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Subject: Merck - Vaccine Packet Insert
Date: Tue, 28 Nov 2000 17:45:14 -0800
This is from another list. This is from the insert that Merck puts into
the vaccine. FYI this is from the new thimerosal free Hep B vaccine. Two points my husband and I noted were: a) Look at the side-effects (even as this is thimerosal free) b) Look at the numbers - I find it surprising that they had such a small number of individuals that were tested and that the percentages were so high. here goes: Hypersensitivity - Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, uticaria, 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: althralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, eccymoses and erythema nodosum (see Warnings and Precautions). Digestive System - Elevation of liver enzymes; constipation Nervous System - Guillain-Barre Syndrome; multiple sclerosis; myelitis including transverse myelitis; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis Integumentary System - Stevens-Johnson Syndrompe; alopecia; petechiae Musculoskeletal System - Arthritis Hematologic Increased erythrocyte sedimentation rate; thrombocytopenia. Immune System - Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis. Psychiatric/Behavioral - Irritability; agitation; somnolence. Special Senses - Optic neuritis; tinnitus; conjunctivitis; visual disturbances. Cardiovascular system - Syncope; tachycardia. The following adverse reaction has been reported with another Hepatitis B vaccine (Recombinant) but not with RECOMBIVAX B; keratitis. Adverse Reactions RECOMBIVAX HB and RECOMBIVAX HB Dialysis Formulation are generally well tolerated. No serious adverse reactions attributable to the vaccine have been reported during the course of clinical trials. No adverse experiences were reported during clinical trials which could be related to changes in the titers of antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials (HELLO !!!) In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency were irritability, fever (greater than or equal to 101 degree oral fever) diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the three-dose regimen (5 mcg) with the 2 dose regiment(10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar. In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administerred to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported: Incidence equal to or greater than 1% of the Injections Local Reaction - Injection site - Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, eccymosis, swelling, warmth and nodule formation. Body as a whole - The most frequent systemic compaints include fatigue/weakness; headache; fever (greater than or equal to 100 degrees F.) and malaise. Sweating achiness; sensation of warmth; lightheadedness; chills and flushing. Digestive System - Vomiting, abdominal pains/cramps; dyspepsia; and dinished appetite. Nausea and diarrhea. Respiratory System - Pharyngitis; and upper respiratory infection, influenza and cough. Nervous system - Vertigo/dizziness and paresthesia Integumentary System - Pruritus; rash (non-specified); angioedema; and urticaria Musculoskeletal system - Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; and neck stiffness. Hemic/Lymphatic System - Lymphadenopathy Psychiatric/behavioral - Insomnia/disturbed sleep Special senses - earache Urogenital system - dysuria Cardiovascular system - hypotension Marketed Experience - The following additional adverse reactions have been reported with use of the marketed vaccine: 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, ecchymosis and erythema nodosum (see WARNINGS and PRECAUTIONS)
Personally I do not understand how this drug company can do clinical
trials with 147 kids for only 5 days and then are able to release it
with no liability whatsoever. Who do they report to? (the FDA?)
What reputable research firm does a clinical trial of 1252 adults and
only follows them for 5 days? What happens to any findings after 5
days? --Good questions that deserve answers. Ingri Cassel, President Vaccination Liberation - North Idaho Chapter |