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Can Chickenpox vaccine cause injury & death?


vaccine injury death

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 a chickenpox vaccine or any other vaccine.

According to the CDC, possible side effects from the varicella (chickenpox) vaccine include:2

  • Pain, swelling, and redness at the injection site
  • Fever
  • Seizures, often associated with fever
  • Full body rash
  • Pneumonia
  • Meningitis
  • Severe allergic reaction
  • Death

During the pre-licensing clinical trial of Merck’s Varivax (Varicella Virus Vaccine, Live) vaccine, reported adverse events included: injection site pain, redness, itching, swelling, rash, induration, bruising, and stiffness; fever; chickenpox-like rash at injection site; generalized chickenpox rash; upper respiratory infection; cough; irritability; nervousness; fatigue; sleep disturbances; loss of appetite; diarrhea; vomiting; inflammation of the ear; contact rash; diaper rash; other rash; heat rash; malaise; teething; headache; abdominal pain; muscle pain; chills; eye complaints; lymphadenopathy; nausea; lower respiratory infection; joint pain; stiff neck; dermatitis; itching; eczema; dry skin; constipation; allergic reaction; canker/cold sore; pneumonitis; and febrile seizures.3

Serious complications reported by Merck since FDA licensure of Varivax have included:4

  • Encephalitis
  • Stroke
  • Guillain-Barre Syndrome
  • Transverse Myelitis
  • Bell’s Palsy
  • Non-febrile seizures
  • Aseptic meningitis
  • Meningitis
  • Paresthesia
  • Dizziness
  • Ataxia
  • Anaphylaxis, including anaphylactic shock
  • Peripheral edema
  • Facial edema
  • Angioneurotic edema
  • Necrotizing retinitis in immunocompromised individuals
  • Thrombocytopenia
  • Idiopathic thrombocytopenic purpura (ITP)
  • Aplastic anemia
  • Vaccine strain chickenpox infection
  • Pneumonia
  • Pneumonitis
  • Pharyngitis
  • Henoch-Schönlein purpura
  • Erythema multiforme
  • Secondary bacterial infections of skin and soft tissue including cellulitis and impetigo
  • Shingles
  • Stevens-Johnson Syndrome

Meningitis or encephalitis caused by the vaccine-strain chickenpox virus have been reported in healthy individuals previously vaccinated with Varivax vaccine months to years after vaccination. Reported cases were commonly associated with a shingles rash.5

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, 6 published in 2012 by the Institute of Medicine (IOM), 15 reported vaccine adverse events following the varicella (chickenpox) virus vaccine were evaluated by a physician committee.7 These adverse events included disseminated vaccine strain virus with and without other organ involvement, vaccine strain viral reactivation (vaccine strain shingles) with and without other organ involvement, varicella encephalopathy, varicella seizures, acute disseminated encephalomyelitis, anaphylaxis, Guillain-Barre Syndrome, stroke, cerebellar ataxia, small fiber neuropathy, onset or exacerbation of arthropathy, transverse myelitis and thrombocytopenia.8

The IOM committee concluded that in 5 out of 15 varicella (chickenpox) virus vaccine-related adverse events, the scientific evidence convincingly supported a causal relationship between the vaccine and the adverse event. These 5 adverse events included disseminated vaccine strain virus without organ involvement, disseminated vaccine strain virus with organ involvement, vaccine strain viral reactivation (vaccine strain shingles) without organ involvement, vaccine strain viral reactivation with organ involvement, and anaphylaxis. In the remaining 10 reported vaccine adverse events, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the chickenpox 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.9

In the past 3 decades, published studies have linked the chickenpox vaccine to serious adverse events in both children and adults. These adverse events include aplastic anemia,10 ocular complications, 11 12 13 14 15 16 17 18 19 streptococcal toxic shock syndrome,20 skin rashes,21 22 thrombocytopenic pupura,23 stroke,24 pneumonia,25 Stevens - Johnson syndrome,26 and central nervous system disorders27 28 including meningitis,29 30 31 32 33 34 and encephalitis.35

Adolescents between the ages of 11 and 17 are also at a higher risk of developing immune thrombocytopenic purpura (ITP) following chickenpox vaccination. 36

In 2013, the vaccine strain chickenpox virus was found to be responsible for the death of a 15-month-old vaccinated child. The young girl developed a chickenpox-like rash 20 days after receiving the chickenpox vaccine. She developed severe respiratory complications despite 2 months of anti-viral medications, and eventually died from sepsis and multi-organ failure.37

Case studies have also found that severe complications can occur in persons with previously undiagnosed HIV infections who developed vaccine strain chickenpox after vaccination.38 39 40 While the live virus chickenpox vaccine is contraindicated in persons with a history of solid organ transplant, when administered, serious complications may occur.41

Persons with a history of chickenpox vaccination may still be at risk for developing severe chickenpox infection,42 with complications which may include transverse myelitis,43 pneumonia,44 and meningitis.45 Children previously vaccinated with the chickenpox vaccine can also develop vaccine-strain shingles infections46 47 48 49 50 51 52 which may result in serious complications.53 54  

In November 2014, the National Vaccine Information Center published a special report The Emerging Risks of Live Virus and Virus Vectored Vaccines: Vaccine Strain Virus Infection, Shedding and Transmission.  This report reviewed the medical literature for evidence that live virus vaccine strain infection, shedding, and potential for transmission occurs, including chickenpox vaccine strain infection and shedding.

This report found that healthy children and adults can transmit vaccine strain chickenpox infection to other healthy children and adults but immune compromised persons were found to be at a special risk for contracting vaccine strain chickenpox infections and suffering complications. Published case studies in the medical literature have reported on vaccine strain chickenpox infections in solid organ transplant recipients,55 newborn infants,56 and individuals with cancer.57

The Varivax chickenpox vaccine package insert states: “Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from a mother who did not develop a varicella-like rash to her newborn infant has been reported. Due to the concern for transmission of vaccine virus, vaccine recipients should attempt to avoid whenever possible close association with susceptible high-risk individuals for up to six weeks following vaccination with VARIVAX.”58 High risk individuals include the immunocompromised; pregnant women who have never had varicella infection and their newborn infants; and premature babies born before 28 weeks gestation.59

According to the CDC, possible side effects from the measles, mumps, rubella, and varicella (MMRV) vaccine include:60

  • Pain, swelling, redness, and rash at the injection site
  • Fever
  • Swelling of the glands in the neck or cheeks
  • Seizures, often associated with fever
  • Full body rash
  • Low platelet count which may result in unusual bruising or bleeding
  • Encephalitis
  • Meningitis
  • Pneumonia
  • Permanent hearing loss
  • Long-term seizure disorder
  • Coma
  • Lower consciousness
  • Brain damage
  • Severe allergic reaction
  • Death

The CDC also reports that there is a higher risk of seizures following the MMRV vaccine when compared with separate injections of MMR and varicella vaccines. This risk is significantly greater when the MMRV vaccine is administered as the first dose of the series.61  

Adverse events reported during the pre-licensure clinical trials of Merck’s ProQuad (MMRV) vaccine included: measles-like rash; chicken-pox rash; fever; injection site pain, tenderness, redness, swelling, ecchymosis, hemorrhage and rash; irritability; rash; viral exanthema; upper respiratory infection; diarrhea; vomiting; nasopharyngitis; eczema; and febrile seizure.62

Serious complications reported by Merck in the ProQuad (MMRV) package insert during vaccine post-marketing surveillance have included:63

  • measles;
  • atypical measles;
  • vaccine strain varicella;
  • varicella-like rash;
  • herpes zoster;
  • herpes simplex;
  • pneumonia and respiratory infection;
  • pneumonitis;
  • bronchitis;
  • epididymitis;
  • cellulitis;
  • skin infection;
  • subacute sclerosing panencephalitis;
  • aseptic meningitis;
  • thrombocytopenia;
  • aplastic anemia (anemia due to the bone marrow’s inability to produce platelets, red and white blood cells);
  • lymphadenitis (inflammation of the lymph nodes);
  • anaphylaxis including related symptoms of peripheral, angioneurotic and facial edema;
  • agitation;
  • ocular palsies;
  • necrotizing retinitis (inflammation of the eye);
  • nerve deafness;
  • optic and retrobulbar neuritis (inflammation of the optic nerve);
  • Bell’s palsy (sudden but temporary weakness of one half of the face);
  • cerebrovascular accident (stroke);
  • acute disseminated encephalomyelitis;
  • measles inclusion body encephalitis;
  • transverse myelitis;
  • encephalopathy;
  • Guillain-Barre syndrome;
  • syncope (fainting);
  • tremor;
  • dizziness;
  • paraesthesia;
  • febrile seizure;
  • afebrile seizures or convulsions;
  • polyneuropathy (dysfunction of numerous peripheral nerves of the body);
  • Stevens-Johnson syndrome;
  • Henoch-Schönlein purpura;
  • acute hemorrhagic edema of infancy;
  • erythema multiforme;
  • panniculitis;
  • arthritis;
  • death

A 2014 published study on the MMRV vaccine use in Canada found that the risk of febrile seizures following MMRV vaccination was double that of children receiving separate doses of MMR and varicella vaccines.64 Additionally, a 2015 meta-analysis found a two-fold increase in febrile seizures between 5 and 12 days following MMRV vaccination in children between the ages of 10 and 24 months.65

MMRV vaccine contains albumin, a human blood derivative, and as a result, a theoretical risk of contamination with Creutzfeldt-Jakob disease (CJD) exists. Merck states that no cases of transmission of CJD or other viral diseases have been identified and virus pools, cells, bovine serum, and human albumin used in vaccine manufacturing are all tested to assure the final product is free of potentially harmful agents.66

As of May 31, 2019, there have been more than 89,018 reports of varicella vaccine (Varicella, MMRV) reactions, hospitalizations, injuries and deaths following varicella vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS). This includes 197 related deaths, 3,187 hospitalizations, and 730 related disabilities. However, the number of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur after chickenpox 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 which 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.67 68 69 70 71

As of Aug 1, 2019, there have been more than 167 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following chickenpox vaccination (Varicella, MMRV), including 11 deaths and 156 serious injuries. ). Of that number, the U.S. Court of Claims administering the VICP has compensated 86 children and adults, who have filed for varicella vaccine injury.72

IMPORTANT NOTE: NVIC encourages you to become fully informed about Chickenpox and the Chickenpox 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 Chickenpox VIS Feb. 12, 2018

3 FDA Varivax Package Insert Jan 23, 2019

4 Ibid

5 Ibid

6 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

7 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. 5 p.239-292

8 Ibid

9 Ibid

10 Angelini P, Kavadas F, Sharma N, Aplastic anemia following varicella vaccine. Pediatr Infect Dis J. 2009 Aug;28(8):746-8

11 Esmaeli-Gutstein B, Winkelman JZ. Uveitis associated with varicella virus vaccine. Am J Ophthalmol. 1999 Jun; 127(6):733-4.

12 Grillo AP, Fraunfelder FW Keratitis in association with herpes zoster and varicella vaccines. Drugs Today (Barc). 2017 Jul;53(7):393-397

13 Naseri A., Good WV, Cunningham ET, Jr. Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination. Am J Ophthalmol. 2003;135(March (3)):415–417

14 Binder NR, Holland GN, Hosea S, Silverberg ML. Herpes zoster ophthalmicus in an otherwise-healthy child. J AAPOS. 2005 Dec;9(6):597-8.

15 Fine HF, Kim E, Flynn TE et al. Acute posterior multifocal placoid pigment epitheliopathy following varicella vaccination. Br J Ophthalmol. 2010 Mar;94(3):282-3, 363.

16 Chouliaras G, Spoulou V, Quinlivan M et al. Vaccine-associated herpes zoster ophthalmicus correction of opthalmicus and encephalitis in an immunocompetent child. Pediatrics. 2010 Apr;125(4):e969-72.

17 Lin P, Yoon MK, Chiu CS. Herpes zoster keratouveitis and inflammatory ocular hypertension 8 years after varicella vaccination. Ocul Immunol Inflamm. 2009 Jan-Feb;17(1):33-5.

18 Nagpal A, Vora R, Margolis TP, Acharya NR. Interstitial keratitis following varicella vaccination. Arch Ophthalmol. 2009 Feb;127(2):222-3

19 Krall P, Kubal A. Herpes zoster stromal keratitis after varicella vaccine booster in a pediatric patient. Cornea. 2014 Sep;33(9):988-9

20 Italiano CM, Toi CS, Chan SP, Dwyer DE. Prolonged varicella viraemia and streptococcal toxic shock syndrome following varicella vaccination of a health care worker. Med J Aust. 2009 Apr 20;190(8):451-3.

21 Gerecitano J, Friedman-Kien A, Chazen GD. Allergic reaction to varicella vaccine. Ann Intern Med. 1997 May 15;126(10):833-4.

22 Bronstein DE, Cotliar J, Votava-Smith JK et al. Recurrent papular urticaria after varicella immunization in a fifteen-month-old girl. Pediatr Infect Dis J. 2005 Mar;24(3):269-70.

23 Lee SY, Komp DM, Andiman W. Thrombocytopenic purpura following varicella-zoster vaccination. Am J Pediatr Hematol Oncol. 1986 Spring;8(1):78-80.

24 Wirrell E, Hill MD, Jadavji T et al. Stroke after varicella vaccination. J Pediatr. 2004 Dec;145(6):845-7.

25 Lohiya GS, Tan-Figueroa L, Reddy S, Marshall S. Chickenpox and pneumonia following varicella vaccine. Infect Control Hosp Epidemiol. 2004 Jul;25(7):530.

26 Christou EM, Wargon O. Stevens-Johnson syndrome after varicella vaccination. Med J Aust. 2012 Mar 5;196(4):240-1.

27 Sunaga Y, Hikima A, Ostuka T, Morikawa A. Acute cerebellar ataxia with abnormal MRI lesions after varicella vaccination. Pediatr Neurol. 1995 Nov;13(4):340-2.

28 Pahud BA, Glaser CA, Dekker CL et al. Varicella Zoster Disease of the Central Nervous System: Epidemiological, Clinical, and Laboratory Features 10 Years after the Introduction of the Varicella Vaccine J Infect Dis. 2011 Feb 1; 203(3): 316–323.

29 Iyer S, Mittal MK, Hodinka RL. Herpes zoster and meningitis resulting from reactivation of varicella vaccine virus in an immunocompetent child. Ann Emerg Med. 2009 Jun;53(6):792-5

30 Levin MJ, DeBiasi RL, Bostik V, Schmid DS. Herpes zoster with skin lesions and meningitis caused by 2 different genotypes of the Oka varicella-zoster virus vaccine. J Infect Dis. 2008 Nov 15;198(10):1444-7.

31 Naruse H, Miwata H, Ozaki T, et al. Varicella infection complicated with meningitis after immunization. Acta Paediatr Jpn. 1993 Aug;35(4):345-7.

32 Schwab J, Ryan M. Varicella zoster virus meningitis in a previously immunized child. Pediatrics. 2004 Aug;114(2):e273-4.

33 Han JY, Hanson DC, Way SS. Herpes zoster and meningitis due to reactivation of varicella vaccine virus in an immunocompetent child. Pediatr Infect Dis J. 2011 Mar;30(3):266-8

34 Fusco D., Krawitz P., Larussa P. et al. VZV meningitis following varicella vaccine J Clin Virol. 2010 Aug; 48(4): 275–277.

35 Chouliaras G, Spoulou V, Quinlivan M et al. Vaccine-associated herpes zoster ophthalmicus correction of opthalmicus and encephalitis in an immunocompetent child. Pediatrics. 2010 Apr;125(4):e969-72.

36 O'Leary ST, Glanz JM, McClure DL et al. The risk of immune thrombocytopenic purpura after vaccination in children and adolescents. Pediatrics. 2012 Feb;129(2):248-55

37 Leung J, Siegel S, Jones JF et al Fatal varicella due to the vaccine-strain varicella-zoster virus Hum Vaccin Immunother. 2014 Jan 1; 10(1): 146–149.

38 Navalkele BD, Henig O, Fairfax M et al. First case of vaccine-strain varicella infection as manifestation of HIV in healthcare worker: a case report and review of the literature. J Hosp Infect. 2017 Dec; 97(4):384-388.

39 Kramer JM, LaRussa P, Tsai WC et al. Disseminated vaccine strain varicella as the acquired immunodeficiency syndrome-defining illness in a previously undiagnosed child. Pediatrics. 2001 Aug; 108(2):E39.

40 Maves RC, Tripp MS, Dell TG et al. Disseminated vaccine-strain varicella as initial presentation of the acquired immunodeficiency syndrome: a case report and review of the literature. J Clin Virol. 2014 Jan; 59(1):63-6.

41 Levitsky J, Te HS, Faust TW, Cohen SM Varicella infection following varicella vaccination in a liver transplant recipient. Am J Transplant. 2002 Oct;2(9):880-2.

42 Leung J, Broder KR, Marin M. Severe varicella in persons vaccinated with varicella vaccine (breakthrough varicella): a systematic literature review. Expert Rev Vaccines. 2017 Apr;16(4):391-400

43 Aslan A, Kurugol Z, Gokben S. Acute transverse myelitis complicating breakthrough varicella infection. Pediatr Infect Dis J. 2014 Nov;33(11):1196-8

44 Lohiya GS, Tan-Figueroa L, Reddy S, Marshall S. Chickenpox and pneumonia following varicella vaccine. Infect Control Hosp Epidemiol. 2004 Jul;25(7):530.

45 Naruse H, Miwata H, Ozaki T et al. Varicella infection complicated with meningitis after immunization. Acta Paediatr Jpn. 1993 Aug; 35(4):345-7.

46 Dreyer S, Hemarajata P, Hogeling M, Henderson GP Pediatric vaccine-strain herpes zoster: a case series. Pediatr Dermatol. 2017 Nov; 34(6):665-667.

47 Iwasaki S, Motokura K, Honda Y et al. Vaccine-strain herpes zoster found in the trigeminal nerve area in a healthy child: A case report. J Clin Virol. 2016 Dec; 85:44-47

48 Ota K, Kim V, Lavi S, et al. Vaccine-strain varicella zoster virus causing recurrent herpes zoster in an immunocompetent 2-year-old. Pediatr Infect Dis J. 2008 Sep;27(9):847-8

49 Moodley A, Swanson J, Grose C, Bonthius DJ Severe Herpes Zoster Following Varicella Vaccination in Immunocompetent Young Children. J Child Neurol. 2019 Mar; 34(4): 184–188.

50 Uebe B, Sauerbrei A, Burdach S, Horneff G. Herpes zoster by reactivated vaccine varicella zoster virus in a healthy child. Eur J Pediatr. 2002 Aug; 161(8):442-4.

51 Leung AK, Robson WL, Leong AG. Herpes zoster in childhood. J Pediatr Health Care. 2006 Sep-Oct;20(5):300-3.

52 Matsubara K, Nigami H, Harigaya H, Baba K. Herpes zoster in a normal child after varicella vaccination. Acta Paediatr Jpn. 1995 Oct;37(5):648-50.

53 Levin MJ, DeBiasi RL, Bostik V, Schmid DS. Herpes zoster with skin lesions and meningitis caused by 2 different genotypes of the Oka varicella-zoster virus vaccine. J Infect Dis. 2008 Nov 15;198(10):1444-7

54 Binder NR, Holland GN, Hosea S, Silverberg ML. Herpes zoster ophthalmicus in an otherwise-healthy child. J AAPOS. 2005 Dec;9(6):597-8.

55 Kraft JN, Shaw JC. Varicella infection caused by Oka strain vaccine in a heart transplant recipient. Arch Dermatol. 2006 Jul;142(7):943-5.

56 Kluthe M, Herrera A, Blanca H et al. Neonatal vaccine-strain varicella-zoster virus infection 22 days after maternal postpartum vaccination. Pediatr Infect Dis J. 2012 Sep;31(9):977-9.

57 Bryan CJ, Prichard MN, Daily S et al. Acyclovir-resistant chronic verrucous vaccine strain varicella in a patient with neuroblastoma. Pediatr Infect Dis J. 2008 Oct;27(10):946-8

58 FDA Varivax Package Insert Jan. 23, 2019

59 Ibid

60 CDC MMRV (Measles, Mumps, Rubella & Varicella) VIS Feb. 12, 2018

61 CDC Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. May 7, 2010; 59(RR03);1-12

62 FDA PROQUAD Package Insert. Jan. 22, 2019

63 Ibid

64 MacDonald SE, Dover DC, Simmonds KA, et al. Risk of febrile seizures after first dose of measles–mumps–rubella–varicella vaccine: a population-based cohort study. CMAJ. 2014 Aug 5; 186(11): 824–829.

65 Ma SJ, Xiong YQ, Jiang LN et al. Risk of febrile seizure after measles-mumps-rubella-varicella vaccine: A systematic review and meta-analysis. Vaccine. 2015 Jul 17;33(31):3636-49

66 FDA PROQUAD Package Insert. Jan. 22, 2019

67 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.

68 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.

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

70 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.

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

72 HRSA National Vaccine Injury Compensation Program Data Report – August 1, 2019. Aug 1, 2019


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