Allergic reactions after egg-free recombinant influenza vaccine: Reports to the US vaccine adverse event reporting system

Clinical Infectious Diseases

Volumn 60, Issue 5, 2015, Pages 777-780

  Woo, Emily Jane ^a  

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

Author keywords

Allergy; Egg; Hypersensitivity; Influenza; Vaccine

Indexed keywords

EGG PROTEIN; INACTIVATED VACCINE; INFLUENZA VACCINE; RECOMBINANT VACCINE;

ADULT; ARTICLE; CLINICAL ARTICLE; DISEASE SEVERITY; DRUG HYPERSENSITIVITY; EGG ALLERGY; EVALUATION STUDY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFLUENZA; MIDDLE AGED; PRIORITY JOURNAL; SELF REPORT; UNITED STATES; VACCINATION; ADOLESCENT; HYPERSENSITIVITY; YOUNG ADULT;

ADOLESCENT; ADULT; HUMANS; HYPERSENSITIVITY; INFLUENZA VACCINES; MIDDLE AGED; UNITED STATES; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 84935432979     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciu948     Document Type: Article

References (16)

1. US Food and Drug Administration. January 16, 2013 Approval Letter-Flublok. Available at: http://www.fda.gov/BiologicsBloodVaccines/ Vaccines/ApprovedProducts/ucm410628.htm. Accessed 4 December 2014.
2. Grohskopf LA, Shay DK, Shimabukuro TT, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices-United States, 2013-2014. MMWR Recomm Rep 2013; 62(RR-07):1-43. Available at: http:// www.cdc.gov/mmwr/preview/mmwrhtml/rr6207a1.htm. Accessed 4 December 2014.
3. 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.
4. Varricchio F, Iskander J, Destefano F, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2004; 23:287-94.
5. Iskander JK, Miller ER, Chen RT. The role of the Vaccine Adverse Event Reporting System (VAERS) in monitoring vaccine safety. Pediatr Ann 2004; 33:599-606.
6. Postmarketing reporting of adverse experiences. Code of Federal Regulations. 21 CFR 600.80. Revised as of April 1, 2014.
7. Ruggeberg JU, Gold MS, Bayas JM, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine 2007; 25:5675-84.
8. DuMouchel W, Pregibon D. Empirical Bayes screening for multi-item associations. In: Proceedings of the seventh ACMSIGKDD international conference on knowledge discovery and data mining. New York: ACM, 2001:67-76.
9. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's Spontaneous Reports database. Drug Safety 2002; 25:381-92.
10. US Food and Drug Administration . Package Insert-Flublok. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ ApprovedProducts/UCM336020.pdf. Accessed 4 December 2014.
11. Kawai AT, Li L, Kulldorff M, et al. Absence of associations between influenza vaccines and increased risks of seizures, Guillain-Barré syndrome, encephalitis, or anaphylaxis in the 2012-2013 season. Pharmacoepidemiol Drug Saf 2014; 23:548-53.
12. McCarthy NL, Gee J, Lin ND, et al. Evaluating the safety of influenza vaccine using a claims-based health system. Vaccine 2013; 31:5975-82.
13. Greene SK, Kulldorff M, Lewis EM, et al. Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project. Am J Epidemiol 2010; 171:177-88.
14. Yih WK, Lieu TA, Kulldorff M, et al. Intussusception risk after rotavirus vaccination in U.S. infants. N Engl J Med 2014; 370:503-12.
15. US Food and Drug Administration. FDA's Sentinel Initiative. Available at: http://www.fda.gov/Safety/FDAsSentinelinitiative/ucm2007250.htm. Accessed 4 December 2014.
16. Centers for Disease Control and Prevention. Clinical Immunization Safety Assessment (CISA) Project. Available at: http://www.cdc.gov/ vaccinesafety/Activities/cisa.html. Accessed 4 December 2014.