VAERES_SearchExample3
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

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Vaccine Type

Results are sorted in by-variable order

Vaccine

Vaccine Manufacturer

VAERS ID

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 tx inbetween 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; bilat symm, 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."

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

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.

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

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.

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

Meningoencephalitis with ADEM and optic neuritis. Headaches, nausea, vomiting. Tx: Methylprednisone.

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

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.

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

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.

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

"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."

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

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.

HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9)

HPV (GARDASIL 9) (1170)

MERCK & CO. INC.

"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).

TopOptionsNotesCitationQuery Criteria

 

Notes:

Caveats:

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.

Help:

See The Vaccine Adverse Event Reporting System (VAERS) Documentation for more information.

Query Date:

Sep 6, 2020 3:05:25 AM

 

TopOptionsNotesCitationQuery Criteria

 

Suggested Citation:

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

 

TopOptionsNotesCitationQuery Criteria

 

Query Criteria:

State / Territory:

The United States/Territories/Unknown

Symptoms:

ENCEPHALITIS; SUDDEN DEATH

Vaccine Products:

HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (HPV4); HUMAN PAPILLOMAVIRUS (TYPES 6, 11,16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (HPV9); HUMAN PAPILLOMAVIRUS VACCINE (HPVX); HUMAN PAPILLOVAVIRUS BIVALENT (HPV2)

VAERS ID:

All

Group By:

Vaccine Type; Vaccine; Vaccine Manufacturer; VAERS ID

Show Totals:

False

Show Zero Values:

False

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Content source: CDC WONDER