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."
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:
  1. Visit
  2. Click on "Search VAERS data"
  3. Read the disclaimer that explains the limitations of the adverse affect reporting system, and how it can only show coincidence, not causation
  4. Click "I have read and understand..." to proceed to the database
  5. Click on the CDC WONDER link
  6. In "1. Organize table layout", group results by VAERS ID, and check the optional measure "Adverse Event Description"
  7. In "3. Select vaccine", select HPV4
  8. In "4. Select event", select event category "Death".
  9. Click 'Send'
As of October 2013, this pulls up 130 reports.

Clicking on the link[]=HPV4&DIED=Yes&SUB_YEAR_HIGH=2013&SUB_MONTH_HIGH=9 will reproduce that search.


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:


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.


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
379874foreign44 suicide not_related
379876foreign186 suicide not_related unknown_date
389806foreign suicide unknown_date
393871foreign3 suicide Depression
425513us2 suicide ORTHO CYCLEN
437999us5 suicide SEPTRA
457904us3 suicide
282372foreign0 autopsy unknown_date Dental operation

Cardiac Problems

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
338561foreign5 autopsy unknown_date BUSPAR; LEXOMIL; hormonal contraceptives (unspecified); magnesium (unspecified) (+) pyridoxine hydrochloride Cardiac Murmur
464985foreign16 not_related
309233unknown56 LAMICTAL; KEPPRA; vitamins (unspecified) Convulsion; Arrhythmia
275428us6 autopsy aortic and mitral valve insufficiency, unknown aetiology
356938us53 Yaz until 3/17/08. Femcon beginning 3/17/08. Anaprox as needed.
405821us28 autopsy LIPITOR
430780us14 Mildly overweight; concern for idiopathic scoliosis

Dilated Cardiomyopathy

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
275438us14 autopsy Yasmin birth control pills; hormal contraceptives None PMH: contraception; Non-smoker

Hypertrophic Cardiomyopathy

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
343612foreign25 autopsy not_related hormonal contraceptives (unspecified)
317757us2 none overweight PMH: recurrent colds/sore throat, neg strep.

Viral Myocarditis

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
325063us8 not_related erythromycin


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
391439unknown unknown_date Convulsion
316983us15 Seizures PMH: "problems w/alcohol".
319810us45 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
380740us37 Trileptol and Keppra Patient had a pre-existing seizure disorder which she was on trileptol and Keppra to control the seizures.
406289us13 Autism
485757us0 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

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
398755foreign0 unknown_date
393575unknown unknown_date


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
307394us85 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.
323430us263 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
336473us25 Iron-deficiency anemia

Diabetic Ketoacidosis

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
291804us50 autopsy not_related Unknown PMH: IDDM, uncontrolled. Smoker. Right buttock abscess 8/31/07. Anemia. Father w/diabetes. ALLERGIES: PCN, cipro, ultram (hives).
324002us15 none


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
441365foreign9 leukemia
494024us0 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

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
318244foreign autopsy unknown_date
339771us181 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.


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
275990unknown unknown_date
300066us Asthma, morbid obesity, smoker, occasional ETOH. OCP unknown

Other chronic illness

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
457993foreign138 autopsy TEMESTA Tonsillectomy
351970unknown45 Migraine; Amphetamine abuse; Bell's palsy


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
350228foreign3 autopsy hormonal contraceptives (unspecified) Asthma bronchial

Bacterial Infection

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
344160us0 PMH: foot swelling. Sickle-cell trait.


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
278865us0 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

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions

Thrombocytopenic Purpura

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
437735us84 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

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions

Ovarian Cancer

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
391339foreign cancer not_related unknown_date

Accidental Death

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
379570foreign48 not_related unknown_date

Ruptured Aneurysm

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
335270foreign86 autopsy unknown_date KESTINE; NASACORT; SERETIDE; albuterol


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
299377foreign16 autopsy
317695foreign2 not_related unknown_date
338452foreign71 autopsy
341030foreign unknown_date
375036foreign50 autopsy VALETTE
380081foreign22 not_related RANTAC; acetaminophen, aminophylline; chloroquine
384205foreign unknown_date
396027foreign unknown_date
424381foreign47 not_related
287888unknown2 autopsy hormonal contraceptives None 7/2/08-records received-HX of heroin and prescription drug abuse.
320909unknown unknown_date
320910unknown unknown_date
322250unknown unknown_date
345435unknown unknown_date
429007unknown unknown_date
305606us2 autopsy Yasmin daily birth control No known drug allergies
310262us4 autopsy
319533us17 autopsy Reported allergy to penicillin and cephid 3/5/09-records received-Allergic to penicillin.
319809us unknown_date
321696us3 3/31 ROCEPHIN; 3/31 ZITHROMAX Hx of pharyngitis; Bacterial Meningitis at 17 mons
334611us12 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.
337242us306 autopsy No medical problems-- no allergies -- No drug use, alcohol or smoking. Had all her medical check ups!!!
337797us240 autopsy Nasonex (Pseudovent 400 substituted for Entex 400 120 capsule),Claritan, Triamcinolene Acetonide cream for rash on wrist. Seasonal allergies. None other.
343777us unknown_date
387160us autopsy
417137us29 NORINYL Hay fever; Animal fur
442402us0 Depakote, Lyrica, Diazapam, Adderall Seizure Disorder
453010us9 Loestrin 1/20mg one daily. Cetraxal 0.2% solution 2 drops bid for 7 days
501663us13 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:

IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
361121foreign radio unknown_date
374780foreign newspaper unknown_date
424378foreign website unknown_date
437971foreign website unknown_date
471789foreign radio spontaneous_report unknown_date
477609foreign spontaneous_report unknown_date
478227foreign6 spontaneous_report
479323foreign hearsay unknown_date
482106foreign social_media unknown_date
500640foreign31 autopsy spontaneous_report not_related unknown_date
502329foreign3 spontaneous_report
279592unknown heard_from unknown_date
280163unknown3 heard_from unknown_date
282747unknown unknown_date
318491unknown internet heard_from unknown_date
320559unknown heard_from unknown_date
350666unknown unknown_date
350967unknown internet unknown_date
361629unknown television hearsay unknown_date unknown
373314unknown internet unknown_date
373315unknown hearsay internet unknown_date
383175unknown newspaper unknown_date
385303unknown heard_from
405381foreign unknown_date
405998unknown magazine cancer unknown_date
412247unknown forum unknown_date
412282unknown magazine unknown_date
413697unknown unknown_date
419237unknown website unknown_date
421582unknown0 unknown_date
425598unknown internet unknown_date
425680unknown0 internet unknown_date
464953unknown unknown_date
471590unknown radio spontaneous_report unknown_date
482344unknown spontaneous_report social_media unknown_date
482352unknown spontaneous_report social_media unknown_date
485188unknown internet spontaneous_report unknown_date
492468unknown spontaneous_report unknown_date
500225unknown spontaneous_report unknown_date
501081unknown3 spontaneous_report
293388us115 newspaper Medical history and concomitant medications not reported; it was unknown if the patient was ill at time of vaccination.
344385us heard_from unknown_date
397437us heard_from unknown_date


IDLocationDays aftr vaccinationNotesOther medicationsPre-existing conditions
459200foreign499 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