Abstract
Objective: A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil® and the RIVM report on Cervarix®. Method: all AEFI from the three sources were recalculated to a percentage of all AEFI reported for each of the two vaccines. And the safety profile was compared to the safety data in the SPC. Results: Comparison of relative AEFI reporting proportions in the global VigiBase database with VAERS for Gardasil® and with RIVM for Cervarix® shows a safety profile in VigiBase similar to the result of PMS on a national level in 2 countries. Conclusion: The post licensure safety profile of both vaccines is consistent with the data in the SPC of these vaccines.
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