FDA: Vaccine Administrators "Must Report" Adverse Events Following Pfizer's Bivalent Booster. NB, "Must Report" means "Mandatory, NOT Optional"
To ignore the FDA's mandate from last December that requires they report adverse events to VAERs after the administration of COVID-19 vaccines is medical malfeasance.
Physicians, pharmacists, and anyone administering COVID-19 vaccines MUST report all serious adverse events that follow the injections - and it’s not optional.
The FDA’s Dec 8, 2022, Fact Sheet for Healthcare Providers Administering (COVID-19) Vaccine contains some language that might be overlooked by some physicians who may believe they should only report vaccine adverse events that have already been attributed to the jabs. The purpose of post-EUA surveillance is to pick up any serious adverse events that may have been missed in the relatively smaller early clinical studies (if indeed any were done before EUA authorization):
“SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of myocarditis, cases of pericarditis, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to recipients.
* Serious adverse events are defined as:
A life-threatening adverse event;
Inpatient hospitalization or prolongation of existing hospitalization;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
A congenital anomaly/birth defect;
An important medical event that based on appropriate medical judgement (sic) may jeopardize the individual and may require medical or surgical intervention to prevent 1 of the outcomes listed above.
It is worth noting that healthcare providers must report these events both to VAERS (the Vaccine Adverse Events Reporting System) and to Pfizer.
Pfizer then must report the data to the FDA - and, importantly, if any adverse event(s) not detected earlier in clinical studies occur at a concerning rate, the FDA has the power to send Pfizer back to the drawing board to do randomized controlled trials to address the signal of risk.
Anyone can report their adverse health outcome, or the death of a loved one, to Pfizer, and Pfizer must report these to the FDA. One can certainly CC the FDA in their report: and this is in addition to, not instead of, making one’s report to VAERS.
Give a gift subscription of Popular Rationalism to a COVID-19 Administering physician to make sure they know their obligations to the FDA.
How do we get them to do it?
I don't understand why it took them almost 3 years to publish this mandatory reporting. Very few doctors are going to cull through their patient records and retroactively report patient reported adverse reactions. The FDA is trying to cover it's tracks now.