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Engerix-B (Hepatitis B Vaccine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Engerix-B (Hepatitis B 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 (4)
Disability (1)

Reports by Reaction Type

Pallor (2)Loss of Consciousness (2)Convulsion (2)Tremor (2)Syncope (2)Heart Rate Decreased (2)Presyncope (2)Asthenia (2)Blood Pressure Decreased (2)Rheumatoid Arthritis (1)Hypokinesia (1)Raynaud's Phenomenon (1)

Possible Engerix-B side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-07

Patient: 48 year old male

Reactions: Drug Resistance, Vaccination Failure, Lipoatrophy

Drug(s) suspected as cause:
Engerix-B
    Indication: Product Used FOR Unknown Indication

Abacavir
    Dosage: unk
    Indication: Antiretroviral Therapy
    Start date: 2007-11-01

Entacavir
    Dosage: unk
    Indication: Antiretroviral Therapy

Hbvaxpro
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lamivudine
    Dosage: unk
    Indication: Antiretroviral Therapy
    Start date: 2006-06-01

Zidovudine
    Dosage: unk
    Indication: Antiretroviral Therapy

Other drugs received by patient: Efavirenz



Possible Engerix-B side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-01-11

Patient: male

Reactions: Pallor, Convulsion, Loss of Consciousness, Tremor, Heart Rate Decreased, Syncope, Presyncope, Blood Pressure Decreased, Asthenia

Drug(s) suspected as cause:
Engerix-B
    Dosage: 1.0 ml im
    Indication: Immunisation

Tubersol
    Dosage: 0.1 ml,
    Indication: Tuberculin Test



Possible Engerix-B side effects in 22 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-08

Patient: 22 year old male

Reactions: Pallor, Loss of Consciousness, Tremor, Convulsion, Syncope, Heart Rate Decreased, Presyncope, Blood Pressure Decreased, Asthenia

Drug(s) suspected as cause:
Tubersol
    Indication: Tuberculin Test
    Start date: 2010-08-09
    End date: 2010-08-09

Engerix-B
    Indication: Immunisation
    Start date: 2010-08-09
    End date: 2010-08-09



Possible Engerix-B side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-10

Patient: 50 year old male

Reactions: Rheumatoid Arthritis, Hypokinesia, Diarrhoea, Alanine Aminotransferase Increased, Raynaud's Phenomenon, Depression, Cutaneous Lupus Erythematosus

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Engerix-B
    Indication: Prophylaxis
    Start date: 2001-03-30
    End date: 2001-03-30

Azathioprine
    Indication: Product Used FOR Unknown Indication

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