References
- DuclosP, Okwo-BeleJM, Gacic-DoboM, CherianT. Global immunization: status, progress, challenges and future. BMC Int Health Hum Rights2009; 9:Suppl 1S2; http://dx.doi.org/10.1186/1472-698X-9-S1-S2; PMID: 19828060
- LankinenKS, PastilaS, KilpiT, NohynekH, MäkeläPH, OlinP. Vaccinovigilance in Europe--need for timeliness, standardization and resources. Bull World Health Organ2004; 82:828 - 35; PMID: 15640918
- BonhoefferJ, BlackS, IzurietaH, ZuberP, SturkenboomM. Current status and future directions of post-marketing vaccine safety monitoring with focus on USA and Europe. Biologicals2012; 40:393 - 7; http://dx.doi.org/10.1016/j.biologicals.2012.07.007; PMID: 22902972
- ZanoniG, BerraP, LucchiI, FerroA, O’FlanaganD, Levy-BruhlD, SalmasoS, TridenteG. Vaccine adverse event monitoring systems across the European Union countries: time for unifying efforts. Vaccine2009; 27:3376 - 84; http://dx.doi.org/10.1016/j.vaccine.2009.01.059; PMID: 19200851
- Miller ER, Haber P, Hibbs B, Broder K. Surveillance for Adverse Events Following Immunization Using the Vaccine Adverse Event Reporting System (VAERS). In Manual for the Surveillance of Vaccine-Preventable Diseases. Centers for Disease Control and Prevention, Atlanta, GA, 2008.
- ColletJP, MacDonaldN, CashmanN, PlessR, Advisory Committee on Causality Assessment. Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Bull World Health Organ2000; 78:178 - 85; PMID: 10743282
- AlicinoC, InfanteMT, GandogliaI, MioloN, MancardiGL, ZappettiniS, CapelloE, OrsiA, TamburiniT, GrandisM. Acute disseminated encephalomyelitis with severe neurological outcomes following virosomal seasonal influenza vaccine. Hum Vaccin Immunother2014; 10:10; http://dx.doi.org/10.4161/hv.28961; PMID: 24785431
- Agenzia Italiana del Farmaco. Report on post-markeing surveillance of vaccines in Italy during 2012. Rome 2013.
- REGULATION. (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Available from https://eudravigilance.ema.europa.eu/human/docs/Regulations/reg_2010_1235_en.pdf.
- ClothierHJ, CrawfordNW, KempeA, ButteryJP. Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria. Commun Dis Intell Q Rep2011; 35:294 - 8; PMID: 22624490
- MichelettiF, MorettiU, TridenteG, ZanoniG. Consultancy and surveillance of post-immunisation adverse events in the Veneto region of Italy for 1992-2008. Hum Vaccin2011; 7:Suppl234 - 9; http://dx.doi.org/10.4161/hv.7.0.14613; PMID: 21301223
- LoughlinAM, MarchantCD, AdamsW, BarnettE, BaxterR, BlackS, CaseyC, DekkerC, EdwardsKM, KleinJ, et al. Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccine2012; 30:7253 - 9; http://dx.doi.org/10.1016/j.vaccine.2012.09.074; PMID: 23063829