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Havrix (Hepatitis A Vaccine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Havrix (Hepatitis A 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 (6)

Reports by Reaction Type

Loss of Consciousness (4)Myelitis (1)Myelitis Transverse (1)Paraplegia (1)Malaise (1)Fatigue (1)Irritable Bowel Syndrome (1)Coordination Abnormal (1)Multiple Sclerosis (1)Maternal Exposure During Pregnancy (1)Maternal Exposure Before Pregnancy (1)Hypoaesthesia (1)

Possible Havrix side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-21

Patient: 73 year old male, weighing 72.7 kg (159.9 pounds)

Reactions: Loss of Consciousness

Drug(s) suspected as cause:
Elocon
    Dosage: top
    Administration route: Topical
    Indication: DRY Skin
    Start date: 2011-03-10
    End date: 2012-01-01

Influenza Virus (Influenza Vaccine)
    Dosage: 1 dl qd
    Indication: Prophylaxis

Havrix
    Dosage: 1 df; qd
    Indication: Prophylaxis

Menthol (Menthol / 00482791 / )
    Indication: DRY Skin

Betamethasone
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Eucerin Urea (Urea / 00481901 / )
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Revaxis (Revaxis / 01525501 / )
    Dosage: 1 dfl qd
    Indication: Prophylaxis

Other drugs received by patient: Aspirin; Betamethasone Valerate; Zebeta



Possible Havrix side effects in 73 year old male

Reported by a pharmacist from United Kingdom on 2012-03-30

Patient: 73 year old male, weighing 72.7 kg (159.9 pounds)

Reactions: Loss of Consciousness

Drug(s) suspected as cause:
Urea (Urea / 00481901 / )
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Elocon
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Havrix
    Dosage: 1 df;qd
    Indication: Prophylaxis

Influenza Virus (Influenza Vaccine)
    Dosage: 1 df;qd
    Indication: Prophylaxis

Betamethasone
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Aqueous Cream (Phenoxyethanol)
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Menthol (Menthol / 00482701 / )
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Revaxis (Revaxis / 01525501 / )
    Dosage: 1 df;qd
    Indication: Prophylaxis



Possible Havrix side effects in male

Reported by a pharmacist from United Kingdom on 2012-03-21

Patient: male, weighing 72.7 kg (159.9 pounds)

Reactions: Loss of Consciousness

Drug(s) suspected as cause:
Havrix
    Dosage: 1inj single dose
    Indication: Prophylaxis

Aqueous Cream + Menthol
    Indication: DRY Skin
    Start date: 2011-01-01

Urea Cream
    Indication: DRY Skin
    Start date: 2011-01-01

Influenza Vaccine
    Dosage: 1inj single dose
    Indication: Prophylaxis

Betnovate
    Indication: DRY Skin
    Start date: 2011-01-01

Revaxis
    Dosage: 1inj single dose
    Indication: Prophylaxis

Elocon
    Indication: DRY Skin
    Start date: 2011-01-01



Possible Havrix side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-03-06

Patient: male

Reactions: Loss of Consciousness

Drug(s) suspected as cause:
Havrix
    Dosage: 1inj single dose
    Indication: Prophylaxis

Revaxis
    Dosage: 1inj single dose
    Indication: Prophylaxis

Aqueous Cream + Menthol
    Indication: DRY Skin
    Start date: 2011-01-01

Urea Cream
    Indication: DRY Skin
    Start date: 2011-01-01

Influenza Vaccine
    Dosage: 1inj single dose
    Indication: Prophylaxis

Betnovate
    Indication: DRY Skin
    Start date: 2011-01-01

Elocon
    Indication: DRY Skin
    Start date: 2011-01-01



Possible Havrix side effects in 37 year old female

Reported by a physician from Switzerland on 2012-02-10

Patient: 37 year old female

Reactions: Maternal Exposure During Pregnancy, Maternal Exposure Before Pregnancy, Premature Delivery

Drug(s) suspected as cause:
Revaxis
    Dosage: .5ml per day
    Indication: Prophylaxis
    Start date: 2010-11-08
    End date: 2010-11-08

Havrix
    Dosage: 1ml per day
    Indication: Prophylaxis
    Start date: 2010-11-08
    End date: 2010-11-08

Priorix
    Dosage: .5ml per day
    Indication: Prophylaxis
    Start date: 2010-11-08
    End date: 2010-11-08

Atovaquone
    Indication: Prophylaxis
    Start date: 2010-11-30
    End date: 2010-12-10



Possible Havrix side effects in male

Reported by a lawyer from Germany on 2012-01-26

Patient: male

Reactions: Myelitis, Myelitis Transverse, Paraplegia, Fatigue, Malaise, Irritable Bowel Syndrome, Coordination Abnormal, Multiple Sclerosis, Cognitive Disorder, Hypoaesthesia, Vaccination Complication, Paraesthesia, Diarrhoea, Vertigo, Gait Disturbance, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Havrix
    Indication: Prophylaxis
    Start date: 2001-05-08
    End date: 2001-05-08

Itraconazole
    Administration route: Oral

Other drugs received by patient: IPV Virelon; TD PUR; IPV Virelon; Stamaril; Vaqta; TD PUR; TD PUR

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