Flu shot swollen lymph nodes

Definitely don’t mean to sound like your mom here, but…did you get your flu shot last year? Follow-up question: Have you gotten yours this year?

Just asking because, you know, the flu can be deadly. Up to 61,200 people died from it last season alone (between October 2018 and May 2019), according to the Centers for Disease Control and Prevention (CDC). Just as a baseline, the flu can cause 12,000 deaths per year during a mild season, and anything over 56,000 deaths per year is considered a more severe bout, per the CDC. Eek.

What’s more: Experts are predicting that this year’s 2019-2020 flu season will be pretty bad, reports The New York Times, based on a recent flu outbreak in Australia, which can sometimes predict what the flu virus will be like in the U.S.

In 2017, Australia had its worst outbreak in 20 years, and the 2017-2018 flu season in the United States (which comes about six months later during winter in the Northern Hemisphere), was one of the worst in modern American memory, with an estimated 79,000 dead.

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In 2018, the flu outbreak in Australia began in April, which was two months earlier than usual per The New York Times, and persisted into October. In Australia, there were more flu-linked deaths than usual, and hospitalizations and nursing home outbreaks “were at moderate to high levels,” Ian Barr, deputy director of World Health Organization Collaborating Center for Reference and Research on Influenza in Melbourne, told The Times.

Currently in the U.S., the number of reported flu cases is still low, according to the weekly CDC FluView report. But as the temp drops, cases are expected to rise.

Hesitant to get jabbed by a needle? We get it: The flu shot is still, well, a shot, and that’s a turn off to some. It can be kind of a crapshoot, too. Case in point: During the 2017-2018 season, a ton of people went under the needle but got the flu anyway because of a “vaccine mismatch,” according to a commentary in the New England Journal of Medicine. In the 2017-2018 season, the flu shot was only about 36 percent effective (womp, womp).

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This past year, though, things were *a bit* better.

The shot proved to be about 47 percent effective during the 2018-2019 season, according to the CDC. To put that into a broader context, the flu shot generally provides about a 65 percent protection rate against contracting the flu, according to Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.

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So while even *that* 47 percent figure might sound low to you, it does not mean you skip your yearly injection (which you should get by the end of October, suggests the CDC). Flu season typically starts in October, peaks in December, and can stick around until May, so you want to be covered for all of it.

“Just because the vaccine isn’t 100 percent doesn’t mean it’s worthless,” says Dr. Adalja. “And even if you do get the flu, you are much less likely to have a severe case requiring hospitalization, less likely to have major destruction to your life, and less likely to spread it.”

Plus, there’s hope that next year’s shot will outdo its two most recent predecessors.

Since there are different flu viruses out there (and they’re constantly changing), the vaccine is reviewed and changed from year to year. The World Health Organization (WHO) has already selected what components should be a part of the 2019-2020 vaccine to best protect against next season’s soon-to-be circulating viruses, too. But again, there’s no way yet to accurately predict how bad this coming year’s flu will be as the virus is always changing.

FYI: The flu shot can’t actually give you the flu.

Another thing to note? Talk of the flu shot’s many side effects is greatly exaggerated. The flu shot can’t actually give you the flu, and while there are some possible side effects, Dr. Adalja says most are rare.

For the actual side effects to be aware of, read through this list. But then, roll up your sleeve anyway because flu season is coming. And guess what? The vaccine is still your best stay-healthy defense.

1. Shoulder soreness

If you receive the flu shot as an intramuscular injection (a.k.a. in your arm, typically), you have a 10 to 64 percent chance of experiencing some muscle soreness in your upper arm, according to the CDC.

That’s because the needle is injected directly into the muscle, causing microscopic damage to the cells, and is designed to cause an inflammatory immune system response. You can take an OTC pain reliever while you wait for the soreness to fade, but if the pain is very noticeable or decreasing your mobility, Dr. Adalja recommends checking with your doctor.

2. Redness or swelling at the injection site

Anytime you pierce the skin and put something into the body it can cause a topical reaction, says Dr. Adalja. This is just a sign that your immune system is activating.

But this redness and swelling where you get your shot is a common side effect that only typically lasts a few days. It’ll go away on its own, but if it’s really bugging you, you can take ibuprofen (Advil) or acetominophen (Tylenol).

3. Body aches

Any vaccine can cause body aches because of the way in which they activate the immune system, says Dr. Adalja.

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If you’re feeling sore in places other than your arm, it’s usually nothing to worry about, though Dr. Adalja notes that the flu shot does take two weeks to become fully effective—so your body aches could be a sign of the actual flu, since viral strains are probably circulating around the time you get the vaccine.

4. Itching at the injection site or a full-body rash

This would signal an allergic reaction, but “it’s very rare to have an allergic reaction to the flu shot,” Dr. Adalja notes. “There are lots of myths about egg allergies and the vaccine,” he explains—because most flu shots and nasal sprays are manufactured using technology that involves small amounts of egg proteins, per the CDC.

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“If you can eat scrambled eggs, you’re not going to have a problem with the flu shot,” Dr. Adalja says. If you have a confirmed egg allergy, you can likely still get the shot, the CDC says.

The caveat: If you experience severe itching at injection site, a rash all over your body, or signs of anaphylactic shock, seek immediate medical attention. And if you’ve had an allergic reaction to the flu shot in the past, you are among those few groups of people who the CDC recommends skip the flu shot.

5. Fever

You probably won’t get a fever because of the vaccine, but if you do, it should be low-grade (i.e. less than 101 degrees). If it’s higher than that, don’t blame your flu shot—you probably have a totally unrelated illness. “Remember that you’re getting the vaccine at the height of respiratory virus season,” says Dr. Adalja. “So you may have been incubating another virus .”

And once again (for the people in the back!): The flu shot cannot give you the flu. While some flu vaccines contain virus strains, they’re not live strains, so they can’t get you sick. Meanwhile some flu shots don’t contain the virus at all (they only contain a specific protein from the influenza virus), per the CDC.

6. Dizziness or fainting

This is less a side effect of the vaccine itself and more a side effect of a needle phobia, says Dr. Adalja. If you think you might have a stress reaction or faint, give your health care provider a heads up so they can make sure you stay seated after the shot to prevent injury.

7. Guillain-Barre syndrome

Guillain-Barre syndrome (GBS) is an auto-immune disorder that’s triggered by a wide variety of things, from vaccines to viral infections.

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GBS causes damage to the nervous system, resulting in symptoms like muscle weakness, numbness, difficulty walking or an odd gait, and even paralysis, says Dr. Adalja. While 70 percent of people fully recover from the disorder, the recovery period can range from weeks to even years, according to the National Institute of Neurological Disorders and Stroke.

But he also says the connection between GBS and the flu vaccine has been overhyped: “People should remember that influenza itself is much more likely to cause GBS than the vaccine.”

And since no more than one or two cases per million people vaccinated will have this side effect, it’s better to take your (super small) chances with GBS than with one of the many common, severe complications that often come with the flu itself.

Sarah Bradley Sarah Bradley is a freelancer writer from Connecticut, where she lives with her husband and three sons. Cassie Shortsleeve Freelance Writer Cassie Shortsleeve is a skilled freelance writer and editor with almost a decade of experience reporting on all things health, fitness, and travel.

Up to 64% of adults and children who receive the flu shot experience pain and/or soreness at the site of the injection, making it the most common side effect of the vaccine. Many patients unpleasantly describe it as feeling like they were “getting punched in the arm,” and we understand that it can be a real discomfort for the one or two days it takes for the soreness to go away. Luckily, there are a few simple steps you can take to reduce or avoid this experience when you attend an !

We spoke to our Assistant Director of Nursing, Andrea Oster, for her tips and tricks for avoiding arm soreness post-shot:
1.) Relax your arm when getting the shot. “It can be hard to do when you’re nervous, but do not tense up,” Andrea says. While you’re sitting, lay your hand flat on your upper leg and relax your shoulder, letting your arm hang until the nurse administers the shot.

2.) Take ibuprofen or Tylenol. A lot of the pain comes from inflammation. Taking a painkiller will do wonders in reducing swelling and assisting with the discomfort.

3.) Use your arm afterwards. “Don’t ‘baby’ it! Work out, write, type and continue your regular routines,” Andrea says. By keeping your arm in motion, you can help the circulation in the injection area return to normal more quickly. If you didn’t use your dominant arm, consider raising it up or moving it in circles to speed along the healing process.

4.) Try cold and warm compresses. Ice the area after the flu shot to reduce any swelling. After one or two days, try a warm compress to help relax the muscle and get the blood flow moving.

5.) Consider an alternative vaccine. There are options! We also offer a nasal spray vaccine, which is available for healthy, non-pregnant individuals between the ages of 2 and 49. It’s great for people who are afraid of needles or children that can’t sit still for a shot.

Why is my arm sore after the flu shot? Soreness in your arm after getting a flu vaccine typically lasts no longer than one or two days. The pain and inflammation is your body’s natural response to a foreign invader. It’s a sign that your immune system is making antibodies, which is what offers you the protection from getting the actual virus. If you experience pain that lasts longer than three days, you should call your doctor.

Do you typically experience arm soreness or other side effects after your flu shot? Tell us in the comments!

Why Does Your Arm Hurt After You Get a Flu Shot?

If you’ve ever gotten a flu shot, you may have felt soreness in your upper arm for a day or two afterward. That’s just a sign the vaccine is working, immunologists say.

The flu vaccine works by introducing your body to a foreign substance called an antigen (in this case, the antigen is a deactivated or “dead” virus similar to the flu virus). Being exposed to an antigen “primes” immune system cells, preparing them to create antibodies should they ever encounter the foreign substance again . The inactive virus in the vaccine can’t make you sick, but it does help sensitize your immune system to potential threats. Essentially, the vaccine puts your body on high alert for anything resembling the flu virus, enabling you to fight off infections and illnesses faster and more effectively than you could otherwise.

In the process of battling the inactive flu virus introduced by the flu vaccine, your immune system also releases mediators like histamine, which causes inflammation. In the event of infection, inflammation is important because it helps your body fight invaders and repair damaged tissue. But it’s also what causes soreness. The flu shot is usually injected into your upper arm, which is why the early immune response—and any pain—tends to be localized there.

Roughly one in five people have this type of painful reaction, immunologist Richard Zimmerman told Popular Science. If you’re susceptible to soreness after receiving a flu shot, there are a few steps you can take to alleviate the pain. Dr. Juanita Mora of the American Lung Association recommends taking an ibuprofen about two hours before getting the shot.

“You can also try icing the injection site to reduce redness and swelling,” Dr. Mora said.

It’s also important to move your arm around after receiving the shot so the vaccine isn’t quite so concentrated in one place. Barring that, you could always try getting the vaccine in your non-dominant arm so that any pain won’t interfere with your everyday activities.

Any pain is worth it, though: Even if you’ve never gotten the flu before, there’s always a chance you could get it in the future. And getting a flu shot also contributes to herd immunity, helping protect higher-risk populations (like children, older adults, and chronically ill individuals) who often can’t receive the flu vaccine for themselves. Keeping up-to-date on vaccines is one of the easiest ways individuals can contribute to community health.

Have you got a Big Question you’d like us to answer? If so, let us know by emailing us at [email protected]

Flu Shot Pain: Why it happens, and How to prevent it

I just got the flu shot – Why does my arm hurt?

Influenza, or the flu, is a contagious respiratory illness caused by a viral infection of the nose, throat, and lungs. The virus travels from person to person through infectious droplets expelled from the nose or mouth, but chances of contracting the virus decrease between 40-60% with the administration of a flu shot. Some individuals suffer pain following vaccination, but there are ways to lower the likelihood of experiencing flu shot pain.

Many people experience pain after receiving the vaccination. Flu shot pain is the sensory response to the immune system’s process of producing antibodies and developing immunity, which is what prevents a vaccinated individual from contracting the disease.

With general fear of muscle pain and as much as 10% of the US population suffering from a fear of needles, many people shy away vaccination each year. Pain, however, is minimal and should not last more than a few days. Although it might seem unavoidable, there are some ways to reduce the risk of shoulder pain and muscle soreness following vaccination.

What can I do to avoid flu shot pain?

If mild arm soreness is off-putting, compare it to the whole-body achiness that comes with contracting the flu virus. Consider these methods for reducing flu shot pain following:

  • Avoid Tensing Your Muscle During Vaccination: Take some deep breaths and clear your mind of any worry before you receive the shot. If you’re among the 10% of U.S. citizens afraid of needles, try looking away to avoid tensing your muscle as the needle enters the skin.
  • Move Your Arm After the Shot: Moving your arm post-injection aids in spreading the vaccination away from the injection site. While the initial pressure and discomfort may lead you instinctively to keep your arm still, the high concentration of medication in one spot can lead to muscle soreness later.
  • Don’t Skip Your Work-Out Routine: Moderate exercise will temporarily boost your body’s immune system for several hours and promotes blood circulation, leading the medication to be dispersed throughout muscle tissue.
  • Use a Cool Compress: As you begin to experience muscle soreness, acting quickly can go a long way toward a speedy recovery and reducing discomfort. A cool compress acts twofold to reduce inflammation and numb the nerves in the skin.
  • Take a Pain Reliever: If pain persists, an over-the-counter pain reliever may provide some relief. Keep in mind that if pain lasts longer than a few days, it may be wise to check in with your doctor.

While you cannot contract the flu from the flu shot, vaccines, like any medication, come with the risk of side effects.

Common side effects include: (1) Soreness, redness, or swelling where the shot was given; (2) low grade fever; (3) muscle aches; or (4) toughness/itching at the injection site. These reactions typically present soon after the flu shot and last one to two days.

In some cases, symptoms of reaction persist and can develop into long-term illnesses.
Injuries Associated with the Flu Vaccine in the NVICP include:

  • Acute Disseminated Encephalomyelitis (ADEM)
  • Brachial Neuritis
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Guillain-Barré Syndrome (GBS)
  • Idiopathic Thrombocytopenic Purpura (ITP)
  • Narcolepsy
  • Rheumatoid Arthritis (RA)
  • Sensorineural Hearing Loss (SNHL)
  • Shoulder Injury Related to Vaccine Administration (SIRVA)
  • Systemic Lupus Erythematosus (SLE)
  • Transverse Myelitis (TM)

If the resulting injury lasts more than 6 months, results in surgical intervention during inpatient hospitalization, or results in death, you may be eligible to petition for compensation through the National Vaccine Injury Compensation Program.

National Vaccine Injury Compensation Program

Vaccines are an important part of public health, working to save lives by preventing disease. Most of the time, vaccines are administered without any serious problems. Like with any medication, however, there is a risk of side effects, ranging from mild to serious.

For this reason, the US government created the National Vaccine Injury Compensation Program (NVICP), a “no-fault” alternative to the traditional legal system. Petitions can be filed by any individual, at any age, after developing an injury believed to be a result of a covered vaccine, if jurisdictional requirements are met.

Conway Homer, P.C. is the most experienced vaccine injury law firm in the United States. We represent clients from all 50 states and have advocated for landmark cases that have shaped the Vaccine Program and made it friendlier and more generous to those individuals who suffer from vaccine injuries.

To get in touch with our dedicated team, .

Fluarix

SIDE EFFECTS

The safety experience with FLUARIX (trivalent influenza vaccine) is relevant to FLUARIX QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions .

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of FLUARIX QUADRIVALENT could reveal adverse reactions not observed in clinical trials.

FLUARIX QUADRIVALENT In Adults

Trial 1 (NCT01204671) was a randomized, double-blind (2 arms) and open-label (one arm), activecontrolled, safety, and immunogenicity trial. In this trial, subjects received FLUARIX QUADRIVALENT (n = 3,036) or one of 2 formulations of comparator trivalent influenza vaccine (FLUARIX, TIV-1, n = 1,010 or TIV-2, n = 610), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The population was aged 18 years and older (mean age: 58 years) and 57% were female; 69% were white, 27% were Asian, and 4% were of other racial/ethnic groups. Solicited events were collected for 7 days (day of vaccination and the next 6 days). The frequencies of solicited adverse events are shown in Table 2.

Table 2: FLUARIX QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa of Vaccination in Adultsb (Total Vaccinated Cohort)

FLUARIX QUADRIVALENTc
n = 3,011-3,015 %
Trivalent Influenza Vaccine (TIV)
TIV-1 (B Victoria)d
n = 1,003 %
TIV-2 (B Yamagata)e
n = 607 %
Any Grade 3f Any Grade 3f Any Grade 3f
Local
Pain 36.4 0.8 36.8 1.2 31.3 0.5
Redness 1.9 0.0 1.7 0.0 2.0 0.0
Swelling 2.1 0.0 2.1 0.0 1.3 0.0
Systemic
Muscle aches 16.4 0.5 19.4 0.8 16.1 0.5
Headache 15.9 0.9 16.4 0.8 13.2 0.7
Fatigue 15.8 0.7 18.4 0.6 14.8 0.5
Arthralgia 8.4 0.5 10.4 0.7 9.4 0.3
Gastrointestinal symptomsg 6.5 0.4 6.5 0.2 5.9 0.3
Shivering 4.2 0.4 5.0 0.3 4.3 0.2
Feverh 1.6 0.0 1.2 0.0 1.5 0.0
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.
n = number of subjects with diary card completed.
aSeven days included day of vaccination and the subsequent 6 days.
bTrial 1: NCT01204671.
cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
fGrade 3 pain: Defined as significant pain at rest; prevented normal everyday activities. Grade 3 redness, swelling: Defined as >100 mm.
Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
Grade 3 fever: Defined as >102.2°F (39.0°C).
gGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
hFever: Defined as ≥99.5°F (37.5°C).

Unsolicited events occurring within 21 days of vaccination (Day 0 to 20) were reported in 13%, 14%, and 15% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively. The unsolicited adverse reactions that occurred most frequently (≥0.1% for FLUARIX QUADRIVALENT) included dizziness, injection site hematoma, injection site pruritus, and rash. Serious adverse events occurring within 21 days of vaccination were reported in 0.5%, 0.6%, and 0.2% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively.

FLUARIX QUADRIVALENT In Children

Trial 2 (NCT01196988) was a randomized, double-blind, active-controlled, safety, and immunogenicity trial. In this trial, subjects received FLUARIX QUADRIVALENT (n = 915) or one of 2 formulations of comparator trivalent influenza vaccine (FLUARIX, TIV-1, n = 912 or TIV-2, n = 911), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Subjects were aged 3 through 17 years and 52% were male; 56% were white, 29% were Asian, 12% were black, and 3% were of other racial/ethnic groups. Children aged 3 through 8 years with no history of influenza vaccination received 2 doses approximately 28 days apart. Children aged 3 through 8 years with a history of influenza vaccination and children aged 9 years and older received one dose. Solicited local adverse reactions and systemic adverse events were collected using diary cards for 7 days (day of vaccination and the next 6 days). The frequencies of solicited adverse events are shown in Table 3.

Table 3: FLUARIX QUADRIVALENT: Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 7 Daysa after First Vaccination in Children Aged 3 through 17 Yearsb (Total Vaccinated Cohort)

FLUARIX QUADRIVALENTc % Trivalent Influenza Vaccine (TIV)
TIV-1 (B Victoria)d % TIV-2 (B Yamagata)e %
Any Grade 3f Any Grade 3f Any Grade 3f
Aged 3 through 17 Years
Local n = 903 n = 901 n = 905
Paing 43.7 1.6 42.4 1.8 40.3 0.8
Redness 23.0 1.0 21.3 0.2 20.9 0.7
Swelling 18.5 0.8 17.2 1.1 14.9 0.2
Aged 3 through 5 Years
Systemic n = 291 n = 314 n = 279
Drowsiness 17.2 1.0 12.4 0.3 13.6 0.7
Irritability 16.8 0.7 13.4 0.3 14.3 0.7
Loss of appetite 15.5 0.3 8.0 0.0 10.4 0.7
Feverh 8.9 0.3 8.9 0.3 8.2 1.1
Aged 6 through 17 Years
Systemic n = 613 n = 588 n = 626
Fatigue 19.7 1.5 18.5 1.4 15.5 0.5
Muscle aches 17.5 0.7 16.0 1.4 15.8 0.5
Headache 16.3 1.3 19.2 0.7 15.2 0.6
Arthralgia 9.8 0.3 9.4 0.7 7.3 0.2
Gastrointestinal symptomsi 9.8 1.0 9.5 0.7 7.2 0.3
Shivering 6.4 0.5 4.4 0.5 5.0 0.0
Feverh 6.0 1.1 8.5 0.5 6.1 0.3
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n = number of subjects with diary card completed.
aSeven days included day of vaccination and the subsequent 6 days.
bTrial 2: NCT01196988.
cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
fGrade 3 pain: Defined as cried when limb was moved/spontaneously painful (children 6 years), or significant pain at rest, prevented normal everyday activities (children ≥6 years).
Grade 3 redness, swelling: Defined as >50 mm.
Grade 3 drowsiness: Defined as prevented normal activity.
Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity.
Grade 3 loss of appetite: Defined as not eating at all.
Grade 3 fever: Defined as >102.2°F (39.0°C).
Grade 3 fatigue, muscle aches, headache, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
gPercentage of subjects with any pain by age subgroup: 39%, 38%, and 37% for FLUARIX QUADRIVALENT, TIV-1, and TIV-2, respectively, in children aged 3 through 8 years and 52%, 50%, and 46% for FLUARIX QUADRIVALENT, TIV-1, and TIV-2, respectively, in children aged 9 through 17 years.
hFever: Defined as ≥99.5°F (37.5°C).
iGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

In children who received a second dose of FLUARIX QUADRIVALENT, TIV-1, or TIV-2, the incidences of adverse events following the second dose were generally lower than those observed after the first dose.

Unsolicited adverse events occurring within 28 days of any vaccination were reported in 31%, 33%, and 34% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively. The unsolicited adverse reactions that occurred most frequently (≥0.1% for FLUARIX QUADRIVALENT) included injection site pruritus and rash. Serious adverse events occurring within 28 days of any vaccination were reported in 0.1%, 0.1%, and 0.1% of subjects who received FLUARIX QUADRIVALENT, TIV-1, or TIV-2, respectively.

FLUARIX (Trivalent Formulation)

FLUARIX has been administered to 10,317 adults aged 18 through 64 years, 606 subjects aged 65 years and older, and 2,115 children aged 6 months through 17 years in clinical trials. The incidence of solicited adverse events in each age-group is shown in Tables 4 and 5.

Table 4: FLUARIX (Trivalent Formulation): Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 4 Daysa of Vaccination in Adults (Total Vaccinated Cohort)

Table 5: FLUARIX (Trivalent Formulation): Incidence of Solicited Local Adverse Reactions and Systemic Adverse Events within 4 Daysa of First Vaccination in Children Aged 3 through 17 Yearsb (Total Vaccinated Cohort)

In children who received a second dose of FLUARIX or the comparator vaccine, the incidences of adverse events following the second dose were similar to those observed after the first dose.

Serious Adverse Events

In the 4 clinical trials in adults (N = 10,923), there was a single case of anaphylaxis within one day following administration of FLUARIX (<0.01%).

Postmarketing Experience

Beyond those events reported above in the clinical trials for FLUARIX QUADRIVALENT or FLUARIX, the following adverse events have been spontaneously reported during postapproval use of FLUARIX (trivalent influenza vaccine). This list includes serious events or events which have causal connection to FLUARIX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Blood And Lymphatic System Disorders

Lymphadenopathy.

Cardiac Disorders

Tachycardia.

Ear And Labyrinth Disorders

Vertigo.

Eye Disorders

Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal Disorders

Abdominal pain or discomfort, swelling of the mouth, throat, and/or tongue.

General Disorders And Administration Site Conditions

Asthenia, chest pain, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches.

Immune System Disorders

Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness.

Infections And Infestations

Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis.

Nervous System Disorders

Convulsion, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, syncope.

Respiratory, Thoracic, And Mediastinal Disorders

Asthma, bronchospasm, dyspnea, respiratory distress, stridor.

Skin And Subcutaneous Tissue Disorders

Angioedema, erythema, erythema multiforme, facial swelling, pruritus, Stevens-Johnson syndrome, sweating, urticaria.

Vascular Disorders

Henoch-Schönlein purpura, vasculitis.

Read the entire FDA prescribing information for Fluarix (Influenza Virus Vaccine)

Influenza a virus vaccine, h1n1, inactivated (Intramuscular)

in-floo-EN-za AY VYE-rus VAX-een, H1N1, in-AK-ti-vay-ted

Medically reviewed by Drugs.com. Last updated on Jan 29, 2019.

Uses for influenza a virus vaccine, h1n1, inactivated

Influenza virus vaccine, H1N1 is used to prevent infection caused by the influenza A (H1N1) 2009 virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a “flu shot”.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before using influenza a virus vaccine, h1n1, inactivated

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to influenza a virus vaccine, h1n1, inactivated or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H1N1 in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H1N1 in children below 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H1N1 in children below 6 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of influenza virus vaccine, H1N1 in the elderly.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter ) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to eggs, egg products, or chicken products, history of—Should not be used in patients with these conditions.
  • Guillain-Barré syndrome, history of—May cause the symptoms of this condition to return.
  • Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well if you have weak immune system.

Proper use of influenza a virus vaccine, h1n1, inactivated

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles.

Some children who have not received the vaccine before should receive 2 doses at least 1 month apart.

Precautions while using influenza a virus vaccine, h1n1, inactivated

It is very important that your child return to your doctor’s office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Avoid contact with people who are sick or at increased risk of getting the infection after you receive this vaccine. Talk to your doctor about this if you have concerns.

Influenza virus vaccine, H1N1 may not protect all persons given the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter ) medicines and herbal or vitamin supplements.

Influenza a virus vaccine, h1n1, inactivated side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Difficulty with moving
  • fever
  • general feeling of discomfort or illness
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • swollen joints
  • unusual tiredness or weakness

Incidence not known

  • Back pain, sudden and severe
  • black, tarry stools
  • bleeding gums
  • blindness
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blue-yellow color blindness
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chest pain
  • chills
  • congestion
  • convulsions
  • cough
  • decreased vision
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • dryness or soreness of the throat
  • eye pain
  • fainting
  • fast heartbeat
  • feeling faint, dizzy, or lightheadedness
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • hives
  • hoarseness
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle weakness, sudden and progressing
  • pain in the arms or legs
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness, soreness, or itching skin
  • runny nose
  • sensation of pins and needles
  • shortness of breath
  • skin rash
  • sneezing
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sores, welting, or blisters
  • stabbing pain
  • stuffy nose
  • sweating
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with swallowing
  • unusual bleeding or bruising
  • voice changes
  • weakness of the muscles in your face
  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Incidence not known

  • Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Medical Disclaimer

More about influenza virus vaccine, h1n1, inactivated

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Interactions
  • Drug class: viral vaccines

Consumer resources

  • Influenza A (H1N1) 2009 Monovalent Vaccine

Professional resources

  • Influenza A Vaccine (FDA)

Related treatment guides

  • Influenza Prophylaxis
  • Swine Flu

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