Injection site redness was the second most frequently reported local reaction. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Some people who have received a dose of the Moderna COVID-19 vaccine are having a delayed reaction that causes a red, and sometimes bumpy rash on the arm. For both age groups, fatigue, headache and new or worsened muscle pain were most common. Data source: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA. Weitere Informationen ber die Verwendung Ihrer personenbezogenen Daten finden Sie in unserer Datenschutzerklrung und unserer Cookie-Richtlinie. No rash or skin itching. Data on systemic reactions were not solicited from persons aged 16-17 years. Researchers Urge Greater Awareness of Delayed Skin Reactions to Moderna COVID-19 Vaccine. For the most recent updates on COVID-19, visit our coronavirus news page. The side effects mean your body is working hard to build the antibodies and cells it will need to fight the virus, if or when you are exposed to it. Consideration for the Pfizer or Moderna vaccinations with a premedication plan? Redness was reported slightly more frequently in the older age group than the younger age group (10.9% vs 7.5% after dose 3). 5 Min Read. Opinions expressed by Forbes Contributors are their own. Since the first months of the vaccination campaign in various continents, there has been a certain number of reports of adverse events, including skin reactions. We take your privacy seriously. Vaccine recipients reported similar rates of local reactions after dose 1 and dose 2, but slightly lower after dose 3. You will be subject to the destination website's privacy policy when you follow the link. The reaction usually occurs "within several days after COVID-19 vaccination," but not immediately after like an allergic reaction, the CDC says. The time or intensity with which peoples immune systems respond to vaccines can differ based on many factors. However, their reactions to vaccination are expected to be similar to those of young adults who were included. Why does moving your sore arm after a vaccine help relieve the discomfort? Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). Thank you, {{form.email}}, for signing up. a Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. Opens in a new tab or window, Visit us on Twitter. Other defenses are implemented by T cells, another type of immune system cell, and monocytes/macrophages. Local reactions, systemic reactions, adverse events, and serious adverse events: Pfizer-BioNTech COVID-19 vaccine. 4 Some less common side effects include nausea and swollen lymph nodes (especially in the armpit). A systemic allergic reaction to a vaccine occurs in one or more parts of the body beyond the injection site. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Fever was more common after the second dose than after the first dose. Jacqueline A. Pongracic, MD, FAAAAI. According to the FDA's vaccine fact sheet, typical side effects of the Pfizer-BioNTech vaccine include: tiredness headache fever chills muscle or joint pain nausea diarrhea swollen lymph. Local reactions, systemic reactions, adverse events, and serious adverse events: Pfizer-BioNTech COVID-19 vaccine. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. In a small new study of 16 people who said they'd experienced an allergic reaction to a dose of the Pfizer vaccine, those who got a follow-up placebo (fake . We know from the CDC that is so rare and it's in the range of 1 to 5 per million people depending on which vaccine you get with the Pfizer or the Moderna." Both medical experts pointed out. Both conditions are triggered by the immune system's reaction to an infection, injury, or . The median onset of local reactions in the vaccine group was 1 to 2 days after either dose and lasted a median duration between 1 and 2 days. Pain at the injection site, a headache and feeling tired and fatigued. Consideration for switching to the Johnson & Johnson vaccine? "We clearly have an imbalance there," Tom Shimabukuro, MD, the deputy director of the CDC's Immunization Safety Office, said during the meeting, as reported by Reuters. Most people have a sore arm right after being vaccinated, and more body-wide effects like fever and chills within 8 to 12 hours. In the Pfizer-BioNTech vaccine trials, more than 77% of participants reported at least one systemic reaction. If you dont have a significant other, this shouldnt be the only reason to find one. But unlike allergic reactions these symptoms do not usually get worse with time, he said. Some people are having delayed reactions to their first dose of a COVID vaccine, with their arms turning red, sore, itchy and swollen a week or so after the shot. Adverse events can range from soreness at the site of injection or a slight fever to more serious issues, such as severe allergic reactions. Local reactions were reported by half (48%) of vaccine recipients and at higher rates than placebo recipients. So can having your significant other repeatedly tell you that you dont look that bad. Wenn Sie Ihre Auswahl anpassen mchten, klicken Sie auf Datenschutzeinstellungen verwalten. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients. Thirteen of the 16 study participants went on to receive a third, unblinded booster dose of the mRNA vaccine in the supervised medical setting, and 10 developed symptoms consistent with ISRR, with a median symptom onset of 7 minutes. A viral Facebook post has repeated misinformation that people vaccinated against COVID-19 will suffer from overactive immune responses called cytokine storms. Having a delayed skin reaction to one dose of the Covid-19 vaccines doesn't mean you should avoid subsequent doses like the booster either. Verywell Health's content is for informational and educational purposes only. Delayed urticaria following a COVID-19 vaccine Acute urticaria can occur 1-2 weeks following vaccination. Salynn Boyles, SAN ANTONIO -- Many reported anaphylactic reactions to COVID-19 vaccination may in fact be attributable to vaccine-induced immunization stress-related response (ISRR), suggested findings from a small study presented here. Opens in a new tab or window, Visit us on LinkedIn. A questionnaire was administered to hospital employees after receiving the Pfizer/BioNTech mRNA COVID-vaccine, and reactions described by 55 of 2073 (2.7 percent) and 33 of 1856 (1.8 percent) respondents after first and second doses respectively were characterized as ISRRs . It is created by eHealthMe based on reports of 401,887 people who have side effects when getting Pfizer BioNTech Covid Vaccine from the CDC and the FDA, and is updated regularly. Some who received their first shot of the Moderna vaccine said their. Opens in a new tab or window, Share on Twitter. Enfermedades de Inmunodeficiencia Primaria, AAAAI Diversity Equity and Inclusion Statement, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-B, Delayed reaction after COVID-19 vaccination. The body's immune system can cause the inflammation in response to an infection or some other trigger, like the vaccine. [emailprotected]. Even if the side effect were linked to the vaccine, a single case report wont tell you how rare the side effect may be. Giving the second dose of Pfizer's two-dose COVID-19 vaccine eight weeks after the first is the "sweet spot" to protect against the fast-spreading Delta variant, a UK research group has said. You can count on these short math quips for a good chuckle. One vaccine recipient reported two SAEs (fever and pain in extremity requiring hospitalization) which were considered potentially related by the investigator and FDA. Among all study vaccine recipients aged 511 years, 86.2% reported at least one local injection site reaction in the 7 days after vaccination. The Moderna and Pfizer-BioNTech COVID-19 vaccines are the first two COVID-19 vaccines authorized by the Food and Drug Administration for emergency use and already have been given to millions of Americans. Common side effects of Pfizer COVID vaccine The Therapeutic Goods Administration lists "very common side effects" of the Pfizer vaccine as: pain/swelling at injection site tiredness headache muscle pain chills fever joint pain Got questions about the COVID vaccines? But Mullane says not to take it before the shot, as it can interfere with your immune response. The most common serious adverse events in the vaccine group which were numerically higher than in the placebo group were appendicitis (7 in vaccine vs 2 in placebo), acute myocardial infarction (3 vs 0), and cerebrovascular accident (3 vs 1). Chills. In an interview with MedPage Today at the American Academy of Allergy, Asthma & Immunology annual meeting, Khalid said ISRR appears to be a widely underrecognized anaphylaxis mimic, and he suggested that the true rate of anaphylaxis following vaccination with mRNA COVID vaccines may be lower than reported. Instead, it describes a whole set of immune system responses that dont begin until at least 12 hours after its encountered a potential invader. "Also, most patients with myocarditis and pericarditis who received care responded well to medicine and rest and quickly felt better.". Fever was more common after the second dose than after the first dose. The overall incidence of unsolicited non-serious adverse events from dose 1 to data cutoff (April 29, 2022) were similar in the vaccine and placebo groups in both age groups: 29.1% vs. 26.3% for the younger age group and 18.5% vs. 18.5% in the older age group, respectively. First published on Thu 13 May 2021 19.01 EDT. Does having a skin reaction to the Covid-19 vaccine mean you may react to other vaccines? Fever. Light rain early.then remaining cloudy with showers overnight. "People were already under stress due to COVID, and they were getting a brand new vaccine and hearing about adverse reactions," Khalid said. We have also observed delayed large local reactions to the mRNA-1273 vaccine, with a median onset on day 8. On December 11, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, administered as 2 doses separated by 21 days. aMild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). Therefore, a T-cell responses would probably be to one of the following: the mRNA, the lipid nanoparticle that encapsulates and helps deliver the mRNA, the solution that carries these nanoparticles in the vaccine, or the spike protein that your cells produce using the mRNA as blueprints. Opens in a new tab or window, Visit us on YouTube. Among all vaccine recipients, 66.6% reported at least one systemic reaction in the 7 days after vaccination. The phase IV clinical study analyzes which people get Pfizer BioNTech Covid Vaccine and have White blood cell count increased. Finally, a study published in the European Journal of Medical Research found delayed skin reactions in 11 (0.16%) of 6821 patients who received the Moderna Covid-19 vaccine at hospitals in Germany such as the University Hospital Dsseldorf in Dsseldorf. Is the COVID Vaccine Safe for People With Lung Cancer? A 70 year-old woman with delayed reaction to first COVID-19 Moderna vaccine. a Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). The remaining SAEs were considered by FDA to be unrelated to the study vaccine. This research was authored by Charles Miller, MD, with the United States Air Force. Its important to note that you cannot get COVID-19 from any of the approved vaccines. bMild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization. Of the 22 allergic reactions occurring within 3 hours of receiving a vaccine dose, 20 occurred in women. Allergist and immunologist at. Both conditions are triggered by the immune system's reaction to an infection, injury, or in this case, the COVID-19 vaccine. RELATED: Cookies used to make website functionality more relevant to you. The observed frequency of reported Bells palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship. ", In a 2019 report, the World Health Organization (WHO) first proposed the term "immunization-stress related response" to refer to "any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.". Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. xhr.send(payload); The study authors also mention that samples taken from skin biopsies confirmed their suspicion of a delayed allergic immune response that is commonly seen in drug reactions. The average duration of lymphadenopathy was approximately 10 days. Although you feel terrible, it's a good thing, because those systemic effects are telling you that your body is making an immune reaction, Mullane says. It is reassuring that the constellation of symptoms appears to have been self-limited during the prior episodes. Klicken Sie auf Alle ablehnen, wenn Sie nicht mchten, dass wir und unsere Partner Cookies und personenbezogene Daten fr diese zustzlichen Zwecke verwenden. Bells palsy was reported by four vaccine recipients and none of the placebo recipients. Some people who get the Moderna vaccinemay experience "COVID arm," a delayed skin reaction with raised, red welts on the arm. Allergic reactions to the Pfizer or Moderna COVID-19 vaccines are very rare, and a new study questions whether many of those that do occur are even real. . This data is presented in Table 8 below. Up to 70% reported body-wide reactions like fatigue, headache, fever, and muscle aches. COVID Reinfection Study Shows Why Older Adults Need to Get Vaccinated. 11/8/2021 This particular reaction is characterized by pain and swelling in the upper arm located at the injection site appearing 7 to 8 days following injection. All information these cookies collect is aggregated and therefore anonymous. How common are side effects after COVID-19 vaccination? Als u niet wilt dat wij en onze partners cookies en persoonsgegevens voor deze aanvullende doeleinden gebruiken, klik dan op 'Alles weigeren'. Pfizer-BioNTech COVID-19 Vaccine (Comirnaty, PF-07302048) Vaccines and Related Biological Products Advisory Committee Briefing Document. In the case of the Covid-19 vaccine, he said: "The data suggests that after one shot, there is an immune response, but it's not as strong as they would like, and that's why they give you the second one. The US Food and Drug Administration (FDA) has said there are three delayed side effects that may happen to people who get the Pfizer or Moderna vaccine. Ice and antihistamines can help alleviate symptoms. COVID arm may appear about seven days after receiving the Moderna vaccine. JAMA Dermatol. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use as a single booster dose in individuals 5 years of age and older at least two months after completion of either primary . One grade 4 fever (>40.0C) was reported in the vaccine group. Four grade 4 fevers (>40.0C) were reported, two in the vaccine group and two in the placebo group. Having a delayed skin reaction to one dose of the Covid-19 vaccines doesnt mean you should avoid subsequent doses like the booster either. The Food and Drug Administration panel voted 7-4 on two separate questions of whether Pfizer's data showed the vaccine was safe and [] WASHINGTON (AP) Federal health advisers on Tuesday . The COVID vaccines are intramuscular, or "IM" for short. As the aforementioned case series showed, not. Khalid said several common symptoms associated with non-allergic ISRR reactions mimic allergic reactions, including tingling, numbness, and tightening of the throat. Others may take hours to develop. So just because you do react to the Covid-19 vaccines doesnt necessarily mean that you should be extra wary when getting other vaccines. By continuing to browse this site, you are agreeing to our use of cookies. The majority of systemic events were mild or moderate in severity, after both doses and in both age groups. Fever >40C was reported in the 6 23 month age group (placebo: 1/597, 0.2%; vaccine: 3/1177, 0.3%) and the 2 4 year age group (placebo: 0/909, 0.0%; vaccine: 3/1824, 0.2%;). Study participants will receive a second dose of vaccine as inpatients under carefully controlled conditions at the National Institutes of Health's Clinical Center in Bethesda, Maryland. The federal agency added new warnings. Place a cold, wet cloth, or ice pack on the injection site for a short time. However, this delayed reaction is still rare. Centers for Disease Control and Prevention. No significant atopic history. These latter types of cells handle delayed hypersensitivity. Of course, its difficult to tell from a single case report whether there was indeed a cause-and-effect relationship between the vaccine and the rash or whether it just happened to be a coincidence. However, this delayed reaction is still rare. One study showed that 70% and 75% of participants reported soreness at the injection site after the first and second doses, respectively. } d Mild: easily consolable; moderate: requiring increased attention; severe: inconsolable; crying cannot be comforted; Grade 4: emergency room visit or hospitalization, aAny fever= 38.0C 29 serious adverse events reported in U.S. after. SEATTLE As thousands of people get the COVID-19 vaccine each day, a new but uncommon side effect has emerged among the vaccinated. Typically, theyve been itchy, painful or both rather than hilarious, exciting, sensual, or empowering. Dr. Blumenthal discussed this research letter and such cases in the following WCVB Channel 5 Boston news segment: Then there was the case series published in JAMA Dermatology from a Yale University School of Medicine team consisting of Margaret S. Johnston, MD, Anjela Galan, MD, Kalman L. Watsky, MD, and Alicia J. Otherwise, occurrence of severe adverse events involving system organ classes and specific preferred terms were balanced between vaccine and placebo groups. These are the most commonly reported side effects. The mild pain that COVID-19 vaccines may cause is similar to what some people report after the tetanus vaccination, Michelle Barron, MD, senior medical director of infection prevention and control for the University of Colorado Health, tells Verywell. Although all of these studies focused on the Moderna vaccine, such skin reactions have occurred with the Pfizer Covid-19 vaccine as well. Pain/tenderness at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. She developed symptoms of a distal rash from the injection site approximately one day after her second dose of the Pfizer vaccine. She developed on day 8 local swelling, rash, and itching at injection site (Not concerned). RELATED:This Vaccine Reaction Means You May Have Already Had COVID, Study Says. Although it's rare, it's possible to have an allergic reaction within the first 15 to 30 minutes after the jab. Now, there are reports of a skin rash at the injection site and the timing of. None of the participants had received the Pfizer-BioNTech vaccine. Mullane says its best to avoid important events or take on key tasks the day after your vaccination if youre concerned about the side effects. These quick and witty jokes are easy to memorize and share. Read our, If You Have a Skin Reaction to the Moderna COVID-19 Vaccine, Don't Panic. All vaccinations occurred at the intensive care unit of the NIH Clinical Center in Bethesda, Maryland, under close medical supervision and monitoring. Getting the COVID-19 vaccine offers you ample protection against the virus but can also cause a few non-serious side effects such as fatigue, soreness at the injection site, nausea, chills, or a slight fever, according to the U.S. Centers for Disease Control and Prevention (CDC). This number dropped to 68 (0.2%) following the second dose of the vaccine. In a small new study of 16 people who said . c Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. if( navigator.sendBeacon ) { That's why your arm may feel sore, turn red, or swell a bit. One line of defense is antibodies produced by your B lymphocytes, which are a type of white blood cell. It would be rash to leave yourself unprotected against Covid-19 simply because you want to avoid getting a rash. From April 2021: A UCSF doctor explains why there are people experiencing side effects after getting their second dose of the Pfizer or Moderna COVID-19 vaccine. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. That means out of a couple hundred people or so, chances are at least one person will have had such a delayed reaction. As the aforementioned case series showed, not everyone who had such reactions after the first dose necessarily had the same experience following the second dose. The most common solicited systemic adverse reaction after any dose was irritability (43.6% 51.2%) among ages 6 23 months and fatigue (24.5% 29.7%) among ages 2 4 years. The median onset for most systemic events in the 2 4 year age group was 2 days after any dose and all events resolved with a duration of 1 2 days after onset. Health Services. The median onset for most systemic events in the 6 23 month age group was 2 days after any dose and all events resolved with a duration of 1 to 2 days after onset. In nearly all cases, the rashes appeared a lot sooner (within three days for all but one) following the second dose. Thats why they tell you to wait around the vaccination location for 15 minutes following the shot and not 11,520 minutes. Most side effects appear within a day or two after being vaccinated. If youre getting ready for the first, second, or booster dose of your COVID-19 vaccine, you may wonder about what side effects to expect and how to deal with them. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. In some cases, the rashes may involve large parts of your body. Delayed localized hypersensitivity reactions to the Moderna COVID-19 vaccine: a case series. There is no data on which to base a decision about administering an alternative vaccine and I think it is unlikely that this approach would have a different outcome since your patient has reacted to non-COVID-19 vaccines in a similar manner. When you hear about other people's experiences, remember that the vaccine side effects can vary greatly. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients and was slightly more common after dose 2. Muscle and joint pain. Delayed reaction after COVID-19 vaccination 11/8/2021 A 59-year-old female with medical history of hypothyroidism, celiac disease, osteopenia, and obstructive sleep apnea was referred to my office to discuss an adverse reaction to the second dose of the Pfizer COVID-19 mRNA vaccine. In addition, reactogenicity data from adolescents aged 12-15 years were obtained and reviewed, and were similar to those from adults aged 18-55 years. Birthing Center Classes. Non-allergic symptoms included numbness, tingling, dizziness, throat tightness, dysphagia, and hypertension, which have all been linked to ISRR, Khalid said. CDC twenty four seven. Side effects of the coronavirus (COVID-19) vaccination Very common side effects in the first day or two include: having a painful, heavy feeling and tenderness in the arm where you had your injection feeling tired headache, aches and chills diarrhoea, nausea and vomiting mild flu-like symptoms Patients with Remarkable, Delayed, Large Local Reactions to the mRNA-1273 Vaccine. If your patient decides to pursue a booster dose, I think supportive care for symptom management with acetaminophen or NSAIDs could be considered. b Mild: decreased interest in eating; moderate: decreased oral intake; severe: refusal to feed; Grade 4: emergency room visit or hospitalization The vaccine cannot cause a COVID-19 infection, so symptoms mean your body is building a healthy immune response. Sheltering Arms Physical Rehabilitation Center. Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability or incapacity. These are not serious and will go away on their own. On day nine developed myalgias, arthralgias (no arthritis), unilateral upper and lower eyelid edema. The delayed localized cutaneous reactions developed in a median (range) of 7 (2-12) days after receiving the Moderna COVID-19 vaccine. Out of more than 141 million fully vaccinated individuals, there have been a total of 789 reported cases of myocarditis or pericarditis as of May 31, per the CDC. The Centers for Disease Control and Prevention (CDC) has long been alerting us about the possibility of side effects after the COVID vaccination, which are the result of our bodies building immunity and protection against the novel coronavirus. 2 Following implementation of vaccination, reports of . Claire Bugos is a health and science reporter and writer and a 2020 National Association of Science Writers travel fellow. Premedication with antihistamine or steroids in this setting is not likely to be helpful. Delayed localized hypersensitivity reactions to the Moderna COVID-19 vaccine: A case series. Here is a link to the CDC guidance https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-B. } ); 2022 Galvanized Media. While not that common relative to the 20 million people in that age group who've been vaccinated, the numbers are still much higher than the 10 to 102 cases of heart inflammation the CDC had estimated for that demographic. I am a writer, journalist, professor, systems modeler, computational and digital health expert, avocado-eater, and entrepreneur, not always in that order. xhr.open('POST', 'https://www.google-analytics.com/collect', true); Wij, Yahoo, maken deel uit van de Yahoo-merkenfamilie. These docs described 16 patients who had skin reactions two to 12 days (for a median of seven days) after receiving the first dose of the Moderna Covid-19 vaccine. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. Reports of lymphadenopathy were imbalanced with 58 more cases in the vaccine group (64) than the placebo group (6); lymphadenopathy is plausibly related to the vaccine. Dermatologists and allergists are studying the side effect, which they've tentatively dubbed "delayed cutaneous . "All of this created an atmosphere where these very real symptoms resulting in real distress were occurring, which were unrelated to the vaccine itself. Fatigue, headache, chills, and new or worsened muscle pain were most common. Library job allowed him to plan the escape. Dont do anything rash just because you get a rash over a week after getting the Covid-19 vaccine. Among a safety expansion cohort (over 2250 children randomized 2:1 vaccine to placebo), 6 participants (0.4%) in the vaccine arm and 3 participants (0.4%) in the placebo arm had events of lymphadenopathy. Therfore, allergy testing for PEG may help provide further insight. Symptoms. of our COVID-19 coverage. That's not a reason to avoid a vaccine because the benefits still outweigh the risks, but it is a good idea to keep a close eye on how you feel after getting your shot. (Table 5). Fatigue, headache, chills, and new or worsened muscle pain were most common. No grade 4 local reactions were reported. (Table 6). They can affect different parts of your body beyond the injection site. The fever resolved in 24 hours. With such over-the-counter treatments, your rash should improve within five days. COVID-19 vaccine reactions can be reported on the CDC's V-safe page. U kunt uw keuzes te allen tijde wijzigen door te klikken op de links 'Privacydashboard' op onze sites en in onze apps. The reactions were limited to the area around the injection site and not serious. One grade 4 fever (>40.0C) was reported in the vaccine group.
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