Why Adverse Events of Special Interest Are Not Side Effects!

Why Adverse Events of Special Interest Are NOT Side Effects!

Pfizer looked out for 1,291 Adverse Events of Special Interest after their COVID-19 vaccine was approved and used to vaccinate billions of people around the world.

Find out why these Adverse Events of Special Interest (AESI) are not actual vaccine side effects!

 

Claim : Adverse Events of Special Interest Are Vaccine Side Effects!

People keep sharing a list of 1,291 adverse events in 9 pages of a Pfizer document that was recently released by the FDA.

They are claiming that these are actual side effects of the Pfizer vaccine. Some claimed that this is proof that Pfizer was fully-aware that their vaccine caused those 1,291 side effects.

Some also claimed that these Adverse Events of Special Interest (AESI) are the reason why Pfizer tried to block the release of those documents for 75 years!

Read more : Pfizer Forced To Release 9 Pages Of Vaccine Side Effects?!
Read more : Did Pfizer Vaccine Documents Reveal 1,291 Side Effects?!

 

Truth : Adverse Events of Special Interest Are NOT Vaccine Side Effects!

The truth is those 1,291 adverse events of special interest (AESI) are not side effects of the Pfizer COVID-19 vaccine.

People making these false claims are accidentally misinterpreting OR intentionally misrepresenting what the document said.

And here are the facts you need to know…

Fact #1 : Pfizer Document Was Released Months Ago

These false claims are based on a Pfizer document called “5.3.6 postmarketing experience.pdf“, which the US FDA released to the PHMPT on 17 November 2021.

It apparently took them more than 3 months to read that document, and “discover” the 9 pages of 1,291 adverse events of special interest.

This not only proves that the FDA was right about how much time it takes to read (and redact) 329,000 Pfizer documents, it also shows that the PHMPT does not really need all 329,000 documents within 108 days.

After all, it took anti-vaccination activists almost that long just to read 5 documents! At this rate, it will take them some 16,450 years to read all 329,000 pages related to the Pfizer vaccine approval…

Read more : Did FDA Ask For 75 Years To Release Pfizer Vaccine Data?

Fact #2 : Pfizer Document Did Not Reveal 1,291 Side Effects

The “List of Adverse Events of Special Interest” (AESI) is NOT a list of side effects caused by the Pfizer mRNA vaccine.

Rather, that was a list of 1,291 potential adverse events that Pfizer was specifically looking for when vaccinated people send in their reports through VAERS or the Yellow Card systems.

Think of it as a shopping list of adverse events that Pfizer wanted their post-authorisation safety teams to look out for.

Even if these adverse events did occur, researchers still need to find out if they actually occurred because of the vaccine, or some other causes.

Fact #3 : Adverse Events Are Not Side Effects

I should now point out that adverse events are not side effects.

Adverse events are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.

All reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.

Even if an adverse event was “possibly caused” by the vaccine, it must still be confirmed that the vaccine directly caused it, because an anaphylactic reaction (for example) can also occur from a bee sting, or an existing peanut allergy.

Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.

Fact #4 : AESI List Not Specific To Pfizer Vaccine

The Adverse Events of Special Interest list is not specific to the Pfizer mRNA vaccine. It’s actually stated on Page 16 of the document.

The company’s AESI list takes into consideration the lists of AESIs from the following expert groups and regulatory authorities: Brighton Collaboration (SPEAC), ACCESS protocol, US CDC (preliminary list of AESI for VAERS surveillance), MHRA (unpublished guideline).

The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.

These AESIs are usually specified before clinical trials even begin, although new ones may be added later. Hence, a generic list is used.

Fact #5 : AESI List Includes Irrelevant Adverse Events

We know that this is a generic AESI list, because it included diseases involving other viruses – Herpes, MERS, Varicella; as well as “exposure to SARS-CoV-2” and other “communicable disease”.

The list also included manufacturing and lab test issues, like “Manufacturing laboratory analytical testing issue, Manufacturing materials issue, Manufacturing production issue“.

Even product supply issues were included – “Product availability issue, Product distribution issue, Product supply issue“.

They are obviously not vaccine side effects, nor related in any way to the performance or safety of the vaccine.

Fact #6 : Pfizer Document Showed No New Safety Concerns

The document actually showed that despite monitoring for 1,291 adverse events of special interest, Pfizer found no new risks from the vaccine.

If you read the Discussion and Summary + Conclusion sections, you will see that the data :

  • did not reveal any “novel safety concerns or risks”
  • support “a favourable benefit risk profile” of the vaccine

In other words – Pfizer looked for “1,291 potential dangers” associated with vaccines in general, and found NO NEW SAFETY CONCERNS / RISKS.

Don’t risk your life or your family’s lives on the bad science and misinformation promoted by anti-vaccination activists.

Please help me fight fake news, by sharing this fact check with your family and friends!

 

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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