This is
an example of the data returned from my (limited) Query about the HPV
vaccine
adverse reactions. See Query Criteria:
at bottom of page.
Note: "Group By" must
be entered in this order on the form: Vaccine Type; Vaccine; Vaccine
Manufacturer; VAERS ID
The
Vaccine Adverse Event Reporting System (VAERS) Result
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from physician concerning a 15 year old female who
was vaccinated with Gardasil. Subsequently the patient may have
experienced encephalitis and was hospitalized. The duration of the stay
was not provided. The physician reporting was not the physician who
administered the vaccine but the treating physician. At the time of the
report the patient had recovered. Additional information has been
requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"Information
has been received from a company representative concerning a 12 year
old female with braces, who was vaccinated with a 0.5 mL dose of
Gardasil (lot # not reported). It was reported that the patient
experienced acute demyelinating encephalomyelitis after getting the
vaccine. The patient's mother reported that two weeks post vaccination.
The patient was walking through the house and collapsed. The patient
stated that she could not feel her leg. The patient was taken to the
hospital. It was reported that two months later and after hours of
physical therapy, the patient still had no feeling in her left leg. It
was also reported that it was difficulty for the patient to walk and
balance and she often needed a little help. The patient's mother
reported that her daughter was ""mad."" The patient was also learning
how to cope with crutches, and a walker. The patient was diagnosed by
her physician to have Acute Demyelinating Encephalomyelitis or ADEM. At
the time of the report, the patient's status was not reported. Acute
demyelinating encephalomyelitis was considered to be disabling an other important medical
event. No further information is available."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"Information
has been received from a physician concerning a 23 year old female with
no medical history, who in approximately December 2007, was vaccinated
with a third dose of GARDASIL. Concomitant therapy ""possibly""
included hormonal contraceptives (unspecified). Subsequently, post
vaccination the patient experienced mild encephalitis. On 04-FEB-2008
the patient was seen in the office for her symptoms. At the time of the
report, the outcome of the patient was unknown. No product quality
complaint was involved. Upon internal review mild encephalitis was
considered to be an other
important medical event. Additional information has been requested."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Sudden
unattended death. Autopsy results pending (inconclusive 2/25/08).
2/26/08 Reviewed pcp
medical records & vax records which reveal patient received
HPV#1 0469U 7/16/07 & HPV#2 09300 9/17/07. In 11/20/07, noted
to have left sided head pain intermittently along with lightheadedness;
dx w/tension HA. HPV#3 was scheduled for 1/16/2008 but postponed due to
no parental signature. Returned to office 1/24/08 for left wrist pain
from cheerleading injury s/p ER vs for same on 1/19/08. Patient last
seen in office by nurse only on 2/20 for HPV #3, no notes for visit.
PMH: kicked in face by horse in past (undated) & had contusion
on cheek; acne vulgaris, started Yasmin & topicals 4/07 w/improvement
after multiple other drug failures; 1/19/08 wrist contusion from
cheerleading. 5/2/08 Autopsy report states COD as undetermined. Autopsy
states patient had intermittent HAs x 2 mo
& had been on BCP x 1 year for acne. Found w/small facial
laceration from striking flower pot when fell. The autopsy was neg for all findings. Scene
indicated sudden death from collapse & fall. Suspected long QT
interval syndrome w/fatal arrhythmia rather than new onset seizure in
patient w/no history of either. Suggested testing family members.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from a physician concerning a female patient who on
an unspecified date was vaccinated with a dose of GARDASIL. It was
reported by the physician, that a daughter of a friend, developed
encephalitis after a dose of GARDASIL. The physician could not provide
any additional information. At the time of this report the patient's
outcome was unknown. No product quality complaint was involved. Upon
internal review, encephalitis was considered to be an other important medical
event. Additional information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from a physician concerning a 20 year old female with
no allergies, who, on an unspecified date, was vaccinated with a dose
of Gardasil. There was no concomitant medication. There were no
illnesses at the time of vaccination. It was noted that the reporting
physician recommended the HPV vaccination to the patient but she was
vaccinated at her college campus. Three to four days post vaccination
the patient experienced a high fever, headache, and blurred vision. The
patient went to the emergency room but was not admitted. The patient
then returned to the emergency room a second time and was admitted to
the hospital for two days. The patient was diagnosed with encephalitis.
At the time of the report, the outcome of the patient was unknown.
Additional information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from a registered nurse concerning a 13 year old
female patient who on 16-JUN-2008 was vaccinated with the first dose of
GARDASIL (Lot # 660387/1967U) IM. There was no concomitant medication.
On 30-JUN-2008 the patient experienced headache, lethargy, slurred
speech and brain swelling. The patient was diagnosed with acute cerebellitis (cerebellar
encephalitis). The patient took an overseas trip when these symptoms
occurred and was hospitalized. The patient will be on IV Acyclovir for
3 weeks and has been on Dexamethasone but is being weaned off. The
patient was on acetazolamide and that was subsequently discontinued.
The patient will be on ceftriaxone for 2 weeks and doxycycline for 28
days. The patient was considered to be recovering. The plan by the
hospital was to discharge the patient on 17-JUN-2008 and have her on a
flight back home by 19-JUL-2008 and to be directly admitted to a
pediatric hospital. Lab Diagnostics studies performed were 3 MRIs to
monitor brain swelling, serology for Lyme's disease IGG, mycoplasma
IGM, mumps IGG and IGM, rubella IGG and IGM, varicella IGG and IGM,
parvovirus IGG and IGM, HSV IGG and IGM, however not results were
reported. Acute cerebellitis
was considered to be immediately life-threatening. The patient sought
medical attention, called the physician's office. Follow-up information
was received which reported that on 19-JUL-2008, the patient was
admitted to the hospital. The patient was subsequently discharged from
the hospital on 22-JUL-2008. It was reported that the patient was sent
home with a PICC line for antibiotics for the next several weeks. The
registered nurse stated that the patient was stable. The registered
nurse reported that the physician felt that the patient's Encephalitis
was related to GARDASIL (Lot # 660387/1967U) vaccination. Additional
information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from a physician concerning a 16 year old (also
reported as 15 year old) female who on an unspecified date was
vaccinated with a first dose of GARDASIL (route and administration site
not reported), and was vaccinated with a second dose of GARDASIL (route
and administration site not reported) (also reported as having been
given the week of 08-AUG-2008). Two months after she received the
initial vaccine, the patient developed memory loss. It was also
reported that shortly after the second vaccination, the patient
developed paralysis of her arm. The patient was evaluated by her
pediatrician, whose initial impression was that the symptoms may have
been a psychology issue. Following this office evaluation the patient
experienced other symptoms such as vomiting and was evaluated at an
emergency room. The patient underwent numerous unspecified tests and
saw unspecified specialists (results not provided). Subsequently the
patient was hospitalized for encephalitis and has since been
discharged. The physician doubts there was a link between the diagnosis
of encephalitis and the vaccination. The physician reported that
someone at the emergency room may have suggested to the patient's
mother that there may be a link between the diagnosis and GARDASIL. The
patient's encephalitis persisted. The physician considered the
encephalitis to be disabling. Additional information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Sudden
death occured on
3/12/2008. 9/4/08-records received-Cause of Death:cardiovascular
collapse as a consequence of pulmonary emboli, dehydration and diabetic
ketacidosis.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"Information
has been received from a physician concerning a 13 year old female who
on an unknown date was vaccinated with GARDASIL. The first dose was
received at another clinic but it was not sure about the second dose.
The physician reported that the patient had cerebritis
and inflammation of the brain after each GARDASIL shot. It was reported
that the doctors concurred that the patient had a stroke. The patient
was hospitalized (duration unspecified) and cerebritis
and inflammation of the brain and stroke were considered to be
immediately life-threatening. The outcome was not reported. The patient
sought medical attention, ""saw doctor and hospital"". Additional
information has been requested."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Patient
developed arthralgias,
change in mental status. Diagnosed with Systemic Lupus Erythematous on
10/23, based on +ANA and +dsDNA. Admitted to Hospital for changes in
mental status, thought to be from lupus cerebritis.
records received 11/14/08-presented to ED 10/28/08-C/O short term
retrograde amnesia. Intermittent blurry vision. C/O joint pain,
headaches nausea for 4 weeks. Left hand weakness. One and half months
prior C/O pain in hands and feet, isolated papules. Difficulty
sleeping. 12/1/08-DC summary received for DOS 10/28-11/6/08-DX:Lupus cerebritis. Change in mental
status.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Approx
3 weeks after getting 1st set of Gardasil, patient complained that she
was weak and was having a hard time speaking. On 11/29/08 patient had 2
seizures. She was was
taken to the ER. Since the first few days of her illness, she stopped
being able to talk, walk and has been completely unresponsive. She is
on a ventilator & has a feeding tube. She has neurological
movements. All of the testing done shows that patient has encephalitis.
The cause of the Encephalitis is a reaction to the Gardasil Vaccine.
2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX:
meningoencephalitis w/significant mental changes & seizures
Records reveal patient experienced seizure that progressed to loss of
speech, sustained focal seizures, oral intake reduced, drowsiness,
floppy. Developed fever in hospital. Neuro & ID consult done. Tx w/antiseizure
meds, antivirals, antibiotics. Transferred to higher level of care peds neuro ICU. 3/9/09 Received
ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure
disorder; history of depression w/suicidal attempts Records reveal
patient had been transferred from outlying hospital. Exam revealed
drowsiness, not able to follow commands, PERRL, hypertonicity of all
limbs, DTRs increased. No PICU bed available & held in ER.
Neuro consult done. Tx
w/antivirals & continued on antiseizure
meds. 3/9/09 Received hospital medical records of 2/10-currently
inpatient FINAL DX: recent viral encephalitis(presumed HSV) &
subsequent neurologic devastation presented w/MSSA septic shock, DIC,
acute on chronic respiratory failure, acute renal failure, s/p
tracheostomy Records reveal patient had been d/c from PICU w/HSV
encephalitis 10/2008 w/resulting severe neurological damage. Now
w/fever, hypotension & decreased mental status. Transferred
from outlying ER w/platelets of 17. Tx
w/IV antibiotics, plts/FFP/PRBC
transfusions, pressors.
Patient trach to vent w/large amount yellow sputum.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from a physician concerning a female patient who in
July or August of 2008, was vaccinated with her second dose of
GARDASIL. In September 2008, the patient had NMDA antibody receptor and
encephalitis. Drug treatment was required. The patient presented at the
emergency room and was hospitalized for 2 months. At the time of
reporting the patient was recovering from the NMDA antibody receptor
encephalitis. The patient was told that she could have recurring
episodes. It was unknown if there would be significant disability.
Additional information has been requested. 4/24/09 Received hospital
medical records of 9/29-11/25/2008. FINAL DX: NMDA receptor positive
encephalopathy; delerium;
g-tube placement; left brachiocephalic IVC clot associated w/PICC line
placement; antiphospholipid antibodies. Records reveal patient symptoms
noted in outlying ER in addition to aggression began approx 5 days prior. Course
waxed & waned w/intermittent decreased alertness & delerium, decreased O2 sats & was in/out of
PICU. Tx w/IVIG x 5
days, steroids, IV antibiotics/antivirals, plasmaphersis
x 4 days, antineoplastics,
feeding tube placement & anticoagulants. Neuro, Rheum &
Psych consult done. Slowly improved & d/c to home w/PCP,
Thrombophilia, Rheum, REhab
& surgery clinic appts.
4/7/09 Received hospital medical records of 9/27-9/29/2008. FINAL DX:
probable encephalitis Records reveal patient experienced acute
confusion, mental status change, repetitive garbled speech then
aphasia, excitable. In hospital had alternating periods of quiescence
& agitation, speech garbled, perseverating, neologisms
& frequently aphasic. ID & Neuro consults done.
Transferred to higher level of care.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
encephalitis
24 h after guardasil
vaccination. Right temporal-occipital T2 flair on MRI with negative HSV
PCR. 3/26/09 Received hospital medical records of 2/17-19/2009
& 3/2-3/17/2009 & GYN & Neuro clinic records.
2/17-2/19/2009 FINAL DX: Seizure & Migraine headache Records
reveal patient experienced bifrontal
HA w/neck pain, dizziness, photophobia, phonophobia,
nausea, vomiting, flashing lights x 4-5 days. Was traveling to ER when
had seizure & possible tongue biting. CT scan in outlying ER
was neg & d/x
to home w/outpatient neuro f/u. Now admitted, tx
w/pain meds, antiseizure
meds & anatinausea
meds 3/2-3/17/2009 FINAL DX: presumptive herpes simplex virus
meningitis Records reveal patient experienced intractable HA, stiff
neck, retrobulbar eye
pain, blurry vision, ear pain, teeth pain, tinnitus, N/V, decreased
appetite, coryza,
constipation, generalized weakness & vision flashes since 2/16,
seen multiple times in ER & 1 admission for same. Had been txinbetween
with steroid taper w/temporary improvement. Several days prior to this
admit developed fevers, night sweats, hallucination single episode
& was essentially bedbound due to worsening pain when standing.
Neurosurg,
Neuro & ID consult done. Tx
w/IV antibiotics, pain meds, IV caffeine, antinausea
meds & antivirals. Improved slowly & was able to
ambulate w/o HA & d/c to home on continued oral antiviral meds
& to return for repeat MRI. GYN Clinic 2/12/2009 FINAL DX: HPV
#1 administered, no Lot #s available. Neuro CLinic
2/23/09 FINAL DX: persistent migraine HA Tx
w/steroid taper, IV antihistamine/antinausea
meds & was instructed to return as scheduled.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Dx-encephalitis
etiology unkonwn. Five
weeks after administration pt
experienced stiffness of neck. Neck pain, back pain, lethargy, no
appetite fever for 7 days then began having seizures which lead to
respiratory failure. 1 1/2 yr
later seizures are ongoing & numerous developmental problems
due to brain atrophy. 5/13/2009-records received-ER visit 9/22/07
presented with C/O one day history of fever, sore throat and
right-sided neck pain. DX: Viral pharyngitis, right cervical adenopathy
most likely due to viral etiology. Office visit 9/26/07-Fever and sore
throat, stiff back and shoulders for 4 days. Tiredness, decreased
appetite. No neck pain.Office
visit 6/8/07-immunization visit received Gardasil, Menactra and Varicella.
Assessment: viral infection, pharyngitis. 5/20/09 - ICD-9 codes
received. 99669 infection and inflammatory reaction due to other
internal prosthetic device/implant/graft, 3159 Unspecified delay in
development, E8782 Surgical operation, anastomosis/bypass/graft, with
abnormal reaction/later complication, no surgical misadventure, V1251
Personal history of venous thrombosis and embolism, Z8981 Primary
hypercoagulable state, V1251 Personal history of venous thrombosis and
embolism, 78039 Convulsions, 326 Late effects of intracranial abcess/pyogenic infection, 34839
Encephalopathy, 1390 Late effects of viral encephalitis, 27651
Dehydration, 3154 Developmental coordination disorder, 31539
Developmental speech disorder. 5/20/09 ED and hospital records received
DOS 9/22/07 to 4/12/09 FINAL DIAGNOSIS: Seizure disorder Post
vaccination: Intially
presented to ED with one day history of fever, sore throat and
right-sided neck pain. Then repeated ED visits due to seizures. Slurred
speech, motor delay. Tachycardia. Skin graft anterior right foot,
followed by cellulitis. Repeated febrile illness with photophobia. Hit
her head several times. Disconjugate
gaze. Facial twitching. Temporal lobectomy. Choreoathetoid
movements of head. Venous thrombosis and embolism left lower extremity,
intracranial abcess,
encephalopathy, viral encephalitis, dehydration, developmental speech
disorder, ventilator dependent for 2 months. 6/11/09 Hospital records
and several discharge summaries recieved
DOS 9/27/07 to 12/13/08 Assessment: Epilepsy secondary to encephalitis.
Patient transferred from another hospital for management of seizures
and respiratory failure. Fever for 4 days, generalized tonic-clonic seizure with rolled back
eyes, foaming and the mouth and urinary incontinence. Placed in
pentobarbital coma, developed thrombus at site of central line
placement, infiltraion
left foot. Level of orientation fluctuates, speech slow. Operative proceedures - left frontal
craniotomy, intraoperative electrocardiography, tailored left temporal
lobectomy, megalo-hippocampectomy.
Seizures persisted postoperatively. Readmitted for increased seizure
activity beginning as slurred speech, head tilting, sometimes secondary
generalization. Readmitted for continued cluster and complex seizures,
suicidal ideation. drooling, staring blankly, perioral cyanosis, has
fallen during seizures 7/2/09 ICD-9 Codes received. 51881, 5990, 34830,
78039, 7948, 4589, 0414
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from an investigator concerning a 37 year old female
with HIV and a history of migraine headaches and methamphetamine abuse
for 20 years who entered a study. On 08-MAY-2009 the patient was
enrolled in A5240 and vaccinated IM with the first dose of GARDASIL,
0.5ml, in deltoid. On 22-JUN-2009 the patient developed the following
adverse events: altered mental status grade 3 (dysarthria, anomia,
confusion); headache grade 3 (presented to HD 22-JUN-09 with AMS, HA).
CT angle of head showed diffuse cerebral edema); left hand numbness
grade 2. On 02-JUL-2009 the patient developed decreased neurological
reflexes grade 4 (life threatening), pupils fixed and dilated
bilaterally grade 4 (life threatening), and death. The report was as
follows: The patient presented to emergency department on 22-JUN-2009
with migraine-like headache, left hand numbness, dysarthria and anomia.
CT read as normal, patient discharged, the patient returned on
23-JUN-2009 with persistent headache, anomia. At that time, she was not
on treatment for HIV and her CD4 count was 263. She was admitted to the
neurology service and empirically treated with antibiotics for
bacterial and HSV meningitis. Lumbar puncture showed borderline low
glucose, elevated protein and a lymphocytic pleocytosis
without red blood cells, CSF tests for EBV, HSV, VZV, Cryptococcus,
VDRL, AFB smear were negative as well as CSF culture for bacteria,
fungus and mycobacteria. CSF cytology was negative, flow cytometry was
not performed. JC virus PCR was ordered, but results not reported.
Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis
titers, serum cryptococcal
antigen, RPR were all negative. Prior quantiferon
testing in 2004 was positive without subsequent isoniazid treatment
chest X ray during admission was negative as were 2 sputum for AFB
smear and culture. MRI showed diffuse cerebral edema with
leptomeningeal enhancement. Repeated lumbar puncture showed
normalization of glucose. During the hospitalization, her symptoms had
improved. Discharged to home 29-JUN-2009 with diagnosis of resolving
viral meningitis vs. HIV encephalopathy. Initial consideration had been
made of TB meningitis but her symptomatic improvement without TB
treatment made this less likely. HIV treatment was not started during
the hospitalization but was planned pending reevaluation after
discharge and final review of all cultures and pending test.
Re-presented emergency department on 01-JUL-2009 complained of
worsening headache, symptoms and confusion; discharged as it was
thought her symptoms were consistent with previous status. Returned to
emergency department that night with confusion and altered mental
status. At 5 AM on 02-JUL-2009, she acutely became unresponsive in the
emergency room, requiring intubation and was noted to have fixed,
dilated pupils bilaterally. Emergent head CT revealed diffuse cerebral
edema and herniation. Pronounced brain dead of unknown cause on
02-JUL-2009. Post mortem pending, would take up to 8 weeks at this site
before results were available. Relevant diagnostic tests conducted at
the time of death occurred were as follows: On 22-JUN-2009,
computerized tomography (CT, CT Scan, CAT Scan) of head: diffuse
cerebral edema: 3 am left ICA aneurysm; bilatsymm, optic
nerve sheath distention. On 23-JUN-2009, magnetic resonance imaging
(MRI) of brain: with contrast, diffuse supratentorial
leptomeningeal enhancement, consistent with leptomeningitis.
Diffuse sulcal
effacement. Vague non enhancing T2/FLAIR hyperintensity
multiple sites suggestive of infectious or toxic/metabolic etiology or
PML. 02-JUL-2009, computerized tomography (CT, CT Scan, CAT Scan) of
brain, profound diffuse sulcal
effacement throughout cerebral hemispheres and posterior fossa. Severe
downward tonsillar herniation and severe upward transtentorial
herniation with compression of brainstem. The reporting investigator
felt the event death was not related to study therapy. Study therapy
association for the other events was not reported. Follow up
information has been received from medical records. The patient had a
past medical history significant for migraine headaches and HIV (new
diagnosis, not on antiretrovirals,
recent CD4 count 263 to 381), substance abuse, recent Bell's palsy
January 2009 and no known drug allergies. She was on no medications
upon admission. The patient's CD4 count on 24-JUN-2009 was 308 and a
viral load on 12-JUN-2009 was 45310, diagnosed in March of 2009 and
currently not on antiretroviral therapy. She was currently living in a
drug rehab facility. The patient also had a history of past
methamphetamine abuse and had been sober since March of 2009. The
patient also had a questionable psychiatric history with a potential
diagnosis of anxiety, borderline personality disorder, and depression.
The patient also had a history of migraine disorders. She presented
with a headache typical of her migraines but with additional features
of left hand numbness, dysarthria, and anomia. The patient underwent a
CT scan which was negative in the ED, and was initially sent home, and
re-presented the next day with similar headache with anomia without
hand numbness. A lumbar puncture was performed in the ED, remarkable
for lymphocytic pleocytosis
and decreased glucose, as well as elevated protein, and an MRI showed
evidence for meningoencephalitis. The patient was admitted to the
neurology service for further work up. The patient was hospitalized
from 23-JUN-2009 to 28-JUN-2009. She was initially placed on
vancomycin, cefapime,
acyclovir, and ampicillin for bacterial meningitis treatment and HIV
encephalitis treatment. When the results of the lumbar puncture were
obtained, the antibiotics were discontinued and the patient remained on
acyclovir until her PCR came back as negative. Infectious disease was
consulted and upon discussion with them, the most likely differential
diagnosis of the patient's encephalitis was HIV encephalitis.
Initially, a diagnosis of possible TB meningitis/encephalitis was
entertained given the slightly low glucose. However, given that the
glucose normalized on repeat lumbar puncture, the improvement of the
patient's condition throughout the hospitalization, and relatively
benign course of the patient's encephalopathy, it was felt that TB was
much less likely. Lymphoma was still a possibility for the patient's
symptoms, and cytology was pending, although this was felt to be a much
less likely diagnosis. The patient was discharged back to her program,
with plans for close followup:
retroviral therapy was to be initiated and she was to be followed up in
neurology within 1 to 2 weeks. The discharge diagnosis on 28-JUN-2009
was human immunodeficiency virus (HIV) encephalopathy. Discharge
medications included IMITREX, amlodipine, compazine
(10 mg PO Q8H, PRN nausea/vomiting), ibuprofen (PRN headache). The
patient was hospitalized again on 02-JUL-2009 with acute mental status
changes. She was brought to the ED and around midnight or 12:15 on
02-JUL-2009 and it was noted at that time that the patient seemed to
again have worsening headache, worsening confusion, as well as
progressive acute mental status changes. Neurology was not contacted
regarding the patient as the ED felt that the previous work up was
satisfactory from a neurological standpoint. Primary medicine evaluated
the patient, and it was determined she would be taken to their service.
It was noted at 5:30 a.m. that the patient had a CT requested by the
primary medicine serve to the ED prior to her transition up to the
floor. Subsequently after that, the patient was noted at approximately
6 a.m. to have fixed pupils bilaterally and a change in blood and
change in heart rate from an atypical bradycardia in the 40's to a
tachycardia. It was thought that the patient would be unable to protect
her airway, and the decision was made to intubate the patient. The
patient was subsequently successfully intubated after several tries.
She was noted to have an acute decrease in her blood pressure to a
hypotension of 50's/40's. It was then thought the patient was acutely
decompensating, and the decision to place a central line was made in
collaboration between the ED and the ICU staff. The ICU staff became
involved at approximately 6:20 a.m. during the tail end of the
intubation period. Central line was placed in the jugular vein. At the
same time, the patient's systolic blood pressure returned to the 110s.
It was then noted that the patient was moving toward hypertension, and
her dopamine was weaned from 10 to 5 and subsequently settled to about
8. She was brought to CT scan and subsequently to the floor. The
initial read by the on-call radiologist demonstrated what appeared to
be some mild edema, but otherwise negative. At approximately 8:30 the
patient was being rounded on the ICU by the faculty and staff, and
staff had noted dilated pupils bilaterally while in the ED after
intubation and presented this to the team. During the examination by
the attending physician, the radiology attending came and noted that
the original read had missed important information regarding the
patient's clinical status. The attending contributed that the patient,
in fact, did demonstrate a herniation of the posterior brain tissue
into the spinal cord region. The patient was initially said to have
decreased neurological reflexes in the ED, and this was corroborated
and simultaneously neurosurgery and neurology were contacted and
activated regarding the patient. Stat orders for mannitol and decadron were sent and
administered to the patient. After evaluation by neurology and
neurosurgery, it was determined that the patient in fact had suffered
brain death. Intervention was discontinued around 10 a.m. and
subsequently neurological evaluation for brain death commenced and
terminated with determination of brain death at 1 p.m. on the afternoon
of July 2, 2009. Support was withdrawn at approximately 1 p.m. The
patient's family was present and requested autopsy to be performed. The
following laboratory tests were performed during the patient's
hospitalizations: sodium of 136, potassium 4.3, chloride of 95, BUN of
12, creatinase of 0.61
and glucose of 111. The patient had an IMR of 1.1, PT of 29.6, white
count 7.9, hemoglobin and hematocrit 12.8 and 37.7 respectively with a
platelet count in the upper 200s. The patient had blood cultures drawn
that were pending, and urinalysis demonstrated 1+ protein, glucose, and
bacteria with 0 to 2 white blood cells and 0 to 2 red blood cells. The
patient also had a lumbar puncture from 29-JUN-2009 this showed 30
white blood cells and 3 red blood cells in tube 1 and 25 white blood
cells and 2 red blood cells in tube 4 that were both lymphocyte
predominant. The patient had several studies done in addition, ALF was
23, ABT 20, alkaline phosphatase 57, and total bilirubin 0.4 with a
direct bilirubin of 0.1. The patient's urine pregnancy was negative,
urine was positive for opiates, and the patient had a serology from a
previous admission that showed cocci and crypto negative. The patient
also had a lactate of 4.6, protein 0.7, albumin 9.4, calcium 9.4,
lipase 24. The patient was also noted to have a viral load of hepatitis
C less than 3200, but also had positive hepatitis C antibodies.
Hepatitis B and hepatitis A were found to be negative. A chest x-ray on
the patient failed to demonstrate focal lesions, although there was
mild left-sided hilar congestion. A CT scan of the head that was
noncontract demonstrated herniation and edema. ECG demonstrated sinus
bradycardia. CT neuro angiogram performed 22-JUN-2009, Impression: 1.
Diffuse bilateral sulcal
effacement of the cerebral hemispheres without herniation. This is
suggestive of diffuse cerebral swelling with causes including toxic,
metabolic, or infectious etiologies. 2. Bilateral symmetric optic nerve
sheath distention without clear elevation of the optic discs suggestive
of elevated intracranial pressure (ICP) correlate with fundoscopic exam findings and/or
clinical symptoms referable to elevated ICP. 3. Incidentally noted 3 mm
left supraclinoid ICA
aneurysm, medially directed, may be a carotid cave aneurysm. 4. No
acute large vessel territory ischemia or infarct, intracranial
hemorrhage or extra-axial collection. There is no abnormal parenchymal
or leptomeningeal enhancement. MRI brain scan with contrast performed
23-JUN-2009. Impression: diffuse sulcal
effacement suggesting diffuse swelling. There is FLAIR hyperintensity and prominent
enhancement within sulci. This may be due to vessel crowding within the
narrowed sulci. However, a leptomeningeal process such as meningitis
can also look like this. Correlation with CSF analysis is recommended.
2. Vague enhancing T2/FLAIR hyperintensity
in the bilateral frontal white matter, left greater than right subinsular white matter, the
left brachium pontis,
the bilateral medial thalami, bilateral anteromedial temporal lobes.
Diagnostic considerations include infectious etiologies such as HIV
encephalopathy, herpes encephalitis, progressive multifocal
leukoencephalopathy, or toxic/metabolic etiology. All medical records
are available upon request. 9/8/09 Autopsy report received. DOD 7/2/09
Acute cerebrovascular event with uncal
and tonsillar herniation due to severe and extensive CNS vasculitis.
Additional clinical information abstracted: Migraines, history of
substance / methamphetamine use, Bell's palsy, altered mental status,
HIV infection. Extensive vasculitis affecting blood vessels in leptomeniniges and throughout
the brain and spinal cord. Severe hypoxic ischemic encephalopathy.
Chronic meningitis. Heavy and congested lungs. Renal cortical scars,
right and left kidneys, suggestive of prior infectious process.
Reactive lymphadenopathy of axillary and paraaortic
lymph nodes.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Diagnosis:
encephalitis Symptoms: confusion, possible seizure
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Patient
had her first Gardasil shot on 02/15/2010. On 02/19/2010, she had a
Grand Mal seizure. She had her 2nd shot on 08/06/2010. She died on
08/19/2010. Medical Examiner listed cause of death as Sudden unexpected
death associated with Seizure Disorder.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
8
days post second vaccination developed severe frontal headache,
lethargy, altered view state. Sympt.
initially were getting progressively worse. Was seen by neurology at
hospital. Eval dx with
immun. encephalitis.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
has been received from a 21 year old female with rituximab allergy who who in 2009 was vaccinated with
a series of 3 doses of GARDASIL (lot # not unknown), as encouraged by
her physician. Concomitant therapy included CELEXA, LAMICTAL, CONCERTA,
lorazepam, rituximab and prednisone. The patient was tired after the
first dose of GARDASIL. Six months after the vaccination series she
experienced limbic encephalitis, shrinkage of the right hippocampus,
short-term memory loss, tiredness and fluid build-up on the temporal
lobe and was hospitalized and treated (not further specified). Lab and
diagnostics studies were performed (results unknown). The patient
stated that her physicians did not know if she could be healed. The
patient reported that she was told that if the shrinkage of her brain
were to continue, she would be required to have brain surgery. At the
time of the report, the patient had not recovered. Additional
information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"Information
has been received from a physician concerning an ""about 16 year old""
female patient who in approximately 2010, about 2 years ago, was
vaccinated with a dose of GARDASIL (dose, route and lot number were not
reported). The physician reported that in approximately 2010, about 2
years ago, the patient developed high fever after administration of
GARDASIL and then the patient developed encephalitis, seizures and
continued mood changes. Patient sought medical attention by visiting
physician's office. At the time of the report the patient's outcome was
not recovered. Upon internal review, the seizure and encephalitis were
determined to be an other
important medical event. Additional information is not expected."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"Information
has been received from a physician concerning a female (age unknown)
who was vaccinated with GARDASIL, and date of therapy started was
unspecified by reporter. Subsequently (reported as ""years ago"") the
patient experienced encephalitis after receiving GARDASIL. It may have
happened around the time that GARDASIL first came out, and it didn't
mention if it was after the first dose or at what point in the series
it was. Physical therapy was given for AE. The therapy with GARDASIL
was discontinued on an unspecified day. Upon internal review,
encephalitis was considered as an
other medical important event. Additional information has
been requested."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"7/3
Aprox 4:30pm
16 yr old girl (PT)
received Gardasil injection (only vaccine given) from PCM during well
visit. Patient was in good health. Aprox
5:05pm PT started to behave strangely, was experiencing ""very vivid
imagery"" said ""this drug is funny"" began hysterically laughing, then
shortly thereafter began hysterically crying. Aprox
5:15pm PT was exhibiting erratic behavior and inability to regulate
emotions, stated she ""couldn't feel her legs, they were heavy and hard
to move"" and felt like ""If she didn't remind herself to breath she
would forget."" Mom returned to PCM, during car ride PT's respiration
was decreasing and becoming light, PT would gasp for air. Upon arrival
to PCM at aprox 5:25pm
PT stated ""throat felt tight and it was hard to breath and feeling
like she was suffocating"" PT's breathing was diminished and heart rate
was increasing PCM directed mother to take PT ER. 5:35pm Upon arrival
and check in at ER PT was ""wobbly"" and having difficulty maintaining
balance. During admittance PT was hysterically crying and disoriented.
PT was having difficulty with gross motor functions (could not button
shirt or walk to bathroom with out
assistance.) PT was admitted and became increasingly erratic in
behavior, hypersensitive to touch, and movement. PT Experienced 3 tachycardic events and had heart
rates as high as 180+, BP rose several time to rate as high as 179/112.
ER administered IV push Benadryl and 1 mg Ativan. PT blood work, tox screen and urine came back
unremarkable and free of drugs. PT was treated for an anaphylactic
reaction, cleared by psych eval
and released. 7/4 PT woke lethargic. Was disoriented and exhibiting
erratic behavior inability to regulate mood throughout the day. At
approximately 5pm PT reported blurred vision, pain in hand, tightening
of throat, and heavy legs. PT was unable to remain in social situations
and removed herself from others, began crying. PT reported feelings of
paranoia. 7/5 PT woke complaining of severe headache, at base of neck,
with pain radiating down spine aprox
3 inches. PT complained of ears feeling stuffy and eyes hurting, and
stomach pain. PT still exhibited inability to regulate mood. PT stated
her vision was ""weird"" and would see blurs of colors. PT saw PCM at aprox 12:45. During course of
exam PCM witness 3 distinct mood changes. PCM witness hypersensitivity
to touch. For the remained of the day PT appear dissociative, and
distant. PT could not remember events throughout the day. 7/6 PT Was
tired and lethargic most of the day. PT verbalized that she felt
incredibly depressed but didn't know why. PT stated that she didn't
want to be around people outside of the home because she was unsure of
how her emotions would come out, and couldn't control, from one moment
to the next if she would cry or not. PT still experienced
numbness/heaviness in legs, blurred vision and pain behind the knees
and elbows. 7/7 PT ""Still did not feel herself and had overwhelming
feeling of depression."" When asked what she would like to do or what
she wanted to eat PT responded ""I don't know"" ""I don't care"" When
mother asked how she was feeling and what symptoms she was experiencing
PT said I don't remember what I felt like or was doing the other days.
PT sated that her vision felt fuzzy and off, ""like she was wearing the
wrong prescription of glasses and her eyes were trying to adjust."" PT
continued to display erratic and atypical behavior. 7/8 PT informed PCM
that she still had a headache and just didn't feel herself but did not
know how to explain it. When asked to compare her symptoms/mood/feeling
to previous week, PT did not remember what behaviors she exhibited
during DAY 2, 3, 4 post vaccination. PT legs feel heavy, experienced
pressure in her ears and stated eyes feel heavy. Companied of an
overall general feeling of ""being sick, tingling in inner ear and
sometime trails of light/colors hues when she looks at things. 7/9 PT
felt depressed. Hard to focus vision. Heaviness in neck and eyes. Mood
fluctuation. Tried to write a grocery list and couldn't. PT had memory
difficulties and was unable to recall events from earlier in the day
and days prior. PT experienced hallucination. 7/10 PT lethargic,
hypersensitive to touch, smell and sound. PT was disoriented and
confused, had a hard time forming sentences, and difficulty pronouncing
some words. PT experienced blurred vision, heavy legs, and had 1
episode of a panic attack. 7/11 PT evaluated by neurologist, and
presented with neurological processing deficits and memory issues. Was
admitted to hospital for full neurological work up. 7/12 Patient
complained of severe headache, numbness in legs, blurred vision, had
memory issues and processing deficits. Could not state correct date,
month, year, and unable to complete tasks that crossed hemisphere,
recall verbal lists or accurately copy some pictures, solve simple math
problems. (PT had no prior history of processing issues or neurological
deficits, and historically has scored proficient or advanced on state
academic exams). 7/13 PT diagnoses with encephalitis. MRI showed
diffused meningeal enhancement. Spinal Tap/ Lumbar puncture was
unremarkable and negative for bacterial meningitis. EEG/EMU was
negative for seizures. There is no know
cause for PT condition and symptoms other than the HPV vaccine. 7/14 PT
still shows processing issues and memory loss as well as short term
memory issues. PT states the ground feel spongy when she walks.
Neurologist has ordered full psycho education work up and ambulatory
EMU."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Sudden
death. He was perfectly healthy. This vaccination is the only thing I
can think of that would have caused this. Everything else in his life
was normal, the same.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
This
spontaneous report as received from an unspecified nurse via a Company
Representative refers to a pediatric patient of unknown age and gender.
The patient's medical history and concurrent conditions were not
provided. On an unknown date the patient was vaccinated with a dose of
GARDASIL, intramuscular (lot number was not provided). It was
unspecified if the patient had received more than one dose in the
series or if this was the first administration in the series. The
reporting nurse mentioned that the patient had been diagnosed with
encephalitis, shortly after the patient was vaccinated with GARDASIL.
The patient was reported to be hospitalized at an unspecified facility,
at the time of this report (approximately in February 2014). The
outcome of encephalitis was unknown. No reporter causality was
provided. Encephalitis was considered medically significant upon
internal review. Additional information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Had
well visit 2/17/14 and was given HPV #1 and Flu shots. Developed
headache within a few days of the visit, followed by nausea, emesis,
and altered speech. Had seizures, was admitted to Hosp. 3/2/14-3/5/14
w/ encephalitis. MRI with left temporo-occipital
abnormality.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Sudden
death. Cardiomegally
with four chamber dilation. Histologic diagnosis of myocarditis. At the
time of this report toxicology is still pending.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
This
spontaneous report as received from a physician, via company
representative, refers to a 15 year old male patient. Patient's
concurrent conditions and medical history was not known. On
10-NOV-2014, the patient was vaccinated with the first dose of GARDASIL
injection and on 19-JAN-2015, patient received the second dose of
GARDASIL, intramuscularly. Concomitant medications were not provided.
On 22-JAN-2015, the patient experienced encephalitis (hospitalization,
medically significant and life threatening). On that day, patient's
parents stated that the patient was 'lying around', was not active and
was not himself. On 23-JAN-2015, at 15:30 hours, the patient was found
unconscious and unresponsive on his bedroom floor. The patient was
taken to emergency room and was then hospitalized. Unspecified testing
was conducted at that hospital. The patient had a follow up appointment
with the physician who stated that the unspecified tests came back
negative. The outcome of encephalitis was unknown. Causality assessment
was not provided. The reporter considered encephalitis to be life
threatening. Upon internal review, encephalitis was considered to be
medically significant. Additional information has been requested.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"This
spontaneous report was received from a consumer via a social media site
concerning a female who on an unspecified date received GARDASIL.
Concomitant medications and medical history were not provided. The
reporter posted on the social media site. No further information was
provided. Follow-up information was received on 04-MAR-2016 from a
consumer via social media concerning a female who was reported to have
received a dose of GARDASIL. It was reported: ""The sudden death of a
12 year old girl... just hours after receiving the HPV GARDASIL vaccine
has shocked the girl's family and sent local medical asking questions
as [...]"". No other information was provided. Additional information
is not expected."
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Information
was received from a chief researcher through an online article via a
company representative referring to unspecified patients of unknown age
and gender. The patients' medical history, concurrent condition and
concomitant therapy were not reported. On unknown dates, the patients
were vaccinated with GARDASIL (lot#, expiration date, dose and route
were unknown). On unknown dates, the patients experienced adverse
events included Guillain-Barre syndrome (paralysis), lupus
erythematosus, thrombus and encephalitis (cerebral palsy). The outcome
of the events was unknown. The causality assessment between the events
and GARDASIL was not reported. Upon internal review, all the events
were determined to be medically significant events. This is one of
several reports received from the same reporter. Additional information
is not expected.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
Encephalitis.
Vasculitis. Autoimmune dysfunction. Guillain
Barre type syndrome. Intractable pain syndrome. Full body burning pain.
Ovarian cysts. Hormonal abnormalities. Traumatic brain. All caused by
HPV.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
This
spontaneous report was received from an unspecified source, concerning
unspecified girls from unknown ages, posted in an online article. The
patients' concurrent conditions, pertinent medical history and
concomitant medications were not provided. On an unknown date, the
patients were vaccinated with GARDASIL (dose number, anatomical
location, lot # and expiration date were not known) for prophylaxis.
Furthermore, it was reported that on unspecified dates, an unknown
number of girls experienced multiple sclerosis and encephalitis, (also
reported as ''brain inflammation''), after vaccination with GARDASIL.
The outcome of the events was not mentioned. The relatedness between
'the events and vaccination with GARDASIL was not provided. This is one
of several reports received from the same source. Additional
information is not expected as no contact details were given. Sender's
Comments: US-009507513-1705USA002407: US-009507513-1705USA002409:
US-009507513-1705USA002410: US-009507513-1705USA002411:
US-009507513-1705USA002412: US-009507513-1705USA002413:
US-009507513-1705USA002414: US-009507513-1705USA002415:
US-009507513-1705USA002416: US-009507513-1705USA002393:
US-009507513-1507ZAF012830.
HUMAN
PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4)
HPV
(GARDASIL) (1098)
MERCK
& CO. INC.
"This
spontaneous report was received from social media ""Revolution For
Choice"", via a vendor regarding a 16 year old female patient. The
patient's medical history, concurrent condition and concomitant
medications were not reported. On an unknown date, the patient was
vaccinated with GARDASIL (dose, frequency, route of administration, lot
# and date of expiry were unknown) for prophylaxis. On an unknown date,
the patient experienced swollen brain (brain oedema),
anxiety, no movement (hypokinesia),
tingliness (paraesthesia), pain/extreme
pain/body pain, constant nausea, worst start to hurt her knees and back
(back pain and arthralgia. The outcome of anxiety, back pain, body
pain, arthralgia, nausea, pain, paraesthesia,
hypokinesia
and brain oedema was
unknown. On 12-OCT-2013, the patient had died suddenly on bed. The
cause of death was not reported. It was not reported if autopsy was
performed. The causality assessment was not reported. Upon internal
review, event of brain oedema
was considered to be medically significant. This is one of the several
reports.; Reported Cause(s) of Death: sudden death."
Optic
neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She
then developed weakness, behavioral change, dysarthria, facial tics,
sensory losses, and difficult-to-manage seizures, w/ multifocal
encephalitis, CSF pleiocytosis.
Broad workup of autoimmune, infectious, oncologic etiologies over the
past month unrevealing so far. Slight improvement on IV steroids, and
no improvement w/ 5 cycles plasmapheresis. She continues to worsen
clinically and remains inpatient.
Sxs
started 4-5 days prior to admission with mild headache, malaise, fever
(max T 104.1), followed by onset of seizures. Admitted to medical
center: 9/17/15. Discharged 3/1/16. Primary dx, epilepsy, unspecified
secondary dx, encephalitis. Discharge dx includes seizure disorder,
impaired ADL, cognitive deficits, muscular deconditioning.
Within
a couple hours after injections, symptoms of encephalitis. Confusion,
agitated, irritable. Severe depression within days and became
withdrawn. Continued to regress socially over the next 2 years.
Diagnosed with Autism Spectrum Disorder in October 2017.
This
spontaneous report as received from a consumer refers to herself a
46-year-old female patient. The patient's medical history, concurrent
condition, concomitant medication was not reported. On an unknown date
in November 2017, the patient was vaccinated with GARDASIL 9 (Lot#,
Expiry date: not reported) for prophylaxis. On an unknown date in
November 2017 (reported as one day after the vaccination), the patient
experienced encephalitis for which the patient had to visit the
emergency room and was treated at an unspecified hospital and was
diagnosed with encephalitis. The outcome of encephalitis was reported
as not recovered. The causality of the adverse event encephalitis with
the suspect GARDASIL 9 was unknown. Upon internal review the adverse
event encephalitis was considered medically significant.
"This
spontaneous report was received from a physician via a field
representative and refers to a 15 year old male patient. No information
was provided regarding the patient's medical history, concomitant
medications or drug reactions/ allergies. The patient concurrent
condition included myalgic
encephalitis. On an unknown date, the patient was vaccinated with
GARDASIL 9 for prophylaxis (dose, route of administration, lot number
and expiration date were not reported). On an unknown date, the patient
was diagnosed with ""myalgic
encephalitis (encephalitis), and felt more sick."" It was unknown if
the patient sought medical attention, if received treatment for the
event or if laboratory diagnostics or studies were performed. The
outcome of the events was reported as not recovered. The causal
relationship between the events and therapy with GARDASIL 9 was not
reported. Upon internal review the event encephalitis was considered to
be medically significant."
the
patient was hospitalized / in serious condition with encephalitis; This
spontaneous report was received from a physician and refers to a
14-year-old female patient. No information about the patient's
pertinent medical history, concomitant medications and drug reactions
or allergies was provided. The patient's immunization history was
uncertain. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52
58 vlp vaccine (yeast)
(GARDASIL 9) (strength, dose, lot number and expiration date were not
provided) intramuscularly for prophylaxis. The reporter was not sure if
it was the patient's first dose or not but stated it was the only
vaccine administered that day. On an unspecified date, reported as a
few days later or a few days after the vaccination, the patient was
hospitalized in a serious condition for encephalitis. She was in the
hospital for about 6 weeks, received an unspecified treatment and on an
unknown date, was discharged. The patient fully recovered on an unknown
date after leaving the hospital (reported as now back in school fully
recovered). The relatedness between the event of encephalitis and the
suspect vaccine was not provided. Upon internal review, the event of
encephalitis was considered to be medically significant.
"the
patient had encephalitis, was on stomach steroids for 2 years and had
fatigue so bad she could not get out of bed/ headache; This spontaneous
report was received from a consumer, concerning a 20-year-old female
patient who was also a daughter of a friend. The patient's pertinent
medical history, concurrent conditions, previous drug reactions or
allergies, and concomitant medications were not reported. On an unknown
date, the patient was vaccinated with hpv
rl1 6 11 16 18 31 33 45 52 58 vlp
vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dosage regimen,
route of administration, anatomical location, lot number and expiration
date were not reported). On an unknown date, the patient developed
encephalitis, had fatigue so bad she could not get out of bed, and also
experienced headache (encephalitis). The patient was on ""stomach""
steroids for 2 years. At the time of the report, the outcome of the
event was unknown (also reported as the patient could be getting better
or getting worse). The causal relationship between the suspect vaccine
and the encephalitis was not reported. Upon internal review, the event
encephalitis was determined to be medically significant. This is one of
two reports received from the same reporter.; Sender's Comments:
US-009507513-2005USA000331:"
HUMAN
PAPILLOMAVIRUS VACCINE (HPVX)
HPV
(NO BRAND NAME) (1102)
UNKNOWN
MANUFACTURER
Information
has been received from an online article via a company representative.
The article stated that a doctor said that the incidence of cervical
cancer was very low and it was impossible for Merck's Human
papillomavirus (HPV) vaccine to lower the already low incidence of
cervical cancer. It was reported that the promotion of this vaccine to
prevent cervical cancer was entirely groundless, although it was
promoted as this. The study confirmed that the indication of this
vaccine had nothing to do with cervical cancer, however, the way of
promotion still ignored this fact. In fact, there was no evidence to
support that this vaccine could prevent any cancer. According to
Merck's labeling, this vaccine (the 1st generation) targeted four types
of all the 40 types of HPV, which could be self-healing in short time.
The article also concerned about the potential risks of this vaccine,
as it indicated all the clinical trials were conducted among the
females aged 15-year old or above, however, Food and Drug
Administration (FDA) and Merck had extended the target users to girls
of 9-year old and above, even boys. It was reported that so far there
had been 15,037 cases of adverse drug reaction for this vaccine, and
the statistics only included cases that met the very stringent
validation criteria. There had been 44 girls that were confirmed to die
of this vaccine (captured in MARRS#1609USA013709). All kinds of adverse
drug reactions included Guillain-Barre syndrome (paralysis), lupus
erythematous, thrombus and encephalitis (Cerebral palsy). This report
refers to unspecified number of patients who experienced Guillain-Barre
syndrome (paralysis), lupus erythematous, thrombus and encephalitis
(Cerebral palsy). Upon internal review, the adverse events were
considered to be medically significant. Additional information has been
requested.
Note: Submitting
a report to VAERS does not mean that healthcare personnel or the
vaccine caused or contributed to the adverse event (possible side
effect).
VAERS
accepts reports of adverse events and reactions that occur following
vaccination. Healthcare providers, vaccine manufacturers, and the
public can submit reports to VAERS. While very important in monitoring
vaccine safety, VAERS reports alone cannot be used to determine if a
vaccine caused or contributed to an adverse event or illness. The
reports may contain information that is incomplete, inaccurate,
coincidental, or unverifiable. Most reports to VAERS are voluntary,
which means they are subject to biases. This creates specific
limitations on how the data can be used scientifically. Data from VAERS
reports should always be interpreted with these limitations in mind.
The
strengths of VAERS are that it is national in scope and can quickly
provide an early warning of a safety problem with a vaccine. As part of
CDC and FDA's multi-system approach to post-licensure vaccine safety
monitoring, VAERS is designed to rapidly detect unusual or unexpected
patterns of adverse events, also known as "safety signals." If a safety
signal is found in VAERS, further studies can be done in safety systems
such as the CDC's Vaccine Safety Datalink (VSD) or the Clinical
Immunization Safety Assessment (CISA) project. These systems do not
have the same limitations as VAERS, and can better assess health risks
and possible connections between adverse events and a vaccine.
Key
considerations and limitations of VAERS data:
Vaccine
providers are encouraged to report any clinically significant health
problem following vaccination to VAERS, whether or not they believe the
vaccine was the cause.
Reports
may include incomplete, inaccurate, coincidental and unverified
information.
The
number of reports alone cannot be interpreted or used to reach
conclusions about the existence, severity, frequency, or rates of
problems associated with vaccines.
VAERS
data are limited to vaccine adverse event reports received between 1990
and the most recent date for which data are available.
VAERS
data do not represent all known safety information for a vaccine and
should be interpreted in the context of other scientific information.
Some
items may have more than 1 occurrence in any single event report, such
as Symptoms, Vaccine Products, Manufacturers, and Event Categories. If
data are grouped by any of these items, then the number in the Events
Reported column may exceed the total number of unique events. If
percentages are shown, then the associated percentage of total unique
event reports will exceed 100% in such cases. For example, the number
of Symptoms mentioned is likely to exceed the number of events
reported, because many reports include more than 1 Symptom. When more then 1 Symptom occurs in a
single report, then the percentage of Symptoms to unique events is more
than 100%. More
information.
Data
contains VAERS reports processed as of 7/14/2020. The VAERS data in
WONDER are updated monthly, yet the VAERS system receives continuous
updates including revisions and new reports for preceding time
periods. More
information.
United
States Department of Health and Human Services (DHHS), Public Health
Service (PHS), Centers for Disease Control (CDC) / Food and Drug
Administration (FDA), Vaccine Adverse Event Reporting System (VAERS)
1990 - last month, CDC WONDER On-line Database. Accessed at
http://wonder.cdc.gov/vaers.html on Sep 6, 2020 3:05:25 AM
