensation/statistics_report.htm |access-date= 4 April 2011 |date= 3 March 2011 |title=National Vaccine Injury Compensation Program statistics reports |publisher=Health Resources and Services Administration |url-status=dead |archive-url=https://web.archive.org/web/20080116100950/http://www.hrsa.gov/vaccinecompensation/statistics_report.htm |archive-date=2008-01-16 }}</ref> As of October 2019, $4.2 billion in compensation (not including attorneys fees and costs) has been awarded over the life of the program.<ref name="hrsa.gov"/>

=== Table injuries ===
As part of NVICP, a table has been created which lists various vaccines, side effects that might plausibly be caused by them, and the time within which the symptoms must present in order to be eligible to apply for compensation.<ref>{{cite web |url=https://www.hrsa.gov/vaccine-compensation/index.html |title=National Vaccine Injury Compensation Program | work = Official web site of the U.S. Health Resources & Services Administration |date=11 May 2017 |access-date=6 February 2019}}</ref><ref>{{cite book | collaboration = Institute of Medicine (US) Committee on the Children's Vaccine Initiative: Planning Alternative Strategies |date=1993 | chapter =National Vaccine Injury Compensation Program | chapter-url=https://www.ncbi.nlm.nih.gov/books/NBK236419/ | veditors = Mitchell VS, Philipose NM, Sanford JP | title = The Children's Vaccine Initiative: Achieving the Vision. |publisher=National Academies Press (US)}}</ref>

For example, for vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT), [[anaphylaxis]] within four hours or [[brachial neuritis]] between two and twenty-eight days after administration, may be compensated.<ref>{{cite web |url=https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/d/injury-table.pdf |title=Vaccine Injury Table |website=[[Centers for Disease Control and Prevention]]}}</ref>

===Vaccine Adverse Event Reporting System===
The [[Vaccine Adverse Event Reporting System]] (VAERS) is a passive [[surveillance]] program administered jointly by the [[Food and Drug Administration]] (FDA) and the [[Centers for Disease Control and Prevention]] (CDC).<ref name=WBB>{{cite journal |vauthors=Woo EJ, Ball R, Burwen DR, Braun MM |title= Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS) |journal= Drug Saf |volume=31 |issue=8 |pages=667–74 |year=2008 |pmid=18636785 |doi= 10.2165/00002018-200831080-00003|s2cid= 40587832 }}</ref>

VAERS is intended to track adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines. The program's success in tracking vaccine injuries has been questioned by some, who allege medical practitioners frequently fail to make reports.<ref>{{cite journal | vauthors = Robak T | title = The reporting sensitivities of two passive surveillance systems for vaccine adverse events| journal =  American Journal of Public Health| volume = 23 | issue = 1 | pages = 11–20 | date = 1 December 1995 | pmc = 1615747 | doi = 10.2105/ajph.85.12.1706| pmid = 7503351 }}</ref> Others say that it may overstate possible injuries since many neurological problems in childhood may manifest around the same ages when vaccines are routinely administered.{{Citation needed|date=October 2007}} [[Dravet syndrome]] is one example of a genetically based neurological disease which frequently manifests at the time of childhood vaccinations.<ref>{{Cite web|url=https://www.dravetfoundation.org/what-is-dravet-syndrome/|title=What is Dravet Syndrome?}}</ref>

===Vaccine Safety Datalink===

The [[Vaccine Safety Datalink]] (VSD), funded by the [[Centers for Disease Control]], is composed of databases from several organizations containing information regarding health outcomes for millions of US citizens and to enhance assessment of vaccine injuries.  It was designed to allow for such things as comparisons between vaccinated and non-vaccinated populations, and for the identification of possible groups at risk for adverse events.{{citation needed|date=March 2022}}

==United Kingdom==

The [[Vaccine Damage Payment Act 1979]] governs AEFIs in the UK, and sets up the [[Vaccine Damage Payment]] Scheme (VDPS).

===Vaccine Damage Payment Scheme===
Under the VDPS, it is thought that thousands of unsuccessful claims have been made.  The maximum payment per claim is currently £120,000.  The 'disability threshold'  before payments are granted is 60%.  The scheme covers vaccinations for illnesses such as [[tetanus]], [[measles]], [[tuberculosis]], and [[meningitis]] C.  As of 2005, the British government had paid out £3.5 million to vaccine injury patients since 1997.<ref>{{cite news |url=http://news.bbc.co.uk/1/hi/health/4356027.stm |title= £3.5m paid out in vaccine damages| work = BBC News |date= 16 March 2005|access-date=6 July 2017 |url-status=live |archive-url= https://web.archive.org/web/20081202090528/http://news.bbc.co.uk/1/hi/health/4356027.stm |archive-date=2 December 2008 }}</ref>

Until the advent of [[COVID-19]], disabled vaccine injury patients were allowed to file a claim up to the age of 21.{{citation needed|date=December 2020}}  On the 2 December 2020, government agreed under regulation secondary to the 1979 Act the statutory £120,000 blanket payout for any person provably damaged by the vaccine, and by the same addition of COVID-19 to the list, government-approved Covax manufacturers were exempted from legal pursuit. Individuals who provide the vaccine (and thus are permitted by government to do so) are also protected.<ref name=slpf>{{cite web |url=https://www.independent.co.uk/news/health/coronavirus-pfizer-vaccine-legal-indemnity-safety-ministers-b1765124.html |title=Coronavirus vaccine: Pfizer given protection from legal action by UK government |first=Shaun |last=Lintern |work=The Independent |date=3 December 2020}}</ref>

==Canada==
Quebec has a legal process to compensate certain forms of vaccination injuries; the program was set up by statute in 1985,<ref name=jpgm/> and its first awards were made in 1988.<ref>{{cite web|title=Québec's compensation for victims of vaccination program – Assistance Measures and Programs – Portail santé mieux-être |url= http://sante.gouv.qc.ca/en/programmes-et-mesures-daide/programme-d-indemnisation-des-victimes-d-une-vaccination/|publisher=Ministère de la Santé et des Services sociaux|language=en|date=April 28, 2017 |url-status=live |archive-url= https://web.archive.org/web/20170515074934/http://sante.gouv.qc.ca/en/programmes-et-mesures-daide/programme-d-indemnisation-des-victimes-d-une-vaccination/ |archive-date=May 15, 2017 }}</ref>

On 10 December 2020, the nations was made aware via an [[op-ed]] published in the ''[[Globe and Mail]]'' that "Canada needs to prepare for rare but serious health problems resulting from [Covid-19] vaccination" by, inter alia, the [[Honourable]] Dr [[Jane Philpott]], former cabinet member and Dean of the Faculty of Health Sciences of [[Queen's University at Kingston|Queen's University]]. The authors observed that, outside of Quebec, "People suffering severe AEFIs are left to assume the costs of legal fees, lost wages, uninsured medical services and rehabilitation supports," and plumped for a [[no-fault system]], in which "compensation is needs-based and not punitive."<ref name="jpgm">{{cite news |last1=Philpott |first1=Jane |last2=MOORE |first2=KIERAN |last3=TOUMISHEY |first3=ETHAN |title=Canada needs to prepare for rare but serious health problems resulting from vaccination |url=https://www.theglobeandmail.com/opinion/article-canada-needs-to-prepare-for-rare-but-serious-health-problems-resulting/ |publisher=The Globe and Mail Inc |date=10 December 2020}}</ref> They go on to write:
{{cquote|In the context of the COVID-19 pandemic, we are concerned that, given the anticipated scale of the COVID-19 immunization campaign and new vaccine technologies employed, mass immunization may result in a small number of Canadians experiencing serious AEFIs, despite adherence to best practices. While AEFIs are possible with routine immunizations, pandemic situations are unique with respect to the speed and scale with which vaccine technologies are developed and distributed. Rare serious AEFIs may not be captured during phases of clinical trials because it may require very large numbers of the population to be immunized for AEFIs to manifest. The anticipated incidence of serious AEFIs can be estimated at 1 in one million immunizations... the potential health consequences of adverse events following immunization borne by the few will be for our collective benefit in stopping the deadly spread of the virus. Operating under this estimate, we anticipate 25 Canadians may suffer a serious health outcome following COVID-19 vaccination, or 0.1 per 100,000 doses.}}

The authors conclude that an "equitable and fair compensation system with a transparent accountability process for monitoring potential AEFIs associated with COVID-19 immunization could increase public confidence in vaccines and promote uptake."<ref name=jpgm/>

== See also ==
* [[Vaccine hesitancy]]
* [[COVID-19 vaccine#Adverse events]]

== References ==
{{Reflist}}

== External links ==
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[[Category:Drug safety]]
[[Category:Vaccination|Injury, Vaccine]]