INFLUENZA VACCINE

Influenza Vaccine Adverse Events Reported to the FDA Over Time

How are Influenza Vaccine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Influenza Vaccine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Influenza Vaccine is flagged as the suspect drug causing the adverse event.

Most Common Influenza Vaccine Adverse Events Reported to the FDA

What are the most common Influenza Vaccine adverse events reported to the FDA?

Dyspnoea	30 (2.7%)
Malaise	28 (2.52%)
Cough	20 (1.8%)
Pyrexia	15 (1.35%)
Diarrhoea	13 (1.17%)
Nasopharyngitis	13 (1.17%)
Asthma	12 (1.08%)
Rash	12 (1.08%)
Urticaria	12 (1.08%)
Headache	11 (.99%)
Nausea	11 (.99%)
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Arthralgia	10 (.9%)
Chills	10 (.9%)
Hypersensitivity	10 (.9%)
Pain	10 (.9%)
Asthenia	9 (.81%)
Memory Impairment	9 (.81%)
Myalgia	9 (.81%)
Pruritus	9 (.81%)
Abasia	8 (.72%)
Death	8 (.72%)
Dehydration	8 (.72%)
Drug Ineffective	8 (.72%)
Drug Interaction	8 (.72%)
Fall	8 (.72%)
Fatigue	8 (.72%)
Interstitial Lung Disease	8 (.72%)
Loss Of Consciousness	8 (.72%)
Pain In Extremity	8 (.72%)
Vomiting	8 (.72%)
Influenza	7 (.63%)
Syncope	7 (.63%)
Condition Aggravated	6 (.54%)
Drug Exposure During Pregnancy	6 (.54%)
Influenza Like Illness	6 (.54%)
Insomnia	6 (.54%)
Urinary Tract Infection	6 (.54%)
Back Pain	5 (.45%)
Blood Creatinine Increased	5 (.45%)
Bronchitis	5 (.45%)
Decreased Appetite	5 (.45%)
Dizziness	5 (.45%)
Hypotension	5 (.45%)
Irritability	5 (.45%)
Movement Disorder	5 (.45%)
Multiple Sclerosis Relapse	5 (.45%)
Pneumonia	5 (.45%)
Sleep Disorder	5 (.45%)
Swelling	5 (.45%)
Vaccination Complication	5 (.45%)
Weight Decreased	5 (.45%)
Blood Glucose Increased	4 (.36%)
Chromaturia	4 (.36%)
Drug Effect Decreased	4 (.36%)
Feeling Abnormal	4 (.36%)
Fibromyalgia	4 (.36%)
Folliculitis	4 (.36%)
Helicobacter Gastritis	4 (.36%)
Hepatic Failure	4 (.36%)
Hot Flush	4 (.36%)
Lower Respiratory Tract Infection	4 (.36%)
Oropharyngeal Pain	4 (.36%)
Presyncope	4 (.36%)
Renal Failure	4 (.36%)
Sinusitis	4 (.36%)
Subcutaneous Abscess	4 (.36%)
Talipes	4 (.36%)
Abdominal Pain	3 (.27%)
Ageusia	3 (.27%)
Agitation	3 (.27%)
Anaemia	3 (.27%)
Anaemia Haemolytic Autoimmune	3 (.27%)
Anaphylactic Shock	3 (.27%)
Anosmia	3 (.27%)
Bacterial Infection	3 (.27%)
Blood Albumin Decreased	3 (.27%)
Body Temperature Increased	3 (.27%)
Chest Discomfort	3 (.27%)
Chronic Obstructive Pulmonary Disea...	3 (.27%)
Circumstance Or Information Capable...	3 (.27%)
Confusional State	3 (.27%)
Contusion	3 (.27%)
Drug Toxicity	3 (.27%)
Dry Mouth	3 (.27%)
Dyskinesia	3 (.27%)
Dysphonia	3 (.27%)
Dyspnoea Exertional	3 (.27%)
Encephalitis	3 (.27%)
Epistaxis	3 (.27%)
Erythema	3 (.27%)
Erythema Multiforme	3 (.27%)
Foetal Distress Syndrome	3 (.27%)
Grand Mal Convulsion	3 (.27%)
Guillain-barre Syndrome	3 (.27%)
Heart Rate Increased	3 (.27%)
Injection Site Pain	3 (.27%)
Ischaemic Stroke	3 (.27%)
Labyrinthitis	3 (.27%)
Lip Swelling	3 (.27%)
Lymphadenopathy	3 (.27%)
Mobility Decreased	3 (.27%)

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This graph shows the top adverse events submitted to the FDA for Influenza Vaccine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Influenza Vaccine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Influenza Vaccine

What are the most common Influenza Vaccine adverse events reported to the FDA?

Respiratory	80 (7.2%)
Infections - Pathogen Unspecified	65 (5.85%)
Neurological	53 (4.77%)
Epidermal And Dermal Conditions	49 (4.41%)
Gastrointestinal Signs	33 (2.97%)
Muscle	25 (2.25%)
Therapeutic And Nontherapeutic Effe...	24 (2.16%)
Bronchial Disorders	21 (1.89%)
Allergic Conditions	20 (1.8%)
Bacterial Infectious	20 (1.8%)
Musculoskeletal And Connective Tiss...	20 (1.8%)
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Joint	18 (1.62%)
Lower Respiratory Tract Disorders	17 (1.53%)
Body Temperature Conditions	15 (1.35%)
Gastrointestinal Motility And Defec...	15 (1.35%)
Injuries	15 (1.35%)
Movement Disorders	14 (1.26%)
Sleep Disorders	14 (1.26%)
Angiedema And Urticaria	13 (1.17%)
Administration Site Reactions	12 (1.08%)
Headaches	12 (1.08%)
Hematology Investigations	11 (.99%)
Hepatic And Hepatobiliary	11 (.99%)
Mental Impairment	11 (.99%)
Physical Examination Topics	11 (.99%)
Viral Infectious	11 (.99%)
Electrolyte And Fluid Balance Condi...	10 (.9%)
Fatal Outcomes	10 (.9%)
Oral Soft Tissue Conditions	10 (.9%)
Appetite And General Nutritional	9 (.81%)
Chemical Injury And Poisoning	9 (.81%)
Demyelinating	9 (.81%)
Renal Disorders	9 (.81%)
Anxiety Disorders	8 (.72%)
Metabolic, Nutritional And Blood Ga...	8 (.72%)
Seizures	8 (.72%)
Urinary Tract Signs	8 (.72%)
Anemias Nonhemolytic And Marrow Dep...	7 (.63%)
Procedural And Device Related Injur...	7 (.63%)
Upper Respiratory Tract Disorders	7 (.63%)
Vascular	7 (.63%)
Cardiac And Vascular Investigations	6 (.54%)
Central Nervous System Vascular	6 (.54%)
Decreased And Nonspecific Blood Pre...	6 (.54%)
Inner Ear And Viiith Cranial Nerve	6 (.54%)
Lifestyle Issues	6 (.54%)
Medication Errors	6 (.54%)
Peripheral Neuropathies	6 (.54%)
Renal And Urinary Tract Investigati...	6 (.54%)
Salivary Gland Conditions	6 (.54%)
Cardiac Arrhythmias	5 (.45%)
Central Nervous System Infections A...	5 (.45%)
Cranial Nerve Disorders	5 (.45%)
Fungal Infectious	5 (.45%)
Gastrointestinal Hemorrhages	5 (.45%)
Heart Failures	5 (.45%)
Hepatobiliary	5 (.45%)
Mood Disorders	5 (.45%)
Musculoskeletal And Connective Tiss...	5 (.45%)
Platelet	5 (.45%)
White Blood Cell	5 (.45%)
Cardiac And Vascular Disorders Cong...	4 (.36%)
Eye	4 (.36%)
Protein And Chemistry Analyses	4 (.36%)
Skin Vascular Abnormalities	4 (.36%)
Tongue Conditions	4 (.36%)
Blood And Lymphatic System Disorder...	3 (.27%)
Cardiac Disorder Signs	3 (.27%)
Connective Tissue Disorders	3 (.27%)
Coronary Artery	3 (.27%)
Deliria	3 (.27%)
Enzyme	3 (.27%)
Fetal Complications	3 (.27%)
Hemolyses And Related Conditions	3 (.27%)
Skin Appendage Conditions	3 (.27%)
Spleen, Lymphatic And Reticulendoth...	3 (.27%)
Suicidal And Self-injurious Behavio...	3 (.27%)
Bone And Joint Injuries	2 (.18%)
Cardiac Valve	2 (.18%)
Dental And Gingival Conditions	2 (.18%)
Embolism And Thrombosis	2 (.18%)
Food Intolerance Syndromes	2 (.18%)
Glucose Metabolism Disorders	2 (.18%)
Hearing	2 (.18%)
Immunology And Allergy	2 (.18%)
Myocardial	2 (.18%)
Neonatal And Perinatal Conditions	2 (.18%)
Neonatal Respiratory	2 (.18%)
Psychiatric And Behavioural Symptom...	2 (.18%)
Toxicology And Therapeutic Drug Mon...	2 (.18%)
Vascular Hemorrhagic	2 (.18%)
Vascular Hypertensive	2 (.18%)
Vascular Inflammations	2 (.18%)
Vision	2 (.18%)
Acid-base	1 (.09%)
Age Related Factors	1 (.09%)
Anal And Rectal Conditions	1 (.09%)
Arteriosclerosis, Stenosis, Vascula...	1 (.09%)
Bile Duct	1 (.09%)
Bone Disorders	1 (.09%)
Changes In Physical Activity	1 (.09%)

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This graph shows the top categories of adverse events submitted to the FDA for Influenza Vaccine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Influenza Vaccine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.