Did v-safe reduce the under-reporting rate for severe adverse events for COVID19 vaccines?

The Case for Vaccine Data Science - Part 4

Note: I mistakenly counted the previous article and the email header would have referred to this as Part 5, but it is actually Part 4 of the Vaccine Data Science series

This is Part 4 of my Case for Vaccine Data Science series.

I want to address another claim made by David Gorski.

It is from the same Gorski article I have been discussing till now.

If anything, given the institution of the V-Safe system and the huge publicity surrounding AEs after COVID-19 vaccination, we would expect the URR to be lower for COVID-19 vaccines than for vaccines in previous years, not higher, especially for the most severe AEs, such as death.

In my previous article, I mentioned the v-safe paper jointly authored by the CDC and Oracle’s v-safe team.

What happened to the v-safe free text entries?

There is a section in the paper where they explain how they do outreach from the v-safe call center if the v-safe participant sought medical care:

All surveys ask participants to indicate whether any of the symptoms or health conditions they reported caused a health impact (defined as being unable to work or attend school, being unable to do normal daily activities, or seeking care from a doctor or other healthcare professional). Any combination of these health impacts can be selected. Participants who indicate they sought medical care are asked to identify the source of care received (virtual, outpatient or urgent care, emergency department, or hospitalization) and receive telephone outreach from a live agent at a v-safe call center to encourage them to complete a report to VAERS; the call center agents offer to complete the report during the phone call. In cases where the participant does not wish to complete the report during the phone call but indicates willingness to report on their own, the agents provide information so that the participant can complete the report at a later time. 

In other words, if someone said they sought medical care in the list of solicited check-the-box options, they got a call from the v-safe call center.

I read on Aaron Siri’s Substack that 7.7% of v-safe users sought medical care.

V-safe’s data shows that 7.7% of its approximate 10 million users reported having to receive medical care after receipt of a Covid-19 vaccine, and over 70% of those users sought outpatient/urgent clinical care, emergency room care, and/or were hospitalized. 

Source

Note: it was confirmed once again on Aaron Siri’s Substack that it was 7.7% of total users and not 7.7% of total reports, so there were no duplicates.

V-Safe Part 8: CDC Falsely Claims To Major Media Outlet That the 7.7% Medical Care Figure Was Wrong!

But we already know that the v-safe call center team did outreach on all these 7.7% of users. This should have resulted in a total of 770000 VAERS reports.

On top of that, we also know that v-safe was designed to omit the severe symptoms reported as potential SAEs to watch out for from the Pfizer trial.

Source

This means

a) if someone sought medical care for one of the symptoms listed above it never showed up in v-safe check-the-box analysis (because they were not even presented as possible options)

b) and technically, everyone who sought medical care should have filed a VAERS report anyway (because that was the fallback that the v-safe team decided on in order to leave out the serious symptoms)

Are there 700K v-safe reports in VAERS?

The next thing to do is to check on these v-safe reports in VAERS.

You can see that the SPLTTYPE field is marked as ‘vsafe’ when the report is filed from a ‘vsafe’ call center.

But there are only around 35K such reports in VAERS at the moment.

Text analysis of v-safe reports in VAERS is still missing

Even if the 35K number is somehow representative of the actual number of serious adverse events, where is the text analysis of at least those VAERS reports?

Given that these are all VAERS reports, and all of them have pretty lengthy write-ups in addition to many other types of useful information such as patient medical history, what did the CDC infer from doing text analysis of those write-ups? Did they publish it? Can we verify it?

To me, this suggests that v-safe is not reducing the underreporting rate of severe adverse events. In fact, in the next article in this series I will show how v-safe likely increased under-reporting of adverse events.