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vaccine injury death

As of May 1, 2021, there had been 1,346 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following rubella (MMR, MMR-V, Mumps-Rubella, Rubella) vaccination, including 68 deaths and 1,278 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 516 children and adults who have filed claims for rubella vaccine injury.

The U.S. government recognizes the following as vaccine injuries related to measles, mumps, and rubella (MMR) vaccine:1

  • Anaphylaxis occurring within four hours of vaccine administration;
  • Encephalopathy or encephalitis occurring within 5 and 15 days of vaccination;
  • Shoulder Injury Related to Vaccine Administration (SIRVA) occurring within 48 hours of vaccination;
  • Vasovagal syncope occurring within one hour of vaccination.

The U.S. government also recognizes chronic arthritis with initial symptoms occurring within 7 and 42 days of any rubella containing vaccine as a vaccine injury.2

Federal Vaccine Adverse Events Reports

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 one 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.3 4 5 6

As of April 23, 2021, there have been more than 101,073 reports of adverse events for rubella containing vaccines (MMR, MMR-V, Mumps-Rubella, Rubella) made to the federal Vaccine Adverse Events Reporting System (VAERS), which include hospitalizations, injuries and deaths. Of these reports there are 457 deaths, 7,570 hospitalizations, and 2,008 related disabilities. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after rubella vaccination, due to VAERS passivity.

The Centers for Disease Control (CDC) report minor side effects from the MMR-V and MMR vaccines to include low-grade fever, injection site redness or rash, pain at the injection site, and facial swelling.

Moderate side effects include a full body rash, temporary low platelet count, temporary stiffness and pain the joints, and seizures.7 8 There is a greater risk of seizures following MMR-V vaccination in comparison to separate doses of MMR and varicella vaccines, especially when given as the first dose of the series.9  Rare serious side effects of both MMR-V and MMR include brain damage, coma, chronic seizure disorder, lowered level of consciousness and loss of hearing.10 11

Serious Complications – ProQuad Vaccines

Serious complications reported by Merck in the ProQuad(MMR-V) package insert during vaccine post-marketing surveillance include:12

  • 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-Barré syndrome;
  • syncope (fainting);
  • tremor;
  • dizziness;
  • paresthesia;
  • 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 MMR-V vaccine in Canada found the risk of febrile seizures to be double in children receiving the MMR-V vaccine when compared to those receiving the MMR and varicella vaccines separately.13 A 2015 meta-analysis found a two-fold increase in febrile seizures between 5 and 12 days or 7 and 10 days following MMR-V vaccination in children between the ages of 10 and 24 months.14

MMR-V 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 that the final product is free of potentially harmful agents.

Serious Complications – MMRII Vaccine

Serious complications reported by Merck in the MMRII package insert during vaccine post-marketing surveillance include:15

  • brain inflammation (encephalitis) and encephalopathy (chronic brain dysfunction);
  • panniculitis (inflammation of the fat layer under the skin);
  • atypical measles;
  • syncope (sudden loss of consciousness, fainting);
  • vasculitis (inflammation of the blood vessels);
  • pancreatitis (inflammation of the pancreas);
  • diabetes mellitus;
  • thrombocytopenia  purpura (blood disorder);
  • Henoch-Schönlein purpura (inflammation and bleeding in the small blood vessels);
  • acute hemorrhagic edema of infancy (rare vasculitis of the skin’s small vessels occurring in infants);
  • leukocytosis (high white blood cell count);
  • anaphylaxis (shock);
  • bronchial spasms;
  • pneumonia;
  • pneumonitis(inflammation of the lung tissues);
  • arthritis and arthralgia (joint pain);
  • myalgia (muscle pain);
  • polyneuritis (inflammation of several nerves simultaneously);
  • measles inclusion body encephalitis (disease affecting the brain of immunocompromised persons);
  • subacute sclerosing panencephalitis (fatal progressive brain disorder caused by exposure to the measles virus);
  • Guillain-Barre Syndrome (GBS)(disease where the body’s immune system attacks the nerves);
  • acute disseminated encephalomyelitis (ADEM) (brief widespread inflammation of the nerve’s protective covering);
  • transverse myelitis (inflammation of the spinal cord);
  • aseptic meningitis;
  • erythema multiforme (skin disorder from an allergic reaction or infection);
  • urticarial rash (hives, itching from an allergic reaction);
  • measles-like rash;
  • Stevens-Johnson syndrome (severe reaction causing the skin and mucous membranes to blister, die, and shed);
  • nerve deafness (hearing loss from damage to the inner ear);
  • otitis media (ear infection);
  • retinitis (inflammation of the retina of the eye);
  • optic neuritis (inflammation of the optic nerve);
  • conjunctivitis (pink eye);
  • ocular palsies (dysfunction of the ocular nerve);
  • epididymitis (inflammation of the epididymis);
  • paresthesia (burning or prickling of the skin);
  • death.

History of Reported Side Effects from Rubella Vaccine

In August 1970, 15 months after approval of the first vaccine targeting rubella, the CDC reported that it had received numerous reports of arthralgia and arthritis in children after rubella vaccine administration. While noting that pre-licensing clinical trials reported that joint problems in children occurred at a rate of less than five percent, health officials stated that “with extensive usage following licensure, many areas were alarmed by a greater  frequency and severity of reactions than were expected.”16

This report also noted that most side effects usually resolved within one to ten days; however, in some cases joint pain persisted and children were hospitalized for evaluation of rheumatoid arthritis or rheumatic fever.17

Children vaccinated with the rubella vaccine derived from dog kidneys (HPV-77:DK-12) had a significantly higher rate of reported joint reactions when compared to children vaccinated with a vaccine derived from duck embryos (HPV-77:DE-5). Other serious events reported after rubella vaccination included transverse myelitis, high fever, ataxia, polyneuritis, aseptic meningitis, temporary paralysis, seizure, and death.18 HPV-77:DK-12 was voluntarily removed from the market in 1973.19

Joint reactions following rubella vaccination continued to be reported and in 1980, the CDC reported that “Susceptible post pubertal women recipients are at the highest risk of joint symptoms; studies have shown that 23%-58% of this group will experience joint  symptoms compared with only 2.5%-10% of children.”20

Two “syndromes” were also reported following rubella vaccination. According to CDC officials:21

“1 syndrome, referred to as the "arm syndrome," affected persons are typically awakened from a sound sleep by paresthesia in the arm and hand. The latent interval ranges from 10-62 days with a mean of 39 days. The symptoms last  from 30 seconds to 1 hour and may occur from 1-6 times per night.

In the "catcher’s crouch" syndrome, the symptoms which begin from 29-70 days (mean of 45 days) after vaccination are pain behind the knee and inability to fully extend the knee. Symptoms are worst upon getting up in the morning, and they diminish during the day. The mean interval between vaccination and onset is about 40 days; intervals of 7-99 days have been reported. Usually symptoms  last from 1-5 weeks.”

Reoccurrences of both syndromes were reported to occur over long periods of time and more frequently reported in persons who had received the HPV-77:DK-12 rubella vaccine.22

Evaluation of Adverse Events by the Institute of Medicine

In the detailed report evaluating medical evidence, Adverse Effects of Pertussis and Rubella Vaccines, published in 1991 by the Institute of Medicine (IOM), committee members concluded that evidence existed of a causal relationship between rubella vaccines and acute and chronic arthritis in adult women.23

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality24, published in 2012 by the Institute of Medicine (IOM), 30 reported vaccine adverse events following the Measles, Mumps, and Rubella (MMR) vaccine were evaluated by a physician committee.25 These adverse events included measles inclusion body encephalitis, febrile seizures, arthritis, meningitis, Guillain Barre Syndrome, autism, diabetes mellitus, optic neuritis, transverse myelitis and more.

In 23 of the 30 measles, mumps, and rubella (MMR) vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the MMR 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.26 The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between febrile seizures, anaphylaxis, and measles inclusion body encephalitis in immunocompromised individuals and the MMR vaccine and favored acceptance of a causal relationship between transient arthralgia in both children and women and the MMR vaccine.27 The IOM committee also concluded that it favored rejection of a causal association between both autism and the MMR vaccine and Type 1 diabetes and the MMR vaccine, however, both of these conclusions were made following the review of only five epidemiological studies.28

Systematic Reviews of the Medical Literature

In 2012, the Cochrane Collaboration examined 57 studies and clinical trials involving approximately 14.7 million children who had received the MMR vaccine. While the study authors stated that they were not able to detect a “significant” association between MMR vaccine and autism, asthma, leukemia, hay fever, type I diabetes, gait disturbance, Crohn’s disease, demyelinating diseases or bacterial or viral infections, they reported that “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”29 

In an updated review published in April of 2020, the Cochrane Collaboration reviewed  87 safety studies associated with MMR, MMR-V, and MMR + Varicella vaccine. This review concluded that there was an association between MMR vaccines containing Leningrad-Zagreb and Urabe mumps strains and aseptic meningitis, but no evidence to support this association for MMR vaccines which contain the Jeryl Lynn mumps strains. This conclusion was based on the evaluation of nine studies, all of which were considered low certainty studies. The Cochrane Collaboration reports low certainty studies to be those where theirconfidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.”30

An association was also found between MMR vaccines and idiopathic thrombocytopenic purpura (ITP) and MMR, MMR-V, and MMR + Varicella vaccines and febrile seizures and the studies evaluated to make this determination were a combination of both moderate certainty and low certainty studies. Moderate certainty studies are those in which the Cochrane Collaboration are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.”31

The Cochrane Collaboration reported that no association was found between MMR vaccine and encephalitis, encephalopathy, cognitive delay, type 1 diabetes, asthma, dermatitis/eczema, hay fever, leukemia, multiple sclerosis, gait disturbance, and bacterial or viral infections; however, all the studies that were evaluated were found to be either low certainty or very low certainty studies. Very low certainty studies are those in which the Collaborative have “very little confidence in the effect estimate” and that “the true effect is likely to be substantially different from the estimate of effect.32

No association was found between autism spectrum disorders and MMR vaccines, and the studies evaluated were a combination of moderate certainty and low certainty studies. The Cochrane Collaboration also reported that there was insufficient evidence to support or reject an association between MMR vaccines and inflammatory bowel disease.33

Research Overview

During the past five decades, there have been many published reports and studies linking rubella-containing vaccines to numerous chronic immune and neurological diseases in children and adults. These include optic neuritis,34 35 retinopathy,36 myelitis,37 38 39 40 acute disseminated encephalomyelitis,41 hearing loss,42 thrombocytopenic purpura,43 44 45 46 47 48 encephalitis,49 and chronic arthritis.50 51 52 53

The rubella vaccine is a live virus vaccine and according to the MMR vaccine package insert:54

Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk. However, transmission of the rubella vaccine virus to infants via breast milk has been documented.”

Persons with primary immunodeficiency deficiencies (PID) who are vaccinated with the live rubella vaccine found in the MMR vaccine are at risk for immunodeficiency related vaccine-derived rubella virus (iVDRV) cutaneous granulomas. Additionally, researchers estimate that thousands of individuals with PID are shedding iVDRV and may put non-immune persons at risk for developing rubella. This shedding may also impact the success of programs aimed at eliminating rubella and congenital rubella syndrome.55

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella 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.

« Return to Vaccines & Diseases Table of Contents

References

1 Health Resources & Services Administration. Vaccine Injury Table Mar. 21, 2017.

2 Health Resources & Services Administration. Vaccine Injury Table Mar. 21, 2017.

3 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.

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

5 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.

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

7 U.S. Centers for Disease Control and Prevention. MMR (Measles, Mumps, & Rubella) VIS. In: Vaccine Information Statements (VISs) Aug.15, 2019.

8 U.S. Centers for Disease Control and Prevention. MMRV (Measles, Mumps, Rubella & Varicella) VIS. In: Vaccine Information Statements (VISs) Aug. 15, 2019.

9 Marin M, Broder KR, Temte JL, et al. Use of Combination Measles, Mumps, Rubella, and Varicella Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR May 2010; 59(RR03):1-12.

10 U.S. Centers for Disease Control and Prevention. MMR (Measles, Mumps, & Rubella) VIS In: Vaccine Information Statements (VISs) Aug. 15, 2019.

11 U.S. Centers for Disease Control and Prevention. MMRV (Measles, Mumps, Rubella & Varicella) VIS In: Vaccine Information Statements (VISs) Aug. 15, 2019.

12 Merck, Sharp & Dohme Corp. Package Insert - Refrigerator-Stable Formulation - ProQuad. U.S. Food and Drug Administration Sept. 17, 2020.

13 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. August 2014; 186(11): 824–829.

14 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. July 2015; 33(31):3636-49.

15 Merck, Sharp & Dohme Corp. Measles, Mumps and Rubella Virus Vaccine, Live Package Insert. U.S. Food and Drug Administration Dec. 14, 2020.

16 U.S. Centers for Disease Control. Rubella Surveillance. August 1970; no. 2: 1-26.

17 U.S. Centers for Disease Control. Rubella Surveillance. August 1970; no. 2: 1-26.

18 U.S. Centers for Disease Control. Rubella Surveillance. August 1970; no. 2: 1-26.

19 U.S. Centers for Disease Control and Prevention. Rubella Surveillance June 1976 to December 1978. May 1980.

20 U.S. Centers for Disease Control and Prevention. Rubella Surveillance June 1976 to December 1978. May 1980.

21  U.S. Centers for Disease Control and Prevention. Rubella Surveillance June 1976 to December 1978. May 1980.

22  U.S. Centers for Disease Control and Prevention. Rubella Surveillance June 1976 to December 1978. May 1980.

23 Institute of Medicine Committee. Chapter: 7 Evidence Concerning Rubella Vaccines and Arthritis, Radiculoneuritis, and Thrombocytopenic Purpura. In: Adverse Effects of Pertussis and Rubella Vaccines. The National Academies Press 1991; pp. 187-205.

24 Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012; pp. 103-238.

25 Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012; pp. 103-238.

26 Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012; pp. 103-238.

27 Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012; pp. 103-238.

28 Institute of Medicine Committee. Evaluating Biological Mechanisms for Adverse Events: Increased Susceptibility. In: Adverse Effects of Vaccines: Evidence and Causality. The National Academies Press 2012; pp. 103-238.

29 Demicheli V, Rivetti A, et al. (Intervention Review). Vaccines for Measles, Mumps and Rubella in Children. The Cochrane Library 2012; Issue 2.

30 Di Pietrantonj C, Rivetti A, Marchione et al. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev April 2020; 4:CD004407.

31 Di Pietrantonj C, Rivetti A, Marchione et al. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev Apr. 2020;4:CD004407.

32 Di Pietrantonj C, Rivetti A, Marchione et al. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev April 2020; 4:CD004407.

33 Di Pietrantonj C, Rivetti A, Marchione et al. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev April 2020; 4:CD004407.

34 Arshi S, Sadeghi-Bazargani H, Ojaghi H et al. The first rapid onset optic neuritis after measles-rubella vaccination: case report. Vaccine September 2004; 22(25-26):3240-2.

35 Kazarian EL, Gager WE. Optic neuritis complicating measles, mumps, and rubella vaccination. Am J Ophthalmol October 1978; 86(4):544-7.

36 Marshall GS, Wright PF, Fenichel GM, et al. Diffuse retinopathy following measles, mumps, and rubella vaccination. Pediatrics December 1985; 76(6):989-91.

37 Agmon-Levin N, Kivity S, Szyper-Kravitz M, et al. Transverse myelitis and vaccines: a multi-analysis. Lupus November 2009; 18(13):1198-204.

38 Joyce KA, Rees JE. Transverse myelitis after measles, mumps, and rubella vaccine. BMJ August 1995; 311(7002):422.

39 Holt S, Hudgins D, Krishnan KR, et al. Diffuse myelitis associated with rubella vaccination. Br Med J October 1976;2(6043):1037-8.

40 Kline LB, Margulies SL, Oh SJ. Optic neuritis and myelitis following rubella vaccination. Arch Neurol July 1982; 39(7):443-4.

41 Tsuru T, Mizuguchi M, Ohkubo Y et al. Acute disseminated encephalomyelitis after live rubella vaccination. Brain Dev June 2000; 22(4):259-61.

42 Stewart BJ, Prabhu PU. Reports of sensorineural deafness after measles, mumps, and rubella immunisation. Arch Dis Child July 1993; 69(1): 153–154.

43 Chang SK, Farrell DL, Dougan K, et al. Acute idiopathic thrombocytopenic purpura following combined vaccination against measles, mumps, and rubella. J Am Board Fam Pract January-February 1996; 9(1):53-5.

44 Vlacha V, Forman EN, Miron D, et al. Recurrent thrombocytopenic purpura after repeated measles-mumps-rubella vaccination. Pediatrics May 1996; 97(5):738-9.

45 Drachtman RA, Murphy S, Ettinger LJ. Exacerbation of chronic idiopathic thrombocytopenic purpura following measles-mumps-rubella immunization. Arch Pediatr Adolesc Med March 1994;148(3):326-7.

46 Rejjal AL, Britten G, Nazer H. Thrombocytopenic purpura following measles-mumps-rubella vaccination. Ann Trop Paediatr 1993;13(1):103-4.

47 Nieminen U, Peltola H, Syrjälä MT, et al. Acute thrombocytopenic purpura following measles, mumps and rubella vaccination. A report on 23 patients. Acta Paediatr  Mar. 1993; 82(3):267-70.

48 Autret E, Jonville-Béra AP, Galy-Eyraud C, et al. [Thrombocytopenic purpura after isolated or combined vaccination against measles, mumps and rubella. Therapie November-December 1996; 51(6):677-80.

49 Gualberto FA, de Oliveira MI, Alves VA, et al. Fulminant encephalitis associated with a vaccine strain of rubella virus. J Clin Virol. Dec 2013;58(4):737-40.

50 Howson CP, Katz M, Johnston RB Jr, et al. Chronic arthritis after rubella vaccination. Clin Infect Dis August 1992; 15(2):307-12.

51 Tingle AJ, Allen M, Petty RE et al. Rubella-associated arthritis. I. Comparative study of joint manifestations associated with natural rubella infection and RA 27/3 rubella immunisation. Ann Rheum Dis. February 1986; 45(2):110-4.

52 Mitchell LA, Tingle AJ, Shukin R et al. Chronic rubella vaccine-associated arthropathy. Arch Intern Med October 1993; 153(19):2268-74.

53 Chantler JK, Ford DK, Tingle AJ. Persistent rubella infection and rubella-associated arthritis. Lancet June 1982; 1(8285):1323-5.

54 Merck, Sharp & Dohme Corp. Measles, Mumps and Rubella Virus Vaccine, Live Package Insert. U.S. Food and Drug Administration Dec. 14, 2020.

55 Perelygina L, Chen MH, Suppiah S et al. Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies. PLoS Pathog October 2019;15(10):e1008080.


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