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Abstract

Credit

This lesson is good for 0.2 CE units, with a passing grade of 70%.

Objectives

1. To describe historical examples of adverse events truly and spuriously associated with vaccination.

2. To describe a rational basis for deciding whether adverse events are causally or coincidentally linked to a medication.

3. To demonstrate how to apply this rational basis to a variety of exposure—outcome associations.

Keywords

adverse events causality immunization side effects vaccines

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References

Khakoo

G.A.

, Lack

Recommendations for using MMR vaccine in children allergic to eggs. BMJ. 2000; 320: 929–32.

Pickering

L.K.

, ed. 2000 Red Book: Report of the Committee on Infectious Diseases, 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000.

Centers for Disease Control and Prevention. Achievements in public health, 1900–1999: Impact of vaccines universally recommended for children—United States, 1990–1998. MMWR. 1999; 48: 243–8.

Grabenstein

J.D.

Immunization from the perspective of a millennium. Hosp Pharm. 2000; 35: 619–30.

Centers for Disease Control and Prevention. Intussusception among recipients of rotavirus vaccine—United States, 1998–1999. MMWR. 1999; 48: 577–81.

Advisory Committee on Immunization Practices. Withdrawal of rotavirus vaccine recommendation. MMWR. 1999; 48: 1007.

Wallach

Interpretation of Diagnostic Tests. 6th ed. Boston: Little, Brown & Co.; 1996.

Grabenstein

J.D.

ImmunoFacts: Vaccines and Immunologic Drugs. St. Louis, MO: Facts and Comparisons, Inc.; November 2000.

Grabenstein

J.D.

Anaphylaxis: Epinephrine and emergency responses. Hosp Pharm. 1997; 32: 1377–8, 1382–9.

10.

Grabenstein

J.D.

Compensation for vaccine injury: Balancing society's need and personal risk. Hosp Pharm. 1995; 30: 831–6.

11.

World Health Organization. Lack of evidence that hepatitis B vaccine causes multiple sclerosis. Weekly Epidemiol Rec. 1997; 72: 149–52.

12.

Dorozynski

Suspension of hepatitis B vaccination condemned. BMJ. 1998; 317: 1034.

13.

National Multiple Sclerosis Society. No foundation for hepatitis B alarm. Inside MS. 1999; 17(1): 3.

14.

Parish

H.J.

A History of Immunization. Edinburgh: E & S Livingstone, Ltd; 1965.

15.

Sherman

, Strauss

Thalidomide: A twenty-five year perspective. Food Drug Cosmetic Law J. 1986; 41: 458–66.

16.

Sartin

J.S.

Gulf war illnesses: Causes and controversies. Mayo Clin Proc. 2000; 75: 811–9.

17.

Riddle

, Hyams

K.C.

, Murphy

F.M.

In the borderland between health and disease following the Gulf War. Mayo Clin Proc. 2000; 75: 777–9.

18.

Ismail

, Everitt

, Blatchley

Is there a Gulf War syndrome?

Lancet. 1999; 353: 179–82.

19.

Straus

S.E.

Bridging the gulf in war syndromes. Lancet. 1999; 353: 162–3.

20.

Centers for Disease Control and Prevention. Guillain-Barré syndrome and influenza vaccine. www.cdc.gov/nip/vacsafe/concerns/GBS/default.htm. Accessed September 9, 2000.

21.

Grabenstein

J.D.

Vaccines and antibodies in relation to pregnancy and lactation. Hosp Pharm. 1999; 34: 949–56, 959–60.

22.

Fenichel

G.M.

Assessment: Neurologic risk of immunization. Neurology. 1999; 52: 1546–52.

23.

Advisory Committee on Immunization Practices. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children. MMWR. 1997; 46(RR-7): 1–25.

24.

Institute of Medicine. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: National Academy Press; 1997.

25.

Gangarosa

E.J.

, Galazka

A.M.

, Wolfe

C.R.

Impact of anti-vaccine movements on pertussis control: The untold story. Lancet. 1998; 351: 356–61.

26.

Advisory Committee on Immunization Practices. Poliomyelitis prevention in the United States: Updated recommendations. MMWR. 2000; 49(RR-5): 1–22.

27.

Classen

J.B.

The timing of immunization affects the development of diabetes in rodents. Autoimmunity. 1996; 24: 137–45.

28.

Classen

D.C.

, Classen

J.B.

The timing of pediatric immunization and the risk of insulin-dependent diabetes mellitus. Infect Dis Clin Pract. 1997; 6: 449–54.

29.

Institute for Vaccine Safety Workshop Panel. Childhood immunizations and type 1 diabetes: Summary of an Institute for Vaccine Safety Workshop. Pediatr Infect Dis J. 1999; 18: 217–22.

30.

Vaccination and its adverse events: Real or perceived. BMJ. 1999; 317: 159–60.

31.

Karvonen

, Cepaitis

, Tuomilehto

Association between type 1 diabetes and Haemophilus influenzae type b vaccination: Birth cohort study. BMJ. 1999; 318: 1169–72.

32.

Blom

, Nystrom

, Dahlquist

The Swedish childhood diabetes study: Vaccinations and infections as risk determinants for diabetes in childhood. Diabetologia. 1991; 34: 176–81.

33.

Dahlquist

, Gothefors

The cumulative incidence of childhood diabetes mellitus in Sweden unaffected by BCG-vaccination. Diabetologia. 1995; 38: 87374.

34.

Heijbel

, Chen

R.T.

, Dahlquist

Cumulative incidence of childhood-onset IDDM is unaffected by pertussis immunization. Diabetes Care. 1997; 20: 173–5.

35.

Hyoty

, Hiltunen

, Reunanen

Decline of mumps antibodies in Type 1 (insulin-dependent) diabetic children and a plateau in the rising incidence of type 1 diabetes after introduction of the mumps-measles-rubella vaccine in Finland. Diabetologia. 1993; 36: 1303–8.

36.

Parent

, Fritschi

, Siemiatycki

Bacille Calmette-Guérin vaccination and incidence of IDDM in Montreal, Canada. Diabetes Care. 1997; 20: 767–72.

37.

Kelsey

J.L.

, Thompson

W.D.

, Evans

A.S.

Methods in Observational Epidemiology. New York: Oxford University Press; 1986.

38.

Rothman

K.J.

, Greenland

Modern Epidemiology. 2nd ed. Philadelphia: Lippincott-Raven; 1998.

39.

Atkinson

, Wolfe

, Humiston

., ed. Epidemiology and Prevention of Vaccine-Preventable Diseases. 6th ed. Atlanta: Centers for Disease Control and Prevention; 2000.

40.

Lett

Field guide to critical thinking. Skeptical Inquirer. 1990; (Winter): 1–7.

41.

Wakefield

A.J.

, Murch

S.H.

, Anthony

Ileal-lymphoid-nodular hyperplasia, nonspecific colitis, and pervasive developmental disorder in children. Lancet. 1998; 351: 637–41.

42.

Liu

, Van Kruiningen

H.J.

, West

A.B.

Immunocytochemical evidence of Listeria, Escherichia coli and Streptococcus antigens in Crohn's disease. Gastroenterology. 1995; 108: 1396–404.

43.

Iizuka

, Nakagomi

, Chiba

Absence of measles virus in Crohn's disease. Lancet. 1995; 345: 199.

44.

Haga

, Funakoshi

, Kuroe

Absence of measles viral genomic sequence in intestinal tissues from Crohn's disease by nested polymerase chain reaction. Gut. 1996; 38: 211–5.

45.

Afzal

M.A.

, Minor

P.D.

, Begley

Absence of measles virus genome in inflammatory bowel disease. Lancet. 1998; 351: 646–7.

46.

Nielson

L.L.W.

, Nielsen

N.M.

, Melbye

Exposure to measles in utero and Crohn's disease: Danish register study. BMJ. 1998; 316: 196–7.

47.

Hermon-Taylor

, Ford

, Sumar

Lancet. 1995; 345: 922–3.

48.

Jones

, Fine

, Piracha

Crohn's disease and measles. Lancet. 1997; 349: 473.

49.

Feeney

, Clegg

, Winwood

A case-control study of measles vaccination and inflammatory bowel disease. Lancet. 1997; 350: 764–6.

50.

Miller

, Waight

Measles, measles vaccination, and Crohn's disease: Second immunisation has not affected incidence in England [letter]. BMJ. 1998; 316: 1745.

51.

Peltola

, Patja

, Leinikki

No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study. Lancet. 1998; 351: 1327–8.

52.

Van Damme

, Lynen

, Kegels

Measles vaccination and inflammatory bowel disease. Lancet. 1997; 350: 1174–5.

53.

Miller

, Goldblatt

, Cutts

Measles vaccination and inflammatory bowel disease. Lancet. 1998; 351: 755–6.

54.

Metcalf

Is measles infection associated with Crohn's disease? The current evidence does not prove a causal link [editorial]. BMJ. 1998; 316: 166.

55.

Nicoll

, Elliman

, Ross

MMR vaccination and autism 1998: Déjà vu-pertussis and brain damage 1974 [editorial]?

BMJ. 1998; 316: 715–6.

56.

Chen

R.T.

, DeStefano

Vaccine adverse events: Causal or coincidental?

Lancet. 1998; 351: 611–3.

57.

Taylor

, Miller

, Farrington

C.P.

Autism and measles, mumps, and rubella vaccine: No epidemiological evidence for a causal association. Lancet. 1999; 353: 2026–9.

58.

Gillberg

, Heijbel

MMR and autism. Autism. 1998; 2: 423–4.

59.

Miller

, Wadsworth

, Diamond

, Ross

Measles vaccination and neurological events. Lancet. 1997; 349: 730–1.

60.

Miller

A.E.

, Morgante

L.A.

, Buchwald

L.Y.

A multicenter, randomized, double-blind, placebo-controlled trial of influenza immunization in multiple sclerosis. Neurology. 1997; 48: 312–4.

61.

Brown

, Lewis

A.M.

, eds. Simian virus 40 (SV40): A possible human polyomavirus; symposium proceedings. Dev Biol Stand. 1998; 94: 1–406.

62.

Strickler

H.D.

, Rosenberg

P.S.

, Devesa

S.S.

Contamination of poliovirus vaccines with simian virus 40 (1955-1963) and subsequent cancer rates. JAMA. 1998; 279: 292–5.

63.

Grabenstein

J.D.

Vaccine side effects: Separating mirage from reality. J Am Pharm Assoc. 1999; 39: 417–9.

64.

Grabenstein

J.D.

The natural history of a vaccine and its disease. Hosp Pharm. 1996; 31: 559, 563–8,571–2.

65.

Grabenstein

J.D.

, Wilson

J.P.

Are vaccines safe? Risk communication applied to vaccines. Hosp Pharm. 1999; 34: 713–8, 721–9.

66.

Wilson

G.S.

The Hazards of Immunization. London: Athlone Press; 1967.