[NPInfo] Any Problems with Gardasil?
stephanie2u at optonline.net
stephanie2u at optonline.net
Fri Aug 17 05:58:45 PDT 2007
My take: she had a vasovagal reaction--very common with teens. The rest of it was hysteria.
Stephanie Walker, FNP
----- Original Message -----
From: Lisa Meyer
Date: Thursday, August 16, 2007 9:21 pm
Subject: Re: [NPInfo] Any Problems with Gardasil?
To: NP Info
> I recently saw a young girl in the ER with a near-sycopal
> episode,
> hyperventilation, complaints of numbness and tingling (which I
> attributed to
> her hyperventilation), and hysteria (crying and rocking). She
> had sudden
> onset of this seconds after receiving a Gardasil vac. I
> attributed all of
> her symptoms at the time to a panic reaction/needle phobia, as
> she was very
> dramatic in her presentation and had no objective signs on exam.
> I now am
> wondering if I was indeed seeing a vaccine reaction, or rather,
> wonder
> whether all of the reported similar reactions could be explained
> by the
> sometimes dramatic and excitable nature of the majority of those
> receiving
> this vaccine (adolescent females). At any rate, we observed her
> in the ED
> for an hour or so, and she gradually improved enough to be
> discharged, but
> continued to "feel weak and shaky". She ended up returning to
> the ED the
> next day and saw another provider since she continued to feel
> not well. I
> have a hard time believing that a vac. reaction (other than
> anaphylaxis)
> would have such an immediate onset... Any thoughts?
>
> Lisa
> ----- Original Message -----
> From: "Paula Sumner"
> To: "NP Info"
> Sent: Wednesday, August 15, 2007 10:28 PM
> Subject: Re: [NPInfo] Any Problems with Gardasil?
>
>
> > This just validates what one MD preceptor told me years ago-he
> waits 5
> > years after a new drug is released just in case of problems..Paula
> >
> > mmhelgert46 at comcast.net wrote: Vaccine Safety Group Releases
> GARDASIL
> > Reaction Report
> > Main Category: / STDs News
> > Article Date: 22 Feb 2007 - 0:00 PDT
> >
> > http://www.medicalnewstoday.com/articles/63586.php
> >
> > The National Vaccine Information Center (NVIC) today released
> a new
> > analysis of the federal Vaccine Adverse Event Reporting System
> (VAERS)
> > reports of serious health problems following HPV vaccination
> (Merck's
> > GARDASIL) during the last six months of 2006. Out of the 385
> individual
> > GARDASIL adverse event reports made to VAERS, two-thirds
> required
> > additional medical care and about one-third of all reports
> were for
> > children 16-years-old and under, with nearly 25 percent of
> those children
> > having received simultaneously one or more of the 18 vaccines
> that Merck
> > did not study in combination with GARDASIL. NVIC is calling on
> the FDA and
> > CDC to warn parents and doctors that GARDASIL should not be
> combined with
> > other vaccines and that young girls should be monitored for at
> least 24
> > hours for syncopal (collapse/fainting) episodes that can be
> accompanied by
> > seizure activity, as well as symptoms of tingling, numbness
> and loss of
> > sensation in the fingers and limbs, all of which should be
> > !
> > reporte
> > d to VAERS immediately.
> >
> > "Because Merck only studied GARDASIL in fewer than 1200 girls
> under age 16
> > in pre-licensure trials, it is critical that doctors and
> parents be made
> > aware of the nature of the initial adverse event reports
> coming into VAERS
> > and that they report serious health problems after vaccination
> when they
> > occur," said NVIC President Barbara Loe Fisher. "There are
> twice as many
> > children collapsing and four times as many children
> experiencing tingling,
> > numbness and loss of sensation after getting a GARDASIL
> vaccination
> > compared to those getting a Tdap (tetanus-diphtheria-acellular
> pertussis)
> > vaccination. There have been reports of facial paralysis and
> > Guillain-Barre Syndrome. And doctors who give GARDASIL in
> combination with
> > other vaccines are basically conducting an experiment on their
> young
> > patients because Merck has not published any safety data for
> simultaneous
> > vaccination with any vaccine except hepatitis B vaccine."
> >
> > According to NVIC's report, a majority of GARDASIL adverse
> event reports
> > to VAERS involved those who suffered fever, nausea, headache
> or pain; 14
> > percent were for syncopal episodes with or without
> neurological signs; and
> > 8 percent experienced tingling, numbness and loss of
> sensation, facial
> > paralysis or Guillain-Barre Syndrome. Although adverse event
> reports to
> > VAERS do not prove causation, they can provide an early
> warning sign that
> > a new vaccine may be causing health problems that could be
> important. For
> > example, reports to VAERS of bowel blockage (intussusception)
> in babies
> > following receipt of Merck's Rota Teq (rotavirus) vaccine
> prompted the FDA
> > to issue a public warning to doctors and consumers on Feb. 13.
> >
> > "About 4 reports per day were filed with VAERS in December
> 2006 for the
> > HPV vaccine," said NVIC Health Policy Analyst Vicky Debold,
> RN, Ph.D.
> > "Some of these girls are being injured when they collapse
> after getting
> > the vaccine and others are complaining of neurological
> symptoms that
> > should not be ignored. Doctors and nurses should take note of
> the patient
> > safety issues related to giving this vaccine. Giving GARDASIL
> > simultaneously with any of the 18 vaccines Merck did not study
> in
> > combination is not an evidence-based guideline and should
> involve informed
> > consent and a signed patient release. To avoid unnecessary
> injuries,
> > teenage girls should be vaccinated laying down, not be left
> unattended and
> > probably should not walk or drive themselves home from the
> doctor's office
> > after they get vaccinated."
> >
> > NVIC also found that there were several VAERS reports of HPV
> infection,
> > genital warts and cervical lesions after GARDASIL vaccination.
> It is
> > unknown if the girls were infected with HPV before being
> vaccinated or if
> > GARDASIL failed to protect them. One case of HPV infection
> occurred in a
> > 22-year-old girl who had participated in a Merck GARDASIL
> trial in 2003
> > when she had shown "strong conversion to all 4 vaccine types"
> but "tested
> > positive for high risk HPV" in 2006, according to the VAERS report.
> >
> > In a May 18, 2006 Background Document for the FDA Vaccines and
> Related
> > Biological Products Advisory Committee (VRPBAC), the FDA staff
> stated that
> > Merck clinical trial data indicated there may be "the
> potential for
> > GARDASIL to enhance cervical disease in subjects who had
> evidence of
> > persistent infection with vaccine-relevant HPV types prior to
> > vaccination." Girls and women now being vaccinated with
> GARDASIL are not
> > routinely being tested for active HPV infection before vaccination.
> >
> > The FDA staff also questioned whether the "HPV types not
> contained in the
> > vaccine might offset the overall clinical effectiveness of the
> vaccine."
> > There are more than 15 types of HPV associated with cervical
> cancer but
> > GARDASIL only contains HPV types 16 and 18. It is unknown
> whether
> > non-vaccine HPV types will become more dominant in the future.
> However,
> > there are indications this could occur because some of the
> seven strains
> > of pneumococcal contained in Wyeth's PREVNAR vaccine, which
> was
> > recommended by the CDC for universal use in all babies in
> 2000, have been
> > replaced by some of the more than 80 other pneumococcal
> strains not
> > contained in the vaccine.
> >
> > VAERS is a passive surveillance system and depends upon
> voluntary
> > reporting of serious health problems following vaccination,
> even though
> > safety provisions in the National Childhood Vaccine Injury Act
> of 1986
> > mandated that health care providers report vaccine adverse
> events. There
> > have been estimates that fewer than 10 percent, even as low as
> 1 to 4
> > percent, of adverse events which occur after prescription drug
> or vaccine
> > use are ever reported to government adverse event reporting systems.
> >
> > "If only 1 to 4 percent of all adverse events associated with
> GARDASIL
> > vaccination are being reported to VAERS, there could have been
> up to
> > 38,000 health problems after GARDASIL vaccination in 2006
> which were never
> > reported," said Fisher. "How many girls are really having
> short-term
> > health problems associated with getting this vaccine that
> could turn into
> > long-term neurological or immune system disorders? And how
> many will go on
> > to develop fertility problems, cancer or damage to their
> genes, all of
> > which Merck admits in its product insert that it has not
> studied at all?
> > We just don't know enough to be mandating GARDASIL for anyone,
> much less
> > vulnerable 11 to 12 year old girls entering puberty."
> >
> > National Vaccine Information Center
> > http://www.nvic.org
> >
> > _______________________________________________
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> > *****************************
> >
> >
> >
> > Paula J. Sumner RN, MSN, HTP, CHt
> > Healing Touch, Hypnotherapy, Emotional Freedom Technique,
> Reiki-2
> > 3500 Westgate Dr., Suite 504-G
> > Durham, NC 27707 (now Carborro too.)
> > 919-490-4656, 8#
> >
> > http://paulajsumner.byregion.net Referral ID#10102918
> >
> > http://www.justanswer.com/home.asp?r=HolisticNurse&bn=2
> >
> > http://www.letstalkcounseling.com/sites/paulasumner
> >
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