With the Pfizer BioNTech BNT162b2 vaccine and Moderna’s mRNA-1273 vaccine currently being administered to select groups, the buzz around the COVID-19 vaccine is palpable. Public response to the idea of a vaccine has also grown more favourable, with a national survey from PEW Research Center indicating that 60 per cent of Americans would definitely or probably get a vaccine for the coronavirus, up from 51 per cent in September. Yet among many people who are in line to get the vaccine, those who aren’t yet eligible, and those who are hesitant, there are questions about exactly what the side effects of those vaccines are, and how often they occur. Collectively, the companies’ clinical trials have tested more than 73,000 people and separately have produced vaccines with over 90 per cent effectiveness. The vaccines teach your body to produce an immune response, and they do have the potential for short-term side effects.
What are the side effects and how often do they occur?
Natasha Bhuyan, MD, a practising family physician based in Phoenix, AZ, says side effects from the COVID-19 vaccine were expected and they are short-lived (think a day or so).“It is entirely normal to experience some side effects with any vaccination: arm soreness, fatigue, body aches, and even fever,” explains Jay W. Lee, MD, MPH, a practising family physician based in Orange County, CA. Side effects were seen in the Moderna vaccine trials The company reported that during its Phase 3 trials it saw:
Fatigue, 9.7% of the time
Muscle aches (myalgia) 8.9%
Joint pain (arthralgia) 5.3%
Headaches 4.5%
Pain at the injection site 4.1%
Redness at the injection site 2%
Side effects seen in the Pfizer vaccine trials
Pfizer reported that during its Phase 3 trials, it saw:
Fatigue 3.8%
Headaches 2%
While the Pfizer report above focused on events that produced severe reactions greater than 2 percent of the time, the CDC reports that other side effects include:
Muscle pain 1.8%
Chills 1.7%
Injection site pain 1.4%
There were also four reported cases of Bell's palsy, which is the sudden weakness in facial muscles (think facial paralysis) on one side of the face, in each company’s trial.
A lot of these side effects aren’t really all that out of the ordinary. The seasonal flu shot, which injects the inactive virus into you to help boost immunity, for example, also has side effects, which, according to the Centers for Disease and Prevention (CDC) include soreness, redness, and/or swelling from the shot, headache, fever, nausea, muscle aches—many of which are similar to what participants in COVID-19 trials have experienced.
When these side effects occur, how long do they last?
For those who experience side effects, they don’t last very long— about 48 hours. For both vaccines, the side effects are most prominent after the booster shot. In an interview with CNN’s Anderson Cooper, one woman who was a part of the Moderna vaccine trials noted having little effect from the first vaccine, but experienced more severe symptoms (muscle, joint and bone pain), lasting for about four hours, after the booster shot.
Again, most of these reactions are normal. They mean the vaccine is doing its job, creating antibodies that will not only help your body build protection against the disease (get the full story on how they work here), but train it to fight diseases much faster. Interestingly, though, younger adults reported experiencing side effects more than older adults.
What about the allergic reactions we’ve heard about?
Trials aside, the administration of the vaccines have seen allergic reactions for some. Among the first were three Alaskans. One had an anaphylactic reaction—a severe, potentially life-threatening allergic reaction—that included a rash on her face and torso, shortness of breath and an elevated heart rate and resulted in her being admitted to the ICU.
Another experienced eye puffiness, lightheadedness, and a scratchy throat, but after being treated with epinephrine, returned to normal. Both healthcare workers experienced these symptoms 10 minutes after receiving their shot. The last also had symptoms of an allergic reaction, which consisted of difficulty breathing, swelling of the tongue, and a hoarse voice. (Three British health care workers with a history of allergies who received the vaccine also developed anaphylactic symptoms.) Morbidity and Mortality Weekly Report says that as of January 3, 21 cases of anaphylaxis were reported. Who, with allergies, should ask their doctor before getting the vaccine
The recent reactions have now prompted the CDC to include language on its website about the potential for anaphylaxis as well the recommendation that folks with a history of it, regardless of the cause, be observed for 30 minutes post-vaccine administration. (Everyone else should be observed for 15 minutes.) And per an FDA fact sheet, if a severe allergic reaction were to occur, signs would likely surface between minutes and an hour post-vaccination.
The CDC recommends that people who have had severe allergic reactions to any ingredients of the vaccines not get vaccinated with the currently available COVID-19 vaccines, and that anyone who had an anaphylactic response to the first dose shouldn't get the second.
What was discovered about allergies during the trials?
It should be noted that a document published by the FDA prior to Pfizer’s EUA did highlight that 0.63 percent of participants experienced “hypersensitivity-related adverse events.” A similar document released by the FDA prior to Moderna’s EUA revealed that 1.5 per cent of participants also experienced hypersensitivity, though “there were no anaphylactic or severe hypersensitivity reactions.” In other words, the potential for allergic reactions was always there. Though, specifically in Pfizer’s trials, it is reported that folks with a history of severe reaction to any vaccine as well as a severe allergic reaction to any part of the study interventions were not included.
What might be causing the allergic reactions
There are some reports that at a recent briefing, Peter Marks, MD, PhD, the director of the Center for Biologics Evaluation and Research (CBER) at the FDA speculated that there might be a link between allergic reactions and polyethene glycol (PEG), which is a component, though in different forms, in both Pfizer’s and Moderna’s vaccines.
Also noteworthy: In an alleged email dated September 25 from Robert F. Kennedy, Jr. and Children's Health Defense to FDA Director Steven Hahn, MD, Marks and National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD as well as several senators and people in Congress concerning Moderna’s COVID-19 vaccine, Kennedy wrote: “The use of PEG in drugs and vaccines is increasingly controversial due to well-documented incidence of adverse PEG-related immune reactions, including life-threatening anaphylaxis.” He went on to write that “roughly seven to ten Americans may already be sensitized to PEG, which may result in reduced efficacy of the vaccine and an increase in adverse side effects.”
According to Purvi Parikh, MD, an allergist and immunologist at NYU Langone, who is also a co-investigator on COVID vaccine trials, “allergic reactions are quite rare” in vaccines in general, pointing to a review study in the Journal of Clinical Allergy and Immunology which found that the rate of anaphylaxis was 1.31 per million vaccine doses. “Also, usually people are allergic to an ingredient rather than vaccine itself,” she says, noting that new CDC recommendations cite that if there’s a reaction, you should not take the second dose, and you should see an allergist for evaluation.
It's possible that the reactions weren’t all allergic reactions
“We are not 100 per cent certain all of these are allergic in nature,” says Dr. Parikh, noting that in her study they excluded those with vaccine allergies, but did include those with other allergies. “Some may be vasovagal reactions [a sudden drop in heart rate and blood pressure leading to fainting] which are common with needles and benign usually or anxiety-related as well.”
Rashid A. Chotani, MD, an infectious disease and biodefense expert and medical director and senior scientist at IEM in Morrisville, NC and HealthCentral’s resident epidemiologist, advises that “no one should say ‘no’ to the vaccine unless they have had serious allergic reactions to vaccines in the past and discuss if they have any issues with their primary care physician, as each case can be unique. The benefits definitely outweigh the risks which can in most cases be dealt with a simple epinephrine pen.”
What to Know About the New COVID Vaccine
What to know about dermal fillers and the vaccine
The FDA’s December briefing on the Moderna vaccine reported that two subjects with dermal fillers in the Phase 3 trail experienced facial swelling and a third had lip swelling. These people received their injections at different time periods prior to their Moderna vaccinations, ranging from two weeks to six months. (At this time there have been no reports of similar incidences with the Pfizer vaccine.)
They’re among the 2.7 million people who received dermal fillers in 2019 (99,783 were men), according to the American Society of Plastic Surgeons. Many experts think there’s no need to furrow those smoothed-out brows over the vaccine/fillers association just yet, especially considering three adverse reactions in a trial of 30,000 plus people is only about.0001 per cent, explains Sola Fasusi, MD, a Miami-based plastic surgeon. “That is an incredibly small percentage,” he says.
It’s a mild concern, rather than a major one, says Aisha Baron, MD, a board-certified plastic and reconstructive surgeon and owner of Breast Body Beauty Plastic & Reconstructive Surgery in Marietta, Georgia. While experts are unsure of what exactly is causing these adverse reactions, there are theories. Vaccines are designed to teach the body to respond to foreign material, and some people’s bodies may see the injectable as foreign, she says.
And it’s not the first time there have been reactions to vaccines among people with fillers. Although all eyes are on COVID vaccines, it’s important to understand that there have been similar issues linked to other vaccines, including the flu vaccine, says MH dermatology advisor Corey L. Hartman, MD. In fact, it was reported that the patient with lip swelling had a similar reaction after receiving the flu vaccine previously. “It seems to be mediated by a cytokine cascade that is specific to the patient and not to the vaccine,” he says. Another interesting discovery: A 2019 study in Clinical, Cosmetic and Investigational Dermatology revealed that some people who’d had the flu or a flu-like illness had reactions—swelling, redness, and hardness—in the places on their bodies where they’d previously had hyaluronic acid fillers.
Sometimes this type of reaction even happens on its own when fillers are placed, Dr. Hartman explains. For people who had this filler site reaction in the Moderna vaccine trial, the issue either resolved itself, or patients were treated with antihistamines and/or steroids (common treatments). Dr. Fasusi agrees, mentioning that “all you can probably safely say at this point is that the reactions that we’ve seen with people who happen to have dermal fillers have been relatively mild and easily treatable.”
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