After reviewing the first month of adverse event reports (AERs) related to the COVID shots, the CDC published their findings, which more or less said something like this:
“Move along, there is nothing to see here.”
In their words, there was nothing “unusual or unexpected.” But when the AERs for COVID shots get compared to an 11-year baseline taken from history, you have to ask yourself what they expected. Did they expect over 7 times as many AERs per million (M) doses? Did they expect over 4 times as many serious AERs per M doses?
Key: AER = adverse event report; SE_Rate = standard error of rate; LB95_X = 95% lower bound on count of events; UB95_X = 95% upper bound on count of events; LB95_R = 95% lower bound on rate; UB95_R = 95% upper bound on rate; LB_COVID = 95% lower bound on rate for COVID shots; UB_Historic = 95% upper bound on rate for all other vaccines from 1991 up to 2001 [see the formula for cell E6 up top]
And did they really expect over 5 times as many fatal AERs per M doses when compared to an historic baseline? The baseline data predicts around 1.1 deaths per M doses, but the report for that first month of COVID shots admits of having 8.2 deaths per M doses (a later report for the first 6 months even had almost twice that).
If 8.2 fatal AERs per M doses was not unusual or unexpected, then what about the 15.05 fatal AERs per M doses found later, covering the first six months? Still not unusual nor unexpected? How high would it have to go for it to become unusual?
The rate ratios in column J are not merely the ones you’d get using the central estimates each time, they are the ones you get after accounting for all statistical variability and using the respective boundaries of 95% intervals formed around the rates. In other words, the uncertainty has been “worked into” those rate ratios.
Another way to say this is that they are statistically-robust (reliable) rate ratios.
Reference
[CDC says nothing to see] — Gee J, Marquez P, Su J, Calvert GM, Liu R, Myers T, Nair N, Martin S, Clark T, Markowitz L, Lindsey N, Zhang B, Licata C, Jazwa A, Sotir M, Shimabukuro T. First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70(8):283-288. doi: 10.15585/mmwr.mm7008e3. PMID: 33630816; PMCID: PMC8344985. https://pmc.ncbi.nlm.nih.gov/articles/PMC8344985/
[first-6-months fatal AER reporting rate of 15.05 fatal AERs per M doses] — Rosenblum HG, Gee J, Liu R, Marquez PL, Zhang B, Strid P, Abara WE, McNeil MM, Myers TR, Hause AM, Su JR, Markowitz LE, Shimabukuro TT, Shay DK. Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Lancet Infect Dis. 2022 Jun;22(6):802-812. doi: 10.1016/S1473-3099(22)00054-8. Epub 2022 Mar 7. PMID: 35271805; PMCID: PMC8901181. https://pmc.ncbi.nlm.nih.gov/articles/PMC8901181/
Findings
During the study period, 298 792 852 doses of mRNA vaccines were administered in the USA. VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths.