FluLaval Side Effects

Generic Name: influenza virus vaccine inactivated,influenza virus vaccine live intranasal

Please note - some side effects for FluLaval may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of FluLaval - for the Consumer

FluLaval

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using FluLaval:

Back pain; chills or shivering; cough; diarrhea; general body discomfort; headache; irritability; mild bruising, pain, redness, swelling, or tenderness at the injection site; mild fever; muscle aches; sore throat; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using FluLaval:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; loss of appetite; muscle weakness; numbness or tingling of the hands or feet; seizures; severe or persistent headache or fever; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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FluLaval Side Effects - for the Professional

Flulaval

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of Flulaval could reveal adverse events not observed in clinical trials.

In clinical trials, the most common (≥10%) local and systemic adverse events were pain, redness, and/or swelling at the injection site, headache, fatigue, myalgia, low grade fever, and malaise.

Safety information for Flulaval was collected in 2 randomized, controlled clinical trials, one in the United States (IDB707-105) and the second in Canada (SPD707-104). The safety population from these trials includes 1,049 adults 18 years of age and older vaccinated with products representative of the licensed formulation of Flulaval. The US study included subjects 18 to 64 years of age who were randomized to receive Flulaval (N = 721) or a US-licensed trivalent, inactivated influenza virus vaccine (FLUZONE) (N = 279). The Canadian study compared 4 vaccine groups: Flulaval, a similar investigational formulation of Flulaval with reduced thimerosal, and 2 Canadian-licensed trivalent influenza vaccines.

Among recipients of Flulaval, 56.6% were women; 92.4% of subjects were white, 6.5% black, 2.7% Native American, and 1.0% Asian. In the US study, 74.8% of the recipients of Flulaval were Hispanic/Latino. The mean age of subjects in the US study was 38 years (range 18-64 years) and 19% of subjects were 50 to 64 years of age. In the Canadian study, the mean age was 63 years (range 50-92 years), and 46.6% were 65 years of age and older.

A series of symptoms and/or findings were specifically solicited by a diary/memory aid used by subjects for at least the day of vaccination and 3 days post-treatment (Table 1). Subjects were actively queried about changes in their health status through 42 days post-vaccination in the US trial, and six months post-vaccination in the Canadian study. In addition, spontaneous reports of adverse events were also collected (Table 2).

Table 1. Solicited Adverse Events in the First 4 Days After Administration of Flulaval or Comparator Influenza Vaccine

Results >1% reported to nearest whole percent; results >0 but ≤1 reported as 1%.
a US-licensed trivalent, inactivated influenza virus vaccine (FLUZONE).
b Includes subjects who received Flulaval and a similar investigational formulation of Flulaval with reduced thimerosal.
c Fever defined as ≥37.5°C in the US study, and ≥38.0°C in the Canadian study.
	US Trial Adults 18 to 64 years of age (80% <50 years of age)		Canadian Trial Adults 50 years of age and older
Adverse Events	Flulaval N = 721 %	Comparator Influenza Vaccinea N = 279 %	Flulavalb N = 328 %
Local
Pain	24	31	21
Redness	11	10	14
Swelling	10	10	6
Systemic
Headache	18	17	10
Fatigue	17	15	10
Myalgia	13	16	11
Feverc	11	10	1
Malaise	10	10	4
Sore throat	9	9	5
Reddened eyes	6	5	3
Cough	6	7	3
Chills	5	2	3
Chest tightness	3	1	2
Facial swelling	1	1	1

Local adverse events occurred with similar frequency in the 2 trials. In the US study, the only significant difference between Flulaval and a US-licensed trivalent, inactivated influenza virus vaccine was an increased frequency of chills in subjects receiving Flulaval.

Table 2 summarizes the most common adverse events in the 2 clinical trials; adverse events were reported, either spontaneously or in response to queries about changes in health status. The most common events were headache and cough in both studies. These, as well as throat pain, were the only adverse events reported by >1% of subjects in the US trial. The Canadian trial featured a longer safety follow-up (6 months vs. 42 days) and enrolled a population exclusively 50 years of age and older. Therefore, spontaneous adverse event reports were more frequent in this trial. As indicated in Table 2, upper respiratory infection, arthralgia, myalgia, nasopharyngitis, back pain, injection site erythema, diarrhea, fatigue, nausea, and nasal congestion were each reported by ≥5% of the recipients of Flulaval in the Canadian study.

Table 2. Adverse Events Reported Spontaneouslya by ≥5% of Subjects in Either Clinical Trial of Flulaval

Results >1% reported to nearest whole percent; results >0 but ≤1 reported as 1%.
a Adverse events in this table were reported spontaneously or in response to queries about changes in health status.
b US-licensed trivalent, inactivated influenza virus vaccine (FLUZONE).
c Includes subjects who received Flulaval and a similar investigational formulation of Flulaval with reduced thimerosal.
	US Trial (safety follow-up 42 days) Adults 18 to 64 years of age (80% <50 years of age)		Canadian Trial (safety follow-up 6 months) Adults 50 years of age and older
Adverse Events	Flulaval N = 721 %	Comparator Influenza Vaccineb N = 279 %	Flulavalc N = 328 %
Headache	7	7	19
Cough	2	2	15
Pharyngolaryngeal pain	2	3	12
Upper respiratory infection	1	1	9
Arthralgia	1	1	8
Myalgia	1	1	7
Nasopharyngitis	1	1	7
Back pain	1	1	6
Injection site erythema	1	1	5
Diarrhea	1	0	5
Fatigue	1	1	5
Nausea	1	1	5
Nasal congestion	1	1	5

Postmarketing Experience

The following additional adverse events have been identified during postapproval use of Flulaval. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their incidence rate or establish a causal relationship to the vaccine. Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting.

Blood and Lymphatic System Disorders: Lymphadenopathy.

Eye Disorders: Conjunctivitis, eye pain, photophobia.

Gastrointestinal Disorders: Dysphagia, vomiting.

General Disorders and Administration Site Conditions: Chest pain, injection site inflammation, rigors, asthenia, injection site rash, influenza-like symptoms, abnormal gait, injection site bruising, injection site sterile abscess.

Immune System Disorders: Allergic edema of the face, allergic edema of the mouth, anaphylaxis, allergic edema of the throat.

Infections and Infestations: Pharyngitis, rhinitis, laryngitis, cellulitis.

Musculoskeletal and Connective Tissue Disorders: Muscle weakness, back pain, arthritis.

Nervous System Disorders: Dizziness, paresthesia, hypoesthesia, hypokinesia, tremor, somnolence, syncope, Guillain-Barré syndrome, convulsions/seizures, facial or cranial nerve paralysis, encephalopathy, limb paralysis.

Psychiatric Disorders: Insomnia.

Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea, dysphonia, bronchospasm, throat tightness.

Skin and Subcutaneous Tissue Disorders: Urticaria, localized or generalized rash, pruritus, periorbital edema, sweating.

Vascular Disorders: Flushing, pallor.

Adverse Events Associated With Influenza Vaccines

Anaphylaxis has been reported after administration of Flulaval. Although Flulaval contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis [see Contraindications (4)].

The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.

Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.

Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have frequently included pain (54.7%), redness (17.5%), and swelling (9.3%). Ecchymosis, induration, injection site mass or abscess, injection site reaction or cellulitis, and warmth at the site of injection have also been reported.

Other

Other side effects have frequently included fatigue (19.7%), headache (19.3%), shivering (3.3%), and fever equal to/greater than 100.4 degrees Fahrenheit (1.7%). Malaise, sweating, vertigo, asthenia, chest pain, chills, and feeling hot have also been reported.

Musculoskeletal

Musculoskeletal side effects have frequently included muscle aches (23%) and arthralgia (6.4%). Pain in extremity has also been reported.

Hematologic

Hematologic side effects have included autoimmune hemolytic anemia, lymphadenopathy, and thrombocytopenia.

Cardiovascular

Cardiovascular side effects have included tachycardia, Henoch-Schonlein purpura, and vasculitis.

Ocular

Ocular side effects have included conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, and serum sickness.

Nervous system

Nervous system side effects have rarely included convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barre syndrome, hypoesthesia, myelitis, neuritis, neuropathy, and paresthesia.

Respiratory

Respiratory side effects have included asthma, bronchospasm, cough, dyspnea, pneumonia, respiratory distress, stridor, pharyngitis, rhinitis, and tonsillitis.

Dermatologic

Dermatologic side effects have included angioneurotic edema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, and urticaria.

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