Elsevier

Vaccine

Volume 33, Issue 29, 26 June 2015, Pages 3288-3292
Vaccine

Review
Deaths following vaccination: What does the evidence show?

https://doi.org/10.1016/j.vaccine.2015.05.023Get rights and content

Abstract

Vaccines are rigorously tested and monitored and are among the safest medical products we use. Millions of vaccinations are given to children and adults in the United States each year. Serious adverse reactions are rare. However, because of the high volume of use, coincidental adverse events including deaths, that are temporally associated with vaccination, do occur. When death occurs shortly following vaccination, loved ones and others might naturally question whether it was related to vaccination. A large body of evidence supports the safety of vaccines, and multiple studies and scientific reviews have found no association between vaccination and deaths except in rare cases. During the US multi-state measles outbreak of 2014–2015, unsubstantiated claims of deaths caused by measles, mumps, and rubella (MMR) vaccine began circulating on the Internet, prompting responses by public health officials to address common misinterpretations and misuses of vaccine safety surveillance data, particularly around spontaneous reports submitted to the US Vaccine Adverse Event Reporting System (VAERS). We summarize epidemiologic data on deaths following vaccination, including examples where reasonable scientific evidence exists to support that vaccination caused or contributed to deaths. Rare cases where a known or plausible theoretical risk of death following vaccination exists include anaphylaxis, vaccine-strain systemic infection after administration of live vaccines to severely immunocompromised persons, intussusception after rotavirus vaccine, Guillain–Barré syndrome after inactivated influenza vaccine, fall-related injuries associated with syncope after vaccination, yellow fever vaccine-associated viscerotropic disease or associated neurologic disease, serious complications from smallpox vaccine including eczema vaccinatum, progressive vaccinia, postvaccinal encephalitis, myocarditis, and dilated cardiomyopathy, and vaccine-associated paralytic poliomyelitis from oral poliovirus vaccine. However, making general assumptions and drawing conclusions about vaccinations causing deaths based on spontaneous reports to VAERS – some of which might be anecdotal or second-hand – or from case reports in the media, is not a scientifically valid practice.

Section snippets

Background

Modern vaccines are among the greatest public health achievements in history, preventing thousands of illnesses and deaths each year in the United States alone [1]. However, as illness, disability and death from vaccine-preventable diseases have decreased, concerns over vaccine safety have increased [2]. Despite the reality that a person is far more likely to be seriously or fatally injured by a disease prevented by vaccines than by a vaccine itself, there appears to be a trend toward increased

Historical events

In the era of modern medicine, some of the first concerns about vaccines causing death date to isolated, but high profile past vaccine safety incidents. The “Cutter Incident” in 1955 involved a flaw in the Salk polio vaccine manufacturing process at Cutter Laboratories that led to production of substantial amounts of what was thought to be inactivated vaccine that contained live poliovirus. The result has been called “…one of the worst pharmaceutical disasters in US history”[11], with 40,000

Current epidemiologic data on death associated with vaccination

Multiple large reviews and studies have been conducted to evaluate the association between vaccination and death. The results have consistently been reassuring. The Institute of Medicine (IOM) reviewed deaths reported to VAERS after childhood vaccines in the early 1990s [19]. Some of the reports did not have enough information to make a determination about causality, but among reports with adequate follow-up, the IOM concluded that the vast majority of reported deaths were coincidental and not

Evidence in favor of causal associations between vaccination and death

Although the evidence supports the safety of vaccines, there are rare instances where causal relationships between vaccination and death have been established or a plausible theoretical risk exists.

Conclusion

Vaccines are rigorously tested and monitored and are among the safest medical products we use. Millions of vaccinations are administered to children and adults in the United States each year. Serious adverse reactions are uncommon and deaths caused by vaccines are very rare. Healthcare providers can take specific actions to help prevent adverse reactions, including proper screening for contraindications and precautions and observing a 15-minute waiting period after vaccinating to prevent

Funding

The review was conducted by the Centers for Disease Control and Prevention (CDC) and no external sources of funding were used.

Acknowledgement

We gratefully acknowledge Dr. Frank DeStefano for his input and review of this article.

Disclosures: No authors have a conflict of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript.

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

References (69)

  • M.M. Braun et al.

    Syncope after immunization

    Arch Pediatr Adolesc Med

    (1997)
  • Centers for Disease Control and Prevention (CDC)

    Achievements in public health, 1900–1999 impact of vaccines universally recommended for children – United States, 1990–1998

    MMWR

    (1999)
  • M. Siddiqui et al.

    Epidemiology of vaccine hesitancy in the United States

    Hum Vaccine Immunother

    (2013)
  • N.S. Clemmons et al.

    Measles-United States, January 4–April 2, 2015

    MMWR

    (2015)
  • Shilhavy B. Zero US measles deaths in 10 years, but over 100 measles vaccine deaths reported. Health Impact News...
  • Huff EA. Measles vaccines kill more people than measles, CDC data proves. Global Research February 5, 2015. Available...
  • Wofford T.A. Look at Anti-Vaxxers’ Monstrously Bad Measles Math. Newsweek February 3, 2015. Available at:...
  • F. Varricchio et al.

    Understanding vaccine safety information from the Vaccine Adverse Event Reporting System

    Pediatr Infect Dis J

    (2004)
  • World Health Organization. Statement regarding interim findings of WHO assessment of deaths of children in Idleb...
  • World Health Organization. Information for health-care workers-managing adverse events; 9 April 2009. Available at:...
  • P.A. Offit

    The Cutter incident, 50 years later

    N Engl J Med

    (2005)
  • N. Nathanson et al.

    The Cutter incident: poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the United States during the spring of 1955. II. Relationship of poliomyelitis to Cutter vaccine

    Am J Hyg

    (1963)
  • P.A. Offit

    The Cutter Incident: how America's first polio vaccine led to the growing vaccine crisis

    (2005)
  • L.K. Pickering et al.

    Vaccines in the pipeline: the path from development to use in the United States

    Pediatr Ann

    (2013)
  • V. Marshall et al.

    Food and Drug Administration regulation and evaluation of vaccines

    Pediatrics

    (2011)
  • D.J. Sencer et al.

    Reflections on the 1976 swine flu vaccination program

    Emerg Infect Dis

    (2006)
  • L.B. Schonberger et al.

    Guillain–Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977

    Am J Epidemiol

    (1979)
  • K. Link

    The vaccine controversy: the history, use and safety of vaccinations

    (2005)
  • Institute of Medicine
  • L.E. Silvers et al.

    The epidemiology of fatalities reported to the Vaccine Adverse Event Reporting System 1990–1997

    Pharmacoepidemiol Drug Saf

    (2001)
  • P. Haber et al.

    Post-licensure surveillance of trivalent live-attenuated influenza vaccine in children aged 2–18 years, Vaccine Adverse Event Reporting System, United States, July 2005–June 2012

    J Pediatric Infect Dis Soc

    (2014)
  • B.A. Slade et al.

    Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine

    JAMA

    (2009)
  • P.L. Moro et al.

    Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990–2013

    J Pediatr

    (2015)
  • Institute of Medicine
  • Cited by (67)

    • Myocarditis following vaccination with Pfizer-BioNTech BNT162b2 against coronavirus infection (COVID-19)

      2022, Autoimmunity, COVID-19, Post-COVID19 Syndrome and COVID-19 Vaccination
    • Hemodynamic Collapse After Influenza Vaccination: A Vaccine-Induced Fulminant Myocarditis?

      2020, Canadian Journal of Cardiology
      Citation Excerpt :

      In this case, the possibility of influenza virus activation after the vaccination is excludable, even if she had undiagnosed immunodeficiency, because she received an inactivated vaccine. An anaphylactic reaction is a major complication of vaccination,1 and cases of biopsy-proven eosinophilic myocarditis following immunization or vaccination have been reported.4 However, such an eosinophil infiltration was not found in this case.

    View all citing articles on Scopus
    View full text