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GardasilVAERSUpdatedDeaths0907

GardasilVAERSUpdatedDeaths0907

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Published by: gardengnome on Nov 09, 2011
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01/24/2013

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FDAFreedom
of
InformationDistribution
VAERSLineListReport
Reportrunon:07SEP200712:15Page1622
VaxName:HPV
(GARDASIL),
HPV(NOBRANDNAME)(Comb.
w/OR)
ReportedDate:10-MAY-07-07-SEP-07Allcomb.wlAND
VaersId:287888-1(D)AgeGenderVaccineDate
22.0F21-May-2007
VAXDetail:Seriousness:MedDRAPTSymptomText:OtherMeds:LabData:History:PrexIllness:PrexVaxIIlns:OnsetDate
23-May-2007
Days
2
ReceivedDate
13-Aug-2007
StatusDate
14-Aug-2007
MfrReportId
WAES0708USA00407
Route
Intramuscular
LastEditDate
14-Aug-2007
OtherVaccine
HPV4
Manufacturer
MERCK
&
CO.INC.
PrevDosesot
0389U
Site
UnknownDIED,ERVISIT,SERIOUSDeathInformationhasbeenreceivedfromanursepractitionerconcerninga22yearoldfemalepatientwithnopertinentmedicalhistoryordrugallergieswhoon21-MAY-2007,wasvaccinated1Mwitha0.5mldoseofGardasil(Lot#657736/0389U).Concomitanttherapyincludedhormonalcontraceptives(unspecified)("MERCEr).On23-MAY-2007,thepatientdiedsuddenly.Thecauseofdeathwasunknown.Unspecifiedmedicalattentionwassought.Laboratorydiagnosticstudiesincludedanautopsywhichshowednofindings.Noproductqualitycomplaintwasinvolved.ThereporterstatedthatGardasildidnotcausethepatient'sdeath.Additionalinformationisnotexpected.hormonalcontraceptivesautopsy-nofindingsNone
 
FDAFreedom
of
InformationDistribution
Reportrunon07SEP200712:15
VAERSLineListReport
Page647
VaxName:HPV
(GARDASIL),
HPV(NOBRANDNAME)(Comb.
w/OR)
ReportedDate:10-MAY-07-07-SEP-07Allcomb.wlAND
VaersId:282372-1(D)Age
17.0
VAXDetail:Seriousness:MedDRAPTSymptomText:OtherMeds:LabData:History:PrexIllness:PrexVaxIIlns:VaccineDate
01-Jun-2007
MfrReportId
WAES0706USA02451
Route
Unknown
LastEditDate
21-Jun-2007
OtherVaccineOnsetDate
01-Jun-2007
Days
o
ReceivedDate
20-Jun-2007
StatusDate
21-Jun-2007
State
FR
~
HPV4
Manufacturer
MERCK&CO.INC.
Lot
NULL
PrevDoses
o
Site
UnknownDIED,SERIOUSAutopsy,Lossofconsciousness,Resuscitation,SuddendeathInformationhasbeenreceivedfromagynecologistwhowasinformedofthecasefromanothergynecologistconcerninga17yearoldfemalewho
in
June2007(week23),wasvaccinatedwithafirstdoseofGardasil(lotnumber,injectionsiteandroutenotreported).Duringtheeveningofthesameday,thepatientwasfoundunconscious(lifeless)bythemother.Resuscitationwasperformedbytheemergencyphysicianbutwasunsuccessful.Thepatientsubsequentlydied.Thecauseofdeathwassuddendeath.Itwasnotedthatthepatienthadadentalsurgerythedaybeforeshewasvaccinated.Anautopsywasdone.Theresultswerenotknown.OtherbusinesspartnernumbersincludeE2007-03769.Additionalinformationhasbeenrequested.UnknownUnknownDentaloperation
 
Reportrunon:07SEP200712:15
VAERSLineListReport
Page499
VaxName:HPV(GARDASIL),HPV(NOBRANDNAME)(Comb.
w/OR)
ReportedDate:10-MAY-07-07-SEP-07Allcomb.
wlAND
VaersId:280163-1(D)Age11.0Gender
F
VaccineDate01-May-2007OnsetDate04-May-2007Days
3
ReceivedDate01-Jun-2007StatusDate04-Jun-2007VAXDetail:
~
HPV4ManufacturerMERCK
&
CO.INC.LotNULLPrevDoses
o
SiteUnknownMfrReportIdWAES0705USA04839RouteUnknownLastEditDate04-Jun-2007OtherVaccineSeriousness:DIED,ERVISIT,LIFETHREATENING,SERIOUSMedORAPTAnaphylacticreaction,Cardiacarrest,DeathSymptomText:Informationhasbeenreceivedfromanursepractitionerwhoheardfromanemergencyroom(ER)nursethatan11yearoldfemalewasvaccinated"withininthepastmonth"inapproximatelyMay2007withafirstdoseofGardasil.Subsequently,3daysaftervaccinationthepatientpresentedtoanER.Sheexperiencedcardiacarrest,requiredlungbypass(ECMO)and"maynothaveexpired."Itwasalsoreportedbythesamenursethatthephysicianfromthehospitalsaidthat"thedeathwasduetoananaphylacticreactiontoGardasil."Theanaphylacticreactionandcardiacarrestwereconsideredtobelifethreateningbythereporter.Additionalinformationhasbeenrequested.OtherMeds:UnknownLabData:History:PrexIllness:PrexVaxIIlns:Unknown

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