Fluvirin Side Effects

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

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

Fluvirin

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 Fluvirin:

Back pain; chills; cough; fatigue; general body discomfort; headache; mild fever; mild pain, redness, swelling, or tenderness at the injection site; muscle or joint aches or pain; nausea; sore throat; stuffy nose; sweating; tiredness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; dizziness; loss of appetite; muscle weakness; numbness or tingling of the hands or feet; red, swollen, blistered, or peeling skin; 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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Fluvirin Side Effects - for the Professional

Fluvirin

Overall Adverse Reaction Profile

Serious allergic reactions, including anaphylactic shock, have been observed in individuals receiving Fluvirin® during postmarketing surveillance.

Clinical Trial Experience

Adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, the adverse reaction 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 rates observed in clinical practice.

Adult and Geriatric Subjects

Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received Fluvirin® in 29 clinical studies since 1982.

In 9 clinical studies since 1997, among 1261 recipients of Fluvirin®, 745 (59%) were women; 1211 (96%) were White, 23 (2%) Asian, 15 (1%) Black and 12 (1%) other; 370 (29%) of subjects were elderly (≥65 years of age). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where Fluvirin® was used as a comparator for an unlicensed vaccine.

After vaccination, the subjects were observed for 30 minutes for hypersensitivity or other immediate reactions. Subjects were instructed to complete a diary card for three days following immunization (i.e. Day 1 to 4) to collect local and systemic reactions. All local and systemic adverse events were considered to be at least possibly related to the vaccine. Local and systemic reactions mostly began between day 1 and day 2. The overall adverse events reported in clinical trials since 1998 in at least 5% of the subjects are summarized in Table 3.

TABLE 1 Solicited Adverse Events in the First 72-96 Hours After Administration of Fluvirin® in Adult (18-64 years of age) and Geriatric (≥65 years of age) Subjects.

	1998-1999*§			1999-2000*§			2000-2001*§
	18-64 yrs	≥ 65 yrs		18-64 yrs	≥ 65 yrs		18-64 yrs	≥ 65 yrs
	N = 66	N = 44		N = 76	N = 34		N = 75	N = 35
Results reported to the nearest whole percent; Fever defined as >38°C
– not reported
* Solicited adverse events in the first 72 hours after administration of Fluvirin®
§ Solicited adverse events reported by COSTART preferred term
^ Solicited adverse events reported by MEDDRA preferred term
Local Adverse Events
Pain	16 (24%)	4 (9%)		16 (21%)	-		9 (12%)	-
Mass	7 (11%)	1 (2%)		4 (5%)	-		8 (11%)	1 (3%)
Inflammation	5 (8%)	2 (5%)		6 (8%)	-		7 (9%)	1 (3%)
Ecchymosis	4 (6%)	1 (2%)		3 (4%)	1 (3%)		4 (5%)	-
Edema	2 (3%)	1 (2%)		1 (1%)	2 (6%)		3 (4%)	1 (3%)
Reaction	2 (3%)	-		2 (3%)	-		4 (5%)	1 (3%)
Hemorrhage	-	-		1 (1%)	-		-	-
Systemic Adverse Events
Headache	7 (11%)	1 (2%)		17 (22%)	3 (9%)		4 (5%)	-
Fatigue	3 (5%)	2 (5%)		4 (5%)	1 (3%)		3 (4%)	-
Malaise	2 (3%)	1 (2%)		2 (3%)	1 (3%)		1 (1%)	-
Myalgia	1 (2%)	-		2 (3%)	-		-	-
Fever	1 (2%)	-		1 (1%)	-		-	-
Arthralgia	-	1 (2%)		-	1 (3%)		-	-
Sweating	-	-		3 (4%)	-		1 (1%)	1 (3%)
	2001-2002*^			2002-2003*^			2004-2005*^
	18-64 yrs		≥ 65 yrs	18-64 yrs		≥ 65 yrs	18-64 yrs	≥ 65 yrs
	N = 75		N = 35	N = 107		N = 88	N = 74	N = 61
Local Adverse Events
Pain	12 (16%)		1 (3%)	14 (13%)		7 (8%)	15 (20%)	9 (15%)
Mass	4 (5%)		1 (3%)	-		-	-	-
Ecchymosis	2 (3%)		-	3 (3%)		3 (3%)	2 (3%)	1 (2%)
Edema	2 (3%)		1 (3%)	6 (6%)		2 (2%)	-	-
Erythema	5 (7%)		-	11 (10%)		5 (6%)	16 (22%)	5 (8%)
Swelling	-		-	-		-	11 (15%)	4 (7%)
Reaction	-		-	2 (2%)		-	-	-
Induration	-		-	14 (13%)		3 (3%)	11 (15%)	1 (2%)
Pruritus	-		-	1 (1%)		-	-	-
Systemic Adverse Events
Headache	8 (11%)		1 (3%)	12 (11%)		9 (10%)	14 (19%)	3 (5%)
Fatigue	1 (1%)		1 (3%)	-		-	5 (7%)	2 (3%)
Malaise	3 (4%)		-	3 (3%)		4 (5%)	1 (1%)	1 (2%)
Myalgia	3 (4%)		-	5 (5%)		3 (3%)	8 (11%)	1 (2%)
Fever	-		-	-		1 (1%)	-	-
Arthralgia	-		-	2 (2%)		-	1 (1%)	-
Sweating	3 (4%)		1 (3%)	-		2 (2%)	-	-
Shivering	-		-	-		1 (1%)	-	-

TABLE 2 Solicited Adverse Events in the First 72 Hours After Administration of Fluvirin® in Adult Subjects (18-49 years of age).

	2005-2006 US Trial
	Fluvirin®
	N = 304
Results reported to the nearest whole percent
– not reported
Local Adverse Events
Pain	168 (55%)
Erythema	48 (16%)
Ecchymosis	22 (7%)
Induration	19 (6%)
Swelling	16 (5%)
Systemic Adverse Events
Headache	91 (30%)
Myalgia	64 (21%)
Malaise	58 (19%)
Fatigue	56 (18%)
Sore throat	23 (8%)
Chills	22 (7%)
Nausea	21 (7%)
Arthralgia	20 (7%)
Sweating	17 (6%)
Cough	18 (6%)
Wheezing	4 (1%)
Chest tightness	4 (1%)
Other difficulties breathing	3 (1%)
Facial edema	-

TABLE 3 Adverse Events Reported by at least 5% of Subjects in Clinical Trials since 1998

	1998-1999§				1999-2000§			2000-2001§
	18-64 yrs	≥ 65 yrs			18-64 yrs	≥ 65 yrs		18-64 yrs	≥ 65 yrs
	N = 66	N = 44			N = 76	N = 34		N = 75	N = 35
Results reported to the nearest whole percent; Fever defined as >38°C
– not reaching the cut-off of 5%
§ Solicited adverse events reported by COSTART preferred term
^ Solicited adverse events reported by MEDDRA preferred term
Adverse Events
Fatigue	8 (12%)	2 (5%)			8 (11%)	2 (6%)		5 (7%)	-
Back pain	4 (6%)	3 (7%)			-	-		-	-
Cough increased	2 (3%)	2 (5%)			-	-		-	-
Ecchymosis	4 (6%)	1 (2%)			4 (5%)	1 (3%)		5 (7%)	-
Fever	3 (5%)	-			-	-		-	-
Headache	12 (18%)	5 (11%)			22 (29%)	5 (15%)		14 (19%)	2 (6%)
Infection	3 (5%)	2 (5%)			-	-		-	-
Malaise	4 (6%)	4 (9%)			4 (5%)	1 (3%)		-	-
Migraine	4 (6%)	1 (2%)			-	-		-	-
Myalgia	4 (6%)	1 (2%)			-	-		-	-
Sweating	5 (8%)	1 (2%)			-	-		-	-
Rhinitis	3 (5%)	1 (2%)			-	-		5 (7%)	2 (6%)
Pharingitis	6 (9%)	1 (2%)			10 (13%)	-		6 (8%)	-
Arthralgia	-	-			-	2 (6%)		-	-
Injection site pain	16 (24%)	4 (9%)			16 (21%)	-		9 (12%)	-
Injection site ecchymosis	4 (6%)	1 (2%)			-	-		4 (5%)	-
Injection site mass	7 (11%)	1 (2%)			4 (5%)	-		8 (11%)	1 (3%)
Injection site edema	-	-			1 (1%)	2 (6%)		-	-
Injection site      inflammation	5 (8%)	2 (5%)			6 (8%)	-		7 (9%)	1 (3%)
Injection site reaction	-	-			-	-		4 (5%)	1 (3%)
	2001-2002^			2002-2003^				2004-2005^
	18-64 yrs		≥ 65 yrs	18-64 yrs			≥ 65 yrs	18-64 yrs	≥ 65 yrs
	N = 75		N = 35	N = 107			N = 88	N = 74	N = 61
Adverse Events
Fatigue	5 (7%)		4 (11%)	11 (10%)			8 (9%)	4 (5%)	2 (3%)
Hypertension	-		-	1 (1%)			4 (5%)	-	-
Rinorrhea	-		-	2 (2%)			5 (6%)	-	-
Headache	20 (27%)		2 (6%)	35 (33%)			18 (20%)	12 (16%)	1 (2%)
Malaise	6 (8%)		1 (3%)	13 (12%)			8 (9%)	-	-
Myalgia	4 (5%)		1 (3%)	10 (9%)			4 (5%)	-	-
Sweating	3 (4%)		3 (9%)	2 (2%)			5 (6%)	-	-
Rhinitis	4 (5%)		-	-			-	-	-
Pharingitis	-		-	-			-	6 (8%)	-
Arthralgia	-		-	5 (5%)			4 (5%)	-	-
Sore throat	4 (5%)		1 (3%)	5 (5%)			4 (5%)	-	-
Injection site pain	13 (17%)		3 (9%)	14 (13%)			7 (8%)	6 (8%)	2 (3%)
Injection site ecchymosis	4 (5%)		1 (3%)	4 (4%)			4 (5%)	-	-
Injection site erythema	5 (7%)		2 (6%)	11 (10%)			5 (6%)	4 (5%)	-
Injection site mass	4 (5%)		1 (3%)	-			-	-	-
Injection site edema	-		-	6 (6%)			2 (2%)	4 (5%)	1 (2%)
Injection site induration	-		-	14 (13%)			3 (3%)	7 (9%)	-

Adults (18 to 64 years of age)

In adult subjects, solicited local adverse events occurred with similar frequency in all trials. The most common solicited adverse events occurring in the first 96 hours after administration (Tables 1 and 2) were associated with the injection site (such as pain, erythema, mass, induration and swelling) but were generally mild/moderate and transient. The most common solicited systemic adverse events were headache and myalgia.

The most common overall events in adult subjects (18-64 years of age) were headache, fatigue, injection site reactions (pain, mass, erythema, and induration) and malaise (Table 3).

Geriatric Subjects (65 years of age and older)

In geriatric subjects, solicited local and systemic adverse events occurred less frequently than in adult subjects. The most common solicited local and systemic adverse events were injection site pain, and headache (Tables 1 and 2). All were considered mild/moderate and were transient.

The most common overall events in elderly subjects (≥65 years of age) were headache and fatigue.

Only 11 serious adverse events in adult and geriatric subjects (18 years and older) have been reported to date from all the trials performed. These serious adverse events were a minor stroke experienced by a 67 year old subject 14 days after vaccination (1990), death of an 82 year old subject 35 days after vaccination (1990) in very early studies; death of a 72 year old subject 19 days after vaccination (1998-1999), a hospitalization for hemorrhoidectomy of a 38 year old male subject (1999-2000), a severe respiratory tract infection experienced by a 74 year old subject 12 days after vaccination (2002-2003), a planned transurethral resection of the prostate in a subject with prior history of prostatism (2004-2005), two cases of influenza (2005-2006), a drug overdose (2005-2006), cholelithiasis (2005-2006) and a nasal septal operation (2005-2006). None of these events were considered causally related to vaccination.

Clinical Trial Experience in Pediatric Subjects

In 1987 a clinical study was carried out in 38 ‘at risk' children aged between 4 and 12 years (17 females and 21 males). To record the safety of Fluvirin®, participants recorded their symptoms on a diary card during the three days after vaccination and noted any further symptoms they thought were attributable to the vaccine. The only reactions recorded were tenderness at the site of vaccination in 21% of the participants on day 1, which was still present in 16% on day 2 and 5% on day 3. In one child, the tenderness was also accompanied by redness at the site of injection for two days. The reactions were not age-dependent and there was no bias towards the younger children.

Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6 - 47 months). Of these, 285 healthy subjects plus 41 ‘at risk' subjects received FLUVIRN®. No serious adverse events were reported.

Fluvirin® should only be used for the immunization of persons aged 4 years and over.

Postmarketing Experience

The following additional adverse reactions have been reported during post-approval use of Fluvirin®. 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. 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.

• Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema.
• Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death.
• Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination.
• Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain.
• Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia.
• Metabolic and nutritional disorders: Loss of appetite.
• Musculoskeletal: Arthralgia; myalgia; myasthenia.
• Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell's Palsy).
• Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis.
• Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobulbous).

Other Adverse Reactions Associated with Influenza Vaccination

Anaphylaxis has been reported after administration of Fluvirin®. Although Fluvirin® 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 polyangiitis (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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