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Gardasil (Human Papillomavirus Vaccine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gardasil (Human Papillomavirus 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 (16)
Death (7)
Life Threatening Events (3)

Reports by Reaction Type

Upper Respiratory Tract Infection (5)Abdominal Pain (4)Fatigue (4)Neuroleptic Malignant Syndrome (3)Activities of Daily Living Impaired (3)Encephalitis Autoimmune (3)Confusional State (2)Pancreatitis Acute (2)Increased Appetite (2)Basilar Migraine (2)Thinking Abnormal (2)Chest Pain (2)

Possible Gardasil side effects in 18 year old female

Reported by a consumer/non-health professional from NEW Zealand on 2012-08-27

Patient: 18 year old female

Reactions: Agitation, Night Sweats, Abdominal Pain, Increased Appetite, Sudden Death, Headache, Fatigue, Thinking Abnormal, Upper Respiratory Tract Infection, Chest Pain, Dizziness, Coordination Abnormal, Acne, Muscular Weakness, Rhinorrhoea, Abnormal Behaviour, Rash, DRY Skin, Amnesia, Paraesthesia, Skin Papilloma, Activities of Daily Living Impaired, Heart Rate Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Depo-Provera
    Dosage: 150 mg, every 3 months
    Indication: Contraception
    Start date: 2008-11-03
    End date: 2008-11-03

Depo-Provera
    Dosage: 150 mg, every 3 months
    Start date: 2009-07-10
    End date: 2009-07-10

Depo-Provera
    Dosage: 150 mg, every 3 months
    Start date: 2009-01-26
    End date: 2009-01-26

Depo-Provera
    Dosage: 150 mg, every 3 months
    Start date: 2009-04-17
    End date: 2009-04-17

Gardasil
    Dosage: single dose
    Indication: Immunisation
    Start date: 2008-09-18
    End date: 2008-09-18

Gardasil
    Dosage: single dose
    Start date: 2008-11-18
    End date: 2008-11-18

Gardasil
    Dosage: single dose
    Start date: 2009-03-17
    End date: 2009-03-17



Possible Gardasil side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-27

Patient: 18 year old female

Reactions: Chest Discomfort, Upper Respiratory Tract Infection, Pulmonary Embolism, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gardasil
    Dosage: unk
    Indication: Immunisation
    Start date: 2011-01-01

Yasmin
    Indication: Acne



Possible Gardasil side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Peripheral Coldness, Pain of Skin, Cystitis, Drug Effect Delayed, Joint Stiffness, Myalgia, Hyperaesthesia, Upper Respiratory Tract Infection, Musculoskeletal Stiffness, Kidney Infection, Feeling Abnormal, Papilloma Viral Infection

Drug(s) suspected as cause:
Gardasil
    Indication: Immunisation
    Start date: 2012-08-13

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-01

Humira
    Start date: 2012-07-01
    End date: 2012-08-13

Humira



Possible Gardasil side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-08-20

Patient: 18 year old female

Reactions: Night Sweats, Abdominal Pain, Agitation, Increased Appetite, Sudden Death, Headache, Thinking Abnormal, Fatigue, Upper Respiratory Tract Infection, Chest Pain, Dizziness, Coordination Abnormal, Acne, Rhinorrhoea, Abnormal Behaviour, Muscular Weakness, DRY Skin, Amnesia, Paraesthesia, Skin Papilloma, Activities of Daily Living Impaired, Heart Rate Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Depo-Provera
    Dosage: 150 mg, every 3 months
    Start date: 2009-01-26
    End date: 2009-01-26

Depo-Provera
    Dosage: 150 mg, every 3 months
    Start date: 2009-07-10
    End date: 2009-07-10

Depo-Provera
    Dosage: 150 mg, every 3 months
    Start date: 2009-04-17
    End date: 2009-04-17

Depo-Provera
    Dosage: 150 mg, every 3 months
    Indication: Contraception
    Start date: 2008-11-03
    End date: 2008-11-03

Gardasil
    Dosage: single dose
    Start date: 2008-11-18
    End date: 2008-11-18

Gardasil
    Dosage: single dose
    Start date: 2009-03-17
    End date: 2009-03-17

Gardasil
    Dosage: single dose
    Indication: Immunisation
    Start date: 2008-09-18
    End date: 2008-09-18



Possible Gardasil side effects in 14 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-09

Patient: 14 year old female

Reactions: Confusional State, Vomiting, Dizziness Postural, Abasia, Basilar Migraine, Loss of Consciousness, Syncope, Drowning, Asthenia, Cardiac Arrest, Crying, Blood Glucose Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gardasil

Yasmin
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Influenza Vaccine



Possible Gardasil side effects in 14 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-13

Patient: 14 year old female

Reactions: Confusional State, Vomiting, Dizziness Postural, Abasia, Basilar Migraine, Loss of Consciousness, Syncope, Drowning, Asthenia, Cardiac Arrest, Crying, Blood Glucose Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gardasil

Yasmin
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Influenza Vaccine



Possible Gardasil side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-07-03

Patient: 18 year old female

Reactions: Upper Respiratory Tract Infection, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gardasil
    Dosage: unk
    Indication: Immunisation
    Start date: 2011-01-01

Yasmin
    Indication: Acne



Possible Gardasil side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29

Patient: female

Reactions: Incorrect Route of Drug Administration, Mutism, Hyperkalaemia, Encephalitis, Hepatic Failure, Multi-Organ Failure, Acute Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Gastrointestinal Obstruction, Renal Failure Acute, Hypertriglyceridaemia, Clonus, Cytolytic Hepatitis, Status Epilepticus, Convulsion, Cardiac Failure, Encephalitis Autoimmune, Septic Shock

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Citalopram Hydrobromide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-01
    End date: 2010-08-13

Gardasil
    Dosage: injectable suspension. human papilloma virus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
    Indication: Immunisation
    Start date: 2008-12-01
    End date: 2009-04-01

Risperdal
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01
    End date: 2010-08-13

Tercian
    Dosage: dose : 50 mg/ 5 ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01
    End date: 2010-08-13

Other drugs received by patient: Lorazepam



Possible Gardasil side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-26

Patient: female

Reactions: Off Label Use, Encephalitis Autoimmune, Neuroleptic Malignant Syndrome

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Citalopram Hydrobromide
    Dosage: 10 mg
    Administration route: Oral
    Start date: 2009-02-01
    End date: 2010-08-13

Gardasil
    Indication: Immunisation
    Start date: 2008-12-01
    End date: 2009-04-01

Risperdal
    Start date: 2010-08-01
    End date: 2010-08-13

Tercian
    Start date: 2010-08-01
    End date: 2010-08-13

Other drugs received by patient: Lorazepam



Possible Gardasil side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-25

Patient: female

Reactions: Incorrect Route of Drug Administration, Hyperkalaemia, Mutism, Encephalitis, Hepatic Failure, Multi-Organ Failure, Acute Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Renal Failure Acute, Hypertriglyceridaemia, Gastrointestinal Obstruction, Cytolytic Hepatitis, Clonus, Status Epilepticus, Convulsion, Cardiac Failure, Encephalitis Autoimmune, Septic Shock

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Citalopram Hydrobromide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-02-01
    End date: 2010-08-13

Gardasil
    Dosage: injectable suspension. human papilloma virus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
    Indication: Immunisation
    Start date: 2008-12-01
    End date: 2009-04-01

Risperdal
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01
    End date: 2010-08-13

Tercian
    Dosage: dose : 50 mg/ 5 ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-01
    End date: 2010-08-13

Other drugs received by patient: Lorazepam



Possible Gardasil side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-17

Patient: 21 year old male

Reactions: Myoclonus, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gardasil

Interferon Gamma NOS

Other drugs received by patient: Valproate Sodium; Ciprofloxacin; Clindamycin



Possible Gardasil side effects in 19 year old female

Reported by a physician from France on 2012-05-10

Patient: 19 year old female

Reactions: Ecchymosis, Idiopathic Thrombocytopenic Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Drospirenone and Ethinyl Estradiol
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-10-01

Gardasil
    Dosage: unk
    Indication: Immunisation
    Start date: 2011-04-01
    End date: 2011-04-01

Gardasil
    Dosage: unk, once
    Start date: 2011-06-01
    End date: 2011-06-01



Possible Gardasil side effects in female

Reported by a physician from France on 2012-05-04

Patient: female

Reactions: Abdominal Pain, Pancreatitis Acute, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Desloratadine
    Administration route: Oral
    Indication: Asthma
    Start date: 2011-01-01
    End date: 2011-10-08

Gardasil
    Indication: Prophylaxis
    Start date: 2011-08-30
    End date: 2011-08-30

Neisvac-C
    Indication: Prophylaxis
    Start date: 2011-10-01
    End date: 2011-10-01

Ventolin
    Indication: Asthma
    Start date: 2011-01-01
    End date: 2011-10-08



Possible Gardasil side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: female

Reactions: Hypersensitivity, Nasopharyngitis, Incorrect Dose Administered, Weight Increased, Hot Flush, Fatigue, Arthralgia, Activities of Daily Living Impaired, Breast Tenderness, Insomnia, Abdominal Distension, Sexual Dysfunction, Toothache

Drug(s) suspected as cause:
Depo-Provera
    Dosage: unk
    Start date: 2010-05-03

Gardasil
    Dosage: unk



Possible Gardasil side effects in female

Reported by a physician from United States on 2012-01-29

Patient: female

Reactions: Myalgia, Fatigue, Pyrexia

Drug(s) suspected as cause:
Gardasil
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Product Used FOR Unknown Indication



Possible Gardasil side effects in female

Reported by a physician from France on 2011-11-28

Patient: female

Reactions: Pancreatitis Acute, Abdominal Pain, Oedema, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Desloratadine
    Administration route: Oral
    Indication: Asthma
    Start date: 2011-01-01
    End date: 2011-10-08

Gardasil
    Indication: Prophylaxis
    Start date: 2011-08-30
    End date: 2011-08-30

Neisvac-C
    Indication: Prophylaxis
    Start date: 2011-10-01
    End date: 2011-10-01

Ventolin
    Indication: Asthma
    Start date: 2011-01-01
    End date: 2011-10-08

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