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Pfizer adverse event data

Thanks Pfizer, for your pfabulous and pfun report



So there’s a new document in town. It’s entitled:

5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021

And here’s the first summary table.


So the first thing we notice is the date. These adverse event reports are from the start date of the roll out into the U.S. population on December 17th, 2020 up to and including February 28th, 2021. That’s 74 days or 2 months and 12 days.


The second thing we notice is the total adverse event count of N = 42,086. Now, if you count the number of adverse events reported to VAERS for this exact time frame according to injection dates, you get N = 84,770 reports in the context of the Pfizer/BioNTech products. It’s literally twice the N reported by Pfizer in their report. Either way, you’re facing 42,086 or 84,770 reports of adverse events in 74 days. And what of the under-reporting factor? I will come back to that…


The third thing we notice is the high number of adverse event reports for children. There are 34 adverse event reports made for children less than 12. How is that possible? Children this young weren’t supposed to be injected in the early days since there was definitely no safety data accumulated at that point. The exclusion criteria age cut-off was 12 in Pfizer’s phase III trial, so how is this possible? And how many of these very young children died?


UPDATE: Monday December 6th, 2021

Baby details. So let’s head down to page 15 in the document where you’ll find a table called ‘Description of Missing Information’. In the descriptive subtext underneath, go to letters ‘c’ and ‘d’.

c. Upon review, 31 additional cases were excluded from the analysis as the data reported (e.g. clinical details, height, weight, etc.) were not consistent with paediatric subjects d. Upon review, 28 additional cases were excluded from the analysis as the data reported (e.g. clinical details, height, weight, etc.) were not consistent with paediatric subjects

Paediatric subjects are people less than 12 years of age. Now correct me if I am wrong here but does this not state that a total of 59 reports of adverse events were dropped because the paediatric subjects (babies) did not fit the height and weight criteria? What the hell does ‘etc.’ entail? Shouldn’t, oh, I don’t know, ‘age’ be one of the criteria used to justify dropping a paediatric case from the analysis if specific parameters are being used as reasons to drop them? To me, it is NOT unreasonable to assume that some of the children in the paediatric cohort were not <12, so this would actually be a reasonable reason to drop them from this cohort and analysis of paediatric subjects. But we have to assume that this is not the case and that all paediatric subjects were <12 years of age and that 59 of them out of 132 (45%) (page 13) were dropped because they were too tall or too fat.

By the way, it is not uncommon to see paediatric VAERS reports ‘disappear’. Is this the weak justification that is being used? They were too fat? Too tall? They couldn’t possibly be a baby. Oh my word.


CONTINUE READING

https://jessicar.substack.com/p/pfizer-adverse-event-data



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