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Can Influenza Vaccine Cause Injury and Death?


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The Institute of Medicine (IOM) has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination.1 However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving an influenza vaccine or any other vaccine.

The most common reported reactions following administration of the inactivated influenza vaccine include headache, muscle ache, fever, and pain, swelling and redness at the injection site.

Children who receive the influenza vaccine at the same time as the DTaP (diphtheria, tetanus, acellular pertussis) and/or pneumococcal (PCV13) are at a higher risk of suffering from a seizure induced by fever.2

One of the most serious documented influenza vaccine reactions is Guillain-Barre Syndrome (GBS). 3  An immune mediated painful and disabling neurological disorder that can occur after viral infection or vaccination, GBS involves inflammation of the peripheral nervous system and can cause temporary or permanent paralysis that may lead to death. 4 GBS usually develops within two to four weeks of vaccination.

Characterized by muscle weakness, unsteady gait, numbness, tingling, pain, GBS can cause paralysis of the face or one or more limbs. It can take several months for recovery or it can leave the affected person with chronic health problems and disability.5 The mortality rate with GBS is highest among the elderly and those who develop severe complications.6

The CDC states that:

“Some studies have found a possible small association of injectable flu vaccine with Guillain-Barré syndrome (GBS). Overall, these studies estimated the risk for GBS after vaccination as fewer than 1 or 2 cases of GBS per one million people vaccinated. Other studies have not found any association. GBS also, rarely, occurs after flu illness. Even though GBS following flu illness is rare, GBS is more common following flu illness than following flu vaccination. GBS has not been associated with the nasal spray vaccine.” 7

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, 8 published in 2012 by the Institute of Medicine (IOM), 27 reported vaccine adverse events following the influenza vaccine were evaluated by a physician committee.9 These adverse events included GBS, stroke, myocardial infarction, Chronic Inflammatory Disseminated Polyneuropathy, Acute Disseminated Encephalomyelitis (ADEM), optic neuritis, Bell’s palsy, encephalopathy, encephalitis, and more.

The IOM committee concluded that in only 1 out of the 27 influenza vaccine-related adverse events – anaphylaxis - the scientific evidence convincingly supported a causal relationship between the vaccine and the adverse event. The committee also concluded that it favored acceptance of an association between the flu vaccine and Oculorespiratory Syndrome, a syndrome which generally occurs between 2- and 24-hours following vaccine administration and is characterized by symptoms which include acute respiratory symptoms (including respiratory distress, throat tightness and/or chest discomfort), red eyes, and facial swelling. After primarily examining epidemiologic studies, the committee members favored rejection of an association between 2 vaccine-related adverse events -Bell’s Palsy and asthma exacerbation or reactive airway disease episodes in children and adults- and the influenza vaccine. For the remaining 23 reported vaccine adverse events, including GBS, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the influenza virus vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination.10

The U.S. government, however, recognized GBS occurring between 3 and 42 days following the influenza vaccine as a vaccine injury and in 2017, GBS was added to the National Vaccine Injury Compensation Program’s Vaccine Injury Table.

Adult influenza vaccine injury claims are now the leading claim submitted to the federal Vaccine Injury Compensation Program (VICP), with GBS as the leading alleged injury.11 12

Additional influenza vaccine injuries recognized by the U.S. government and included in the Vaccine Injury Table include anaphylaxis within 4 hours of vaccination, vasovagal syncope within 1 hour of vaccination, and shoulder injury related to vaccine administration (SIRVA) within 48 hours of vaccination. SIRVA is a recognized injury resulting from the administration of the vaccine antigen or needle into or around the bursa of the shoulder. SIRVA causes an inflammatory response and manifests as pain and reduced mobility to the shoulder in which the vaccine was administered.13

Published studies have linked the influenza vaccine to numerous serious adverse events including Acute Disseminated Encephalomyelitis (ADEM), 14 15 16 17 18 19 20 21 22 23 stroke,24 brachial neuritis,25 26 encephalopathy,27 arthritis,28 bullous pemphigoid,29 30 31 32 33 34 35vasculitis,36 37 38 39, myocardial infarction,40 transverse myelitis,41 42 43 44 45 optic neuritis,46 47 Bell’s Palsy,48 and more. 49

A Canadian study published in 2015 found that the effectiveness of the flu vaccine decreased when a person received the shot two years in a row. Because of these negative findings which implied that the vaccine increased a person’s susceptibility to influenza, study authors recommended further research be completed. 50 51

In 2017, a Centers for Disease Control (CDC) funded study reported that women vaccinated in the early part of their pregnancy with a flu vaccine containing the pandemic H1N1 (H1N1pdm09) strain and who also had been previously vaccinated the prior season with a H1N1pdm09-containing flu vaccine had a greater risk of miscarriage in the first four weeks following vaccination. The CDC conducted further research among women who were pregnant during the 2012-2013 through 2014-2015 flu seasons and eligible to receive the flu vaccine. This study, which contradicted their previous findings, reported that the influenza vaccine did not cause miscarriages in the women evaluated in the study.52 53

As of June 30, 2020, there have been more than 178,684 reports of influenza vaccine reactions, hospitalizations, injuries and deaths following influenza vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 1,790 related deaths, 14,197 hospitalizations, and 3,671 related disabilities. Moderate reactions reported include fever, local reactions (pain, redness, swelling at the site of the injection), headache, fatigue, sore throat, nasal congestion, cough, joint and muscle pain, and nausea. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur after influenza vaccination.

 

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.54 55 56 57 58

As of Aug 1, 2020, there have been 6,368 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following influenza vaccination, including 188 deaths and 6,180 serious injuries.59

IMPORTANT NOTE: NVIC encourages you to become fully informed about Influenza and the Influenza vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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References

1 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. Evaluating Biological Mechanisms of Adverse Events (p. 57-102), Increased Susceptibility (p. 82). Washington, DC: The National Academies Press 2012.

2 CDC Inactivated Influenza VIS Aug. 15, 2019

3  Kwong JC, Vasa PP et al. Risk of Guillain Barre Syndrome after seasonal influenza vaccinations and influenza health care encounters: a self-controlled study. The Lancet Infectious Diseases 2013; 13(9): 769-776.

4  GBS Flu Vaccine Reaction Leaves Nurse A Quadriplegic. National Vaccine Information Center Oct. 31, 2011.

5 CDC Guillain-Barré syndrome and Flu Vaccine. Oct. 16, 2015

6 Van den Berg B, Bunschoten C et al. Mortality in Guillain-Barré Syndrome. Neurology 2013; 80(18): 1650-1654

7 CDC Flu Vaccine Safety Information Oct. 5, 2017.

8 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012

9 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. (Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility). Washington, DC: The National Academies Press. 2012. Chap. 6 p.293-420

10 Ibid

11 Department of Health and Human Services. Advisory Committee on Childhood Vaccines (ACCV) Meeting. Mar. 3, 2011.

12 HRSA Vaccine Injury Compensation Program Data and Statistics Sept. 1, 2019

13 HRSA Vaccine Injury Table Mar. 21, 2017

14 Huynh W, Cordato DJ, Kehdi E et al. Post-vaccination encephalomyelitis: literature review and illustrative case. J Clin Neurosci. 2008 Dec;15(12):1315-22.

15 Nakamura N, Nokura K, Zettsu T et al. Neurologic complications associated with influenza vaccination: two adult cases. Intern Med. 2003 Feb;42(2):191-4.

16 Shoamanesh A, Traboulsee A. Acute disseminated encephalomyelitis following influenza vaccination. Vaccine. 2011 Oct 26;29(46):8182-5

17 Lee ST, Choe YJ, Moon WJ, et al. An adverse event following 2009 H1N1 influenza vaccination: a case of acute disseminated encephalomyelitis. Korean J Pediatr. 2011 Oct;54(10):422-4

18 Maeda K, Idehara R. Acute disseminated encephalomyelitis following 2009 H1N1 influenza vaccination. Intern Med. 2012;51(14):1931-3.

19 Machicado JD, Bhagya-Rao B, Davogustto G, McKelvy BJ. Acute disseminated encephalomyelitis following seasonal influenza vaccination in an elderly patient. Clin Vaccine Immunol. 2013 Sep;20(9):1485-6.

20 Arai M, Takagi D, Nagao R. Acute disseminated encephalomyelitis following influenza vaccination: report of a case with callosal disconnection syndrome. Rinsho Shinkeigaku. 2014;54(2):135-9.

21 Andrade SD, Andrade MG, Santos PJ et al. Acute disseminated encephalomyelitis following inactivated influenza vaccination in the Brazilian Amazon: a case report. Rev Soc Bras Med Trop. 2015 Jul-Aug;48(4):498-500

22 Ravaglia S, Ceroni M, Moglia A et al. Post-infectious and post-vaccinal acute disseminated encephalomyelitis occurring in the same patients. J Neurol. 2004 Sep;251(9):1147-50.

23 Hoshino T, Uchiyama Y, Ito E, et al. Simultaneous development of acute disseminated encephalomyelitis and Guillain-Barré syndrome associated with H1N1 09 influenza vaccination. Intern Med. 2012;51(12):1595-8.

24 Vainer-Mossel ED, Mekori YA, Mor A. Ischemic stroke in a patient with lupus following influenza vaccination: a questionable association. Isr Med Assoc J. 2009 Mar;11(3):186-7.

25 Taras JS, Donohue KW Radial nerve motor palsy following seasonal influenza vaccination: a case report. J Surg Orthop Adv. 2014 Spring;23(1):42-4.

26 Shaikh MF, Baqai TJ, Tahir H. Acute brachial neuritis following influenza vaccination. BMJ Case Rep. 2012 Nov 28;2012

27 Antony SJ, Fleming DF, Bradley TK. Postvaccinial (influenza) disseminated encephalopathy (Brown-Sequard syndrome) J Natl Med Assoc. 1995 Sep;87(9):705-8.

28 Asakawa J, Kobayashi S, Kaneda K, et al. Reactive arthritis after influenza vaccination: report of a case. Mod Rheumatol. 2005;15(4):283-5.

29 Walmsley N, Hampton P Bullous pemphigoid triggered by swine flu vaccination: case report and review of vaccine triggered pemphigoid J Dermatol Case Rep. 2011 Dec 12; 5(4): 74–76.

30 Lear JT, Tan BB, English JS. Bullous pemphigoid following influenza vaccination. Clin Exp Dermatol. 1996 Sep;21(5):392.

31 Fournier B, Descamps V, Bouscarat F, et al. Bullous pemphigoid induced by vaccination. Br J Dermatol. 1996 Jul;135(1):153-4.

32 Downs AM, Lear JT, Bower CP, Kennedy CT Does influenza vaccination induce bullous pemphigoid? A report of four cases. Br J Dermatol. 1998 Feb;138(2):363.

33 Byrd RC, Mournigham KJ, Baca-Atlas M, Generalized Bullous fixed-drug eruption secondary to influenza vaccine JAAD Case Reports 2018 Oct 12; 4(9): 953-955.

34 Al-Mutairi N, Al-Fouzan A, Nour-Eldin O. Fixed drug eruption due to influenza vaccine. J Cutan Med Surg. 2004 Jan-Feb;8(1):16-8

35 García-Doval I, Rosón E, Feal C et al. Generalized bullous fixed drug eruption after influenza vaccination, simulating bullous pemphigoid. Acta Derm Venereol. 2001 Nov-Dec;81(6):450-1.

36 Hull JH, Mead SH, Foster OJ et al. Severe vasculitic neuropathy following influenza vaccination. J Neurol Neurosurg Psychiatry. 2004 Oct;75(10):1507-8.

37 Mader R, Narendran A, Lewtas J et al. Systemic vasculitis following influenza vaccination--report of 3 cases and literature review. J Rheumatol. 1993 Aug;20(8):1429-31.

38 Blumberg S, Bienfang D, Kantrowitz FG. A possible association between influenza vaccination and small-vessel vasculitis. Arch Intern Med. 1980 Jun;140(6):847-8.

39 Duggal T, Segal P, Shah M et al. Antineutrophil cytoplasmic antibody vasculitis associated with influenza vaccination. Am J Nephrol. 2013;38(2):174-8

40 Ritter O1, Bonz A, Strotmann J, Langenfeld H. Myocardial infarction after influenza vaccination. Z Kardiol. 2003 Nov;92(11):962-5.

41 Bakshi R, Mazziotta JC. Acute transverse myelitis after influenza vaccination: magnetic resonance imaging findings. J Neuroimaging. 1996 Oct;6(4):248-50.

42 Sato N, Watanabe K, Ohta K, Tanaka H. Acute transverse myelitis and acute motor axonal neuropathy developed after vaccinations against seasonal and 2009 A/H1N1 influenza. Intern Med. 2011;50(5):503-7.

43 Vieira MA, Costa CH, Vieira CP et al. Transverse myelitis with Brown-Sèquard syndrome after H1N1 immunization. Arq Neuropsiquiatr. 2012 Jul;70(7):555.

44 Nakamura N, Nokura K, Zettsu T et al. Neurologic complications associated with influenza vaccination: two adult cases. Intern Med. 2003 Feb;42(2):191-4.

45 Cho JH, Park Y, Woo N. A case of neuromyelitis optica spectrum disorder following seasonal influenza vaccination. Mult Scler Relat Disord. 2019 May;30:110-113.

46 Jun B, Fraunfelder FW Atypical Optic Neuritis After Inactivated Influenza Vaccination. Neuroophthalmology. 2017 Aug 17;42(2):105-108

47 Hull TP, Bates JH. Optic neuritis after influenza vaccination. Am J Ophthalmol. 1997 Nov;124(5):703-4.

48 Chou CH, Liou WP, Hu KI Bell's palsy associated with influenza vaccination: two case reports. Vaccine. 2007 Apr 12;25(15):2839-41.

49 Institute of Medicine Committee to Review Adverse Effects of Vaccines  Adverse Effects of Vaccines Evidence and Causality. Influenza Vaccine. pp 293-420.  Washington, D.C. The National Academies Press 2012.

50 Skowronski DM, Chambers C et al. Interim estimates of 2014/15 vaccine effectiveness against influenza A(H3N2) from Canada's Sentinel Physician Surveillance Network, January 2015. Euro Surveill  2015 Jan 29;20(4).

51 Yourex-West H, McIntosh S, Canadian study finds flu shot could increase risk of getting sick. Global News. Jan. 30, 2015.

52 CDC Flu Vaccination & Addressing Concerns Pregnant Women Might Have about Flu Vaccine Safety July. 5, 2019

53 Wrangham, T ACIP: 2018-2019 Flu Vaccine 44 Percent Effective National Vaccine Information Center Apr. 7, 2019

54 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.

55 FDA.gov. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. Reprint from JAMA. June 9, 1993.

56 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health

57 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.

58 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010

59 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program Data—September 1, 2019. National Vaccine Injury Compensation Program. Sept 1, 2019


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