The new Lancet report, a story and another story

A very short write-up... and a correction that makes it worse...

Update: I made a mistake. And it makes everything even harder to explain. It was pointed out to me by a colleague that in fact, the 0-7 day-out window was NOT applied to the VAERS data, only to the v-safe data in the Lancet study. My reading eyes glazed over that point. They state in the Methods:

We included all VAERS reports that were submitted for US residents who received mRNA vaccines and processed from Dec 14, 2020, to June 14, 2021, including any interval from vaccination to event report.

Apologies. Please read on to see corrected numbers.*

A new report has been published in The Lancet entitled: “Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe”¹ and it made me mad. It made me mad because the conclusion or rather ‘the interpretation’ was the following:

Safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that most reported adverse events were mild and short in duration.

Mild. Short. I see.

Bonus points for anyone who knows why I posted this photo.

Before I start (and finish) assessing this ‘piece of work’, I want to tell my readers a story. I woke up yesterday morning to a very heart-breaking message. It was from someone I didn’t know who had gotten my number from a colleague. He gave me his permission to talk about his situation. His message was the following:

Hi Jessica, I received your number from _ _. She believes you might help my situation regarding some symptoms Im having after taking the vaccine . She thinks it might be related to ACE2 article that you wrote. I would really appreciate your help. Im really suffering. Thank you. _

I immediately referred him to a colleague I know who successfully treats both COVID-19 and injection-related pathologies with success. I also gave him my best advice on therapeutics (zinc ionophores, Vitamins and Curcum). He told me he was already taking them. Out of interest, I asked him for some background information: his age, previous problems with his health, when exactly he got his injections, how long after the symptoms started and what the symptoms were. He’s 39 , previously a runner (10 km a day), never had a health problem and was on no meds. These are the symptoms he listed that began shortly following the second injection in July.

General Feeling sick and weakness - Feeling of being electrified - Trembling all over the body - Streams and tingling in the chest - Tingling and trembling in the chest and upper abdomen - Waves of heat, cold all over the body - Numbness/Heat in the head and forehead - Motor difficulty talking or walking. - Dizziness and instability - Muscle weakness - a feeling of intense warmth and tingling in the skin - Confusion - A feeling of warmth in the breath - Palpitations and tremors from the chest - Endurance difficulty. - Not sweating

Sound mild to you? Clearly, he is suffering neurological issues and cardiovascular issues, neither of which I would consider ‘mild’, by any stretch of the imagination. It’s been 8 months that he has been suffering. Every single day. Imagine that feeling of never-ending pain and not knowing what will happen the next day.

This morning he wrote to me again: “Hard morning. Strong tingling sensations from the chest. I'm not sure if it's my heart shaking and tingling or the nervous system but it paralyzes me.”

I told him that I believed that he is primarily suffering post-injection neurological side effects and the best advice I could give was to see my colleague as soon as possible. He went today. He is on Ivermectin now. He will update me tomorrow. He messaged me whilst at her office and told me that she said she has seen worse and that she thinks he will make a full recovery. I am praying that he does. He has touched my heart with his honest plea for help and I must help him. I cannot stand to watch suffering.

He was rejected by every single doctor he went to for help and was told that his symptoms ‘were in his head’. Those are the ‘doctors’ who deserve to have their medical licenses revoked! Is that your caring profession? Well done in-doctor-inated! Way to follow protocol.

This is not a solo story but it is personal to me now. I hear, see and write about these types of symptoms all day, every day. They are not uncommon, they are not mild in many cases, and can be very long-lasting.

Alright. Now to the paper. Let’s talk about that first before I bring in my VAERS numbers for comparison. I will write about what they reported in this study in the context of the VAERS data only and not the v-safe. This is going to be quick and dirty.

The data was sectioned off to include the first 6 months (from Dec 14, 2020, to June 14, 2021) of data. Great. Good stuff.

During the study period, 298,792,852 doses of mRNA vaccines were administered in the USA. VAERS processed 340,522 reports: 313,499 (92·1%) were non-serious, 22,527 (6·6%) were serious (non-death), and 4,496 (1·3%) were deaths.

Awesome. Let’s use this. According to their quoted numbers, 1/877 people that got injected suffered an adverse event (AE). That seems like high risk gambling to me. Of the individuals who did suffer an AE, 1/76 died. So you would have a 1/66666 (not a joke) chance of dying if you got injected. By their numbers. Again, that seems high to me. If someone told me that I have a 1/66666 chance of dying from an injection that I don’t need, I would not take the injection. So right out of the ‘gates’ (hardy har) the AE data doesn’t look good to me. It’s still off-the-rails atypical count-wise when one compares the COVID-19-related counts to counts from the past for all vaccines combined.

Also, these numbers don’t consider the under-reporting factor (URF). If we do, in fact, consider an URF of 41, the chances of succumbing to an AE becomes 1/21 and of dying becomes 1/1,600 (if we consider the URF for death to be 41 as well). Which it probably isn’t, but you get the drift. If the URF for death is 6 then the chances become 1/11,076. Still high if you ask me. The number of Severe AEs (SAEs) is claimed to be 22,527. This means that with an URF of 41, one has a 1/324 chance of succumbing to an SAE and even without the URF, a 1/13,264 chance.

*Corrections applied to include ALL VAERS data during time interval spanning December 14, 2020 to June 14, 2021.

Just as a side note, the numbers they report are already bad to me. And they are highly underestimated, as you will see in the following.

By now, most people know that I am a bit of a VAERS hag. Guilty as charged. So let’s hag out. I siphoned off the data for the first 6 months according to their dates - from Dec 14, 2020, to June 14, 2021. In fact, I did this for 3 different sets of date data. I did this for an important reason. In VAERS, there are 6 different date types reported - 3 of which are the Vax Date (VD), Onset Date (OD) and Received Date (RD). These dates should always be in temporal sequential order (or be the same). If the VAERS system was functioning perfectly, each report filed to VAERS would have a VD (the day the individual received a dose of product), an OD (the day the individual started suffering an AE) and the RD (the day the report/ID was uploaded to the front-end system). Discrepancies can certainly occur due to duplicate entries and their removal during the vetting process and also due to known backlog², so although it would be acceptable to me to have fewer RD entries than VD and OD entries for these reasons, I would expect this to occur only to a certain degree.

I created data frames that included the chunk of date data from Dec 14, 2020, to June 14, 2021 for all 3 of these for the aforementioned reasons and also since oftentimes, there is missing date data. When stratifying VAERS data according to date, it is vital to examine the differences between the numbers of reports according to the different date types (ie: VD, OD and RD). Again, logically, if there were no errors, these numbers should match very well. If nothing else, the number of people injected (according to VD) filing reports to VAERS, should definitely match the number of onset reports (according to OD). I didn’t get a match in any of the three data frame counts with regard to each other, and also not with regard to the estimate in this Lancet report. It is not known for which dates the data originated from in the Lancet report. I would assume based on the comparison of the counts that they chose the RD data.

The closest I got to their estimate when I filtered using the RD data was 371,775, which, incidentally, is closer than I got when I had filtered the data 7 days post injection. That’s good, right? Not really. For the VD data filter I got 545,275 reports and for OD data filter I got 499,432 reports. What this means, is that in the first 6 months, 545,275 reports were filed that had documented VD data, 499,432 reports were filed that had documented OD and 371,775 reports ended up in the front-end system (RD). What is disturbing to me about VAERS when reporting on dates is that these counts are only determinations of the number of VAERS IDs with existing date data. The true number is inevitably different. I can easily determine what percentage of entries have date data per type, but that’s for another Substack.

I am concerned about the differences in the number of VAERS ‘processed 340,522 reports’ in the Lancet study and my calculated number of VAERS reports. I had written in the previous version of this article that I was not concerned. The reason that I am now concerned is that the closest match to their processed count of 340,533 is my RD data count of 371,775. However, as I described, these entries represent only the entries that ‘made it’ into the front end VAERS database. Therefore, was the lowest count picked for a reason? I don’t know.

The number of deaths by the RD count is 6,114. The number of SAEs is 68,124 which comprises 18% of all AEs. To be clear, an SAE includes: death, hospitalizations, an emergency doctor visit, a birth defect, a life threatening illness or a disability.³ Recall that they also define an SAE as something that “make[s] normal daily activities difficult or impossible.”

I do not know where the authors got their estimate of 22,527 SAEs (6.6%). There are at least 68,124 SAEs by my count (RD). By the way, if I use my data frame from the VD data block (Total AEs: 545,275) we get 107,599 SAEs (20% of all AEs) and 10,051 deaths, and from the OD data block (Total AEs: 499,432) we get 87,893 SAEs (18% of all AEs) and 7,647 deaths. Their estimate for SAEs is low by any measure used. The bottom line here is that even when I use the lowest possible count, the numbers still do not match (and I would never use the RD data over the OD data because I believe the RD data misrepresents the number of VAERS reports actually filed) and the SAE and death counts are underestimated by 3 and 1.4 times, respectively.

I have learned many lessons over the past 2 years. One of them is not to waste time. Ever since the Lancet’s episode of ‘let’s make hydoroxychloroquine ungreat again’, I just have very little respect for this journal. Once you commit fraud, you should be eliminated. Truly, a fallen hero of mine.

By the way, this work was funded by none other than the US Centers for Disease Control and Prevention.

We declare no competing interests.

Really?

To summarize this update, the numbers are even less comparable now after considering all of the data (not just reports 7 days-post injection) in the date chunk December 14, 2020 to June 14, 2021. The absolute count (if we consider the RD data) is 1.1 times underestimated (which is acceptable), the SAE count is 3 times underestimated and the death count is 1.4 times underestimated. I cannot explain these discrepancies but I do know that I have faced this before with works produced by these authors.

As a bonus, the absolute counts (if we consider the VD and OD data) are 1.6 and 1.5 times underestimated, respectively, the SAE counts are 4.8 and 3.9 times underestimated, also respectively, and the death counts are 2.2 and 1.7 times underestimated, also also respectively.

I know this is written badly. I will try to improve the sentence structures to make it more readable soon. Thanks for patience.

1. https://doi.org/10.1016/S1473-3099(22)00054-8

2. It is known that there is a backlog and that there are many logistical issues with VAERS.

3. “VAERS reports were classified as serious if any of the following outcomes were documented: inpatient hospitalisation, prolongation of hospitalisation, permanent disability, life-threatening illness, congenital anomaly or birth defect, or death.”