South Florida Sun-Sentinel (Sunday)
Vaccine reactions, from mild to major
People report effects after getting shot
COVID vaccinations have been going into the arms of Floridians for six weeks, and initial reports from people who receive the shots suggest wide-ranging adverse effects — from fevers to strokes — are limited but can be significant.
Some of the most crucial revelations focus on how seniors — studied minimally in trials but considered a priority in Florida — are reacting to the vaccine. So far, reported side effects range from the common such as fever, chills and headache to the more serious including chest pains, palpitations and stroke.
The Centers for Disease Control and Prevention has a team assigned to investigate all reported reactions, plow through medical records, and identify any patterns. Floridians have made 417 reports of COVID19 vaccine “adverse events” through Jan. 22, out of more than 8,500 nationwide.
The CDC also is investigating 16 deaths in Florida that occurred shortly after the individuals received their vaccination. Those individuals range in age from 56 to 94, and 13 died within two days of receiving a vaccine. Only one had received a second dose, according to reports in the national Vaccine Adverse Event Reporting System.
“Every death reported
will be investigated to determine the cause,” said Martha Sharan, a CDC spokeswoman.
The 56-year-old was a South Florida doctor who had a blood platelet count far below normal ranges and died in the hospital two weeks after receiving a first dose of a Pfizer COVID-19 vaccine. A spokesman for Pfizer said the company is investigating but does not at this time believe “there is any direct connection to the vaccine.”
“It is important to note that serious adverse events, including deaths that are unrelated to the vaccine, are unfortunately likely to occur at a similar rate as they would in the general population,” the Pfizer spokesman told the Sun Sentinel.
People who receive the vaccine are asked to report any reaction they believe could be linked to the shot into a national database.
At the time shots are given, a healthcare worker observes the recipient for
15 to 30 minutes. Then, it is up to the senior care facility, hospital, pharmacy or the person receiving the shot to report a reaction potentially linked to the vaccination.
Many of the most severe reactions reported so far affected people older than
75 who had multiple underlying conditions, including cardiomyopathy, angina, dementia, Alzheimer’s, diabetes, diverticulitis, hypertension and COPD.
Based on self-reported reactions as of Jan. 22, the vaccine reaction tracking database includes this information:
8,523 COVID-19 vaccine adverse event reports in the U.S.
417 COVID-19 vaccine adverse events reports from Florida
329 deaths in the U.S.; 213 are individuals 65 or older.
Sixteen deaths in Florida;
13 are individuals 65 years or older.
648 hospitalizations in U.S.; 26% are 65 or older
50 hospitalizations in Florida; 46% are 65 or older
Reported reactions represent a small fraction of total vaccinations. Since vaccine distribution began in the U.S. on Dec. 14, more than 26 million doses have been administered, including 1.8 million in Florida.
“Remember for the most part we are vaccinating older people at higher risk of many things including death,” said Dr. Marrissa Levine, director of the Center for Leadership in Public Health Practice at the University of South Florida. “We can’t draw conclusions early in the process.”
Allergic reactions such as anaphylaxis, a potentially life-threatening reaction, have grabbed most of the headlines thus far, but still are rare. Nationwide there have been 60 cases of anaphylaxis reported after either COVID vaccine, with the median start of symptoms roughly 7½ minutes after injection.
“Our safety system rapidly detected these reports of anaphylaxis, and the CDC and FDA are in the process of assessing this,” Tom Shimabukuro, the CDC’s Vaccine Safety Team Lead, said during a recorded call with healthcare providers. “It is early, and we will continue to communicate with the public and healthcare providers.”
Floridians of all ages reported adverse reactions that included chest discomfort or pain, palpitations, difficultly breathing, increased blood pressure. tremors, pain in extremities and throat tightness or swelling.
Shimabukuro said along with self-reports, the CDC and FDA also will look at health data from large providers and Medicare to monitor vaccine reaction and safety.
Florida’s vaccination strategy
From the time vaccines became available in December, Florida has been at the forefront of giving them to seniors, and Gov. Ron DeSantis has deemed longterm care facilities, senior living communities and anyone older than 65 eligible for immunization.
Sixty-nine-year-old Debbie Millheiser of Plantation said she received her second dose this week and had no fear of a reaction. “You need to think of the outcome,” she said. “The risk is better than if you don’t get the vaccine.”
Millheiser said she has friends who had headaches or chills after vaccination, but she felt only tiredness, and only after the second dose. A retired hospital worker, Millheiser said even after H1N1 vaccines, older people had more reactions.
“They are at higher risk due to their immune systems and comorbidities. They have more issues than someone fairly healthy,” she said. “But they should still get vaccinated, and that’s what we need to get across.”
More research suggested
Scientists say the frail and elderly need to be studied more when it comes to the COVID vaccine — a study that likely will happen in real time. In Florida, more than 1.8 million people have now been vaccinated — about 450,000 are older than 75.
Dr. Roy Soiza, a researcher on the aged at the University of Aberdeen in the United Kingdom, said this group of extreme elderly and frail generally was a small part of clinical trials for the COVID vaccine, despite being earmarked as the earliest recipients in the national vaccination program.
According to self-reported data, at least 20 of the 329 deaths following vaccination reported so far in the U.S. were people who were in hospice, including a 76-year old man in Florida who passed away at his senior living facility on Jan. 8 — two days after receiving the Pfizer BioNTech shot. At lea three dozen people who died had COVID-19 just weeks before getting vaccinated, or they had been exposed to the virus.
“With more information, we could figure out ways to mitigate side effects,” said Dr. Zucai Suo, a professor of biomedical science at Florida State University. “We don’t have a clear picture of which things might be going wrong. At the moment, I’m not sure what this population is experiencing is any different a reaction than if you gave them the placebo.”
The Food and Drug Administration, which issued the Emergency Use Authorization to allow the two COVID vaccines — from Pfizer and from Moderna — to be given out in the United States, said it, too, will review each case of a serious adverse reaction.
“Any reports of death following the administration of vaccines are promptly and rigorously investigated jointly by FDA and CDC,” FDA spokeswoman Alice Hunt said.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, says only a fraction of people report their vaccine reactions. She also noted that one federally funded 2011 study found that less than 1% of vaccine-related reactions are reported to the national database.
“The COVID-19 vaccines were fast-tracked to licensure,” Fisher said “If timely vaccine adverse event reports are not made to VAERS as these new vaccines are rolled out to millions of people in the U.S., federal health officials cannot fully evaluate emerging vaccine reaction patterns or identify red flags that may not have been picked up in clinical trials.”
Already, anti-vaccination groups are blaming patients’ reactions on COVID shots, even while there is no direct link.
Norway made international headlines this month after revealing that more than 30 people — all over
70 and all already sick — died shortly after being vaccinated against COVID19. Norway Prime Minister Erna Solberg said in an interview with Bloomberg Live that the country may no longer give vaccines to the most vulnerable of the elderly “because that might speed up a process where they were, what we would say, at the end-of-life phase anyway.”
Coming out of clinical trials, Moderna and Pfizer BioNTech reported some common side effects of the COVID vaccines, which typically lasted several days; those included pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea, vomiting, and fever. The manufacturer said more people experienced these side effects after the second dose than after the first dose.
“Those are the most known from the trials,” Sharan of the CDC said. “But we still don’t know all the effects and some may be based on medical conditions, age and fragility. That’s why we are encouraging people to report. We are watching closely.”