Postmarketing safety surveillance for typhoid fever vaccines from the Vaccine Adverse Event Reporting System, July 1990 through June 2002

Clinical Infectious Diseases

Volumn 38, Issue 6, 2004, Pages 771-779

  Begier, Elizabeth M ^a   Burwen, Dale R ^a   Haber, Penina ^b   Ball, Robert ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b CENTERS FOR DIS CONTR AND PREV   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENALIN; ANTHRAX VACCINE; DIPHENHYDRAMINE; DIPHTHERIA TETANUS VACCINE; HEPATITIS A VACCINE; HEPATITIS B VACCINE; IMMUNOGLOBULIN; LIVE VACCINE; MEFLOQUINE; MENINGOCOCCUS VACCINE; POLIOMYELITIS VACCINE; POLYSACCHARIDE VACCINE; TYPHOID VACCINE; YELLOW FEVER VACCINE; TYPHOID PARATYPHOID VACCINE;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGED; AGITATION; ALLERGIC REACTION; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTHRALGIA; ASTHENIA; CELLULITIS; CEREBROVASCULAR ACCIDENT; CHILD; CONJUNCTIVITIS; DEHYDRATION; DEMYELINATING DISEASE; DIPLOPIA; DISABILITY; DIZZINESS; DRUG FATALITY; DRUG SURVEILLANCE PROGRAM; DYSPNEA; ENCEPHALITIS; ENTERITIS; FACE EDEMA; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; GASTROENTERITIS LIKE DISEASE; GASTROINTESTINAL SYMPTOM; GUILLAIN BARRE SYNDROME; HEADACHE; HOSPITALIZATION; HUMAN; HYPERSENSITIVITY; HYPERTENSION; INFANT; INJECTION PAIN; INJECTION SITE HYPERSENSITIVITY; INTESTINE PERFORATION; JEJUNUM DISEASE; LARYNX EDEMA; LARYNX SPASM; MALE; MENTAL DISEASE; MINIMAL CHANGE NEPHROTIC SYNDROME; MUSCLE WEAKNESS; MYALGIA; MYELITIS; NAUSEA; NEPHROTIC SYNDROME; NEUROLOGIC DISEASE; NON INSULIN DEPENDENT DIABETES MELLITUS; PAIN; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RASH; REVIEW; SALMONELLA ENTERICA; SEIZURE; SEPSIS; SMALL INTESTINE DISEASE; SMALL INTESTINE INFLAMMATION; SPONTANEOUS ABORTION; SYMPTOM; SYNCOPE; TACHYCARDIA; THORAX PAIN; THROAT DISEASE; THROAT TIGHTENING; TRAVELLER DIARRHEA; TYPHOID FEVER; UNEASINESS; URTICARIA; VASODILATATION; VIRUS PNEUMONIA; VOMITING; WHEEZING; ARTICLE; DRUG EFFECT; IMMUNOLOGY; POSTMARKETING SURVEILLANCE; SAFETY;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DIZZINESS; FATIGUE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; PRURITUS; SAFETY; SALMONELLA ENTERICA; TYPHOID FEVER; TYPHOID-PARATYPHOID VACCINES;

EID: 1642297235     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/381548     Document Type: Review

References (34)

1. TYPHIM VI. Vi polysaccharide typhoid vaccine. Product label. Aventis Pasteur SA. In: Physician desk reference. 56th ed. Montvale, NJ: Medical Economics, 2002:825-7.
2. VIVOTIF BERNA. Live oral Ty21a typhoid vaccine. Product label. Berna Biotech AG. In: Physician desk reference. 56th ed. Montvale, NJ: Medical Economics, 2002:997-8.
3. Engels EA, Falagas ME, Lau J, Bennish ML. Typhoid fever vaccines: a meta-analysis of studies on efficacy and toxicity. BMJ 1998; 316:110-6.
4. Panchanathan V, Kumar S, Yeap W, et al. Comparison of safety and immunogenicity of a Vi polysaccharide typhoid vaccine with a whole-cell killed vaccine in Malaysian Air Force recruits. Bull World Health Organ 2001; 79:811-7.
5. Mermin JH, Townes JM, Gerber M, et al. Typhoid fever in the United States, 1985-1994: changing risks of international travel and increasing antimicrobial resistance. Arch Intern Med 1998; 158:633-8.
6. Typhoid immunization recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 1994; 43(RR-14):1-7. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00035643.htm.
7. Olsen SJ, Bleasdale SC, Magnano AR, et al. Outbreaks of typhoid fever in the United States, 1960-99. Epidemiol Infect 2003; 130:13-21.
8. Mermin JH, Villar R, Carpenter C, et al. A massive epidemic of multidrug-resistant typhoid fever in Tajikistan associated with consumption of municipal water. J Infect Dis 1999; 179:1416-22.
9. Centers for Disease Control and Prevention. High priority potential bioterrorism agents list. Available at: http://www.bt.cdc.gov/Agent/agentlist. asp. Accessed 12 January 2004.
10. Torok TJ, Tauxe RV, Wise RP, et al. A large community outbreak of salmonellosis caused by intentional contamination of restaurant salad bars. JAMA 1997; 278:389-95.
11. Acharya IL, Lowe CU, Thapa R, et al. Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi: a preliminary report. N Engl J Med 1987; 317:1101-4.
12. Klugman KP, Gilbertson IT, Koornhof HJ, et al. Protective activity of Vi capsular polysaccharide vaccine against typhoid fever. Lancet 1987; 2(8569):1165-9.
13. Lebacq E. Comparative tolerability and immunogenicity of Typherix or Typhim Vi in healthy adults: 0, 12-month and 0, 24-month administration, BioDrugs 2001; 15(Suppl 1):5-12.
14. Mirza NB, Wamola IA, Estambale BA, Mbithi E, Poulet M. Typhim Vi vaccine against typhoid fever: a clinical trial in Kenya. East Afr Med J 1995; 72:162-4.
15. Levine MM, Black RE, Ferreccio C, et al. The efficacy of attenuated Salmonella typhi oral vaccine strain Ty21a evaluated in controlled field trials. In: Holmgren J, Lindberg A, Möllby R, eds. Development of vaccines and drugs against diarrhea. 11th Nobel Conference. Lund, Sweden: Studentlitteratur, 1986:90-101.
16. Simanjuntak CH, Paleologo FP, Punjabi NH, et al. Oral immunisation against typhoid fever in Indonesia with Ty21a vaccine. Lancet 1991; 338:1055-9.
17. Black RE, Levine MM, Ferreccio C, et al. Efficacy of one or two doses of Ty21a Salmonella typhi vaccine in enteric-coated capsules in a controlled field trial. Chilean Typhoid Committee. Vaccine 1990; 8:81-4.
18. Ferreccio C, Levine MM, Rodriguez H, Contreras R. Comparative efficacy of two, three, or four doses of TY21a live oral typhoid vaccine in enteric-coated capsules: a field trial in an endemic area. J Infect Dis 1989; 159:766-9.
19. Levine MM, Ferreccio C, Black RE, Germanier R. Large-scale field trial of Ty21a live oral typhoid vaccine in enteric-coated capsule formulation. Lancet 1987; 1(8541):1049-52.
20. Zanardi LR, Haber P, Mootrey GT, Niu MT, Wharton M. Intussusception among recipients of rotavirus vaccine: reports to the vaccine adverse event reporting system. Pediatrics 2001; 107:E97.
21. Centers for Disease Control and Prevention. Adverse events associated with 17D-derived yellow fever vaccination - United States, 2001-2002. MMWR Morb Mortal Wkly Rep 2002; 51:989-93.
22. US Food and Drug Administration (FDA). COSTART coding symbols for thesaurus of adverse reaction terms. Rockville, MD: Public Health Service, FDA, 1995.
23. US Food and Drug Administration. 21 CFR Part 600.80. Postmarketing reporting of adverse experiences. Fed Reg 1997; 62:52252-3.
24. Ellenberg SS, Chen RT. The complicated task of monitoring vaccine safety. Public Health Rep 1997; 112:10-20.
25. Zhou W, Pool V, Iskander JK, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS), United States 1991-2001. MMWR Surveill Summ 2003; 52(SS-1):1-24 [erratum appears in MMWR Morb Mortal Wkly Rep 2003; 52:113].
26. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10:483-6.
27. Pool V, Braun MM, Kelso JM, et al. Prevalence of anti-gelatin IgE antibodies in people with anaphylaxis after measles-mumps-rubella vaccine in the United States. Pediatrics 2002; 110:e71.
28. Kutteh WH, Kantele A, Moldoveanu Z, Crowley-Nowick PA, Mestecky J. Induction of specific immune responses in the genital tract of women after oral or rectal immunization and rectal boosting with Salmonella typhi Ty 21a vaccine. J Reprod Immunol 2001; 52:61-75.
29. Ball R. Methods of assuring vaccine safety. Expert Review Vaccines. 2002; 1:89-96.
30. Wise RP, Salive ME, Braun MM, et al. Postlicensure safety surveillance for varicella vaccine. JAMA 2000; 284:1271-9.
31. Ball R, Braun MM, Mootrey GT. Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System. Clin Infect Dis 2001; 32:1273-80.
32. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998; 339:1797-802.
33. Lathrop SL, Ball R, Haber P, et al. Adverse event reports following vaccination for Lyme disease: December 1998-July 2000. Vaccine 2002; 20:1603-8.
34. Chen RT, Mullen JR. The Vaccine Adverse Events Reporting System (VAERS): a new resource for data on vaccine safety for travelers. In: Label HO, Stetten R, Kozarsky PE, eds. Travel medicine 2: proceedings of the second conference on international travel medicine. Atlanta: International Society of Travel Medicine, 1991:128-30.