What the Heck is the Harvard Pilgrim Study and did it really say that about the underreporting of vaccine adverse events?

What the Heck is the Harvard Pilgrim Study and did it really say that about the underreporting of vaccine adverse events?

There has been much social media chatter about some Harvard Pilgrim study and how it found that vaccine adverse events and deaths are underreported by a factor of 100. As a litigator in the vaccine field, this is something I have come across and have used, so I thought it might be helpful to some readers to post the study, and maybe clear-up some misimpressions in circulation.  So, here is the study:  r18hs017045-lazarus-final-report-2011(6)

For those who just want the highlights (and a little more) here is what’s what:

What is a Harvard Pilgrim? It is a health insurance company in Massachusetts that has some research affiliation with Harvard (and as of 2019 it merged with the Tufts Health plan).

What did it study and why?

According to the listed purpose: “This research project was funded to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS) . . ..”

***

“Public and professional confidence in vaccination depends on reliable postmarketing surveillance systems to ensure that rare and unexpected adverse effects are rapidly identified. The goal of this project is to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS).”

Noble goals for sure, though most of you would take issue that AE’s from vaccines are “rare and unexpected.”

What was the universe studied?

This is from the first paragraph of the Results section.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference.”

So what about this thing about less than 1 percent of vaccine AE’s are reported?

Ok, now we get to the heart of it. Pay very close attention:

“Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA).

Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.”

That’s a mouthful, and I could spend hours and pages about what this means (and doesn’t), but what I’m not seeing here is a source for the less than 1% underreporting of vaccine AE’s, and I wish there was.

I am also not seeing any mention of deaths. While death associated with a medical intervention is surely the most extreme AE, I don’t think it is reasonable to extrapolate the less than 1% number to deaths, in terms of an extrapolation argument that the 500 (or now 1,200) deaths associated with the COVID vaccine is really 100 times that amount. And with the widespread reporting of individual COVID-associated deaths, I think we would know if there were really 50,000 to 100k deaths from the COVID vaccine in the few months in which the vaccines have been administered.  So to my mind, making the argument that COVID vaccine deaths are underreported by a factor of a hundred based on this study is both unjustified and ridiculous on its face.

Of course, the quoted language from the results about how low reporting rates slow identification of problem drugs which  “endanger[s] public health” is music to the ears of the vaccine concerned. As is the listing of all the reasons practitioners do not report AE’s.

Were there any limitations or impediments to the study?

you betcha!

“Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”

I guess everyone just got too busy or they didn’t think it was important enough to increase the efficacy of the AE reporting system.

So there you have it

While interesting, and certainly confirmatory of what most of you believe, it seems a little thin in general.  But even beyond that, we live in pandemic times with a still (for now at least) very active social media reporting on serious adverse events from the COVID vaccines, which is unparalleled to the vaccine context a dozen or so years ago when this study was performed. Therefore, I question the soundness of the extrapolation that some are making from this study onto the COVID vaccine AE situation, and more so about extrapolating about deaths. I think the latter should stop forthwith because it shows a lack of contact with reality, and thus undercuts credibility.

BUT MORE TO THE POINT,

I think there are much better and direct data points for extrapolation for the possible underreporting of Covid vaccine-related adverse events, and it is sort of obvious, namely, the reported data from the clinical trial itself. A while back, I did a post on the phase 1 clinical trial results for the Moderna vaccine. Here is that post. http://rickjaffeesq.com/2020/07/28/digging-into-the-moderna-vaccine-clinical-trials-protocols-and-results/

The bottom line is that after the second dose, 100% of Phase 1 subjects who received the Moderna vaccine had either a mild or moderate local and a mild or moderate systemic side effect from the vaccine. That’s right, 100%.

Two related caveats: Clinical trial AE reporting involves active follow-up with test subjects, obviously.  The VAER’s system is passive and voluntary. One would certainly expect a passive system not to be nearly as robust as an active reporting system. Relatedly, common sense might tell us that a passive, voluntary reporting system might well significantly underreport localized mild symptoms, i.e., a sore arm from a needle stick.

Those two caveats aside, (and assuming half of the 42 million delivered shots were the Moderna vaccine and half the reported 5k or now 12k VAER total reported side effects were from the Moderna vaccine), how is it that the active surveillance reported AE rate of 100%  goes down to 0.0005 (math might be wrong but it’s surely a couple of zeros after the decimal point.)

Either those Moderna folk made a really big improvement to the vaccine before EUA administration (which of course they couldn’t have legally) or this is pretty good evidence of the very significant underreporting of the passive VAER reporting system for the Moderna vaccine.

And in fairness, the FDA has recently admitted that its AE reporting system for the COVID vaccines is not fully up in place yet. Ya think? And this is all when most of the 42 million vaccinated have only received one of the two doses. But based on the above, don’t expect VAER’s to capture what is really going on, at least compared to what was reported in Moderna’s Phase 1 clinical trial results. I guess my point is that to me, Moderna’s actual reported clinical trial AE data is a much better basis for extrapolation than this Harvard Pilgrim thing.

Rick Jaffe, Esq.

 

 

 

 

 

 

29 thoughts on “What the Heck is the Harvard Pilgrim Study and did it really say that about the underreporting of vaccine adverse events?

  1. Are you saying that this statement is false? “Likewise, fewer than 1% of vaccine adverse events are reported.” Not quite sure how to wrap my head around this.

  2. I am saying:
    1. I don’t see a source in the study for the less the 1 percent. It seems like it’s based on something, or it’s an assumption, but I can’t say because there is no source, unlike the drug rate which is attributed to the FDA
    2. I’m saying that you can’t necessarily extrapolate that statement which was in 2008 or 2010 to now in the COVID world because of the intense social media scrutiny about AE’s which didn’t exist for fully licensed vaccines back then where there was much underreporting because docs would tell parents just to take baby motrin or whatever and it will resolve itself and not do a VAER report
    3. You certainly can’t extrapolate to deaths being the ultimate AE because deaths aren’t mentioned and there’s no way there would be 50 to 100k deaths from the COVID vaccine and we wouldn’t know it.

      1. I did a post about the Harvard Pilgrim study recently. That 1% is an unsourced estimate which appears to include all AE’s including mild local AE’s like a sore arm and I don’t think you can apply that unsourced estimate to the COVID world where serious AE’s get reported and recirculated in the vaccine concerned social media world.

  3. Thank you for addressing this issue. I’ve been pointing out the lack of a source for that 1% rate for years because it drives me crazy how many people think it’s a result of that trial. I’ve tried to find the original source, including emailing Lazarus for it, but to no avail–with the exception that in 1995, Rosenthal & Chen found a rate of <1% for least serious adverse events (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1615747/pdf/amjph00450-0108.pdf). After a lull, now with covid, that 1% has made a come-back in social media, and even Children's Health Defense has cited it in two of its recent articles.

  4. less than 1% makes sense for sore arms. On the other side if it, I think PCP’s for kids reactively downplay the seriousness of side effects reported by parents which if they were unrelated to a vaccine might result in a recommendation to the emergency room. It’s an assumption that the side effect will resolve without any long-term effect. Many in fact do, but some result in long-term effects, like developmental after encephalitic like reactions. I suspect/guess that is underreported.

    1. You obviously have not researched vaccine side effects science. Also, the CDC didn’t drop the ball; they did not want to take it further. Where’s the incentive, when HHS is in charge of vax safety, manufacturers are immune to liability aside from the kangaroo court, and government public health agencies are a revolving door of pharmaceutical industry players and investors? Rather, the CDC incentive is to not take the research further, same way they choose not to do a vax/unvax study, though they have the data.

      Again, the side effects are much more than sore arms. Myriad of chronic health issues now an epidemic in the USA, are linked to injections and other pharmaceuticals.

      1. “You obviously have not researched vaccine side effects science.”

        Why do you say this? Everything Jaffe has said makes sense to me. Also, everything you have said makes sense, except for your assessment of his knowledge of the science. Could you explain?

          1. thx for posting that article. I think the pre-Harvard Pilgrim study information is very interesting and important, especially because I think the actual study is not strong as I have indicated in the post and in comments. I also don’t think the findings can be extrapolated to the COVID pandemic context (and certainly not to deaths as I said in the post) because of a lack of separation of mild local side effects which I don’t think is viewed as a valid reason not to vaccinate a person in a pandemic. Of course many believe there is no pandemic and everyone is entitled to their opinion about anything I suppose.

          2. I’m familiar with that article, but my question was to Lana. Would like to engage with her, but so far, no response.

          3. I would like to add what I think is a crucial point: The Harvard Pilgrim “study” was not a study of VAERS reporting rates. It was a trial of the automated reporting system, ESP-VAERS, which was designed to increase existing reporting rates by health care professionals. It collected neither unreported adverse events nor events reported by non health care professionals (e.g., general public, drug companies). Therefore, not only could the 1% reporting rate (# of reported events / # of experienced events) cited in the report not possibly be a result of this trial, but also the trial’s actual results could not possibly represent VAERS overall reporting rates when unassisted by automated technology, regardless of whether the vaccines in question were administered during a pandemic.

  5. CDC did another similar VAERS reporting study with Ohio Pilgrim. That one has more detail about the AEs reported.

  6. “I guess everyone just got too busy or they didn’t think it was important enough to increase the efficacy of the AE reporting system.”
    That may not be a complete list of reasons. Judging by how CDC, WHO and other such org. behave I would not be so polite in guessing “why they did what they did”. Take-downs of YT, Twitter accounts of those who go counter to the TV narrative speak loudly.

    “The bottom line is that after the second dose, 100% of Phase 1 subjects who received the Moderna vaccine had either a mild or moderate local and a mild or moderate systemic side effect from the vaccine. That’s right, 100%.”
    So how were these subjects chosen ? Some specialists who know this field suggest these were “healthy” people. Now to extrapolate these results to a population of millions who are not healthy , well that is some serious extrapolating. Even the 95% claim should be researched closer by those who are interest because it is not as it seem, it’s a relative number of improved protection as opposed to the placebo group.

  7. I believe it’s standard practice to conduct trials with healthy and non-pregnant people and then give the vax to everyone, including pregnant women.

    1. Wouldn’t a reasonable question be, if everyone knows that VAERS is inadequate, why hasn’t it been improved upon all these years later?

      1. I think there are many reasons AE’s are underreported for drugs and vaccines, but my uninformed guess is that a big reason is that AE’s include local and mild, which really don’t affect the safety or determination of whether to give a drug or vaccine, because all medical interventions can cause some mild side effect is some people. And it’s not only the docs’ fault. I took statins twice and got bad side effects twice and had to stop it, but I never reported it to the prescribing doc. I just stopped it.

        1. You’re dwelling on minor AEs. There are also serious AEs and we have no idea to what extent. And it’s because “they” don’t want to know. It they did, we would have had a better system a long time ago.
          It’s also why CDC and HHS didn’t answer the phone when Harvard Pilgrim called. AEs can be pulled right out of patient’s EMRs. Easy peasy. Instead, we’re stuck with a lot of coincidences.

          1. I find it puzzling that HHS funded the project, but CDC didn’t want anything to do with it.

            As for their lack of desire for a better system, they already have access to data from health care organizations (e.g., Vaccine Safety Datalink), so they don’t need one. Since the general public doesn’t have access to these databases, we’re stuck with a passive reporting system that is designed only to show rare events that can only be detected after vaccines get distributed en masse. These can of course be very serious, but get dismissed because of their rarity (in comparison to # of people vaccinated) without regard to the devastation inflicted on people who experience them. This is what burns me.

          2. That’s really what I meant.
            They have the data link but don’t share that information with the public.
            That fact alone gives some of us pause.

          3. They say it’s because of confidentiality, from what I understand. But it seems that they could disguise identifying info if they wanted. There are strict rules that researchers have to follow in order to access the database. For one thing, they have to access through the CDC’s onsite monitors. Another is, they can’t align patient numbers between databases. A couple of researchers got banned for doing that. So I imagine putting the system online with confidentiality protections would be a big job.

  8. Seems like the idea that people should be reporting anything other than major side effects is not realistic. Its not a flaw in vaers. Trials have given everyone most of the known side effects data. When you are told the side effects are likely to be fever chills, aches, sore arm headaches and more then why would anyone report it unless in a trial. It becomes an expected result.. anecdotally everyone i know has had something, myself and fiance literally a sore arm if I could call it that. Most others would be aches and tired.. I would purely guess that major side effects are reported at a much higher rate and deaths would likely be close to 100 percent.

    1. But, as Kevin said, it’s purely a guess. If the information is available on the data link, why not share it with us?
      It gives some of us pause. And gives others an opportunity to scream foul.

  9. Elephant in the Room
    Okay, so you’re suggesting the rate of reporting is better than 1%??? Any guess on how much more? Maybe 10%, 25% or a whopping 50%???
    Even at that rate, the AE are alarming!

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