Under-reporting of vaccine/drug injuries (UK & US)

[Guest guest]

THE CLINICAL IMPACT OF ADVERSE EVENT REPORTING

http://www.fda.gov/downloads/Safety/MedWatch/UCM168505.pdf

Underreporting

Another major concern with any spontaneous reporting system is

underreporting of adverse events16,30-32. It has been estimated that

rarely more than 10% of serious ADRs, and 2-4% of non-serious reactions,

are reported to the British spontaneous reporting program30.

A similar estimate is that the FDA receives by direct report less than

1% of suspected serious ADRs32. This means that cases spontaneously

reported to any surveillance program, which comprise the numerator,

generally represent only a small portion of the number that have actually

occurred. The effect of underreporting can be somewhat lessened if

submitted reports, irrespective of number, are of high quality

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

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