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Fluzone (Influenza Virus Vaccine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fluzone (Influenza Virus Vaccine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (10)
Death (5)
Life Threatening Events (1)

Reports by Reaction Type

Orthostatic Hypotension (4)Constipation (4)Ileus (4)Dyspnoea (4)Wheezing (3)Death (3)Lymphadenopathy (2)Chills (2)Oropharyngeal Pain (2)Pyrexia (2)Neck Pain (2)Cough (2)

Possible Fluzone side effects in 67 year old male

Reported by a physician from United States on 2012-08-21

Patient: 67 year old male, weighing 89.0 kg (195.8 pounds)

Reactions: Ileus, Orthostatic Hypotension, non-Small Cell Lung Cancer, Failure To Thrive, Constipation, Disease Progression

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 80 mg, daily, tablet
    Administration route: Oral
    Indication: Cardiovascular Event Prophylaxis
    End date: 2011-11-05

Benzonatate
    Dosage: 100 mg, as needed
    Administration route: Oral
    Indication: Cough
    End date: 2011-11-05

Coreg
    Dosage: 3.125 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-10-10

Crizotinib
    Dosage: 250 mg, 2x/day
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-06-03
    End date: 2011-10-24

Fluzone
    Dosage: 1 df, single, injection
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Dosage: unk, tablet
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-11-05

Levofloxacin
    Dosage: 750 mg/ d5w 150 ml q24h, ivpb
    Start date: 2011-10-15
    End date: 2011-10-18

Levothyroxine Sodium
    Dosage: 50 ug, 1x/day,
    Administration route: Oral
    Indication: Hypothyroidism
    End date: 2011-11-05

Meropenem
    Dosage: 1 gram in 50 ml ns q8h, ivpb
    Start date: 2011-10-15
    End date: 2011-10-19

Potassium Chloride
    Dosage: 20 meq, 1x/day, tablet
    Administration route: Oral
    Indication: Supplementation Therapy
    End date: 2011-11-05

Vancomycin HCL
    Dosage: 1750 mg, once, ivpb
    Start date: 2011-10-15
    End date: 2011-10-15

Vancomycin HCL
    Dosage: 1500 mg, 2x/day, ivpb
    Start date: 2011-10-15
    End date: 2011-10-16

Zetia
    Dosage: 10 mg, 1x/day, tablet
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-11-05

Zocor
    Dosage: 40 mg, 1x/day, tablet
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-11-05



Possible Fluzone side effects in 67 year old male

Reported by a physician from United States on 2012-08-09

Patient: 67 year old male, weighing 89.1 kg (196.0 pounds)

Reactions: Death, Ileus, Orthostatic Hypotension, Constipation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aspirin
    Indication: Prophylaxis
    End date: 2011-11-05

Benzonatate
    Indication: Cough
    End date: 2011-11-05

Coreg
    Indication: Hyperlipidaemia
    End date: 2011-10-10

Crizotinib
    Dosage: 250mg twice per day
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-06-03
    End date: 2011-10-24

Fluzone
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Indication: Hypertension

Levothyroxine Sodium
    Dosage: 50mcg per day
    Indication: Hypothyroidism
    End date: 2011-11-05

Potassium Chloride
    Dosage: 20meq per day
    Administration route: Oral
    End date: 2011-11-05

Zetia
    Dosage: 10meq per day
    Indication: Hyperlipidaemia
    Start date: 2011-11-05

Zocor
    Dosage: 40mg per day
    Indication: Hyperlipidaemia
    End date: 2011-11-05



Possible Fluzone side effects in 67 year old male

Reported by a physician from United States on 2012-08-08

Patient: 67 year old male, weighing 89.0 kg (195.8 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Aspirin
    Indication: Cardiovascular Event Prophylaxis
    End date: 2011-11-05

Benzonatate
    Indication: Cough
    End date: 2011-11-05

Coreg
    Indication: Hypertension
    End date: 2011-10-10

Fluzone
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Indication: Hypertension
    End date: 2011-11-05

Levothyroxine Sodium
    Indication: Hypothyroidism
    End date: 2011-11-05

Potassium Chloride
    Indication: Supplementation Therapy
    End date: 2011-11-05

Zetia
    End date: 2011-11-05

Zocor
    End date: 2011-11-05

Other drugs received by patient: Investigational Drug



Possible Fluzone side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 67 year old male, weighing 89.0 kg (195.8 pounds)

Reactions: Abdominal Pain, Pancreatic Mass, Blood Albumin Decreased, Orthostatic Hypotension, Loss of Consciousness, Balance Disorder, Oedema Peripheral, Fluid Retention, Ataxia, Platelet Count Decreased, Left Atrial Dilatation, Atelectasis, Haemorrhage, Constipation, Metastases To Pancreas, Fall, Left Ventricular Dysfunction, Neuropathy Peripheral, Fatigue, Ileus, Pancreatic Pseudocyst, Pleural Effusion, Abdominal Distension, Splenic Haematoma, Procedural Pain, Dyspnoea, Nausea, Diastolic Dysfunction, Livedo Reticularis, Haemoglobin Decreased, Lung Consolidation, Pulmonary Valve Incompetence, Syncope, Blood Potassium Decreased, Metastases To Spleen, Mitral Valve Incompetence, Localised Intraabdominal Fluid Collection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aspirin
    Indication: Prophylaxis
    End date: 2011-11-05

Aspirin
    Indication: Coronary Artery Disease
    End date: 2011-11-05

Benzonatate
    Indication: Cough
    End date: 2011-11-05

Coreg
    Indication: Hypertension
    End date: 2011-10-10

Crizotinib
    Dosage: 250mg - bid - oral
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-06-03
    End date: 2011-10-24

Fluzone
    Dosage: df - subcutaneous
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Indication: Hypertension
    End date: 2011-11-05

Levothyroxine Sodium
    Dosage: 50mcg - qd
    Indication: Hypothyroidism
    End date: 2011-11-05

Potassium Chloride
    Dosage: 20meq - qd
    Indication: Nutritional Support
    End date: 2011-11-05

Zetia
    Dosage: 10 mg - qd
    Indication: Hyperlipidaemia
    End date: 2011-11-05

Zocor
    Dosage: 40 mg - qd
    Indication: Hyperlipidaemia
    End date: 2011-11-05



Possible Fluzone side effects in male

Reported by a physician from United States on 2012-07-16

Patient: male, weighing 89.0 kg (195.8 pounds)

Reactions: Death, Ileus, Orthostatic Hypotension, Constipation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: unk
    Indication: Cardiovascular Event Prophylaxis
    End date: 2011-11-05

Benzonatate
    Dosage: unk
    Indication: Cough
    End date: 2011-11-05

Coreg
    Dosage: unk
    Indication: Hypertension
    End date: 2011-10-10

Crizotinib
    Dosage: 250 mg, 2x/day
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2011-06-03
    End date: 2011-10-24

Fluzone
    Dosage: 1 df, unk
    Indication: Influenza Immunisation
    Start date: 2011-10-05
    End date: 2011-10-05

Lasix
    Dosage: unk
    Indication: Hypertension
    End date: 2011-11-05

Levothyroxine Sodium
    Dosage: 50 ug, 1x/day
    Indication: Hypothyroidism
    End date: 2011-11-05

Potassium Chloride
    Dosage: 20 meq, 1x/day
    Indication: Supplementation Therapy
    End date: 2011-11-05

Zetia
    Dosage: 10 mg, 1x/day
    Indication: Hyperlipidaemia
    End date: 2011-11-05

Zocor
    Dosage: 40 mg, 1x/day
    Indication: Hyperlipidaemia
    End date: 2011-11-05



Possible Fluzone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: female

Reactions: Dyspnoea, Wheezing

Drug(s) suspected as cause:
Fluzone
    Indication: Immunisation
    Start date: 2011-09-26
    End date: 2011-09-26

Tubersol
    Indication: Tuberculin Test
    Start date: 2011-09-26
    End date: 2011-09-26

Other drugs received by patient: Lexapro; Trazodone HCL; Cardizem; Estrogen / Progesterone



Possible Fluzone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-14

Patient: female

Reactions: Dyspnoea, Wheezing

Drug(s) suspected as cause:
Fluzone
    Indication: Immunisation
    Start date: 2011-09-26
    End date: 2011-09-26

Tubersol
    Indication: Tuberculin Test
    Start date: 2011-09-26
    End date: 2011-09-26

Other drugs received by patient: Lexapro; Estrogen / Progesterone; Cardizem; Trazodone HCL



Possible Fluzone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-21

Patient: female

Reactions: Dyspnoea, Wheezing

Drug(s) suspected as cause:
Fluzone
    Indication: Immunisation
    Start date: 2011-09-26
    End date: 2011-09-26

Tubersol
    Indication: Tuberculin Test
    Start date: 2011-09-26
    End date: 2011-09-26



Possible Fluzone side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-24

Patient: female

Reactions: Lymphadenopathy, Neck Pain, Chills, Pyrexia, Oropharyngeal Pain, Cough

Drug(s) suspected as cause:
Fluzone
    Indication: Immunisation
    Start date: 2011-10-03
    End date: 2011-10-03

Tuberculin NOS
    Indication: Tuberculin Test
    Start date: 2011-10-03
    End date: 2011-10-03



Possible Fluzone side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: female

Reactions: Lymphadenopathy, Neck Pain, Chills, Oropharyngeal Pain, Pyrexia, Cough

Drug(s) suspected as cause:
Fluzone
    Indication: Immunisation
    Start date: 2011-10-03
    End date: 2011-10-03

Tuberculin NOS
    Indication: Tuberculin Test
    Start date: 2011-10-03
    End date: 2011-10-03

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