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From the 4/30/2021 release of VAERS data:

Found 1,936 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 210671 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2002-10-15
Onset:2003-07-16
   Days after vaccination:274
Submitted: 0000-00-00
Entered: 2003-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy
SMQs:, Cardiac failure (narrow), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/Placebo
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301350

Write-up: An 81 year old female received RSV vaccine or Placebo and influenza vaccine in the RSV 11 study on 10/15/02; and on 7/16/03 died at home of congestive heart failure, 274 days after vaccination. The subject had been placed on hospice for severe CHF not responding to treatment. The pt was hospitalized 3 times in February 2003, May 2003 and June 2003 for CHF, atrial fibrillation and ischemic cardiomyopathy. A death certificate and other pertinent record will be sent as soon as available. The investigator assessed the events as unrelated to the study products. Additional info received 10/7/03. There is no hospital summary since subject died at home. Copy of certificate of death received. Cause of death: congestive heart failure-approximate interval between onset and death-5 years. Secondary cause: atrial fibrillation-approximate interval between onset and death-2 years. Other significant conditions contributing to death but not resulting in the underlying cause given-breast cancer. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: No further info is expected. Case is closed.


VAERS ID: 207986 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2002-11-05
Onset:2003-07-14
   Days after vaccination:251
Submitted: 2005-05-31
   Days after onset:687
Entered: 2003-08-19
   Days after submission:651
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Coronary artery disease, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Placebo, RSV, Lipitor, Unaretic, Combivent, Atrovent
Current Illness:
Preexisting Conditions: COPD; HTN; Colon cancer 1992
Allergies:
Diagnostic Lab Data: Pending studies: Toxicology-blood, vitreous humor, bile, liver, stomach contents.
CDC Split Type: 200301328

Write-up: A 70 year old male received RSV vaccine or Placebo and Influenza vaccine on 11/05/2002 and 251 days later died. Obituary stated patient died suddenly, no further information at this time. The investigator assessed the event as unrelated to the study product. Follow up information received 08/12/2003. Subject # 00100989. The investigator spoke with family member regarding patient''s death. Patient was found by his wife sitting in a chair. Autopsy was performed and cause of death was listed as "massive myocardial infarction". Investigator assessed the event as unrelated to the study product. Additional information received 09/03/2003. Certificate of Death: Date of death: 07/14/2003. Manner of Death: Natural cause. Immediate Cause: Arrythmia/MI. Approximate interval between onset and death is 1 day. Due to or as a consequence of: End state emphysema. Approximate interval between onset and death is years. Did tobacco use contribute to death: Yes. Preliminary Anatomic Diagnosis: 07/16/2003. Diagnosis: Coronary Artery Atherosclerosis: Left circumflex 75% narrowed (left dominant circulation). Cardiomegaly, 500 grams. Severe Centriacinar Emphysema, bilateral. Subsidiary Diagnosis: Nodular hypertrophy of prostate. Simple renal cyst, left. Small pulmonary embolus. Meckel''s diverticulum. Colonic diverticula. Probable cause of death: Cardiac Arrhythmia secondary to coronary artery disease. Autopsy Limitations: none. Embalmed: no. Pending studies: Toxicology-blood, vitreous humor, bile, liver, stomach contents. Medical Records received on 8/27/2003 states arrythmia and coronary artery disease.


VAERS ID: 211506 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Washington  
Vaccinated:2002-11-13
Onset:2003-07-01
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2003-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coronary artery disease, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/Placebo; Psyllium oral power, Ranitidine, Furosemide, Nitroglycerin, Albuterol, Beclomethasone NS, Hydrocodone/Acetaminophen, Tamazepam, Ipratropium bromide inhaler, Lisinopril, Salmeterol inhaler, Prednisone, Theophyline
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302689

Write-up: This subject is a 76 year old male who died while enrolled in the RSV11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 11/13/02. The investigator was informed by one of the family members that the subject had died in July, 2003. Specific dates not reported. Causality was not reported. Further info from the investigator has been requested. The death certificate received on 11/20/03 states myocardial infarction and CAD. Follow up on 11/26/03: "Efforts are being made to contact next of kin and to obtain a death certificate through the State. No details are known at this time. Additional info received 11/18/03. The subject died on 07/08/03, 237 days post immunization. Death Cert: Cause of Death: Acute MI due to CAD. The acute MI was reported by the investigator as not related to the study vaccine." Follow up on 12/16/2003: "Additional information received 12/01/2003: Complementary Information Form: Diagnoses at Enrollment: COPD, Bronchiectasis, Ischemic heart disease. Medication: Psyllium oral power, Ranitidine, Furosemide, Nitroglycerin, Albuterol, Beclomethasone NS, Hydrocodone/Acetaminophen, Tamazepam, Ipratropium bromide inhaler, Lisinopril, Salmeterol inhaler, Prednisone, Theophyline."


VAERS ID: 210896 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2002-10-09
Onset:2003-06-21
   Days after vaccination:255
Submitted: 0000-00-00
Entered: 2003-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Cough, Dyspnoea, Emphysema, Lung disorder, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Placebo/RSV, NPH and Humulin-R insulin, Humabid LA, Digitek, potassium chloride, Theophylline, Zyrtec, Aspirin, Protonix, Lisinopril, Imdur, Lasix, Flonase, Serevent, Atrovent, Albuterol, Flovent, and Prednisone.
Current Illness:
Preexisting Conditions: Chronic obstrictive pulmonary disease; Congestive heart failure. Information from previous hospitalization received 11/11/2002: Past medical history includes: Congestive heart failure, which requires oxygen at 3 L/m at night, Type 1 Diabetes, Coronary Artery Disease, chronic sinusitis, hypertension, hearing loss, T & A, cholecystectomy, left orchiectomy, ventral hernia repair and a benign colon polyp removal. The subject is a former smoker. Subject developed a cough, chest congestion and shortness of breath 30 days post-immunization and was admitted to the hospital on 11/08/2002. A chest x-ray showed patchy bibasilar infiltrates superimposed upon fibrotic changes. Treatment included intravenous Solumedrol, antibiotics, Levaquin, Lanoxin, Surfak and oxygen. The subject recovered and was discharged from the hospital six days later on 11/14/2002. The event of an acut exacerbation of chronic obstructive pulmonary disease was reported by the Investigator as unrelated to the study vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302373

Write-up: This subject is a 69 year old male who died of natural causes while enrolled in RSV S & I study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/9/02. The subject died 255 days post immunization on 6/21/03. The death was reported by the investigator as not related to the study vaccine. Cause of death was not reported. Additional info is requested. Subject developed a cough, chest congestion and SOB 30 days post immunization and was admitted to the hospital on 11/8/02. A chest x-ray showed patchy bibasilar infiltrates superimposed upon fibrotic changes. Treatment included IV Solumedrol, antibiotics, Levaquin, Lanoxin, Surfak, and oxygen. The subject recovered and was discharged from the hospital six days later on 11/14/02. The event of an acute exacerbation of COPD was reported by the investigator as unrelated to the study vaccine. A 15-day follow up report received 11/13/2003 adds: Additional info received 10/21/2003: Copy of Death Certificate dated 06/25/2003. Cause of Death: Emphysema, due to tobacco abuse, coronary artery disease, insulin dependent diabetes mellitus. No autopsy was performed.


VAERS ID: 206890 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Arizona  
Vaccinated:2002-10-10
Onset:2003-06-18
   Days after vaccination:251
Submitted: 0000-00-00
Entered: 2003-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cold sweat, Coronary artery disease, Cough, Diabetes mellitus, Dyspnoea, Hyperlipidaemia, Lung disorder, Pain, Pallor, Pneumonia, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-11
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Furosemide, Aldactone, potassium chloride, Verapamil, HCL, Glyburide, Leva Thyroxine, Simvastatin, Ibuprofen, ASA, vitamin E, vitamin C, visicer formula, Albuterol, Atrovent, Vancenase, SVN albuterol/Atrovent, Tequin, Prednisone, oxygen, hy
Current Illness:
Preexisting Conditions: CABG x 5, CHF, HTN, CAD, hypercholesterolemia, L ventricular dysfunction, COPD, pulmonary fibrosis, diabetes-type 2, spinal stenosis, severe OA.
Allergies:
Diagnostic Lab Data: Medical procedures, medications: Oxygen March 7, 2003, Tequin March 7, 2003, Blood cultures negative, Tequin March 12-16, 2003, Prednisone tapor 20mg-DC March 12, 2003---Blood pressure 123/83, pulse 92, respirations 28, temp 101.6 orally, O2 sat 93% on three liters
CDC Split Type: 200301447

Write-up: A 75 year old male received RSV vaccine of Placebo and Influenza vaccine in the RSV 11 study on Oct 10, 2002 and on June 18, 2003, 251 days later was admitted to impatient hospice for pain management of spinal stenosis OA. Patient''s wife called to site to say patient had passed away July 11, 2003, 274 days after vaccination. The investigator assessed the event as unrelated to the study product. Further information has been requested. On March 7, 2003 148 days after vaccination the patient developed pneumonia and was admitted to hospital on March 7, 2002. The patient was given steroids. From follow up information received April 4, 2003 the pneumonia symptoms were ongoing.Discharge summary for March 7, 2003 to March 12, 2003. Diagnosis: left lower lobe pneumonia, chronic obstructive pulmonary disease, coronary artery disease, diabetes, hyperlipidemia. Hospital course: The patient was admitted with shortness of breath. He was found to have a left lower lobe infiltrate on chest x-ray. He was treated with oxygen and IV tequin. Blood cultures werenegative. Sputum culture grew out only usual oral flora. The patient continued to have shortness of breath. Steroids were added. He had hyperglycemia related to that, but did ultimately improve. He leaves here with normal white count. He ias being discharged to home with medications as prior to admit. He was told that his blood sugars will improve as he is rapidly tapered off of his Prednisone. He will be on Tequin 400mg po qd for five more days and Prednisone 20/20,10/10,5/5 and then off. He will follow up with his primary care ohysician. It is recommended that in one to two weeks, he have a follow up chest x-ray to assure clearing of his infiltrate. From follow up information received June 6, 2003-Diagnosis left lower lobe pneumonia,COPD outcome recovered. From follow up information received June 22, 2003 : Emergency dept report 03/07/2003. This is a 75 year old male who presents to the emergency dept with his wife. He states that he has had a fever every night for the last two weeks. He was diagnosed with oneumonia in the first on March and just finished a Z pack and really dose not feel any better. He says he has been coughing up some grayish brownish sputum but today he has not been able to cough anything up. He just really feels miserable. He feels more miserable today than he has. He denies any chest pain. He denies any abdominal pain, denies any nausea, vomiting, diarrhea. He denies any extremity swelling. He feels generally weak and bad. Review of system: The review of sytems is otherwise negative. This is a well developed well nourished elderly male, resting on the cart. He appears tachypneic with some conversational dyspnea. Skin is warm and dry. There are no rashes or lesions. He appears well hydrated. HEENT Normocephalic, atraumatic. Eyes, ears, nose and mouth normal. Neck Supple and non tender. No obvious asymmetry or palpable mass. He has no increased jugular venous pressure noted. Hearts: regular rate and rythm. Lungs: significant for decreased air movements in his bases bilaterally. Abdomen Normoactive bowel sounds, soft, no palpabe masses or tenderness. No rebound, guarding or peritoneal signs. Extremities: no clubbing, cyanosis or edema. Here in the emergency dept, chest x-ray, CBC comprehensive metabolic panel, blood cultures x 2. EKG were performed. His chest x-ray interpreted by myself was significant for right hilar infiltrate as well as what looks like a left lower extremity pneumonia. His white count is 10,200, hemoglobin and hematocrit 13.4 and 39.6 respectively with 211,000 platelets 77.2 % granulocytes, 7.9 absolute granulocytes on his differential. His glucose is elevated at 140 and otherwise all values on his comprehensive metabolic panel are within normal limits. EKG interpreted by myself is a normal sinus rhythm, rate 90, axis normal. Itervals are within normal limits. No evidence of acute injury, ischemia or infarction. Emergency dept course and interventi


VAERS ID: 205223 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-14
Onset:2003-06-14
   Days after vaccination:243
Submitted: 0000-00-00
Entered: 2003-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Duoneb; Flovent; Combivent; Slow-Bid; Lanoxin; Tenormin; Prevacid; Zestril; Lasix; Aldactone; Coumadin; Allopurinol; Zithromax
Current Illness:
Preexisting Conditions: COPD; CAD; CHF; Bypass x2; Hypertension; MI; Emphysema; Gout; Indigestion; Dysrhythmia; Respiratory Infection; Ischemic Heart Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301033

Write-up: A 71 year old male received RSV Vaccine or Placebo and Influenza Vaccine on 10/14/02 and 243 days later died on 6/14/03. Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks. Signs/Symptoms/Diagnosis: No data at present time. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: "A 71 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/14/2002 and 243 days later died on 06/14/2003. Patient obituary discovered in newspaper, the investigator will contact family in a couple of weeks. Signs/Symptoms/Diagnosis: No data at present time. The investigator assessed the event as unrelated to the study product. Follow up information received 07/01/2003. Investigator spoke with family members, regarding death. They stated that subject died in bed. Family physician thought cause of death was heart attack. Autopsy was performed. Results of the autopsy are not known yet. Diagnosis: MI?. The investigator site assessed the event as unrelated to the study product. Further information is expected." Follow up on 02/09/04: "Additional information received 02/02/04. After multiple attempts, unable to obtain autopsy results."


VAERS ID: 209117 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Illinois  
Vaccinated:2002-03-10
Onset:2003-06-14
   Days after vaccination:461
Submitted: 0000-00-00
Entered: 2003-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Condition aggravated
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Placebo/ RSV
Current Illness:
Preexisting Conditions: Cough; Shortness of breath; Hemoptysis; Pneumonia; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301835

Write-up: This subject is a 83 year old female who died 6/15/03 in the hospital while enrolled in the RSV 1I study with RSV vaccine. The subject received a dose of RSV vaccine or Placebo and Influenza vaccine on 10/03/2002. The subject developed congestive heart failure and COPD with acute exacerbation 254 days post immunization and was admitted to the hospital 254 days later on 6/14/03. The subject died 255 days post immunization on 6/15/03. The investigator has assessed the events as unrelated to the study products. Medical Certificate of Death: Immediate cause resulting in Death - Congestive heart failure. Further information has been requested.


VAERS ID: 209462 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2002-10-30
Onset:2003-06-01
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2003-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Cardiovascular disorder, Chest pain, Hypertension
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301995

Write-up: The medical record states chest pain, hypertension and heart failure. Aditional info received 9/26/03. A death certificate was obtained for the subject. Date of death: 6/8/03. The cause of death was due to ischemic cardiovascular disease. Relevant hisotry section contains cardiology consultation and 2D Echo and Doppler study 2/11/03 and medical history notes 4/23/03 and 2/28/03. The ischemic cardiovascular disease was reported by the investigator as unrelated to the study product. Cardiology consultation 2/11/03. Pt presents today for evaluation prior to undergoing total hip replacement scheduled for 2/20/03. Dr has requested prior to pt undergoing a surgical procedure. Presently pt seems to be doing quite well, with her primary complaint being of hip pain that is now limiting her mobility. Specifically she denies chest discomfort, shortness of brreath, dyspnea on exertion (although she is not able to probably do enough to develop dyspnea), lower extremity swelling, orthopnea, PND, chest discomfort or palpitations. She seems to be complying with her medications fairly well although, as usual, she expresses a desire to "get off them." Current medications: Coumadin, Spironolactone 26mg qd, Lasix 40mg qd, KCI 20meg qd, Coenzyme Q10, 50mg qd, Atacand/HCT 16/12.5mg qd, Triamterene 100mg qd. Physical examination: she is a lean female in no acute distress. Wt was not recorded today, but in late January it was 126.25lbs. P 84 and irregularly irregular. BP146/72 in the left arm in the seated position using a normal size cuff. HEENT exam reveals normocephatic, atraumatic head. Conjunctiva and lids are clear. Mucus membranes are dry but pink. Neck is supple without lymphadenopathy or thryromegaly. JVP is 9cm with negative HJR. Carotids are 2+ bialterally without brutis. Lungs are clear to auscultation and there is no accessory muscle use in her respiratory effort at rest. Cardiac exam reveals on enlarged an dlaterally displaced apical impulse with an irregularly irregular rhythm and a normal S1, S2. There are no gallops or rubs. There is a 11/V1 systolic murmur at the left lower sternal border which is unchanged. Extremities reveal no edema, and the peripheral pulses are 2+ and symmetric throughout. A 12-lead lectrocardiogram was obtained at hte time of her visit. This revealed atrial fibrillation with a controlled ventricular response of 80 beats/minute. She has a left anterior fascicular block, and LVH with secondary QRS widening and repolarization abnormalities. Since her last tracing dated 4/12/02 her heart rate was decreased by 10 beats/minute, but otherwise there are no significant changes. Also at the time of her visit, she underwent a 2D echo and doppler study which is reported separately. Impressions: 1) hypertension iwth hypertensive cardiomyopathy. The hypertension is relatively well controlled at this time. In addition, it is noted that her heart failure, which was rather severe back in April of last year, has improved significantly since then. More than likely this is due to the addition of Spironolactone and Atacand to her medical regimen. 2) Bialteral hip osteoarthritis with the left being worse than the right. She is scheduled to undergo surgery for hip replacement in ten days. I will forward a letter the Dr with specific recommendations regarding ways to minimize potential adverse events related to the pt''s cardiac dysfunction perioperatively. Plan: 1) Continue current medications at their current dosages with the exception of Coumadin which will be discontinued seven days prior to this surgery with the substitutionof IV heparin for the Coumadin three days prior to the surgery. 2) Start Toprol XL 12.5 mg qhs today, and continue for at least one month following this surgery. 3) Return for follow-up with me in six to eight weeks. 2D echo and doppler study 2/11/03. Indication: heart failure. Bialteral atrial enlargement with a left atrial internal dimension of 48mm in the parastenal long axis view. Concentric left ventricular hypertrophy with left ventricular enlargement and moderately severe systolic dysfunction which is likely due to hypertensive cardiomyopoathy. The LVEF today is measured at 37 percent which is an improvement from 10 to 15 percent measured approxximately ten months ago. Right ventricular enlargement with normal systolic function. Aortic valve with normal leaflets but annular calcification. There is mild AR but no AS. Mitral valve with normal anterior mitral leaflet, but the posterior leaflet is somewhat limited in its mobility. There is mitral annular calcification and moderate mitral regurgitation which is due to the abnormal posterior leaflet. Normal tricuspid valve with moderate TR and moderately elevated PA systolic pressure of 51mm/Hg. Medical history notes: 4/23/03. Pt returned for follow-up of heart failure and hypertension. Actually follow-up was specifically requested by Dr due to worsening symptoms of chest pain. Sine her last visit the pt reports the occurrence of chest pain about once a week at random times. There is no relationship to exercise or time of day. She denies SOB, dyspnea on exertion, rhythm disturbance, orthopnea, PND, anorexia, early satiety and lower extremity swelling. She does report chest pain/discomfort. She denies nausea, vomiting, diarrhea, diaphoresis or pleuritic pain. She is planning a trip on 5/9/03. Current medications: Coumadin, Spironolactone 25mg qd, Lasix 40mg qd, KCI 20meg qd, Coenzyme Q10, 50mg qd, Atacand/HCT, 16/12.5mg qd, multivitamin one qd, Synthroid 25mcg qd. A 12-lead electrocardiogram was obtained at the time of her visit which revealed atrial fibrillation with a ventricular response at 80, normal axis, a left anterior fascicular block and normal QT interval. Sine her last tracing dated 2/11/03 there are no significant changes. Impression: chest pain. Given atypical pattern and character, suspect non-cardiac etiology. Heart failure. Remarkably stable. Hypertension. Relatively well controlled on current medications. Plan: samples of Protonix 40mg one po qam. Follow up on Monday 4/28/03 at 8:30am. If chest pain is unimproved with the addition of proton pump inhibitor, will likely refer for adenosine sestamibi vs dobutamine echo (non-exercise due to severe osteoarthritis). Medical history notes: 4/28/03: Pt returned for follow-up of chest pain. At her last visit (4/23/03) I started her on Protonix, 40mg qd, based on the suspicion that the chest pain might be due to GERD. Since her last visit she reports definite decrease in her chest pain. Current mecication: Coumadin, Spironolactone 25mg qd, Lasix 40mg qd, KCI 20mcg qd, Coenzyme Q10, 50mg qd, Atacand/HCT 16/12.5mg qd, multivitamin one qd, Synthroid 25mcg qd, Protonix 40mg qd. Impression: chest pain. Improved significantly after five days of Protonix. Plan: continue Protonix, 40mg qd for four weeks (total), then 40mg qod for four weeks, then discontinue. Follow up in two months. Note to Dr. Autopsy report received on 10/01/2003 states COD was cardiovascular disease.


VAERS ID: 205222 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-16
Onset:2003-05-09
   Days after vaccination:205
Submitted: 0000-00-00
Entered: 2003-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: K-Dur, Enteric coated aspirin, Zaroxolyn, Prevacid, Lasix, Atenolol, Allopurinol, 2 liters of oxygen, Lantus, Humalog, Quinine, Combivent,
Current Illness:
Preexisting Conditions: Type 2 diabetes poorly controlled, Recent HB1C of 8.8; Congestive heart failure felt more to be diastolic with recent ejection fraction of 55% and chronic ascites; Coronary artery disease status post coronary artery bypass grafting; Chronic bilateral leural effusions status post decortication; History of gout; Chronic renal insufficiency, Baseline BUN and creatinine recently 72/2.1; Ventral hernia; Glaucoma; GERD, COPD, Right bundle branch block;
Allergies:
Diagnostic Lab Data: BP: 109/59; Pulse: 81; Respirations 16; Pulse oximetry: 95% on 3 liters; alert and oriented x 3; CT of head: negative for bleed or stroke; ENG: Consistent with atrial flutter with irregular ventricular response ranging from 80-90; Blood glucose: 224; BUN and creatinine: 64/1.8; Sodium: 131; Potassium: 3.3; Chloride: 84; CO2: 37; Alkaline Phosphatase: 341; CK: 34; LDH: 709; Lipase: 301; White count: 14; Hematocrit: 39.7; Platelets: 330,000; Neutrophils: 8.5%; Lymphs and 0.4% eosinophils;
CDC Split Type: 200301034

Write-up: A 68 year old male received RSV vaccine or Placebo and Influenza Vaccine on 10/16/02 and 205 days later died on 5/9/03. Investigator was notified by patient''s family that he died at home. Will speak to family in a couple of weeks. The Investigator assessed the event as unrelated to the study product. Follow up on 07/08/2003: "A 68 year old male received RSV vaccine or Placebo and Influenza vaccine on 10/16/2002 and 205 days later died on May 9, 2003. Investigator was notified by patient''s family that he died at home. Will speak to family in a couple weeks. The investigator assessed the event as unrelated to the study product. Follow up information received 07/01/2003. Investigator spoke with family members regarding death. Death certificate lists CHF as cause of death. Subject went from a lengthy hospitalization to a nursing home where he died approximately 1 week later. Prior hospitalization in File # 2003-00364. The Investigator assessed the event as unrelated to the study product. HISTORY OF PRESENT ILLNESS: The patient is a 68 year old white male well known to me who is being admitted to hospital for acute syncope with resultant facial contusions and left knee contusion. The patient was seen by myself last week in the ofice for his usual followup and also had an episode of either slipping vs. syncope with resultant left facial contusion and left conjuctival hemorrhage. He was back to his baseline status and saw doctor at hospital today who is his cardiologist. He suggested placing him on a Holter monitor because of the facial ontusion and questionable syncopal episode. The patient left the hospital. Apparently, the patient became lightheaded and passed out. He landed on his face and chest and does not recall any events thereafter until he was at the hospital. He was complaning of chest discomfort which he felt was due to contusing his chest but was treated as if it was cardiac in origin with aspirin, Nitroglycerin paste and morphine. He also was placed in a left knee immobilizer. He underwent a CAT scan of his head which was normal. Chest x-ray revealed questionable mild congestive heart failure. His labs are notable for his usual chronic renal insufficiency, hypoatremia, hypoalemia and an elevated white count of 14,000. It was determined that the patient needed to be further evaluated due to his complicated history as well as syncope and possible cardiac issues. He has since been transferred to a other hospital where he is presently complaining left knee discomfort and mild palpable chest discomfort. He is not short of breath and is frustrated with the overall situation.


VAERS ID: 209929 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2002-10-14
Onset:2003-04-17
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2003-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Adenocarcinoma, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-23
   Days after onset: 159
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Serevent; Thyroid; Slo-Bid; Flovent; Ambien; Claritin; Viag; Vioxx; ASA; Afrin; Rhinocort; Protonix; Lorate
Current Illness:
Preexisting Conditions: Mass: body of pancreas
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200300447

Write-up: This subject is a 71 year old male who was admitted to the hospital for an exploratory laparotomy and was found to have metastatic adenocarcinoma while enrolled in RSV 11 study. The subject received RSV vaccine or Placebo and Influenza Vaccine on 10/14/02. The subject developed stomach pain and weight loss and 185 days post-immunization on 4/17/03 was admitted to the hospital for an exploratory laparotomy and liver biopsy and was found to have metastatic adenocarcinoma consistent with pancreatic origin. Oncologist recommended palliative chemotherapy. Investigator is awaiting more records and will send when received. Patient was discharged on 4/22/03. Outcome is ongoing. Diagnosis: Metastatic Adenocarcinoma to the liver from the pancreas. The investigator assessed the event as unrelated to the study product. Follow up information received on 5/23/03. MediPort insertion was done on 5/8/03. On the 5/6/03 chemotherapy was initiated with Gemzar, 1000mg IV on day one and day eight, also Xeloda 650mg BID for 14 days. This cycle it to be repeated every 21 days as long as blood counts tolerate. Subject was also started on Pancrease 2 to 3 tablets before meals for indigestion and Duragesic 50mcg every 72 hours for pain relief. Additional information received on 9/24/03. The subject died 344 days after receiving RSV vaccine or Placebo and Influenza vaccine. Death: 9/23/03. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested.


VAERS ID: 208170 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2002-10-16
Onset:2003-04-01
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2003-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Laboratory test abnormal, Lung neoplasm malignant, Pallor, Productive cough, Stupor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-13
   Days after onset: 133
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Placebo, RSV, Vicodin, Combivent, Pulmicort, Serevent, Duragesic, Ativan
Current Illness:
Preexisting Conditions: Lung cancer diagnosed April 2003. Chronic obstructive pulmonary disease, osteoarthritis, osteoporosis. Lung cancer with bone metastasis. No known allergies.
Allergies:
Diagnostic Lab Data: Sodium 136; K 4.7; Chloride 98; CO2 28; BUN 22; Creatinine 1.2; Glucose 124; White count 12.7; Hematocrit 39; Platelet count 558; O2 saturation 91% on two liters nasal cannula; Chest x-ray: right lung basilar opacity with effusion; EKG: sin
CDC Split Type: 200301615

Write-up: This subject is a 73 year old female who was admitted to the hospital due to increased dyspnea, cough and sputum on 8/7/03 while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/16/02. The subject developed lung cancer 6 months post immunization (diagnosed in April 2003) and presented with increased dyspnea, cough and sputum 295 days post immunization and was admitted to the hospital 295 days later on 8/7/03. Subject died in hospital 6 days later on 8/13/03. The event was reported by the investigator as not related to the study product. A follow up report received 8/26/2003 adds: This subject is a 73 year old female who was admitted to the hospital due to increased dyspnea, cough and sputum on 08/07/2003 while enrolled in the RSV 11 study with RSV Vaccine. The pt received RSV Vaccine or Placebo and Influenza vaccine on 10/16/2002. The subject developed lung cancer 6 months post immunization (diagnosed in April 2003) and presented with increased dyspnea, cough and sputum 295 days post immunization and was admitted to the hospital 295 days later on 08/07/2003. Pt died in hospital 6 days later on 08/13/2003. The event was reported by the Investigator as not related to the study product. Medical Records received on 8/26/2003 states pallor and unresponsive.


VAERS ID: 206182 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Unknown  
Vaccinated:2002-09-28
Onset:2003-03-18
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2003-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiomegaly, Condition aggravated, Dyspnoea, Emphysema, Intermittent claudication, Laboratory test abnormal, Oedema, Pneumonia, Pulmonary congestion, Respiratory failure, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pletal; Acron; Allergan D; Ambien; Oxygen; Albuterol; Prednisone; Pulmicort; Biaxin; Suprex, Medrol Dose pack; Lasix; Accupril; Rocephin; Azithromycin; Solumedrol; Trental; Flovent; Celexa; Xopenex; humabid LA; Plavix; Lrazepam; K-Dur; Atro
Current Illness:
Preexisting Conditions: Emphysema (diagnosed 2000), chronic bronchitis (diagnosed 1980), COPD (diagnosed 2000), allergies (diagnosed 2000-allergies to sulfa, iodine, oxycontin, oxycodone), HTN (diagnosed 2000), dizziness (diagnosed 2002), ASHD (diagnosed 2000), circulatory insufficiency (diagnosed 2002), depression/anxiety (diagnosed 2002), insomnia (diagnosed 2002), cataract L eye (diagnosed 2002), spinal stenosis. Pt had a right breast masectomy for Ca in 1992, cataract in R eye removed in 2002, pacemaker in 1990, carotid endart. Rt in 1993, TIA 9remote) in 1994.
Allergies:
Diagnostic Lab Data: Chest x-ray which shows marking consistent with chronic obstructive pulmonary disease and mild cardiomegaly. White blood count elevated throughout hospital stay secondary to high dose steroid use.
CDC Split Type: 200300031

Write-up: A 80 year old female received RSV vaccine or Placebo and Influenza vaccine on 9/28/02 and 171 days later died on 3/18/03 of respiratory failure secondary to COPD. Death certificate states immediate cause was respiratory failure due to or a consequence of chronic obstructive lung disease due to or as a consequence of tobacco. The investigator assessed the events as unrelated to study products. On 10/17/02 the pt had been hospitalized with pneumonia, treated with Biaxin 10/29/02 to 11/2/02, Suprex 10/29/02 to 11/2/02 and Medrol Dose Pack 10/29/02. The pt recovered 10/29/02 (the date of discharge). The investigator assessed the events as unrelated to the study products. On 12/2/02 the pt was hospitalized for signs and symptoms of CHF and COPD. The pt was discharged on 12/5/02 and the condition was on going. On 12/9/02 the pt was hospitalized for COPD/AECB/bilateral pedal edema and CHF. A chest x-ray was done which showed pulmonary edema. The pt was discharged on 12/11/02 and the condition was on going. Follow-up info received 3/25/03. Discharge summary received for 12/2/02 to 12/5/02. Admission diagnosis date: chronic obstructive pulmonary disease, emphysema exacerbation, congestive heart failure. Discharge diagnosis date 12/5/02: 1. Chronic obstructive pulmonary disease exacerbation, emphysema. 2. Congestive heart failure with hypersensitive episodes. 3. Intermittent claudication. Diagnostic studies: Chest x-ray which shows marking consistent with chronic obstructive pulmonary disease and mild cardiomegaly. White blood count elevated throughout hospital stay secondary to high dose steroid use. This is a 79 year old female with long standing chronic obstructive pulmonary disease that has been having shortness of breath for a couple of days. She has a history of pacemaker and congestive heart failure. The pt was started on high dose Solu-Medrol and also Lasix diuresis and given Rocephin and Azithromycin in the hospital stay. The pt''s symptoms improved each day with her breathing better and her pitting edema subsequently also diminished. Condition on discharge: The pt is stable and breathing much improved with no more chest tightness. The pt is stable for discharge. Discharge medications: Azithromycin 250mg po qd x 5 days and tapering Prednisone 20mg bid x 3 days and then qd x 3 days. The pt is to continue home medicines. The pt is to follow up with doctor in 5 to 7 days and encourage to ambulate at home and also use her incentive spirometry. Manufacturer number 2003-00031 was previously reported as number 2003-03-1109. Additional info received 7/8/03. Correction on administration date of vaccine to 9/28/02 for cases crossed referenced with this SAE, Linked cases for this pt-SAE 2002-10-10793, 2002-12-0874, 2002-12-0875


VAERS ID: 214944 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Florida  
Vaccinated:2002-11-06
Onset:2003-03-09
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2004-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cozaar; Celebrex; Digoxin; Neurontin
Current Illness:
Preexisting Conditions: HTN; CHF; Back pain - laminectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200300660

Write-up: A male (unknown age) received RSV vaccine or Placebo and Influenza vaccine on 11/6/02 and later died (unknown date). The subject was lost to follow up. The phone was disconnected and certified letter returned with deceased 11/3/03 written on the envelope unopened. Will try and get information from PCP and follow up. Patient has a history of Hypertension, CHF, and back pain. Information from 5/15/03 telephone conversation with the Investigation. A 67 year old male, no family, has tried calling patient''s family physician who is not available. The subject was called for follow up, found phone disconnected, then a certified letter was sent which was returned with deceased marked on it. Further information is expected. Follow up information received on 6/5/03. Investigator spoke to subjects doctor on 5/20/03, stated that he did not know his patient had passed away. Doctor does not know what happened or which hospital patient went to. No other information available. Additional information received on 1/12/04. Death certificate. DOB 4/22/35. Subject died on 3/9/03, 123 days post immunization. The state does not release cause of death information. Follow up on 01/21/04 : "The death was reported by the investigator as not related to the study vaccine. Subject died 03/09/03. Cause of death is unknown. Symptoms and treatment related to the serious adverse events are unknown. Subject had a history of hypertension and congestive heart failure. No further information is available."


VAERS ID: 210670 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2002-10-30
Onset:2003-03-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2003-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Asthenia, Atrial fibrillation, Blood pressure decreased, Cardiac failure congestive, Coma, Depression, Dyspnoea, Malaise, Myocardial infarction, Weight decreased
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/Placebo, Coumadin, Diltiazem, Lasix, Lanoxin, Altace, Prevacid
Current Illness:
Preexisting Conditions: CHF; History of diverticulitis; Temporal arteritis; Polymyalgia rheumatic
Allergies:
Diagnostic Lab Data: All lab tests normal; Barium swallow all normal. Abdominal ultrasound 16/2/03.
CDC Split Type: 200300247

Write-up: An 81 year old female received RSV vaccine or placebo and Influenza vaccine on 10/30/02 and 107 days later came into the office with weakness, shortness of breath, malaise. She presented with BP 92/50 and weight loss of 20 lbs over the last month. She had not been eating very well. She was sent by ambulance to the hospital and admitted on 2/14/03. Signs/Symptoms/Diagnosis included esophageal dysfunction 9scheduled to have barium swallow in hospital), CHF, depression. The patient was treated with IV fluids and Prevacid. There was one episode of CHF due to over vigorous hydration which resolved. She refused to eat. Evaluated by psychiatry, transferred to psychiatry 2/20/03. The patient was prescribed Remeron from 2/20/03 until death. Patient was not responding in treatment program for depression. Found unresponsive in bed 3/1/03. CPR initiated there was no response and she was pronounced dead. Diagnosis was : Depression, Anxiety, Atrial Fib, Mitral Regurgitation. Cause of death was given as probable myocardial infarction. No autopsy will be performed. The investigator assessed the events as unrelated to the study products. Further information is expected. Additional information received on 10/7/03: Copy of death certificate: signed 3/1/03; date of death:3/1/03. Cause of death: lethal arrythmia - approximate interval between onset and death - 30 minutes. Secondary cause: atrial fib - approximate interval between onset and death - 5 years. Other significant conditions contributing to death but not resulting in the underlying cause given in Part 1 - Mitral valve regurgitation. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: 10/17/2003: No new info is anticipated. Case is closed. Death Certificate received on 10/27/2003 states COD was arrthymia and atrial fibrillation.


VAERS ID: 197385 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2003-01-14
Onset:2003-01-14
   Days after vaccination:0
Submitted: 2003-01-17
   Days after onset:3
Entered: 2003-02-07
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 312026A / 2 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Anorexia, Cardiac failure, Chills, Lethargy
SMQs:, Cardiac failure (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ascriptin, Lasix, Lanoxin, Flomax, Tylenol
Current Illness: c/o of chills - was in a w/c
Preexisting Conditions: PT was terminally ill, was not expected to live $g Oct. 02. CHF, renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received influenza vaccine on Tuesday and complained of chills and lethargy the following afternoon. Family was instructed to take him to a doctor as he had a terminal illness, but pt refused to go as he feared he would be placed in a nursing home. Nurse contacted family today and again encouraged he go to hospital as he was not eating, bed-bound and less responsive. He died when he got to hospital 1/17/03. Death certificate received on 3/5/2003 indicates CHF as the cause of death.


VAERS ID: 196572 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-01-08
Onset:2003-01-10
   Days after vaccination:2
Submitted: 2003-01-21
   Days after onset:11
Entered: 2003-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 4020032 / UNK - / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR U0704 / 1 - / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UB307AB / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE. HIV test done on 1-8-03. Results pending.
Preexisting Conditions: History of IV drug abuse including heroin prior to military enlistment
Allergies:
Diagnostic Lab Data: Autopsy performed by Dr. Results pending. Specimens to be sent to CDC for testing.
CDC Split Type:

Write-up: Pt. died 2 days after receiving vaccines. Autopsy resutls pending. Specimens to be sent to CDC for testing. Autopsy report received on 2/12/2003 indicates overdose.


VAERS ID: 231409 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-28
Onset:2002-12-27
   Days after vaccination:60
Submitted: 2004-12-20
   Days after onset:724
Entered: 2004-12-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lanoxin; Prinovil; Atenolol; Lasix; Lopid; Coumadin; Aspirin; Flovent; Combivent; Axid; Dynbac
Current Illness:
Preexisting Conditions: COPD, Pacemaker 1995, Atrial fibrillation, angina, MI in 1991, hypertension, edema, gastric reflux, bronchitis, elevated cholesterol.
Allergies:
Diagnostic Lab Data:
CDC Split Type: F20030552

Write-up: 77 year old male was vaccinated with RSV vaccine or placebo and Influenza vaccine on 10/28/02 and 60 days later collapsed and died at home while showering. It was stated that the patient apparently died of cardiac arrhythmia. Relevant medical history includes a pacemaker in 1995, atrial fibrillation, angina, MI in 1991 and COPD. The subject was unblinded at the request of the investigator for documentation in view of organ donation. The participant received the RSV vaccine. The investigator assessed the event as unrelated to the study products. Additional information received on 12/17/04: The subject collapsed and died at home while showering. Apparently, the cause of death was cardiac arrhythmia. No death certificate is available. Additional information received on 12/20/04 from the investigator: The lot number for the study product was verified to be the same as the subject number and it was confirmed that this subject was unblinded.


VAERS ID: 199061 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Female  
Location: South Dakota  
Vaccinated:2002-11-21
Onset:2002-12-08
   Days after vaccination:17
Submitted: 2002-02-27
   Days after onset:284
Entered: 2003-03-10
   Days after submission:376
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E33472HA / 1 RL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5355A2 / 3 RL / UN

Administered by: Private       Purchased by: Private
Symptoms: Bronchitis acute, Cerebral ischaemia, Cough, Dyspnoea, Laryngitis, Pneumonia, Pyrexia, Stridor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-10
   Days after onset: 301
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy-laryngotracheitis, bronchopneumonia, ischemic brain changes.
CDC Split Type: 03002

Write-up: Admitted to hospital with difficulty breathing, fever, croupy cough, inspratory stridor, acute bronchitis.


VAERS ID: 816253 (history)  
Form: Version 2.0  
Age: 0.58  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2002-11-12
Onset:2002-11-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2019-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0904CA / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNAGIS
Current Illness:
Preexisting Conditions: lung disease, high blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe respiratory distress throughout the night prior to his death, requiring increased nebulizer treatments.


VAERS ID: 194726 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Oregon  
Vaccinated:2002-10-19
Onset:2002-11-08
   Days after vaccination:20
Submitted: 2002-11-29
   Days after onset:21
Entered: 2002-12-10
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0875AA / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Balance disorder, Dysphonia, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-12-04
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death certificate received on 2/5/2003 indicates GBS as the cause of death.


VAERS ID: 194915 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2002-10-30
Onset:2002-11-08
   Days after vaccination:9
Submitted: 2002-11-20
   Days after onset:12
Entered: 2002-12-13
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2002-12-23
   Days after onset: 45
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Methadone
Current Illness:
Preexisting Conditions: BMH: chronic back pain-on Methadone program; gastric bypass 1992, left knee surgery 1997, volvulus repair 1994
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was given flu vaccine 10/30/02 in an outpatient setting. Pt admitted to hospital 11/8/02 with progressive ascending paralysis. Pt diagnosed as having developed Guillain Barr? syndrome. Per aclnowledgement letter: I do not have any way of obtaining this information. pt did not receive the vaccine at our institution. 60 Day Follow up States: Pt expired (exact date unknown) Death affiliated to GBS


VAERS ID: 217666 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2002-11-02
Onset:2002-11-03
   Days after vaccination:1
Submitted: 2004-03-11
   Days after onset:494
Entered: 2004-03-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR V0929AA / UNK RA / -

Administered by: Private       Purchased by: Other
Symptoms: Cerebrovascular accident, Chills, Diarrhoea, Erythema, Headache, Myocardial infarction, Paralysis, Peripheral coldness, Pneumonia, Pyrexia, Urinary tract infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-04
   Days after onset: 273
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Cholesterol; Blood pressure; Blood thinner; Water pill
Current Illness: NONE
Preexisting Conditions: HBP; Retroperiteneal fibrosis; High cholesterol; Swelling of the leg
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection was given Saturday morning, 11/2/02. Sunday night around 11 or so, started throwing up, fever diarrhea, chills, headache. He continued getting up, going to the restroom with the vomiting and diarrhea until about 10am Monday morning 11/4/02. He told my mom sometime later that he could not move his legs. I went to their house around 2:30 PM. Upon entering his room, he was laying in bed on top of the covers. I felt his foot and ankle, they were cool to the touch. I felt his back when he was trying to sit up and it was burning hot. His face was red. He was speaking. He wanted my son and I to help him get up. We were unable to lift him. I called a nurse friend of mine at 2:55 PM to have her stop by and take his blood pressure and kind of check him over. While I was on the phone with her, my mom yelled for me to call an ambulance. It took the ambulance about 5-10 minutes to get to their home. Dad was speaking to the paramedics, telling them what all was going on. They loaded him into the ambulance and he was still alert and speaking. Somewhere in the 2-3 minute trip to the emergency room, my dad died. Upon entering the emergency room, they had made it a code blue call and continued working on him. The ER doctor worked on dad until 6:00 PM when he was life flighted to another hospital. He was taken to ICU where we were told by the doctors they did not know if he would make it through the night. He was in ICU for 7 days. The doctors ran several tests. During this time, we learned that he had become paralyzed from the waist down, he had a spinal stroke, a head stroke and they were not sure if any damage had been done when he actually died (lack of oxygen to the brain). After 2 weeks in the hospital, dad was moved to a rehab center, from there to a skilled nursing facility and from there, home. Over the next 8.5 months, dad was in and out of the hospital. The longest time between hospital stays was 35 days. On 7/1/03, dad was taken to the hospital for fever. He had a UTI. He was in the hospital for about 10 days and they could not figure out why he kept running a fever at night. He was transferred to another hospital. He was given an injection and it reacted with the medication they had him on, he went into rigors, had a massive heart attack and died on 8/4/03. The death certificate received on 3/23/04 states pontine stroke and pneumonia.


VAERS ID: 183721 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: New York  
Vaccinated:2001-10-16
Onset:2002-11-01
   Days after vaccination:381
Submitted: 2002-04-16
   Days after onset:199
Entered: 2002-04-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 90659 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Anaemia, Angina pectoris, Aspartate aminotransferase increased, Atrial fibrillation, Blood albumin decreased, Blood alkaline phosphatase increased, Blood calcium decreased, Blood glucose increased, Blood urea increased, Carbon dioxide increased, Cardiomegaly, Enzyme abnormality, Gastrointestinal haemorrhage, Haematocrit decreased, Haemoglobin decreased, Hepatic neoplasm malignant, Hepatomegaly, Hyperbilirubinaemia, Hypertension, Lymphopenia, Platelet count decreased, Red blood cell count decreased, Red blood cell sedimentation rate increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Liver malignant tumours (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-18
   Days after onset: 318
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix; Adalat; Loppressor; Lopid; MT Patch; Axid; Vioxx
Current Illness: NONE
Preexisting Conditions: Per F/U 6/25/02: heart disease, hypertension, diabetes mellitus, tuberculosis, asthma, pneumonia, bronchitis, jaundice, anemia, gall bladder disease, kidney disease, arthritis, veneral disease, mental illness, rheumatic fever
Allergies:
Diagnostic Lab Data: 11/2/01-Glucose 147 (H); CO2-34 (H); Calcium-8.2 (L); Albumin-3.1 (L); Total bilirubin-2.0 (H); AST and ALT-109 (H) and 186 (H)RBC-3.86 (L); HGB-12.2 (L) HCT-35.2 (L); Platelets-121 (L); MPV-6.9 (L); Neutrophil-80.4 (H); Lymphocyte-8.5 (L); ESR-24 (H). On 11/1/01-BUN 30 (H); CO2-33 (H); Total bilirubin-2.1 (H); Direct bilirubin-1.0 (H); ALK phosphatase-124 (H); AST-123 (H); ALT-205 (H); RBC-3.94 (L); HGB-12.1 (L); HCT-36.0 (L); MPV-7.2 (L); SEGS-74.0 (H); Lymphocyte-7.0 (L); MONOCYTE-14.0 (H); Myelocyte-1.0 (H); PT-14.2 (H); INR-1.40 (H); PTT-22.3 (L); Lipase-151 (H); CT lung-liver is enlarged with nodules, multiple lesions compatible with metastic disease of liver; Chest PA-heart enlarged;
CDC Split Type:

Write-up: Patient was under doctor''s care for years. On October 4th, patient had an enzyme test and the numbers were low (45). He had the flu shot on October 16th. November 1st, he had stage 4 liver cancer. His enzymes were over 260. Patient died on 12/18/2001. Diagnosed at hospital with hepatomegally with liver mass, hypertention, GI bleeding/anemia. Also diagnosed with unstable angina. Pt sent to ER by MD for LUQ pain X 1 week per F/U 6/25/02 and afibrillation.


VAERS ID: 193720 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Texas  
Vaccinated:2002-11-01
Onset:2002-11-01
   Days after vaccination:0
Submitted: 2002-11-01
   Days after onset:0
Entered: 2002-11-21
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0982AA / UNK RA / -

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Respiratory failure
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rocephin TGM IM, Albuterol, Atrovent, xalatian, Advair, Seravent, Lasix, Ambien, Iron, Zanaflex, Lexapro, Elavil, Respirdol, Potassium, Cipro, Floxin, Penicillin, Levaquin, Adhesive Tape, Naprosyn, Timoptic
Current Illness: Asthma
Preexisting Conditions: Nail-patella syndrome, glaucoma, hematuria, hep C, personaltiy disorder, bipolar, narcotic dependence, asthma, hypercholesterolemia, chronic pain.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received flu vaccine and a Rocephin injection after office visit. She developed an anaphylactic reaction and subsequently respiratory failure. Despite resuscitation attempts, patient died. Anaphylactic reaction.


VAERS ID: 345967 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-10-11
Onset:2002-11-01
   Days after vaccination:21
Submitted: 2009-05-08
   Days after onset:2379
Entered: 2009-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide, Dysstasia, Gait disturbance, Injection site atrophy, Injection site pain, Lasegue's test positive, Muscle atrophy, No reaction on previous exposure to drug, Pain, Sciatica, Tenderness, Weight decreased
SMQs:, Peripheral neuropathy (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Repaglinide
Current Illness: Diabetes mellitus type 2 B; Medical diet
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examination: 02 December 2002: tenderness of right side, lateral to lumbar column; Lasegue''s sign on right side at 70? positive; no paresis. 12 December 2002: fluent way of walking; muscle power in legs uneventful; no problems when walking on toes or heels; Lasegue''s sign bilateral negative; right side of hip completely flexible.
CDC Split Type: D0040224A

Write-up: A physician reported the occurrence of lumboischialgia in a 71-year-old male who was vaccinated with INFLUSPLIT SSW 02/03. The subject suffered from Diabetes mellitus type IIb which was treated with diet and NOVONORM. Previous vaccinations with INFLUSPLIT SSW 02/03 were well tolerated. On 11 October 2003 the subject received a dose of INFLUSPLIT SSW 02/03. The subject reported that he developed injection site pain approximately five to six days post vaccination, which became worse from day to day. He also reported that he developed muscular atrophy from the injection site to the foot which still became worse so that he hardly was able to walk. He consulted an emergency doctor several times. Analgesics were not successful. The reporting physician stated that the subject consulted an emergency doctor on 01 December 2002 whom he had told that he suffered from pain in the right iliac wing, occasionally radiating to the right leg for about eight days. The emergency doctor diagnosed lumboischialgia. On 02 December 2002 the subject consulted the reporting physician. The subject described pain in the lumbar column radiating to the right leg. Examination revealed tenderness of the right side lateral to the lumbar column and positive Lasegue''s sign on right side at 70?. There was no paresis. The events were treated with diclofenac. On 12 December 2002 the subject again visited the reporter because of ongoing right gluteal pain. The subject complained on walking difficulties and said he was hardly able to stand on his feet because of the pain. This time the subject suspected a causal relationship to the vaccination. Examination of the subject showed a fluent way of walking, muscle power in his legs was uneventful and he had no problems when walking on his toes or heels. Lasegue''s sign was bilateral negative, the right side of his hip completely flexible. The reporter diagnosed lumboischialgia. He suggested referral to a specialist but the subject refused. At the time of reporting the subject was not recovered. He mentioned that he additionally lost 4kg of body weight in the meantime. The reporting physician considered that lumboischialgia was unlikely related to vaccination with antiinfluenza vaccine. He did not mention any muscular atrophy and weight loss and hence he did not specify the causality for these events. Follow-up information was received on 04 May 2009 from the subject''s wife. The wife stated that the patient had committed suicide, because he could not cope with the extreme pain any more. She considered that all was caused by vaccination with INFLUSPLIT SSW in 2003. The subject died from completed suicide. It was unknown whether an autopsy was performed. No further information will be available.


VAERS ID: 197504 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Colorado  
Vaccinated:2002-10-29
Onset:2002-10-29
   Days after vaccination:0
Submitted: 2003-02-05
   Days after onset:99
Entered: 2003-02-11
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 7+ RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain, Anorexia, Chest pain, Injection site reaction, Metabolic acidosis, Nausea, Pain, Pyrexia, Shoulder pain, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-23
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations: Illness~Influenza (Seasonal) (no brand name)~~0.00~In Patient
Other Medications: Advil; Lomotil
Current Illness: NONE
Preexisting Conditions: Topical allergic reactions; Bypass surgery
Allergies:
Diagnostic Lab Data: WBC 20,000 - 40,000; Severe metabolic acidosis; Heart attack; CT Scans negative
CDC Split Type:

Write-up: Within 2 hours, high fever, brown spot size of nickel at injection site, ache all over, stopped eating and drinking. 3 Advil for 3 hours for unrelieved pain. 2 weeks - abdominal pain and nausea. One week - chest pain and right shoulder pain.


VAERS ID: 195346 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: New York  
Vaccinated:2002-10-23
Onset:2002-10-25
   Days after vaccination:2
Submitted: 2002-12-12
   Days after onset:48
Entered: 2002-12-26
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E35812CA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Gastrointestinal disorder
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-23
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paxil, Vioxx, Inderol, Premarin, Norvasc, Ativan
Current Illness: Infected total knee 5/02
Preexisting Conditions: DM, HTN, SIADH, osteoarthritis, malnurishment, bipolar disorder
Allergies:
Diagnostic Lab Data: Leukocytes 19,500, 92 cegs, 4 lymphs, 4 mono K: 5.6 NA: 119 K: 516 BUN 32 CHL 90
CDC Split Type:

Write-up: 12/25/02 at 12 noon; tongue noted to be edematous and unable to swallow food. Given Benadryl and transported to ER c/o throat swelling and erythema to upper arms bilaterally. Dehydrated with hyponatremia. Rx: hydration, antibiotic-steroid IV. Diagnosed Stevens Johnson syndrome to drug reaction.


VAERS ID: 192931 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Illinois  
Vaccinated:2002-10-18
Onset:2002-10-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2002-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0910AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Encephalitis, Headache, Migraine, Upper respiratory tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OTC, Afrin, Valine
Current Illness: NONE
Preexisting Conditions: History of recurrent sinusitis. Asthma, Meningoencephaitis Viral
Allergies:
Diagnostic Lab Data: CSF 114 94%, CIE-nl, original nl CT/MRI brain. 10/27 herniation.
CDC Split Type:

Write-up: Administered 10/18/02. Developed URI 10/23 migraines with headache, vomiting. Progressed to encephalitis with hospital admission 10/25. Doing fairly well. Onset seizures 10/26. Transferred to another facility. Recurrent seizures. Herniation brain. Death.


VAERS ID: 192477 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Washington  
Vaccinated:2002-10-17
Onset:2002-10-21
   Days after vaccination:4
Submitted: 2002-11-01
   Days after onset:11
Entered: 2002-11-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0983AA / 3 - / IM
YF: YELLOW FEVER (YF-VAX) / CONNAUGHT LABORATORIES U0253AA / 1 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Multi-organ failure, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Pathelogy studies at AF17 now
CDC Split Type:

Write-up: Pt died of distributive shock and multisystem organ failure on 10/26/02.


VAERS ID: 193771 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Michigan  
Vaccinated:2002-10-17
Onset:2002-10-21
   Days after vaccination:4
Submitted: 2002-11-21
   Days after onset:31
Entered: 2002-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0911AA / 1 LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Congenital anomaly, Pneumonia, Unevaluable event
SMQs:, Congenital, familial and genetic disorders (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 1. Claritin syrup 5 mg once a day. 2. Zantac 9 mg twice a day. 3. Reglan 1 mg 3 times a day. 4. Multivitamin 1 mL 1 times per day. 5. Iron 90 mg 3 times per day. 6. Pulmicort 0.5 mg twice a day. 7. Inhaled tobramycin 300 mg twi
Current Illness: 1. Hypoxic-ischemic encephalopathy. 2. Seizure disorder. 3. Cerebral palsy. 4. Recurrent aspiration. 5. Diffuse lymphad
Preexisting Conditions: 1. Hypoxic-ischemic encephalopathy. 2. Seizure disorder. 3. Cerebral palsy. 4. Recurrent aspiration. 5. Diffuse lymphadenopathy and hepatosplenomegaly of unknown etiology. 7. Chronic urticaria. 8. Failure to thrive, improvement after G-tube placement.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt died 4 days after administration of vaccine


VAERS ID: 192848 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Unknown  
Vaccinated:2002-10-01
Onset:2002-10-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2002-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 763353 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Hypertrophy
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200544

Write-up: It was received from a regulatory authority on 10/29/00, concerning an 88 year old pt who experienced cardiac failure and ventricular hypertrophy which led to death 16 days after receiving the Fluvirin vaccine on 10/1/02. The pt had a medical history of dementia, lower respiratory tract infection in June 2002, influenza and anaemia. The pt had been receiving the flu vaccination since 1993. On 10/17/02, 16 days after vaccination, the vaccinee developed an acute cardiac failure following left ventricular hypertrophy and subsequently died. A post mortom examination was performed and cardiac failure was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.


VAERS ID: 191552 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2002-10-15
Onset:2002-10-15
   Days after vaccination:0
Submitted: 2002-10-17
   Days after onset:2
Entered: 2002-10-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Unknown
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN, DM
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 68 year old male reported to have received two vaccines (flu and "pneumonia"). Ambulance was called. Pt was purple from neck up. Medical examiner declined autopsy.


VAERS ID: 192915 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Unknown  
Vaccinated:2002-10-13
Onset:2002-10-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2002-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 763459 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200200543

Write-up: It was received from a regulatory authority on 10/29/00, concerning a 76 year old female pt who experienced ischaemic heart disease resulting in death 2 days after receiving the Fluvirin vaccine on 10/13/02. On 10/15/02, two days after vaccination, the pt experienced ischaemic heart disease and died. A post mortem examination was performed and coronary artery disease was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.


VAERS ID: 197125 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2002-10-09
Onset:2002-10-10
   Days after vaccination:1
Submitted: 2003-01-31
   Days after onset:113
Entered: 2003-02-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UO908AA / 7+ LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Dyspnoea, Lung disorder, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-10-24
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prednisone, albuterol,hytrin, xanox,fosomax, axid, icar-c, roxcodore
Current Illness: COPD
Preexisting Conditions: COPD, lung cancer, hypertension
Allergies:
Diagnostic Lab Data: none
CDC Split Type: MS03005

Write-up: Fever greater than 101 degrees F, chills, shortness of breath, Hospitalized 10/11/02 through 10/16/02 and 10/19/02 through 10/24/02. Death certificate received on 2/19/2003 indicates end stage COPD as the cause of death.


VAERS ID: 182605 (history)  
Form: Version 1.0  
Age: 98.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2001-11-17
Onset:2002-01-01
   Days after vaccination:45
Submitted: 2002-03-15
   Days after onset:73
Entered: 2002-03-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018038 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood chloride decreased, Coronary artery disease, Haemoglobin decreased, Influenza, Myocardial infarction, Nasal congestion, Pyrexia, Respiratory tract infection
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Agitation; Coronary artery disease NOS; Dementia of the Alzheimer''s type NOS; Hypertension NOS; Hypothyroidism; Rami (unspecified) fracture NOS
Allergies:
Diagnostic Lab Data: On 1/23/02, blood chloride 97meq/L (decreased) and haemoglobin 10.5g/dL (decreased); mean cell haemoglobin 31.9pg/cell (increased) and blood thyroid stimulating hormone-pending
CDC Split Type: HQ0814321FEB2002

Write-up: A nurse reported that a 98 year old female resident in a long-term care facility received a dose of Flu Shield ''01-''02 on 11/17/01. In 1/02, the resident developed a "severe" respiratory infection characterized by congestion and fever. On 1/22/02, a dx of influenza A was confirmed by rapid antigen testing. She was treated with Tamiflu (oseltamivir phosphate) and Tylenol (acetaminophen). According to the reporter, the pt "was responding" to these interventions. However, on 1/26/02, the pt died. The pt''s physician indicated that the cause of death was myocardial infarction secondary to coronary artery disease. The physician "didn''t think her death was flu-related" but noted that influenza "may have been a contributory factor but not the primary cause of death". This is 1 of 8 residents from this facility who experienced adverse events following receipt of Flu Shield ''01-''02 (lot 4018038); however, this is the only pt who died. The reporter also noted that 7 employees of the facility experienced adverse events following receipt of Flu Shield ''01-''02 (lot 4018038).


VAERS ID: 180784 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: New York  
Vaccinated:2001-12-26
Onset:2001-12-28
   Days after vaccination:2
Submitted: 2002-01-25
   Days after onset:28
Entered: 2002-02-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018029 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Cardiac arrest, Chest discomfort, Dizziness, Eructation, Hypercholesterolaemia, Hyperhidrosis, Lethargy, Nasal congestion, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Lipodystrophy (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol; Synthroid
Current Illness: NONE
Preexisting Conditions: Chronic controlled hypertension; hypothyroidism; allergic to PCN
Allergies:
Diagnostic Lab Data: Last cholesterol was 225.
CDC Split Type:

Write-up: At 24 hours pt felt lethargic, dizzy. After dinner that night he was sweating, burping. At 48 hours pt had pain in left arm, congestion and tightness in chest. COD as per death certificate -- cardiorespiratory arrest


VAERS ID: 191604 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Florida  
Vaccinated:2001-12-13
Onset:2001-12-15
   Days after vaccination:2
Submitted: 2002-10-28
   Days after onset:317
Entered: 2002-10-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 90658 / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 90732 / UNK - / -

Administered by: Other       Purchased by: Public
Symptoms: Condition aggravated, Decreased appetite, Haemoptysis, Lethargy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Pneumonia
Preexisting Conditions: Alzheimer''s, Alcohol Abuse, Varicose Veins
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pneumonia worsened: lack of appetite, lethargy, coughing blood on 12/15/01 and adm. to hosp.


VAERS ID: 179213 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2001-12-10
Onset:2001-12-11
   Days after vaccination:1
Submitted: 2001-12-12
   Days after onset:1
Entered: 2001-12-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UO708AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sulfa allergy
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: Unexplained death. Awaiting autopsy COD as per autopsy report -- combination of methadone and oxycodone intoxication


VAERS ID: 179131 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: New York  
Vaccinated:2001-11-16
Onset:2001-12-07
   Days after vaccination:21
Submitted: 2001-12-13
   Days after onset:6
Entered: 2001-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E04831KA / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Development disability, Down''s Syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No symptoms of adverse reaction noted following administration of vaccine. Cause of death pneumonia.


VAERS ID: 179130 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: New York  
Vaccinated:2001-11-30
Onset:2001-12-01
   Days after vaccination:1
Submitted: 2001-12-13
   Days after onset:12
Entered: 2001-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E04831KA / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Inderal; Metamucil; Ativan; Vitamin E; Cogentin; Risperdal
Current Illness: NONE
Preexisting Conditions: Development disability; severe MR; mild to moderate scoliosis; intermittent explosive disorder; PICA; history of pin worms; allergy to Navane and Nitrous Oxide
Allergies:
Diagnostic Lab Data: Autopsy performed
CDC Split Type:

Write-up: No symptoms of adverse reaction noted following administration of vaccine. Autopsy performed and cause of death was listed as "Cardiorespiratory failure as a consequence of seizure".


VAERS ID: 179151 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Ohio  
Vaccinated:2001-11-02
Onset:2001-11-29
   Days after vaccination:27
Submitted: 2001-12-17
   Days after onset:18
Entered: 2001-12-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0675BA / UNK RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Guillain-Barre syndrome, Lung disorder
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: metformin; allopurinol
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Guillain Barre syndrome, axonal form. Per doc 214332, 60 day follow-u, patient was discharged to a rehabilitation facility. He reportedly died several days later. I am unsure at the cause of death, though I suspect he may have suffered a massive pulmonary embolism.


VAERS ID: 178960 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Missouri  
Vaccinated:2001-11-28
Onset:2001-11-28
   Days after vaccination:0
Submitted: 2001-11-28
   Days after onset:0
Entered: 2001-12-13
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018041 / 5 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Child maltreatment syndrome
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phenobarbital; Baclofen; Robinul; Extendryl; Zyrtec Syrup; Nasonex Spray; Senocot Children''s Syrup; NaFl; Acetaminophen Solution; Atrovent Neb
Current Illness: NONE
Preexisting Conditions: Shaken baby syndrome at 5 weeks of age; Blind; CA; Seizures; 13 weeks premature; Disorder microcephaly; NPO with G-tubes
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: MO2001063

Write-up: The pt had no problems immediately after injection or prior to being discovered dead in crib at 05:45 on 11/28/01. On the last check of pt at 03:00 on 11/28/01, he was laughing and playing. Death certificate indicates the child died from shaken baby syndrome (suffering from this since 5 weeks old according to the dept of health).


VAERS ID: 178592 (history)  
Form: Version 1.0  
Age: 99.0  
Sex: Male  
Location: Michigan  
Vaccinated:2001-11-20
Onset:2001-11-23
   Days after vaccination:3
Submitted: 2001-12-04
   Days after onset:11
Entered: 2001-12-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UO691AA / 6 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Nephritis, Pyrexia, Urinary retention, Urine analysis abnormal, White blood cell disorder
SMQs:, Acute renal failure (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Positive for bacteria in urine, polynephritis, WBC 40,000 +.
CDC Split Type:

Write-up: High fever 1 AM on 11/23/2001. Taken to hospital. Diagnosis of Urosepsis.


VAERS ID: 232360 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2001-11-12
Onset:2001-11-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2005-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, Sepsis, Urinary tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-06
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, ceti
Current Illness:
Preexisting Conditions: Diabetes Mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100473

Write-up: A report was received from a health professional on 11Dec01 regarding a 78 year old female pt who experienced urinary tract infection (14Nov01), pneumonia (23Nov01), sepsis (unk date) and subsequently died on 06Dec01 after receiving Fluvirin vaccine on 12Nov01. The pt''s medical history included Non insulin diabetes mellitus, hypertension, chronic obstructive pulmonary disease, bipolar disorder, glaucoma, anxiety and right hip replacement. The pt was also receiving brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, cetirizine hydrochloride, paracetamol and insulin. On 12Nov01, the pt received Fluvirin vaccine. Two days later, the pt was hospitalized for urinary tract infection, which resolved on 19Nov01. Then the pt was admitted to hospital for pneumonia on 23Nov01 and discharged on 28Nov01. On 06Dec01, the pt was re-admitted to hospital for an unk reason and died secondary to sepsis on the same day. No death certificate was available. The pt had received a flu vaccine last year without any problem. The reporter has assessed the relationship of study medication to the events as unrelated.


VAERS ID: 178034 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2001-11-13
Onset:2001-11-13
   Days after vaccination:0
Submitted: 2001-11-15
   Days after onset:2
Entered: 2001-11-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0676AA / UNK LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Apnoea, Cardiac arrest, Chills, Livedo reticularis, Musculoskeletal stiffness, Mydriasis, Pulse absent
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of by-pass surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt received Influenza 0.5ml, IM, LA at approx. 12:45. At 14:31, he was found DOA in his car at a local plaza. The fire dept report states that the pt was found slumped behind the wheel of his car. Pt was found to be pulseless/apneic and clutching a NTG bottle in his left hand. The pt was cold, mottled with pooling in the face and arms. Estimated down time 1/2 to 1 hours, according shopkeeper (maybe longer) who noticed car in space for extended time. No trauma noted. Pupils fixed/dilated, pooling in face secondary to position. Pt leaning over steering wheel; neck, arms stiff. Rigor secondary to pt pooling line in hands/forearms, extended down time. Cold, pale/mottled, dry; obvious morbidity. COD as per death certificate -- cardiorepiratory arrest


VAERS ID: 178142 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2001-11-07
Onset:2001-11-12
   Days after vaccination:5
Submitted: 2001-11-20
   Days after onset:8
Entered: 2001-11-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Rash maculo-papular, Vasculitis
SMQs:, Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft
Current Illness: UNK
Preexisting Conditions: Aphasia; Cardiovascular disorder NOS; Cerebrovascular accident NOS
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ8617920NOV2001

Write-up: A physician reported that a female in her late 80''s received an injection of Flu Shield (''01-''02). On 11/12/01, approx. 5 to 7 days post vax, she developed a severe, blistering, maculopapular rash on the front and back of her trunk. She was treated with valacyclovir and steroids. On 11/18/01, she died. No further information was available at the date of this report. Death certificate states cause of death as vasculitis with other significant condition of stroke.


VAERS ID: 178149 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: California  
Vaccinated:2001-11-10
Onset:2001-11-12
   Days after vaccination:2
Submitted: 2001-11-21
   Days after onset:9
Entered: 2001-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 7+ - / IM

Administered by: Other       Purchased by: Public
Symptoms: Coronary artery disease, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had been to PCP on 11/8/01 for a check-up and she was healthy, no medical problems and blood work was normal. She was found on 11/13/01 per housekeeper on the floor. MD signed the death certificate as "atrial fib" but said COD was either heart attach or CVA. No autopsy done. Actual death certificate states cause of death as ventricular fibrillation due to coronary artery disease.


VAERS ID: 177708 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-05
Onset:2001-11-06
   Days after vaccination:1
Submitted: 2001-11-14
   Days after onset:8
Entered: 2001-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; Cardura; Cardizem; Vasotec; Effexor; Imdur; Lopressor; Plavix; Prevacid;Trazadone; Nitroglycerin; Tylenol; Zantac
Current Illness: Hemiparesis due to CVA
Preexisting Conditions: CVA with hemiparesis; hypertension and coronary bypass surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP2001003870

Write-up: The pt was institutionalized in a nursing home and received a Flurvirin injection on 11/5/01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 11/6/01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unknown. Death certificate states cause of death to be coronary artery disease.


VAERS ID: 232259 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2001-11-05
Onset:2001-11-06
   Days after vaccination:1
Submitted: 2002-10-10
   Days after onset:337
Entered: 2005-01-14
   Days after submission:827
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin, Cardora, Cardizem, Vasotec, Effexor, Imdur, Lopressor, Plavix, Prevacid, Trazadone, Nitroglycerin, Tylenol, Zantac
Current Illness:
Preexisting Conditions: Acute but ill-defined cerebrovascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100387

Write-up: A report received from a health care professional on 08Nov01 regarding a 61 year old male pt who died on 06Nov01 after receiving Fluvirin vaccine on 05November2001. Relevant medical history included right CVA(hemiparesis), hypertension and coronary bypass surgery. The pt was taking acetylsalicylic acid, doxazosin mesilate, diltiazem hydrochloride, enalapril maleate, venlafaxine hydrochloride, isosorbide mononitrate, metoprolol tartrate, clopidogrel sulfate, lanscprazole, trazodone, glyceryl trinitrate, parecetamol and ranitidine hydrochloride. The pt was institutionalized in a nursing home and received a Fluvirin injection on 05Nov01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 06Nov01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unk.


VAERS ID: 178470 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: California  
Vaccinated:2001-11-04
Onset:2001-11-05
   Days after vaccination:1
Submitted: 2001-11-29
   Days after onset:24
Entered: 2001-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Dysphagia, Pain, Pharyngolaryngeal pain, Skin exfoliation, Swelling face, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allopurinol; benazepril; burnetanide; KCI; simvastatin; warfarin; colchicine; prenatal vitamins; epoetin alpha; pamidronate; metolazone; insulin
Current Illness:
Preexisting Conditions: Multiple myeloma; Rheumatic heart disease with mechanical valve; Gout; DM; HTN; decreased renal function and Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt developed body aches, chills, sore throat and increasing difficulty swallowing with swelling of lip, 1 day after receiving influenza vaccine injection and about 8 weeks after beginning Allopurinol (history of receiving influenza vaccine yearly without reaction; Allopurinol initially 100mg OD but increased to 300mg several weeks later). Pt had 80% to 90% body surface area sloughing (Toxic Epidermal Necrolysis). Admitted to the hospital, 1 day after development of above mentioned signs and symptoms; allopurinol discontinued and treated with antibiotics and steroids. After 16 days in the hospital, he was transferred to another hospital service where steroids were discontinued; treated with IVIG, silver nitrate topical. Wounds continued to slough and pt expired on 5th hospital day.


VAERS ID: 177705 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Florida  
Vaccinated:2001-10-31
Onset:2001-11-03
   Days after vaccination:3
Submitted: 2001-11-07
   Days after onset:4
Entered: 2001-11-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E06221KA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac failure congestive, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: End stage cardiomyopathy; chronic atrial fibrillation; IDDM; renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt expired at 11:30 AM on 11/3/01. Death certificate states cause of death as cardiopulmonary arrest due to congestive heart failure. Other significant conditions noted were endstage cardiomyopathy and IDDM. Cause of Death as per Death Certificate was cardiopulmonary arrest.


VAERS ID: 177308 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Texas  
Vaccinated:2001-10-22
Onset:2001-10-29
   Days after vaccination:7
Submitted: 2001-10-31
   Days after onset:2
Entered: 2001-11-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0674AA / 1 - / IM

Administered by: Other       Purchased by: Military
Symptoms: Dementia, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SA0113

Write-up: The patient rapidly developed respiratory failure with oxygen desaturation days after receving the vaccination. Annual follow up states that pt did not recover. Replied to your letter dated 06/26/02 by fax on 07/17/02. Death certificate sent, as requested. Annual follow up on 11/25/03: "It is unknown if the patient recovered from the adverse event." Death Certificate Info: Immediate cause: Pneumonia. Underlying cause: Advanced Dementia. Significant Conditions: Diabetes Follow up on 06/01/2004: states it is unknown if the pt recovered from the adverse event.


VAERS ID: 177309 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Texas  
Vaccinated:2001-10-22
Onset:2001-10-29
   Days after vaccination:7
Submitted: 2001-10-31
   Days after onset:2
Entered: 2001-11-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0674AA / 1 - / IM

Administered by: Other       Purchased by: Military
Symptoms: Apnoea, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-11-09
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zoloft, Deparene, Phenobarbitol, Cogentin, Premarin
Current Illness:
Preexisting Conditions: Dementia, Hypertension, Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: SA0112

Write-up: The patient rapidly developed respiratory failure and oxygen desaturation days after vaccination. Transferred to hospital. Per F/U on 6/25/02: immediate cause of death; respiratory failure and pneumonia.


VAERS ID: 178523 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2001-10-25
Onset:2001-10-27
   Days after vaccination:2
Submitted: 2001-12-03
   Days after onset:37
Entered: 2001-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Ascites, Cardiomegaly, Dyspnoea, Hypoxia, Mitral valve incompetence, Myalgia, Pyrexia, Respiratory disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-17
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisone 20 mg BID times 3 weeks. Discontinued same day.
Current Illness: Pulmonary fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Bronchoscopy; open lung biopsy; CXR-infiltration
CDC Split Type:

Write-up: 2 days, post vax, the vaccinee complained of chills, myalgias and shortness of breath. 3 days, post vax, his temperature was 102F; CXR with infiltrate and pulse ox 85%. He was admitted and rx''d with Zithromax, O2 and steroids. CXR and clinical determination to ARDS, mechanical ventilation and death. Autopsy findings state cardiomegaly and left and right ventricular hypertrophy; focally calcified mitral valve. Secondary findings: ascites.


VAERS ID: 178150 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-10-15
Onset:2001-10-15
   Days after vaccination:0
Submitted: 2001-11-19
   Days after onset:35
Entered: 2001-11-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 759803 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Coma, Convulsion, Electroencephalogram abnormal, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Mixtard; Levothyroxine Sodium; Lasilix Special (furosemide); Cibacene (benazepril hydrochloride); Zopiclone; Epoietine (erythropoietin); Speciafoloine (folic acid); Emla; Polaramine; Imodium; Eucalcic (calcium carbonate); Xayexalate (sodium
Current Illness:
Preexisting Conditions: Obesity; Renal failure; Essential Hypertension; Diabetes Mellitus; Congestive heart failure; Unspecified Hypothyroidism
Allergies:
Diagnostic Lab Data: EEG on 10/17/01 revealed post anoxic damage of the encephalon trunk which had expanded to the cortex on 10/19/01; CT scan on 10/24/01 revealed old lacuna and post anoxic oedema; Cardiac echography, cervical doppler and inferior limb doppler were nml.
CDC Split Type: PJP2001003930

Write-up: On 10/15/01, the pt received Fluvirin while glucose level was 0.90 g/l. A few hours later, she experienced malaise which was reported as moderate and persistent (no further details). On 10/16/01, the pt experienced sudden malaise followed by convulsions and a cardiac arrest. The pt was revived shortly after cardiac massage and dialysis was commenced in case of hyperkalemia (no prior checking of potassium and glucose levels was performed). The pt''s outcome was dx''d as coma with status convulsions. The pt died on 11/2/01 and the cause of death was reported as status convulsions. The reporter stated that potassium levels prior to dialysis were frequently high due to pt non-compliance. There was also an important sodium retention. There was insufficient information to determine the reporter''s assessment.


VAERS ID: 179776 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-10-15
Onset:2001-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2002-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 75980J / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood potassium increased, Brain oedema, Cardiac arrest, Coma, Electroencephalogram abnormal, Hypoglycaemia, Malaise, Sodium retention, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Hypoglycaemia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Mixtard; levothyroxin sodium; Lasilix Special; Cibacene; zopiclone; erythopoeitin; furosemide; Speciafoldine; Emla; Dolamamine; Imodium; Eucalcic; Kayexalate Nifluril; Piascledine; Atarax; Voltaren
Current Illness:
Preexisting Conditions: Diabetes Mellitus; obesity; dialysis for renal failure due to diabetes; hypertension; congestive heart failure; hypothyroidism
Allergies:
Diagnostic Lab Data: EEG-post anoxic damage of the encephalon trunk which had expanded to the cortex on 10/19/01; CT scan-old lacuna and post anoxic oedema; cardiac echography, cervical doppler and inferior limp doppler-nml
CDC Split Type: PJP200100393

Write-up: A report was received on 11/13/01 regarding a 68 year old female pt who experienced malaise, coma, convulsions and a cardiac arrest on 10/16/01 and who later died from status convulsions on 11/2/01 after receiving Fluvirin vaccine on 10/15/01. The pt had previously received influenza vaccine with no side effects. She had no history of convulsions. On 10/15/01, the pt received Fluvirin while glucose level was 0.90g/l. A few hours later, she experienced sudden malaise followed by convulsions and a cardiac arrest. The pt was revived shortly after cardiac massage and dialysis was commenced in case of hyperkalemia (no prior checking of potassium and glucose levels was performed). The pt''s outcome was dx''d as coma with status convulsions. The pt died on 11/2/01 and the cause of death was reported as status convulsions. The reporter stated that potassium levels prior to dialysis were frequently high due to pt non-compliance. There was also an important sodium retention. There was insufficient information to determine the reporter''s causality assessment. Further information was received on 12/28/01; According to the reporter, the risk factors and the onset period of the convulsions (which was a slightly too long) after the vaccination, makes it difficult for a causal relationship between the flu vaccination and the convulsions followed by a cardiac arrest to be established. On the other hand, aporex (Di-Antalvic) may have been at the origin of the convulsions through hypoglycemia.


VAERS ID: 177680 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2001-10-10
Onset:2001-10-11
   Days after vaccination:1
Submitted: 2001-11-08
   Days after onset:28
Entered: 2001-11-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Injection site pain, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Deltacortril; Xanax; Lanoxin; Agelan (indapamide)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100344

Write-up: A report was received on 10/31/01 concerning a 72 year old male pt who experienced back pain, injection site pain, myalgia and syncope, which were considered serious as the pt later died, 1 day after receiving the Fluvirin vaccine on 10/10/01. Relevant concomitant medications taken included prednisolone,alprazolam, digexin and indapamide homahydrate. On 10/11/01,the patient experienced back pain,injection site pain, myalgia, syncope, 1 day after receiving the fluvirin vaccine on 10/10/01. The patient subsequently died, date and cause of death have not been provided. The reporter has assessed the relationship of study medication to the event as possible. Further information received on 02/02/02 indicated the following: The patient had sognificant concomitant illnesses including possible vasculitis, anxiety, paroxysmal atrial fibrillation and high blood pressure. The patient initially experienced local pain in the deltoid area and than flu-like myalgia, followed by left lumbar pain, prostration, hospitalization and death.The cause of death is possible viral septicaemia but this has not been confirmed.The patient had been given intravenous antibiotics for his symptoms. No death certificate available.


VAERS ID: 181457 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Iowa  
Vaccinated:2001-10-09
Onset:2001-10-10
   Days after vaccination:1
Submitted: 2001-10-19
   Days after onset:9
Entered: 2002-02-19
   Days after submission:123
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0572EA / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Bacterial infection, Cardiogenic shock, Chills, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Heart valve replacement; CAD
Allergies:
Diagnostic Lab Data: C & S X 2-reported as staph aureus
CDC Split Type: IL01053

Write-up: We were contacted by HD who received a call from a MD stating pt received flu shot on 10/09/01 and developed rigors and a fever of 103F later that night. He was seen in ER and developed cardiogenic shock and died.


VAERS ID: 177953 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-02
Onset:2001-07-01
   Days after vaccination:241
Submitted: 2001-11-14
   Days after onset:136
Entered: 2001-11-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Alveolitis fibrosing, Condition aggravated, Cough, Dyspnoea, Hypoxia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prednisolone
Current Illness: Cough, dyspnea, pulmonary fibrosis
Preexisting Conditions: Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Pulse Oximetry-60%
CDC Split Type: WAES01110870

Write-up: Information has been received from the Health Authority concerning an 80 year old male who on 11/2/00 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and also an influenza virus vaccine. It was reported that, post vax, the pt presented with activation of lung fibrosis with increasing shortness of breath on exertion and progressive cough. Eight months later, in approx. 7/01, the pt died from progressive cryptogenic fibrosing alveolitis. It was reported that the pt required increased steroids (prednisolone increased from his usual 10mg daily to 30mg). Oxygen saturation was 60% on exercise. The pt died of respiratory failure with hypoxia. Cryptogenic pulmonary fibrosis had been stable for 3 years. No post mortem was performed. It was reported that the case was closed. No further info is available.


VAERS ID: 164758 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2000-12-19
Onset:2000-12-20
   Days after vaccination:1
Submitted: 2000-12-21
   Days after onset:1
Entered: 2001-01-17
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008175 / 1 - / IM

Administered by: Public       Purchased by: Public
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of heart problems in the past.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: LA010101

Write-up: The pt experienced a heart attach and died. The pt had a hx of heart problems in the past.


VAERS ID: 164158 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Arizona  
Vaccinated:2000-12-13
Onset:2000-12-15
   Days after vaccination:2
Submitted: 2000-12-19
   Days after onset:4
Entered: 2000-12-28
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0453AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: K-Dur, bumetanide, nitroglycerine, Zeroxin, Lipitor, Azmacort, Atrovent
Current Illness: NONE
Preexisting Conditions: CAD; Chronic CHF
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death within 48 hours, post vax; Myocardial Infarction.


VAERS ID: 165924 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Idaho  
Vaccinated:2000-12-01
Onset:2000-12-15
   Days after vaccination:14
Submitted: 2001-01-02
   Days after onset:18
Entered: 2001-02-16
   Days after submission:45
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / PFIZER/WYETH 4008181 / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lescol, Verapamil, Zestril, Zantac, Coumadin, ASA, Vitamins
Current Illness: NONE
Preexisting Conditions: No known allergies, CAD, PVD, HTN, PUD, Oral CA, Hyperlipidemia
Allergies:
Diagnostic Lab Data: CT Scan head, CBC Chem panel - All Wnl
CDC Split Type: ID01003

Write-up: This patient has Guillain Barre'' Syndrome, He was hospitalized. Follow up 07/06/2001: "Final diagnosis was GBS. Patient experienced other previous illnesses or medical conditions before the onset of GBS, however, it was not stated. Patient was previously vaccinated with INfluenza prior."


VAERS ID: 165525 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Alabama  
Vaccinated:2000-12-08
Onset:2000-12-09
   Days after vaccination:1
Submitted: 2000-12-09
   Days after onset:0
Entered: 2001-02-02
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008187 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Mydriasis, Pulmonary congestion, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: insulin in AM and PM
Current Illness:
Preexisting Conditions: type I diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt was found in bed at home without a pulse of respirations at 8:00 am on 12/9/00. She was given a glucogon injection and CPR was started and continued until EMS arrived. The pt was intubated and 2 doses of epinephrine and 1 dose of atropine were given during transport to the ER. The pupils were fixed and dilated. At the ER, the pt received epinephrine and atropine in the ER. The pt expired at 9:30 AM on 12/9/00 with cause of death being cardiopulmonary arrest. The pt had taken the normal dose of insulin on 12/8/00 with an accucheck of 147 at 10:20PM on 12/8/00. She had received the flu vaccine at 3:00PM on 12/8/00 in the physicians office. Death certificate states cause of death to be cardiopulmonary arrest. Autopsy report states: pulmonary vascular congestion and edema.


VAERS ID: 169361 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Unknown  
Location: Alabama  
Vaccinated:2000-12-08
Onset:2000-12-09
   Days after vaccination:1
Submitted: 2001-01-16
   Days after onset:38
Entered: 2001-05-02
   Days after submission:105
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008174 / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5878312JAN2001

Write-up: A healthcare professional reported that a 4 year old child received an injection of the Flu Shield 2000-2001 formula on 12/8/00. The following day, the child died. No further information was available at the date of this report.


VAERS ID: 164361 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:2000-12-05
Onset:2000-12-08
   Days after vaccination:3
Submitted: 2000-12-28
   Days after onset:20
Entered: 2001-01-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0428AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Cough, Diarrhoea, Headache, Influenza like illness, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type: U200000993

Write-up: It was reported that a male pt received Fluzone SV ''00-''01 vaccination on 12/5/00. Approx. 3 days, post vax, pt developed "flu-like" symptoms. Pt was admitted to the hospital on 12/10/00. Pt expired on 12/18/00 and an autopsy was done, results not provided. Further information requested. Autopsy also states patient had headaches, muscle aches, diarrha, nausea, vomiting, fever, cough, sore throat, abdominal pain.


VAERS ID: 163596 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Alabama  
Vaccinated:2000-12-04
Onset:2000-12-05
   Days after vaccination:1
Submitted: 2000-12-05
   Days after onset:0
Entered: 2000-12-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0415AA / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Cortef, DDAVP, Synthroid, Dimetapp, Ventolin
Current Illness: ROM, URI
Preexisting Conditions: Optic Glioma, Panhypopituitarism, GERD, Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt arrived at the medical center in full arrest. Grandmother had found him struggling for breath in bed. Death certificate received states cause of death: respiratory arrest due to cardiac arrest due to respiratory distress. Other significant conditions noted was a brain tumor.


VAERS ID: 163673 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2000-11-30
Onset:2000-12-01
   Days after vaccination:1
Submitted: 2000-12-12
   Days after onset:11
Entered: 2000-12-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E59090GA / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Circulatory collapse, Feeling abnormal, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: CT200006

Write-up: Pt volunteer fireman, called out on evening of 12/1/00, was photographer. Wasn''t feeling well. Vomited at the scene. Refused treatment by EMT''s. Returned home, collapsed and EMT''s were unable to resuscitate.


VAERS ID: 166141 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-23
Onset:2000-11-27
   Days after vaccination:35
Submitted: 2001-02-15
   Days after onset:80
Entered: 2001-02-26
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Cardiac disorder, Cardiac failure, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole, Aspirin, Simvastatin, Gliclazide, Nifedipine, Trandolapril, and Doxazosin.
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES01020713

Write-up: Information has been received from a health professional concerning a 76 year old male who on 10/12/00 was vaccinated IM with a dose of Pneumococcal vaccine 23 Polyvalent. Concomitant therapy included on 10/23/00, a dose of Influenza virus vaccine. It was reported that the patient suddenly died on 11/27/00. A post mortem was performed and revealed the cause of death a bronchopneumonia, ischemic heart disease, and heart failure. The reporter states that the death was possibly coincidental. Further info is not expected. The case is closed.


VAERS ID: 165497 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Texas  
Vaccinated:2000-11-21
Onset:2000-11-26
   Days after vaccination:5
Submitted: 2001-01-23
   Days after onset:58
Entered: 2001-02-01
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR 40428AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cerebral haemorrhage, Cerebrovascular disorder, Delirium, Headache, Vein disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa
Current Illness: depression, stress reaction
Preexisting Conditions: seasonal allergies, stress reaction, depression
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: The mother states patient had a headache and had been vomiting and collapsed.Mom found her unrepsonsive. Went to ER found blood in head. Went by care flight and 2nd hospital for surgery attempted; didn''t wake, worse bleeding from "abnormal plexus of veins" in cerebellum patient expired. Death certificate states cause of death to be cerebral herniation due to rupture of cerebellar arteriovenous malformation.


VAERS ID: 163506 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Georgia  
Vaccinated:2000-11-21
Onset:2000-11-21
   Days after vaccination:0
Submitted: 2000-11-22
   Days after onset:1
Entered: 2000-12-11
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR 40422CA / 4 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA00123

Write-up: The pt received the flu shot on 11/21/00 without complications. The pt was found ill at home by his son and subsequently died at 5:00pm that same day.


VAERS ID: 165970 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Florida  
Vaccinated:2000-11-15
Onset:2000-11-15
   Days after vaccination:0
Submitted: 2001-02-13
   Days after onset:90
Entered: 2001-02-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E71290LA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Aneurysm, Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received phone from from daughter of pt requesting manufacturer and lot number. Stated that her father died at 8:30 PM the day he received the flu vaccine from a heart aneurysm.


VAERS ID: 179927 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2000-11-14
Onset:2000-11-14
   Days after vaccination:0
Submitted: 2000-12-15
   Days after onset:31
Entered: 2002-01-14
   Days after submission:395
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E66350NA / UNK RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Cardiac arrest, Coma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: PCN allergy; history of diabetes and hypertension.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SC00094

Write-up: The pt received influenza vaccine during AM hours. The pt seemed fine for several hours but was found unresponsive by a neighbor that afternoon. Resuscitation efforts failed and the pt was pronounced dead at 17:52 on 11/14/00. Her death was felt to be sudden cardiac death with a history of diabetes and hypertension. Please not the date of the event, 11/14/01, is the correct date. The pt died on the same day he received influenza immunization.


VAERS ID: 165569 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: California  
Vaccinated:2000-11-08
Onset:2000-11-09
   Days after vaccination:1
Submitted: 2001-01-18
   Days after onset:70
Entered: 2001-02-06
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E67330KA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Headache, Injection site haemorrhage, Injection site pain, Neck pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol #3, Atrovent Inhaler, Valium, Altace, Pravachol/Azmacort
Current Illness:
Preexisting Conditions: Bronchitis, asthma, back and heart surgery history with back surgery 2 months previously and hayfever. Myeloid leukemia, ASHD.
Allergies:
Diagnostic Lab Data: Blood work, Urine test, Bone Marrow
CDC Split Type: CA000163

Write-up: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.


VAERS ID: 161790 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2000-11-03
Onset:2000-11-08
   Days after vaccination:5
Submitted: 2000-11-10
   Days after onset:2
Entered: 2000-11-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008173 / 1 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Abdominal pain, Cough, Pneumonia, Pyrexia, Respiratory distress, Restlessness, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-02-07
   Days after onset: 91
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: nitrofurantoin, Zantac, Ditropan, ibuprofen, Tylenol PM, cyanocobalamin (vit-B), Paxil, furosemide, prednisone
Current Illness: NONE
Preexisting Conditions: Senile dementia, UTI, dermatitis, depression, stomach function disease, pernicious anemia, neurogenic bladder, insomnia, pemphigoid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 11/8/00 at 02:00, pt moaning with abdominal pain. On 11/9/00 at 01:00, pt moaning with increased temperature to 99 (ax), wheezing, restless and at 03:30 started coughing. SpO2 90%. Given Tylenol and Robitussin. At 21:40, pt moaning, wheezing in lower lobes. V/S 76/41, 114, 48, 97.4F (ax); SpO2 78%. Transferred by ambulance to hospital. Of the 21 individuals receiving immunizations 11/3/00, there were only 2 on prednisone that had sudden respiratory distress on the 6th day, post vax. Follow up received on 4/24/01 states the pt passed away on 2/7/01. Cause of Death - pneumonia.


VAERS ID: 163254 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-11
Onset:2000-11-05
   Days after vaccination:25
Submitted: 2000-11-29
   Days after onset:24
Entered: 2000-12-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 757702 / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort, Salbutamol
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006190

Write-up: A 50 year old man experienced a sudden unexplained death, 25 days post vax. The pt was also on Pulmicort and salbutenol for asthma. A postmortem exam was not performed. Cause of death unknown. The reporter states they were merely reporting an occurrence and there was no additional relevant information to note.


VAERS ID: 170129 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Alabama  
Vaccinated:2000-10-27
Onset:2000-11-04
   Days after vaccination:8
Submitted: 2001-05-08
   Days after onset:184
Entered: 2001-05-23
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Cough, Dyspnoea, Hyperventilation, Hypoxia, Oedema, Pneumonia, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Morbid obesity (411 lbs, 5''5"), seizure disorder (long standing history), history of GERD, mild to moderate mental retardation, NKDA, history of medication noncompliance, and type II diabetes mellitus.
Allergies:
Diagnostic Lab Data: RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative.
CDC Split Type:

Write-up: This patient was admitted thru the ER on 11/04/01 with progressive SOB, chest pain in the mid-chest associated only with cough, and deep breath. According to the family the patient there were no new problems until one day after the patient received the influenza vaccine when he ran a fever and became progressively following that injection. The influenza vaccine was given about 1 week PTA. On the day of admission, he developed severe, SOB, and developed pleuritic chest pain. RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative. On admit the patient had scattered rhonchi.


VAERS ID: 162632 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-10-05
Onset:2000-11-03
   Days after vaccination:29
Submitted: 2000-11-22
   Days after onset:19
Entered: 2000-11-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gangrene, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ferrousSo4, glyburide, tolbutamide
Current Illness:
Preexisting Conditions: diabetes mellitus, metabolic disorder
Allergies:
Diagnostic Lab Data: blood culture
CDC Split Type: WAES00111386

Write-up: Approximately 4 weeks post vax, the pt experienced gas gangrene of the left arm and was hospitalized. She had been unwell for two days before admission, initially with a sore left arm and then systematically unwell. On 11/3/00 within several hours of admission to the hospital, the pt died. Clostridium septicus was cultured from blood cultures on 11/7/00. A post-mortem apparently showed no other pathology, although histology results were awaited. The sites of vaccination were not recorded and therefore are unavailable. The cause of death was gangrene. F/U no further info is expected. The case is considered closed.


VAERS ID: 164060 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2000-11-01
Onset:2000-11-02
   Days after vaccination:1
Submitted: 2000-12-19
   Days after onset:47
Entered: 2000-12-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E65620HA / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Myocardial infarction, Pneumonia, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-12
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Coumadin
Current Illness:
Preexisting Conditions: Arteriosclerotic cardiovascular disease; unknown atrial fibrillation
Allergies:
Diagnostic Lab Data: Influenza titer-neg
CDC Split Type: MPI2000049800

Write-up: Report received on 12/12/00, via telephone from a nurse regarding a possible adverse event associated with Fluvirin. On 11/1/00, an 80 year old male pt (DOB 8/1920), received vaccination with Fluvirin and 1 day later, developed a fever of unknown origin. The pt was seen in the ER and hospitalized. He was dx''d with pneumonia and died on 11/12/00 from respiratory failure secondary to the pneumonia. An influenza titer was done during the pt''s hospitalization with negative results. On follow-up, the reporter also stated that the physician felt that it was a coincidence of events that ensued following vaccination. No other information was available at the present time. Attempts are being made to obtain further information. FU shows the pt had a non Q wave myocardial infarction.


VAERS ID: 163777 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-27
Onset:2000-11-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2000-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ventolin, Becotide, KEtotifen, Co-Amilofruse, Flecainide
Current Illness:
Preexisting Conditions: asthma, allergic rhinitis, atrial fibrillation, left ventricular failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006440

Write-up: A 63 year old male pt with a hx of asthma, allergic rhinitis, atrial fibrillation and left ventricular failure, developed a pulmonary embolism 6 days after receiving Fluvirin vaccine. The pt was also receiving Ventolin, Recotide, ketotifen, Co-amilofruse, and flecenide. The pt died the day of the event. The reported considered this event to be unrelated to the Fluvirin vaccination.


VAERS ID: 232301 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2000-11-02
Onset:2000-11-02
   Days after vaccination:0
Submitted: 2002-10-10
   Days after onset:706
Entered: 2005-01-14
   Days after submission:827
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / 2 - / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Hypoxia, Pulmonary fibrosis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisolone 10mg
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100359

Write-up: An anonymised single pt print received on 05Nov01 regarding a 80 year old male pt who experienced aggravated pulmonary fibrosis (date not provided) after receiving influenza vaccine (brand unspecified) on 02Nov00.The pt had received Pneumovax II vaccine on the same day. The pt''s medical history included cryogenic pulmonary fibrosis which had been stable for 3 years and concomitant medication included prednisolone. After flu and Pneumovax injections, the pt experienced aggravated lung fibrosis with increasing shortness of breath on exertion and progressive cough. The pt''s oxygen saturation was 60% on exercise. Therapeutic measures taken as a result of the event included prednisolone increased from 10mg daily to 30mg daily. The pt died (date not specified) of respiratory failure with hypoxia


VAERS ID: 167704 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2000-11-01
Onset:2000-11-01
   Days after vaccination:0
Submitted: 2001-03-19
   Days after onset:138
Entered: 2001-03-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E6562CHA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Apnoea, Asthenia, Blood glucose increased, Cardiac failure congestive, Disorientation, Dyspnoea, Hypoxia, Infection, Movement disorder, Myocardial infarction, Nausea, Osteoporosis, Pain, Pharyngolaryngeal pain, Pneumonia, Psychotic disorder, Pyrexia, Speech disorder, Tremor
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cancer, heart attack 1999, Cataract surgery 2000, pneumonia 2x.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This patient was admitted to the hospital on 11/01/00 and died on 11/12/00. The patient was examined and given a flu shot on 11/01/00, he had shortness of breath and sore legs, so the doctor wanted to do a CXR, R-Tibia X-ray, and a EKG. His diagnosis was osteoporosis. The patient was taken to the ER on 11/01/00 at 10 PM because he had terrible tremors, fever, weakness, and nausea. The patient was immediately admitted to the hospital and he told the doctor of his flu shot the doctor said he had a mild heart attack, had a high fever, and there appeared to be an infection in his lungs. The patient had two previous bouts with pneumonia treated with antibiotics an no lung problems since then. The patient was put in the ICU on a respirator. Saw an infectious disease doctor who focused on his right leg because she thought there might be an infection but there was no sign of infection. The patient was eventually put in telemetry on the 8th floor. He had a monitor that would show signs of a heart attack at the nurses station. His fever was still high and the wife was told they would watch her husband to make sure the fever goes down but there were no cold blankets, no ice packs. He was on a nose device for oxygen. The wife and friends observed a lack of activity in looking in on the patient. By Sat. there was no news as to the infection or the fever. On Sat. night the patient spent time with his wife had two visitors who thought he was bloated, he was weak, when he went to the bathroom. Prior to his trip to the bathroom the wife noticed that he did not have his oxygen nose piece in. It was carefully wrapped and hanging in the back of the patient''s bed. The patient said they took it off. That evening when the wife left she asked for the nurses to help and look in on her husband because he was weak and could fall and hurt himself. That evening about 8:30 PM the wife received a phone call her husband took a turn for the worse and was being put back on a respirator and back into ICU. When she arrived she was not able to see her husband until 10:30 PM, three nurses assured her that he had been in the bathroom and had an attack, while they were with him. A female resident told the wife she had to put a tube down his throat because he could not breathe. The next three days were critical (the doctor said the next 24 hours). The patient was very weak, his kidney were slowing. By Thursday he improved and the respirator was removed. They were going to test him, he was put in a chair and strapped; he swallowed soft items; he was at first disoriented (ICU psychosis) as the nurses and doctors put it. He then wanted water and said his throat hurt. He was moved back to Telemetry on Friday afternoon was alert and talking. The doctors were told again of the patient''s recent flu shot before his attack and the doctors could not believe it. They were more concerned with the patient lungs than his heart. The doctor told the wife that the patient had congestive heart failure and sometimes a bigger attack occurs after a small one. The family never knew of his congestive heart failure. To the family''s knowledge he was not ordered to curtail some heavy activities. The patient was put on an ice blanket because the fever was up. The wife requested for his move back up to the 8th floor that her husband be put across from the nurses station and not at the end of the hall, the doctor noted that. The wife asked why he was being taken off from the monitor so fast. The patient was still weak, he could not move his arms, his speech was weak. About 9 PM on Saturday the patient''s sugar was high 300+. He needed insulin, and his wife requested that they make sure he sipped some ensure or he would bottom out. The wife was worried about her husband at this point a nurse had said he was "very sick" so she requested to speak with the doctor in the morning (Sunday) and reminded the nurses he had a living will on file. The patient told his wife she''d better go it was getting late and that was the last time she saw her husband alive. She received a call at approximately 3 AM that he had taken a turn for the worse, same night, same staff, same floor as the previous week. The wife reminded the nurse of the living will. When she arrived at the door of her husbands room she found 25 people in the room with paddles, pumps, respirators, electronic shocks. She screamed at the same resident from the previous week that she should have know better, that they had talked. She asked why they had put her husband through that when she talked about this very thing with the nurses around 10 PM that night. The resident said oh you didn''t want us to do it, she then turned around went back into the room and told everyone to stop. The resident told the wife that her husband was not breathing and they did everything to revive him. The wife stated that this is not what her husband wanted and asked everyone in the room how would they feel if it was their son or husband. The husband was dead and the wife had several questions.


VAERS ID: 161041 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Ohio  
Vaccinated:2000-10-19
Onset:2000-10-20
   Days after vaccination:1
Submitted: 2000-10-23
   Days after onset:3
Entered: 2000-10-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0335AB / 2 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CAD, DM, HTN, MI, CVA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received flu vax on 10/19/00. She expired in her sleep on 10/20/00.


VAERS ID: 172391 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2000-10-06
Onset:2000-10-20
   Days after vaccination:14
Submitted: 2001-05-14
   Days after onset:206
Entered: 2001-06-26
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E68780KA / UNK - / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Asthenia, Cough, Dysarthria, Dysphagia, Paresis, Rhinitis
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-20
   Days after onset: 516
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI - neg, Lyme - neg, EMG w/tensilon test - neg
CDC Split Type: PA0147

Write-up: Two weeks following immunizations with flu vaccine developed cough, coryza, weakness over the course of week developed dysarthia, dysphagia with cranial nerve paresis on exam. Diagnosed with ALS. According to 213289, 60 day follow up, patient died 03/20/2002 from ALS, unassociated with flu vaccine. Follow up on 09/18/2001: "The patients right arm was prepped and draped in a sterile fashion. 1% Xylocaine was employed for local anesthesia. A hand injection of contrast through a peripheral angiocath provided opacification of the deep veins of the right arm. The right basilic vein was accessed under fluoroscopic guidance with a micropuncture set. A cook PICC catheter was then trimmed to a length of 36cm and advanced through a peel-away sheath into the SVC. A hand injection of contrast through the catheter reveals the tip in the superior vena cava. The catheter was flushed and sutured in place. The catheter was then heparinized with 400 units Heparin and the patient was returned to the post-operative lounge in stable condition. "


VAERS ID: 162098 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2000-10-17
Onset:2000-10-17
   Days after vaccination:0
Submitted: 2000-11-06
   Days after onset:20
Entered: 2000-11-17
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol, Bisacodyl, Cagipen, Micralax, Mystecline
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000005610

Write-up: Approximately 1 - 1.5 hours post vax, a 93 year old pt subsequently experienced sudden collapse and then sudden death which was unexplained. The pt was very frail but in satisfactory condition when the Fluvirin was given.


VAERS ID: 160801 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Illinois  
Vaccinated:2000-10-10
Onset:2000-10-15
   Days after vaccination:5
Submitted: 2000-10-20
   Days after onset:5
Entered: 2000-10-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Chest X-ray abnormal, Respiratory distress
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: chest x-ray - interstitial infiltrates
CDC Split Type: U2000007670

Write-up: The pt experienced respiratory distress and congestive heart failure. The pt was hospitalized in ICU on a ventilator and CTB on 10/15/00. Interstitial infiltrates noted on chest x-ray by Pulmonologist.


VAERS ID: 161416 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Illinois  
Vaccinated:2000-10-10
Onset:2000-10-15
   Days after vaccination:5
Submitted: 2000-11-02
   Days after onset:18
Entered: 2000-11-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR - / UNK - / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Apnoea, Cardiac failure congestive, Chest X-ray abnormal, Respiratory distress
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: CHF; pneumonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Chest X-ray-interstitial infiltrates noted.
CDC Split Type: U2000007672

Write-up: It was reported that a 79 year old male pt received a Fluzone SV ''00-''01 vaccination on 10/10/00. Reportedly, the pt developed respiratory distress and congestive heart failure. The pt was hospitalized in ICU on a ventilator and cease to breath on 10/15/00. Interstitial infiltrates notes on chest X-ray by Pulmonologist. Follow-up from 10/24/00, upon further evaluation is was discovered that the pt died on 10/15/00. Follow-up correspondence received on 11/2/00, it was reported that the pt died on 10/16/00 not on 10/15/00 as previously reported. Additional pt and responsible physician information were also provided.


VAERS ID: 162761 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-06
Onset:2000-10-12
   Days after vaccination:6
Submitted: 2000-11-21
   Days after onset:40
Entered: 2000-11-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute leukaemia, Back pain, Chest X-ray abnormal, Chest pain, Cough, Leukocytosis, Pyrexia, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-07
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: CXR-showed an infiltrate; blood tests-showed leucocytosis (23000/microL) and thrombocytopenia; bone marrow biopsy-pending.
CDC Split Type: WAES00111387

Write-up: Information has been received from a healthcare professional concerning a 61 year old male pt who on 10/6/00 was vaccinated with pneumococcal vaccine 23 polyvalent and influenza virus vaccine. On 10/12/00, the pt developed a cough, chest pain and back pain and was treated with antibiotics. He presented again with fever on 10/31/00. He was admitted to the hospital where a dx of acute leukemia was made. The pt died one week later. To be noticed that on 9/22/00, all laboratory findings, including total blood count had been within the normal range. Further information is expected. The cause of death was acute leukemia. F/U states; no further information is available. The case is closed.


VAERS ID: 162989 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-10-01
Onset:2000-10-10
   Days after vaccination:9
Submitted: 2000-11-27
   Days after onset:48
Entered: 2000-12-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisolone, Morphine, Amitriptylline, Temazepam
Current Illness:
Preexisting Conditions: Date unknown: fibrosing alveolitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006100

Write-up: An anonymised single pt print received concerning a 71 year old man who developed Guillain-Barre Syndrome, 9 days, post vax. He died 6 days, later. A post mortem was not carried out but the probable cause of death was reported as GBS. No further information was provided.


VAERS ID: 160872 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2000-10-09
Onset:2000-10-09
   Days after vaccination:0
Submitted: 2000-10-18
   Days after onset:9
Entered: 2000-10-25
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E66340HA / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Dyspnoea, Pulmonary embolism, Respiratory arrest, Sinus arrest, Staring
SMQs:, Anaphylactic reaction (broad), Disorders of sinus node function (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unspecified inhaler
Current Illness:
Preexisting Conditions: obesity, diabetes, diabetic neuropathies, transverse myelitis, neurogenic bladder control, asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPI2000047920

Write-up: The evening of the vax, the pt complained of shortness of breath and requested use of inhaler. The pt''s husband noted little or no relief. The pt was then transferred to bed from her motorized cart. the husband observed her to stare at the ceiling for approximately 20 seconds. She became frightened and asked him to get help. A neighbor (who happens to be a Pulmonologist) was called. He found the pt with "no sinus rhythm" and was unable to resuscitate her. There was no evidence of bronchospasm, no hives, and no report of audible wheezing. The death certificate lists "Pulmonary arrest" as cause of death. Reporting MD and Pulmonologist suspect pulmonary embolus as exact cause of death. Additional information has been requested. Follow up report received 11/07/2000: One of 2 spontaneous reports received from a physician, regarding possible adverse events associated with uses of Fluvirin, lot # H66340HA. A 55 year old morbidly obese female (weight $g 350 pounds), with a history of diabetes with diabetic neuropathics, possible transverse myelitis (recent development of neurogenic bladder control problems), and mild asthma, (requiring recent increased use of her inhalers), received vaccination with Fluvirin in October 2000. Later that evening, patient complained of shortness of breath and requested use of inhaler. Husband noted little or no relief. Patient was then transferred to bed, from her motorized cart. Husband observed her to stare at the ceiling for approximately 20 seconds. She becaem frightened and asked him to get help. A neighor (who happens to be a Pulmonologist) was called. He found patient with no sinus rhythm and was unable to resuscitate her. There was no evidence of bronchospasm, no hives, and no report of audible wheezing. The death certificate lists "Pulmonary arrest" as cause of death. Reporting MD and Pulmonologist suspect pulmonary embolus as exact cause of death. Follow up information received, November 1, 2000 from the primary care physician. Medical history significant for hypothyroidism, and allergies to penicillin, rvp dye, shellfish, and Tegretol.


VAERS ID: 163136 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2000-10-03
Submitted: 2000-11-29
   Days after onset:57
Entered: 2000-12-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol, aspirin, tamsulosin, Phenergan
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000006240

Write-up: The pt died suddenly a few days after receiving one dose of Fluvirin. There was no allergic reaction at the time of vaccination. The pt was also receiving atenolol and aspirin for angina pectoris, tansulosin and Phenergan. A postmortem exam was not performed. Cause of death is reported as unknown. However the reporter thinks the sudden death may have been caused by long standing IHD, and the role of Fluvirin vaccine was coincidental.


VAERS ID: 133836 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: New York  
Vaccinated:1999-11-29
Onset:1999-12-24
   Days after vaccination:25
Submitted: 2000-01-28
   Days after onset:35
Entered: 2000-02-09
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0104AA / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0043J / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Guillain-Barre syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Cardiomyopathy (broad), Demyelination (narrow), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2000-05-22
   Days after onset: 149
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Norvase, Dilantin
Current Illness: NONE
Preexisting Conditions: Seizure disorder, HTP
Allergies:
Diagnostic Lab Data: + CP and FMG
CDC Split Type:

Write-up: Pt was dx w/ Guillian-Barre. Cause of death given as cardiac arrest.


VAERS ID: 155888 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:1999-11-29
Onset:1999-12-03
   Days after vaccination:4
Submitted: 2000-06-29
   Days after onset:208
Entered: 2000-07-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Military       Purchased by: Military
Symptoms: Dyspnoea, Fatigue, Hypoxia, Nausea, Pneumonitis, Pyrexia, Rheumatoid factor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-01-06
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Methotrexate tablet, amantadine, calcium
Current Illness: UNK
Preexisting Conditions: arthritis, parkinsonism, blepharitis, drug hypersensitivity
Allergies:
Diagnostic Lab Data: open lung biopsy-acute interstitial pneumonitis. A bronchoscopy examination on 12/10/99 was unremarkabl; however, microscopic analysis of pooled bronchoalveolar levage revealed acute and chronic inflammation with rare atypical squamous and bronchial epithelial cells. Bronchial lavage cultures were negative. A chest x-ray on 12/13/99, revealed progressive RUL infiltrate with no improvement in severe bilateral lparenchymal disease compared to 12/12/99. A chest x-ray on 12/15/99 revealed significant improvement since 12/14. Lab test results in December 1999 included: rheumatoid factor, positive; ANA negaitve; and ESR 106. Based on these lab results and the fact that the pt remained afebrile, the neurologist suggested htat an autoimmune process should be considered. ON 12/10/99, C-ANCA and P-ANCA were both negtive. The pt''s WBC count rose steadily from 14,400 cells/mm^3 on 12/10/99 to 40,700 cells/mm^3 on 1/6/00. . Findings during a lung biopsy on 12/21/99 were a severely diffuse process with ver friable weak lung prenchyma incapable of holding either stapling devices and/or sutures. Cultures of lung tissue were negative for bacteria, virus and fungi. Blood cultures on 12/20/99 were positive for coagulase-negative Staphylococci and sputum cultures were positive for presumptive Candida albicans. A sputum culture on 1/4/00 was positive for P. seruginosa. A PPD performed during the hospital stay was negative. On 12/23/99, a chest x-ray revealed a small apical pneumothorax and development of what appeared tobe pneumopericardium and neumomediastinum since 12/22/99, with persistent bilateral pulmonary densities consistent with severe pulmonary edema. Hematology results on 12/7/99,included WBC and absolute neutrophil count which rose from 7.3 x 10^3 and 6.12 x 10^3 respectively, to 12.4 x 10^3 and 10.68 x 10^3 on 12/9/99. Seurm osmolarity was 253 and potassium was 2.4 on 12/7/99. Lab test results on 12/8/99 were creatinine 0.4; sodium 125; and chloride 94. Blood, pleural fluid, and urine cultures were negative. A chet x-ray on 12/7/99, revealed a dense upper lobe consolidation (lung infiltration NOS) with focal areas at the right base and mid-lung. A chest x-ray on 12/9/99 revealed worsening bialteral air-space consistent with pneumonia, pulmonary hemorrhage, or atypical pulmonary edema. A CT scan of the chest showed a predominatly alveolar process with marked areas of consolitation involving the lungs bilaterally; a moderately large right-sided pleural effusion; right lobe volume loss; and atherosclerotic aortic disease. An abdominal x-ray on 12/8/99 was suggestive of ileus.
CDC Split Type: HQ7946728JUN2000

Write-up: Pt received flu vax on 11/29/99. The pt was receiving weekly methotrexate to treat rheumatoid arthritis at the time of immunization. She became ill on 12/3/99. On 12/7/99, she was seen by her physician and hospitalized in the ICU. She required mechanical ventilator on 12/12/99. The pt died on 1/6/00. The treating physicians reportedly attributed this event to the methotrexate therapy. The husband attributed this event to an interaction between the flu vax and methotrexate. On Follow-up pt had a history of Parkinsonism. Medical records were recieved on 7/12/00. The pt had increasing shortness of breath and fatigue for months prior to hospitalization. On 12/7/99, she was hospitalized because of fatigue, shortness of breath, nausea, and possible low-grade fever. Medical history included allergies to metoclopramide, ibuprofen, and salsalate. During hospitalization, her rheumatoid factor was positive; ANA titer was negative, ESR was 106mm/hr. Chest x-ray revealed "severe bilateral parenchymal disease since December 12, 1999." Follow up info was received from a medical center on 8/17/00, 9/28, and 10/25/00.The pt is a non-smoker and abstains from alcohohl. She has a past hisotry of bilateral silicone breast implant with subsequent removal, partial vaginal hysterectomy, tubal ligation. She also had problems with occasional choking and gasping while eating and drinking, though no recent episodes of aspiration were reported. the pt''s medical history includes a recent treatment with Mirapex and requip, which were discontinued due to "intolerance." Therapy with Methotrexate 15mg weekly for rheumatoid arthritis began in 1997 and ceased after 12/5/99. The pt received her 1999-2000 formula influenza virus vaccine on 11/29/99, approximately 14 hrs afte her methotrexate dose. A chest x-ray revealed bialteral infiltrates with the greatest concentration int he left perihilar and righ tupper lobe region. The differential diagnosis at this time included congestive heart failure, aspiration, connective tissue disease, drug reaction, atypical community acquired pneumonia, and other atypical infections. Immunosuppresive therapy, including methotrexate, was withdrawn. A bronchoscopy examination on 12/10/99 was unremarkable; however, microscopic analysis of pooled bronchoalveolar levage revealed acute and chronic inflammation with rare atypical squamous and bronchial epithelial cells. Bronchial lavage cultures were negative. The pt was inturbated and ventilated on 12/12/99. A chest x-ray on 12/13/99, revealed progressive RUL infiltrate with no improvement in severe bilateral lparenchymal disease compared to 12/12/99. The pt was also treated with piperacillin/tazobactam and imipenem/cilastatin. Additional therapy included furosemide, propofol and lorazempam. Physical examination on 12/13/99 revealed lungs iwth bialteral rhonchi and rales. A chest x-ray on 12/15/99 revealed significant improvement since 12/14. Lab test results in December 1999 included: rheumatoid factor, positive; ANA negaitve; and ESR 106. Based on these lab results and the fact that the pt remained afebrile, the neurologist suggested htat an autoimmune process should be considered. ON 12/10/99, C-ANCA and P-ANCA were both negtive. The pt''s WBC count rose steadily from 14,400 cells/mm^3 on 12/10/99 to 40,700 cells/mm^3 on 1/6/00. Amantadine was discontinued due to the pt''s fatigue. Findings during a lung biopsy on 12/21/99 were a severely diffuse process with ver friable weak lung prenchyma incapable of holding either stapling devices and/or sutures. The lung was extremely abnormal and did not appear to be ventilating or aerating well. Microscopic analysis revealed rapidly progressive diffuse alveolar damage considdtent with acute interstitial pneumonitis of unknown etiology. The abnormalities were temporally uniform and reflected an episode of massive acute lung injury occurring at a single point in time. The pt continued to have a persisitent broncho-alveolar fistula following thoracic surgery. Cultures of lung tissue were negative for bacteria, virus and fungi. Blood cultures on 12/20/99 were positive for coagulase-negative Staphylococci and sputum cultures were positive for presumptive Candida albicans. A sputum culture on 1/4/00 was positive for P. seruginosa. A PPD performed during the hospital stay was negative. On 12/23/99, a chest x-ray revealed a small apical pneumothorax and development of what appeared tobe pneumopericardium and neumomediastinum since 12/22/99, with persistent bilateral pulmonary densities consistent with severe pulmonary edema. The impression was that ARDS was a consideration. Corticosteroid therapy with subsequently initiated. The consumer reported that the pt had lost "50% of her then reduced lung capacity" and she required an increase in her oxygen from "60% to 100% and requiring paralyzing drugs." A chest x-ray on 1/6/00 revealed a reduced right apical pneumothorax with dense infiltrates bilaterally. There appeared to be increase in air within the right basilar pleural space compared to prior film. Subcutaneous emphysema is increased in the right axillary region. She died on 1/6/00, from respiratory failure secondary to acute interstitial penumonitis. The consumer reported that the event was a result of a compromised immune system, which the consumer felt was exacerbated by the influenza virus vaccine. The pulmonologist confirmed the pneumonitis, but due to its uncertain etiology, could not confirm that the pt had pneumonia. Further medical records recieved on 9/28/00, provided additional medical history of bone mass decreased (osteopenia), gastro-oesophageal reflux disease; los of balance resulting in falls, and headaches NOS. Medications included /Relafen, Sinemet. On 12/7/99, the pt''s flu-like illness included scratchy, then sore throat, cough and chills. Hematology results on 12/7/99,included WBC and absolute neutrophil count which rose from 7.3 x 10^3 and 6.12 x 10^3 respectively, to 12.4 x 10^3 and 10.68 x 10^3 on 12/9/99. Seurm osmolarity was 253 and potassium was 2.4 on 12/7/99. Lab test results on 12/8/99 were creatinine 0.4; sodium 125; and chloride 94. Blood, pleural fluid, and urine cultures were negative. A chet x-ray on 12/7/99, revealed a dense upper lobe consolidation (lung infiltration NOS) with focal areas at the right base and mid-lung. A chest x-ray on 12/9/99 revealed worsening bialteral air-space consistent with pneumonia, pulmonary hemorrhage, or atypical pulmonary edema. A CT scan of the chest showed a predominatly alveolar process with marked areas of consolitation involving the lungs bilaterally; a moderately large right-sided pleural effusion; right lobe volume loss; and atherosclerotic aortic disease. An abdominal x-ray on 12/8/99 was suggestive of ileus. Her diagnosis at this time was RUL infiltrate and pleural effision, thought to be secondary to aspiration. She also had ileus and hyponatremia secondary to SIADH, both considered secondary to the pulmonary proces. The pt also had increased lower extremity weakness. (Reference methotrexate case number HQ7226113JUN2000).


VAERS ID: 154213 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:1999-11-08
Onset:1999-12-01
   Days after vaccination:23
Submitted: 2000-06-09
   Days after onset:190
Entered: 2000-06-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 736042 / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Dysphagia, Pneumonia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: flu-like reaction?~Influenza (Seasonal) (no brand name)~?~0.00~In Patient
Other Medications: None reported
Current Illness:
Preexisting Conditions: myocardial infarction, occlusion of artery in leg, possible history of bronchiectasis; chronic lymphocytic leukemia (not actively treated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MPU2000003300

Write-up: Approximately one month post vax, this pt experienced a cerebrovascular accident. As a result, she developed swallowing difficulties requiring insertion of a PEG tube. She then developed pneumonia and died. The report states Fluvirin was given because she had an immunoglobulin deficiency. Her WBC was raised. The report states that she had received the vax in October 1996 which was followed by a flu-like reaction and then another Fluvirin with a pneumococcal vax in April (no problems reported).


VAERS ID: 226764 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:1999-11-28
Onset:1999-12-01
   Days after vaccination:3
Submitted: 2004-09-16
   Days after onset:1750
Entered: 2004-09-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Joint swelling, Laboratory test abnormal, Musculoskeletal stiffness, Myalgia, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Sleep disorder, Tenosynovitis, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Follow up data received from HA on 09/06/04. The pt was reported to have been chronically immunosuppressed for a steroid-responsive optic neuropathy.
Allergies:
Diagnostic Lab Data: Results of blood testing on 1/13/00: White cell count 12000/mircoL [4-11], Neutrophil 10100/microL [2-7.5]. All other full blood count test within the normal range. Glandular fever screen negative. Endocrinology: Thyroid function test (T3, T4, TSH) within the normal range. Biochemistry: Sodium, Potassium, Urea within the normal range. Serum Creatinine 51 umol/L [55-100]. Liver and Bone profile: Total protein 59 g/L [60-79]. Albumin 36g/L [40-50]. CRP 80 mg/L [0-10]. Globulin, ALT, AST, Alkaline phosphatase, Gamma GT, Bilirubin, Calcium, Corrected Calcium, Creatine kinase, Inorganic Phosphate - within the normal range. Results on 1/26/00: Hematology: Platelet count 634000/microL [150-400]. ESR 86 mm/hr [1-20]. All other full blood count test within the normal range. Biochemistry: RA Latex 0 IU/ml [0-20]. Follow up on 2/7/01: Results of further investigations performed on the 1/13/00: Immunoglobulins: IgA 1g/L [0.8-4], IgG 9.3 g/L [6-16], IgM 1.7 g/L [0.5-2]. Protein Electrophoresis: Serum protein electrophoresis showed a normal pattern. Complement studies: C3 Complement 1.18 g/L [0.75-1.65], C4 Complement 0.43 g/L [0.14-0.54]. ME/Post viral screen: Parvovirus screen negative. Comment: No evidence of recent infection.
CDC Split Type: F200100269

Write-up: It was reported that a 41 year old woman was vaccinated on 11/28/99 with an Influenza vaccine. 3 weeks later, she developed redness at the site of the injection over her right upper arm associated with soreness and pain in most of her peripheral joints and muscles. She was stiff for about 3 hours in the morning as well as in the evening and a short course of oral prednisolone 15mg daily for 5 days provided some benefit. Her sleep pattern was disturbed and she found it difficult to roll over in bed. Her general health was otherwise good. As her condition was not progressing significantly, she was admitted at hospital on 1/12/00. At admission, she had mild pyrexia 37.2 C and looked unwell. She had mild soft tissue swelling of the MCP joint and both wrists and a degree of flexor tenosynovitis. There was marked tenderness over the muscles of the upper arm and thighs but no overt weakness. The reflexes were normal. Her blood investigation showed mild neutrophilia with normal hemoglobin, thyroid function tests, liver and bone profile and creatine kinase. C-reactive protein was markedly elevated at 80. Viral titers are not provided. See lab data. The rheumatologist though her symptoms were the likely result of a viral illness and in view of her discomfort and functional disability, she was treated with an intramuscular injection of Depomedrone 120mg and enteric coated Naproxen. She responded well to the injection and was allowed home on 1/15/00. She was seen by the rheumatologist again on 1/18/00, and had continue to improve. She was still presenting some stiffness in the morning but is fully mobile. She had minimal synovitis in her wrists and IP joints of the thumbs. She was remaining under treatment with enteric coated Naproxen 500mg twice daily, Tramadol 50mg four times a day and Temazepam 20mg at night. According to the last data received from the rheumatologist, she was fully recovered in February 2000. Further data have been requested. Follow up on 2/7/01: Results of further investigations performed on the 1/13/00 were received from the rheumatologist (see lab data). Further data on the origin of the suspected influenza vaccine are awaited from the vaccinating physician. Follow up on 4/10/02: Data not received. Case to be considered as closed. Follow up information reported on 9/6/04. It is reported that the patient has now died. The reporter states that the cause of death is unrelated to the event presented following the injection. No further details as to date of death reported. It was reported that the death was sudden but that no post-mortem was carried out. The cause of death is reported to be unknown. Additional information on previous medical history is also supplied. The patient was reported to have been chronically immuno-suppressed for a steroid-responsive optic neuropathy.


VAERS ID: 513372 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:1999-11-20
Onset:1999-11-25
   Days after vaccination:5
Submitted: 2013-11-16
   Days after onset:5105
Entered: 2013-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Influenza, Laboratory test abnormal, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-17
   Days after onset: 4102
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Type II pill
Current Illness: No
Preexisting Conditions: Type II diabetes
Allergies:
Diagnostic Lab Data: MRI, Catscan, blood work, spinal tap, test for poss. syndromes like Guillain Barre & others I can not remember
CDC Split Type:

Write-up: Flu symptoms- nausea, diarrhea.


VAERS ID: 150155 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Minnesota  
Vaccinated:1999-11-15
Onset:1999-11-20
   Days after vaccination:5
Submitted: 2000-03-08
   Days after onset:109
Entered: 2000-03-17
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES U0163AA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hallucination, Headache
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: B12 shot
Current Illness: NONE
Preexisting Conditions: hx of rectal incontinence, abdominal injuries, bilateral hearing loss, dementia, hypertension, degenerative joint disease, anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe headaches, hallucinations, occasional confusion, short term memory loss, delusions, and paranoia of unclear duration. The pt also experienced loss of control of left foot. The pt experienced bleeding from the rectum (bright red). Annual FU: pt died. no other info provided.


VAERS ID: 131642 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Minnesota  
Vaccinated:1999-10-26
Onset:1999-11-12
   Days after vaccination:17
Submitted: 1999-11-15
   Days after onset:3
Entered: 1999-12-02
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES U1032AA / 5 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Brain oedema, Convulsion, Encephalitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-11-15
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APAP, carbamazepine
Current Illness:
Preexisting Conditions: 30wk prematurity, triplet, mild BPD-resolved; hx of seizures, hx of encephalitis, bronchitis
Allergies:
Diagnostic Lab Data: nasopharyngeal culture 11/14/99: parainfluenzavirus type I
CDC Split Type:

Write-up: brainstem & cerebellar edema leading to brain death adm 11/12/99 w/nl LP, MRI;f/u MRI 11/14/ brainstem, cerebellar edema prior hx of CNS problems p/last year''s vax also;acute demyelinating encephalomyelitis 10/98 w/bilat temporal lobe; Autopsy stated final diagnosis of seizure and fever,


VAERS ID: 131452 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Louisiana  
Vaccinated:1999-11-04
Onset:1999-11-07
   Days after vaccination:3
Submitted: 1999-11-15
   Days after onset:8
Entered: 1999-11-29
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES U0167AA / 2 LL / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0871H / 1 RL / -

Administered by: Public       Purchased by: Unknown
Symptoms: Asphyxia, Convulsion, Injury
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: phenobarbital;
Current Illness: NONE
Preexisting Conditions: lissencephaly, microcephaly, sz disorer;
Allergies:
Diagnostic Lab Data:
CDC Split Type: LA991103

Write-up: pt expired 11/7/99-COD accidental asphyxiation d/t lissencephaly, microcephaly;


VAERS ID: 162101 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Iowa  
Vaccinated:1999-10-14
Onset:1999-10-29
   Days after vaccination:15
Submitted: 2000-11-13
   Days after onset:381
Entered: 2000-11-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4998217 / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Haemoptysis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1999-12-23
   Days after onset: 55
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations: Cough~Influenza (Seasonal) (no brand name)~~82.00~In Patient
Other Medications: Accupred, Lasix, K-Dur, Prilosec
Current Illness:
Preexisting Conditions: Hypertension, CHF, hypercholesterolemia,
Allergies:
Diagnostic Lab Data: X-rays, lung scrub, tests (nos).
CDC Split Type:

Write-up: Pt received flu shot on 10/14/1999, developed severe cough 10/29, was coughing up blood on 10/30. Was hospitalized 10/30 and received transfusion on 10/31. Tests were conducted and he was referred on 11/14. Pt died on 12/23/99.


VAERS ID: 131449 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:1999-10-11
Onset:1999-10-24
   Days after vaccination:13
Submitted: 1999-11-03
   Days after onset:10
Entered: 1999-11-29
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES U011AB / 7+ LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-10-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~~In patient
Other Medications: 2 types insulin, synthroid, antidepressants-buspar;anapheril, Ritalin, flexaril, melatonin
Current Illness: NONE; blood sugar nl 10/23, 10PM
Preexisting Conditions: diabetes (for 37 years), Graves disease (for 20yrs), diabetic depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA9924

Write-up: pt was found dead 12.5 days p/vax;


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