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COVID-19 vaccine side effects & deaths: The lack of information on how, where to report

By Heidi Hatch 

Like many others, Eunjin Kim felt like she’d been hit with an instant case of influenza after getting her second shot of the Moderna COVID-19 vaccine.

I was laying there with a down comforter and with the electric blanket and still shivering,” Kim said.

Carissa Spencer didn’t have to wait for her second shot of the Pfizer vaccine to feel like something wasn’t right. She had swelling that moved down the right side of her body.

“I was extremely nervous, it wasn’t very attractive at all,” Spencer said.

Eunjin Kim, Carissa Spencer, and Cari Banks are some of the Utahan’s who’ve experienced side effects after getting first or second doses of the COVID-19 vaccine. (KUTV)

Cari Banks also received the Pfizer vaccine. Hours after getting the first shot, she was rushing to the nearest hospital. Four days and two emergency rooms later, Banks was released from University of Utah Hospital.

I got up there and coded again and they brought me back down. All the breathing and wheezing had ruptured my vocal cord.”

By now, you’ve probably heard from friends and family who’ve received at least one dose of a COVID-19 vaccine. Some feel nothing beyond a prick or a sore arm; others have likely warned you to take a sick day or maybe two after each shot.

The question now, how many of those experiencing side effects are reporting them?

KUTV: Heidi Hatch investigates the vaccine side effects reported in Utah and the confusion over how and where to report those to the scientists making critical decisions about COVID-19 vaccines.{ }

https://kutv.com/news/coronavirus/covid-19-vaccine-side-effects-deaths-the-lack-of-information-on-how-where-to-report?video=fd6f0f8684c04e65970f33592037a248&jwsource=cl
A recent report in The New York Times looked at the issues that have followed the vaccine rollout, including the lack of follow-up in documenting side effects after COVID-19 vaccines.

For now, federal regulators are counting on a patchwork of existing programs that they acknowledge are inadequate because of small sample size, missing critical data or other problems,” reporter Sheila Kaplan wrote.

Nationally, there have been very few reports on possible side effects and where to report them. Here in Utah, guiding people to the right resources post vaccine has not been a priority. Utah’s coronavirus website lists a few possible side effects, but does not provide links or a guide for vaccine recipients on where or how to report in the event they experience side effects.

With so many people getting the same vaccines all at once, most people are hearing post vaccine experiences varying from mild, to terrifying. For a growing number here in Utah and across the country, the COVID-19 vaccine taken to save a life put them dangerously close to losing their own.

Nationally, there have been very few reports on possible side effects of the COVID-19 vaccines and where to report them. (KUTV)

While the COVID-19 vaccines will save lives, the three COVID-19 vaccines currently available in the U.S. were brought to market in record time and are currently only approved for emergency use. Reports of adverse events will be paramount in improving vaccines in the weeks, months and possibly years to come.

VAERS

The CDC’s “Vaccine Adverse Event Reporting System” was created in 1990 as an early warning system to detect possible safety problems in U.S.-licensed vaccines, and yet 30 years later, most people have no idea it exists.

With nearly half a million doses now in arms in Utah, as of this publication only 114 reports of adverse events from Utah have been made to VAERS. The number seems “reasonable” to Utah Department of Health director of immunizations Rich Lakin. (Note: There were 88 reports to VAERS at the time of Lakin’s interview with 2News.)

The adverse event reports made to VAERS in Utah and across the country are extremely low compared to how many anecdotal reports there are of people getting sick after receiving the vaccine.

The personal experiences an individual might see online about vaccine side effects are likely only coming from their close circle of friends and family. Currently, Facebook has blocked searches for vaccine side effects. The only way to see the first-hand accounts is if the post comes from a friend. Otherwise, a search will result in a list of approved information from the World Health Organization or the CDC.

(Facebook, on what they are blocking: about.fb.com/news/2020/12/coronavirus)

Even with filters in place, there are plenty of accounts from friends and family members reporting everything from flu-like symptoms to heart attacks and even miscarriages after receiving the vaccine.

A local Utah ICU nurse and expectant mother posted her vaccine experience on the Intermountain Moms Facebook group:

A local Utah ICU nurse and expectant mother posted her vaccine experience on the Intermountain Moms Facebook group. (Screengrab from Facebook with poster’s name blurred / KUTV)

“I am an ICU nurse,” the woman, whom 2News is not identifying, wrote. “I am highly exposed to COVID patients. I am a firm believer in vaccines. I felt strongly that I needed to get the vaccine. Unfortunately, I found out that baby girl no longer had a heart beat last week. The size of baby at time of miscarriage correlates within a few days of my first dose of Pfizer vaccine. We had already heard baby girl’s heart beat and were told that we had a less than 5% chance of miscarriage. I will never know if it was the vaccine, but I will always wonder. I am now fully vaccinated, but with my experience I don’t think I would do it again.”

While official reports to systems like VAERS are low, Utahan’s are still seeing serious side effects. Cari Banks is one who ended up not just in the emergency room, but in the ICU for three days.

ANAPHYLAXIS

“I couldn’t process the air fast enough,” Cari Banks said.

The 62-year-old mother and grandmother works for the University of Utah Health system and was one of the first to receive the vaccine. She got her first and only dose of the Pfizer vaccine on Jan. 11.

She had an appointment to get the shot at 11 a.m. Banks said it was a smooth process, where she was in and out in no time.

Cari Banks also received the Pfizer vaccine. Hours after getting the first shot, she was rushing to the nearest hospital. Four days and two emergency rooms later, Banks was released from University of Utah Hospital. (KUTV)

Back at home where she was working, her stomach started to feel queasy, like she was getting a stomach bug. Three hours later, she was struggling to breathe. She described the feeling as having a heavy weight on her chest.

“It started out as asthma-type wheezing and being able to get enough (air) in and out,” Banks said.

From there, her struggle to breathe “sky rocketed.” She called her partner, saying she needed to get to the hospital. They started out with the goal of getting to the University of Utah, but stopped at the nearest ER as Banks started to feel like she was “dying.”

“They asked me, did I eat anything?” Her reply, “the only thing different is I had the COVID vaccine that day,” Banks recalled.

Banks said she was treated at her local hospital with epinephrine, a drug used for asthma attacks and allergic reactions. After several hours of breathing treatments, the EpiPen and Benadryl, she was exhausted but breathing easier and sent home for the night.

By 10 a.m. the next morning, she was in distress again. This time, they went straight to the University of Utah trauma center.

Cari Banks ended up in the University of Utah trauma center after her first and only dose of the Pfizer COVID-19 vaccine. (KUTV)

“I immediately went to the COVID-ICU,” she said. Once there, “they did the swab and determined it wasn’t COVID, but it was a reaction to the shot or vaccine.”

Once stabilized, Banks said she was moved to another floor. The move was short lived.

“I got up there and coded again and they brought me back down,” Banks said, using the hospital slang term “coded” to describe when a patient experiences a cardiopulmonary emergency.

All the breathing and wheezing had ruptured my vocal cord,” she said.

Banks spent three days in the ICU. A month-and-a-half later, she’s working to get her strength and her voice back. Sleep is another thing she’s not getting enough of as she fights post-traumatic stress and the worry she will stop breathing if she goes to sleep.

While Banks’ allergic reaction is rare, Dr. Tamara Sheffield, a vaccine specialist with Intermountain Healthcare, said there are more allergic reactions than expected from the trials.

“In terms of what is higher than we would see in other vaccines, anaphylaxis is moderately higher,” Sheffield said.

Dr. Tamara Sheffield, a vaccine specialist with Intermountain Healthcare, said there are more allergic reactions to the COVID-19 vaccines than expected from the trials. (KUTV)

Sheffield has been keeping close tabs on the vaccine rollout and says, “it is very rare to have a severe allergy of anaphylaxis.”

For vaccines in general she says we see one anaphylactic reaction per 1.5 million who receive a vaccine. The number of reactions, she says, have been higher with the new COVID vaccines.

“With Pfizer, we are getting five per million doses who have an anaphylactic reaction and for the Moderna, 2.8 reactions per million doses,” Sheffield said.

Because there were severe reactions in the first few weeks of the rollout, vaccination centers prepared for the possibility of more reactions.

The nice thing is we are careful to give these vaccines in medical settings where we can administer medications for anaphylaxis,” said Sheffield.

Now, at most vaccine locations recipients have to wait 15 minutes before they are cleared to leave. Unfortunately for Banks, it wasn’t until hours later and at home when her body started to show signs of a severe reaction.

NEW CDC GUIDELINES ON WATCHING FOR ANAPHYLAXIS POST COVID-19 VACCINE

Rich Lakin, the health department’s immunizations director, sat down to discuss what he is seeing in terms of reactions and side effects to the new vaccines.

As he talks to people who’ve had the vaccine, he expects they are going to tell him “they have side effects, but that is a natural response,” Lakin said.

All medications, he said, have side effects, and “everyone is going to have a different response.”

Rich Lakin, the health department’s immunizations director, sat down to discuss what he is seeing in terms of reactions and side effects to the new vaccines. (KUTV)

With so many people responding differently to the vaccine, many at home are wondering if anyone is tracking this information to make the vaccines safer. Lakin said the state is asking everyone to report to VAERS.

Reporting to VAERS is a reasonable expectation when you work in the business of vaccines, and yet the Vaccine Adverse Reporting System hasn’t been mentioned — let alone a main topic at a news conference about the virus in Utah to date. The state, local hospitals and local health departments hold regular COVID-19 updates, and there has yet to be a focus on where people should report vaccine side effects.

Each health department does have a handout for people as they arrive or leave after their vaccine appointment. The handout in Salt Lake County lists possible side effects and several places where you can go if you do get symptoms. There’s a number for the vaccine manufacturer, the new v-safe reporting system rolled out with the new COVID-19 vaccines, and a web address for VAERS.

Banks has not yet made a report to VAERS, assuming “the hospital just reported it.”

The CDC’s “Vaccine Adverse Event Reporting System” was created in 1990 as an early warning system to detect possible safety problems in U.S.-licensed vaccines, and yet 30 years later, most people have no idea it exists. (KUTV)

Lakin said the caregiver, the hospital and the patient should all be reporting reactions to VAERS, the main clearinghouse and tool where people should gravitate.

VAERS is an important but imperfect tool. It relies on individuals to report and document their experiences. The VAERS system gathers information; it does not determine if a vaccine caused the reported health problem. It can, however, show unexpected or concerning patterns for researchers, doctors, and drug manufacturers.

Lakin receives a weekly VAERS report from the CDC on Utah cases. From those reports, Lakin said health officials are seeing mostly “swollen arms, headaches, fevers, there are some with severe reactions.”

It’s up to the person who feels those things to decide if they are worth reporting.

FLU-LIKE SYMPTOMS

Eunjin Kim, an occupational therapist in Salt Lake County, said the first shot was nothing more than a sore arm. The second shot knocked her out with 102-degree fever, a nasty headache, and body aches.

Kim said her coworkers warned her to be ready, saying, “ooh, the second shot is bad.”

Eunjin Kim receives her second shot of the Moderna COVID-19 vaccine. (Photo provided by Eunjin Kim)

You hear that, she said, and “I’m like, I’m a tough girl, I can do this.”

She got through it, but had a rough 24 hours.

“If this is even a bit of what people with COVID feel,” she really feels for them, Kim said.

SWOLLEN LYMPH NODES

Carissa Spencer, a single working mom, reacted to the first shot. She experienced swelling down the right side of her body.

“It was the same arm that I had gotten the shot on,” Spencer said.

The next day “it was more swelling — to my back, where you could push it — and the next day it had moved even further down on my body.”

Carissa Spencer, a single working mom, reacted to the first shot. She experienced swelling down the right side of her body. (KUTV)

She had a pouch of fluid that was nerve-racking. Working from home, she didn’t have her co-workers in a cubicle to ask if what she was experiencing was normal or if she needed to get help.

She got her shot in Salt Lake County and “called the number on the paper they gave us for Pfizer.” She explained what was happening and asked if it was normal. Pfizer told her to call and report to another number, where she got a recording, Spencer said.

Days later, Spencer went to urgent care, where she was told the swelling was in her lymph nodes — something that is now a known and common side effect.

Swollen lymph nodes have become so common, local hospitals held a news conference in Utah asking women to avoid getting mammograms for several weeks after getting the COVID-19 vaccine so the swollen lymph would not raise concerns of cancer.

DOCTORS: WAIT FOR MAMMOGRAM AFTER GETTING TO COVID VACCINE

Spencer did everything right. She called the numbers the county provided, used the new v-safe app, and yet she got the runaround.

Kim was vaccinated at her place of work and was given a piece of paper where she could report symptoms back to her employer — not to VAERS, as the state is recommending.

As of March 3, the CDC has received reports of 97,458 adverse events with 1,381 deaths in people who have taken at least one dose of the approved COVID-19 vaccines. (KUTV)

People in Utah either don’t know they should be reporting or, when they do, don’t know where to go. There is no one clearinghouse where everyone getting a shot is being directed to report side effects.

As of publication, the CDC says 2 million people have signed on to use the newly rolled-out v-safe smart phone tool where you get daily prompts to answer questions about how you feel. Two million is, however, a miniscule number compared to the nearly 25 million people fully vaccinated and a total of 76 million doses administered in the United States as of March 1. The vast majority of those vaccinated have chosen not to use the CDC’s new v-safe reporting system.

“V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. Through v-safe, you can quickly tell CDC if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you and get more information. V-safe will also remind you to get your second COVID-19 vaccine dose if you need one.” – CDC

V-SAFE

A CDC spokesman said the v-safe app is being merged into VAERS. 2News cannot verify if that is, in fact, happening.

Spencer said she reported through both v-safe and VAERS but, as of publication, there’s no evidence of a report that matches her reported side effects. Neither system contains personal information and only VAERS can be searched through a CDC program called Wonder.

All three women who told 2News their stories out of the desire to educate others on possible side effects, what is normal, and how to report symptoms.

Spencer’s lymph node swelling subsided and she received the second dose without issue. She has not yet decided if her son will get the vaccine when it is approved for children. She does look forward to her new-found freedom with a stamped vaccine card so she can travel again.

   Eunjin Kim at her job as an occupational therapist in Salt Lake County. (KUTV)

Kim said the vaccine was worth it for the peace of mind it gives her at work, as she works up close and personal with her patients.

Banks, who suffered a life-threatening event, will not receive a second vaccine and said she will avoid boosters if they eventually come out on a yearly basis as well.

As the COVID-19 vaccines are developed and ultimately approved for non-emergency use, or even possibly taken off the market, information from VAERS and everyday people will guide those decisions.

The only way we get good data is if people report into VAERS,” Lakin said. “Our number one concern in public health is safety.”

Report an Adverse Event to VAERS: Click here. If you need assistance with reporting to VAERS, email info@VAERS.org or call 1-800-822-7967.

ADVERSE EVENTS AND DEATHS

As of March 3, the CDC has received reports of 97,458 adverse events with 1,381 deaths in people who have taken at least one dose of the approved COVID-19 vaccines. (Those statistics are constantly changing.) Four of those reported deaths were made in Utah through VAERS either by caregivers or loved ones of those who received at least one dose of a COVID-19 vaccine.

Deaths in Utahan’s Who’ve … by Alyssa Roberts

Dr. Sheffield with Intermountain notes the CDC has reported “they have no known deaths caused from vaccine.”

“We have individuals in these age groups who, because of age, many of them pass away after having the vaccine,” Sheffield said. “We need a real clear distinction on that.”

In Utah, four deaths have been reported; the first three are older Utahan’s in the same high-risk category as those at most risk of dying from COVID-19.

In Utah, 500,000 COVID-19 vaccine shots have been administered, with 114 reports of side effects and four reported deaths of people who had gotten a shot. (KUTV)

The fourth and most recent death was reported by the father of a 39-year-old single mother who had no known health issues before receiving the shots in early February.

Sheffield explained the difference in numbers of deaths reported (1,381) and the CDC’s statement of “no vaccine deaths,” saying it comes down to what can and can’t be proven.

“You have to look at what it (the numbers) are saying,” said Sheffield.

Is it saying the vaccine caused the deaths, or there were deaths in people who received vaccine? And those are two very different things.”

It is important to note that if you are injured by a COVID-19 vaccine you cannot sue for damages. In February, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act. The law, created in 2005, provides legal protection to U.S. companies making or distributing medical supplies like vaccines unless there is “willful misconduct” by a drug maker.

There is a National Vaccine Compensation program for all U.S. vaccines, but it does not appear the new, not fully approved COVID vaccines are eligible for submission. If you have questions, visit: www.hrsa.gov.

“In very rare cases, a vaccine can cause a serious problem, such as a severe allergic reaction. In these instances, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.” – Health Resources and Services Administration.

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