COVID Vaccine Safety

[PPediRN]

FDA releases data that it based its emergency use authorization for the Pfizer vaccine. Not good.

Cumulative Analysis of Post-authorization Adverse Event Reports.pdf

[RockHoundMN]

On 12/2/2021 at 9:42 AM, PPediRN said:

FDA releases data that it based its emergency use authorization for the Pfizer vaccine. Not good. 

It's really important to understand what you're reading. The trouble with doing your own "research" with a predetermined outcome in mind, is that you miss the details and see only what you're looking for. 

I've taken a little liberty here in copying what I consider to be important details:

The limitations of post-marketing adverse drug event reporting  should be considered when interpreting these data:

• Reports are submitted voluntarily, and the magnitude of underreporting is unknown. Some of the factors that may influence whether an event is reported include: length of time since marketing, market share of the drug, publicity  about  a drug or an AE, seriousness of the reaction, regulatory  actions, awareness by health professionals and consumers of adverse drug event reporting, and litigation.

• In some reports, clinical information (such as medical history,  validation of diagnosis, time from drug use to onset of illness, dose, and use of concomitant drugs) is missing or incomplete, and follow-up information may  not be available.

• An accumulation of adverse event reports (AERs) does not necessarily  indicate that a particular AE was caused by  the drug; rather, the event may  be  due to an underlying disease or some other factor(s) such as past medical history  or  concomitant medication.

[hppygr8ful, ASN, RN, EMT-I]

The summary of the study is..................Wait for it!

"5. SUMMARY AND CONCLUSION Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2. Pfizer will continue routine pharmacovigilance activities on behalf of BioNTech according to the Pharmacovigilance Agreement in place, in order to assure patient safety and will inform the Agency if an evaluation of the safety data yields significant new information for BNT162b2."

[toomuchbaloney]

On 12/2/2021 at 5:42 AM, PPediRN said:

FDA releases data that it based its emergency use authorization for the Pfizer vaccine. Not good. 

https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf 

I bet that bit of fear mongering went over better in social media comment sections than it did in this nursing forum. Isn't it curious how education and understanding can allay covid fears?

[Guest219794]

On 12/2/2021 at 9:42 AM, PPediRN said:

FDA releases data that it based its emergency use authorization for the Pfizer vaccine. Not good. 

https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf 

So- whats your thinking on this?  

[toomuchbaloney]

On 12/3/2021 at 10:51 AM, hherrn said:

So- whats your thinking on this?  

Are you assessing for critical thinking versus groupthink?

[Guest219794]

4 hours ago, toomuchbaloney said:

Are you assessing for critical thinking versus groupthink?

Wondering what the thought process in posting this was.  I am not even sure what the groupthink on this one would be.  The document cited continues the expert consensus that vaccination is the way to go.

Not sure what the "Not good" is about.

Also, would love some insight into the poster's thought process in entering the discussion on the topic with this.

[toomuchbaloney]

37 minutes ago, hherrn said:

Wondering what the thought process in posting this was.  I am not even sure what the groupthink on this one would be.  The document cited continues the expert consensus that vaccination is the way to go.

Not sure what the "Not good" is about.

Also, would love some insight into the poster's thought process in entering the discussion on the topic with this.

They are regurgitating not thinking...

[NewRN'16, ADN, RN]

*sighs*

Seriously now? 

I didn't expect I was going to run into antivax propaganda on here too. 

[Guest219794]

On 12/3/2021 at 9:35 PM, NewRN'16 said:

*sighs*

Seriously now? 

I didn't expect I was going to run into antivax propaganda on here too. 

Where have you been?  Most threads here get derailed in this direction, even if they don't start that way.

Often, it is the poster's first post on Covid.  Or first post period.  Sometimes they continue, but often the poster disappears.  

If this thread continues, you can expect it to be discovered by somebody who has never participated in the past, who joins specifically to share an opinion contrary to the position of trained, educated professionals.

[NewRN'16, ADN, RN]

31 minutes ago, hherrn said:

Where have you been?  Most threads here get derailed in this direction, even if they don't start that way.

Often, it is the poster's first post on Covid.  Or first post period.  Sometimes they continue, but often the poster disappears.  

If this thread continues, you can expect it to be discovered by somebody who has never participated in the past, who joins specifically to share an opinion contrary to the position of trained, educated professionals.

 

I guess I don't visit the site often enough. I really didn't expect an antivax OP on here though. 

(So fed up with nonsense antivaccine propaganda on social media, I have a hard time blocking them all.). 

[CommunityRNBSN, BSN, RN]

Can you clarify “not good”? I see no red flags (or yellow flags) in the document you linked to.