Forum for reporting adverse reactions to Anthrax Vaccine.
Saying American soldiers should not be used as "guinea pigs for experimental drugs," a federal judge ordered the Pentagon to stop mandatory anthrax vaccinations started in 1998.
Excerpted QUOTES from FDA-approved label:
Preliminary results of a recent unpublished retrospective study of infants born to women in the U.S. military service worldwide in 1998 and 1999 suggest that the vaccine may be linked with an increase in the number of birth defects when given during pregnancy (unpublished data, Department of Defense). Although these data are unconfirmed, pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential
risk to the fetus.
Animal reproduction studies have not been conducted with BioThrax.
Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination clearly outweigh the potential risks to the fetus.
Post Licensure Adverse Event Surveillance
Data regarding potential adverse events following anthrax vaccination are available from the Vaccine Adverse Event Reporting System (VAERS).8 The report of an adverse event to VAERS is not proof that a vaccine caused the event. Because of the limitations of spontaneous reporting systems, determining causality for specific types of adverse events, with the exception of injection-site reactions, is often not possible using VAERS data alone. The following four paragraphs describe
spontaneous reports of adverse events, without regard to causality.
From 1990 to October 2001, over 2 million doses of BioThrax have been administered in the United States. Through October 2001, VAERS received approximately 1850 spontaneous reports of adverse events. The most frequently reported adverse events were erythema, headache, arthralgia, fatigue, fever, peripheral swelling, pruritus, nausea, injection site edema, pain/tenderness and dizziness.
Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening. The serious adverse events most frequently reported were in the following body system categories: general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue
disorders, and musculoskeletal, connective tissue and bone disorders. Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax. None of these hypersensitivity reactions have been fatal.
Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.
Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).
Forum Link1: Vaccination Recommended Books
Forum Link2: Vaccine Info and Vaccination Hazards