FluMist Side Effects

Generic Name: influenza virus vaccine inactivated

Please note - some side effects for FluMist 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 FluMist - for the Consumer

FluMist

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 FluMist:

Chills; cough; decreased appetite; headache; mild fever (in children); muscle aches; runny or stuffy nose; sore throat; stomach pain; tiredness or weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); decreased movement of the face muscles; ear pain; irritability; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache, fever, or chills; symptoms of meningitis (eg, mental or mood changes, nausea or vomiting, sensitivity to light, severe headache, stiff neck); symptoms of pericarditis (eg, chest pain, lightheadedness, shortness of breath, tiredness, weakness); wheezing.

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.

Top

FluMist Side Effects - for the Professional

Flumist

Flumist is not indicated in children <24 months of age. In a clinical trial, among children 6-23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred in 5.9% of Flumist recipients compared to 3.8% of active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). Wheezing was not increased in children ≥24 months of age.

Hypersensitivity, including anaphylactic reaction, has been reported post-marketing.

[See Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2).]

Adverse Reactions in Clinical Trials 

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 9537 children and adolescents 1-17 years of age and 3041 adults 18-64 years of age received Flumist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 described below. In addition, 4179 children 6-59 months of age received Flumist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric Flumist recipients 6 months-17 years of age, 50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019, and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%), while in D153-P501, 99% of subjects were Asian.

Adverse Reactions in Children and Adolescents

In a placebo-controlled safety study (AV019) conducted in a large Health Maintenance Organization (HMO) in children 1-17 years of age (n = 9689), an increase in asthma events, captured by review of diagnostic codes, was observed in children <5 years of age (Relative Risk 3.53, 90% CI: 1.1, 15.7). This observation was prospectively evaluated in Study MI-CP111.

In MI-CP111, an active-controlled study, increases in wheezing and hospitalization (for any cause) were observed in children <24 months of age, as shown in Table 1.

Table 1 Percentages of Children with Hospitalizations and Wheezing from MI-CP111

*  Injectable influenza vaccine made by Sanofi Pasteur Inc. †  From randomization through 180 days post last vaccination. ‡  Wheezing requiring bronchodilator therapy or with significant respiratory symptoms evaluated from randomization through 42 days post last vaccination.
Adverse Reaction	Age Group	Flumist	Active Control*
Hospitalizations†	6-23 months (n = 3967)	4.2 %	3.2 %
	24-59 months (n = 4385)	2.1 %	2.5 %
Wheezing‡	6-23 months (n = 3967)	5.9 %	3.8 %
	24-59 months (n = 4385)	2.1 %	2.5 %

Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6-11 months of age (n = 1376) were 6.1% in Flumist recipients and 2.6% in active control recipients.

Table 2 shows an analysis of pooled solicited events, occurring in at least 1% of Flumist recipients and at a higher rate compared to placebo, post Dose 1 for Study D153-P501 and AV006 and solicited events post Dose 1 for Study MI-CP111. Solicited events were those about which parents/guardians were specifically queried after vaccination with Flumist. In these studies, solicited events were documented for 10 days post vaccination. Solicited events post Dose 2 for Flumist were similar to those post Dose 1 and were generally observed at a lower frequency.

Table 2 Summary of Solicited Events Observed within 10 Days after Dose 1 for Vaccine* and either Placebo or Active Control Recipients; Children 2-6 Years of Age

*   Frozen formulation used in AV006; Refrigerated formulation used in D153-P501 and MI-CP111. †   Injectable influenza vaccine made by Sanofi Pasteur Inc. ‡   Number of evaluable subjects (those who returned diary cards) for each event. Range reflects differences in data collection between the 2 pooled studies.
	D153-P501 & AV006			MI-CP111
	Flumist		Placebo	Flumist	Active Control†
	N=876-1759‡		N=424-1034‡	N=2170‡	N=2165‡
Event	%		%	%	%
Runny Nose/ Nasal Congestion	58		50	51	42
Decreased Appetite	21		17	13	12
Irritability	21		19	12	11
Decreased Activity (Lethargy)	14		11	7	6
Sore Throat	11		9	5	6
Headache		9	7	3	3
Muscle Aches	6		3	2	2
Chills	4		3	2	2
Fever
100-101°F Oral	9		6	6	4
101-102°F Oral	4		3	4	3

In clinical studies D153-P501 and AV006, other adverse reactions in children occurring in at least 1% of Flumist recipients and at a higher rate compared to placebo were: abdominal pain (2% Flumist vs. 0% placebo) and otitis media (3% Flumist vs. 1% placebo).

An additional adverse reaction identified in the active-controlled trial, MI-CP111, occurring in at least 1% of Flumist recipients and at a higher rate compared to active control was sneezing (2% Flumist vs. 1% active control).

In a separate trial (MI-CP112) that compared the refrigerated and frozen formulations of Flumist in children and adults 5-49 years of age, the solicited events and other adverse events were consistent with observations from previous trials. Fever of >103°F was observed in 1 to 2% of children 5-8 years of age.

In a separate placebo-controlled trial (D153-P526) using the refrigerated formulation in a subset of older children and adolescents 9-17 years of age who received one dose of Flumist, the solicited events and other adverse events were generally consistent with observations from previous trials.  Abdominal pain was reported in 12% of Flumist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of Flumist recipients compared to 0% of placebo recipients.

Adverse Reactions in Adults

In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least 1% of Flumist recipients and at a higher rate compared to placebo include runny nose (44% Flumist vs. 27% placebo), headache (40% Flumist vs. 38% placebo), sore throat (28% Flumist vs. 17% placebo), tiredness/weakness (26% Flumist vs. 22% placebo), muscle aches (17% Flumist vs. 15% placebo), cough (14% Flumist vs. 11% placebo), and chills (9% Flumist vs. 6% placebo).

In addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1% of Flumist recipients and at a higher rate compared to placebo were: nasal congestion (9% Flumist vs. 2% placebo) and sinusitis (4% Flumist vs. 2% placebo).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Flumist. Because these reactions 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 vaccine exposure.

Cardiac disorders: Pericarditis

Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome)

Gastrointestinal disorders: Nausea, vomiting, diarrhea

Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)

Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis

Respiratory, thoracic, and mediastinal disorders: Epistaxis

Skin and subcutaneous tissue disorders: Rash

Top

Side Effects by Body System - for Healthcare Professionals

Respiratory

Respiratory side effects have frequently included cough, runny nose, and nasal congestion. Otitis media, sneezing, rhinitis, sinusitis, and epistaxis have also been reported.

In a clinical trial, among children 6 to 23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred in 5.9% of FluMist recipients compared to 3.8% of active control (injectable influenza vaccine made by Sanofi Pasteur Inc) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). Wheezing was not increased in children 24 months of age and older.

Gastrointestinal

Gastrointestinal side effects have frequently included sore throat and vomiting. Abdominal pain and diarrhea have been infrequently reported. Nausea has been reported rarely.

Musculoskeletal

Musculoskeletal side effects have frequently included muscle aches.

Other

Other side effects have included decreased appetite, irritability, decreased activity, tiredness/weakness, headache, muscle aches, chills, and fever.

Nervous system

Nervous system side effects have included Guillain-Barré syndrome, Bell's Palsy, meningitis, eosinophilic meningitis, and vaccine-associated encephalitis. The frequency and/or causal relationship has not been established.

An increased frequency of Guillain-Barre syndrome (GBS) was reported in 1976 with the administration of the swine influenza vaccine. Among individuals who received the swine influenza vaccine in 1976, the rate of GBS that exceeded the background rate was <10 cases per 1 million persons vaccinated with the risk for influenza vaccine-associated GBS higher among individuals over 25-years-old compared to individuals younger than 25-years-old. GBS has an annual incidence of 10 to 20 cases per 1 million adults; therefore it is difficult to obtain strong epidemiologic evidence for a possible increase in risk. Investigations, to date, have not reported a substantial increase in the incidence of GBS associated with influenza vaccines (other than the 1976 swine influenza vaccine), and if influenza does pose a risk, it is probably slightly more than 1 additional case per 1 million individuals vaccinated.

Dermatologic

Dermatologic side effects have included rash.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, facial edema, and urticaria.

Cardiovascular

Cardiovascular side effects in post-marketing reports have included pericarditis. The frequency and relationship to vaccine exposure has not been determined.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.