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File: 970107_sep96_decls31_0003.txt
Subject: REQUEST FOR DETERMINATION INVESTIGATE DRUGS 31 DEC 90
Unit: OTSG
Parent Organization: HSC
Box ID: BX003202
Folder Title: REQUESTS FOR DETERMINATION - OBTAINING INFORMED CONSENT
Document Number: 1
Folder Seq #: 26
INFOR-NIATION ABOUT BOTULINUM VACCINE
You are being given a vaccine called botulin@m taxoid because you
are considered at risk of exposure to botulism. Botulism can
cause serious paralysis or death. it is caused by toxins that
interfere with the normal transmission of nerve signals.
Botulism can arise from; (a) contaminated food and water, (b)
contaminated wounds, or (c) a biological warfare attack. Symptoms
of botulism can begin as early as three hours or as late as
several days after exposure to the toxin. Symptom& include
blurred vision, generalized weakness, difficulty in swallowing
and talking. Treatment after exposure is primarily supportive
and there is an antitoxin/antidote which may be beneficial. Your
primary protection against botulinum toxin is the use of your
chemical protective mask and overgarment. vaccination with
botulinum toxoid is expected to provide additional protection for
individuals exposed to the toxin. However, no vaccine is 100%
effective. No other vaccine is available which can give you this
protection.
This is an investigational (not yet licensed) vaccine that has
been safely given to over 3000 laboratory workers and scientists
over the past 25 years. It will be administered as a series of
three injections under the supervision of qualified medical
personnel.
About 92% of people who are vaccinated report no significant side
effects beyond the local pain experienced at the time the vaccine
is given. However, like other vaccines you have been given, this
one may have some side effects. side effects occur in 4% to St
of people. When they occur, they are usually at the site of
injection and include pain, tenderness, swelling, redness and/or
itching. All these are common symptoms with the typhoid vaccine
you have already received. The number of these local reactions
ease after the first injection. Rarely an
individual may develop a small lump at the injection site which
lasts for several days to weeks before going away. Local
reactions that can interfere with performance of your duties are
very uncommon. Generalized reactions may include fever,
tiredness, headache and/or muscle pain and occur in less than It
of people. Rarely (less than 1 in 1000 injections) an individual
may be unable to perform duties for a day or two. As with any
vaccination, a very rare, unexpected, potentially severe, side
effect not previously observed could occur. If you are pregnant
it is not known if this vaccine will harm your unborn baby.
However, Most vaccines do not harm an unborn baby when given to
the mother.
If a reaction that worries you occurs after you leave the area
where the vaccine was given you should report to sick call.
You may he one of a group to receive a postcard in the next few
weeks asking for information on your Experiences with this vaccine.
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Document 3 f:/Week-36/BX003202/REQUESTS FOR DETERMINATION - OBTAINING INFORMED CONSENT/request for determination investigate drugs 31:01029715472632
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003202
Unit = OTSG
Parent Organization = HSC
Folder Title = REQUESTS FOR DETERMINATION - OBTAINING INFORMED CONSENT
Folder Seq # = 26
Subject = REQUEST FOR DETERMINATION INVESTIGATE DRUGS 31
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 02-JAN-1997