May 15, 2013 VAERS Database Search on Flu Shot Deaths

05/15/2013 14:36

I did a search on May 15, 2013 on deaths by flu shot (seasonal as well as H1N1 and other strains) from 1980-2013.  Attached and below are the results.  

 

 

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The Vaccine Adverse Event Reporting System (VAERS) Results

 
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Event Category Month Vaccinated Month Reported VAERS ID
  Adverse Event Description Click to sort by Adverse Event Description ascending Click to sort by Adverse Event Description descending
< 6 months Death Oct., 2007 Oct., 2007 292942-1 This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children's Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown. 10/16/07 T/C to reporter who provided patient demographics. 10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported. D/C to home 10/6 with f/u scheduled for 10/8. 11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home. Lethargic w/multiple apneic events at pcp office on 10/8/07. WBC 16.8, platelets 20,000 in pcp poffice. Pcp placed on O2 & called EMS. Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007. Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated. Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.
< 6 months Death Oct., 2007 Oct., 2007 Total  
< 6 months Death Oct., 2007 Total  
< 6 months Death Nov., 2010 Dec., 2010 412768-1 Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.
< 6 months Death Nov., 2010 Dec., 2010 Total  
< 6 months Death Nov., 2010 Total  
< 6 months Death Total  
< 6 months Total  
6-11 months Death Dec., 2003 Jan., 2005 232509-1 Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.
6-11 months Death Dec., 2003 Jan., 2005 Total  
6-11 months Death Dec., 2003 Total  
6-11 months Death Nov., 2007 Dec., 2007 298905-1 Patient collapsed while eating breakfast at home. He was taken to the ER and pronounced dead. 12/18/07 Reviewed hospital ER records which reveal patient in usual state of health on 11/27 when coughed & then collapsed at home. Was unresponsive in ER & resuscitation unsuccessful. ER COD stated as sudden cardiac death. 1/21/08 Reviewed autopsy report which states COD as complication from congenital cardiac disease (probable arrhythmia.
6-11 months Death Nov., 2007 Dec., 2007 Total  
6-11 months Death Nov., 2007 Total  
6-11 months Death Oct., 2008 Oct., 2008 330148-1 Patient received Fluzone on Monday 10.21.08, and died on Tuesday pm on 10.22.08 12/18/08 Autopsy report states COD as sudden unexplained infant death. Manner of death is undetermined. Report also states patient getting over cold w/runny nose & cough, no fever, on day of vaccination. Had been put to sleep on back & found on stomach in crib.
6-11 months Death Oct., 2008 Oct., 2008 Total  
6-11 months Death Oct., 2008 Total  
6-11 months Death Nov., 2008 Dec., 2008 333759-1 5 days after vaccines administered pt was found face-down in crib not breathing. Resuscitation not successful. No other signs of illness. Presumed SIDS vs suffocation. 3/9/09-autopsy report received-COD Sudden Infant Death Syndrome.
6-11 months Death Nov., 2008 Dec., 2008 Total  
6-11 months Death Nov., 2008 Total  
6-11 months Death Dec., 2008 Dec., 2008 336129-1 Death - Mom discovered infant's head wedged between pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive asphyxia. Compressive markings of skin of chest, shoulders and sides of face. Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic junctions, right more than left.
6-11 months Death Dec., 2008 Dec., 2008 Total  
6-11 months Death Dec., 2008 Total  
6-11 months Death Jan., 2009 Mar., 2009 340925-1 Patient died of influenza A on 2/10/09. 3/16/09-preliminary anatomic diagnoses received-Influenza A infection with Staphylococcus aureus superinfection and septic shock. Bilateral hemorrhagic bronchopneumonia. Staphylococcus aureus isolated on postmortem lung culture;antibiotic sensitivity pending. Influenza A virus identified by PCR testing on antemortem tracheal aspirate. Bilateral adrenal hemorrhage Waterhouse-Friderichsen syndrome). Coagulopathy widespread glomerular microthrombi. Congestive organomegaly, lungs, liver, kidneys and spleen. Admitted 2/10/09.
6-11 months Death Jan., 2009 Mar., 2009 Total  
6-11 months Death Jan., 2009 Total  
6-11 months Death Jan., 2010 Jan., 2010 376710-1 According to mother, mom called office stated that she walked into baby room he was unresponsive, she called EMS and baby was taken to local ER where he was pronounced dead. Have not spoken to mother, she called office and spoke with nurse.
6-11 months Death Jan., 2010 Jan., 2010 378368-1 upper respiratory complaints - admitted to ICU.
6-11 months Death Jan., 2010 Jan., 2010 Total  
6-11 months Death Jan., 2010 Total  
6-11 months Death Apr., 2010 Apr., 2010 385142-1 Patient had life threatening lissencephaly aspiration (G Butter Fed) & mixed apnea known risk & partial no code.
6-11 months Death Apr., 2010 Apr., 2010 Total  
6-11 months Death Apr., 2010 Total  
6-11 months Death Sep., 2010 Oct., 2010 404173-1 Pt. deceased 10/11/2010. Unknown cause at present time; per mo-pt found in crib, prone, not breathing on morning of 10/11/2010. Past history significant for spinal muscular atrophy Type II. Treated for pneumonia 9/20-9/22/2010.
6-11 months Death Sep., 2010 Oct., 2010 Total  
6-11 months Death Sep., 2010 Total  
6-11 months Death Oct., 2010 Mar., 2011 420013-1 This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician. A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease. Relevant medical history was unknown. The relevant concomitant medications were unknown. The infant had only been administered two doses of PREVNAR 13 instead of four doses. On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection. Treatment was not reported. On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home. On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized. On 14MAR2011, while in the hospital, he had seizures. An x-ray was performed which revealed an enlarged heart. The patient then had cardiac arrest. On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis. Treatments in response to the events were not reported. On 15MAR2011, the infant died. An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis. The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
6-11 months Death Oct., 2010 Mar., 2011 Total  
6-11 months Death Oct., 2010 Total  
6-11 months Death Nov., 2010 Nov., 2010 407754-1 Previously healthy baby taken to ER by EMS unresponsive, with no pulse, no respirations. Details of what occurred prior to EMS arrival to apartment are unknown. One report is that the baby was in the bath with an older sibling, or mom was in the bathroom with another child, heard something in another room and then went and found the baby unresponsive. Mom started CPR, it took 5 - 10 minutes before the fire department arrived and continued CPR, the EMS arrived and found the baby on the floor with vomitis in hair, continued CPR, intubated, were unsuccessful in placing an IV line and administered Epinephrine via the ET. Upon arrival to the ER the baby was asystolic, IV started, 3 rounds of Epinephrine and Atropine administered via the IV and one dose of Na Bicarb, the ET tube was removed and another one placed, NG tube placed. All attempts were unsuccessful. The baby was pronounced at 10:48 PM. Medical Examiner to handle case.
6-11 months Death Nov., 2010 Nov., 2010 Total  
6-11 months Death Nov., 2010 Total  
6-11 months Death Dec., 2010 Apr., 2011 421334-1 None stated.
6-11 months Death Dec., 2010 Apr., 2011 Total  
6-11 months Death Dec., 2010 Total  
6-11 months Death Oct., 2011 Jan., 2012 446850-1 Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.
6-11 months Death Oct., 2011 Jan., 2012 Total  
6-11 months Death Oct., 2011 Total  
6-11 months Death Feb., 2012 Mar., 2012 452453-1 Baby died at home DOA at hosp.
6-11 months Death Feb., 2012 Mar., 2012 Total  
6-11 months Death Feb., 2012 Total  
6-11 months Death Total  
6-11 months Life Threatening Dec., 2003 Jan., 2005 232509-1 Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.
6-11 months Life Threatening Dec., 2003 Jan., 2005 Total  
6-11 months Life Threatening Dec., 2003 Total  
6-11 months Life Threatening Oct., 2011 Jan., 2012 446850-1 Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.
6-11 months Life Threatening Oct., 2011 Jan., 2012 Total  
6-11 months Life Threatening Oct., 2011 Total  
6-11 months Life Threatening Total  
6-11 months Permanent Disability Dec., 2003 Jan., 2005 232509-1 Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.
6-11 months Permanent Disability Dec., 2003 Jan., 2005 Total  
6-11 months Permanent Disability Dec., 2003 Total  
6-11 months Permanent Disability Total  
6-11 months Hospitalized Dec., 2003 Jan., 2005 232509-1 Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.
6-11 months Hospitalized Dec., 2003 Jan., 2005 Total  
6-11 months Hospitalized Dec., 2003 Total  
6-11 months Hospitalized Oct., 2010 Mar., 2011 420013-1 This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician. A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease. Relevant medical history was unknown. The relevant concomitant medications were unknown. The infant had only been administered two doses of PREVNAR 13 instead of four doses. On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection. Treatment was not reported. On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home. On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized. On 14MAR2011, while in the hospital, he had seizures. An x-ray was performed which revealed an enlarged heart. The patient then had cardiac arrest. On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis. Treatments in response to the events were not reported. On 15MAR2011, the infant died. An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis. The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
6-11 months Hospitalized Oct., 2010 Mar., 2011 Total  
6-11 months Hospitalized Oct., 2010 Total  
6-11 months Hospitalized Oct., 2011 Jan., 2012 446850-1 Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.
6-11 months Hospitalized Oct., 2011 Jan., 2012 Total  
6-11 months Hospitalized Oct., 2011 Total  
6-11 months Hospitalized Total  
6-11 months Hospitalized, Prolonged Dec., 2003 Jan., 2005 232509-1 Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.
6-11 months Hospitalized, Prolonged Dec., 2003 Jan., 2005 Total  
6-11 months Hospitalized, Prolonged Dec., 2003 Total  
6-11 months Hospitalized, Prolonged Oct., 2010 Mar., 2011 420013-1 This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician. A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease. Relevant medical history was unknown. The relevant concomitant medications were unknown. The infant had only been administered two doses of PREVNAR 13 instead of four doses. On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection. Treatment was not reported. On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home. On 14MAR2011, the patient was taken to the physician's office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized. On 14MAR2011, while in the hospital, he had seizures. An x-ray was performed which revealed an enlarged heart. The patient then had cardiac arrest. On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis. Treatments in response to the events were not reported. On 15MAR2011, the infant died. An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis. The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
6-11 months Hospitalized, Prolonged Oct., 2010 Mar., 2011 Total  
6-11 months Hospitalized, Prolonged Oct., 2010 Total  
6-11 months Hospitalized, Prolonged Total  
6-11 months Emergency Room Dec., 2003 Jan., 2005 232509-1 Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.
6-11 months Emergency Room Dec., 2003 Jan., 2005 Total  
6-11 months Emergency Room Dec., 2003 Total  
6-11 months Emergency Room Apr., 2010 Apr., 2010 385142-1 Patient had life threatening lissencephaly aspiration (G Butter Fed) & mixed apnea known risk & partial no code.
6-11 months Emergency Room Apr., 2010 Apr., 2010 Total  
6-11 months Emergency Room Apr., 2010 Total  
6-11 months Emergency Room Nov., 2010 Nov., 2010 407754-1 Previously healthy baby taken to ER by EMS unresponsive, with no pulse, no respirations. Details of what occurred prior to EMS arrival to apartment are unknown. One report is that the baby was in the bath with an older sibling, or mom was in the bathroom with another child, heard something in another room and then went and found the baby unresponsive. Mom started CPR, it took 5 - 10 minutes before the fire department arrived and continued CPR, the EMS arrived and found the baby on the floor with vomitis in hair, continued CPR, intubated, were unsuccessful in placing an IV line and administered Epinephrine via the ET. Upon arrival to the ER the baby was asystolic, IV started, 3 rounds of Epinephrine and Atropine administered via the IV and one dose of Na Bicarb, the ET tube was removed and another one placed, NG tube placed. All attempts were unsuccessful. The baby was pronounced at 10:48 PM. Medical Examiner to handle case.
6-11 months Emergency Room Nov., 2010 Nov., 2010 Total  
6-11 months Emergency Room Nov., 2010 Total  
6-11 months Emergency Room Oct., 2011 Jan., 2012 446850-1 Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.
6-11 months Emergency Room Oct., 2011 Jan., 2012 Total  
6-11 months Emergency Room Oct., 2011 Total  
6-11 months Emergency Room Total  
6-11 months Total  
1-2 years Death Nov., 2006 Dec., 2009 370987-1 Fever, seizure approximately 8 days after vaccines. Diagnosed with viral encephalitis at hospital. 12/03/09 Vac record received for DOS 11/22/09 12/22/09: Provisional Autopsy report received for date of exam 10/9/09. Findings: Clinical history of seizures; presented with status epilepticus and Influenza A (H1N1) positivity. A. Heavy lungs. B. Clinical hx. of encephalitis and brain herniation. C. Other findings: Heavy heart, pericardial effusion, hepatosplenomegaly. 12/04/09 DC summary for DOS received for DOS 09/09/09 - 10/07/09. Final DX: Hypoxic ischemic encephalopathy Pt presented with seizure, rigors, tonic-clinic seizures. On neurological exam: febrile seizure, developed blown R pupil, diffuse cerebral edema, increased ICP; tx: hypertonic saline, pentobarbital, Tamiflu, Ativan, Dilantin, Manitol, serum sodium; Pt's condition worsened and Pt was not responsive. Physician related cerebral edema to H1N1 influenza related encephalitis or metabolic disorders. Pt expired on 10/07/09.
1-2 years Death Nov., 2006 Dec., 2009 Total  
1-2 years Death Nov., 2006 Total  
1-2 years Death Dec., 2006 Dec., 2006 269826-1 Pt found unresponsive at home and brought to ED - unable to resuscitate; pronounced dead. 5/9/08 Autopsy report states COD as changes c/w viral pneumonia, bilateral & manner of death as natural. Autopsy report states patient arrested while at home & transported to ER.
1-2 years Death Dec., 2006 Dec., 2006 Total  
1-2 years Death Dec., 2006 Total  
1-2 years Death Sep., 2007 Oct., 2007 291678-1 Healthy 18 mo male with history of febrile seizure in 3/07 given MMR II, VZV, DTaP & Flu vaccine on 9/24/07. Child discovered by mother deceased in bed approx 9/25/07. 11/30/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined. Anatomic diagnoses: pulmonary congestion & edema, sudden of unknown etiology. Patient was found unresponsive face down on mattress in crib.
1-2 years Death Sep., 2007 Oct., 2007 Total  
1-2 years Death Sep., 2007 Total  
1-2 years Death Oct., 2007 Oct., 2007 295043-1 Child had flu shot @ about 10 am. Waited in office for 20 minutes. Went home w/mother and private duty nurse. Nurse reported he was fussy after the immunization. She held him until he went to sleep. They put child to bed in parental bedroom upstairs. Nurse went to kitchen to get g-tube feeds ready. Apnea alarm went off shortly thereafter. When RN got to the child, he was face down in the bed and blue. They administered CPR, called 911. He was airlifted to hospital, where he was pronounced dead approximately two hours after receiving the flu shot. 11/13/07 Received autopsy report which reveals COD as complications of cerebral dysgenesis of indeterminate etiology; arthrogryposis multiplex congenita was a significant contributing factor. Had been placed on side for nap but was found prone. Disabilities rendered unable to lift head/body to protect airway. 11/16/07 Received vax records from pcp. VAERS database updated w/same.
1-2 years Death Oct., 2007 Oct., 2007 Total  
1-2 years Death Oct., 2007 Nov., 2007 295195-1 Client passed away today. Cause of death unknown at this time. An autopsy is to be performed down state. 8/18/09 Autopsy report 11/02/06. Additional information abstracted: Medical complications of omphalocele. History of repair of congenital omphalocele. Severe abdominal adhesions with extensive dilation of loops of small and large intestine. Status post gastrostomy tube placement. Acute proximal and distal convoluted tubular necrosis of kidneys. Extensive intersitial calcification of kidneys.
1-2 years Death Oct., 2007 Nov., 2007 Total  
1-2 years Death Oct., 2007 Total  
1-2 years Death Nov., 2008 Jan., 2009 337669-1 "Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR #1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later ""barely breathing""; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-died at local hospital a couple of hours later. 2/12/09 PCP and hospital records received from FDA. Pt with mild fever 11/24/08 put down to nap. Ptfound to be diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160, RR 32 with rhonchi bilaterally R>L. Dx with severe croup at local hospital with transport planned to higher level of care. In ER unresponsive in severe respiratory distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression- Respiratory Failure. Cardiac arrest. CPR unsuccesful. 3/25/09 Autopsy report received with COD: Community Acquired Pneumonia. Manner of Death: natural. Final DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms purulent multifocal pneumonia. 2) Moderate Cerebral Edema. 3) Serous Pleural and Peritoneal Effusions."
1-2 years Death Nov., 2008 Jan., 2009 Total  
1-2 years Death Nov., 2008 Total  
1-2 years Death Dec., 2008 Jan., 2009 336785-1 Patient seen on 12/18/08, received immunizations, had low grade fever next day and then was brought to ER lifeless. 2/17/09-records received COB bacterial sepsis. Other significant conditions contributing to death but not related to terminal conditions:sickle cell anemia trait. krk
1-2 years Death Dec., 2008 Jan., 2009 Total  
1-2 years Death Dec., 2008 Total  
1-2 years Death Jan., 2009 Jan., 2009 338667-1 Sudden death at home morning of 1/28/09. 6/1/09 Autopsy report states COD as sudden unexpected infant death & manner of death as natural. Report also states patient found dead in crib, tox screens & cultures all neg.
1-2 years Death Jan., 2009 Jan., 2009 Total  
1-2 years Death Jan., 2009 Total  
1-2 years Death Oct., 2009 Oct., 2009 360751-1 Patient was seen on 10/1/09. Death reported on 10/4/09. Pt has seizure disorder along with encephalocele. / DANDY WALKER Syndrome. Had received vaccines on 10/1/09.
1-2 years Death Oct., 2009 Oct., 2009 Total  
1-2 years Death Oct., 2009 Jan., 2010 377577-1 Parents report onset of diarrhea and abdominal pain in AM on day following vaccination. He presented to the ED 3 days following vaccination with acute gastroenteritis, renal failure, repiratory distress and shock. He was admitted to the PICU from the ED with a diagnosis of acute gastroenteritis +/- HUS. He died later that evening in the PICU.
1-2 years Death Oct., 2009 Jan., 2010 Total  
1-2 years Death Oct., 2009 Total  
1-2 years Death Nov., 2009 Nov., 2009 365786-1 Patient Died.
1-2 years Death Nov., 2009 Nov., 2009 366686-1 Pt lethargic, with non custodial parent out of town. Febrile 11-8-09 -> 11-9-09. Found unresponsive. Died in AM 11-9-09. ? foul play.
1-2 years Death Nov., 2009 Nov., 2009 367270-1 Arrived to ED at 1214 via EMS. In asystole and CPR in progress. Intubated and defibrillated in field. Interosseous IV started in ED. Epinephrine, bicarb, and glucose administered. Code stopped at 1236. 11/17/09 PCP medical records and ED records received service date 11/5/09. Assessment: Cardiopulmonary arrest. Child presented for H1N1 vaccination with nasal congestion and oxygen via nasal cannula. No mention from mother of concerns, no noticeable distress from child. Later at home grandmother heard O2 Oximeter beep, found child unresponsive and not breathing. Mother performed CPR. EMS started ACLS, intubated, and defibrillated. Interosseous IV. Pupils on admission Fixed and dilated. No spontaneous respirations. No cardiac activity - asystole. No pulse. No blood pressure. Skin cyanotic and cool. Code terminated. Deceased.
1-2 years Death Nov., 2009 Nov., 2009 Total  
1-2 years Death Nov., 2009 Total  
1-2 years Death Dec., 2009 Dec., 2009 374649-1 12/16 2130. Presented to ED 12/16 with fever 104.8. Treated with TYLENOL and discharged to home. Returned to ED on 12/17-0615 - altered Mental Status, diarrhea, Rash, T 99.8 - Cardiac arrest - Intubation, code Meds, ROCEPHIN, Vancomycin, acyclovir. Transferred. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. \ksk 12/31/09 ED consultation records received. Service date 12/17/09. Assessment: Thrombocytopenia, purpuric rash, cardiopulmonary respiratory arrest, shock with septic and hypovolemic metabolic acidosis, hematemesis, screen for meningococcemia. Child presented to the ED the previous evening with a temperature of 104.8 F was medicated for fever and discharged. This AM presents with a purpuric rash all extremities. Diarrhea, lethargic. Decreased level of consciousness. Intubated and attempted to stabilize for air transport. Abdominal distention. Blood-tinged mucus fluid from nose and mouth. Full CPR. Pulseless electrical activity.
1-2 years Death Dec., 2009 Dec., 2009 Total  
1-2 years Death Dec., 2009 Jan., 2010 377459-1 DEATH. (Toddler was napping in crib during day. Parent found child in full arrest. (Unclear if he'd be seizing prior.) CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.
1-2 years Death Dec., 2009 Jan., 2010 Total  
1-2 years Death Dec., 2009 Total  
1-2 years Death Jan., 2010 May, 2010 388916-1 Pt. received vaccines on 1/7/10 and was found unresponsive in crib on 1/28/10. Autopsy showed pt. died from Fibroelastosis of the heart.
1-2 years Death Jan., 2010 May, 2010 Total  
1-2 years Death Jan., 2010 Total  
1-2 years Death Feb., 2010 Feb., 2010 381178-1 "28 month old (ex - 30 week preemie) male was seen in pediatric clinic for outpatient evaluation of croup. Examining attending physician described barking cough but no stridor at rest. Given dexamethasone 9 mg and vaccines. Child put to bed ""fine"". Found dead next morning. Unsuccessful resuscitation."
1-2 years Death Feb., 2010 Feb., 2010 Total  
1-2 years Death Feb., 2010 Total  
1-2 years Death Mar., 2010 Mar., 2010 382341-1 reported child developed a fever early this am with possible febrile seizure. Child was placed down for afternoon nap mother went in room to check on child realized something wrong/ not moving/responding turned child over and discovered child was blue. Coroner did note child had had an emesis.
1-2 years Death Mar., 2010 Mar., 2010 Total  
1-2 years Death Mar., 2010 Apr., 2010 386283-1 My daughter was sick. She was complaining about pain in her stomach, she was vomiting for previuos 4 days. So I decided to take her to her pediatrician and check what is wrong with her. Instead she was given 5 vaccines at her pediatrician office. He said that she is fine. She was given second dose of H1N1, HIB, Hepatitis A, varicella and tuberculosis shot. Since this time she was uncontrollable crying and she was being in constant pain. She could not keep the food. She was throwing up. The next day she collapsed, she stop breathing, she was unconscious. My wife call the ambulance. In a hospital doctors said that she had bleeding on one side of her brain. They transfer her from one hospital to another. She was still unconscious but moving her limbs. The next day morning doctors decided to perform surgery on her brain because of the bleeding. She never came out from that. The brain was dead. She was dead...
1-2 years Death Mar., 2010 Apr., 2010 Total  
1-2 years Death Mar., 2010 Total  
1-2 years Death Oct., 2010 Oct., 2010 404258-1 Patient was found pulseless and apneic in her bed by mom in the morning (0500). CPR performed and pt taken to ED. Unable to resuscitate.
1-2 years Death Oct., 2010 Oct., 2010 Total  
1-2 years Death Oct., 2010 Total  
1-2 years Death Dec., 2010 Jan., 2011 414096-1 Details unknown. I was notified by agency that pt expired 12/31/10.
1-2 years Death Dec., 2010 Jan., 2011 Total  
1-2 years Death Dec., 2010 Total  
1-2 years Death Sep., 2011 Oct., 2011 436743-1 Parents found patient blue and not breathing at home. Code Blue to hospital.
1-2 years Death Sep., 2011 Oct., 2011 Total  
1-2 years Death Sep., 2011 Total  
1-2 years Death Jan., 2012 Feb., 2012 448544-1 UNKNOWN- ADVERSE EVENT ONSET TIME IS UNKNOWN.
1-2 years Death Jan., 2012 Feb., 2012 Total  
1-2 years Death Jan., 2012 Total  
1-2 years Death Feb., 2012 Feb., 2012 450453-1 Patient found unresponsive by babysitter. EMS called to scene. Patient transported to ER at Medical Center. Time of death noted to be 20:48 on 2/8/12 by ER.
1-2 years Death Feb., 2012 Feb., 2012 Total  
1-2 years Death Feb., 2012 Total  
1-2 years Death Jan., 2013 Feb., 2013 483215-1 Patient deceased.
1-2 years Death Jan., 2013 Feb., 2013 485004-1 Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.
1-2 years Death Jan., 2013 Feb., 2013 Total  
1-2 years Death Jan., 2013 Total  
1-2 years Death Total  
1-2 years Life Threatening Nov., 2006 Dec., 2009 370987-1 Fever, seizure approximately 8 days after vaccines. Diagnosed with viral encephalitis at hospital. 12/03/09 Vac record received for DOS 11/22/09 12/22/09: Provisional Autopsy report received for date of exam 10/9/09. Findings: Clinical history of seizures; presented with status epilepticus and Influenza A (H1N1) positivity. A. Heavy lungs. B. Clinical hx. of encephalitis and brain herniation. C. Other findings: Heavy heart, pericardial effusion, hepatosplenomegaly. 12/04/09 DC summary for DOS received for DOS 09/09/09 - 10/07/09. Final DX: Hypoxic ischemic encephalopathy Pt presented with seizure, rigors, tonic-clinic seizures. On neurological exam: febrile seizure, developed blown R pupil, diffuse cerebral edema, increased ICP; tx: hypertonic saline, pentobarbital, Tamiflu, Ativan, Dilantin, Manitol, serum sodium; Pt's condition worsened and Pt was not responsive. Physician related cerebral edema to H1N1 influenza related encephalitis or metabolic disorders. Pt expired on 10/07/09.
1-2 years Life Threatening Nov., 2006 Dec., 2009 Total  
1-2 years Life Threatening Nov., 2006 Total  
1-2 years Life Threatening Oct., 2009 Jan., 2010 377577-1 Parents report onset of diarrhea and abdominal pain in AM on day following vaccination. He presented to the ED 3 days following vaccination with acute gastroenteritis, renal failure, repiratory distress and shock. He was admitted to the PICU from the ED with a diagnosis of acute gastroenteritis +/- HUS. He died later that evening in the PICU.
1-2 years Life Threatening Oct., 2009 Jan., 2010 Total  
1-2 years Life Threatening Oct., 2009 Total  
1-2 years Life Threatening Dec., 2009 Dec., 2009 374649-1 12/16 2130. Presented to ED 12/16 with fever 104.8. Treated with TYLENOL and discharged to home. Returned to ED on 12/17-0615 - altered Mental Status, diarrhea, Rash, T 99.8 - Cardiac arrest - Intubation, code Meds, ROCEPHIN, Vancomycin, acyclovir. Transferred. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. \ksk 12/31/09 ED consultation records received. Service date 12/17/09. Assessment: Thrombocytopenia, purpuric rash, cardiopulmonary respiratory arrest, shock with septic and hypovolemic metabolic acidosis, hematemesis, screen for meningococcemia. Child presented to the ED the previous evening with a temperature of 104.8 F was medicated for fever and discharged. This AM presents with a purpuric rash all extremities. Diarrhea, lethargic. Decreased level of consciousness. Intubated and attempted to stabilize for air transport. Abdominal distention. Blood-tinged mucus fluid from nose and mouth. Full CPR. Pulseless electrical activity.
1-2 years Life Threatening Dec., 2009 Dec., 2009 Total  
1-2 years Life Threatening Dec., 2009 Jan., 2010 377459-1 DEATH. (Toddler was napping in crib during day. Parent found child in full arrest. (Unclear if he'd be seizing prior.) CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.
1-2 years Life Threatening Dec., 2009 Jan., 2010 Total  
1-2 years Life Threatening Dec., 2009 Total  
1-2 years Life Threatening Jan., 2013 Feb., 2013 485004-1 Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.
1-2 years Life Threatening Jan., 2013 Feb., 2013 Total  
1-2 years Life Threatening Jan., 2013 Total  
1-2 years Life Threatening Total  
1-2 years Permanent Disability Nov., 2006 Dec., 2009 370987-1 Fever, seizure approximately 8 days after vaccines. Diagnosed with viral encephalitis at hospital. 12/03/09 Vac record received for DOS 11/22/09 12/22/09: Provisional Autopsy report received for date of exam 10/9/09. Findings: Clinical history of seizures; presented with status epilepticus and Influenza A (H1N1) positivity. A. Heavy lungs. B. Clinical hx. of encephalitis and brain herniation. C. Other findings: Heavy heart, pericardial effusion, hepatosplenomegaly. 12/04/09 DC summary for DOS received for DOS 09/09/09 - 10/07/09. Final DX: Hypoxic ischemic encephalopathy Pt presented with seizure, rigors, tonic-clinic seizures. On neurological exam: febrile seizure, developed blown R pupil, diffuse cerebral edema, increased ICP; tx: hypertonic saline, pentobarbital, Tamiflu, Ativan, Dilantin, Manitol, serum sodium; Pt's condition worsened and Pt was not responsive. Physician related cerebral edema to H1N1 influenza related encephalitis or metabolic disorders. Pt expired on 10/07/09.
1-2 years Permanent Disability Nov., 2006 Dec., 2009 Total  
1-2 years Permanent Disability Nov., 2006 Total  
1-2 years Permanent Disability Total  
1-2 years Hospitalized Nov., 2006 Dec., 2009 370987-1 Fever, seizure approximately 8 days after vaccines. Diagnosed with viral encephalitis at hospital. 12/03/09 Vac record received for DOS 11/22/09 12/22/09: Provisional Autopsy report received for date of exam 10/9/09. Findings: Clinical history of seizures; presented with status epilepticus and Influenza A (H1N1) positivity. A. Heavy lungs. B. Clinical hx. of encephalitis and brain herniation. C. Other findings: Heavy heart, pericardial effusion, hepatosplenomegaly. 12/04/09 DC summary for DOS received for DOS 09/09/09 - 10/07/09. Final DX: Hypoxic ischemic encephalopathy Pt presented with seizure, rigors, tonic-clinic seizures. On neurological exam: febrile seizure, developed blown R pupil, diffuse cerebral edema, increased ICP; tx: hypertonic saline, pentobarbital, Tamiflu, Ativan, Dilantin, Manitol, serum sodium; Pt's condition worsened and Pt was not responsive. Physician related cerebral edema to H1N1 influenza related encephalitis or metabolic disorders. Pt expired on 10/07/09.
1-2 years Hospitalized Nov., 2006 Dec., 2009 Total  
1-2 years Hospitalized Nov., 2006 Total  
1-2 years Hospitalized Oct., 2009 Jan., 2010 377577-1 Parents report onset of diarrhea and abdominal pain in AM on day following vaccination. He presented to the ED 3 days following vaccination with acute gastroenteritis, renal failure, repiratory distress and shock. He was admitted to the PICU from the ED with a diagnosis of acute gastroenteritis +/- HUS. He died later that evening in the PICU.
1-2 years Hospitalized Oct., 2009 Jan., 2010 Total  
1-2 years Hospitalized Oct., 2009 Total  
1-2 years Hospitalized Dec., 2009 Jan., 2010 377459-1 DEATH. (Toddler was napping in crib during day. Parent found child in full arrest. (Unclear if he'd be seizing prior.) CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.
1-2 years Hospitalized Dec., 2009 Jan., 2010 Total  
1-2 years Hospitalized Dec., 2009 Total  
1-2 years Hospitalized Jan., 2013 Feb., 2013 485004-1 Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.
1-2 years Hospitalized Jan., 2013 Feb., 2013 Total  
1-2 years Hospitalized Jan., 2013 Total  
1-2 years Hospitalized Total  
1-2 years Emergency Room Nov., 2006 Dec., 2009 370987-1 Fever, seizure approximately 8 days after vaccines. Diagnosed with viral encephalitis at hospital. 12/03/09 Vac record received for DOS 11/22/09 12/22/09: Provisional Autopsy report received for date of exam 10/9/09. Findings: Clinical history of seizures; presented with status epilepticus and Influenza A (H1N1) positivity. A. Heavy lungs. B. Clinical hx. of encephalitis and brain herniation. C. Other findings: Heavy heart, pericardial effusion, hepatosplenomegaly. 12/04/09 DC summary for DOS received for DOS 09/09/09 - 10/07/09. Final DX: Hypoxic ischemic encephalopathy Pt presented with seizure, rigors, tonic-clinic seizures. On neurological exam: febrile seizure, developed blown R pupil, diffuse cerebral edema, increased ICP; tx: hypertonic saline, pentobarbital, Tamiflu, Ativan, Dilantin, Manitol, serum sodium; Pt's condition worsened and Pt was not responsive. Physician related cerebral edema to H1N1 influenza related encephalitis or metabolic disorders. Pt expired on 10/07/09.
1-2 years Emergency Room Nov., 2006 Dec., 2009 Total  
1-2 years Emergency Room Nov., 2006 Total  
1-2 years Emergency Room Dec., 2006 Dec., 2006 269826-1 Pt found unresponsive at home and brought to ED - unable to resuscitate; pronounced dead. 5/9/08 Autopsy report states COD as changes c/w viral pneumonia, bilateral & manner of death as natural. Autopsy report states patient arrested while at home & transported to ER.
1-2 years Emergency Room Dec., 2006 Dec., 2006 Total  
1-2 years Emergency Room Dec., 2006 Total  
1-2 years Emergency Room Oct., 2007 Oct., 2007 295043-1 Child had flu shot @ about 10 am. Waited in office for 20 minutes. Went home w/mother and private duty nurse. Nurse reported he was fussy after the immunization. She held him until he went to sleep. They put child to bed in parental bedroom upstairs. Nurse went to kitchen to get g-tube feeds ready. Apnea alarm went off shortly thereafter. When RN got to the child, he was face down in the bed and blue. They administered CPR, called 911. He was airlifted to hospital, where he was pronounced dead approximately two hours after receiving the flu shot. 11/13/07 Received autopsy report which reveals COD as complications of cerebral dysgenesis of indeterminate etiology; arthrogryposis multiplex congenita was a significant contributing factor. Had been placed on side for nap but was found prone. Disabilities rendered unable to lift head/body to protect airway. 11/16/07 Received vax records from pcp. VAERS database updated w/same.
1-2 years Emergency Room Oct., 2007 Oct., 2007 Total  
1-2 years Emergency Room Oct., 2007 Total  
1-2 years Emergency Room Oct., 2009 Jan., 2010 377577-1 Parents report onset of diarrhea and abdominal pain in AM on day following vaccination. He presented to the ED 3 days following vaccination with acute gastroenteritis, renal failure, repiratory distress and shock. He was admitted to the PICU from the ED with a diagnosis of acute gastroenteritis +/- HUS. He died later that evening in the PICU.
1-2 years Emergency Room Oct., 2009 Jan., 2010 Total  
1-2 years Emergency Room Oct., 2009 Total  
1-2 years Emergency Room Nov., 2009 Nov., 2009 365786-1 Patient Died.
1-2 years Emergency Room Nov., 2009 Nov., 2009 Total  
1-2 years Emergency Room Nov., 2009 Total  
1-2 years Emergency Room Dec., 2009 Dec., 2009 374649-1 12/16 2130. Presented to ED 12/16 with fever 104.8. Treated with TYLENOL and discharged to home. Returned to ED on 12/17-0615 - altered Mental Status, diarrhea, Rash, T 99.8 - Cardiac arrest - Intubation, code Meds, ROCEPHIN, Vancomycin, acyclovir. Transferred. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. \ksk 12/31/09 ED consultation records received. Service date 12/17/09. Assessment: Thrombocytopenia, purpuric rash, cardiopulmonary respiratory arrest, shock with septic and hypovolemic metabolic acidosis, hematemesis, screen for meningococcemia. Child presented to the ED the previous evening with a temperature of 104.8 F was medicated for fever and discharged. This AM presents with a purpuric rash all extremities. Diarrhea, lethargic. Decreased level of consciousness. Intubated and attempted to stabilize for air transport. Abdominal distention. Blood-tinged mucus fluid from nose and mouth. Full CPR. Pulseless electrical activity.
1-2 years Emergency Room Dec., 2009 Dec., 2009 Total  
1-2 years Emergency Room Dec., 2009 Jan., 2010 377459-1 DEATH. (Toddler was napping in crib during day. Parent found child in full arrest. (Unclear if he'd be seizing prior.) CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.
1-2 years Emergency Room Dec., 2009 Jan., 2010 Total  
1-2 years Emergency Room Dec., 2009 Total  
1-2 years Emergency Room Jan., 2013 Feb., 2013 485004-1 Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.
1-2 years Emergency Room Jan., 2013 Feb., 2013 Total  
1-2 years Emergency Room Jan., 2013 Total  
1-2 years Emergency Room Total  
1-2 years Total  
3-5 years Death Sep., 2006 Dec., 2006 268863-1 Child passed away 10/18/06. Patient was chronically ill with pontocerebellar atrophy, had shortened life expectancy 1/11/07 Received medical records from hospital which reveal patient admitted 10/13/06 secondary to cardiopulmonary arrest. Apparently had been in usual state of health & was riding in car w/parent when suddenly became pale with circumoral cyanosis & stopped breathing. Parent initiated rescue breathing & called EMS who then initiated CPR, intubated & gave epi during transport to outlying hospital before transfer to this Hospital. Made DNR & expired on 10/18/06. PMH: undefined degenerative neurologic disorder, feeding tube, salivary gland removal. Hx of previous arrest from respiratory secretions. Had otitis media 10 days prior to admit tx w/antibiotics. Birth HX: Adopted. Normal development till 9 mos of age when lost milestones. Currently, eyes open spontaneously, non verbal, sits only with support. unable to grasp. Joint contractures of all extremities. LABS: MRI revealed hypoxic/ischemic event to putamen/caudate (some new), cerebral atrophy & cerebellar degenerative changes. Trach c/s grew pan susceptible pseudomonas. Blood & urine c/s all neg. WBC 12.8 on admit, max of 26.8 on 10/16. CXR showed LLL density due to atelectasis & collapse. FINAL DX: None provided. 4/6/07 Received Death Certificate which reveals COD as upper airway obstruction; hypoxic ischemic encephalopathy; cerebral atrophy; and neuromuscular disease (unspecified).
3-5 years Death Sep., 2006 Dec., 2006 Total  
3-5 years Death Sep., 2006 Total  
3-5 years Death Oct., 2009 Oct., 2009 361101-1 Patient pulled out trach (witnessed by family members), unable to replace trach, trach site began gushing blood, patient coded. Temperature in ER was 36.9 at the time of arrival at 8:22 p.m. Pronounced dead at 8:47 p.m.
3-5 years Death Oct., 2009 Oct., 2009 Total  
3-5 years Death Oct., 2009 Dec., 2009 373484-1 H1N1 injection administered on 10.23.09. Patient became ill 5 days later with pneumonia. History of pulmonary hypertension. PICU.
3-5 years Death Oct., 2009 Dec., 2009 Total  
3-5 years Death Oct., 2009 Total  
3-5 years Death Nov., 2009 Nov., 2009 370733-1 respiratory distress resulting in death 12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. DX: Cardiopulmonary arrest. Pt presented with s/p cardiopulmonary arrest on 11/23/09 with MOF, hypotensive, coarse bs. Kidneys not functioning, coagulopathy, metabolic acidosis. tx: epinephrine, diuretics, vasopressors, bicarbonates, antibiotics. Pt condition worsened despite ICU tx. Pt expired. 12/29/09 Death Certificate Received. DOD 11/24/09. Cause of Death: Methicillin-Resistant Staphylococcus Aureus Pneumonia.
3-5 years Death Nov., 2009 Nov., 2009 Total  
3-5 years Death Nov., 2009 Total  
3-5 years Death Nov., 2010 Dec., 2010 413215-1 On 12/6/10, developed fever & headache. Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10.
3-5 years Death Nov., 2010 Dec., 2010 Total  
3-5 years Death Nov., 2010 Total  
3-5 years Death Aug., 2011 Sep., 2011 436253-1 Patient was found dead in bathroom after no obvious reaction.
3-5 years Death Aug., 2011 Sep., 2011 Total  
3-5 years Death Aug., 2011 Total  
3-5 years Death Total  
3-5 years Life Threatening Nov., 2010 Dec., 2010 413215-1 On 12/6/10, developed fever & headache. Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10.
3-5 years Life Threatening Nov., 2010 Dec., 2010 Total  
3-5 years Life Threatening Nov., 2010 Total  
3-5 years Life Threatening Total  
3-5 years Hospitalized Oct., 2009 Dec., 2009 373484-1 H1N1 injection administered on 10.23.09. Patient became ill 5 days later with pneumonia. History of pulmonary hypertension. PICU.
3-5 years Hospitalized Oct., 2009 Dec., 2009 Total  
3-5 years Hospitalized Oct., 2009 Total  
3-5 years Hospitalized Nov., 2010 Dec., 2010 413215-1 On 12/6/10, developed fever & headache. Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10.
3-5 years Hospitalized Nov., 2010 Dec., 2010 Total  
3-5 years Hospitalized Nov., 2010 Total  
3-5 years Hospitalized Total  
3-5 years Emergency Room Oct., 2009 Oct., 2009 361101-1 Patient pulled out trach (witnessed by family members), unable to replace trach, trach site began gushing blood, patient coded. Temperature in ER was 36.9 at the time of arrival at 8:22 p.m. Pronounced dead at 8:47 p.m.
3-5 years Emergency Room Oct., 2009 Oct., 2009 Total  
3-5 years Emergency Room Oct., 2009 Total  
3-5 years Emergency Room Nov., 2010 Dec., 2010 413215-1 On 12/6/10, developed fever & headache. Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10.
3-5 years Emergency Room Nov., 2010 Dec., 2010 Total  
3-5 years Emergency Room Nov., 2010 Total  
3-5 years Emergency Room Total  
3-5 years Total  
6-17 years Death Dec., 2003 Jun., 2008 314404-1 DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)
6-17 years Death Dec., 2003 Jun., 2008 Total  
6-17 years Death Dec., 2003 Total  
6-17 years Death Nov., 2007 Apr., 2008 308661-1 We received on 12 FEB 2008 from a healthcare professional the following information: A 7-year-old male patient, born on 21 JUN 2000 was vaccinated with FLUVIRIN (batch no. unknown) on 19 NOV 2007. The patient was killed in an automobile traffic accident on 01 FEB 2008. The subject had participated in a clinical trial sponsored by MedImmune. FLUVIRIN was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the FLUVIRIN, but other than that has not been involved. Although the event did not occur during the duration of the trial, and the investigator did not see any causal relationship to the vaccination with FLUVIRIN, he reported the event to the IRB and NVD because the child had died.
6-17 years Death Nov., 2007 Apr., 2008 Total  
6-17 years Death Nov., 2007 Total  
6-17 years Death Oct., 2008 Mar., 2009 342393-1 Possible vaccine failure. Child expired with Flu A cultured. 5/20/09-autopsy report received-COD-cardiopulmonary arrest. Due to: systemic infection with influenza type A/H1. Sudden onset of muscle and leg cramps on 2/14/09, URI symptoms last day or so including sore throat. Suddenly developed tachypnea fever and diaphoresis within 20n minutes of onset of leg cramps. In ED fever of 107, tachycardia and dyspnea, developed flutter then bradycardia. Intubated, v-tach, coded and expired.
6-17 years Death Oct., 2008 Mar., 2009 Total  
6-17 years Death Oct., 2008 Total  
6-17 years Death Jan., 2009 Feb., 2009 340286-1 Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA. 5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions. Autopsy limited to lung only. 4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing. Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia. Pulm, ID, heme consults done. Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG. Progressively declined, extubated per family request & expired shortly therafter.
6-17 years Death Jan., 2009 Feb., 2009 Total  
6-17 years Death Jan., 2009 Total  
6-17 years Death Aug., 2009 Feb., 2010 380740-1 Patient received the HPV as well as the flu nasal spray on Aug 25th. I first declined getting her the vaccination but her doctor ensured me that it was safe. I had declined the same vaccination a year earlier at the downtown public health center. Patient was getting ready for school and was standing by her closet, and all of a sudden she fell, she lost total control of her legs. She went to school and could not engage in any of the activities because of the numbness in her legs and the swelling of her foot. She also, started to get a really bad headache. Days later she woke up out of her sleep complaining of a severe headache, which usually she gets if she has a seizure but she hadn't had a seizure this night. She continued to say she had not feeling in her foot and tingling feeling in her leg. After I examined her foot I noticed it was swollen. The next morning I called her doctors office and made her doctors appointment for Oct 23rd. During the month of October she had irregular periods. My daughter never made it to Oct 23rd, which as also her birthday. She passed on Oct. 17th, I found her cold unresponsive in her room at 7am, which I went in to wake her up to take her morning pills.
6-17 years Death Aug., 2009 Feb., 2010 Total  
6-17 years Death Aug., 2009 Total  
6-17 years Death Oct., 2009 Oct., 2009 361353-1 None Stated. On 10/19/09, the PCP stated that coroner called him and told him that he found consolidation of the lungs on autopsy. Autopsy report is not complete yet. 10/20/09 ER records received service date 10/14/09. Assessment: Cardiac arrest. CPR initiated. Pupils fixed and dilated. Apnea, pale. Rigor, lividity. 1022/09 PCP /Nursing medical records received, service dates 11/11/03 to 10/14/09. Assessment: Death. Office staff unable to contact patient's family, eventually visited patient's home. learnd that patient was found dead at home and taken to ER. 11/3/09 Additional ER records received for service date 10/14/09. Found supine on floor at home apneic and pulseless. Cardiac arrest. CPR initiated. 12/8/09 Autopsy received. Pronounced dead on 10/13/2009 Final cause of death: Pneumococcal Pneumonia. Pandemic Influenza A. Additional Information Abstracted: Other contributing conditions - Leukopenia, history of leukemia, Down syndrome. Drug Screen Heart Blood: Dextromethorphan <0.10 ug/ml, Promethazine 0.11 ug/ml. \ksk 12/28/09 Pathology report received. Receipt date 10/23/2009. Sign out date 12/21/2009. Diagnosis: Lung - Diffuse alveolar damage and bronchopneumonia. Immunohistochemical and molecular evidence of novel influenza A H1N1. Immunohistochemical and molecular evidence of Streptococcus pneumoniae. Immunohistochemical evidence of Neisseria meningitidis without molecular confirmation. No immunohistochemical evidence of Group A Streptococcus or Haemophilus influenzae. All follow-up attempts have been completed per company SOPs. No further information available.
6-17 years Death Oct., 2009 Oct., 2009 Total  
6-17 years Death Oct., 2009 Total  
6-17 years Death Dec., 2009 Dec., 2009 374692-1 Heart stop beating, past away.
6-17 years Death Dec., 2009 Dec., 2009 Total  
6-17 years Death Dec., 2009 Mar., 2010 381778-1 15 hours after vaccinated started feeling ill, headache, nausea, vomiting. To hospital where diagnosed w/ meningitis. Died a few days later.
6-17 years Death Dec., 2009 Mar., 2010 Total  
6-17 years Death Dec., 2009 Total  
6-17 years Death Nov., 2010 Nov., 2010 410080-1 Hives, pucking, then DEATH
6-17 years Death Nov., 2010 Nov., 2010 Total  
6-17 years Death Nov., 2010 Jan., 2011 414511-1 ADEM secondary to agency from administration of live virus flu vaccine to patient following interferon confusion, fever, coma, death. Contact hospital doctor for details.
6-17 years Death Nov., 2010 Jan., 2011 Total  
6-17 years Death Nov., 2010 Total  
6-17 years Death Dec., 2010 Dec., 2010 413092-1 respiratory and cardiac arrest resulting in death
6-17 years Death Dec., 2010 Dec., 2010 Total  
6-17 years Death Dec., 2010 Total  
6-17 years Death Mar., 2011 Aug., 2011 430780-1 Found dead in bed in a.m. by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
6-17 years Death Mar., 2011 Aug., 2011 Total  
6-17 years Death Mar., 2011 Total  
6-17 years Death Dec., 2011 Dec., 2011 444950-1 Went for well child check 12/2 no issues flu vaccination given. Next day developed flu like illness with fever 102.3, body aches lethargy, treated with Tylenol and Motrin, symptoms waxed and waned got significantly worse Tuesday 12/6/11 with dyspnea. Patient went unresponsive on way to pediatrician emergent resuscitation and died 12/6/11.
6-17 years Death Dec., 2011 Dec., 2011 Total  
6-17 years Death Dec., 2011 Jun., 2012 457319-1 This social media report (initial receipt: 04-Jun-2012) concerns a 7-year-old female patient. On ??-Dec-2011 the patient received her fatal dose of flu vaccine (manufacturer, brand name and batch number were not reported) and was pronounced dead about 92 hours later on 06-Dec-2011. The cause of death was not reported.
6-17 years Death Dec., 2011 Jun., 2012 Total  
6-17 years Death Dec., 2011 Total  
6-17 years Death Sep., 2012 Oct., 2012 467247-1 11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR 82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at hospital.
6-17 years Death Sep., 2012 Oct., 2012 Total  
6-17 years Death Sep., 2012 Total  
6-17 years Death Total  
6-17 years Life Threatening Dec., 2003 Jun., 2008 314404-1 DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)
6-17 years Life Threatening Dec., 2003 Jun., 2008 Total  
6-17 years Life Threatening Dec., 2003 Total  
6-17 years Life Threatening Jan., 2009 Feb., 2009 340286-1 Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA. 5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions. Autopsy limited to lung only. 4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing. Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia. Pulm, ID, heme consults done. Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG. Progressively declined, extubated per family request & expired shortly therafter.
6-17 years Life Threatening Jan., 2009 Feb., 2009 Total  
6-17 years Life Threatening Jan., 2009 Total  
6-17 years Life Threatening Dec., 2009 Mar., 2010 381778-1 15 hours after vaccinated started feeling ill, headache, nausea, vomiting. To hospital where diagnosed w/ meningitis. Died a few days later.
6-17 years Life Threatening Dec., 2009 Mar., 2010 Total  
6-17 years Life Threatening Dec., 2009 Total  
6-17 years Life Threatening Total  
6-17 years Permanent Disability Dec., 2003 Jun., 2008 314404-1 DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)
6-17 years Permanent Disability Dec., 2003 Jun., 2008 Total  
6-17 years Permanent Disability Dec., 2003 Total  
6-17 years Permanent Disability Total  
6-17 years Hospitalized Dec., 2003 Jun., 2008 314404-1 DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)
6-17 years Hospitalized Dec., 2003 Jun., 2008 Total  
6-17 years Hospitalized Dec., 2003 Total  
6-17 years Hospitalized Jan., 2009 Feb., 2009 340286-1 Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA. 5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions. Autopsy limited to lung only. 4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing. Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia. Pulm, ID, heme consults done. Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG. Progressively declined, extubated per family request & expired shortly therafter.
6-17 years Hospitalized Jan., 2009 Feb., 2009 Total  
6-17 years Hospitalized Jan., 2009 Total  
6-17 years Hospitalized Dec., 2009 Mar., 2010 381778-1 15 hours after vaccinated started feeling ill, headache, nausea, vomiting. To hospital where diagnosed w/ meningitis. Died a few days later.
6-17 years Hospitalized Dec., 2009 Mar., 2010 Total  
6-17 years Hospitalized Dec., 2009 Total  
6-17 years Hospitalized Nov., 2010 Jan., 2011 414511-1 ADEM secondary to agency from administration of live virus flu vaccine to patient following interferon confusion, fever, coma, death. Contact hospital doctor for details.
6-17 years Hospitalized Nov., 2010 Jan., 2011 Total  
6-17 years Hospitalized Nov., 2010 Total  
6-17 years Hospitalized Dec., 2010 Dec., 2010 413092-1 respiratory and cardiac arrest resulting in death
6-17 years Hospitalized Dec., 2010 Dec., 2010 Total  
6-17 years Hospitalized Dec., 2010 Total  
6-17 years Hospitalized Total  
6-17 years Hospitalized, Prolonged Dec., 2003 Jun., 2008 314404-1 DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)
6-17 years Hospitalized, Prolonged Dec., 2003 Jun., 2008 Total  
6-17 years Hospitalized, Prolonged Dec., 2003 Total  
6-17 years Hospitalized, Prolonged Jan., 2009 Feb., 2009 340286-1 Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA. 5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions. Autopsy limited to lung only. 4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing. Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia. Pulm, ID, heme consults done. Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG. Progressively declined, extubated per family request & expired shortly therafter.
6-17 years Hospitalized, Prolonged Jan., 2009 Feb., 2009 Total  
6-17 years Hospitalized, Prolonged Jan., 2009 Total  
6-17 years Hospitalized, Prolonged Total  
6-17 years Emergency Room Dec., 2003 Jun., 2008 314404-1 DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)
6-17 years Emergency Room Dec., 2003 Jun., 2008 Total  
6-17 years Emergency Room Dec., 2003 Total  
6-17 years Emergency Room Dec., 2009 Mar., 2010 381778-1 15 hours after vaccinated started feeling ill, headache, nausea, vomiting. To hospital where diagnosed w/ meningitis. Died a few days later.
6-17 years Emergency Room Dec., 2009 Mar., 2010 Total  
6-17 years Emergency Room Dec., 2009 Total  
6-17 years Emergency Room Nov., 2010 Jan., 2011 414511-1 ADEM secondary to agency from administration of live virus flu vaccine to patient following interferon confusion, fever, coma, death. Contact hospital doctor for details.
6-17 years Emergency Room Nov., 2010 Jan., 2011 Total  
6-17 years Emergency Room Nov., 2010 Total  
6-17 years Emergency Room Dec., 2010 Dec., 2010 413092-1 respiratory and cardiac arrest resulting in death
6-17 years Emergency Room Dec., 2010 Dec., 2010 Total  
6-17 years Emergency Room Dec., 2010 Total  
6-17 years Emergency Room Total  
6-17 years Total  
18-29 years Death Oct., 2006 Jul., 2010 393893-1 Patient diagnosed with meningococcemia, serogroup W-135.
18-29 years Death Oct., 2006 Jul., 2010 Total  
18-29 years Death Oct., 2006 Total  
18-29 years Death Jun., 2007 Dec., 2008 335764-1 Patient vaccinated with Menactra on 6/25/07 (lot U2236AA). Culture confirmed meningococcal disease on 9/26/07. Blood culture was positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on 9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status, blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem blood culture positive for neisseria meningitidis, serogroup C. Bilateral hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae, scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace infiltration consistent with terminal ventilator dependence. Bilateral pleural effusions.
18-29 years Death Jun., 2007 Dec., 2008 Total  
18-29 years Death Jun., 2007 Total  
18-29 years Death Oct., 2007 Nov., 2007 296231-1 A 25-year-old patient, with no reported concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a left deltoid (route not provided) dose of Adacel (lot number C2758AA), and a dose (route not provided) of FluMist (manufacturer MedImmune) (lot number 500486P) on 17 October 2007. Fifteen days post-vaccinations, on 01 November 2007, the patient expired in his sleep. At the time of the report, the autopsy was not complete. No cause of death has been determined at this time. 12/14/07 Received vax record from provider which confirms lot #s as reported. 1/18/08 Reviewed autopsy report which states COD as idiopathic mitral prolapse. Findings at autopsy included: enlarged dilated heart w/LVH & clean coronaries; parachute deformity w/hooding of anterior mitral cusp & lengthening of the chordae tendineae w/mild white thickening of the septal endocardim behind mitral valve; hyperinflated lungs; pneumomediastinum; enlarged liver/spleen/hepatic portal lymph nodes.
18-29 years Death Oct., 2007 Nov., 2007 Total  
18-29 years Death Oct., 2007 Total  
18-29 years Death Nov., 2008 Dec., 2008 334611-1 "Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered ""possible seizure"" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient's parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient's mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne. 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin. Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive a"
18-29 years Death Nov., 2008 Dec., 2008 Total  
18-29 years Death Nov., 2008 Total  
18-29 years Death Oct., 2009 Nov., 2009 369428-1 10/22/09 fever, cough, SOB: healthy 14 yo sib with clinical H1N1. TAMIFLU began 75 BID. 10/23/09 seen in office & at home resp decompensation admitted to PICU: BiPAP. DNI order. Bilateral severe pneumonia died approx. 1pm 10/25/09. 12/14/09 Death Certificate received. DOD 10/25/09. Cause of death: Pneumonia. Additional information abstracted: Rett Syndrome. 12/14/09 Hospital records received, service dates 10/23/09 to 10/25/09. Assessment: Medically frail with hypovolemia, respiratory distress, ABG concerning for ARDS, likely due to H1N1 infection w/ bacterial superinfection. Patient presents with increasing work of breathing, fever, and cough. O2 Tamiflu at home. Tachypnea. Wheeze, shortness of breath. Crackles, rhonchi, flaring, retractions. Decreased responsiveness. Admitted to ICU. Mechanical ventilation. Edema of feet. Expired. 12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to 10/25/09. Assessment: Pneumonia present on admission, respiratory distress present on admission.
18-29 years Death Oct., 2009 Nov., 2009 Total  
18-29 years Death Oct., 2009 Oct., 2010 404478-1 "A couple weeks after receiving the H1N1 Flumist, client complained of being tired and felt tired ""all the time""."
18-29 years Death Oct., 2009 Oct., 2010 Total  
18-29 years Death Oct., 2009 Total  
18-29 years Death Nov., 2009 Nov., 2009 367792-1 Patient had sudden cardiac arrest and had CPR from onset, was picked up by EMS and transported to hospital and pronounced dead at approx 11:30 PM. 12/16/09 Report of death received for 11/03/09. Decedent fell on the floor while in a social gathering. No pulse, CPR performed by school nurse for 10 mins until EMS came. Decedent had emesis while compressions were performed. EMS started ACLS, intubation, 3 IV lines, 4 Epi, 3 Atropine and 1 amp Bicarb. Sinus rhythm established 1 time, but lost. CPR unsuccessful. Decendent pronounced dead. 12/16/09 Autopsy results revealed no visible internal signs of trauma. All systems autopsy: normal. Teeth in poor condition. Cardiovascular system: myocardium: focal areas of fibrosis, atrial; bulges in atrial and ventricular muscular fee walls, interventricular septum 3cm thick. Pathologist opinion: Hypertrophic cardiomyopathy (790gr). Heart severely congested and lungs heavy with possible aspiration. 12/24/09 Toxicology report received. This report showed that no drugs were used. 01/04/09 Medical/dental record received for DOS 10/29/09. Debridement performed. Anesthesia used. Moderate to heavy generalized bleeding. Tx: Chlorhexidine gluconate oral rinse. DX: Gingivitis, periodontal disease.
18-29 years Death Nov., 2009 Nov., 2009 Total  
18-29 years Death Nov., 2009 Jan., 2010 376329-1 Pt died of Hemorrhagic shock within minutes of non-emergent c/section.
18-29 years Death Nov., 2009 Jan., 2010 Total  
18-29 years Death Nov., 2009 Mar., 2010 383459-1 Patient was admitted to the hospital on 2/23/2010 with cough and increased green sputum production. Had had low grade fevers, none higher than 100 degrees. He states that he has had increased dyspnea on exertion. He states that he normally requires about 4-1/2 liters of home O2 while at rest and 6 liters while he is up with activity and he states that his saturation is normally about 94-95 percent.
18-29 years Death Nov., 2009 Mar., 2010 Total  
18-29 years Death Nov., 2009 Total  
18-29 years Death Dec., 2009 Feb., 2010 379514-1 Patient unresponsive at home after being discharged on 12/12/09 at 9:15pm. Patient arrested, brought to hospital and pronounced dead at 11:40 PM.
18-29 years Death Dec., 2009 Feb., 2010 Total  
18-29 years Death Dec., 2009 Total  
18-29 years Death Mar., 2010 Mar., 2010 383127-1 He recieved the H1N1 vaccine around 9:00 am. At he at 12:00 Complaining of chest pain. No Diagnosis, then released from hospital. He Died at midnight (12:00 am) from a ruptured aorta.
18-29 years Death Mar., 2010 Mar., 2010 Total  
18-29 years Death Mar., 2010 Total  
18-29 years Death Oct., 2010 Oct., 2010 405951-1 HEADACHE, Swolen painful arms
18-29 years Death Oct., 2010 Oct., 2010 Total  
18-29 years Death Oct., 2010 Total  
18-29 years Death Sep., 2011 Sep., 2011 435707-1 Member was given the Flumist on 09/22/2011. On 09/25/2011, member was feeling chest pain and not feeling well after dinner and going to the Club. Mamber was found down face in vomit by his friends. CPR was started and 911 activated. Paramedics arrived and continued CPR en route to Hospital where CPR was continued unsuccesfully. Member was pronounced dead at 0215 by Dr.
18-29 years Death Sep., 2011 Sep., 2011 Total  
18-29 years Death Sep., 2011 Total  
18-29 years Death Oct., 2011 Oct., 2011 438031-1 Case number PHEH2011US06146 is an initial spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot raised his blood sugar to a diabetic coma that he did not wake up. The patient received care at hospital. The critical team worked on him for 12-hours and he expired on 03 Oct 2011. No other information was provided.
18-29 years Death Oct., 2011 Oct., 2011 Total  
18-29 years Death Oct., 2011 Total  
18-29 years Death Feb., 2012 Feb., 2012 450086-1 PATIENT PRESENTED WITH VOMITING AND DIARRHEA ON 8 FEB. AAS SHOWED PULM INFILTRATE. PT STARTED ON PO ABX. PT STARTED FEELING FEVERISH ON THE EVENING OF 8 FEB. 9 FEB WOKE UP FEELING LIGHTHEADED AND DIZZY. TAKEN BY AMBULANCE TO ED, WHERE SHE SUFFERED RESP ARREST. CODED 3 TIMES. ADMITTED TO ICU ON VENT. DEVELOPED MULTI-ORGAN SYSTEM FAILURE. DIED ON 10 FEB.
18-29 years Death Feb., 2012 Feb., 2012 Total  
18-29 years Death Feb., 2012 Total  
18-29 years Death Total  
18-29 years Hospitalized Oct., 2006 Jul., 2010 393893-1 Patient diagnosed with meningococcemia, serogroup W-135.
18-29 years Hospitalized Oct., 2006 Jul., 2010 Total  
18-29 years Hospitalized Oct., 2006 Total  
18-29 years Hospitalized Jun., 2007 Dec., 2008 335764-1 Patient vaccinated with Menactra on 6/25/07 (lot U2236AA). Culture confirmed meningococcal disease on 9/26/07. Blood culture was positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on 9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status, blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem blood culture positive for neisseria meningitidis, serogroup C. Bilateral hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae, scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace infiltration consistent with terminal ventilator dependence. Bilateral pleural effusions.
18-29 years Hospitalized Jun., 2007 Dec., 2008 Total  
18-29 years Hospitalized Jun., 2007 Total  
18-29 years Hospitalized Oct., 2009 Nov., 2009 369428-1 10/22/09 fever, cough, SOB: healthy 14 yo sib with clinical H1N1. TAMIFLU began 75 BID. 10/23/09 seen in office & at home resp decompensation admitted to PICU: BiPAP. DNI order. Bilateral severe pneumonia died approx. 1pm 10/25/09. 12/14/09 Death Certificate received. DOD 10/25/09. Cause of death: Pneumonia. Additional information abstracted: Rett Syndrome. 12/14/09 Hospital records received, service dates 10/23/09 to 10/25/09. Assessment: Medically frail with hypovolemia, respiratory distress, ABG concerning for ARDS, likely due to H1N1 infection w/ bacterial superinfection. Patient presents with increasing work of breathing, fever, and cough. O2 Tamiflu at home. Tachypnea. Wheeze, shortness of breath. Crackles, rhonchi, flaring, retractions. Decreased responsiveness. Admitted to ICU. Mechanical ventilation. Edema of feet. Expired. 12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to 10/25/09. Assessment: Pneumonia present on admission, respiratory distress present on admission.
18-29 years Hospitalized Oct., 2009 Nov., 2009 Total  
18-29 years Hospitalized Oct., 2009 Total  
18-29 years Hospitalized Nov., 2009 Nov., 2009 367792-1 Patient had sudden cardiac arrest and had CPR from onset, was picked up by EMS and transported to hospital and pronounced dead at approx 11:30 PM. 12/16/09 Report of death received for 11/03/09. Decedent fell on the floor while in a social gathering. No pulse, CPR performed by school nurse for 10 mins until EMS came. Decedent had emesis while compressions were performed. EMS started ACLS, intubation, 3 IV lines, 4 Epi, 3 Atropine and 1 amp Bicarb. Sinus rhythm established 1 time, but lost. CPR unsuccessful. Decendent pronounced dead. 12/16/09 Autopsy results revealed no visible internal signs of trauma. All systems autopsy: normal. Teeth in poor condition. Cardiovascular system: myocardium: focal areas of fibrosis, atrial; bulges in atrial and ventricular muscular fee walls, interventricular septum 3cm thick. Pathologist opinion: Hypertrophic cardiomyopathy (790gr). Heart severely congested and lungs heavy with possible aspiration. 12/24/09 Toxicology report received. This report showed that no drugs were used. 01/04/09 Medical/dental record received for DOS 10/29/09. Debridement performed. Anesthesia used. Moderate to heavy generalized bleeding. Tx: Chlorhexidine gluconate oral rinse. DX: Gingivitis, periodontal disease.
18-29 years Hospitalized Nov., 2009 Nov., 2009 Total  
18-29 years Hospitalized Nov., 2009 Mar., 2010 383459-1 Patient was admitted to the hospital on 2/23/2010 with cough and increased green sputum production. Had had low grade fevers, none higher than 100 degrees. He states that he has had increased dyspnea on exertion. He states that he normally requires about 4-1/2 liters of home O2 while at rest and 6 liters while he is up with activity and he states that his saturation is normally about 94-95 percent.
18-29 years Hospitalized Nov., 2009 Mar., 2010 Total  
18-29 years Hospitalized Nov., 2009 Total  
18-29 years Hospitalized Total  
18-29 years Emergency Room Dec., 2009 Feb., 2010 379514-1 Patient unresponsive at home after being discharged on 12/12/09 at 9:15pm. Patient arrested, brought to hospital and pronounced dead at 11:40 PM.
18-29 years Emergency Room Dec., 2009 Feb., 2010 Total  
18-29 years Emergency Room Dec., 2009 Total  
18-29 years Emergency Room Mar., 2010 Mar., 2010 383127-1 He recieved the H1N1 vaccine around 9:00 am. At he at 12:00 Complaining of chest pain. No Diagnosis, then released from hospital. He Died at midnight (12:00 am) from a ruptured aorta.
18-29 years Emergency Room Mar., 2010 Mar., 2010 Total  
18-29 years Emergency Room Mar., 2010 Total  
18-29 years Emergency Room Total  
18-29 years Total  
30-39 years Death Oct., 2003 May, 2005 237654-1 10/05/2003 admitted for UTI, 10/7/03 home (not related). 10/15/03 admitted loss of mobility, 10/23/03 home. 10/28/03 ER UTI, vomiting, home. 11/6/03 Vomiting, weakness admit, died 11/21/03.
30-39 years Death Oct., 2003 May, 2005 Total  
30-39 years Death Oct., 2003 Total  
30-39 years Death Oct., 2009 Oct., 2009 362855-1 Patient got sick with flu like symptoms on 10/24 around 1PM, went to hospital with trouble breathing around 9PM, was pronounced deceased at 1AM on 10/25. 10/27/09 ER and hospital records received service date 10/25/09. Assessment: Death due to septic shock secondary to infection of unknown source. Asplenia. Patient had nausea, vomiting, chills, stomach cramping, diarrhea, tachypnea, hypotension, diaphoresis for one day. Limited oral intake. Became cyanotic around lips, fingernails, and toenails. Presented to ER hypotensive, hypoxic, no longer breathing. Tachycardia. Cardiac arrest presenting as pulseless electrical activity (PEA). Hyperacidemia. Resusitation. Intubated and transported to ICU. Bilateral infiltrates consistent with acute respiratory distress syndrome. End-organ damage including kidneys and brain. Repeated PEA. No pulse. Mottling of head and extremities. Overwhelming sepsis and septic shock. Patient expired. 11/02/09: Primary Care Records received for date of service 10/9/09. Seasonal flu vaccine record received VAERS updated. Assessment: Presented with vaginal bleeding x 3 weeks, had hx. of D&C in 08 2/2 heavy vaginal bleeding. Also presented with a cold that started 5 days prior, afebrile at visit. Seasonal Flu vaccine given. 11/05/09 Diagnostic/lab results received. IDPB Test results: Lung section shows increased interstitial inflammatory infiltrates. Heart section shows focal interstitial edema and extravasation. No evidence of myocarditis. Liver section shows increased portal infiltrates and dilated sinusoids with Kupffer cell hyperplasia. Special stains: Scattered gram-positive cocci in lung, heart and liver. Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver. (-) for influenza virus. PCR Assays: Negative for 2009 pandemic H1N1 influenza A virus. PCR for penumoniae pending. 12/14/09 Autopsy Records receivedI. DOD 10/25/09. Final Cause of Death: Streptococcus Pneumonia Sepsis. II. Hemolytic Anemia with Splenectomy. Additional information abstracted: Arteriovenous malformation of brain. Cholecystectomy remote. Blood cultures (+) for streptococcus pneumonias.
30-39 years Death Oct., 2009 Oct., 2009 Total  
30-39 years Death Oct., 2009 Nov., 2009 367386-1 Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time. 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease. Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.
30-39 years Death Oct., 2009 Nov., 2009 370257-1 The patient received her H1N1 vaccine at her place of work on October 16, 2009. On 11/3/2009 she died at home. The cause of death is unknown. The autopsy results were unremarkable. Labs and frozen sections are pending. She is alleged to have had a seizure disorder and neurologic records are being subpoenaed by the Coroner.
30-39 years Death Oct., 2009 Nov., 2009 Total  
30-39 years Death Oct., 2009 Total  
30-39 years Death Nov., 2009 Dec., 2009 372790-1 We received via agency, and Norvartis Pharmaceuticals, from a healthcare professional the following information on 01 DEC 2009: A 34-year-old female patient, born on 01 SEP 1975, pregnant for the third time in 27 weeks gestation, was vaccinated i.m. with seasonal FLUVIRIN, batch no. unknown) on 18 NOV 2009. The patient was also vaccinated with pandemic FLUVIRIN (batch no. unknown) on the same day (please see MA2009-5711 for reference). The patient also had a medical history of blighted ovum. On 30 NOV 2009 the patient collapsed and died on 30 NOV 2009. Autopsy was pending at time of report. A male male infant was delivered by C-section. Agency Ref. no: NA09-008971. Norvartis Pharmaceuticals ref. no.: S2009US27919. 12/30/09 ED records summary received. Service date 11/30/09. Assessment: Collapsed, unresponsive, asystolic rhythm. EMS found patient unresponsive, collapsed on floor, in asystolic rhythm. Presented at ED unresponsive, no spontaneous respirations, asystolic rhythm. Cental cyanosis, prior intubation, oxygen, epinephrine. Fixed dilated pupils, no corneal reflex. Pale. No spontaneous cardiac sounds. Fetal heart tones noted. Emergency C-Section, premature infant delivered and resusitated. 1/6/09 ED records received. Service date 11/30/09. Assessment: Cardiac arrest, expired. Pregnant patient arrived in full cardiac arrest. Asystole/Pulseless. Reflexes absent. Emergency low transverse cesarean. Male fetus delivered.
30-39 years Death Nov., 2009 Dec., 2009 Total  
30-39 years Death Nov., 2009 Total  
30-39 years Death Dec., 2009 Dec., 2009 372134-1 12/03/09 Temp. 98.9-Flu vaccine given (Influenza) on 7-3 shift. 8:45 PM 12/3/09 Temp. 102.9, pulse 145-Dr. notified-CIPRO 500 mg via GT given as an order BID. Change to ROCEPHIN 1 gm IM x 7 days, TYLENOL given, cold compresses. 12:20 AM 12/04/09 resident ceased to breathe. 12/9/2009 Death certificate received. DOD 12/4/09. Cause of Death: Pneumonia. Traumatic Encephalopathy.
30-39 years Death Dec., 2009 Dec., 2009 373547-1 "Per co-workers, patient reported ""not feeling well"" on 12/04/09. 12/29/09 Autopsy received. DOD 12/06/2009. Cause of Death: Long-term Sequelae of Spina Bifida. Additional information abstracted: Contributory - Associated Chronic and Acute Urinary Tract Infection. Summary of Autopsy Findings: I. Spina bifida - A. Large puckered lower lumbar scar. B. Chronic lower extremity atrophy with bilateral foot deformities. C. Indurated scars and large scarring - buttock and legs. D. Chronic and acute urinary tract infections. E. Posterior absence of corpus callosum. F. Ventriculoperitoneal shunt. G. Congested, dusky leptomeninges with associated cerebral edema. II. Other findings - A. Moderate atherosclerotic coronary artery disease. B. Minimal to moderate cardiac hypertophy. C. Acute visceral adhesions. D. Old abdominal adhesions. E. Status-post cholecystectomy."
30-39 years Death Dec., 2009 Dec., 2009 Total  
30-39 years Death Dec., 2009 Total  
30-39 years Death Jan., 2010 Jan., 2010 376990-1 unknown
30-39 years Death Jan., 2010 Jan., 2010 Total  
30-39 years Death Jan., 2010 Total  
30-39 years Death Dec., 2010 Jan., 2011 414753-1 12/16/2010. Patient's wife called to report that he developed nausea, headache, sweats, aching, cold two days ago (1 day after the flu vaccine was administered). On 12/15/10 he had more difficulty breathing but didn't mention this on 12/16/10 although he still had body aches. I recommended that he receive ibuprofen 800 mg tid until the symptoms subsided. Go to ER for increased difficulty breathing. 12/20/10. Hospital ED physician called to report that patient was found by his wife in the morning to be difficult to arouse. His abdomen was distended and he had nausea with increased secretions. 911 was called. They found his pulse to be thready and while being transported to the ER went into ventricular fibrillation and then asystole. A full code was done in the ER but they were unable to resuscitate him and he died.
30-39 years Death Dec., 2010 Jan., 2011 Total  
30-39 years Death Dec., 2010 Total  
30-39 years Death Total  
30-39 years Life Threatening Oct., 2009 Nov., 2009 367386-1 Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time. 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease. Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.
30-39 years Life Threatening Oct., 2009 Nov., 2009 Total  
30-39 years Life Threatening Oct., 2009 Total  
30-39 years Life Threatening Total  
30-39 years Hospitalized Oct., 2003 May, 2005 237654-1 10/05/2003 admitted for UTI, 10/7/03 home (not related). 10/15/03 admitted loss of mobility, 10/23/03 home. 10/28/03 ER UTI, vomiting, home. 11/6/03 Vomiting, weakness admit, died 11/21/03.
30-39 years Hospitalized Oct., 2003 May, 2005 Total  
30-39 years Hospitalized Oct., 2003 Total  
30-39 years Hospitalized Oct., 2009 Oct., 2009 362855-1 Patient got sick with flu like symptoms on 10/24 around 1PM, went to hospital with trouble breathing around 9PM, was pronounced deceased at 1AM on 10/25. 10/27/09 ER and hospital records received service date 10/25/09. Assessment: Death due to septic shock secondary to infection of unknown source. Asplenia. Patient had nausea, vomiting, chills, stomach cramping, diarrhea, tachypnea, hypotension, diaphoresis for one day. Limited oral intake. Became cyanotic around lips, fingernails, and toenails. Presented to ER hypotensive, hypoxic, no longer breathing. Tachycardia. Cardiac arrest presenting as pulseless electrical activity (PEA). Hyperacidemia. Resusitation. Intubated and transported to ICU. Bilateral infiltrates consistent with acute respiratory distress syndrome. End-organ damage including kidneys and brain. Repeated PEA. No pulse. Mottling of head and extremities. Overwhelming sepsis and septic shock. Patient expired. 11/02/09: Primary Care Records received for date of service 10/9/09. Seasonal flu vaccine record received VAERS updated. Assessment: Presented with vaginal bleeding x 3 weeks, had hx. of D&C in 08 2/2 heavy vaginal bleeding. Also presented with a cold that started 5 days prior, afebrile at visit. Seasonal Flu vaccine given. 11/05/09 Diagnostic/lab results received. IDPB Test results: Lung section shows increased interstitial inflammatory infiltrates. Heart section shows focal interstitial edema and extravasation. No evidence of myocarditis. Liver section shows increased portal infiltrates and dilated sinusoids with Kupffer cell hyperplasia. Special stains: Scattered gram-positive cocci in lung, heart and liver. Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver. (-) for influenza virus. PCR Assays: Negative for 2009 pandemic H1N1 influenza A virus. PCR for penumoniae pending. 12/14/09 Autopsy Records receivedI. DOD 10/25/09. Final Cause of Death: Streptococcus Pneumonia Sepsis. II. Hemolytic Anemia with Splenectomy. Additional information abstracted: Arteriovenous malformation of brain. Cholecystectomy remote. Blood cultures (+) for streptococcus pneumonias.
30-39 years Hospitalized Oct., 2009 Oct., 2009 Total  
30-39 years Hospitalized Oct., 2009 Nov., 2009 367386-1 Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time. 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease. Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.
30-39 years Hospitalized Oct., 2009 Nov., 2009 Total  
30-39 years Hospitalized Oct., 2009 Total  
30-39 years Hospitalized Nov., 2009 Jan., 2010 377053-1 Pt reports going into Pre-term delivery 5 days after vaccine was given. Baby died about 1 month after delivery. Delivered 11/23/09.
30-39 years Hospitalized Nov., 2009 Jan., 2010 Total  
30-39 years Hospitalized Nov., 2009 Total  
30-39 years Hospitalized Total  
30-39 years Hospitalized, Prolonged Oct., 2009 Nov., 2009 367386-1 Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time. 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease. Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.
30-39 years Hospitalized, Prolonged Oct., 2009 Nov., 2009 Total  
30-39 years Hospitalized, Prolonged Oct., 2009 Total  
30-39 years Hospitalized, Prolonged Total  
30-39 years Emergency Room Oct., 2003 May, 2005 237654-1 10/05/2003 admitted for UTI, 10/7/03 home (not related). 10/15/03 admitted loss of mobility, 10/23/03 home. 10/28/03 ER UTI, vomiting, home. 11/6/03 Vomiting, weakness admit, died 11/21/03.
30-39 years Emergency Room Oct., 2003 May, 2005 Total  
30-39 years Emergency Room Oct., 2003 Total  
30-39 years Emergency Room Oct., 2009 Oct., 2009 362855-1 Patient got sick with flu like symptoms on 10/24 around 1PM, went to hospital with trouble breathing around 9PM, was pronounced deceased at 1AM on 10/25. 10/27/09 ER and hospital records received service date 10/25/09. Assessment: Death due to septic shock secondary to infection of unknown source. Asplenia. Patient had nausea, vomiting, chills, stomach cramping, diarrhea, tachypnea, hypotension, diaphoresis for one day. Limited oral intake. Became cyanotic around lips, fingernails, and toenails. Presented to ER hypotensive, hypoxic, no longer breathing. Tachycardia. Cardiac arrest presenting as pulseless electrical activity (PEA). Hyperacidemia. Resusitation. Intubated and transported to ICU. Bilateral infiltrates consistent with acute respiratory distress syndrome. End-organ damage including kidneys and brain. Repeated PEA. No pulse. Mottling of head and extremities. Overwhelming sepsis and septic shock. Patient expired. 11/02/09: Primary Care Records received for date of service 10/9/09. Seasonal flu vaccine record received VAERS updated. Assessment: Presented with vaginal bleeding x 3 weeks, had hx. of D&C in 08 2/2 heavy vaginal bleeding. Also presented with a cold that started 5 days prior, afebrile at visit. Seasonal Flu vaccine given. 11/05/09 Diagnostic/lab results received. IDPB Test results: Lung section shows increased interstitial inflammatory infiltrates. Heart section shows focal interstitial edema and extravasation. No evidence of myocarditis. Liver section shows increased portal infiltrates and dilated sinusoids with Kupffer cell hyperplasia. Special stains: Scattered gram-positive cocci in lung, heart and liver. Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver. (-) for influenza virus. PCR Assays: Negative for 2009 pandemic H1N1 influenza A virus. PCR for penumoniae pending. 12/14/09 Autopsy Records receivedI. DOD 10/25/09. Final Cause of Death: Streptococcus Pneumonia Sepsis. II. Hemolytic Anemia with Splenectomy. Additional information abstracted: Arteriovenous malformation of brain. Cholecystectomy remote. Blood cultures (+) for streptococcus pneumonias.
30-39 years Emergency Room Oct., 2009 Oct., 2009 Total  
30-39 years Emergency Room Oct., 2009 Nov., 2009 367386-1 Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time. 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease. Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.
30-39 years Emergency Room Oct., 2009 Nov., 2009 Total  
30-39 years Emergency Room Oct., 2009 Total  
30-39 years Emergency Room Total  
30-39 years Total  
40-49 years Death Sep., 2009 Oct., 2009 360527-1 None stated. 11/30/09 Death Certificate Received. DOD 10/03/2009. Final Cause of Death: Acute Methadone Toxicity. Additional Information - Underlying conditions: Constrictive Atherosclerotic Artery Disease.
40-49 years Death Sep., 2009 Oct., 2009 Total  
40-49 years Death Sep., 2009 Total  
40-49 years Death Oct., 2009 Oct., 2009 363458-1 Client contacted Dr.'s office on 10/27/09 approximately equal to 0900 c/o feeling lightheaded and was not sure whether it was due to low BP or having received an H1N1 injection the day prior (10/26/09). Position: ESE Paraprofessional (worked with special needs children). An autopsy will be performed. 10/29/09 PCP medical records received service dates 10/26/09 to 10/28/09 includes vaccine records. Assessment: URI, low blood pressure, fatigue. On 10/27/09 Patient presents with low blood pressure and fatigue. Slight sore throat and post nasal drainage. Weak, 'woozy'. Weight loss of 38 lbs since 2/08. On 10/28/09 notified that patient had expired. 12/28/09 Note from Medical Examiner. DOD 10/28/09. Patient found unresponsive in bed at home. History of recurring deep vein thrombosis. Autopsy results show saddle embolus resulting in death. Local Health Department requested this office's assistance in regards to possible infection with H1N1. 1/5/09 Autopsy Report received. DOD 10/28/09. Final Cause of Death: Pulmonary Thromboembolism Due To Recurrent Lower Extremity Deep Vein Thrombosis. Additional Information Abstracted: Contributing - Morbid Obesity, Uterine Leiomyomata.
40-49 years Death Oct., 2009 Oct., 2009 Total  
40-49 years Death Oct., 2009 Nov., 2009 365165-1 UNKNOWN.
40-49 years Death Oct., 2009 Nov., 2009 Total  
40-49 years Death Oct., 2009 Jan., 2010 376388-1 "Seen in clinic 10/21/09 with cough, congestion, and ""feels hot"". Prescribed TAMIFLU on 10/21/09 and given intranasal H1N1 vaccine on 10/21. Subsequently apparently had flu-like symptoms and tiredness for unspecified period of time and apparently found unresponsive in home. Resuscitation unsuccessful."
40-49 years Death Oct., 2009 Jan., 2010 Total  
40-49 years Death Oct., 2009 Jul., 2010 392671-1 On day of vaccination throat was closing up for about 40 minutes after vaccine, then was dizzy for several days after. Stated she didn't feel good. On 12/4/09 was diagnosed with heart valve damage both mitral and tricuspid and dilated cardiomyopathy. Was admitted to CCU on 12/10/09 and died. Had H1N1 vaccine on 10/23/09.
40-49 years Death Oct., 2009 Jul., 2010 Total  
40-49 years Death Oct., 2009 Total  
40-49 years Death Nov., 2009 Nov., 2009 370052-1 Admitted to hospital 11/13/09. Expired 11/23/09. Doctor's note state pt received H1N1 and Seasonal flu vaccine 3 days prior to admission. 11/25/09 Hospital records received service dates 11/13//09 to 11/22/09. Assessment: Pneumonia, diphtheria Patient presents with cough and shortness of breath. Body aches, yellow sputum, right-sided chest pain with deep inspiration. Sore throat. Fever. Intubated and mechanically ventilated. 1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to 11/23/09. Assessment: Severe bilateral pneumonia with adult respiratory distress syndrome. Respiratory failure with hypoxemia, sepsis, diarrhea, acute renal failure, hypernatremia, hypoalbuminemia. Patient seen at ED and diagnosed with pneumonia. Seen at PCP office later that day and admitted to hospital. Intensive care, intubation, ventilator. High fever, hypotension, resusitation. Patient expired.
40-49 years Death Nov., 2009 Nov., 2009 Total  
40-49 years Death Nov., 2009 Dec., 2009 372029-1 Vaccine administered 11/20/09. Found deceased unknown cause 11/21/09.
40-49 years Death Nov., 2009 Dec., 2009 373905-1 Pt. had c/o chest pain x 1 d. Approx. 4 pm on 11/18/09, pt collapsed in parking lot at MD office. Resuscitation attempted at office, during EMS transport and hospital. Pt. died of MI. 12/21/09 Death Certificate received. DOD 11/18/09. Cause of death: Myocardial infarct due to High Cholesterol, Hypertension, Hypothyroidism. Additional information abstracted: Had c/o of chest pain at doctor's office, nurse found in cardiac arrest. EMS upon arrival found patient pulseless and apneic, CPR being performed. Resusitation including IV meds and defibrillation. Transported to hospital. 12/21/09 ER records received, service date 11/18/09. Assessment: Cardiopulmonary resusitation unsuccessful. Patient had C/O of chest pain. Found unresponsive, no respirations, no pulse, cyanotic, pupils fixed and dilated.
40-49 years Death Nov., 2009 Dec., 2009 Total  
40-49 years Death Nov., 2009 Jul., 2010 393060-1 Pt died. Autopsy revealed Giant cell myocarditis. Pt received H1N1 vaccine 2 1/2 months prior. Unsure if related.
40-49 years Death Nov., 2009 Jul., 2010 Total  
40-49 years Death Nov., 2009 Total  
40-49 years Death Dec., 2009 Jan., 2010 376499-1 Unknown if symptoms occured following vaccination but patient passed away 3 days later.
40-49 years Death Dec., 2009 Jan., 2010 Total  
40-49 years Death Dec., 2009 Total  
40-49 years Death Oct., 2011 Feb., 2012 449283-1 Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.
40-49 years Death Oct., 2011 Feb., 2012 Total  
40-49 years Death Oct., 2011 Total  
40-49 years Death Nov., 2011 Dec., 2011 446332-1 "Initial report was received on 19 December 2011 from a consumer who is also the patient's parent and additional information was received from a health care professional. A 43-year-old male patient received an injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc. lot not reported, on 17 November 2011 (also reported as 18 November 2011). The patient had a medical history of increased blood pressure and ""Dbj"". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient's concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines. The parent stated that the patient was seen by her on 18 November 2011 and he had been sick after receiving the influenza vaccine and was having a severe headache and could not eat. The patient had called 911 on Sunday and was taken to a hospital. The patient died on 21 November 2011. The outcome was reported as fatal. Documents held by sender: None."
40-49 years Death Nov., 2011 Dec., 2011 Total  
40-49 years Death Nov., 2011 Total  
40-49 years Death Sep., 2012 Oct., 2012 467340-1 Case number PHEH2012US019182 is an initial spontaneous report received from a pharmacist on 28 Sep 2012. This report refers to a 49-years-old male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1204901, expiry date: May 2013) intramuscularly on 25 Sep 2012. On 26 Sep 2012, he felt sick and nauseous. It was reported that he suffered a heart attack at his work site and expired before the ambulance arrived on 27 Sep 2012. No further information was available.
40-49 years Death Sep., 2012 Oct., 2012 Total  
40-49 years Death Sep., 2012 Total  
40-49 years Death Total  
40-49 years Hospitalized Nov., 2009 Nov., 2009 370052-1 Admitted to hospital 11/13/09. Expired 11/23/09. Doctor's note state pt received H1N1 and Seasonal flu vaccine 3 days prior to admission. 11/25/09 Hospital records received service dates 11/13//09 to 11/22/09. Assessment: Pneumonia, diphtheria Patient presents with cough and shortness of breath. Body aches, yellow sputum, right-sided chest pain with deep inspiration. Sore throat. Fever. Intubated and mechanically ventilated. 1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to 11/23/09. Assessment: Severe bilateral pneumonia with adult respiratory distress syndrome. Respiratory failure with hypoxemia, sepsis, diarrhea, acute renal failure, hypernatremia, hypoalbuminemia. Patient seen at ED and diagnosed with pneumonia. Seen at PCP office later that day and admitted to hospital. Intensive care, intubation, ventilator. High fever, hypotension, resusitation. Patient expired.
40-49 years Hospitalized Nov., 2009 Nov., 2009 Total  
40-49 years Hospitalized Nov., 2009 Total  
40-49 years Hospitalized Total  
40-49 years Emergency Room Oct., 2009 Nov., 2009 365165-1 UNKNOWN.
40-49 years Emergency Room Oct., 2009 Nov., 2009 Total  
40-49 years Emergency Room Oct., 2009 Total  
40-49 years Emergency Room Nov., 2011 Dec., 2011 446332-1 "Initial report was received on 19 December 2011 from a consumer who is also the patient's parent and additional information was received from a health care professional. A 43-year-old male patient received an injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc. lot not reported, on 17 November 2011 (also reported as 18 November 2011). The patient had a medical history of increased blood pressure and ""Dbj"". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient's concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines. The parent stated that the patient was seen by her on 18 November 2011 and he had been sick after receiving the influenza vaccine and was having a severe headache and could not eat. The patient had called 911 on Sunday and was taken to a hospital. The patient died on 21 November 2011. The outcome was reported as fatal. Documents held by sender: None."
40-49 years Emergency Room Nov., 2011 Dec., 2011 Total  
40-49 years Emergency Room Nov., 2011 Total  
40-49 years Emergency Room Total  
40-49 years Total  
50-59 years Death Oct., 2007 Nov., 2007 296690-1 oct.28.2007 treated for upper respritory viral infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral infection complecated by influensa vaccine.oct.27 2007died heart failer complecated by virial infection 11/16/07 Reviewed vaccine record from pcp & VAERS database updated w/same. 11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital medical records which reveal patient experienced chest & left arm pain, cold & clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived. EMS rhythm strip revealed BBB w/ST segment depression. In ER, vomited & had diarrhea. EKG revealed atrial fib w/rapid ventricular response. DX w/acute bronchitis & atrial fib w/RVR. Became unresponsive & developed cardiac arrest. Resuscitated & intubated. While being tansferred to higher level of care via helicopter, coded again. Returned to ER & unable to resuscitate. 3/7/2008 Judge states he signed death certificate as directed by state law when patient is not in hospital & only seen in ER but paper copy no longer available. States COD as undetermined & manner of death natural. 3/11 Death certificate reviewed & states COD as undetermined & manner of death as natural.
50-59 years Death Oct., 2007 Nov., 2007 297565-1 "Miller - Fisher Syndrome. Respiratory failure. 12/07/2007 MR received for DOS 11/18-29/2007 with DX: Miller-Fisher Syndrome. Pt expired on 11/29/2007. Progress note 11/28/07 states "" diagnosis of brain death due to massive intracranial hemorrhage"". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness. Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R>L, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult 11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination. PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator. On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity. On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above. Final DX: Massive cerebrovascular accident with subarachnoid hemorrhage. Brain dead with flat EEG and (+) apnea test. Bactermia with enterococcus faecalis and coagulase-negative staphylococcus. S/P comatose state. Miller Fisher Syndrome on admission. pemphigus vulgaris. S/P respiratory failure. 01/11/2008 Death Cert received. Immediate COD: Cerebrovascular Accident-Approximate interval:onset to death-hours. Ascending Polyneuropathy-onset to death: days. Pemphigus-onset to death: years."
50-59 years Death Oct., 2007 Nov., 2007 Total  
50-59 years Death Oct., 2007 Mar., 2008 308620-1 Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.
50-59 years Death Oct., 2007 Mar., 2008 Total  
50-59 years Death Oct., 2007 May, 2008 311987-1 information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death. 05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain). Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08. Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema. 9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process. Failed high dose steroids & plasma exchange. Tx w/mitoxantrone treatment & second course of high dose steroids in ICU. Mental & respiratory status deteriorated, significant muscle spasms & pain. Mechanical ventilation. Brain lesions continued to grow & new lesions appeared. Developed decerebrate posturing. Comfort care only decided & transferred to hospital closer to family home. 5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day. Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck. Referred to neuro-ophthal. 6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day. Had used Cialis & noted difficulty reading next AM w/HA. Then developed blurry vision, decreased vision & pain over 3 days. Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve. Admitted for stat MRI & IV steroids. No improvement & D/C to home on continued tapering steroids. 7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis
50-59 years Death Oct., 2007 May, 2008 Total  
50-59 years Death Oct., 2007 Total  
50-59 years Death Jan., 2008 Feb., 2008 304711-1 "01/25/08 11:00 PM Couldn't breathe or talk at fist. Then c/o pain in chest - then all over. 11:06 Ambulance called. 11:35 Ambulance arrived. Transported to hospital. 09/08 Had problems with SOB to ER - ""Test did not show anything"" (info given by daughter). 2/12 /08-myocardial infarction per coroner's office. no autopsy performed. 4/7/08-ER records received for DOS 1/26/08-cardiac arrest. Prounced 0054."
50-59 years Death Jan., 2008 Feb., 2008 Total  
50-59 years Death Jan., 2008 Total  
50-59 years Death Sep., 2009 Oct., 2009 361585-1 Pt reported to be at hospital on vent since Oct 2 2009 with Guillain-Barre syndrome. 10/21/09 Hospital records DC summary received service dates 10/2/09 to 10/20/09. Assessment: Death due to sepsis, respiratory failure, disseminated intravasular coagulopathy, acute renal failure, cirrhosis. Patient presented with hx of lower extremity weakness progressing to all four extremities. Was admitted to another facility where he became short of breath and hypoxic, intubated and developed ARDS. Neurological exam - areflexia severe axonal senserimotor polyneuropathy.Tranferred to MSU service for plasma exchange. Multiple infections including ventilator aquired pneumonia. DIC. Bloody stools. Metabolic acidosis, DNR, death.
50-59 years Death Sep., 2009 Oct., 2009 Total  
50-59 years Death Sep., 2009 Total  
50-59 years Death Oct., 2009 Nov., 2009 367379-1 Killed in a car accident while pulling out of the street where the clinic was located. Was turning left onto a divided highway when the driver's side door was hit by an oncoming vehicle. Died on impact.
50-59 years Death Oct., 2009 Nov., 2009 Total  
50-59 years Death Oct., 2009 Dec., 2009 371498-1 Unk. Pt. deceased unattended. 11/23/09 Sheriff officer said her doctor ruled heart attack and diabetes as cause of death. 12/10/09 Coroner's report received. Pronounced dead 11/09/09. Died of Natural Causes related to diabetes, irregular heart rate - had pacemaker, COPD - asthma, high blood pressure, thyroid disease, reflux disease, arthritis. 12/16/09 Death Certificate received. DOD 11/09/09. Cause of Death: Cardiopulmonary Arrest, Chronic Obstructive Pulmonary Disease, Hypertension, Diabetes.
50-59 years Death Oct., 2009 Dec., 2009 Total  
50-59 years Death Oct., 2009 Apr., 2010 386360-1 Death - 13 hours after Influenza A administration. Spouse had evidence of febrile event when found. spouse had been exposed to son with H1N1 (swine) continuously for 5 days in preceding 8 days before death. It was unknown at time that son had H1N1 and only became known to us 6 weeks after patient's death.
50-59 years Death Oct., 2009 Apr., 2010 Total  
50-59 years Death Oct., 2009 May, 2010 386863-1 Apparently had flu-like symptoms starting about 2 OCT 09. He had lab work & flu shot at the Health Clinic, on 6 OCT 09. He had a respiratory arrest at home on 9 OCT 09. H1N1 influenza from lung cultures & Nl Swab at autopsy.
50-59 years Death Oct., 2009 May, 2010 Total  
50-59 years Death Oct., 2009 Nov., 2010 410690-1 Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome
50-59 years Death Oct., 2009 Nov., 2010 Total  
50-59 years Death Oct., 2009 Total  
50-59 years Death Nov., 2009 Nov., 2009 366608-1 General malaise, nausea, hypotension. 11/13/09: Medical record for date of correspondence 11/13/09: Assessment: Received H1N1 vaccine 11/6/09 at a dialysis appointment and did not feel well, c/o nausea and malaise on 11/7 & 11/8/09, according to pt's husband, she continued to feel unwell on 11/10/09. On the morning of 11/11/09 the patient was found to have died in her sleep. 11/13/09: Hospital discharge summary(hospitalizaton prior to vaccine), hemodialysis clinic records and correspondence of case summary received. On 11/09/09, patient received out-patient dialysis. The patient had gained four pounds since her previous dialysis appointment. 12/21/09 Death Certificate received. DOD 11/11/09. Cause of Death: Hypertensive cardiovascular disease.
50-59 years Death Nov., 2009 Nov., 2009 Total  
50-59 years Death Nov., 2009 Dec., 2009 373122-1 Notified by patient's co-worker that patient had passed away. 12/15/09 Death Certificate received. DOD 12/08/2009. Cause of Death: Myocardial Infaction. Atherosclerotic Coronary Vascular Disease.
50-59 years Death Nov., 2009 Dec., 2009 374023-1 Client admitted to hospital for respiratory symptoms. Diagnosis - pneumonia - diagnosed with viral pneumonia. Cause or type unknown at time of death. 12/23/09 Discharge summary, hospital records received. Service dates 12/5/09 to 12/11/09. Assessment: Bilateral extensive pneumonia/acute respiratory distress syndrome. Acute hypoxia, respiratory failure. Anxiety/depression. Chronic anemia. Pulmonary hypertension. Right ventricular dysfunction. Patient developed acute onset of fevers, chills, shortness of breath, productive cough. Decreased breath sounds. Patient admitted to ICU. On ventilator. Acute renal failure. Discharged to higher level facility. 12/23/09 Discharge Summary, hospital records received. Service dates 12/11/2009. Assessment: ARDS, multiorgan failure, thrombocytopenia, multiple arterial and deep venous clots right upper and left upper extremities, right-sided pneumothorax, hemodynamic instability, possible heparin-induced thrombocytopenia. Patient transferred from another facility intubated with left lower lobe pneumonia. Small pupils, nonreactive. Crackles left chest. Hypotension. Bladder infection. Developed shock liver and acute renal failure with oliguria. Patient expired.
50-59 years Death Nov., 2009 Dec., 2009 Total  
50-59 years Death Nov., 2009 May, 2010 388189-1 "Shortly after H1N1 vaccine ""began having flu-like symptoms"". 1 week prior to death had nausea, vomiting, fever & diarrhea."
50-59 years Death Nov., 2009 May, 2010 Total  
50-59 years Death Nov., 2009 Total  
50-59 years Death Dec., 2009 Dec., 2009 374073-1 Nausea/vomiting became unresponsive went into cardiopulmonary arrest and died - was unable to be resuscitated by emergency department staff.
50-59 years Death Dec., 2009 Dec., 2009 Total  
50-59 years Death Dec., 2009 Jan., 2010 376066-1 Weakness, Shortness of breath, elevated troponins, acute renal failure - Diagnosis per neurology Guillane Barre 2' vaccination? - Patient received plasmaphoresis x5 days, required intubation and subsequent trach and PEG and discharge to SNF.
50-59 years Death Dec., 2009 Jan., 2010 378001-1 Increased hepatic encephalopathy and non-responsiveness followed by a coma for about eight days. Diagnosis was later rendered that patient had suffered central pontine myelinolysis.
50-59 years Death Dec., 2009 Jan., 2010 378423-1 He had diarrhea many times throughout the night and all day the next day. I live an hour and a half from him and he traveled home on Tuesday having to stop to go to the bathroom twice. He got home and had diarrhea all day on Tuesday 12/15/2009. He also told me all week that he was feeling very weak. He was even having trouble walking. I had told him all week to go to the emergency room and he kept telling me he would be ok. Finally on Friday 12/18/2009 he agreed to call the emergency squad after I told him I would meet him at the Hospital. The emergency squad arrived and being a big man he decided to walk to the squad. He went down the first of two steps and died. They tried to bring him back but was unsuccessful.
50-59 years Death Dec., 2009 Jan., 2010 Total  
50-59 years Death Dec., 2009 Total  
50-59 years Death Jan., 2010 Jan., 2010 377750-1 Death apparent heart attack 1/16/10. Pt. w/ CAD/ angioplasty 7/09 w/ stent placement. On multiple meds, smoker, denied symptoms 1/14/10.
50-59 years Death Jan., 2010 Jan., 2010 Total  
50-59 years Death Jan., 2010 Total  
50-59 years Death Aug., 2011 Sep., 2011 435354-1 At 12:30 PM patient laid down for a nap he offered no co at that time, at 2 PM I (wife) found patient unresponsive no pulse no respiratory effort. His skin was cold and moteled I dailed 911 and began chest compressions as instructed by 911 operator. I never got a pulse first responders and also worked on patient and transfered him to hospital he was pronounced dead at 2:08 pm on 09/07/2011.
50-59 years Death Aug., 2011 Sep., 2011 Total  
50-59 years Death Aug., 2011 Total  
50-59 years Death Oct., 2011 Oct., 2011 440529-1 Reported to us that patient received Flu shot on 10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ failure.
50-59 years Death Oct., 2011 Oct., 2011 Total  
50-59 years Death Oct., 2011 Total  
50-59 years Death Nov., 2011 Mar., 2012 452383-1 DEATH.
50-59 years Death Nov., 2011 Mar., 2012 Total  
50-59 years Death Nov., 2011 Total  
50-59 years Death Dec., 2012 Jan., 2013 480310-1 According to son who was interrogated, decedent received flu vaccine 12/19 at hospital and was not feeling well after that; found dead at home 12/23, hemorrhagic pericarditis.
50-59 years Death Dec., 2012 Jan., 2013 Total  
50-59 years Death Dec., 2012 Total  
50-59 years Death Feb., 2013 Feb., 2013 483818-1 Reported by family that he was found dead on 2/2/13.
50-59 years Death Feb., 2013 Feb., 2013 Total  
50-59 years Death Feb., 2013 Total  
50-59 years Death Total  
50-59 years Life Threatening Oct., 2007 Nov., 2007 297565-1 "Miller - Fisher Syndrome. Respiratory failure. 12/07/2007 MR received for DOS 11/18-29/2007 with DX: Miller-Fisher Syndrome. Pt expired on 11/29/2007. Progress note 11/28/07 states "" diagnosis of brain death due to massive intracranial hemorrhage"". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness. Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R>L, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult 11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination. PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator. On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity. On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above. Final DX: Massive cerebrovascular accident with subarachnoid hemorrhage. Brain dead with flat EEG and (+) apnea test. Bactermia with enterococcus faecalis and coagulase-negative staphylococcus. S/P comatose state. Miller Fisher Syndrome on admission. pemphigus vulgaris. S/P respiratory failure. 01/11/2008 Death Cert received. Immediate COD: Cerebrovascular Accident-Approximate interval:onset to death-hours. Ascending Polyneuropathy-onset to death: days. Pemphigus-onset to death: years."
50-59 years Life Threatening Oct., 2007 Nov., 2007 Total  
50-59 years Life Threatening Oct., 2007 Mar., 2008 308620-1 Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.
50-59 years Life Threatening Oct., 2007 Mar., 2008 Total  
50-59 years Life Threatening Oct., 2007 Total  
50-59 years Life Threatening Sep., 2009 Oct., 2009 361585-1 Pt reported to be at hospital on vent since Oct 2 2009 with Guillain-Barre syndrome. 10/21/09 Hospital records DC summary received service dates 10/2/09 to 10/20/09. Assessment: Death due to sepsis, respiratory failure, disseminated intravasular coagulopathy, acute renal failure, cirrhosis. Patient presented with hx of lower extremity weakness progressing to all four extremities. Was admitted to another facility where he became short of breath and hypoxic, intubated and developed ARDS. Neurological exam - areflexia severe axonal senserimotor polyneuropathy.Tranferred to MSU service for plasma exchange. Multiple infections including ventilator aquired pneumonia. DIC. Bloody stools. Metabolic acidosis, DNR, death.
50-59 years Life Threatening Sep., 2009 Oct., 2009 Total  
50-59 years Life Threatening Sep., 2009 Total  
50-59 years Life Threatening Oct., 2009 Nov., 2010 410690-1 Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome
50-59 years Life Threatening Oct., 2009 Nov., 2010 Total  
50-59 years Life Threatening Oct., 2009 Total  
50-59 years Life Threatening Oct., 2011 Oct., 2011 440529-1 Reported to us that patient received Flu shot on 10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ failure.
50-59 years Life Threatening Oct., 2011 Oct., 2011 Total  
50-59 years Life Threatening Oct., 2011 Total  
50-59 years Life Threatening Nov., 2011 Mar., 2012 452383-1 DEATH.
50-59 years Life Threatening Nov., 2011 Mar., 2012 Total  
50-59 years Life Threatening Nov., 2011 Total  
50-59 years Life Threatening Total  
50-59 years Permanent Disability Dec., 2009 Jan., 2010 376066-1 Weakness, Shortness of breath, elevated troponins, acute renal failure - Diagnosis per neurology Guillane Barre 2' vaccination? - Patient received plasmaphoresis x5 days, required intubation and subsequent trach and PEG and discharge to SNF.
50-59 years Permanent Disability Dec., 2009 Jan., 2010 Total  
50-59 years Permanent Disability Dec., 2009 Total  
50-59 years Permanent Disability Total  
50-59 years Hospitalized Oct., 2006 Nov., 2006 267701-1 Recent history of end stage renal disease. On dialysis for last 3 weeks. Discharged from hospital 10/24/06. 3-4 days ago, developed gradual increase in weakness, fatigue. Not able to get up without assistance. 11/08 intubated. 11/14 trache placed. 1/2/07 Received medical records from hospital which reveal patient admitted 3 times: 10/13/06-10/19/06 -- Final Dx: renal failure, secondary to acute tubular necrosis; hx of DVT & PE; & Wolff-Parkins-White syndrome; anemia; metabolic acidosis & hyperkalemia, resolved. Procedures during that hospitalization included: US guided percutaneous biopsy or right kidney 10/13/06; MRA of abdomen 10/17; placement of dialysis cath & initiation of dialysis 10/18/06. LABS: creatinine 7.3 (up from 2.9 2 wks prior during hospitalization for chest pain). 10/21/06-10/25/06 -- Final Dx: Abdominal & back pain; tachyarrhythmia tx w/ablation. 10/31/06-11/30/06. Intubated on 11/8/06 due to resp muscle weakness. Numerous episodes of plasmapheresis; numerous courses of IV immunoglobulin. Feeding tube & trach placed 11/14/06. FINAL DX: Guillain Barre Syndrome believed to be due to flu vax; renal failure, dialysis dependent; fevers, secondary to vancomycin; profound weakness; & history of DVT & PE. Information received from annual follow up indicates patient has not recovered. Only able to move eyes & jaw. Vent dependent. Patient died 1/26/07. Developed multiple myeloma. Had renal failure prior to this. In chronic atrial fibrillation. Per 60 day follow up: Continued to have minor improvements in neurologic function, including some neck flexion and some purposeful function of leg muscles, prior to his death due to other complications, on 1/26/07. He was a dialysis pt. who had bouts of C. difficile, dysrhythmia and ventricular tachycardia during the last days of life.
50-59 years Hospitalized Oct., 2006 Nov., 2006 Total  
50-59 years Hospitalized Oct., 2006 Total  
50-59 years Hospitalized Oct., 2007 Nov., 2007 297565-1 "Miller - Fisher Syndrome. Respiratory failure. 12/07/2007 MR received for DOS 11/18-29/2007 with DX: Miller-Fisher Syndrome. Pt expired on 11/29/2007. Progress note 11/28/07 states "" diagnosis of brain death due to massive intracranial hemorrhage"". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness. Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R>L, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult 11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination. PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator. On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity. On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above. Final DX: Massive cerebrovascular accident with subarachnoid hemorrhage. Brain dead with flat EEG and (+) apnea test. Bactermia with enterococcus faecalis and coagulase-negative staphylococcus. S/P comatose state. Miller Fisher Syndrome on admission. pemphigus vulgaris. S/P respiratory failure. 01/11/2008 Death Cert received. Immediate COD: Cerebrovascular Accident-Approximate interval:onset to death-hours. Ascending Polyneuropathy-onset to death: days. Pemphigus-onset to death: years."
50-59 years Hospitalized Oct., 2007 Nov., 2007 Total  
50-59 years Hospitalized Oct., 2007 Mar., 2008 308620-1 Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.
50-59 years Hospitalized Oct., 2007 Mar., 2008 Total  
50-59 years Hospitalized Oct., 2007 May, 2008 311987-1 information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death. 05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain). Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08. Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema. 9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process. Failed high dose steroids & plasma exchange. Tx w/mitoxantrone treatment & second course of high dose steroids in ICU. Mental & respiratory status deteriorated, significant muscle spasms & pain. Mechanical ventilation. Brain lesions continued to grow & new lesions appeared. Developed decerebrate posturing. Comfort care only decided & transferred to hospital closer to family home. 5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day. Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck. Referred to neuro-ophthal. 6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day. Had used Cialis & noted difficulty reading next AM w/HA. Then developed blurry vision, decreased vision & pain over 3 days. Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve. Admitted for stat MRI & IV steroids. No improvement & D/C to home on continued tapering steroids. 7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis
50-59 years Hospitalized Oct., 2007 May, 2008 Total  
50-59 years Hospitalized Oct., 2007 Total  
50-59 years Hospitalized Sep., 2009 Oct., 2009 361585-1 Pt reported to be at hospital on vent since Oct 2 2009 with Guillain-Barre syndrome. 10/21/09 Hospital records DC summary received service dates 10/2/09 to 10/20/09. Assessment: Death due to sepsis, respiratory failure, disseminated intravasular coagulopathy, acute renal failure, cirrhosis. Patient presented with hx of lower extremity weakness progressing to all four extremities. Was admitted to another facility where he became short of breath and hypoxic, intubated and developed ARDS. Neurological exam - areflexia severe axonal senserimotor polyneuropathy.Tranferred to MSU service for plasma exchange. Multiple infections including ventilator aquired pneumonia. DIC. Bloody stools. Metabolic acidosis, DNR, death.
50-59 years Hospitalized Sep., 2009 Oct., 2009 Total  
50-59 years Hospitalized Sep., 2009 Total  
50-59 years Hospitalized Oct., 2009 Nov., 2010 410690-1 Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome
50-59 years Hospitalized Oct., 2009 Nov., 2010 Total  
50-59 years Hospitalized Oct., 2009 Total  
50-59 years Hospitalized Nov., 2009 Dec., 2009 374023-1 Client admitted to hospital for respiratory symptoms. Diagnosis - pneumonia - diagnosed with viral pneumonia. Cause or type unknown at time of death. 12/23/09 Discharge summary, hospital records received. Service dates 12/5/09 to 12/11/09. Assessment: Bilateral extensive pneumonia/acute respiratory distress syndrome. Acute hypoxia, respiratory failure. Anxiety/depression. Chronic anemia. Pulmonary hypertension. Right ventricular dysfunction. Patient developed acute onset of fevers, chills, shortness of breath, productive cough. Decreased breath sounds. Patient admitted to ICU. On ventilator. Acute renal failure. Discharged to higher level facility. 12/23/09 Discharge Summary, hospital records received. Service dates 12/11/2009. Assessment: ARDS, multiorgan failure, thrombocytopenia, multiple arterial and deep venous clots right upper and left upper extremities, right-sided pneumothorax, hemodynamic instability, possible heparin-induced thrombocytopenia. Patient transferred from another facility intubated with left lower lobe pneumonia. Small pupils, nonreactive. Crackles left chest. Hypotension. Bladder infection. Developed shock liver and acute renal failure with oliguria. Patient expired.
50-59 years Hospitalized Nov., 2009 Dec., 2009 Total  
50-59 years Hospitalized Nov., 2009 Total  
50-59 years Hospitalized Dec., 2009 Jan., 2010 376066-1 Weakness, Shortness of breath, elevated troponins, acute renal failure - Diagnosis per neurology Guillane Barre 2' vaccination? - Patient received plasmaphoresis x5 days, required intubation and subsequent trach and PEG and discharge to SNF.
50-59 years Hospitalized Dec., 2009 Jan., 2010 378001-1 Increased hepatic encephalopathy and non-responsiveness followed by a coma for about eight days. Diagnosis was later rendered that patient had suffered central pontine myelinolysis.
50-59 years Hospitalized Dec., 2009 Jan., 2010 Total  
50-59 years Hospitalized Dec., 2009 Total  
50-59 years Hospitalized Oct., 2011 Oct., 2011 440529-1 Reported to us that patient received Flu shot on 10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ failure.
50-59 years Hospitalized Oct., 2011 Oct., 2011 Total  
50-59 years Hospitalized Oct., 2011 Total  
50-59 years Hospitalized Total  
50-59 years Hospitalized, Prolonged Oct., 2007 Nov., 2007 297565-1 "Miller - Fisher Syndrome. Respiratory failure. 12/07/2007 MR received for DOS 11/18-29/2007 with DX: Miller-Fisher Syndrome. Pt expired on 11/29/2007. Progress note 11/28/07 states "" diagnosis of brain death due to massive intracranial hemorrhage"". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness. Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R>L, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult 11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination. PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator. On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity. On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above. Final DX: Massive cerebrovascular accident with subarachnoid hemorrhage. Brain dead with flat EEG and (+) apnea test. Bactermia with enterococcus faecalis and coagulase-negative staphylococcus. S/P comatose state. Miller Fisher Syndrome on admission. pemphigus vulgaris. S/P respiratory failure. 01/11/2008 Death Cert received. Immediate COD: Cerebrovascular Accident-Approximate interval:onset to death-hours. Ascending Polyneuropathy-onset to death: days. Pemphigus-onset to death: years."
50-59 years Hospitalized, Prolonged Oct., 2007 Nov., 2007 Total  
50-59 years Hospitalized, Prolonged Oct., 2007 Mar., 2008 308620-1 Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.
50-59 years Hospitalized, Prolonged Oct., 2007 Mar., 2008 Total  
50-59 years Hospitalized, Prolonged Oct., 2007 Total  
50-59 years Hospitalized, Prolonged Oct., 2009 Nov., 2010 410690-1 Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome
50-59 years Hospitalized, Prolonged Oct., 2009 Nov., 2010 Total  
50-59 years Hospitalized, Prolonged Oct., 2009 Total  
50-59 years Hospitalized, Prolonged Dec., 2009 Jan., 2010 378001-1 Increased hepatic encephalopathy and non-responsiveness followed by a coma for about eight days. Diagnosis was later rendered that patient had suffered central pontine myelinolysis.
50-59 years Hospitalized, Prolonged Dec., 2009 Jan., 2010 Total  
50-59 years Hospitalized, Prolonged Dec., 2009 Total  
50-59 years Hospitalized, Prolonged Total  
50-59 years Emergency Room Oct., 2006 Nov., 2006 267701-1 Recent history of end stage renal disease. On dialysis for last 3 weeks. Discharged from hospital 10/24/06. 3-4 days ago, developed gradual increase in weakness, fatigue. Not able to get up without assistance. 11/08 intubated. 11/14 trache placed. 1/2/07 Received medical records from hospital which reveal patient admitted 3 times: 10/13/06-10/19/06 -- Final Dx: renal failure, secondary to acute tubular necrosis; hx of DVT & PE; & Wolff-Parkins-White syndrome; anemia; metabolic acidosis & hyperkalemia, resolved. Procedures during that hospitalization included: US guided percutaneous biopsy or right kidney 10/13/06; MRA of abdomen 10/17; placement of dialysis cath & initiation of dialysis 10/18/06. LABS: creatinine 7.3 (up from 2.9 2 wks prior during hospitalization for chest pain). 10/21/06-10/25/06 -- Final Dx: Abdominal & back pain; tachyarrhythmia tx w/ablation. 10/31/06-11/30/06. Intubated on 11/8/06 due to resp muscle weakness. Numerous episodes of plasmapheresis; numerous courses of IV immunoglobulin. Feeding tube & trach placed 11/14/06. FINAL DX: Guillain Barre Syndrome believed to be due to flu vax; renal failure, dialysis dependent; fevers, secondary to vancomycin; profound weakness; & history of DVT & PE. Information received from annual follow up indicates patient has not recovered. Only able to move eyes & jaw. Vent dependent. Patient died 1/26/07. Developed multiple myeloma. Had renal failure prior to this. In chronic atrial fibrillation. Per 60 day follow up: Continued to have minor improvements in neurologic function, including some neck flexion and some purposeful function of leg muscles, prior to his death due to other complications, on 1/26/07. He was a dialysis pt. who had bouts of C. difficile, dysrhythmia and ventricular tachycardia during the last days of life.
50-59 years Emergency Room Oct., 2006 Nov., 2006 Total  
50-59 years Emergency Room Oct., 2006 Total  
50-59 years Emergency Room Oct., 2007 Mar., 2008 308620-1 Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.
50-59 years Emergency Room Oct., 2007 Mar., 2008 Total  
50-59 years Emergency Room Oct., 2007 Total  
50-59 years Emergency Room Oct., 2009 Nov., 2010 410690-1 Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome
50-59 years Emergency Room Oct., 2009 Nov., 2010 Total  
50-59 years Emergency Room Oct., 2009 Total  
50-59 years Emergency Room Oct., 2011 Oct., 2011 440529-1 Reported to us that patient received Flu shot on 10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ failure.
50-59 years Emergency Room Oct., 2011 Oct., 2011 Total  
50-59 years Emergency Room Oct., 2011 Total  
50-59 years Emergency Room Nov., 2011 Mar., 2012 452383-1 DEATH.
50-59 years Emergency Room Nov., 2011 Mar., 2012 Total  
50-59 years Emergency Room Nov., 2011 Total  
50-59 years Emergency Room Total  
50-59 years Total  
60-64 years Death Oct., 2007 Oct., 2007 293120-1 Patient received influenza vaccine at 1105 AM 10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM. Resuscitative efforts were unsuccessful.
60-64 years Death Oct., 2007 Oct., 2007 Total  
60-64 years Death Oct., 2007 Total  
60-64 years Death Nov., 2007 Feb., 2008 304418-1 She was immediately sick. Very sick for 4 more days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27 respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07. Database updated. Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed. Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med records. Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.
60-64 years Death Nov., 2007 Feb., 2008 305043-1 On 11/21 the husband noticed that patient was having confusion and forgetting little things. The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic. The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk. Once at the hospital the patient was given steroids, antibiotics, and antifungals. The patient improved for two days and then got progressively worse each day after that. The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28. Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine. 8/26/08 Death certificate states COD as acute disseminated encephalomyelitis. 2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day Admitted 11/21-11/28/2007 when she expired. Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact. Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds. Received IVIG x 2. By hospital day #4, conditioned worsened & was unresponsive w/left side weakness. C/S neg & antibiotics/antivirals were d/c. Continued to deteriorate & on vent. Family decision to withdraw tx as condition contined to worsen & pt expired. 5/2/08 Reviewed pcp medical records which included vax record that confirms as reported. Office note of 11/16/07 was for flu shot only, no pcp note. 10/24 vs for URI s/s x approx 1 week. Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite. Apouse had been ill w/viral syndrome. CXR that day revealed patchy RUL infiltrate; CBC WNL. 10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder. She had less cough & improved appetite but was still tired. CXR that day revealed near resolution of pneumonia. Records also included some hospital medical records. Neurosurgery & neurology consults done. Patient w/fever on admission.
60-64 years Death Nov., 2007 Feb., 2008 Total  
60-64 years Death Nov., 2007 Total  
60-64 years Death Sep., 2008 Jan., 2009 336403-1 Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus. Expired 9/29/08. 2/9/09-COD-pulmonary embolism.
60-64 years Death Sep., 2008 Jan., 2009 Total  
60-64 years Death Sep., 2008 Aug., 2009 355396-1 On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
60-64 years Death Sep., 2008 Aug., 2009 Total  
60-64 years Death Sep., 2008 Total  
60-64 years Death Oct., 2008 Nov., 2008 331269-1 Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5'F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.
60-64 years Death Oct., 2008 Nov., 2008 Total  
60-64 years Death Oct., 2008 Total  
60-64 years Death Sep., 2009 Oct., 2009 359582-1 Flu like symptoms: Fever, SOB. Was admitted to the hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim autopsy report received with the following findings: Multilobar pneumonia (all lobes severely involved). Post mortem bacterial, fungal, acid fast and viral cultures pending. H1N1 (-). Renal failure probably 2' to acute tubular necrosis. 10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of fever, malaise. nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and thought to be viral, sx progressed, cough worsened and patient became dyspneic. To hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam, Cleocin, Xigris, Serum Bicarbonate. DC DX's: Severe Multilobar Pneumonia, Respiratory failure, Renal failure, Metabolic Acidosis. 12/29/09 Autopsy report received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to Legionella, non-pneumophilia species. Additional information abstracted: Patient developed community-acquired bilateral pneumonia causing severe hypoxia and multiorgan system failure.
60-64 years Death Sep., 2009 Oct., 2009 Total  
60-64 years Death Sep., 2009 Mar., 2010 381986-1 tin.
60-64 years Death Sep., 2009 Mar., 2010 Total  
60-64 years Death Sep., 2009 Total  
60-64 years Death Oct., 2009 Nov., 2009 366976-1 Pre dialysis on 10/30/09 complained of achiness (generalized), feeling cold, difficulty breathing. Lungs were clear (oxygen administered w/ ease of breathing), BP 129/41, HR 81 - regular temp 98.38. TYLENOL given for pain #7/10 on pain scale. Patient 3.4 kg > EDW. Edema +2 pitting in right leg. Reported patient condition to Nephrologist. Hemodialysis treatment initiated and completed without complication. Patient refused to be evaluated at ER and discharged home in stable condition. 11/13/09 Medical records received. Dialysis records for DOS 10/28-10/30. C/o fainting x3 at home. Can't stay awake. Vaccine given same day (10/28). Admits he had called 911 x2 looking for help that day. Seen 2 days later and c/o coldness, hurting all over. Can't breath. Kept asking for help. Staff offered to call 911. Refused. Afebrile. No flu like sx noted by staff other than achy. Dialysis tx given. D/C to home. Follow-up call made. Pt OK. Went to bed. 11/16/09 Two discharge summaries received, hospital records. Service dates 10/30/09 to 11/10/09. Assessment: Dehydration, swine flu reaction, Patient presented with fevers, generalized aches, and pains. Very weak and sick. Headache. Non-healing ulcer on right heel. While in hospital became lethargic and difficult to arouse. Developed high fever (105.5), more confused and lethargic. Bradycardic, patient intubated, lost peripheral pulses, resusitation not sucessful, pronounced deceased. 0/04/2010 Death Certificate received. DOD 11/10/2009. Cause of Death: Coronary artery disease, severe peripheral vascular disease, chronic obstructive pulmonary disease, septicemia. Other significant conditions: Status post left below knee amputation, depression, diabetes.
60-64 years Death Oct., 2009 Nov., 2009 Total  
60-64 years Death Oct., 2009 Total  
60-64 years Death Nov., 2009 Nov., 2009 370081-1 Pt went to the gym and died from a heart attack/stroke?? within 24hrs of obtaining H1N1 injection. 12/22/09 ED records received. Service dates 11/23/09 to 11/24/09. Assessment: Cardiac arrest. EMS called because of chest pain, arrested on route to ED. Intubation. Resusitation. Ventricular Fibrillation. Patient presents in cardiac arrest. Radial pulses absent. Pupils fixed and dilated. Skin mottled, clammy, temperature is cool. Pronounced expired
60-64 years Death Nov., 2009 Nov., 2009 370514-1 "Patient reported to ER 1 day after receiving H1N1 vaccine with ""flu like symptoms"", ""hurting all over"". VS and lab stable - treated for lower back pain. Sent home with instructions to report back if problems continue. Patient reported to ER on 11-20-09. Report is not available. Sister states pt. was treated and sent home. Boyfriend discovered pt. dead at home after returning home from store. 12/2/2009 ED record for 11/19/2009 and 11/20/2009 and dialysis records for 11/13, 11/16 and 11/18/2009. Patient presented to ED with c/o's flu-like sx: ""aching and pain all over"", no other sx noted. PE was negative. Tx: IM pain meds Morphine and Dilaudid, po Zofran. Dc'd with Rx for Lortab On 11/20/2009 presented to another ED with c/o's ""hurting all over and with c/o's nausea/vomiting. Tx: Demerol and Vistaril Dc''d with dx of chronic back pain. Notes state that later on 11/20/2009 patient expired at home. 1/7/2010 Death Certificate received. DOD 1120/09. Cause of Death: Acute Myocardial Infarction. Additional information abstracted: Other Significant Conditions - Diabetes."
60-64 years Death Nov., 2009 Nov., 2009 Total  
60-64 years Death Nov., 2009 Total  
60-64 years Death Dec., 2009 Nov., 2011 441707-1 1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.
60-64 years Death Dec., 2009 Nov., 2011 Total  
60-64 years Death Dec., 2009 Total  
60-64 years Death Sep., 2010 Sep., 2010 399572-1 Was informed that patient died 2 days after flu shot, no symptoms were reported by police office department.
60-64 years Death Sep., 2010 Sep., 2010 Total  
60-64 years Death Sep., 2010 Total  
60-64 years Death Nov., 2010 Nov., 2010 409289-1 Received INFLUENZA vaccine approx 5 pm 11-15-10. Did not awaken from sleep 11-16-10 ->EMS->pulseless electrical activity-> CPR -> Emergency Dept. Multiple attempts at resuscitation failed. Pt expired 11-16-10.
60-64 years Death Nov., 2010 Nov., 2010 Total  
60-64 years Death Nov., 2010 Total  
60-64 years Death Oct., 2011 Nov., 2011 441679-1 "61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening ""wasnt feeling right"". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs."
60-64 years Death Oct., 2011 Nov., 2011 Total  
60-64 years Death Oct., 2011 Feb., 2012 450832-1 Patient started feeling flu-like symptoms (nausea, diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later passed away while playing Squash/handball on 10/19/11.
60-64 years Death Oct., 2011 Feb., 2012 Total  
60-64 years Death Oct., 2011 Total  
60-64 years Death Oct., 2012 Oct., 2012 472279-1 This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 62-year-old male patient, who had a medical history of recent massive heart attack and narcolepsy. He had no known drug allergy. He was taking 'a lot of medications' (type unspecified). On 11-Oct-2012 the patient received AFLURIA (batch number: P58306) injection at a dose of 0.5 mL intramuscularly. On the day of vaccination, the patient did not complain of any symptoms and went home without any adverse events. On 13-Oct-2012 the patient was found dead. The cause of death was still being investigated. According to the pharmacist (reporter), the patient had many health problems including a recent massive heart attack (date unspecified).
60-64 years Death Oct., 2012 Oct., 2012 Total  
60-64 years Death Oct., 2012 Total  
60-64 years Death Total  
60-64 years Life Threatening Nov., 2007 Feb., 2008 304418-1 She was immediately sick. Very sick for 4 more days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27 respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07. Database updated. Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed. Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med records. Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.
60-64 years Life Threatening Nov., 2007 Feb., 2008 Total  
60-64 years Life Threatening Nov., 2007 Total  
60-64 years Life Threatening Sep., 2008 Aug., 2009 355396-1 On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
60-64 years Life Threatening Sep., 2008 Aug., 2009 Total  
60-64 years Life Threatening Sep., 2008 Total  
60-64 years Life Threatening Oct., 2008 Nov., 2008 331269-1 Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5'F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.
60-64 years Life Threatening Oct., 2008 Nov., 2008 Total  
60-64 years Life Threatening Oct., 2008 Total  
60-64 years Life Threatening Dec., 2009 Nov., 2011 441707-1 1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.
60-64 years Life Threatening Dec., 2009 Nov., 2011 Total  
60-64 years Life Threatening Dec., 2009 Total  
60-64 years Life Threatening Oct., 2011 Nov., 2011 441679-1 "61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening ""wasnt feeling right"". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs."
60-64 years Life Threatening Oct., 2011 Nov., 2011 Total  
60-64 years Life Threatening Oct., 2011 Total  
60-64 years Life Threatening Total  
60-64 years Permanent Disability Sep., 2008 Aug., 2009 355396-1 On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
60-64 years Permanent Disability Sep., 2008 Aug., 2009 Total  
60-64 years Permanent Disability Sep., 2008 Total  
60-64 years Permanent Disability Sep., 2009 Mar., 2010 381986-1 tin.
60-64 years Permanent Disability Sep., 2009 Mar., 2010 Total  
60-64 years Permanent Disability Sep., 2009 Total  
60-64 years Permanent Disability Total  
60-64 years Hospitalized Nov., 2007 Feb., 2008 304418-1 She was immediately sick. Very sick for 4 more days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27 respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07. Database updated. Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed. Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med records. Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.
60-64 years Hospitalized Nov., 2007 Feb., 2008 Total  
60-64 years Hospitalized Nov., 2007 Total  
60-64 years Hospitalized Sep., 2008 Aug., 2009 355396-1 On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
60-64 years Hospitalized Sep., 2008 Aug., 2009 Total  
60-64 years Hospitalized Sep., 2008 Total  
60-64 years Hospitalized Oct., 2008 Nov., 2008 331269-1 Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5'F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.
60-64 years Hospitalized Oct., 2008 Nov., 2008 Total  
60-64 years Hospitalized Oct., 2008 Total  
60-64 years Hospitalized Sep., 2009 Oct., 2009 359582-1 Flu like symptoms: Fever, SOB. Was admitted to the hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim autopsy report received with the following findings: Multilobar pneumonia (all lobes severely involved). Post mortem bacterial, fungal, acid fast and viral cultures pending. H1N1 (-). Renal failure probably 2' to acute tubular necrosis. 10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of fever, malaise. nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and thought to be viral, sx progressed, cough worsened and patient became dyspneic. To hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam, Cleocin, Xigris, Serum Bicarbonate. DC DX's: Severe Multilobar Pneumonia, Respiratory failure, Renal failure, Metabolic Acidosis. 12/29/09 Autopsy report received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to Legionella, non-pneumophilia species. Additional information abstracted: Patient developed community-acquired bilateral pneumonia causing severe hypoxia and multiorgan system failure.
60-64 years Hospitalized Sep., 2009 Oct., 2009 Total  
60-64 years Hospitalized Sep., 2009 Mar., 2010 381986-1 tin.
60-64 years Hospitalized Sep., 2009 Mar., 2010 Total  
60-64 years Hospitalized Sep., 2009 Total  
60-64 years Hospitalized Oct., 2009 Nov., 2009 366976-1 Pre dialysis on 10/30/09 complained of achiness (generalized), feeling cold, difficulty breathing. Lungs were clear (oxygen administered w/ ease of breathing), BP 129/41, HR 81 - regular temp 98.38. TYLENOL given for pain #7/10 on pain scale. Patient 3.4 kg > EDW. Edema +2 pitting in right leg. Reported patient condition to Nephrologist. Hemodialysis treatment initiated and completed without complication. Patient refused to be evaluated at ER and discharged home in stable condition. 11/13/09 Medical records received. Dialysis records for DOS 10/28-10/30. C/o fainting x3 at home. Can't stay awake. Vaccine given same day (10/28). Admits he had called 911 x2 looking for help that day. Seen 2 days later and c/o coldness, hurting all over. Can't breath. Kept asking for help. Staff offered to call 911. Refused. Afebrile. No flu like sx noted by staff other than achy. Dialysis tx given. D/C to home. Follow-up call made. Pt OK. Went to bed. 11/16/09 Two discharge summaries received, hospital records. Service dates 10/30/09 to 11/10/09. Assessment: Dehydration, swine flu reaction, Patient presented with fevers, generalized aches, and pains. Very weak and sick. Headache. Non-healing ulcer on right heel. While in hospital became lethargic and difficult to arouse. Developed high fever (105.5), more confused and lethargic. Bradycardic, patient intubated, lost peripheral pulses, resusitation not sucessful, pronounced deceased. 0/04/2010 Death Certificate received. DOD 11/10/2009. Cause of Death: Coronary artery disease, severe peripheral vascular disease, chronic obstructive pulmonary disease, septicemia. Other significant conditions: Status post left below knee amputation, depression, diabetes.
60-64 years Hospitalized Oct., 2009 Nov., 2009 Total  
60-64 years Hospitalized Oct., 2009 Total  
60-64 years Hospitalized Dec., 2009 Nov., 2011 441707-1 1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.
60-64 years Hospitalized Dec., 2009 Nov., 2011 Total  
60-64 years Hospitalized Dec., 2009 Total  
60-64 years Hospitalized Oct., 2011 Nov., 2011 441679-1 "61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening ""wasnt feeling right"". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs."
60-64 years Hospitalized Oct., 2011 Nov., 2011 Total  
60-64 years Hospitalized Oct., 2011 Total  
60-64 years Hospitalized Total  
60-64 years Hospitalized, Prolonged Nov., 2007 Feb., 2008 304418-1 She was immediately sick. Very sick for 4 more days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27 respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07. Database updated. Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed. Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med records. Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.
60-64 years Hospitalized, Prolonged Nov., 2007 Feb., 2008 Total  
60-64 years Hospitalized, Prolonged Nov., 2007 Total  
60-64 years Hospitalized, Prolonged Sep., 2008 Aug., 2009 355396-1 On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
60-64 years Hospitalized, Prolonged Sep., 2008 Aug., 2009 Total  
60-64 years Hospitalized, Prolonged Sep., 2008 Total  
60-64 years Hospitalized, Prolonged Oct., 2008 Nov., 2008 331269-1 Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5'F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.
60-64 years Hospitalized, Prolonged Oct., 2008 Nov., 2008 Total  
60-64 years Hospitalized, Prolonged Oct., 2008 Total  
60-64 years Hospitalized, Prolonged Sep., 2009 Mar., 2010 381986-1 tin.
60-64 years Hospitalized, Prolonged Sep., 2009 Mar., 2010 Total  
60-64 years Hospitalized, Prolonged Sep., 2009 Total  
60-64 years Hospitalized, Prolonged Total  
60-64 years Emergency Room Sep., 2008 Jan., 2009 336403-1 Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus. Expired 9/29/08. 2/9/09-COD-pulmonary embolism.
60-64 years Emergency Room Sep., 2008 Jan., 2009 Total  
60-64 years Emergency Room Sep., 2008 Aug., 2009 355396-1 On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome
60-64 years Emergency Room Sep., 2008 Aug., 2009 Total  
60-64 years Emergency Room Sep., 2008 Total  
60-64 years Emergency Room Oct., 2008 Nov., 2008 331269-1 Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5'F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.
60-64 years Emergency Room Oct., 2008 Nov., 2008 Total  
60-64 years Emergency Room Oct., 2008 Total  
60-64 years Emergency Room Sep., 2009 Mar., 2010 381986-1 tin.
60-64 years Emergency Room Sep., 2009 Mar., 2010 Total  
60-64 years Emergency Room Sep., 2009 Total  
60-64 years Emergency Room Dec., 2009 Nov., 2011 441707-1 1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.
60-64 years Emergency Room Dec., 2009 Nov., 2011 Total  
60-64 years Emergency Room Dec., 2009 Total  
60-64 years Emergency Room Nov., 2010 Nov., 2010 409289-1 Received INFLUENZA vaccine approx 5 pm 11-15-10. Did not awaken from sleep 11-16-10 ->EMS->pulseless electrical activity-> CPR -> Emergency Dept. Multiple attempts at resuscitation failed. Pt expired 11-16-10.
60-64 years Emergency Room Nov., 2010 Nov., 2010 Total  
60-64 years Emergency Room Nov., 2010 Total  
60-64 years Emergency Room Oct., 2011 Nov., 2011 441679-1 "61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late '90's and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening ""wasnt feeling right"". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs."
60-64 years Emergency Room Oct., 2011 Nov., 2011 Total  
60-64 years Emergency Room Oct., 2011 Total  
60-64 years Emergency Room Total  
60-64 years Total  
65+ years Death Dec., 2003 Dec., 2007 299262-1 On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises. They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician. She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm. On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed. On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but very weak and her family made attempts to drive her quickly to Emegency Room for treatment. She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin. Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus
65+ years Death Dec., 2003 Dec., 2007 Total  
65+ years Death Dec., 2003 Total  
65+ years Death Oct., 2006 Oct., 2006 265563-1 Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant. Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius. At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.
65+ years Death Oct., 2006 Oct., 2006 Total  
65+ years Death Oct., 2006 Dec., 2006 268775-1 Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
65+ years Death Oct., 2006 Dec., 2006 Total  
65+ years Death Oct., 2006 Total  
65+ years Death Oct., 2007 Oct., 2007 293594-1 Client presented to drive through flu exercise for influenza vaccination. Gave history of having had flu shots in past without incident. No contraindications to vaccinations identified. Client was vaccinated and returned home. At some time after returning home client went to Hospital emergency room where he coded and expired. 10/23/07 Reviewed hospital medical records which reveal patient experienced weakness & decreased respirations upon arriving home s/p flu shot. Collapsed in seat of pickup truck. EMS intubated, started CPR & transported to hospital. CXR revealed right pneumothorax & chest tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with atherosclerotic cardiovascular disease & CHF as contributing factors.
65+ years Death Oct., 2007 Oct., 2007 294274-1 "Patient's daughter called after the event and reported that patientexperienced wheezing, cough and syncope ""later that day"" after he returned home from flu clinic. She did not indicate which, if any, hospital he was taken to, but that she had called his physician. Cardiologist. She reported that her father died on Sunday 10-21-2007 11/6/07 Received hospital clinic & cardiology medical records which reveal patient experienced CAD, s/p CABG (1982 & 1990) & severe LVD s/p ICD biventricular deployment; chronic back problems; hyperlipidemia; diabetes type 2; & controlled HTN. Cardiac cath of 4/2006 revealed patent left internal mammary arter to LAD bypass graft w/other grafts being occluded. Had been hospitalized 7/07 for pacemaker device discharge. Had DOE at that time. Pacer rate was increased due to myocardial ischemia. Developed chest pain, nausea & additional DOE. Dx w/unstable angina 7/11/07 & admitted to hospital. 1/18/08 Reviewed ER records of 10/22/07 which reveal patient fell & had witnessed cardiac arrest at home 50 min prior to arrival in ER. Had been intubated & IV access placed in field. ECG revealed V-fib & then asystole & patient expired 10/22/07. 1/29/08 Cardiac arrest per death certificate."
65+ years Death Oct., 2007 Oct., 2007 294842-1 1 week after administration found dead at home. History of COPD and squamous cell lung cancer RUL with obstruction of airway and s/p palliative treatment. Daughter felt he became more lethargic 24 hours after vaccination and requested we report this. No autopsy performed by medical examiner and death certificate pending. 11/27/07 Reviewed death certificate which states COD as right lung pancoast tumor due to chronic obstructive pulmonary disease. 1/4/08 Reviewed medical records which reveal patient experienced cough, recurrent RUL infections which responded to antibiotic tx, RUE pain s/p brachial plexus involvement, poor appetite on 10/18/07. Dx w/RUL lung Pancoast squamous cell carcinoma, stage B & tx w/chemo & radiation tx.
65+ years Death Oct., 2007 Oct., 2007 294848-1 patient was not acutely ill but was found dead in her chair within 24 hours of flu vaccine. 1/15/08 Death certificate states COD as acute myocardial infarction w/chronic ischemic heart disease as contributing factor.
65+ years Death Oct., 2007 Oct., 2007 294850-1 Patient found dead in his chair 36 hours after vaccine. Had not been acutely ill prior to vaccination. 11/02/07 Received medical records from reporter which reveal patient w/extensive medical hx. H&P of 5/07 indicates had recent diarrhea, apple core lesion in mid to distal sigmoid colon, severe dementia, SOB & extremely poor appetite who had been admitted to hospital then transferred to LTC due to lethargy, fatigue & falls. Had cellulitis & inflammation of lower leg but afebrile on day of vax. Next day had congested productive cough w/green phlegm & vomiting. 10/28 had increased congestion, unresponsive w/dusky color. BP 89/66 & placed on O2 due to sats of 50-60%. Taken to hospital. 11/16/07 Received hospital ER medical records of 10/28/2007. FINAL ER DX: respiratory failure, sepsis Records reveal patient experienced fever, lethargy altered mental status & abdominal guarding. Exam revealed bilateral diffuse rhonchi, increased respiratory rate, diffuse abdominal tenderness & guarding, decreased bowel sounds, pitting edema of LE's & tachycardia, temp 101.3. Patient was DNR & comfort measures provided until expiration. ME declined case.
65+ years Death Oct., 2007 Oct., 2007 Total  
65+ years Death Oct., 2007 Nov., 2007 296073-1 We received from a health care professional via the agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL 1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The patient died shortly after the vaccination after he left the facility and walked down the hall. Caller felt that individual was properly screened, reported no allergies to any component, and filled out the waiver for the vaccine prior to administration, and had prior flu vaccinations. The reporter felt the death was coincidental based on the age and history of the patient. Company assessment: Seriousness criterion: death. Causality: insufficient data. Expectedness assessment according to manufacturer label: Death after Fluvirin is not expected. No change in benefit-risk-ratio. No measure necessary. Addendum We received from a health care professional via the medical agencies additional information on 29 OCT 2007: The batch-no. was 78478 (and not 78428 as previously reported). No change in assessment. NA07-005622
65+ years Death Oct., 2007 Nov., 2007 296120-1 Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.
65+ years Death Oct., 2007 Nov., 2007 296240-1 Unknown 11/16/07 Reviewed death certificate which reveals COD as liver cancer.
65+ years Death Oct., 2007 Nov., 2007 Total  
65+ years Death Oct., 2007 Apr., 2009 345053-1 Patient (68 year old male) received a flu shot on 10/10/07. He died that night in his sleep of a massive heart attack, presumably in the early morning hours of 10/11/07. Although previously diagnosed with mild artherosclerosis, he had never had a prior heart attack. He had just visited his doctor the previous day and been given a clean bill of health. 5/6/09 Autopsy report states COD as artherosclerotic & hypertensive-type cardiovascular disease w/obesity as contributing condition. Manner of death natural. Report also states 40-50% stenosis of LAD by calcified atherosclerotic plaque; atherosclerosis of aorta; cardiomegaly; obesity, BMI 34; hx of hypercholesterolemia; mild pulmonary edema/congestion; prostatic nodular hyperplasia; hx of seizure disorder.
65+ years Death Oct., 2007 Apr., 2009 Total  
65+ years Death Oct., 2007 Total  
65+ years Death Nov., 2007 Nov., 2007 295504-1 On 11-02-2007 during routine office visit for arthritis and HTN, Flu vaccine given. Pt left the office with no c/o any. She went to shop and few hours later she was brought back in lethargic condition. O2 - 4 Epipen - applied, 911 - called, and she was transported by ambulance to Emergency Room. 12/11/07 Reviewed hospital ER records & death summary which reveal patient experienced severe substernal chest pain & collapsed while shopping 11/2/2007. EMS took to ER where she developed complete heart block & bradycardia. Tx w/meds, pacemaker & intubation. Resuscitated & taken for cardiac cath. In cath lab, arrested & CPR started. Developed ventricular fibrillation non responsive to defibrillation & meds & pronounced. 1/11/08 Received death certificate which states COD as ventricular fibrillation, acute MI & ateriosclerotic heart disease.
65+ years Death Nov., 2007 Nov., 2007 Total  
65+ years Death Nov., 2007 Apr., 2008 309447-1 Palpitations, restlessness, stomach discomfort pharyngeal edema, headache, dizziness, chest pain, decreased blood pressure. 7/28/08-death certificate received; COD:respiratory failure. Chronic obstructive pulmonary disease.
65+ years Death Nov., 2007 Apr., 2008 Total  
65+ years Death Nov., 2007 May, 2008 313132-1 "This case was received from a consumer in the United Stated on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was ""heart attack"" according to the patient's son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia. 7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales. 9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration."
65+ years Death Nov., 2007 May, 2008 Total  
65+ years Death Nov., 2007 Total  
65+ years Death Dec., 2007 Dec., 2007 300933-1 At 10:30, patient assessed for contraindications for vaccine. No contraindications, consent signed, vaccine given. No s/d of reaction. 13:50, patient found by staff, unresponsive, no pulse, no respiration's. MD notified. Stated patient expired due to disease and secondary diagnosis. 6/3/08 Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial fibrillation, CHF & cerebrovascular disease.
65+ years Death Dec., 2007 Dec., 2007 Total  
65+ years Death Dec., 2007 Total  
65+ years Death Oct., 2008 Oct., 2008 328577-1 Patient was vaccinated on 10/13/2008 in the AM. He ate lunch then went to Physical Therapy for rehabilitation following knee replacement surgery. He died during his PT appointment. 5/5/09-death certificate received-Final COD cardio pulmonary arrest.
65+ years Death Oct., 2008 Oct., 2008 329901-1 Report received from the foreign regulatory authority via a foreign license partner on 20-OCT-2008. A 69 year old female patient (initial: K; DOB: unknown) received influenza vaccine, HV: FLukovax PF Ini (CSL bulk no: 0980K009) (KV batch no: PI080801; expiry: 31-JUL-2009), on 07-OCT-2008 at 10:00. The patient had a past medical history of chronic pain and leukocytopenia. No details of concomitant medication were provided. On 07-OCT-2008, at 12:00 (two hours after influenza vaccine administration) the patient vomited. Between 19:00 and 20:00 (9 or 10 hours after influenza vaccine administration), the patient developed shock and arrhythmia. The patient died at 15:40 on 08-OCT-2008. The patient's doctor diagnosed sepsis as the cause of death and stated that there was no relation between the cause of death and the injected vaccine. The company considered events as unassessable/unclassifiable in relation to suspect drug. The authority assessed these events as unrelated to the vaccination. This case was reported as serious because of death. Information derived from this AE report does not change the current safety profile of CSL influenza vaccine (FLUVAX). Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided.
65+ years Death Oct., 2008 Oct., 2008 329902-1 Report received from the foreign regulatory authority via a foreign license partner on 20-OCT-2008. A 70 year old male patient (initial S, DOB unknown) received KV FLUKOVAX PF Ini. (CSL influenza vaccine from bulk no: 0980K009) (KV batch no: PI080801; expiry date: 31-JUL-2009) on the morning of 13-OCT-2008. The patient had a history of hypertension. No details of concomitant medications were provided. On 13-OCT-2008 at 13:10 the patient collapsed. At 13:30 (twenty minutes later) the patient was unconscious. The patient died at 15:10 on 13-OCT-2008. The company considered events as unassessable/unclassifiable in relation to the suspect drug. The authority has assessed these events as unrelated to the vaccine. Information derived from this AE report does not change the current safety profile of CSL influenza vaccine (FLUVAX). This case was reported as serious because of death. Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided.
65+ years Death Oct., 2008 Oct., 2008 330032-1 Friday 10/10/2008: Patient was in good shape when I took him to MD - for a review of his blood test results. He was advised to get a flu shot. They were available in the lobby with a paper from the Dr. He got the flu vaccines shot. Saturday 10/11/2008: He sounds as if he has a hard time breathing. -7 P.M. - Saturday 10/11/2008: Patient goes to hospital via ambulance. 911. Sunday 10/12/2008: Patient called me to advise me that he is in the hospital. Monday 10/13/2008: I visit patient in hospital and he is non-responsive and barely alive. Monday 10/13/2008: Patient died from pneumonia. Prior to the flu vaccine he was in good health. I believe the vaccine should not have been advised as it killed him. 10/28/08 Death certificate states COD as respiratory failure w/pneumonia & myelodysplasia as contributing causes. 10/28/08 Reviewed hospital medical records of 10/12-10/13/2008. FINAL DX: CHF; A-fib w/RVR; acute respiratory failure; acute exacerbation of COPD; acute exacerbation of chronic renal insufficiency & failure; malnutrition. Records reveal patient experienced SOB, bilateral leg edema, atrial fibrillation w/rapid ventricular response. Cardioverted & admitted to ICU. Developed acute respiratory failure, agitation, confusion worsened & placed on BiPAP. Tx w/IV antibiotics. Pt was DNR, no intubation. 11/25/08 Reviewed PCP medical records Office record of 8/20/08 reveals pt disoriented s/p ER visit for visual disturbance, HA & temporal arteritis. Had been started on steroids. RTC 9/19/08 s/p ER visit after fall w/o sequelae. RTC 9/29 w/fatigue. RTC 10/10 stating felt better. No record of flu shot, was given by unknown company in lobby of physician office building.
65+ years Death Oct., 2008 Oct., 2008 Total  
65+ years Death Oct., 2008 Nov., 2008 332724-1 she presneted 10/23 for a blood pressure check up and in the course of that we did an annual flu shot for her. See the flu shot note: 10/23/08 The following questions were answered by the patient: Are you currently ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No Have you ever had a severe allergic reaction after getting the flu vaccine? (difficulty breathing, aiway swelling, hives, etc.) No Patient was given the opportunity to ask questions prior to immunization and have them answered to their satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009 Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08 Dose: 0.5 ml Site: left deltoid She then reproted on 10/31 with swelling in hands and feet and rash. It looked like allergic reaction. she was not ill so we treated her as an out patient. she called a few days later and was getting worse. I had her admitted to hospital. I have not received a formal report. One of the diagnosis that was on the top of the list was influenza vaccine vasculitis. she was not getting better. The Dr. that was caring for her reported that her dau, a hospice nurse talked to her about what was going on and patient decieded to not have any more needle pokes or evaluation. She was sent to nursing home and died the next day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis. acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated. Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate states COD as acute renal failure with vasculitis & immunologic reaction as contributing factors.
65+ years Death Oct., 2008 Nov., 2008 Total  
65+ years Death Oct., 2008 Dec., 2008 335622-1 Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt's neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.
65+ years Death Oct., 2008 Dec., 2008 Total  
65+ years Death Oct., 2008 Oct., 2009 359066-1 Anaphylaxis shock. Angioedema. Death.
65+ years Death Oct., 2008 Oct., 2009 359853-1 Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available. 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility. 10/15/09 Medical records received for date of service 10/9/08. Shingles (Zostavax) vaccine administered on 10/9/08. Physician reports that pt. did not call office to report an adverse reaction. 10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.
65+ years Death Oct., 2008 Oct., 2009 Total  
65+ years Death Oct., 2008 Total  
65+ years Death Nov., 2008 May, 2011 422403-1 Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
65+ years Death Nov., 2008 May, 2011 Total  
65+ years Death Nov., 2008 Total  
65+ years Death Sep., 2009 Oct., 2009 359602-1 he had a hard time navigating to the bathroom on 2 separate occasions and is unable to walk on his own. 10/19/09 Physician fax received for date of service 10/12/09. Dx: Death secondary to Guillain-Barre Syndrome. Assessment: Intubated due to GBS. EMG showed denervation distally. Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. Assessment: Severe Guillian-Barre Syndrome. Patient developed profound, progressive and generalized weakness over the last 24-36 hours. Numbness toes, feet, fingers. Unable to walk on his own. Peripheral edema. Rhonchi bilateral. Intubated. Subdural hematoma. Hematuria with clots. Gallbladder polyp, Renal cyst. Atrial fibrillation. Sinus Bradycardia. Left ventricular hypertrophy. Nonresponsive to voice / touch. DTR's absent. IVIG Administered.
65+ years Death Sep., 2009 Oct., 2009 361716-1 Pt had no obvious reaction to the vaccine. 10/23/09 Death certificate received. DOD 9/20/09. Cardiogenic shock, Hypoxic encephalopathy. Ventricular fibrillation. 11/17/09: Discharge Summary and Medical Records received for date of service 9/20/09: Final Dx: Out of hospital cardiac arrest, ventricular fibrillation, cardiogenic shock, severe hypoxic encephalopathy, respiratory failure. Assessment: Experienced sudden onset severe chest pain at home. Ambulance arrived and found pt. in ventricular fibrillation. Received 2 shocks en route to hospital and upon arrival was intubated with additional CPR and defibrillations. Major vasopressors were administered for support of blood pressure. CPK was 3000. Admitted to ICU and maintained on maximal support for 12 hours including ventilation, temporary pacemaker and major vasorpressors at high doses. No urinary output. Pupils fixed and unresponsive. Pt. eventually experienced cardiac arrest and died after DNR was signed.
65+ years Death Sep., 2009 Oct., 2009 Total  
65+ years Death Sep., 2009 Nov., 2009 365416-1 Patient showed a marked decline in functioning starting about 12 hours after the vaccine was administered. Pt was shaky, weak, could not put words together. Pt's doctor was contacted on Sept 8, ruled out UTI. Seen by doctor on Sept 24. Pt was unable to stand or use legs, so she was taken to the hospital on Oct 8. Pt was admitted to hospital Oct 8 at Hospital, admitted to hospice on Oct. 13, and passed away Oct 17. 11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. Dx: End stage Alzheimers Dimentia, dysphagia, HTN, arthritis, hypothyroidism, scoliosis, and sundowners. Assessment: Presented unable to ambulate that morning, not able to communicate. Pts. baseline is to ambulate using walker, toilet and converse but over past 3-4 weeks she has steady decline and is no longer lucid and has no insight. Urine, blood work and CXR all used to rule out infectious process. Patient unable to improve in any way, palliative care discussed and hospice home decided on by family for comfort care measures only.
65+ years Death Sep., 2009 Nov., 2009 Total  
65+ years Death Sep., 2009 Jan., 2010 378186-1 PT PRESENTED TO ER WITH NEUROPOTHY AND LEG WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT. FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG.
65+ years Death Sep., 2009 Jan., 2010 Total  
65+ years Death Sep., 2009 Feb., 2010 379008-1 Tingling in extremities followed by weakness and inability to walk. Hospitalized and received plasmapheresis for GBS. D/c to nursing home for rehab therapy.
65+ years Death Sep., 2009 Feb., 2010 Total  
65+ years Death Sep., 2009 Jan., 2011 414136-1 My mom received shingles vac. on 7/15/09. In May she developed a very intense case of shingles & developed severe neuropathy in her left leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted living, never fully recovered & died 10/26/10.
65+ years Death Sep., 2009 Jan., 2011 Total  
65+ years Death Sep., 2009 Total  
65+ years Death Oct., 2009 Oct., 2009 359951-1 10/3 - started with mental changes 24 hours after influenza vaccine. Dx with encephalitis.
65+ years Death Oct., 2009 Oct., 2009 360397-1 "Patient to PMD for physical. Was feeling well and received flu vaccine. Upon arriving home minutes later told wife ""I don't feel well"" and collapsed. Brought to ED in full cardiac arrest. Unable to resuscitate. 10/19/09 ER records received service date 10/2/09. Assessment: Cardiac Arrest. Patient arrived unresponsive, intubated with CPR in progress. Asystole on monitor with no spontaneous respirations. External trauma to eyes. ICD-9 code 427.5 cardiac arrest. 12/16/09 Death Certificate received. DOD 10/02/09. Cause of Death - Hypertensive and arteriosclerotic heart disease."
65+ years Death Oct., 2009 Oct., 2009 360706-1 Pt. expired on 10/3/09. Attending MD did not believe immunization was cause of death but reported because of dose temporal proximity. (Pt. expired approx. 24 hrs after receiving the flu vaccine). 10/16/09 Death Certificate: Cardiorespiratory arrest, Diabetes mellitus type 2, Hypertension.
65+ years Death Oct., 2009 Oct., 2009 361215-1 Temp 103.2 at 0240 AM, rapid respirations began approx 12 hours later. 10/19/09 Death Certificate DOD 10/5/09 - Complications / effects of Influenza Vaccine. 10/19/09 Nursing Home medical records received service dates 10/1/09 to 10/5/09. Patient develops elevated temperature. Tylenol given, blankets removed and cool cloths applied. Oxygen via face mask. Respiration rate increased, mouth breathing. Appetite poor, not eating. Lethargic. Coughing. Unable to swallow. Unresponsive to voice or painful stimuli. Unable to obtain BP or radial pulse. Labored respirations. Stopped breathing. Death. Concurrent Illness: Toe has red flat area.
65+ years Death Oct., 2009 Oct., 2009 361282-1 Unknown. 11/6/09 Autopsy report received. DOD 10/12/09. Anatomic Diagnosis: 1. Coronary artery disease. 2. Cardiac rupture with cardiac tamponade. 3. Pleural effusion. 4. Status post cholecystectomy and appendectomy. 11/12/09 Coroner - Final Cause of Death: Severe coronary atherosclerosis.
65+ years Death Oct., 2009 Oct., 2009 361579-1 patient found dead in the morning by his son. presumed cardiac cause of death, although flu vaccine given 10/12/09 seems unlikely as a cause, it can not be excluded. Autopsy is not planned. 12/31/09 Death Certificate received. DOD 10/15/09. Cause of Death: Unknown. Other conditions: End Stage Kidney Failure. Cardiomyopathy.
65+ years Death Oct., 2009 Oct., 2009 Total  
65+ years Death Oct., 2009 Nov., 2009 367469-1 difficulty breathing, unable to talk, was taken to hospital via ambulance, O2 sat 88% later died. 12/7/09 Death Certificate recieved. DOD 11/9/09. Cause of Death: Chronic Obstructive Lung Disease. Additional information abstracted - Other significant conditions: ASHD; GI bleed. 11/25 and 12/4 Medical records and discharge summary received. DOS 10/23/09 Final DX: Acute on chronic congestive heart failure likely s/to a combination of diastolic dysfunction, severe HTN and valvular heart disease. COPD, New onset of atrial fibrillation, CAD s/p coronary artery bypass grafting 2006. PVD with h/o moderate carotid disease, HTN, DM type 2, Valvular heart disease w/moderate to severe mitral regurgitation and moderate pulmonary hypertension by echocardiogram. C/O fatigue, SOB, dizziness, edema. Lethargy. Breathless. Bil carotid bruits. ICU. D/C. Poor prognosis. DOS 11/02 Final DX: Acute renal failure, suspect patient was prerenal azotemia w/eleveated blood urea nitrogen to creatanine ratio related to diuretics, poor oral intake, and congestive heart failure. Hypokalemia related acute renal failure in setting of medications which can increase potassium. Bradycardia likely related to hypokalemia in addition to medication which can slow heart rate. Now s/p pacemaker placement. Hypotension r/to symptomatic bradycardia, anemia, underlying CHF w/ bil pleural effusions, respiratory failure w/adequate gas exchange. Admit for malignant hypertension and COPD, improved and was D/C to home. Prognosis poor. 5 days later c/o lethargy, hypotension, bradycardia, intubated. BP 90/60. Decreased breath sounds bil. 3rd degree AV block, acute renal failure. Hypokalemia. Multiorgan failure. Acute resp failure. UTI.
65+ years Death Oct., 2009 Nov., 2009 Total  
65+ years Death Oct., 2009 Feb., 2010 381102-1 Fell at home 10/21/2009. By weekend began paralysis of arms and legs. Had trouble eating and swallowing. 10/24/2009 to ER Hospitalized 2-3 days. Discharged and returned to hospital for two additional visits, nursing home placement for 3 weeks. Returned home mid December 2009 with nurses and hospice care. MD told family he thought she had Guillain Barre but would not put it in writing.
65+ years Death Oct., 2009 Feb., 2010 Total  
65+ years Death Oct., 2009 Sep., 2010 398497-1 This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
65+ years Death Oct., 2009 Sep., 2010 Total  
65+ years Death Oct., 2009 Nov., 2010 406577-1 Approximately 3-4 weeks after flu shot began to have tingling of face and arm. Symptoms progressed to lower extremities Experienced sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family states multiple tests were done. 2) Released and went to neurology clinic in another state for second opinion. 3) Admitted to another hospital and then transferred to a rehab facility in another state. 4) Family had him brought back to original hospital.
65+ years Death Oct., 2009 Nov., 2010 Total  
65+ years Death Oct., 2009 Total  
65+ years Death Nov., 2009 Nov., 2009 365381-1 77 y/o with Afib and lung cancer given H1N1 (Sanofi) on 11/3/09- Died. 11/5/09-prob. heart attack. 11/06/09 Medical records received. DOS 08/21/08-03/24/09. PCP office notes. Visits note looked well, unremarkable PEs with well healed surgical scars, clear bronchial to minimal wheeze, CBCs WNL w/some low 02 sats (92% on R/A). Extrems trace PTE, until 03/24/09. DX bad cold w/ white mucus and cough. Nausea, low grade fever. Lung sounds benign. Mild leukocytosis, possible infection. Tx Levaquin. 4/28/09 Congestion continued, thick mucus, worse since pneumonia. Bronchial w/minimal wheezes. CBC WNL. EKG sinus rhythm, systolic murmur. Subsequent visits showed 02 sat 91%, weight loss. 11/03 occasional SOB, H1N1 vaccine given. Labs & Diags EKG- normal, sinus mechanism, bradycardia 48. 12/17/09 Death Certificate received. DOD 11/05/09. Cause of Death. Myocardial infarction. Other information abstracted: Other medical conditions - lung cancer, atrial fibrillation.
65+ years Death Nov., 2009 Nov., 2009 370216-1 Family reports that he came into the house from outdoors c/o chest pain and abdominal pain. 11/30/09 Coroner Report Received. DOD 11/12/09. Cause of Death: Probable Myocardial Infarction, due to seasonal flu, with other significant conditions of Diabetes.
65+ years Death Nov., 2009 Nov., 2009 370596-1 Wife called home health and said pt wasn't feeling well, was more drowsy than usual. HH Aide visited at 9:15 AM. He was afebrile and respirations were 36. Skin was cold and clammy. Aide encouraged daughter to take him to ER. Daughter stated she thought he might get to feeling better and that if he didn't get better or if he seemed worse, she would take him. RN talked to wife later in afternoon around 3:00 PM and wife reported he had eaten some and seemed to be feeling a little better. When his wife went to wake him early Thursday AM , she could not arouse him and she called 911. When they responded the coroner was called. 12/3/09 Death Certificate received. DOD 11/26/09. Final Cause of Death: Myocardial Infarction, NOS & Chronic Pulmonary Disease, Dementia, Stroke (CVA).
65+ years Death Nov., 2009 Nov., 2009 Total  
65+ years Death Nov., 2009 Mar., 2010 383746-1 Patient received H1N1virus shot late AM 11-20-2009. On the way home she was tired, near lunch I gave her peaches & a little soup. Heart rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up & went to bathroom & died.
65+ years Death Nov., 2009 Mar., 2010 Total  
65+ years Death Nov., 2009 Jun., 2010 390851-1 Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.
65+ years Death Nov., 2009 Jun., 2010 Total  
65+ years Death Nov., 2009 Total  
65+ years Death Dec., 2009 Dec., 2009 372288-1 Vaccine given 12/1 at 10:30 AM. Pt immediately reacted with increased temp and SOB. BENADRYL given 25mg stat and q 8 hours. Pt alert/oriented. 12/2 At 1:55 AM, pt temp 102.7, TYLENOL given. 12/3 Temp 99, pulse 110 at 1000 AM, oriented to self only. 12/4 At 0500 pt died. * Pt on hospice; dx: Parkinson's. 12/9/09 Death certificate received. DOD 12/4/2009. Cause of death: Respiratory Failure. Cardiac Failure. Parkinsons Disease.
65+ years Death Dec., 2009 Dec., 2009 375144-1 Resident complained of being dizzy and not feeling well, went unresponsive and passed away at 9:30 PM. Resident was a comfort care only resident no medical attention was necessary. 01/12/2010 Death Certificate received. DOD 12/27/09. Cause of Death: Congestive Heart Failure as a consequence of CAD. Additional information abstracted: Contributing factors - Diabetes mellitus.
65+ years Death Dec., 2009 Dec., 2009 375507-1 Patient reported cold-like symptoms (congestion and sneezing) and was seen for that and for blood in his semen. He was given H1N1 vaccine and was released. The next morning he was found dead of a suspected heart attack.
65+ years Death Dec., 2009 Dec., 2009 375527-1 Patient presented to the emergency department on 12/13/09 with 2-3 days of fatigue and lower extremity weakness. The patient was admitted to the hospital and experienced progressive ascending paralysis with subsequent respiratory distress which required intubation on 12/15/09. Per the immunology physicians note on 12/17, diagnosis was Acute Inflammatory Demyelinating neuropathy consistent with Guillain-Barre Syndrome. The patient received a course of five plasmapheresis treatments, followed by one treatment of IVIG.
65+ years Death Dec., 2009 Dec., 2009 Total  
65+ years Death Dec., 2009 Sep., 2011 434287-1 Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.
65+ years Death Dec., 2009 Sep., 2011 Total  
65+ years Death Dec., 2009 Total  
65+ years Death Jan., 2010 Jan., 2010 376969-1 Suspect H1N1 caused interaction with COUMADIN/coagulation.
65+ years Death Jan., 2010 Jan., 2010 378027-1 No adverse reactions within first hour after vaccination administered. Notified of client's death on 01/15/2010.
65+ years Death Jan., 2010 Jan., 2010 Total  
65+ years Death Jan., 2010 Feb., 2010 379507-1 Lethargic, stopped drinking, stopped eating on the 21st. On the 22nd his arms layed limp at his sides when previously they were rigid and locked from the Parkinson's. He would not eat or drink on the 22nd.
65+ years Death Jan., 2010 Feb., 2010 380328-1 Loss of appetite, confusion, lethargy, excessive mucus. Patient did not want to be hospitalized. Jan 14 thru Jan 18, 4 AM.
65+ years Death Jan., 2010 Feb., 2010 Total  
65+ years Death Jan., 2010 Total  
65+ years Death Mar., 2010 May, 2010 388188-1 "Received H1N1 & Pneumonia vaccine 12 March 2010. Apparently developed fever that night & the following 2 days was ""achy, dizzy & had nausea all day"". On 12 Mar, complained of neck pain & dizziness, developed lethargy & then became unresponsive."
65+ years Death Mar., 2010 May, 2010 Total  
65+ years Death Mar., 2010 Total  
65+ years Death Sep., 2010 Sep., 2010 398967-1 Patient received combination Flu shot on 01-17-1- at approx. 1PM. Had shot at doctor's office. Had blood drawn at hospital at 1:38PM. After arriving home, deceased complained of being sick to stomach and hot. Began vomiting and had black, runny diarrhea. Overnight patient condition deteriorated, lung filled with fluid and had no pulse when EMS arrived at approx, 12:40 PM 9-18-10. Patient pronounced dead at 1:07 PM on 9-18-10. On 9-18-10 AM before EMS arrived patient vomiting brown bile and had runny, black diarrhea
65+ years Death Sep., 2010 Sep., 2010 Total  
65+ years Death Sep., 2010 Oct., 2010 401548-1 Wife reports after leaving the Health Department, she and her husband completed some errands, the stopped approximately one hour later to let their dogs exercise. After getting out of the truck for a few minutes, he returned to the truck, then suddenly collapsed onto her lap. Was transported to Hopital.
65+ years Death Sep., 2010 Oct., 2010 401842-1 "Initial report was received 30 September 2010 from a health care professional, who received the report from the patient's wife. A 74-year-old male patient who had a history of asthma and allergies to weeds and molds, had received a first dose of FLUZONE HIGH-DOSE (lot number, route and site of administration unknown at the time of the report) and an unspecified allergy shot on 21 September 2010. On 24 September 2010, three days post vaccination, the patient developed a slight fever which resolved the following day. According to the reporter, the patient went to bed on 26 September 2010 and the following day on 27 September 2010, six days post vaccination, the patient was found dead in bed. The patient had no concurrent illness at the time of vaccination. The patient had been taking EFFEXOR, FLOMAX, ""NEURONTIN"", Hydromorphone and ""guiafesen""concomitantly. The patient had also received allergy shots in the past. At the time of the report, it was unknown if an autopsy had been performed. No additional information was provided at the time of the report. Documents held by sender: None."
65+ years Death Sep., 2010 Oct., 2010 Total  
65+ years Death Sep., 2010 Jan., 2011 414974-1 Per patients daughter, he developed Guillain Barre Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away on 1/6/2011.
65+ years Death Sep., 2010 Jan., 2011 Total  
65+ years Death Sep., 2010 May, 2011 422660-1 Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject's medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on 'JV' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient's protein was normal. In the subject's CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject's condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient's sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.
65+ years Death Sep., 2010 May, 2011 Total  
65+ years Death Sep., 2010 Total  
65+ years Death Oct., 2010 Oct., 2010 404792-1 "Initial information received from a health care professional on 15 October 2010. A 75-year-old male patient with a history of severe cardiopulmonary issues (unspecified), cataracts, and who was ""crippled"", received a dose of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3635AA, on 13 October 2010 at 10:00 a.m. The route and site of vaccination were not reported. Following vaccination, the patient experienced no adverse events or reactions and was reported to be ""fine"" at 8:30p.m. that evening. The following day, on 14 October 2010 at 11:00 a.m., he was found dead by his sister. Autopsy status is unknown and no cause of death was reported. Per the reporter, the patient had been very ill prior to vaccination and his quality of life was poor. Follow-up information received on 18 October 2010 from a health care professional. The reporter stated that it is unknown if an autopsy was planned for the patient, but that if the patient had been seen by one of their physicians during the month prior to the event it is unlikely an autopsy would be performed. In addition, the reporter stated that the patient's past medical history of cardiopulmonary issues (unspecified) were ""more cardiac rather than pulmonary"", but no specifics were provided. List of documents held by sender: none"
65+ years Death Oct., 2010 Oct., 2010 Total  
65+ years Death Oct., 2010 Nov., 2010 409766-1 "Sudden onset of weakness (back and neck)progressed to lower extremities described as ""gel legs"", difficulty standing DX with Guillain-Barre Syndrome"
65+ years Death Oct., 2010 Nov., 2010 Total  
65+ years Death Oct., 2010 Total  
65+ years Death Nov., 2010 Dec., 2010 413664-1 After 2 weeks SP immunization Resid - Began to c/o increased weakness & numbness. Sat -> MD. Apt with MD. Started on neurontin 11/20. Sat on floor. L/T increased weakness. 11/21 -> hosp with signs & sx of CVA.
65+ years Death Nov., 2010 Dec., 2010 Total  
65+ years Death Nov., 2010 Mar., 2011 418006-1 Pt. came into clinic for annual flu shot. Was non-ill appearing. Wife received same flu shot at the same time with no adverse rxn. Pt. then went home and later passed away in house (residence).
65+ years Death Nov., 2010 Mar., 2011 Total  
65+ years Death Nov., 2010 Total  
65+ years Death Sep., 2011 Oct., 2011 439265-1 Death.
65+ years Death Sep., 2011 Oct., 2011 439266-1 Death.
65+ years Death Sep., 2011 Oct., 2011 439267-1 Death.
65+ years Death Sep., 2011 Oct., 2011 439269-1 Death.
65+ years Death Sep., 2011 Oct., 2011 Total  
65+ years Death Sep., 2011 Total  
65+ years Death Oct., 2011 Oct., 2011 437391-1 Police reported to us that patient was found dead in her home the day after flu vaccine was administered. We had no communication w/ pt after office visit 10/4.
65+ years Death Oct., 2011 Oct., 2011 437570-1 "DATE OF EXAM: 10/07/2011 at 08:20. SUBJECTIVE: The patient is an 80-year-old lady who was brought in to the Emergency Room last night unconscious. I reviewed the reviewed the history in the system as well as reviewed the history from the patient's family at bedside. The patient's daughter saw the patient during lunchtime and had lunch with her. She was in her usual state of health. She has not had any fever or chills. No productive cough, no chest pain, no abdominal pain and no diarrhea. She was in her usual state of health without any evidence of an infectious process. After lunch time, the patient was supposed to get her flu shot and was on her way to get her flu shot. The patient's family believes that she has gotten her flu shot. They were not told otherwise. It is presumed that the patient has received her flu shot. We are at this time unsure of the route it was given if indeed she received it. At around 6:00 after work, the same daughter came to visit the patient to cook her dinner. She was noted to be unconscious, sitting up in her electrical wheelchair. The patient does have episodes of syncope and has had multiple episodes in the past. Normally this is associated with ""bowel movement"" vasovagal syncope). At this time, the patient was not on the toilet bowl. The patient's daughter did not smell or see any evidence of bowel or bladder incontinence or any sign that she had tried to move her bowels. The patient's daughter tried to pick her up, thinking that this was one of her usual episodes of syncope. She asked the nursing staff to help her wake the patient up, but when they could not wake up the patient, EMS was called. When EMS arrived, the patient was noted to have low blood pressure. The patient's daughter believes that she had taken all of her morning medications since her medication dispenser for that day was empty. The only thing that they are not sure of is whether or not the patient took her ""fibromyalgia pill"". The patient was then brought to the emergency room. The patient remained unconscious and had to be intubated to protect her airway. She was given IV fluid boluses without good response and started on vasopressor initially with dopamine and subsequently changed to Levophed. While the patient was in the emergency room, the patient was noted to have a pulseless electrical activity. They were not sure how long the patient had pulseless electrical activity and so CPR was performed. The patient sustained some broken ribs as well as mild pneumothorax. I have counseled the patient's family regarding this and they are aware. The patient remains unresponsive on the vent. Occasionally, she tried to move her upper extremities. She is noted to have some movements of the lower extremity, but is not necessarily consistent with stimulation and not necessary purposeful. Occasionally, she will bite down on her ET tube. She is also noted occasionally to be ""ruminating"". The patient has guaiac positive
65+ years Death Oct., 2011 Oct., 2011 438416-1 Sudden onset of decline. Audible, course crackles upper airways. O2 sats 88% on 4L O2, BP 112/70, P90, R24, T98.6. Elevated HOB, nebulizer given. MD immediately informed w/orders, if no improvement w/PRN neb tx or worsening sx's, transfers to ER for eval. Guardian notified & in agreement w/MD orders. During neb tx, O2 sats decreased to 84% w/audible course crackles, BP 102/78, P89, R34. Ambulance called, arrived & during assessment per ambulance crew, rt. expired at 2145. Ambulance crew informed Co. Sheriff of death. No concerns re: death. Guardian & MD informed of rt.'s passing. Funeral home notified.
65+ years Death Oct., 2011 Oct., 2011 438770-1 Pt. had emesis that she vomited on the floor, she then tried getting up & fell. Resident was confused, weak, & had pale color. Sent to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib, dehydration, rapid ventricular response, & mental status changes.
65+ years Death Oct., 2011 Oct., 2011 Total  
65+ years Death Oct., 2011 Total  
65+ years Death Nov., 2011 Jun., 2012 457541-1 "Began with bilateral neuritis type symptoms both arms. Proceeded to ""walking pneumonia"", CHF polymyositis, mixed connective tissue disease, kidney failure & death. Tx- 2 inj of steroids, long term high dose steroids, immune suppression, dialysis & death."
65+ years Death Nov., 2011 Jun., 2012 Total  
65+ years Death Nov., 2011 Total  
65+ years Death Sep., 2012 Sep., 2012 465916-1 "Patient complained of ""achiness"" around 2:30 to 3:00 pm. His symptoms progressed to stiffness and soreness by bedtime and needed help with his clothing before bed. Around Midnight, there was a loss of bowel control and he passed away."
65+ years Death Sep., 2012 Sep., 2012 Total  
65+ years Death Sep., 2012 Nov., 2012 475174-1 Initial report was received from a consumer on 14 November 2012, and involves a case of misuse, inappropriate age at vaccine administration. An 88-year-old female patient received an injection of FLUZONE Intradermal, sanofi pasteur Inc., (lot number, route, site, side and dose in series not reported) on 22 September 2012, which is indicated for patients 18 to 64 years of age. On 08 October 2012, 16 days post vaccination, the patient was found dead. The patient's past medical history was reported as not applicable (n/a) and illness at time of vaccination was reported as none. The patient used home oxygen. It was not reported if an autopsy was done. No other details were provided. The patient's outcome was reported as fatal on 08 October 2012. Documents held by sender: None.
65+ years Death Sep., 2012 Nov., 2012 Total  
65+ years Death Sep., 2012 Total  
65+ years Death Oct., 2012 Oct., 2012 468865-1 Per family pt had a good day and eve, no signs of allergic reaction or difficulty. He failed to wake up the next morning. Time of death 10:37 AM.
65+ years Death Oct., 2012 Oct., 2012 Total  
65+ years Death Oct., 2012 Dec., 2012 476377-1 Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
65+ years Death Oct., 2012 Dec., 2012 Total  
65+ years Death Oct., 2012 Jan., 2013 480995-1 Vaccine 10-3-12. To ER 10-12-12 with (L) arm pain. Seen 10-13-12 & transferred to cardiologist at hospital she declined there, was diagnosed with Guillain-Barre, transferred to where she expired.
65+ years Death Oct., 2012 Jan., 2013 482371-1 Hospitalized 12/12/12 through 12/22/12 at medical center. Complaints of 6 months' increasing edema in hands and feet, current unsteady gait, decreased strength. Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance. Stopped at community hospital while en route. DOA at community hospital. Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain. Ruled out MI at that time.
65+ years Death Oct., 2012 Jan., 2013 Total  
65+ years Death Oct., 2012 Total  
65+ years Death Nov., 2012 Dec., 2012 476400-1 Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been given a flu shot early that day. Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been giving a flu shot early that day. At approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient stating that he was going to the bathroom because he did not feel well. The next morning the patient did not respond to phone calls or knocking on the door by relatives. Upon gaining entry to the home, the patient was found dead on the floor between his bedroom and bathroom hallway. The patient was naked and face down on the floor when found. The patient had no history of heart problems and had never experienced a heart attack.
65+ years Death Nov., 2012 Dec., 2012 Total  
65+ years Death Nov., 2012 Total  
65+ years Death Jan., 2013 Jan., 2013 480899-1 Neighbor reported that the patient died 1-7-13. Inital cause has been diagnosed as vomiting and diarrhea probably caused by a virus. Due to its close approximation to vaccination I am reporting this incident.
65+ years Death Jan., 2013 Jan., 2013 Total  
65+ years Death Jan., 2013 Total  
65+ years Death Total  
65+ years Life Threatening Oct., 2006 Dec., 2006 268775-1 Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
65+ years Life Threatening Oct., 2006 Dec., 2006 Total  
65+ years Life Threatening Oct., 2006 Total  
65+ years Life Threatening Oct., 2007 Nov., 2007 296120-1 Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.
65+ years Life Threatening Oct., 2007 Nov., 2007 Total  
65+ years Life Threatening Oct., 2007 Total  
65+ years Life Threatening Oct., 2008 Jul., 2009 350818-1 Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk. She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date. 8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG; s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall. Neuro consult done. Intensive care. BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm, Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion, Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
65+ years Life Threatening Oct., 2008 Jul., 2009 Total  
65+ years Life Threatening Oct., 2008 Total  
65+ years Life Threatening Nov., 2008 May, 2011 422403-1 Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
65+ years Life Threatening Nov., 2008 May, 2011 Total  
65+ years Life Threatening Nov., 2008 Total  
65+ years Life Threatening Sep., 2009 Jan., 2010 378186-1 PT PRESENTED TO ER WITH NEUROPOTHY AND LEG WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT. FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG.
65+ years Life Threatening Sep., 2009 Jan., 2010 Total  
65+ years Life Threatening Sep., 2009 Feb., 2010 379008-1 Tingling in extremities followed by weakness and inability to walk. Hospitalized and received plasmapheresis for GBS. D/c to nursing home for rehab therapy.
65+ years Life Threatening Sep., 2009 Feb., 2010 Total  
65+ years Life Threatening Sep., 2009 Total  
65+ years Life Threatening Oct., 2009 Nov., 2009 367469-1 difficulty breathing, unable to talk, was taken to hospital via ambulance, O2 sat 88% later died. 12/7/09 Death Certificate recieved. DOD 11/9/09. Cause of Death: Chronic Obstructive Lung Disease. Additional information abstracted - Other significant conditions: ASHD; GI bleed. 11/25 and 12/4 Medical records and discharge summary received. DOS 10/23/09 Final DX: Acute on chronic congestive heart failure likely s/to a combination of diastolic dysfunction, severe HTN and valvular heart disease. COPD, New onset of atrial fibrillation, CAD s/p coronary artery bypass grafting 2006. PVD with h/o moderate carotid disease, HTN, DM type 2, Valvular heart disease w/moderate to severe mitral regurgitation and moderate pulmonary hypertension by echocardiogram. C/O fatigue, SOB, dizziness, edema. Lethargy. Breathless. Bil carotid bruits. ICU. D/C. Poor prognosis. DOS 11/02 Final DX: Acute renal failure, suspect patient was prerenal azotemia w/eleveated blood urea nitrogen to creatanine ratio related to diuretics, poor oral intake, and congestive heart failure. Hypokalemia related acute renal failure in setting of medications which can increase potassium. Bradycardia likely related to hypokalemia in addition to medication which can slow heart rate. Now s/p pacemaker placement. Hypotension r/to symptomatic bradycardia, anemia, underlying CHF w/ bil pleural effusions, respiratory failure w/adequate gas exchange. Admit for malignant hypertension and COPD, improved and was D/C to home. Prognosis poor. 5 days later c/o lethargy, hypotension, bradycardia, intubated. BP 90/60. Decreased breath sounds bil. 3rd degree AV block, acute renal failure. Hypokalemia. Multiorgan failure. Acute resp failure. UTI.
65+ years Life Threatening Oct., 2009 Nov., 2009 Total  
65+ years Life Threatening Oct., 2009 Jan., 2010 378191-1 Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistant with Guillain-Barre Syndrome and was treated with IVIG.
65+ years Life Threatening Oct., 2009 Jan., 2010 Total  
65+ years Life Threatening Oct., 2009 Sep., 2010 398497-1 This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
65+ years Life Threatening Oct., 2009 Sep., 2010 Total  
65+ years Life Threatening Oct., 2009 Total  
65+ years Life Threatening Nov., 2009 Jun., 2010 390851-1 Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.
65+ years Life Threatening Nov., 2009 Jun., 2010 Total  
65+ years Life Threatening Nov., 2009 Total  
65+ years Life Threatening Dec., 2009 Sep., 2011 434287-1 Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.
65+ years Life Threatening Dec., 2009 Sep., 2011 Total  
65+ years Life Threatening Dec., 2009 Total  
65+ years Life Threatening Total  
65+ years Permanent Disability Oct., 2008 Dec., 2008 335622-1 Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt's neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.
65+ years Permanent Disability Oct., 2008 Dec., 2008 Total  
65+ years Permanent Disability Oct., 2008 Total  
65+ years Permanent Disability Sep., 2009 Jan., 2011 414136-1 My mom received shingles vac. on 7/15/09. In May she developed a very intense case of shingles & developed severe neuropathy in her left leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted living, never fully recovered & died 10/26/10.
65+ years Permanent Disability Sep., 2009 Jan., 2011 Total  
65+ years Permanent Disability Sep., 2009 Total  
65+ years Permanent Disability Nov., 2009 Jun., 2010 390851-1 Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.
65+ years Permanent Disability Nov., 2009 Jun., 2010 Total  
65+ years Permanent Disability Nov., 2009 Total  
65+ years Permanent Disability Oct., 2012 Dec., 2012 476377-1 Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
65+ years Permanent Disability Oct., 2012 Dec., 2012 Total  
65+ years Permanent Disability Oct., 2012 Total  
65+ years Permanent Disability Total  
65+ years Hospitalized Dec., 2003 Dec., 2007 299262-1 On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises. They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician. She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm. On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed. On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but very weak and her family made attempts to drive her quickly to Emegency Room for treatment. She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin. Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus
65+ years Hospitalized Dec., 2003 Dec., 2007 Total  
65+ years Hospitalized Dec., 2003 Total  
65+ years Hospitalized Oct., 2006 Oct., 2006 265563-1 Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant. Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius. At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.
65+ years Hospitalized Oct., 2006 Oct., 2006 Total  
65+ years Hospitalized Oct., 2006 Dec., 2006 268775-1 Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
65+ years Hospitalized Oct., 2006 Dec., 2006 Total  
65+ years Hospitalized Oct., 2006 Total  
65+ years Hospitalized Oct., 2007 Nov., 2007 296120-1 Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.
65+ years Hospitalized Oct., 2007 Nov., 2007 Total  
65+ years Hospitalized Oct., 2007 Total  
65+ years Hospitalized Nov., 2007 May, 2008 313132-1 "This case was received from a consumer in the United Stated on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was ""heart attack"" according to the patient's son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia. 7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales. 9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration."
65+ years Hospitalized Nov., 2007 May, 2008 Total  
65+ years Hospitalized Nov., 2007 Total  
65+ years Hospitalized Oct., 2008 Nov., 2008 332724-1 she presneted 10/23 for a blood pressure check up and in the course of that we did an annual flu shot for her. See the flu shot note: 10/23/08 The following questions were answered by the patient: Are you currently ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No Have you ever had a severe allergic reaction after getting the flu vaccine? (difficulty breathing, aiway swelling, hives, etc.) No Patient was given the opportunity to ask questions prior to immunization and have them answered to their satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009 Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08 Dose: 0.5 ml Site: left deltoid She then reproted on 10/31 with swelling in hands and feet and rash. It looked like allergic reaction. she was not ill so we treated her as an out patient. she called a few days later and was getting worse. I had her admitted to hospital. I have not received a formal report. One of the diagnosis that was on the top of the list was influenza vaccine vasculitis. she was not getting better. The Dr. that was caring for her reported that her dau, a hospice nurse talked to her about what was going on and patient decieded to not have any more needle pokes or evaluation. She was sent to nursing home and died the next day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis. acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated. Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate states COD as acute renal failure with vasculitis & immunologic reaction as contributing factors.
65+ years Hospitalized Oct., 2008 Nov., 2008 Total  
65+ years Hospitalized Oct., 2008 Dec., 2008 335622-1 Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt's neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.
65+ years Hospitalized Oct., 2008 Dec., 2008 Total  
65+ years Hospitalized Oct., 2008 Jul., 2009 350818-1 Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk. She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date. 8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG; s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall. Neuro consult done. Intensive care. BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm, Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion, Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
65+ years Hospitalized Oct., 2008 Jul., 2009 Total  
65+ years Hospitalized Oct., 2008 Oct., 2009 359066-1 Anaphylaxis shock. Angioedema. Death.
65+ years Hospitalized Oct., 2008 Oct., 2009 359853-1 Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available. 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility. 10/15/09 Medical records received for date of service 10/9/08. Shingles (Zostavax) vaccine administered on 10/9/08. Physician reports that pt. did not call office to report an adverse reaction. 10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.
65+ years Hospitalized Oct., 2008 Oct., 2009 Total  
65+ years Hospitalized Oct., 2008 Total  
65+ years Hospitalized Nov., 2008 May, 2011 422403-1 Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
65+ years Hospitalized Nov., 2008 May, 2011 Total  
65+ years Hospitalized Nov., 2008 Total  
65+ years Hospitalized Sep., 2009 Oct., 2009 359602-1 he had a hard time navigating to the bathroom on 2 separate occasions and is unable to walk on his own. 10/19/09 Physician fax received for date of service 10/12/09. Dx: Death secondary to Guillain-Barre Syndrome. Assessment: Intubated due to GBS. EMG showed denervation distally. Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. Assessment: Severe Guillian-Barre Syndrome. Patient developed profound, progressive and generalized weakness over the last 24-36 hours. Numbness toes, feet, fingers. Unable to walk on his own. Peripheral edema. Rhonchi bilateral. Intubated. Subdural hematoma. Hematuria with clots. Gallbladder polyp, Renal cyst. Atrial fibrillation. Sinus Bradycardia. Left ventricular hypertrophy. Nonresponsive to voice / touch. DTR's absent. IVIG Administered.
65+ years Hospitalized Sep., 2009 Oct., 2009 361716-1 Pt had no obvious reaction to the vaccine. 10/23/09 Death certificate received. DOD 9/20/09. Cardiogenic shock, Hypoxic encephalopathy. Ventricular fibrillation. 11/17/09: Discharge Summary and Medical Records received for date of service 9/20/09: Final Dx: Out of hospital cardiac arrest, ventricular fibrillation, cardiogenic shock, severe hypoxic encephalopathy, respiratory failure. Assessment: Experienced sudden onset severe chest pain at home. Ambulance arrived and found pt. in ventricular fibrillation. Received 2 shocks en route to hospital and upon arrival was intubated with additional CPR and defibrillations. Major vasopressors were administered for support of blood pressure. CPK was 3000. Admitted to ICU and maintained on maximal support for 12 hours including ventilation, temporary pacemaker and major vasorpressors at high doses. No urinary output. Pupils fixed and unresponsive. Pt. eventually experienced cardiac arrest and died after DNR was signed.
65+ years Hospitalized Sep., 2009 Oct., 2009 Total  
65+ years Hospitalized Sep., 2009 Jan., 2010 378186-1 PT PRESENTED TO ER WITH NEUROPOTHY AND LEG WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT. FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG.
65+ years Hospitalized Sep., 2009 Jan., 2010 Total  
65+ years Hospitalized Sep., 2009 Feb., 2010 379008-1 Tingling in extremities followed by weakness and inability to walk. Hospitalized and received plasmapheresis for GBS. D/c to nursing home for rehab therapy.
65+ years Hospitalized Sep., 2009 Feb., 2010 Total  
65+ years Hospitalized Sep., 2009 Jan., 2011 414136-1 My mom received shingles vac. on 7/15/09. In May she developed a very intense case of shingles & developed severe neuropathy in her left leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted living, never fully recovered & died 10/26/10.
65+ years Hospitalized Sep., 2009 Jan., 2011 Total  
65+ years Hospitalized Sep., 2009 Total  
65+ years Hospitalized Oct., 2009 Oct., 2009 359951-1 10/3 - started with mental changes 24 hours after influenza vaccine. Dx with encephalitis.
65+ years Hospitalized Oct., 2009 Oct., 2009 Total  
65+ years Hospitalized Oct., 2009 Nov., 2009 367469-1 difficulty breathing, unable to talk, was taken to hospital via ambulance, O2 sat 88% later died. 12/7/09 Death Certificate recieved. DOD 11/9/09. Cause of Death: Chronic Obstructive Lung Disease. Additional information abstracted - Other significant conditions: ASHD; GI bleed. 11/25 and 12/4 Medical records and discharge summary received. DOS 10/23/09 Final DX: Acute on chronic congestive heart failure likely s/to a combination of diastolic dysfunction, severe HTN and valvular heart disease. COPD, New onset of atrial fibrillation, CAD s/p coronary artery bypass grafting 2006. PVD with h/o moderate carotid disease, HTN, DM type 2, Valvular heart disease w/moderate to severe mitral regurgitation and moderate pulmonary hypertension by echocardiogram. C/O fatigue, SOB, dizziness, edema. Lethargy. Breathless. Bil carotid bruits. ICU. D/C. Poor prognosis. DOS 11/02 Final DX: Acute renal failure, suspect patient was prerenal azotemia w/eleveated blood urea nitrogen to creatanine ratio related to diuretics, poor oral intake, and congestive heart failure. Hypokalemia related acute renal failure in setting of medications which can increase potassium. Bradycardia likely related to hypokalemia in addition to medication which can slow heart rate. Now s/p pacemaker placement. Hypotension r/to symptomatic bradycardia, anemia, underlying CHF w/ bil pleural effusions, respiratory failure w/adequate gas exchange. Admit for malignant hypertension and COPD, improved and was D/C to home. Prognosis poor. 5 days later c/o lethargy, hypotension, bradycardia, intubated. BP 90/60. Decreased breath sounds bil. 3rd degree AV block, acute renal failure. Hypokalemia. Multiorgan failure. Acute resp failure. UTI.
65+ years Hospitalized Oct., 2009 Nov., 2009 Total  
65+ years Hospitalized Oct., 2009 Jan., 2010 378191-1 Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistant with Guillain-Barre Syndrome and was treated with IVIG.
65+ years Hospitalized Oct., 2009 Jan., 2010 Total  
65+ years Hospitalized Oct., 2009 Feb., 2010 381102-1 Fell at home 10/21/2009. By weekend began paralysis of arms and legs. Had trouble eating and swallowing. 10/24/2009 to ER Hospitalized 2-3 days. Discharged and returned to hospital for two additional visits, nursing home placement for 3 weeks. Returned home mid December 2009 with nurses and hospice care. MD told family he thought she had Guillain Barre but would not put it in writing.
65+ years Hospitalized Oct., 2009 Feb., 2010 Total  
65+ years Hospitalized Oct., 2009 Sep., 2010 398497-1 This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject's past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject's PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .
65+ years Hospitalized Oct., 2009 Sep., 2010 Total  
65+ years Hospitalized Oct., 2009 Total  
65+ years Hospitalized Nov., 2009 Jun., 2010 390851-1 Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.
65+ years Hospitalized Nov., 2009 Jun., 2010 Total  
65+ years Hospitalized Nov., 2009 Total  
65+ years Hospitalized Dec., 2009 Dec., 2009 375527-1 Patient presented to the emergency department on 12/13/09 with 2-3 days of fatigue and lower extremity weakness. The patient was admitted to the hospital and experienced progressive ascending paralysis with subsequent respiratory distress which required intubation on 12/15/09. Per the immunology physicians note on 12/17, diagnosis was Acute Inflammatory Demyelinating neuropathy consistent with Guillain-Barre Syndrome. The patient received a course of five plasmapheresis treatments, followed by one treatment of IVIG.
65+ years Hospitalized Dec., 2009 Dec., 2009 Total  
65+ years Hospitalized Dec., 2009 Sep., 2011 434287-1 Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.
65+ years Hospitalized Dec., 2009 Sep., 2011 Total  
65+ years Hospitalized Dec., 2009 Total  
65+ years Hospitalized Jan., 2010 Jan., 2010 376969-1 Suspect H1N1 caused interaction with COUMADIN/coagulation.
65+ years Hospitalized Jan., 2010 Jan., 2010 Total  
65+ years Hospitalized Jan., 2010 Total  
65+ years Hospitalized Sep., 2010 Jan., 2011 414974-1 Per patients daughter, he developed Guillain Barre Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away on 1/6/2011.
65+ years Hospitalized Sep., 2010 Jan., 2011 Total  
65+ years Hospitalized Sep., 2010 Total  
65+ years Hospitalized Oct., 2010 Nov., 2010 409766-1 "Sudden onset of weakness (back and neck)progressed to lower extremities described as ""gel legs"", difficulty standing DX with Guillain-Barre Syndrome"
65+ years Hospitalized Oct., 2010 Nov., 2010 Total  
65+ years Hospitalized Oct., 2010 Total  
65+ years Hospitalized Oct., 2011 Oct., 2011 437570-1 "DATE OF EXAM: 10/07/2011 at 08:20. SUBJECTIVE: The patient is an 80-year-old lady who was brought in to the Emergency Room last night unconscious. I reviewed the reviewed the history in the system as well as reviewed the history from the patient's family at bedside. The patient's daughter saw the patient during lunchtime and had lunch with her. She was in her usual state of health. She has not had any fever or chills. No productive cough, no chest pain, no abdominal pain and no diarrhea. She was in her usual state of health without any evidence of an infectious process. After lunch time, the patient was supposed to get her flu shot and was on her way to get her flu shot. The patient's family believes that she has gotten her flu shot. They were not told otherwise. It is presumed that the patient has received her flu shot. We are at this time unsure of the route it was given if indeed she received it. At around 6:00 after work, the same daughter came to visit the patient to cook her dinner. She was noted to be unconscious, sitting up in her electrical wheelchair. The patient does have episodes of syncope and has had multiple episodes in the past. Normally this is associated with ""bowel movement"" vasovagal syncope). At this time, the patient was not on the toilet bowl. The patient's daughter did not smell or see any evidence of bowel or bladder incontinence or any sign that she had tried to move her bowels. The patient's daughter tried to pick her up, thinking that this was one of her usual episodes of syncope. She asked the nursing staff to help her wake the patient up, but when they could not wake up the patient, EMS was called. When EMS arrived, the patient was noted to have low blood pressure. The patient's daughter believes that she had taken all of her morning medications since her medication dispenser for that day was empty. The only thing that they are not sure of is whether or not the patient took her ""fibromyalgia pill"". The patient was then brought to the emergency room. The patient remained unconscious and had to be intubated to protect her airway. She was given IV fluid boluses without good response and started on vasopressor initially with dopamine and subsequently changed to Levophed. While the patient was in the emergency room, the patient was noted to have a pulseless electrical activity. They were not sure how long the patient had pulseless electrical activity and so CPR was performed. The patient sustained some broken ribs as well as mild pneumothorax. I have counseled the patient's family regarding this and they are aware. The patient remains unresponsive on the vent. Occasionally, she tried to move her upper extremities. She is noted to have some movements of the lower extremity, but is not necessarily consistent with stimulation and not necessary purposeful. Occasionally, she will bite down on her ET tube. She is also noted occasionally to be ""ruminating"". The patient has guaiac positive
65+ years Hospitalized Oct., 2011 Oct., 2011 438770-1 Pt. had emesis that she vomited on the floor, she then tried getting up & fell. Resident was confused, weak, & had pale color. Sent to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib, dehydration, rapid ventricular response, & mental status changes.
65+ years Hospitalized Oct., 2011 Oct., 2011 Total  
65+ years Hospitalized Oct., 2011 Total  
65+ years Hospitalized Nov., 2011 Jun., 2012 457541-1 "Began with bilateral neuritis type symptoms both arms. Proceeded to ""walking pneumonia"", CHF polymyositis, mixed connective tissue disease, kidney failure & death. Tx- 2 inj of steroids, long term high dose steroids, immune suppression, dialysis & death."
65+ years Hospitalized Nov., 2011 Jun., 2012 Total  
65+ years Hospitalized Nov., 2011 Total  
65+ years Hospitalized Oct., 2012 Dec., 2012 476377-1 Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
65+ years Hospitalized Oct., 2012 Dec., 2012 Total  
65+ years Hospitalized Oct., 2012 Total  
65+ years Hospitalized Total  
65+ years Hospitalized, Prolonged Oct., 2007 Nov., 2007 296120-1 Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.
65+ years Hospitalized, Prolonged Oct., 2007 Nov., 2007 Total  
65+ years Hospitalized, Prolonged Oct., 2007 Total  
65+ years Hospitalized, Prolonged Oct., 2008 Dec., 2008 335622-1 Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt's neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.
65+ years Hospitalized, Prolonged Oct., 2008 Dec., 2008 Total  
65+ years Hospitalized, Prolonged Oct., 2008 Jul., 2009 350818-1 Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk. She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date. 8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG; s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall. Neuro consult done. Intensive care. BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm, Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion, Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
65+ years Hospitalized, Prolonged Oct., 2008 Jul., 2009 Total  
65+ years Hospitalized, Prolonged Oct., 2008 Total  
65+ years Hospitalized, Prolonged Nov., 2008 May, 2011 422403-1 Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
65+ years Hospitalized, Prolonged Nov., 2008 May, 2011 Total  
65+ years Hospitalized, Prolonged Nov., 2008 Total  
65+ years Hospitalized, Prolonged Sep., 2009 Jan., 2011 414136-1 My mom received shingles vac. on 7/15/09. In May she developed a very intense case of shingles & developed severe neuropathy in her left leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted living, never fully recovered & died 10/26/10.
65+ years Hospitalized, Prolonged Sep., 2009 Jan., 2011 Total  
65+ years Hospitalized, Prolonged Sep., 2009 Total  
65+ years Hospitalized, Prolonged Nov., 2009 Jun., 2010 390851-1 Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.
65+ years Hospitalized, Prolonged Nov., 2009 Jun., 2010 Total  
65+ years Hospitalized, Prolonged Nov., 2009 Total  
65+ years Hospitalized, Prolonged Total  
65+ years Emergency Room Dec., 2003 Dec., 2007 299262-1 On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises. They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician. She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm. On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed. On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but very weak and her family made attempts to drive her quickly to Emegency Room for treatment. She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin. Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus
65+ years Emergency Room Dec., 2003 Dec., 2007 Total  
65+ years Emergency Room Dec., 2003 Total  
65+ years Emergency Room Oct., 2006 Oct., 2006 265563-1 Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant. Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius. At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.
65+ years Emergency Room Oct., 2006 Oct., 2006 Total  
65+ years Emergency Room Oct., 2006 Dec., 2006 268775-1 Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
65+ years Emergency Room Oct., 2006 Dec., 2006 Total  
65+ years Emergency Room Oct., 2006 Total  
65+ years Emergency Room Oct., 2007 Oct., 2007 293594-1 Client presented to drive through flu exercise for influenza vaccination. Gave history of having had flu shots in past without incident. No contraindications to vaccinations identified. Client was vaccinated and returned home. At some time after returning home client went to Hospital emergency room where he coded and expired. 10/23/07 Reviewed hospital medical records which reveal patient experienced weakness & decreased respirations upon arriving home s/p flu shot. Collapsed in seat of pickup truck. EMS intubated, started CPR & transported to hospital. CXR revealed right pneumothorax & chest tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with atherosclerotic cardiovascular disease & CHF as contributing factors.
65+ years Emergency Room Oct., 2007 Oct., 2007 Total  
65+ years Emergency Room Oct., 2007 Nov., 2007 296120-1 Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.
65+ years Emergency Room Oct., 2007 Nov., 2007 Total  
65+ years Emergency Room Oct., 2007 Total  
65+ years Emergency Room Nov., 2007 Nov., 2007 295504-1 On 11-02-2007 during routine office visit for arthritis and HTN, Flu vaccine given. Pt left the office with no c/o any. She went to shop and few hours later she was brought back in lethargic condition. O2 - 4 Epipen - applied, 911 - called, and she was transported by ambulance to Emergency Room. 12/11/07 Reviewed hospital ER records & death summary which reveal patient experienced severe substernal chest pain & collapsed while shopping 11/2/2007. EMS took to ER where she developed complete heart block & bradycardia. Tx w/meds, pacemaker & intubation. Resuscitated & taken for cardiac cath. In cath lab, arrested & CPR started. Developed ventricular fibrillation non responsive to defibrillation & meds & pronounced. 1/11/08 Received death certificate which states COD as ventricular fibrillation, acute MI & ateriosclerotic heart disease.
65+ years Emergency Room Nov., 2007 Nov., 2007 Total  
65+ years Emergency Room Nov., 2007 Total  
65+ years Emergency Room Oct., 2008 Dec., 2008 335622-1 Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt's neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.
65+ years Emergency Room Oct., 2008 Dec., 2008 Total  
65+ years Emergency Room Oct., 2008 Jul., 2009 350818-1 Less than one week later sleepiness, weakness. By 2 wk after the vaccination she developed bilat leg weakness and could no longer walk. She was admitted to hospital 12-6-2008. Was diagnosed with GUILLAIN BARRE syndrome. Follow up received 7/21/2010: She only partially recovered from the Guillain Barre and died at the hospital last year. I do not have access to her chart now and cannot remember the exact date. 8/27/09 Received hospital medical records of 12/6/08-6/23/2009 FINAL DX: acute inflammatory demyelinating polyneuropathy/Guillain-Barre syndrom w/quadriparesis w/respiratory failure, s/p tracheostomy, s/p ventilator, s/p IVIG; s/p G-tube placement; recurrent UTI due to VRE/Klebsiella; atrial fib s/p pacemaker; acure renal failure, resolved. Records reveal patient experienced acute onset generalized weakness, leg cramps, dyspnea, sleepy, difficulty walking, fall. Neuro consult done. Intensive care. BP dropped, developed dysphagia, atrial fib, areflexic, fever, sepsis, multiple UTIs, decreased mental status, intubated & mech ventilation, bradycardia, DVT right arm, Tx w/IVIG x 5 doses x 2 courses, blood transfusions, IV antibiotics, pacemaker insertion, Progress very slow & ultimately d/c to inpatient rehab facility. Principal ICD9 codes: 3570, 34400, 51881, 5990
65+ years Emergency Room Oct., 2008 Jul., 2009 Total  
65+ years Emergency Room Oct., 2008 Oct., 2009 359066-1 Anaphylaxis shock. Angioedema. Death.
65+ years Emergency Room Oct., 2008 Oct., 2009 359853-1 Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available. 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility. 10/15/09 Medical records received for date of service 10/9/08. Shingles (Zostavax) vaccine administered on 10/9/08. Physician reports that pt. did not call office to report an adverse reaction. 10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.
65+ years Emergency Room Oct., 2008 Oct., 2009 Total  
65+ years Emergency Room Oct., 2008 Total  
65+ years Emergency Room Nov., 2008 May, 2011 422403-1 Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
65+ years Emergency Room Nov., 2008 May, 2011 Total  
65+ years Emergency Room Nov., 2008 Total  
65+ years Emergency Room Sep., 2009 Jan., 2010 378186-1 PT PRESENTED TO ER WITH NEUROPOTHY AND LEG WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT. FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG.
65+ years Emergency Room Sep., 2009 Jan., 2010 Total  
65+ years Emergency Room Sep., 2009 Feb., 2010 379008-1 Tingling in extremities followed by weakness and inability to walk. Hospitalized and received plasmapheresis for GBS. D/c to nursing home for rehab therapy.
65+ years Emergency Room Sep., 2009 Feb., 2010 Total  
65+ years Emergency Room Sep., 2009 Total  
65+ years Emergency Room Oct., 2009 Nov., 2009 367469-1 difficulty breathing, unable to talk, was taken to hospital via ambulance, O2 sat 88% later died. 12/7/09 Death Certificate recieved. DOD 11/9/09. Cause of Death: Chronic Obstructive Lung Disease. Additional information abstracted - Other significant conditions: ASHD; GI bleed. 11/25 and 12/4 Medical records and discharge summary received. DOS 10/23/09 Final DX: Acute on chronic congestive heart failure likely s/to a combination of diastolic dysfunction, severe HTN and valvular heart disease. COPD, New onset of atrial fibrillation, CAD s/p coronary artery bypass grafting 2006. PVD with h/o moderate carotid disease, HTN, DM type 2, Valvular heart disease w/moderate to severe mitral regurgitation and moderate pulmonary hypertension by echocardiogram. C/O fatigue, SOB, dizziness, edema. Lethargy. Breathless. Bil carotid bruits. ICU. D/C. Poor prognosis. DOS 11/02 Final DX: Acute renal failure, suspect patient was prerenal azotemia w/eleveated blood urea nitrogen to creatanine ratio related to diuretics, poor oral intake, and congestive heart failure. Hypokalemia related acute renal failure in setting of medications which can increase potassium. Bradycardia likely related to hypokalemia in addition to medication which can slow heart rate. Now s/p pacemaker placement. Hypotension r/to symptomatic bradycardia, anemia, underlying CHF w/ bil pleural effusions, respiratory failure w/adequate gas exchange. Admit for malignant hypertension and COPD, improved and was D/C to home. Prognosis poor. 5 days later c/o lethargy, hypotension, bradycardia, intubated. BP 90/60. Decreased breath sounds bil. 3rd degree AV block, acute renal failure. Hypokalemia. Multiorgan failure. Acute resp failure. UTI.
65+ years Emergency Room Oct., 2009 Nov., 2009 Total  
65+ years Emergency Room Oct., 2009 Jan., 2010 378191-1 Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistant with Guillain-Barre Syndrome and was treated with IVIG.
65+ years Emergency Room Oct., 2009 Jan., 2010 Total  
65+ years Emergency Room Oct., 2009 Total  
65+ years Emergency Room Nov., 2009 Nov., 2009 370596-1 Wife called home health and said pt wasn't feeling well, was more drowsy than usual. HH Aide visited at 9:15 AM. He was afebrile and respirations were 36. Skin was cold and clammy. Aide encouraged daughter to take him to ER. Daughter stated she thought he might get to feeling better and that if he didn't get better or if he seemed worse, she would take him. RN talked to wife later in afternoon around 3:00 PM and wife reported he had eaten some and seemed to be feeling a little better. When his wife went to wake him early Thursday AM , she could not arouse him and she called 911. When they responded the coroner was called. 12/3/09 Death Certificate received. DOD 11/26/09. Final Cause of Death: Myocardial Infarction, NOS & Chronic Pulmonary Disease, Dementia, Stroke (CVA).
65+ years Emergency Room Nov., 2009 Nov., 2009 Total  
65+ years Emergency Room Nov., 2009 Jun., 2010 390851-1 Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.
65+ years Emergency Room Nov., 2009 Jun., 2010 Total  
65+ years Emergency Room Nov., 2009 Total  
65+ years Emergency Room Dec., 2009 Sep., 2011 434287-1 Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.
65+ years Emergency Room Dec., 2009 Sep., 2011 Total  
65+ years Emergency Room Dec., 2009 Total  
65+ years Emergency Room Sep., 2010 Jan., 2011 414974-1 Per patients daughter, he developed Guillain Barre Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away on 1/6/2011.
65+ years Emergency Room Sep., 2010 Jan., 2011 Total  
65+ years Emergency Room Sep., 2010 Total  
65+ years Emergency Room Oct., 2011 Oct., 2011 438770-1 Pt. had emesis that she vomited on the floor, she then tried getting up & fell. Resident was confused, weak, & had pale color. Sent to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib, dehydration, rapid ventricular response, & mental status changes.
65+ years Emergency Room Oct., 2011 Oct., 2011 Total  
65+ years Emergency Room Oct., 2011 Total  
65+ years Emergency Room Oct., 2012 Nov., 2012 474765-1 "This spontaneous report as received from an office manager refers to a 72 years old female patient with high blood pressure and osteopenia, and with no drug allergies/drug reactions. The patient was vaccinated with, 0.5 ml ZOSTAVAX (0240AE; expiration date; 15-MAR-2013) on 29-OCT-2012 intramuscularly. No other co-suspects were reported. Concomitant medications included: OCUVITE PRESERVISION. On approximately 01-NOV-2012, about 4 days after receiving the vaccine, the patient developed a ""full"" case of shingles. The office manager reported that the rash began on the left side of the patient's forehead and spread ""very close"" to her left eye. The patient experienced pain and swelling of the left eye. The rash continued to spread to the right side of the patient's forehead. The patient went to an unspecified urgent care center and an unspecified ""eye center"" for treatment on an unspecified date. She was given an unspecified dose of VALTREX to treat the symptoms. The patient was also seen by the Physician Assistant, on an unspecified date. It was reported that there was no laboratory test done. On an unspecified date, the patient told the office manager that her left eye is less swollen, the pain has lessened and that the rash seems to ""drying"". It was reported that on an unspecified date the patient died. The relatedness for a ""full"" case of shingles was unknown for ZOSTAVAX. Additional information has been requested."
65+ years Emergency Room Oct., 2012 Nov., 2012 Total  
65+ years Emergency Room Oct., 2012 Dec., 2012 476377-1 Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.
65+ years Emergency Room Oct., 2012 Dec., 2012 Total  
65+ years Emergency Room Oct., 2012 Jan., 2013 480995-1 Vaccine 10-3-12. To ER 10-12-12 with (L) arm pain. Seen 10-13-12 & transferred to cardiologist at hospital she declined there, was diagnosed with Guillain-Barre, transferred to where she expired.
65+ years Emergency Room Oct., 2012 Jan., 2013 Total  
65+ years Emergency Room Oct., 2012 Total  
65+ years Emergency Room Total  
65+ years Not Serious Oct., 2012 Nov., 2012 474765-1 "This spontaneous report as received from an office manager refers to a 72 years old female patient with high blood pressure and osteopenia, and with no drug allergies/drug reactions. The patient was vaccinated with, 0.5 ml ZOSTAVAX (0240AE; expiration date; 15-MAR-2013) on 29-OCT-2012 intramuscularly. No other co-suspects were reported. Concomitant medications included: OCUVITE PRESERVISION. On approximately 01-NOV-2012, about 4 days after receiving the vaccine, the patient developed a ""full"" case of shingles. The office manager reported that the rash began on the left side of the patient's forehead and spread ""very close"" to her left eye. The patient experienced pain and swelling of the left eye. The rash continued to spread to the right side of the patient's forehead. The patient went to an unspecified urgent care center and an unspecified ""eye center"" for treatment on an unspecified date. She was given an unspecified dose of VALTREX to treat the symptoms. The patient was also seen by the Physician Assistant, on an unspecified date. It was reported that there was no laboratory test done. On an unspecified date, the patient told the office manager that her left eye is less swollen, the pain has lessened and that the rash seems to ""drying"". It was reported that on an unspecified date the patient died. The relatedness for a ""full"" case of shingles was unknown for ZOSTAVAX. Additional information has been requested."
65+ years Not Serious Oct., 2012 Nov., 2012 Total  
65+ years Not Serious Oct., 2012 Total  
65+ years Not Serious Total  
65+ years Total  
Unknown Death Apr., 2010 May, 2010 386690-1 Initial report received from a physician via health authority on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch number 107522P1) on 29 Apr 2010. 24 hours after vaccination, the patient presented with sudden respiratory failure on 30 Apr 2010 and two hours later, the patient died. Medical history of the patient was unknown. Autopsy was performed and cause of death was stated as bronchopneumonia.
Unknown Death Apr., 2010 May, 2010 Total  
Unknown Death Apr., 2010 Total  
Unknown Death Total  
Unknown Total  
Total  
Note: Submission of a VAERS report does not constitute admission that healthcare personnel or the vaccine caused or contributed to the event.
TopOptionsNotesCitationQuery Criteria
Notes:
Caveats:

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.

Note that the Event Category for hospitalization also includes prolonged hospitalizations. More information.

Data contains VAERS reports processed as of 3/12/2013. 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.

DISCLAIMER: Please note that VAERS staff follow-up on all serious and other selected adverse event reports to obtain additional medical, laboratory, and/or autopsy records to help understand the health concern raised. However, in general, coding terms in VAERS do not change based on the information received during the follow-up process. VAERS data on WONDER should be used with caution as numbers and conditions do not reflect data collected during follow-up. Note that information included in the VAERS data does not mean that the vaccine caused the adverse event. Review cautions in the interpretation of this data: More information.
Help: See The Vaccine Adverse Event Reporting System (VAERS) Documentation for more information.
Query Date: May 15, 2013 7:52:22 PM
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 https://wonder.cdc.gov/vaers.html on May 15, 2013 7:52:22 PM
TopOptionsNotesCitationQuery Criteria
Query Criteria:
Title:  
Age: All
Date Reported: All
Date Vaccinated: 1980, 1981, 1982, 1983, 1984, 1985, 1986, 1987, 1988, 1989, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013
Event Category: All
Gender: All
Manufacturers: All
Onset Interval: All
Recovered: All
Serious: All
State / Territory: The United States, Territories, and Unknown
Symptoms: DEATH, DEATH NEONATAL
Vaccine Products: INFLUENZA A (H1N1) MONOVALENT (FLU(H1N1)), INFLUENZA A (H1N1) MONOVALENT, INTRANASAL SPRAY (FLUN(H1N1)), INFLUENZA (SEASONAL) VIRUS VACCINE (FLU(SEASONAL)), INFLUENZA (SEASONAL) INTRANASAL VACCINE (FLUMIST) (FLUN(SEASONAL))
VAERS ID: 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1, 232509-1
Group By: Age, Event Category, Month Vaccinated, Month Reported, VAERS ID
Show Totals: True
Show Zero Values: Disabled
 
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