Despite repeatedly claiming that serious harms of Pfizer’s mRNA vaccine are RARE, an investigation found no drug regulator could quantify the rate. Experts say it's "hypocritical."
and watch Table S3: "Participants Reporting at Least 1 Adverse Event from Dose 1 to 1 Month After Dose 2 During the Blinded Follow-up Period".
This table reports about 262 persons with Severe Adverse Events in the (21,926) BNT162b2 group, versus 150 in the (21,921) placebo group.
Using MedCalc's 'Comparison of two rates' for statistics, the incidence rate difference is 0.5% (95% Confidence Interval 0.33% to 0.69%) with P-value of less than 0.0001.
This means that about one person in every 200 persons injected with Pfizer’s mRNA vaccine suffered a related severe adverse event. Number Needed to Harm between 144-300 with 95% confidence.
So yes, severe adverse events of this jab are 'uncommon' but definitely not rare, and this was probably known to Pfizer quite early on...
Good catch, although "severe" adverse events are different from the "serious" ones discussed by Fraiman et al. The acronym SAE refers to serious adverse events.
Severe = "Prevents daily activity and requires medical intervention"
One lame excuse after the next to avoid confronting the data that condemns their argument. They think they can get away with this because they've been doing it for years, for decades. We mustn't let them off the hook this time, because they are intent on continuing with more of the same anti-science pettifoggery.
When one also takes into account the high level of underreporting of adverse reactions (41-fold has been quoted for VAERS in the USA), as well as reluctance by ATAGI and other bodies to ascribe any adverse outcomes to the "vaccines", the true level of SAE's becomes extremely troubling.
In my practice I have seen possibly 200 cases where Covid "vaccine" AE's are likely.
I have reported less than 10 of these- either where the link to the jab is unclear, or at times when the additional work involved in making a report has made it difficult given my hectic clinical workload.
Worldwide increase in all-cause mortality is an excellent window into the level of SAE's, though there remains no interest in MSM or any regulatory bodies (or Public Health Departments) in looking for a cause!
V-Safe the same spontaneous reporting database that all authorities say is “not causal” so they just ignore it. They should quantify what they believe to be causal events (but they won’t 😞)
Kudos for getting the FDA on the record. It was clear from the start that COVID shots were intended not to benefit patients, but to protect hospitals (and the NHS) from infectious patients.
Hi Maryanne. Love your work. Have been following for many years. I’m wondering if you’ve come across any articles/studies relating to adverse events for females reproductive and menstrual issues after taking the mRNA covid vaccines. I’m in natural health and myself and many colleagues are seeing female patients who have experienced adverse events relating to their menstrual cycles post vaccine. If you have any articles or preliminary research you’d be happy to share I’d love to take a look. Thanks.
It seems that the initial rate of severe adverse events from Pfizer's BNT162b2 mRNA Covid-19 Vaccine was (silently) reported on November 4, 2021.
Please look at this https://www.nejm.org/doi/full/10.1056/nejmoa2110345
article's Supplementary Appendix: https://www.nejm.org/doi/full/10.1056/nejmoa2110345#:~:text=2005KB-,Supplementary%20Appendix,-PDF
and watch Table S3: "Participants Reporting at Least 1 Adverse Event from Dose 1 to 1 Month After Dose 2 During the Blinded Follow-up Period".
This table reports about 262 persons with Severe Adverse Events in the (21,926) BNT162b2 group, versus 150 in the (21,921) placebo group.
Using MedCalc's 'Comparison of two rates' for statistics, the incidence rate difference is 0.5% (95% Confidence Interval 0.33% to 0.69%) with P-value of less than 0.0001.
This means that about one person in every 200 persons injected with Pfizer’s mRNA vaccine suffered a related severe adverse event. Number Needed to Harm between 144-300 with 95% confidence.
So yes, severe adverse events of this jab are 'uncommon' but definitely not rare, and this was probably known to Pfizer quite early on...
Yes, certainly not ‘rare.’ Fraiman et al took data from the journal articles as well as from the FDA and Heath Canada websites (regulatory data)
Good catch, although "severe" adverse events are different from the "serious" ones discussed by Fraiman et al. The acronym SAE refers to serious adverse events.
Severe = "Prevents daily activity and requires medical intervention"
Serious = "Death, Life-threatening, Hospitalization, Disability or Permanent Damage, Birth Defect"
Much earlier, on December 31, 2020, the first report on this trial, in the same journal: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
This article has a similar supplementary appendix
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2034577/suppl_file/nejmoa2034577_appendix.pdf
with similar evidence shown on Table S3:
240 (1.1%) persons with Severe Adverse Events in the (21,621) BNT162b2 group,
versus
139 (0.6%) in the (21,631) placebo group.
I just hope this content is presented to the UK covid enquiry and that it has an open mind and takes these points on board.
One lame excuse after the next to avoid confronting the data that condemns their argument. They think they can get away with this because they've been doing it for years, for decades. We mustn't let them off the hook this time, because they are intent on continuing with more of the same anti-science pettifoggery.
Agree 👍
When one also takes into account the high level of underreporting of adverse reactions (41-fold has been quoted for VAERS in the USA), as well as reluctance by ATAGI and other bodies to ascribe any adverse outcomes to the "vaccines", the true level of SAE's becomes extremely troubling.
In my practice I have seen possibly 200 cases where Covid "vaccine" AE's are likely.
I have reported less than 10 of these- either where the link to the jab is unclear, or at times when the additional work involved in making a report has made it difficult given my hectic clinical workload.
Worldwide increase in all-cause mortality is an excellent window into the level of SAE's, though there remains no interest in MSM or any regulatory bodies (or Public Health Departments) in looking for a cause!
The V-Safe data indicates a serious adverse event rate of about 7.7%. This would put it in the "common" realm.
V-Safe the same spontaneous reporting database that all authorities say is “not causal” so they just ignore it. They should quantify what they believe to be causal events (but they won’t 😞)
Kudos for getting the FDA on the record. It was clear from the start that COVID shots were intended not to benefit patients, but to protect hospitals (and the NHS) from infectious patients.
Hi Maryanne. Love your work. Have been following for many years. I’m wondering if you’ve come across any articles/studies relating to adverse events for females reproductive and menstrual issues after taking the mRNA covid vaccines. I’m in natural health and myself and many colleagues are seeing female patients who have experienced adverse events relating to their menstrual cycles post vaccine. If you have any articles or preliminary research you’d be happy to share I’d love to take a look. Thanks.
Thank you Cassie, much appreciated. Menstrual disturbances are certainly an issue following covid-19 vaccination. There are a few studies that have linked the two - most notably, a large NIH study https://www.nih.gov/news-events/news-releases/study-confirms-link-between-covid-19-vaccination-temporary-increase-menstrual-cycle-length
Also, here is a systematic review of pharmacovigilance databases
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9683843/
Hope this helps.