Adverse Event Archives

As of today, there are 6,183 COVID-19 vaccine related deaths in the United States according to the CDC’s VAERs website. We as health care providers are required to report vaccine related injury to the VAERs site.

And, yet, when we site this data (being the ONLY DATA available to us as clinicians required to make judgement calls in real time on the use of these vaccines) we are labeled “conspiracy theorists.”

Many of you have been very vocal, threatening me and stopped following my social media channels recently,: “Dr. Nally, why do you keep harping on this vaccine risk issue? I used to trust you . . .”

In fact, Facebook has consistently blocked me from doing any “live-streaming” for the last six months. They keep finding posts from 1-2 years ago that “violate community standards” and extend my ban on live-stream posting privilege’s.”

The Answer: Because, two more of my patients have been hospitalized with life-threatening blood clots in the lungs after vaccination, both of which have never had any history of clotting problems. “Houston, THIS IS A PROBLEM! Are you listening?!”

https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6D180E77E02D9533F8867A5708ED

Are there errors in public reporting? Of course. That is to be expected. However, some researchers that use these data sets state that VAERs reporting may be under-reported generally by up to a factor of 5. That means that the number of vaccine related deaths could between 6,000 – 39,900 as of today.

Of course, Reuters.com, FactCheck.org and Snopes.com have no medical malpractice risk looming over their heads when they make their “fact checking” statements, nor do they have the life and health of a family member depending on their recommendations sitting in front of them in the exam room.

So, you be the judge. Just remember, the Swine Flu vaccine got pulled off the market after 450 cases of Guillain-Barre Syndrome (GBS) appeared and 3 deaths in elderly patients were reported within days of vaccination (https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html).

Influenza and Menactra vaccines increase the risk of GBS by 2 per 1,000,000 doses (https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html).

Currently the CDC admits that COVID-19 vaccines have been directly implicated in:

Blood Clots (life-threatening thrombosis and thrombocytosis syndrome) like blood clots in the lungs occur in 7 per 1,000,000 vaccinations.

Anaphylaxis occurs in 5 per 1,000,000 vaccinations.

Guillain-Barre Syndrome (GBS) has occurred in 137 patients vaccinated.

Myocarditis/Pericarditis has been confirmed in over 700 cases of those vaccinated. (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html)

It is hard to imagine a more dangerous and asinine way of making decisions than by abdicating those health decisions into the hands of people who pay no price for being wrong.

So, for a virus that has a 99.98% unvaccinated survival rate across the US population, is the risk of giving up your freedom of choice worth taking?

Well, that’s really your choice. My job as your physician is to give you the pros and the cons. That’s what I’ve done. You’ve probably already commented to me about how you either agree or disagree with me. That’s OK. Because, unlike many other medical professionals, I’ve done my job.

Now, you need to decide, is the risk of a mandated vaccine worth defending your freedom over, or do you give up this hill, tuck your tail between your legs, roll up your sleeve and then retreat?

As for me, I may be alone, but I’m standing on this hill. You’re going to have to bury me to take it.

There is a great deal of interest in the otolaryngology (ENT) community and the general medical community at large with the perception that hearing loss rates have increased after COVID vaccinations. The American Academy of Otolaryngology-Head and Neck Surgery estimates that sudden sensorineural hearing loss affects 5 to 27 per 100,000 people annually, with about 66,000 new cases a year in the U.S.

Estimates of sudden sensorineural hearing loss after COVID-19 vaccination ranged from 0.3 to 4.1 per 100,000 per year based on the recent Vaccine Adverse Events Reporting System (VAERS) data according to Eric Formeister, MD, MS, of Johns Hopkins University School of Medicine in Baltimore, and co-authors in JAMA Otolaryngology-Head & Neck Surgery.

“Among the otolaryngology community and larger medical community, there is a lot of interest surrounding a perception of an increased rate of sudden hearing loss that has been observed in some patients after COVID vaccination,” Formeister told MedPage Today.

“However, sudden hearing loss can also occur naturally, so it is not known whether sudden hearing loss occurring after COVID vaccination is coincidental or may be related to the vaccine,” he added. “Further, some patients who have suffered sudden hearing loss after the first dose have been hesitant to receive the second dose due to safety concerns.”

Formeister and his colleagues found 147 reports of sudden hearing loss, deafness, deafness unilateral, deafness neurosensory, and hypoacusis associated with COVID vaccinations from December 14, 2020 to March 2, 2021 in the VAERS system.

However, Formeister and MedPage Today downplayed these 147 reports, stating that of these reports, only 40 had a temporal association (hearing loss onset occurred within 3 weeks of vaccination). Because of how they were reported only these 40 were considered high credibility (they had been reported by a healthcare clinician with documented audiologic findings or steroid treatment). Formeister states that these 40 reports were classified as “most likely.” However, the Johnson & Johnson vaccine was not included in this report.

The mean age in the most likely group was 56 years old, and most cases (63%) involved women. Twelve people received Moderna vaccines and 28 received Pfizer. Sudden sensorineural hearing loss occurred an average of 4 days after vaccination. Thirty of the 40 cases were treated with steroids.

Based on about 86 million SARS-CoV-2 vaccine doses that had been administered in the U.S. during the study period and using only the 40 most likely reports, the researchers estimated a minimum incidence of 0.3 per 100,000 per year, assuming a single vaccine dose per person.

Maximum incidence using all 147 accounts in the VAERS database, based on two vaccine doses per person in the time period, was estimated to be 4.1 per 100,000 per year. This took into account the fact that the exact number of unique individuals receiving a vaccine was unknown.

Formeister states that “These results so far provide evidence that COVID vaccination is not associated with sudden hearing loss” because it is statistically identical to the rate of hearing loss seen in the general public each year.

“One of the pushes behind this publication is to urge clinicians and patients alike to report adverse events to the Vaccine Adverse Events Reporting System, so we may accrue more data to allow a more accurate prediction of the rate of sudden hearing loss after COVID-19 vaccination,” he noted.

If you experience hearing loss symptoms after vaccination should contact their healthcare provider immediately. Sudden sensorineural hearing loss is potentially treatable, but treatment efficacy is time-sensitive.

The reporting period did not include vaccines other than Pfizer and Moderna, the researchers acknowledged. VAERS reports are unverified and subject to underreporting bias. Because people may experience multiple adverse effects after vaccination and these may not be fully captured in VAERS and the reports of hearing loss may be more that we are aware.