What are the Risks with the Hepatitis B Vaccine?

The Vaccine Injury Compensation Program (VICP) established a Hepatitis B-Neurological Demyelinating Omnibus Proceeding.

Here’s one compensated case for Transverse Myelitis:
http://www.ccandh.com/decisions/stevens_2-24-06.pdf

A compensated case for Multiple Sclerosis:
http://www.ccandh.com/decisions/werderitsh_5-26-06.pdf

A compensated case for Guillain-Barré Syndrome:
http://www.ccandh.com/decisions/gilbert_3-30-06.pdf

From the Recombivax (Merck) package insert:
http://www.merck.com/product/usa/pi_circul…combivax_pi.pdf

Hypersensitivity

Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, or symptoms consistent with a hypotensive episode have been reported within the first few hours after vaccination.

An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum (see WARNINGS and
PRECAUTIONS).

Digestive System
Elevation of liver enzymes; constipation

Nervous System
Guillain-Barré Syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell’s Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis

Integumentary System
Stevens-Johnson Syndrome; alopecia; petechiae; eczema

Musculoskeletal System
Arthritis
Pain in extremity

Hematologic
Increased erythrocyte sedimentation rate; thrombocytopenia

Immune System
Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis; polyarteritis nodosa

Psychiatric/Behavioral
Irritability; agitation; somnolence

Special Senses
Optic neuritis; tinnitus; conjunctivitis; visual disturbances
Cardiovascular System
Syncope; tachycardia.

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http://www.neurology.org/cgi/content/abstract/63/5/838

Conclusions: These findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS, and challenge the idea that the relation between hepatitis B vaccination and risk of MS is well understood.

(fulltext here)
http://www.mdconsult.com/das/article/body/…01704000838.pdf

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