May 2011: Flaws in VAERS data

This month I will investigate flaws in the VAERS data. It should come as no surprise that there are mistakes in VAERS data: this sort of thing happens all the time. The culprit is people, and people make mistakes. Let's look at two problems:

Problem 1: Hospitalization. There are two outcomes in each VAERS report related to hospitalization: Hospitalized and Extended Stay in Hospital. Could it be that a VAERS report indicates an extended hospital stay but does not indicate hospitalization? Clearly, that would be a mistake. To find out, go to Section 4 of the search form and set Hospitalized? to "No" and Extended stay? to "Yes". The result shows 627 VAERS reports with this mistake!

The ramifications of this mistake are actually significant, because the government often makes a distinction between those VAERS reports that are "serious" and those that are not. Non-serious VAERS reports are typically discarded as unimportant. The definition of "serious" includes hospitalization, life-threatening, disabled, or death, but it does not consider the extended-stay outcome. In fact, of those 627 reports with the hospitalization mistake, 505 of them are non-serious and would, if the mistake were fixed, become serious situations.

Problem 2: Gardasil underreporting. Each VAERS report lists the vaccinations that were given and also has a write-up that describes the problem. Is it possible that Gardasil is mentioned in the write-up but is not in the list of vaccinations that were given? To find out, check Expert Mode (needed to search for vaccines that were not given). Then in Section 2, set the Write-up field to "gardasil". Finally, in Section 3, choose the "HPV" and "HPV4" vaccines and check Excluded. HPV4 is Gardasil and HPV is a generic vaccine that could be Gardasil or Cervarix. By excluding both of these possibilities, we are finding VAERS reports that specifically do not list Gardasil.

How many reports match this search? 116! But let me immediately point out that this search does not necessarily indicate a mistake in the VAERS data. A careful reading of the write-ups in these reports reveals that many of them mention Gardasil without claiming that it was given to the patient. Some of the write-ups say that "Gardasil was not given" or that the patient intended to get Gardasil but was given a different vaccine instead. Some describe newborn infants who were exposed to Gardasil during their mother's pregnancies. Of the 116 reports uncovered by this search, 43 of them follow one of these patterns and indicate that Gardasil was not given.

And what about the 73 reports that claim Gardasil was given? Why wasn't it listed in the report? Some are clearly human error (either the VAERS submission form was filled-out incorrectly or a typo was made). Some appear to combine multiple medical situations into a single report and lose information in the process. Some list an "unknown" vaccine having been given, but it is clear from the writeup what that vaccine actually was.

Remember that I am not a health professional, so it is possible that some of these 73 VAERS reports are simply not Gardasil-related. In any case, here are the 73 reports that I think are mistakes. The numbers listed here are the VAERS ID numbers. Click on them to see the full report.

188549 273437 275509 275604 282553 290709 290916 291020 291023 291131
292483 294675 299087 302119 302324 303464 305287 305397 305679 306626
306710 307011 308064 308192 308245 309086 313806 313931 314847 316136
318397 318485 319741 321093 321118 321327 323639 324149 324636 327723
330258 330468 335597 336766 339137 341496 342125 342365 343296 344175
348025 350028 351587 354656 356422 359436 365986 368786 370905 377450
381727 386584 388326 388387 394854 397983 398183 407916 417338 418531
421475 423293 423546 Some people might jump to the conclusion that this an attempt to hide information, but I do not think so. There are many people involved in the collection of this data, all of whom can make mistakes:

• Patients and relatives. Inexperienced people can easily make mistakes when filling out the VAERS submission forms.
• Doctors. Busy doctors filling-out forms at the end of a long day can make mistakes.
• Drug companies. Some reports are submitted by the drug companies, and they are dealing with third-hand data.
• VAERS. The people at the VAERS agency might make mistakes, too. To me, this is the least likely explanation as I discussed a few months ago. In fact, I'm hoping that this blog reaches the appropriate people, and that the VAERS data is fixed. If this happens, then people reading this blog years from now will not be able to reproduce the mistakes I've described.

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