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Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician''s assistant (PA), via a company representative, concerning a female patient who was vaccinated (date unspecified) with a dose of Gardasil the PA reported that "the patient died of a blood clot 3 hours after getting the Gardasil vaccine." The PA clarified that the patient was not vaccinated at her office. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a licensed visiting nurse via a nurse practitioner. The nurse practitioner was told by a friend that a female patient was vaccinated with Gardasil and two weeks alter developed a blood clot. Subsequently the patient died. The cause of death was from the blood clot. The reporting licensed visiting nurse considered the blood clot to be immediately life-threatening and disabling. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a nurse practitioner who heard from an emergency room (ER) nurse that an 11 year old female was vaccinated "within in the past month" in approximately May 2007 with a first dose of Gardasil. Subsequently, 3 days after vaccination the patient presented to an ER. She experienced cardiac arrest, required lung bypass (ECMO) and "may not have expired." It was also reported by the same nurse that the physician from the hospital said that "the death was due to an anaphylactic reaction to Gardasil." The anaphylactic reaction and cardiac arrest were considered to be life threatening by the reporter. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician who attended a conference that mentioned two patients who were vaccinated with Gardasil. Subsequently the patients died. The cause of death not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified) ("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient''s death. Additional information is not expected. 7/2/08-records received-Adverse effect of drugs.Toxicology survey findings:urine positive for methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine, diphenhydramine and naproxen. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of Gardasil (yeast, unknown lot number) and in July 2007, was vaccinated with the second dose of Gardasil. In September 2007, the patient died. No further details or symptoms were known regarding the patient''s death. The physician mentioned that an autopsy would be done however, had not received the results yet. The reporting physician felt that the patient''s death was not related to therapy with Gardasil. Additional information has been requested. 10/11/2007 Patient demographics provided by CDC. 10/15/07 Received vax record from pcp. VAERS database updated w/same. 10/15/07 Received pcp & hospital medical records from CDC which reveal patient experienced vomiting with elevated blood sugars who became unresponsive & pulseless. CPR started & taken to ER on 9/19/07. Resuscitation was unsuccessful & patient pronounced 9/19/07. 10/26/07 Reviewed autopsy report which reveals COD as diabetic ketoacidosis & manner of death as natural. Patient had been found by parent unresponsive at home. History of severe diabetes mellitus. Vitreous glucose 667 (H). | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon ''appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination. 10/18/07 Patient name received from FDA. 10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis. 10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007. VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm. 11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day. Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus. Intubated & IV antibiotics started & transferred to higher level of care. Neurosurgery & ID consults done. Pupils dilated & nonreactive. Diffuse cerebral edema leading to brain herniation & death. 12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007. Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia. Temp in ER max 104.7 Became nonresponsive w/posturing in ER. Intubated. Started on IV antibiotics & transferred to higher level of care. | |||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes Write-up: Information has been received from a physician''s assistant concerning a 12 year old female with no reported medical history who on approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was not where the vaccine was administered, rather they were the patient''s family physician. On 06-OCT-2007 the patient died in her sleep. No further information was provided. No lot number was given. Additional information has been requested. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a large female who received one dose of Gardasil. Subsequently, the patient was found dead in her truck from a blood clot that traveled from her legs to her lungs. The cause of death was reported to be a blood clot. Additional information has been requested. 3/5/08 Autopsy states COD as pulmonary thromboembolus w/deep vein thrombosis of right leg & obesity as contributing factor. | |||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a consumer concerning her 12 year old daughter with a history of seizures and heart arrhythmias, who on 25-JAN-2007 was vaccinated with a first dose of Gardasil. On 27-APRIL-2007 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included LAMICTAL, vitamins (unspecified) and KEPPRA. Subsequently, the patient began to have seizures, developed a rash on her arm, and was complaining about headaches. On 22-JUN-2007 the patient experienced a heart arrhythmia and was hospitalized. Due to the arrhythmia the patient was placed on life support and died on 29-JUN-2007. The patient''s mother reported that the patient had an electrocardiogram (EKG) about 5 years ago to test for prolonged QT syndrome. The test came back normal. It was reported that at that time the patient was in and out of the emergency room due to having seizures periodically. The patient had been seeing a neurologist and had not had any seizures for about two years until she received the second dose of Gardasil. The patient''s mother reported after her daughter''s death and burial she had received copies of her daughter''s medical records. Throughout the reports it showed that for the past five years the patient had prolonged QT syndrome, and proguda syndrome "which causes seizures and heart arrythmias." The patient''s cause of death was prolonged QT syndrome, brain death, and proguda syndrome. No product quality complaint was involved. The seizures, rash, headaches, heart arrythmias, prolonged QT syndrome, brain death, and proguda syndrome were considered to be other important medical events. Additional information is not available. | |||||||||||||||||||||||
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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&SYMPTOMS=Death_%2810011906%29&VAX=HPV4
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