Pfizer has released data on Adverse effects

[statementstate]

What do we think about them keep it unavailable for so long? Has anyone else had a read and seen things unexpected? They were sent to me this morning in a file, so I can't attach, but if anyone has a link to share, that would be helpful.

Have you read them? What's your thoughts?

@BernadetteRostankowskiWolowitz yes, but I cannot understand whether it is a list of side effects they expected to see, as opposed to actual side effects reported, because just about everything is on there.

Would be nice for someone who is experienced in these papers to weigh in. The person who sent it to me also has no clue, but you can imagine how frightening and confusing such a document can be when viewed from unexperienced eyes that aren't about to interpret and break down the data in front of them.

I am trying to find a link. It is over 30 pages so makes no sense to copy it here.
I just want someone to explain it if they can.

Are you a journalist?

They were probably you know....collating data which is why it wasn't released before they had that info, if they were psychic I expect they'd have more exciting things to use their powers for.

[quote statementstate]@BernadetteRostankowskiWolowitz yes, but I cannot understand whether it is a list of side effects they expected to see, as opposed to actual side effects reported, because just about everything is on there.

Would be nice for someone who is experienced in these papers to weigh in. The person who sent it to me also has no clue, but you can imagine how frightening and confusing such a document can be when viewed from unexperienced eyes that aren't about to interpret and break down the data in front of them.

I am trying to find a link. It is over 30 pages so makes no sense to copy it here.
I just want someone to explain it if they can.[/quote]
hi @statementstate - yes it's total reported adverse effects in a large sample of people who were vaccinated

Simple conclusion: It's reassuring. Nothing in there generates a higer signal than what you would expect by chance.

The reason that "just about everything is on there" is because it's every single health condition a large number of people (n=42,086) experienced in a period of 3 months - this includes things like poisoning and choking which you wouldn't expect to be actually caused by vaccination, it's just something that happened in the time period after someone was vaccinated.

Same logic applies to the ~1000 deaths reported - dying in the three months after vaccination does not mean these people died due to vaccination.

As with yellow card and vaers data - to find meaning in these kinds of data you need to compare this to how many people would have died in a comparable population who hadn't been vaccinated. Important to say that if no one died after they'd been vaccinated, we would have found something that causes immortality!

I will see if I can find a link from someone qualified who goes through the document. Various out of context stats are already all over social media so please ignore posts like that.

Here's the full doc for anyone interested: phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf

Who emailed it to you?

Have they kept them unavailable? You get a leaflet listing potential side effects when you get your jab and you can see what people are reporting on the yellow card scheme can't you? I expect it takes time to verify actual side effects though so a delay in officially publishing them is to be expected. Where is this published though? I'm having no luck googling it. Who sent you the document?

Oh, cross post there with leafygreens!

Can't find a huge amount of scientific commentary on it yet @statementstate - but it's fair to say that there's this kind of reaction every time pharmacovigliance data is made available for the coronavirus vaccines, and everytime the same basic caveats are ignored by people pushing various agendas.

Here's one pretty useful thread:
twitter.com/ENirenberg/status/1498852915758485509

Why would it be frightening? I'd assume if there was anything actually frightening on there it would be in the press already

It was sent to me this morning by a colleague @leafyygreens asking me if I could make sense of it. While most of it was quite clear, I was uncertain about the side effects of special interest from page 30 onward as it was a few pages long. @Coughee this list isn't a list I saw with the leaflet. I think it makes sense to ask people who may know better how to interpret such data, which is why I have asked online.

The delay has been questioned because the initial timeline for release was set for decades from now apparently. The data covers the 3 months after vaccination right?

Kept unavailable for so long?

What on earth do you mean?

It has been one of the more eye opening things to learn about how many people understand research data, collection to publication of results.

This is a real time set of data, published in stages, as each stage of data analysis was completed. Nobody has a time machine or a crystal ball.

YABVU to pose what sounds very much like a journalist question or to be starting yet another unfounded conspiracy theory.

The delay has been questioned because the initial timeline for release was set for decades from now apparently. The data covers the 3 months after vaccination right?

That makes no sense.

And what is "this" that you were sent?

@SamphiretheStickerist

Kept unavailable for so long?

What on earth do you mean?

It has been one of the more eye opening things to learn about how many people understand research data, collection to publication of results.

This is a real time set of data, published in stages, as each stage of data analysis was completed. Nobody has a time machine or a crystal ball.

YABVU to pose what sounds very much like a journalist question or to be starting yet another unfounded conspiracy theory.

I’m assuming she’s heard they didn’t want to pubslish the data until 75 years had passed, but we’re forced to publish now. I’ve read that somewhere. I’m not sure where it’s come from, but I’m taking everything I read about this atm with a large pinch of salt

Thanks @leafyygreens for the Twitter link from what I was able to read before being prompted to sign in (I am not on twitter) it was reassuring. I usually do not engage in Covid talk online anymore and today has reminded me of why.

75 years? I hadn't fallen across that one Louise

OP, liberal pinches of salt are required for this, I suspect.

If it sounds ridiculous chances are it actually is ridiculous.

@SamphiretheStickerist I would advise you to step back and adjust your tone, because it is not appreciated and unwarranted. Unless you can be helpful please seek another thread to aim your aggression at as I refuse to engage in the interaction you seek.

Not everything is a conspiracy and attitudes like yours scare people from wanting to get answers from people who have expertise in the subject of vaccines.

And if it helps, that Twitter that is linked to is pretty good. And, if you scroll to page 30 you will see that the blunt, short conclusion is that nothing unexpected was noted.

So, early analysis of the first tranche of data threw up nothing unusual, nothing unexpected, nothing that worried anyone.

Bearing in mind what that stage of analysis actually was - the start of the ongoing, lifetime of the drug's use monitoring* - there is nothing being kept from anyone.

*Might this be the 75 year thing? A misunderstanding around the final / closing data being available at the end of use of the drug?

@LouiseBelchersBunnyEars you are exactly right, I just couldn't recall how long. Thank you for clarifying. I take all these blasts of information now with a grain of salt. I really think I have some trauma from all we have endured over the past two years. This is the first time in a long time I have actively asked for information from anyone online on the matter of Covid19/vaccinations and probably will be the last in a long time judging from the response of the poster above you.

You can advise me anything you want to. But it won't stop me, or anyone else, questioning any post that carries misinformation, deliberate or through misunderstanding.

Maybe look to the aggression in your own posting?!

The 75 year thing was all over the news at the time, SamphiretheStickerist.

Here's a piece from early January:
www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/

Oh! The FDA data. Thanks for clarifying that.

I had ignored that at the time because it just seemed ridiculous. There was so much other data available for the same period.

A very UK / Europe centred reaction I admit. The heel dragging in the US seemed unimportant, still does to some extent.

I work in pharmaceutical regulations. Nothing has been hidden. This is standard monitoring of post-authorisation safety data. It is collected on an ongoing basis and confirmed signals of new adverse events are added to the labelling as required. Please trust pharma companies, we know what we're doing and are highly regulated

This is the op's first ever post....

My understanding is they did want a 75 year timeline for release and the FDA weren't happy with it

www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/

I presume it's to avoid people finding material to back up any legal cases but I can only speculate. Then again, given recent issues with Moderna gene sequencing, it could be similar?

Is it easier to sue in America?

Re VAERS, it was an eye opener to see what I put in my report vs their interpretation of my report!

@EmmaH2022

My understanding is they did want a 75 year timeline for release and the FDA weren't happy with it

www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/

I presume it's to avoid people finding material to back up any legal cases but I can only speculate. Then again, given recent issues with Moderna gene sequencing, it could be similar?

Is it easier to sue in America?

Re VAERS, it was an eye opener to see what I put in my report vs their interpretation of my report!

@EmmaH2022

Re VAERS, it was an eye opener to see what I put in my report vs their interpretation of my report!

What do you mean? VAERS is a log of any adverse event reported after vaccination. They don't attempt to interpret individual accounts, it's just used to identify signals of side effects that appear to happening at a higher rate than in the general population.

Also aren't you based in the UK? We don't have VAERS here.