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Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a medical assistant concerning a 22 year old female with no known medical history and no known allergies who was vaccinated with GARDASIL. Subsequently the patient experienced an unexplainable death. The mother of the patient found her daughter unresponsive and dead in her bed. It was noted that this death was reported to VAERS and the death was not caused by GARDASIL. It is unknown if medical attention was sought. The medical assistant considered the death to be disabling and life-threatening. No further information is available. | ||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope. She was taken to an emergency room and released. The patient was vaccinated with a second dose of GARDASIL (unspecified time). Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided). The patient was vaccinated with a third dose of GARDASIL at 15 years old. Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause. The physician has asked the mother for the autopsy report. The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling. Additional information has been requested. 2/13/09 Autopsy report received. COD: Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder. Pulmonary congestion and edema. Passive visceral congestion. 2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired. | ||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Initial and follow up information has been received from a physician, who was told by one of his patients, that the mother of a consumer was told by a neurologist that there were 4,400 kids who have died following vaccination with GARDASIL. No product quality complaint was involved. Attempts are being made to verify the existence of patients. Additional information has been requested. | ||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with her third dose of GARDASIL. Subsequently the patient experienced soreness at the injection site and fatigue. The outcome of soreness at the injection site and fatigue was not reported. Two months after receiving her third dose of GARDASIL, the patient died. The cause of death was "viral insult to the heart". Unspecified medical attention was sought. Follow-up information was received via telephone call from the physician. The patient was a family member. She did not have the vaccination dates or lot numbers since she did not give them. The physician reported that the patient''s mother thought that the patient died related to GARDASIL. She did not have the cause of death. The physician refused to provide patient information, information was gave to the coroner. The physician considered "viral insult to the heart" 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 physician concerning his patient''s daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The patient''s mother told to the physician that her daughter died in her dorm room 4 days after receiving the dose. The physician did not have much information because he did not administer the vaccine and the patient''s daughter was not his patient. The reporter did not know the name of the physician who administered the vaccine. The physician considered the event to be life threatening. Additional information has been requested. | ||||||||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: To Whom It May Concern: My daughter went to our nurse practitioner at Health Care Center on March 31, 2008 for a sore throat. She complained of her throat for about two days prior. Pt would get pharyngitis and strep about twice a year since she was 13. She received a shot of ROCEPHIN in the office on March 31st as well she was given a prescription for ZITHROMAX (Z-PAK) at the same time. I''m not sure exactly what time her appointment was it was around 11:00 am. that day. She dropped off her prescription at the pharmacy and I picked up on my way home. She took her first dose of ZITHROMAX on the 31st. She stayed home from school the next two days. She slept late both days which is not abnormal for her. In the evenings we played rummy, she was congested and coughing a little. She complained of a headache the next night and I gave her some ibuprofen. On Wednesday April 3rd she went to school, (school gets out at 3:05 p.m.) after school she went to tract practice. Her tract practice was a short one, I know she ran but I''m not sure how much. She stopped at a convenience store on the way home from school and got a Red Bull. She went home and changed clothes for work. She called me between 4:30 and 5:00 p.m. on her way to work to tell me about the road being blocked due to rain where we live. She parked her car and was walking the short distance into where she works she collapsed and started seizing. A lady in the drive through told the owner that she had fallen and he went out immediately. He said she was shaking, the employees inside called 911 and then me. The owner told me she stopped shaking and took a few strained breaths and then went limp. The police officer arrive within three minutes, he was a first responder. He did not check for a pulse or attempt CPR (I am in the process of getting a police report as well). Just as I got there an off duty paramedic arrived and started CPR. It took quite awhile before the ambulance arrived; she had been down too long. I later learned that they did not get her heart started until just before the ambulance arrived at the hospital. Pt officially died on April 7th, the decision was made on April 6th that she become an organ donor. My daughter was a very healthy, vibrant, and beautiful person! Any other information you need I will do my best to provide. I STILL have not received the autopsy report. I did talk to them Friday and they said it would be within the next two weeks. Sincerely, pt''s mother 9/19/08 Autopsy report states COD as apparent cardiac rhythm disturbance of undetermined etiology. Report states pathologic findings of: hx of sudden fall & cardiac arrest; subgaleal hemorrhage, fontoparietal scalp; tongue abrasions c/w tooth marks; hx of recent illness; agonal seizures; bilateral cerebral edema; catecholamine induced myotoxicity; bilatreral lobar pneumonia; organ & tissue harvesting. | ||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a registered nurse (R.N.) concerning a 22 year old female (a relative of another employee) who was vaccinated with a third dose of GARDASIL. Subsequently the patient died. The cause of death was unknown. Additional information has been requested. | ||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillain Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the [[name]] or off the bed, difficulty lifting [[name]] off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved [[name]] weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her [[name]]. Approx 3 [[name]] after the fall, patient had severe muscle weakness while exercising. Had been out of state for 7 months until 11 days prior to admit. Weakness progressed & hospitalized. Tx w/IVIG. Rheum, Neuro consulted. Responded well to IVIG. D/C to home w/PT & outpatient clinic f/u. 11/18/08 Reviewed hospital medical records of 7/1-8/26/2008. FINAL DX: neuromuscular weakness, respiratory insufficiency Records reveal that patient experienced fall & hit her [[name]] w/o LOC. Had neck & shoulder discomfort. 3 [[name]] later was unable to raise arms above her [[name]] & had muscle soreness. Seen by out of state chiropractor & orthopedist, c-spine films done. Bilateral UE weakness continued to progress w/SOB. reduced PFTs & admitted 7/1/08 for GBS w/u. Had mild swallowing difficulty & dysarthria. Neuro consult done but not included in records received. No d/c summary available. Have OT/PT notes from 7/9-7/28/08. Seen in ER on 7/28/08 for continued neuromuscular weakness, nausea & dehydration & subsequently transferred to higher level of care. | ||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: 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. | ||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included erythromycin, solution, topical. On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized. On 05-AUG-2008, the patient experienced myocarditis and died. Diagnosis was myocarditis but the doctor said it was not related to GARDASIL. The last time she was seen in this office was 2005. No additional information at this time. Additional information has been requested. 10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor. 9/22/08 Reviewed PCP medical records. Reveals patient experienced abdominal pain, chest pain & aching everywhere. Expired 8/5/08 w/viral infection of the heart. Concomitant med was erythomycin topical solution for acne. Patient noted to be in good health on day of vaccination. 4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days. Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB, respiratory distress w/hypoxemia, azotemia, shocklike symptoms. EKG w/diffuse ST changes & ST elevations. Dx w/acute anteroseptal MI Emergent cardiac cath revealed EF 23% & balloon pump placed. Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed. | ||||||||||||||||||||||||||
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