Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine

JAMA

Volumn 292, Issue 14, 2004, Pages 1702-1710

  Wise, Robert P ^a   Iskander, John ^b   Pratt, R Douglas ^a   Campbell, Scott ^b   Ball, Robert ^a   Pless, Robert P ^b,c   Braun, M Miles ^a  

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

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

^c PUBLIC HEALTH AGENCY OF CANADA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADRENALIN; ANTIBIOTIC AGENT; CEFPODOXIME; CHICKENPOX VACCINE; DIPHTHERIA VACCINE; HEPATITIS B VACCINE; MEASLES MUMPS RUBELLA VACCINE; PERTUSSIS VACCINE; PNEUMOCOCCUS VACCINE; STEROID; TETANUS TOXOID; VACCINE; HEPTAVALENT PNEUMOCOCCAL CONJUGATE VACCINE; MENINGOCOCCUS VACCINE;

ABSCESS; ALLERGY; ALOPECIA; ANAPHYLACTOID PURPURA; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ANOREXIA; APLASTIC ANEMIA; ARTHRALGIA; ARTHRITIS; ARTICLE; ASTHMA; ATAXIA; BACTERIAL INFECTION; BACTERIAL MENINGITIS; BOTULISM; BRAIN DISEASE; BRAIN EDEMA; BRONCHIOLITIS; BRONCHOSPASM; CELLULITIS; CEREBELLAR ATAXIA; CHICKENPOX; CHOREA MINOR; CLINICAL TRIAL; CONGENITAL MALFORMATION; CONVULSION; CYTOMEGALOVIRUS INFECTION; DEATH; DEMYELINATING DISEASE; DIARRHEA; DIGESTIVE SYSTEM FUNCTION DISORDER; DISABILITY; DIZZINESS; DROWSINESS; DRUG APPROVAL; DRUG HYPERSENSITIVITY; DRUG SAFETY; DYSPHAGIA; ECCHYMOSIS; EPILEPTIC STATE; ERYTHEMA; ERYTHEMA MULTIFORME; EYE MOVEMENT DISORDER; FACE EDEMA; FATALITY; FEBRILE CONVULSION; FEVER; GAIT DISORDER; GROUPS BY AGE; HEALTH SURVEY; HOT FLUSH; HUMAN; HYPEREMIA; HYPERGLYCEMIA; HYPERKINESIA; IDIOPATHIC THROMBOCYTOPENIC PURPURA; IMMUNE MEDIATED INJURY; INJECTION SITE; INSOMNIA; INTUSSUSCEPTION; IRRITABILITY; ISCHEMIA; LARYNX EDEMA; LICENSING; LIVER CONGESTION; LIVER DISEASE; LUNG CONGESTION; LUNG DYSPLASIA; MEASLES; MENINGITIS; MOOD DISORDER; MORTALITY; MUMPS; MUSCLE HYPOTONIA; MYOCARDITIS; NERVOUSNESS; NEUROLOGIC DISEASE; NYSTAGMUS; OTITIS MEDIA; PALLOR; PATHOLOGICAL CRYING; PETECHIA; PNEUMONIA; POSTVACCINAL ENCEPHALITIS; PRIORITY JOURNAL; PRURITUS; PURPURA; RASH; RESPIRATORY DISTRESS; RISK ASSESSMENT; RUBELLA; SEIZURE; SEPTIC SHOCK; SERUM SICKNESS; SIDE EFFECT; SLEEP DISORDER; SLURRED SPEECH; STEVENS JOHNSON SYNDROME; STREPTOCOCCUS INFECTION; STREPTOCOCCUS PNEUMONIAE; STRIDOR; SUDDEN INFANT DEATH SYNDROME; SYNCOPE; THROMBOCYTOPENIA; THYMOMA; TIC; TOXIC EPIDERMAL NECROLYSIS; TREATMENT FAILURE; TREMOR; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VASCULITIS; VASODILATATION; VIRUS ENCEPHALITIS; VIRUS INFECTION; VOMITING; WHEEZING; ADOLESCENT; CHEMICALLY INDUCED DISORDER; CHILD; DRUG SURVEILLANCE PROGRAM; INFANT; PRESCHOOL CHILD; UNITED STATES; UTILIZATION REVIEW;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANAPHYLAXIS; CHILD; CHILD, PRESCHOOL; HUMANS; INFANT; MENINGOCOCCAL VACCINES; PNEUMOCOCCAL VACCINES; SEIZURES; SERUM SICKNESS; THROMBOCYTOPENIA; UNITED STATES;

EID: 5044241016     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.292.14.1702     Document Type: Article

References (34)

1. Wyeth Lederle Vaccines. Philadelphia, Pa. Pneumococcal 7-valent conjugate vaccine (Diphtheria CRM197 Protein), Prevnar. 2000. Available at: http://www.fda.gov/cber/label/pneuled021700LB.pdf. Accessibility verified September 17, 2004.
2. Ellenberg SS, Chen RT. The complicated task of monitoring vaccine safety. Public Health Rep. 1997;112:10-20.
3. Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:187-195.
4. Braun MM, Ellenberg SS. Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994. J Pediatr. 1997;131:529-535.
5. Postmarketing Reporting of Adverse Experiences. 59 Federal Register 54042 (1994) (codified at 21 CFR 600.80).
6. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine. 1994;12:542-549.
7. Coding COSTART. Symbols for Thesaurus of Adverse Reaction Terms. Rockville, Md: Public Health Service, Food and Drug Administration; 1995.
8. Ball R. Methods of ensuring vaccine safety. Expert Rev Vaccines. 2002;1:161-168.
9. Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT. An overview of the Vaccine Adverse Event Reporting System (VAERS) as a surveillance system. Vaccine. 1999;17:2908-2917.
10. 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;52:1-24.
11. Rosenthal S, Chen RT. Reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health. 1995;85:1706-1709.
12. Verstraeten T, Baughman AL, Cadwell B, Zanardi L, Haber P, Chen RT; Vaccine Adverse Event Reporting System Team. Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. Am J Epidemiol. 2001;154:1006-1012.
13. Weber JCP. Epidemiology of adverse reactions to non-steroidal antiinflammatory drugs. Adv Inflamm Res. 1984;6:1-7.
14. Notice to Readers. Updated Recommendations on the Use of Pneumococcal Conjugate Vaccine in a Setting of Vaccine Shortage - Advisory Committee on Immunization Practices. MMWR Weekly. December 21, 2001;50(50):1140-2. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5050a4.htm. Accesibility verified September 8, 2004.
15. Stratton KR, Howe CJ, Johnston RB Jr. Adverse events associated with childhood vaccines other than pertussis and rubella: summary of a report from the Institute of Medicine. JAMA. 1994;271:1602-1605.
16. Beeler J, Varricchio F, Wise R. Thrombocytopenia after immunization with measles vaccines: review of the vaccine adverse events reporting system (1990 to 1994). Pediatr Infect Dis J. 1996;15:88-90.
17. Miller E, Waight P, Farrington CP, Andrews N, Stowe J, Taylor B. Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Child. 2001;84:227-229.
18. Wise RP, Salive ME, Braun MM, et al. Postlicensure safety surveillance for varicella vaccine. JAMA. 2000;284:1271-1279.
19. Cohen AD, Shoenfeld Y. Vaccine-induced autoimmunity. J Autoimmun. 1996;9:699-703.
20. Shetty AK, Desselle BC, Ey JL, Correa H, Galen WK, Gedalia A. Infantile Henoch-Schonlein purpura. Arch Fam Med. 2000;9:553-556.
21. Jefferson T, Demicheli V. No evidence that vaccines cause insulin dependent diabetes mellitus. J Epidemiol Community Health. 1998;52:674-675.
22. Stratton K, Wilson CB, McCormick MC, eds. Immunization Safety Review, Multiple Immunizations and Immune Dysfunction. Washington, DC: Institute of Medicine, National Academy Press; 2002.
23. Black SB, Lewis E, Shinefield HR, et al. Lack of association between receipt of conjugate haemophilus influenzae type B vaccine (HbOC) in infancy and risk of type 1 (juvenile onset) diabetes: long term follow-up of the HbOC efficacy trial cohort. Pediatr Infect Dis J. 2002;21:568-569.
24. DeStefano F, Mullooly JP, Okoro CA, et al. Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitus. Pediatrics. 2001;108:E112.
25. Halsey NA. The science of evaluation of adverse events associated with vaccination. Semin Pediatr Infect Dis. 2002;13:205-214.
26. Wise RP, Kiminyo KP, Salive ME. Hair loss after routine immunizations. JAMA. 1997;278:1176-1178.
27. Silvers LE, Ellenberg SS, Wise RP, Varricchio FE, Mootrey GT, Salive ME. The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997. Pharmacoepidemiol Drug Saf. 2001;10:279-285.
28. Hoffman HJ, Hunter JC, Damus K, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death: results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome risk factors. Pediatrics. 1987;79:598-611.
29. Griffin MR, Ray WA, Livengood JR, Schaffner W. Risk of sudden infant death syndrome after immunization with the diphtheria-tetanus-pertussis vaccine. N Engl J Med. 1988;319:618-623.
30. Byard RW, Mackenzie J, Beal SM. Vaccination and SIDS: information from the South Australian SIDS Database. Med J Aust. 1995;163:443-444.
31. Byard RW, Mackenzie J, Beal SM. SIDS and immunization rates in South Australia. J Paediatr Child Health. 1998;34:101.
32. Jonville-Bera AP, Autret-Leca E, Barbeillon F, Paris-Llado J. Sudden unexpected death in infants under 3 months of age and vaccination status - a case-control study. Br J Clin Pharmacol. 2001;51:271-276.
33. Stratton K, Almario DA, Wizeman TM, McCormick MC, eds. Immunization Safety Review Committee, Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy. Washington, DC: Institute of Medicine; 2003.
34. Institute for Safe Medication Practices. Safety Briefs. ISMP Medication Safety Alert! Institute for Safe Medication Practices. 2002;7:2. Available at: http://www.ismp.org Accessibility verified September 17, 2004.