VAERS reports of death following vaccination with Gardasil
The CDC collects reports of bad things that happen to people after vaccination
so that they can be studied to see if the vaccine is causing them.
Let's look at reports of death following vaccination with Gardasil,
and group them into categories suitable for
comparing them against known incidence rates in the general US population.
But first, a definition
Statements like
"There were 68 confirmed deaths associated with the #HPV
vaccine, #Gardasil, alone as of 2011. More in the last 2years.
scribd.com/doc/127818325/Annals-of-Medicine-HPV-Vaccine"
are common on the Internet. But "confirmed death" is an ambiguous
term. Does it mean "confirmed to be caused by the vaccine"?
Until recently, the CDC had a web page
"Reports of Health Concerns Following HPV Vaccination"
which said
[Some reports] remain unconfirmed due to no identifiable patient information
in the report such as a name and contact information to confirm the report.
A death report is confirmed (verified) after a medical doctor reviews
the report and any associated records. In the 34 reports confirmed, there
was no unusual pattern or clustering to the deaths that would suggest that
they were caused by the vaccine and some reports indicated a cause of death
unrelated to vaccination.
So when referring to VAERS reports, "confirmed deaths" means
"confirmed to have good data and contact info", not
"confirmed to be caused by Gardasil".
The CDC has since stopped using the word "verified" with relation to
VAERS reports on their HPV web page, possibly to avoid this ambiguity.
Retrieving Adverse Effects Reports
Here's how to get a list of all reports of death following vaccination
with Gardasil in the US, straight from the VAERS database:
- Visit vaers.hhs.gov
- Click on "Search VAERS data"
- Read the disclaimer that explains the limitations of the adverse affect
reporting system, and how it can only show coincidence, not causation
- Click "I have read and understand..." to proceed to the database
- Click on the CDC WONDER link
- In "1. Organize table layout", group results by VAERS ID, and check
the optional measure "Adverse Event Description"
- In "3. Select vaccine", select HPV4
- In "4. Select event", select event category "Death".
- Click 'Send'
As of October 2013, this pulls up 130 reports.
Clicking on the link
http://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&VAX[]=HPV4&DIED=Yes&SUB_YEAR_HIGH=2013&SUB_MONTH_HIGH=9 will reproduce that search.
Summary
Of the 130 death reports analyzed, 1 was a duplicate, and 43 were hearsay;
these 44 reports were set aside as problematic (see below).
Of the remaining 86 death reports, 7 had causes that seemed certain to not be related to the vaccination.
Of the remaining 79 death reports, the causes of death were as follows:
- 34 Unknown
- 8 Suicide
- 8 Cardiac problems
- 6 Seizures
- 5 Death of child of vaccinee
- 3 Neurological problems
- 2 Diabetic Ketoacidosis
- 2 Leukemia
- 2 Pulmonary Embolism
- 2 Thrombosis
- 2 Viral infection
- 2 Other chronic illness
- 1 Asthma
- 1 Bacterial infection
- 1 Thrombocytopenic Purpura
Data
The individual reports are presented here,
grouped roughly by cause of death,
along with how the CDC Wonder search tool
classified their location (either US, foreign, or unknown),
current medication, and pre-existing conditions.
The "Notes" field are my personal comments, based on keywords found in the reports.
Suicide
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
379874 | foreign | 44 | suicide not_related | |
|
379876 | foreign | 186 | suicide not_related unknown_date | |
|
389806 | foreign | | suicide unknown_date | |
|
393871 | foreign | 3 | suicide | | Depression
|
425513 | us | 2 | suicide | ORTHO CYCLEN |
|
437999 | us | 5 | suicide | SEPTRA |
|
457904 | us | 3 | suicide | |
|
282372 | foreign | 0 | autopsy unknown_date | | Dental operation
|
Cardiac Problems
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
338561 | foreign | 5 | autopsy unknown_date | BUSPAR; LEXOMIL; hormonal contraceptives (unspecified); magnesium (unspecified) (+) pyridoxine hydrochloride | Cardiac Murmur
|
464985 | foreign | 16 | not_related | |
|
309233 | unknown | 56 | | LAMICTAL; KEPPRA; vitamins (unspecified) | Convulsion; Arrhythmia
|
275428 | us | 6 | autopsy | | aortic and mitral valve insufficiency, unknown aetiology
|
356938 | us | 53 | | Yaz until 3/17/08. Femcon beginning 3/17/08. Anaprox as needed. |
|
405821 | us | 28 | autopsy | LIPITOR |
|
430780 | us | 14 | | | Mildly overweight; concern for idiopathic scoliosis
|
Dilated Cardiomyopathy
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
275438 | us | 14 | autopsy | Yasmin birth control pills; hormal contraceptives | None PMH: contraception; Non-smoker
|
Hypertrophic Cardiomyopathy
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
343612 | foreign | 25 | autopsy not_related | hormonal contraceptives (unspecified) |
|
317757 | us | 2 | | none | overweight PMH: recurrent colds/sore throat, neg strep.
|
Viral Myocarditis
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
325063 | us | 8 | not_related | erythromycin |
|
Seizures
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
391439 | unknown | | unknown_date | | Convulsion
|
316983 | us | 15 | | | Seizures PMH: "problems w/alcohol".
|
319810 | us | 45 | autopsy | | Unknown. PMH: 1 prior seizure 8/2007. 4/28/09 Additional records received from PCP at CDC's request. Pt in for OV 1/30/07 with c/o allergy sx and requesting HPV#1-given 0012U. Returned 3/22/07 for HPV#2-given 1427F with Boostrix AC52B012AA. Mild URI 4/25/07. OV 6/12/07 in F/U to ER visit for seizure on 6/11/07. Syncope noted. Sent for tests. OV 6/28/07 Echo and blood work
|
380740 | us | 37 | | Trileptol and Keppra | Patient had a pre-existing seizure disorder which she was on trileptol and Keppra to control the seizures.
|
406289 | us | 13 | | | Autism
|
485757 | us | 0 | | DILANTIN; Phenobarb | Microcephaly; seizure The following information was obtained through follow-up and/or provided by the government. 4/15/30 PMH: Congenital hydrocephalus with VP shunt. GDD and g-tube dependent. Global Developmental Delay. Seizure disorder.
|
Death of Child or Unborn Child of Vaccinated Mother
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
398755 | foreign | 0 | unknown_date | |
|
487849 | foreign | 53 | | |
|
497193 | foreign | | | |
|
393575 | unknown | | unknown_date | |
|
489163 | us | | | |
|
Neurological
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
307394 | us | 85 | | none | none 4/8/08-records received-PMH: attention deficit hyperactivity disorder and congenital strabismus. Migraines. Cognitive delay, developmental delay and motor delay. Allergies:strawberries cause an itch. In May sustained injury with pain in leg which improved but never returned completely to normal. 4/16/08-records received-PMH: Pityriasis lichennoides. Allergy to strawberries causes itching. Attention deficit disorder.
|
323430 | us | 263 | | therapy unspecified | None 11/28/2007 - Received Twinrix, IM, RA, lot# AHABB100AA PMH: purpura fulminans age 5 or 8 s/p chickenpox. Pulmonary HTN in childhood. Underweight at birth & Nissen surgery w/G-tube as newborn for 1st year of life, repair of pectus excavatum age 17. Oral contraceptives, hypothyroidism. Allergic sulfa. Family hx of seizures
|
336473 | us | 25 | | | Iron-deficiency anemia
|
Diabetic Ketoacidosis
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
291804 | us | 50 | autopsy not_related | | Unknown PMH: IDDM, uncontrolled. Smoker. Right buttock abscess 8/31/07. Anemia. Father w/diabetes. ALLERGIES: PCN, cipro, ultram (hives).
|
324002 | us | 15 | | none |
|
Leukemia
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
441365 | foreign | 9 | leukemia | |
|
494024 | us | 0 | leukemia | None known | None known The following information was obtained through follow-up and/or provided by the government. PMH: back strain Dec 2011. Occasional marijuana use.
|
Pulmonary Embolism
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
318244 | foreign | | autopsy unknown_date | |
|
339771 | us | 181 | autopsy | | 5/7/09-records received-5/7/09-records received-office visit 4/21/00-evaluation for dehydration, vomiting, sore throat and febrile. Impression strep pharyngitis. 9/2/05-routine physical. Assessment:overweight. Office visit 1/4/08-C/O lump in neck noticed in 9/07. Intermittently hurts. Assessment:mild lymphadenopathy.
|
Thrombosis
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
275990 | unknown | | unknown_date | |
|
300066 | us | | | | Asthma, morbid obesity, smoker, occasional ETOH. OCP unknown
|
Other chronic illness
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
457993 | foreign | 138 | autopsy | TEMESTA | Tonsillectomy
|
351970 | unknown | 45 | | | Migraine; Amphetamine abuse; Bell's palsy
|
Asthma
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
350228 | foreign | 3 | autopsy | hormonal contraceptives (unspecified) | Asthma bronchial
|
Bacterial Infection
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
344160 | us | 0 | | | PMH: foot swelling. Sickle-cell trait.
|
Influenza
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
278865 | us | 0 | | Topamax | PMH: migraine headaches. Family HX: younger sister also w/strep neg sore throat. Letter from school that group A strep infections present.
|
Disseminated Herpes Viral Disease
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
372910 | foreign | 189 | | |
|
Thrombocytopenic Purpura
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
437735 | us | 84 | | none | Immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab in 2004.
|
Early Onset Amyotrophic lateral sclerosis
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
449334 | unknown | 968 | | |
|
Ovarian Cancer
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
391339 | foreign | | cancer not_related unknown_date | |
|
Accidental Death
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
379570 | foreign | 48 | not_related unknown_date | |
|
Ruptured Aneurysm
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
335270 | foreign | 86 | autopsy unknown_date | KESTINE; NASACORT; SERETIDE; albuterol |
|
Unknown
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
299377 | foreign | 16 | autopsy | |
|
317695 | foreign | 2 | not_related unknown_date | |
|
338452 | foreign | 71 | autopsy | |
|
341030 | foreign | | unknown_date | |
|
375036 | foreign | 50 | autopsy | VALETTE |
|
380081 | foreign | 22 | not_related | RANTAC; acetaminophen, aminophylline; chloroquine |
|
384205 | foreign | | unknown_date | |
|
387594 | foreign | 96 | | |
|
396027 | foreign | | unknown_date | |
|
419174 | foreign | 3 | | |
|
424381 | foreign | 47 | not_related | |
|
287888 | unknown | 2 | autopsy | hormonal contraceptives | None 7/2/08-records received-HX of heroin and prescription drug abuse.
|
297528 | unknown | 21 | | |
|
320909 | unknown | | unknown_date | |
|
320910 | unknown | | unknown_date | |
|
322250 | unknown | | unknown_date | |
|
345435 | unknown | | unknown_date | |
|
429007 | unknown | | unknown_date | |
|
305606 | us | 2 | autopsy | Yasmin daily birth control | No known drug allergies
|
310262 | us | 4 | autopsy | |
|
319533 | us | 17 | autopsy | | Reported allergy to penicillin and cephid 3/5/09-records received-Allergic to penicillin.
|
319809 | us | | unknown_date | |
|
321696 | us | 3 | | 3/31 ROCEPHIN; 3/31 ZITHROMAX | Hx of pharyngitis; Bacterial Meningitis at 17 mons
|
334611 | us | 12 | | None known. ?? oral contraceptive or an antibiotic for acne. | Acne. PMH: PCN allergy. Acne. On OCs (Yaz). 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with c h x sinusitis. Tx: Biaxin.
|
337242 | us | 306 | autopsy | | No medical problems-- no allergies -- No drug use, alcohol or smoking. Had all her medical check ups!!!
|
337797 | us | 240 | autopsy | Nasonex (Pseudovent 400 substituted for Entex 400 120 capsule),Claritan, Triamcinolene Acetonide cream for rash on wrist. | Seasonal allergies. None other.
|
343777 | us | | unknown_date | |
|
387160 | us | | autopsy | |
|
403759 | us | 8 | | |
|
417137 | us | 29 | | NORINYL | Hay fever; Animal fur
|
442402 | us | 0 | | Depakote, Lyrica, Diazapam, Adderall | Seizure Disorder
|
450655 | us | | | |
|
453010 | us | 9 | | Loestrin 1/20mg one daily. Cetraxal 0.2% solution 2 drops bid for 7 days |
|
501663 | us | 13 | | | No known allergies.
|
Problematic Reports
As the VAERS Data page says,
VAERS reports can be submitted voluntarily by anyone, including healthcare
providers, patients, or family members. Reports vary in quality and
completeness. They often lack details and sometimes can have information
that contains errors.
For instance, reports which simply quote from published or broadcast reports
are likely to be duplicates of direct reports from the doctors or parents
of the patient. (These are often called "spontaneous reports" in the VAERS
write-up.)
Likewise, indirect reports (where someone is reporting something they
heard from someone else), and which lack detailed information,
are likely to be duplicate or invalid.
Both of these kinds of reports are considered hearsay, and should probably
be considered invalid.
Here are the reports which appear to be hearsay:
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
361121 | foreign | | radio unknown_date | |
|
374780 | foreign | | newspaper unknown_date | |
|
424378 | foreign | | website unknown_date | |
|
437971 | foreign | | website unknown_date | |
|
471789 | foreign | | radio spontaneous_report unknown_date | |
|
477609 | foreign | | spontaneous_report unknown_date | |
|
478227 | foreign | 6 | spontaneous_report | |
|
479323 | foreign | | hearsay unknown_date | |
|
482106 | foreign | | social_media unknown_date | |
|
500640 | foreign | 31 | autopsy spontaneous_report not_related unknown_date | |
|
502329 | foreign | 3 | spontaneous_report | |
|
279592 | unknown | | heard_from unknown_date | |
|
280163 | unknown | 3 | heard_from unknown_date | |
|
282747 | unknown | | unknown_date | |
|
318491 | unknown | | internet heard_from unknown_date | |
|
320559 | unknown | | heard_from unknown_date | |
|
350666 | unknown | | unknown_date | |
|
350967 | unknown | | internet unknown_date | |
|
361629 | unknown | | television hearsay unknown_date | | unknown
|
373314 | unknown | | internet unknown_date | |
|
373315 | unknown | | hearsay internet unknown_date | |
|
383175 | unknown | | newspaper unknown_date | |
|
385303 | unknown | | heard_from | |
|
405381 | foreign | | unknown_date | |
|
405998 | unknown | | magazine cancer unknown_date | |
|
412247 | unknown | | forum unknown_date | |
|
412282 | unknown | | magazine unknown_date | |
|
413697 | unknown | | unknown_date | |
|
419237 | unknown | | website unknown_date | |
|
421582 | unknown | 0 | unknown_date | |
|
425598 | unknown | | internet unknown_date | |
|
425680 | unknown | 0 | internet unknown_date | |
|
464953 | unknown | | unknown_date | |
|
471590 | unknown | | radio spontaneous_report unknown_date | |
|
482344 | unknown | | spontaneous_report social_media unknown_date | |
|
482352 | unknown | | spontaneous_report social_media unknown_date | |
|
485188 | unknown | | internet spontaneous_report unknown_date | |
|
492468 | unknown | | spontaneous_report unknown_date | |
|
500225 | unknown | | spontaneous_report unknown_date | |
|
501081 | unknown | 3 | spontaneous_report | |
|
293388 | us | 115 | newspaper | | Medical history and concomitant medications not reported; it was unknown if the patient was ill at time of vaccination.
|
344385 | us | | heard_from unknown_date | |
|
397437 | us | | heard_from unknown_date | |
|
Duplicates
ID | Location | Days aftr vaccination | Notes | Other medications | Pre-existing conditions |
459200 | foreign | 499 | | RISPERDAL; TERCIAN; SEROPRAM; TEMESTA | 06/--/2010, Tonsillectomy; Major depression; Trichotillomania; Obsessive-compulsive disorder; Duplicate of 457993
|
Assessing Reporting Rates and Assigning Causality
The CISA
has a number of publications about the difficult task of assessing
causes of death reports.
"Causality assessment
of adverse events reported to the Vaccine Adverse Event Reporting System
(VAERS)" found
"A stratified random sample of 100 VAERS reports received in 2004 contained
13 fatal cases, 19 cases with non-fatal disabilities, 39 other serious
non-fatal cases and 29 non-serious cases. Experts knowledgeable about
vaccines and clinical outcomes, reviewed each VAERS report and available
medical records... In the end, only 3 (3%) of the AEFI were classified as
definitely causally related to vaccine received."
In the US, the CDC is responsible for monitoring vaccine safety.
Their Immunization Safety Office runs VAERS, as well as the Vaccine Safety
Datalink and the Clinical Immunization Safety Assessment (CISA) Network.
In 2009, they published
"Postlicensure
safety surveillance for quadrivalent human papillomavirus recombinant
vaccine" (PDF)
in JAMA. This is the most detailed look at HPV VAERS reports available so
far. Here's what it said about reports of deaths:
"There were 32 VAERS reports of death
following qHPV vaccination (Table 2).
Eight of the reports were second-hand
reports that could not be verified. Four
were manufacturer reports with no
identifying information for confirmation
or medical review. Twenty of the
reports (62.5%) could be verified
through clinical review of medical records
and autopsy reports. Of these
cases, 14 (70%) were after qHPV alone.
The other 6 cases reported qHPV as well
as a variety of other vaccines. Nine cases
occurred after dose 1, 5 after dose 2, and
6 after dose 3.
Mean age was 18 years (median, 17
years; range, 12-26 years). There was
no clustering by age. The mean time
from last qHPV immunization to AEFI
onset was 39 days (median, 14.5 days;
range, 2-288 days). The mean time from
last qHPV immunization to death was
47 days (median, 14.5 days; range, 2 to
405 days).
Causes of death included 4 unexplained
deaths, 2 cases of diabetic ketoacidosis
(1 complicated by pulmonary
embolism), 1 case related to
prescription drug abuse, 1 case of juvenile
amyotropic lateral sclerosis, 1
case of meningoencephalitis (Neisseria
meningitidis serogroup B), 1 case of
influenza B viral sepsis, 3 cases of pulmonary
embolism (1 associated with
hyperviscosity due to diabetic ketoacidosis),
6 cardiac-related deaths (4 arrhythmias
and 2 cases of myocarditis),
and 2 cases due to idiopathic
seizure disorder.
The PRR for deaths in 6- to 17-yearolds
was 1.4 (chi^2=0.42, P=.52). The PRR
for deaths in 8- to 29-year-olds was 1.2
(chi^2=0.01, P=.92). Neither of these met
the screening criteria for signal detection.
"
and Table 2 in that paper showed an incidence per 100,000 doses of
8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticari;
0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barre syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and
pancreatitis; and 0.009 for motor neuron disease.
See Also
All Those HPV Vaccine Deaths Aren't After All
- similar post over at justthevax.blogspot.com