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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: 205281 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Mississippi  
Vaccinated:2003-05-28
Onset:2003-05-29
   Days after vaccination:1
Submitted: 2003-06-06
   Days after onset:8
Entered: 2003-06-24
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1281M / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1049M / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 0750 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491577 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Sudden infant death syndrome, Unevaluable event
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-29
   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: Cold
Preexisting Conditions: URI (4/28/03)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Report from coroner is that child deceased on 5/29/03.


VAERS ID: 205517 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2001-01-01
Submitted: 2003-06-24
   Days after onset:903
Entered: 2003-06-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung neoplasm malignant, Pulmonary embolism, 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), 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), Non-haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-20
   Days after onset: 749
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: Autopsy results: Respiratory failure; Metastaic mesothelioma; Pulmonary embolism.
CDC Split Type: HQWYE680218JUN03

Write-up: A legal complaint was received from an attorney regarding an adult white male. The decedent''s history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the mid 1950''s, the decedent was administered OPV or IPV. Sometime on or about 1/01, the decedent was reportedly diagnosed with metastatic mesothelioma of the right lung. The legal complaint stated that the decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent including, but not limited to breathing difficulties, asbestos is, lung and/or other cancer, mesothelioma, and/or lung damage. On 1/20/03, he died from respiratory failure. Pulmonary embolism was indicated as another significant condition contributing to the death.


VAERS ID: 205929 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: North Carolina  
Vaccinated:2003-06-12
Onset:2003-06-13
   Days after vaccination:1
Submitted: 2003-07-01
   Days after onset:18
Entered: 2003-07-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 576A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA805AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0626 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490894 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-13
   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: Tussi organidin DM
Current Illness: URI
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was found unresponsive at 4am 6/13/03. Autopsy report received on 8/21/2003 states COD was SIDS.


VAERS ID: 205930 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-07-07
Entered: 2003-07-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

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

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: Rabies exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20030347

Write-up: We received from our license partner the information that in a local newspaper the following case was reported: A 50 year old male patient was admitted to a hospital in October 2002 and was administered Rabipur following exposure. Afterwards he was discharged from hospital. Following rabies symptoms he was readmitted to the same hospital. Following deterioration of his condition, he was moved to another hospital on 12/4/02, where he died on 12/8/02. We are awaiting further information.


VAERS ID: 206129 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: California  
Vaccinated:2003-06-06
Onset:2003-06-07
   Days after vaccination:1
Submitted: 2003-06-24
   Days after onset:17
Entered: 2003-07-14
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 587A2 / 2 RL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1218M / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0460 / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489747 / 2 LL / -

Administered by: Public       Purchased by: Public
Symptoms: Cardiac disorder, Cardiac valve disease, Lymphocyte morphology abnormal, Myocarditis, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-08
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy: Increased heart size/bicuspid pulmonary valve . Myocarditis with lymphocytic infiltration.
CDC Split Type:

Write-up: Immunizations given 6/6. Child presented at hospital on 6/7 with fever, increased work on breathing. Respiratory code and death early AM 6/8. Autopsy: Increased heart size/bicuspid pulmonary valve . Myocarditis with lymphocytic infiltration.


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: 206325 (history)  
Form: Version 1.0  
Age: 98.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2002-11-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-07-17
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, Coronary artery disease, Lung disorder, Myocardial infarction, Oesophageal disorder, Pneumonia, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), 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: 2003-05-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuteral; Lasix; Klor-Con; Tylenol PM; Roxanol; Levsin; Ativan
Current Illness:
Preexisting Conditions: Coronary Artery Disease; Triple Coronary Bypass; Unstable Angina; Myocardial Infarction; Congestive Heart Failure; Acute Coronary Syndrome; Esophageal Stricture; Dyspnea; COPD; DJD; Pneumonia; Dysphagia; Dementia
Allergies:
Diagnostic Lab Data: Physical Exam: Temp: 97.6, Pulse 72, R 24, BP 112/78; HEENT: Pupils reacting to light. Resident is free of communicable disease including active Tuberculosis: Yes.
CDC Split Type: 200300899

Write-up: A 98 year old female received RSV vaccine or Placebo and Influenza Vaccine on 11/4/02 and 212 days later died. Records have been requested and will send follow-up when more information received. The Investigator assessed the event as unrelated to the study product. Follow up information received 7/11/02. Subject expired 5/6/03 at nurse home. Diagnosis: Respiratory failure, chronic obstructive pulmonary disease, congestive heart failure, myocardial infarction, pneumonia, acute coronary syndrome, esophageal stricture. Follow up on 08/22/2003: "Hospice Services RN Admission Assessment 05/06/03: DNR signed: Yes; Terminal Diagnosis: ES, CHF; Other Diagnosis: Acute Coronary Syndrome, Esophageal Stricture, Dyspnea, COPD; Radiation TX: None; Functional Limitations: Bowel/Bladder Incontinence, Ambulation, Speech; Activities permitted: Total bedrest; Mental Status: Unresponsive; Physical Assessment: Skin: Cool, Dry, Skin tugor: fair; Wound Care Record: Cleanse skin tear to R arm with NSS, apply triple antibiotic ointment, cover with dry dressing BID, D/C when healed; Sensor: hearing unknown, speech: nonverbal; Cardiovascular: Pulse-weak, Pedal Pulse-absent left and right. Fingers and feet cyanotic; Respiration: shallow at rest, cough: non, non-smoker; Lung sounds: diminished, crackles. Oxygen 4 L/min; Nutrition/Hydration: No intake; Gastrointestinal: Abdomen soft. Bowel sounds: x4 Quadrants, Hypoactive, Bowel incontinence; Genito-urinary: Urine amber, clear, indwelling catheter; Abuse screen: no suspected abuse/neglect; Pain assessment: "no indication of pain"; Additional Assessment: no labwork scheduled; Activities of Daily Living: unable to ambulate, transfer, dressing, eating, toileting, bathing; Psycho social status: Caregiver understands illness is terminal: Yes; Care Needs: Symptom management; Caregiver''s emotional response to current health status: continue with plan for symptom managment; Spiritual issues: last rights given 05/06/2003. Interval History and Physican Exam: 06/01/2003. History of Present Illness: 98 year old female treated for Resp. Failure, and DJD and now here for further managment. Past Medical History: CHF, DJD, Pneumonia, Dysphagia, Dementia; We are unable to obtain a death certificate for subject. Our site has made several phone calls to the son of the deceased subject referenced above and have received no response to our calls for a death certificate. We have no other contact person and we are not aware that an autopsy was performed. The only information that we have was received from the Health Center and was faxed to you on 07/11/2003. The note written by the Dr. states that the subject expired in this facility on 05/06/2003. You should already have this for your file. If you need us to fax it again, please let us know.


VAERS ID: 206350 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Washington  
Vaccinated:2003-06-18
Onset:0000-00-00
Submitted: 2003-06-23
Entered: 2003-07-18
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 524A2 / UNK RL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1076L / UNK RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1189 / UNK LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491178 / UNK LL / -
RV: ROTAVIRUS (ROTASHIELD) / PFIZER/WYETH 337272 / UNK MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-20
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: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: WA031950

Write-up: Coroner ruled SIDS.


VAERS ID: 206796 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: California  
Vaccinated:2003-07-21
Onset:2003-07-23
   Days after vaccination:2
Submitted: 2003-07-24
   Days after onset:1
Entered: 2003-07-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21885B9 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA853AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491183 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-23
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Patient received vaccines on 7/21. Patient expired during the night of 7/22-23. Do not know if expired before or after midnight of 7/22.


VAERS ID: 206879 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Georgia  
Vaccinated:2003-07-03
Onset:2003-07-03
   Days after vaccination:0
Submitted: 2003-07-31
   Days after onset:28
Entered: 2003-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 598A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0169N / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0334 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491572 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-03
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: IMMUNIZATIONS GIVEN SAME DAY PATIENT EXPIRED FROM SIDS. NO ADVERSE REACTION NOTED TO IMMUNIZATION.


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: 206892 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2003-02-06
Onset:2003-02-22
   Days after vaccination:16
Submitted: 2004-08-19
   Days after onset:543
Entered: 2003-08-01
   Days after submission:384
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Premature baby
SMQs:, Neonatal disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-02-22
   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: Complications due to prematurity
Preexisting Conditions: Complications due to prematurity
Allergies:
Diagnostic Lab Data: Autopsy findings: premature twin infant born at 28 5/7 weeks; birth weight 821gm, pregnancy complicated by severe preeclampsia and maternal lupus. Cesarean birth complicated by breech extraction. Prolonged hospitalization complicated by: multiple episodes of mild necrotizing neterocolitis without pneumatosis requiring long-term parenteral hyperlimentation. TPN-associated liver disease with marked cholestasis, portal fibrosis, and bile ductule hyperplasia. Abnormal liver function test on 2/22/03 at 11:30. Elevated conjugated bilirubin on 2/21/03. Anasarca. No Evidence of acute or resolved necrotizing enterocolitis. Radiographic evidence of osteopenia and metaphyseal beaking of hte proximal humeri, distal femurs, and distal tibias consistent with rickets (vitamin D deficiency). Candidal sepsis treated with amphotericin and fluconazole. Multiple episodes of apnea and bradycardia treated with surfactant, caffeine, mechanical ventilation, and dopamine. Diffuse pulmonary atelectasis with focal hyaline membranes. No evidence of bronchopulmonary dysplasia. Anemia of prematurity requiring multiple blood transfusions. Haemoglobin 5.3g/dL, hematocrit 17.2%. Generalized visceral pallor with clear yellow fluid in heart instead of blood. Reactive bone marrow with shift towards immature elements and marked extramedullary hematopoesis of liver and spleen. splenomegaly 37.3gm. White blood cells count of 27.3K with immature myeloid elements consistent with leukomoid reaction on 2/22/03. Epicardial, pleural and thymic petechiae. Thymic involution. Cause of death: Complications of prematurity.
CDC Split Type: 200301433

Write-up: This subject is a two month, 21 day old male, who was pronounced dead on Feb 22, 2003 due to complications of prematurity while enrolled in a Daptecel study. The subject did not receive any doses of study vaccine, howvere, they did receive other pediatric vaccines: IPV, HbOC, Hep B, Infanrix, and Prevnar. The last doses to the event were given on Feb 06, 2003. The subject developed complications due to prematurity priori to receiving any vaccinations. The subject was pronounced dead at medical center. The event of complications due to prematurity was reported by the investigator as unrelated to the study vaccine. Case closed. Cause of death- complications of prematurity. The radiographic findings are abnormal and indicative of diffuse metabolic bone disease, specifically rickets. The type of periosteal reaction seen in this case is common in sick premature infants and resukts from the stress induced by routine handling (such as diaper changing) placed on weakened bones. There is no sutopsy or radiographic evidence of abusive trauma. Subject has several complications of prematurity. The most significant is anemia, reflected by the diffuse visceral pallor, reactive bone marrow, and extreme EMP with splenomegaly. The etiology of the anemia is not entirely clear. Initially the anemia fit the picture seen in premature infants. however, there appears to have been a significant drop in hematocrit over a 12 hour period (25.5 % to 17.2%, with the second value taken one hour after resuscitative efforts started). The initial CBC showed fragmented RBC''s suggestive of intravascular hemolysis, however, bilirubin studies were not done. The differential diagnosis for hemolytic anemias includes congenital and acquired etiologies. The subject was treated for a fungal infection during his initial hospitalization at UCD. DIC from recurrent fungal sepsis is a possible cause for the rapid anemia. His laboratory studies on the day of death clinically reflect DIC (low platelet count, elevated PT and PTT, and decreased fibrinogen): however his sever liver disease could also explain the latter three indices. The elevated WBC with left shift is supportive of sepsis: however, this could also reflect the market EMH in the spleen, which lacks the control ofthe bone marrow in releasing blood elements into circulation. Rectal temp was recorded as 89.1 degrees F at 0733 (methodist). External examination: Body is that of a well developed over hydrated, well nourished 17", 7lbs, light brown pigmented, male infant, whose appearance is smaller than the rpeorted age of 2 months and 21 days. Weight is 2940grm. Head circumference 34.2cm. Chest circumference 32.4cm. Abdominal circumference 34.0cm. Crown-rump length 33.2cm. Crown heel length 47.0cm. The head is edematous with marked periobital edema. The eyes have cloudy corneas and dark irides. The lips and oral mucosa are pale, moist and without trauma, there is marked scrotal edema precluding evaluation of the testes. The umbilicus is distended, but there is no heriantion. External evidence of injury: there is marked edema of the scalp. The anterior fontanel measures 3.0cm. The sutures are mobile, but not widened or overlapping. Lungs (x5)- dissuse atelectasis: focal hyaline membranes in one section from the right lung, increased number of alveolar macrophages; no acute or interstitial inflammation. Liver: architecture distroted by portal fibrosis with bile ductule proliferation, lobular disarray with hepatocyte degeneration, and cholestasis, and microvesicular steatosi: patchy moderate extramedullary hematopoesis. Kidney; patchy extramedullary hematopoesis. Splee: total effacement of architecture by ,arked extramedullary hematopoesis consisting of mixed lineage cells similar to what is seen in the bone marrow. Fungal stain is negative. The brain is small with a mature gyral an 0.8 cm opercula over insukar lobes. The brain is not swollen. There is no sign of herniation or of cerebral midline shift. The leptomeninges are thin, delicate, and transparent. Note: There is no gross or histologic evidence of resolving germinal matrix hemorrhage or periventricular leukomalacia. Follow up on 04/21/04: "After a medical review of the case, a new version of the report has been generated to add the adverse event term "condition aggravated", and to add the interval between the date of immunization and the fatal outcome due to aggravation of the prematurity condition, 16 days."


VAERS ID: 206893 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: California  
Vaccinated:2002-12-27
Onset:2003-06-08
   Days after vaccination:163
Submitted: 2004-08-19
   Days after onset:438
Entered: 2003-08-01
   Days after submission:384
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Encephalopathy, Hepatomegaly, Multi-organ failure, Pneumonia
SMQs:, Liver related investigations, signs and symptoms (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-08
   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: Autopsy findings: Heavy lungs with hypostatic pneumonia and diffuse alveolar damage; Ischemic encephalopathy; Thymic involutional changes; Hepatomegaly, congestive; Generalized visceral congestion; Minor contusion of legs.
CDC Split Type: 200301431

Write-up: This subject is a 9 month old female, who was enrolled in a Phase IV P3T08 (Daptacel) study. The subject received two doses of study vaccine; the last dose prior to the event was given on 12/27/02. The subject died of multiple system organ failure due to near-drowning, 163 days post-immunization. The event of drowning was reported by the investigator as unrelated to the study vaccine. Autopsy results are pending. From additional information received on 11/4/03 from the autopsy report: It was determined by an investigation that an autopsy would be necessary to establish the cause of death. Based on the known circumstances and cause of death, the manner of death is an accident. The drowning occurred in a wading pool. Follow up on 11/25/2003: "Information has been received from an investigator concerning a 9 month old Hispanic female patient who was enrolled in a phase IV diptheria toxoid/pertussis vaccine/tetanus (DAPTACEL) study. On 12/27/2002, the patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). Concomitant vaccination on 12/27/2002 included a second dose of diphtheria toxoid/pertussis vaccine/tetanus (DAPTACEL), a dose of poliovirus vaccine (IPOL), a dose of Haemophilus influenzae vaccine (+) tetanus toxoid and a dose of Streptococcus pneumoniae vaccine (PREVNAR). 163 days post vaccination on 06/08/2003 at 15:52, the patient died. The cause of death was "multi-organ failure due to near drowning." Autopsy findings included: heavy lungs with hypostatic pneumonia and diffuse alveolar damage; ischemic encephalopathy; thymic involutional changes; congestive hepatomegaly; generalized visceral congestion; minor contisions of legs. External examination revealed a normally developed, adequately nourished Hispanic female infant who appeared consistent with the reported age of almost ten months. Internal examination revealed histology-sections of all major viscera were submitted per the SIDS protocol; X-rays-total body X-rays showed no recent healing fractures or bony malformations; "evidence-none"; CNS-vascular congestion, interstitial edema, diffuse changes of ischemic neuronal necrosis; lung-advanced changes of diffuse alveolar damange (hyaline membrane disease) with patchy acute pneumonia and scattered small airways filled by PMN''s, interstitial emphysema, one section of right lung showed consolidation by frank acute purulent bronchopneumonia, a section of trachea showed mild chrinoc mucosal inflammation; larynx-chronic mucosal inflammation with focal acute inflammation and necrosis, mild chronic mucositis also noted in epoglottis; no significant histopathology in the heart, speen, pancreas, bone marrow, adrenal lymph node, pituitary, diaphragm, submandibular gland, liver, kidney, fallopian tube or ovary. The case is closed. The event of drowing was reported by the investigator as unrelated to the study vaccine. Other business partner numbers include 10380574, 2003-01431, P3T08. Additional information is not expected. This report no longer meets the criteria for submission because the relationship to study therapy has been changed."


VAERS ID: 206894 (history)  
Form: Version 1.0  
Age: 0.65  
Sex: Male  
Location: California  
Vaccinated:2002-11-26
Onset:2003-03-23
   Days after vaccination:117
Submitted: 2004-08-19
   Days after onset:514
Entered: 2003-08-01
   Days after submission:384
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 2 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Heart disease congenital, Trisomy 21
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-23
   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: RSV
Current Illness:
Preexisting Conditions: Down''s syndrome and congenital heart disease.
Allergies:
Diagnostic Lab Data: Physical Examination: Physical examination reveals an alert, active male in no acute distress. Vital Signs: Revealed a weight of 5.9 kg, pulse was 120 and regular, respirations were 40 with minimal subcostal retractions. There was absence of stridor noted. Cardiac: Examination revealed a well-healed midline throacotomy scar. Point of maximal impulse was at the lower left sternal border with increased ventricular impulse. There is a diffuse systolic thrill at the lower to mid left sternal border. Normal S1. The S2 is split and slightly accentuated. Grade 3/6 harsh, high-pitched, crescendo murmur was heard at the upper left sternal border and radiated along the left clavicle into the lower left sternal border. It started at the first sound and occupied the first one-half of systole. No diastolic murmur, S3, S4 of click. Abdomen: Abdominal examination revealed the liver to be at the right costal margin. Spleen tip was not palpable. Extremities: Examination of the extremities revealed good peripheral pulses with no evidence of a radial femoral lag. Diagnositic Studies: Electrocardiogram revealed left axis deviation, right atrial hypertrophy, and right ventricular hypertropphy which is unchanged from previously. Impression: My impression is that this patient is tolerating his cardiac lesion well at the present time. He has received two doses of Synagis already. I will reevaluate the patient again after discharge from the University.
CDC Split Type: 2003014281

Write-up: This subject is an 11 month old male, who died on 3/23/03 from congenital heart disease while enrolled in a Phase IV Daptacel study. The subject received two doses of study vaccine; the last dose prior to the event was given on 11/26/02. The subject had a pre-existing congenital heart disease and Down''s syndrome and died 356 days post-immunization. The event of congenital heart disease was reported by the investigator as unrelated to the study vaccine. No autopsy performed. Case is closed. Follow up on 08/12/2003: "This is a 10.5 month old male seen for evaluation. The patient has Down''s syndrome and was diagnosed by fetal echo to have a permeative atrial ventricular canal. Initially the patient was placed on digoxin and Lasix but subsequently developed pulmonic stenosis, so these were discontinued. The patient had an initial cardiac cetherization on 09/10/2002. This revealed a permeative atrial-ventricular canal with a moderate left-to-right shunt and some right-to-left shunt and a TOR pressure drop across the pulmonic valve. The patient had pulmonary artery pressures which were twice normal and modestly elevated pulmonary vascular resistance. Subsequently, the patient on 09/26/2002, had a pulmonary artery band performed for a MD. Postoperative course was complicated by severe postoperative respiratory syndrome with problems necessitating prolonged intubation secondary to tracheal stenosis. In addition, the patient had post pericardiotomy syndrome which was treated with ibuprofen without complication. The patient recently had repeat cardiac catherization on 01/16/2003, which confirmed the above diagnosis. The patient is presently scheduled for surgery on 02/27/2003. This would consist of having resection of his tracheal ________ by MD and a Glen procedure by another MD. Since the patient''s last evaluation one month ago, there been no symptoms of feeding difficulties, respiratory difficulties, increasing stridor or syncope noted. Mother states that the patient did have some breathing problems for approximately four or five days after catherization secondary to his intubation. However, subsequently he has not had inspiratory or expiratory stridor. Follow up on 04/14/04: "After a medical review of the case, a new version of the report has been generated to add the adverse event term "condition aggravated", and to correct the interval between the date of immunization and the fatal outcome, from 356 to 117 days."


VAERS ID: 206895 (history)  
Form: Version 1.0  
Age: 1.29  
Sex: Female  
Location: California  
Vaccinated:2003-03-17
Onset:2003-05-22
   Days after vaccination:66
Submitted: 2003-07-23
   Days after onset:62
Entered: 2003-08-01
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Hepatic necrosis, Hepatitis, Renal failure, Respiratory failure, Sepsis, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (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), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-05-31
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301423

Write-up: This subject is a one year old female, who was admitted to the hospital due to systemic inflammatory response syndrome while enrolled in a Phase IV Daptacel study. The subject received one dose of Daptacel vaccine: along with other pediatric vaccines on 3/17/03. The subject developed symptoms 65 days post immunization and was admitted to the hospital three days later 5/25/03. The subject was transferred from hospital to another hospital on 5/26/03 with the diagnosis of acute respiratory failure, presumed streptococcal sepsis and hepatitis. While at hospital, the pt expired on 5/31/03 with a diagnosis of SIRS, acidosis and acute liver necrosis. The event of systemic inflammatory response syndrome was reported by the investigator as unrelated to the study vaccine. No autopsy was performed. Follow up on 04/21/04: "New version created to place Infanrix into pt''s history screen." Medical Records received on 8/05/2003 states kidney failure and thrombocytopenia.


VAERS ID: 206991 (history)  
Form: Version 1.0  
Age: 0.04  
Sex: Female  
Location: Hawaii  
Vaccinated:2003-05-29
Onset:2003-05-30
   Days after vaccination:1
Submitted: 2003-08-03
   Days after onset:65
Entered: 2003-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0236N / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Cardiomegaly, Decreased appetite, Dyspnoea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-30
   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 suspected
Preexisting Conditions: See prior explanation
Allergies:
Diagnostic Lab Data: At 27 weeks gestation during a routine prenatal visit, fetal heart rate was noted to be 60 checked by two OBs. Mother was not in labor or ill. Mother was transfered to a tertiary care center where all monitoring was negative, evaluation for Lupus was negative, and no documentation of fetal arrhythmias occured. Fetal echocrdiography by an experienced Ppediatric cardiologist showed no cardiac abnormalaties, normal heart size, vessels, valves, and intact ventricular septum. Mother eventually delivered at term a healthy female infant with no demonstrable cardia murmurs or arrythmias. Exam within 24 hours of death was entirely normal. Autopsy was significant in that cardiomegaly (dry heart weight of 47 grams), VSD of 5mm, and "probe patent PDA were noted. All other organs were entirely wnl. Microscopic studies failed to reveal any myocardial abnormalities or signs of inflammation. Airway was clear, patent and there were no pulmonary infiltrates or signs of aspiration or inflammation. Standard newborn screening test results were normal.
CDC Split Type:

Write-up: Greater than 12 hours after vaccine given patient developed decreased feeding and a single episode of vomiting. Approximately four hours after vomiting,and after patient was asleep, and not watched by parents, parents noted child had gasping, irregular repirations. Parents bundled child a took child by private car to the nearest emergency room, but did not observe child on the way. Upon entrance to the ER, child was noted to be asystolic and apneic. Full resucitative efforts failed. Autopsy Report received on 10/16/2003 states COD is cardiomegaly.


VAERS ID: 206937 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2001-09-01
Submitted: 2003-07-31
   Days after onset:698
Entered: 2003-08-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung disorder, 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-08
   Days after onset: 68
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: Autopsy results-Respiratory failure due to malignant mesothelioma of pleura.
CDC Split Type: HQWYE213528JUL03

Write-up: A legal complaint was received from an attorney regarding an adult male decedent. The decedent history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, "sometime in the 1950''s, decedent was administered OPV or IPV." On or about September 2001, at 60 years of age, the decedent was reportedly diagnosed with mesothelioma. The legal complaint states that the "contaminated vaccine products were toxic and carcinogenic" and that the "decedent''s exposure to asbestos, asbestos-containing products, and SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 11/8/01, the decedent died. The autopsy reported cause of death was respiratory failure due to malignant mesothelioma of pleura.


VAERS ID: 206999 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Arkansas  
Vaccinated:2003-07-31
Onset:2003-08-01
   Days after vaccination:1
Submitted: 2003-08-04
   Days after onset:3
Entered: 2003-08-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1385AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0284N / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0907 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492857 / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-01
   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: NONE
Current Illness: NONE
Preexisting Conditions: History of prematurity-delivered at 32 weeks gestation
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Pt found not breathing by mother while asleep the night after the shots were administered. Transported by ambulance to closest ER and was pronounced D.O.A. Initial diagnosis of SIDS with autopsy pending. Autopsy Report received on 12/01/2003 ruled out SIDS and states COD is undetermined.


VAERS ID: 207581 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: California  
Vaccinated:2003-04-15
Onset:2003-05-06
   Days after vaccination:21
Submitted: 2004-08-19
   Days after onset:471
Entered: 2003-08-08
   Days after submission:377
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Blood pressure increased, Dyspnoea, Heart rate increased, Respiratory rate increased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-05-21
   Days after onset: 15
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: Complex Congenital heart disease including double outlet right ventricle with subpulmonic stenosis, total anomalous pulmonary venous return, large ASD, VSD, and AV canal, and a right aortic arch. The pt underwent a modified Blalock Taussing shunt procedure, PDA ligation, and ligation of the collateral aortal pumonic artery on 11/1/02 at Hospital. During the operation, the pt''s left phrenic nerve was injured and subsequent to the operation he developed respiratory distress due to the left phrenic nerve palsy. The pt''s congenital syndrome also includes malrotation. heterotaxy, and asplenia. The pt subsequently underwent a Ladd''s procedure and plication of the left hemidiaphragm on 11/13/02. Subsequent to that procedure, the pt did develop Klebsiella pneumonia for which he was treated. He also developed due to prolonged intubation, problems with vocal cord dysfunction and aphonia which resolved during subsequent NICU stay. The pt was discharged home from NICU on 12/14/02. The pt''s birth history is pertinent for a 37 week spontaneous vaginal delivery with Apgars of 9 and 9 and no immediate perinatal complications. However, subsequently the pt did develop some degree of respiratory distress, and then a heart murmur was ausculated which led to the pt''s workup and diagnosis. As previously stated the pt did not received his two month immunizations. In addition he was started on the Synercid protocol and was given one dose of Alta Bates prior to dicharge from the NICU.
Allergies:
Diagnostic Lab Data: Electrolytes revealed a sodium of 136, potassium of 4.7, chloride of 89, bicarb of 22, BUN of 6, creatinine of 0.5, glucose of 263 with a calcium of 9.7, magnesium of 3, and phosphorus of 8.5. The pt''s electrolytes were followed during admission, given that the pt does have an underlying hypokalemic metabolic alkalosis secondary to chronic diuretic therapy. On the 9th, sodium chloride and potassium chloride supplements were re-initiated for a sodium of 132, potassium of 3.6, chloride of 85, and bicarb of 37 with a BUN of 1 and creatinine of 0.3. Follow up electrolytes on the 11th, revealed a sodium of 133, potassium of 4.8, chloride of 85, bicarb of 36, BUN of 3 and creatinine of 0.3. At that time magnesium was 2, calcium was 10.4 and phosphorus was 6.7. Initial labs revealed a white count of 19,000 with a hemoglobin of 16.4, platelets of 306,000 differential of 45 polys and 47 lymphocytes. Urinalysis revealed moderate blood, otherwise negative. Blood and urine cultures were obtained. A chest x-ray obtained revealed increased pulmonary blood flow on the left with persistent evidence of left hemidiaphragm palsy but no clear evidence of infiltrate. Blood cultures obtained at the time of admission grew out Citrobacter freundii. A lumbar puncture performed on 1/3/03 again after initiation of antibiotics, revealed a glucose of 70, protein of 41, WBC of 1, RBC of 1, negative gram stain and subsequent negative culture. Urine cultures also returned back negative. A renal ultrasound was obtained on 01/08/2003 which was negative for any evidence of hydronephrosis or other renal anamalies. The pt''s hemoglobin and hematocrit on the day of transfer were 13.7 and 42.8 respectively. EEG report: date of exam:1/16/03, reason for EEG: focal seizures, Impression: This is a mildly abnormal tracing because of slowing disorganization of the left frontotemporal aspect and a single sharp wave from the left frontocentral area, possibly consistent with the child''s focal seizure disorder. Chest films from his recent hospitalization are also not available today but generally showed hyperinflation of the right lung with an elevated left hemidiaphragm and diminished volume on the left side. His heart was in the midline and at the upper limits of normal in size. ECHO: A color flow study was obtained a UCSF on 2/13/03 and showed a velocity of 3.9 meters per second across his native pulmonary outflow tract (suggesting a 60 torr peak systolic pressure gradient), no aortic obstruction, a patent shunt with pulmonary arteries that appear to have primarily shunt flow, a nonrestrictive flow pattern between the right superior vena cava and the right atrium and additional venous flow going superior in the region of the pulmonary veins.
CDC Split Type: 200301432

Write-up: This pt is a 7-month-old male with history of congenital heart disease, who was admitted to the hospital while enrolled in a Phase IV P3T08 (Daptacel) study. The pt received one dose of Daptacel, the last dose prior to the event was given on 04/15/2003. Infant received Infanrix for the first 2 doses of Primary series. The pt developed an increased respiratory rate and marked difficulty breathing, 36 days post-immunization and was admitted to the hospital the same day. The pt had a known history of complex congenital heart disease, including total anomalous pulmonary venous return, complete AV canal, atrial septal defect, and ventricular septal defect, double outlet right ventricle, subpulmonic stenosis, and right aortic arch who presented in acute respiratory distress. The pt was admitted to hospital on 05/06/2003 for cardiac catheterization. He was being evaluated for a Glenn procedure after having had his modified BT shunt months ago. The child was discharged home on 05/15/2003 with the advice that the family contact a transplant center, as the hospital felt that his cardiac status would not tolerate the Glenn procedure. He was discharged home on an increased dose of Captopril. He had a baseline increased respiratory rate and then marked difficulty breathing after a 3 AM feed. He was taken to the ER where it was noted that his heart rate was 200, blood pressure 91/68, respiratory rate in the 80s. He was evaluated by a physician and taken to the pediatric intensive care unit. He initially was described as having only slightly prolonged capillary refill time but then his perfusion worsened over the next hour and he had poor peripheral pulses and his blood pressure decreased to 69 systolic. At that time, the pt''s intraosseum was placed but the fluid began extravasating. The pt''s heart rate then acutely decreased from the 200s to 120s and then he developed asystole. A code was called and the pt underwent cardiopulmonary resuscitation for approximately 45 minutes. At one point, after high-dose epinephrine, pulse was re-established but this lasted only a few minutes and then the pt lost his blood pressure and then rhythm despite continued resuscitation with drugs and cardiopulmonary resuscitation. The pt was pronounced at 8:28 AM. He was originally intubated by one physician and then reintubated by another physician because of possible ET tube plugging, although the ET tube was found not to be plugged. In fact the pt was difficult to ventilate because of probable increase in pulmonary edema due to his heart failure. He was resuscitated through a second interosseum that was placed by anesthesia. The family agreed to an autopsy on this pt. The event of congenital heart disease was reported by the investigator as unrelated to the study vaccine. From additional info received on 08/13/2003, requested by VAERS (ID #207581), previous hospital records, lab and diagnostic test results were provided: 12/30/02 follow-up of complex heart disease. Had 3.5 right modified BT shunt at CHO on 11/1/02 for asplenia with complete AVC, DOKV, TGV, PS and subPS, APVR to R-SVC without obstruction, secundum ASD and right arch. Post-op had L phrenic palsy requiring diaphragm plication. Home 12/14 on 27 calorie MBM, Lasix, digoxin, aldactone, NaCl, KCl, PenVK and ASA. Tires with feeds. O2 saturations now and at discharge high 80''s. Exam shows mild-moderate retractions, 2-3/6 systolic and continuous murmur along LSB. Impression: anatomy as above with mild-moderate CHF. Will d/c NaCl and KCl. Lasix and aldactone to 5mg BID, digoxin to 0.5 ml BID. Hospitalization 1/02/03-01/12/03 Principal diagnosis: Citrobacter freundii bacteremia and respiratory distress. The pt was hospitalized in the Pediatric Intensive Care Unit from 01/02/2003 to 01/07/2003 at which point he was transferred to ward status and was hospitalized on the ward from the evening on 01/07/2003 to 01/12/2003, prior to transfer to another hospital intensive care unit. Follow up on 04/21/04: "After a medical review of the case, a new version of the report has been generated to consider the Adverse event term "condition aggravated", since this is the immediate cause of the fatal outcome. Bacteremia has been removed from the list of adverse events as the bacteremia occurred before vaccination and it is described within the pt medical history."


VAERS ID: 207692 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Vermont  
Vaccinated:1997-10-22
Onset:0000-00-00
Submitted: 2003-08-02
Entered: 2003-08-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1998-03-05
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:

Write-up: At 2 months of age, 8/27/97, HIB #1, Hep B #1, IVP #2, DTaP #1; 10/22/97 HIB #2, Hep B #2, IPV #2, DTaP #2. Reacted to immunization with fever then several hours later convulsions. Seizures not present prior. No improvement over several weeks. Took child to hospital and doctor gave 10/27/97 shots; I said no. She did them anyway. Child died a few months later. 8/12/03: Information received from corrections facility where the reporter is an inmate, indicates that he may not receive outside phone calls but letters are permitted. A letter of request for ER and inpatient record was faxed for the admission on 11/22/03. 8/14/03 This record was received and includes: the ER evaluation; the H&P and the Discharge Summary w/ an addendum that includes the findings from the transfer hospital where child was hospitalized for more extensive evaluation of abnormal head CT. The discharge diagnosis on 11/25/97 was Failure To Thrive. The addendum which was added after the child''s transfer and evaluation at the higher level of care facility was a diagnosis of Krabbe Disease, an autosomal recessive genetic disorder leading to progressive demyelination of the nervous system. As a result of this evaluation, it was also determined that the mother''s father was also the child''s father and this man was later arrested and arraigned on sexual assault charges. There was no autopsy done on this patient per Office of Chief Medical Examiner. 8/13/03 Call to PMD for this child from birth to the time of his death, to request immunization and relevant OV records. Since it has been 5 yrs since the death of this patient, they have placed the records in storage. She has agreed to locate the records and send them to VAERS 9/3/03 Official Certificate of Death received which confirms the cause of death as Krabbe''s Disease. A copy of the 5 pp. Discharge Summary from hospital is received for the admission from 11/25/97-12/02/97. The discharge diagnosis is listed as progressive leukodystrophy, probable Krabbe Disease. It is not clear if or when the immunization records with lot#s will be received. That information will be added when available. Follow-up is otherwise complete.


VAERS ID: 207693 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Ohio  
Vaccinated:2003-07-29
Onset:2003-07-29
   Days after vaccination:0
Submitted: 2003-07-29
   Days after onset:0
Entered: 2003-08-12
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0256N / 1 LA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U0839AA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arteriosclerosis, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), 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: 2003-07-29
   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:

Write-up: Follow up received on 08/22/2003: "I am responding to your VAERS request regarding the patient, who died on 07/29/2003. An autopsy was performed at our facility; however, the cause and manner of death are ruled as pending at this time. A copy of the autopsy will be forwarded to you upon its completion."


VAERS ID: 207831 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Florida  
Vaccinated:2003-07-23
Onset:2003-07-26
   Days after vaccination:3
Submitted: 2003-08-11
   Days after onset:16
Entered: 2003-08-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21881E9 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0255N / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492856 / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-26
   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:
Current Illness: NONE
Preexisting Conditions: Prematurity; No prenatal care; Jaundice; GERD
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Impression: SIDS. This case was reported by a nurse and described an infant who died after receiving diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The vaccine provider submitted a report directly to VAERS. The patient''s past medical history included premature birth at 34 weeks'' gestation; there had been no prenatal care. The medical history also included gastric reflux. Concurrent medications were not reported. On 7/21/03 the patient received an injection of Pediarix (lot 21881E9), as well as, other unspecified vaccines. Three days post immunization, on 7/26/03, the patient died. Cause of death was unknown. An autopsy was performed; the results were not available as of 8/13/03. Death certificate confirms the cause of death as SIDS. - 10/16/2003 autopsy report rec''d. COD confirmed as SIDS.


VAERS ID: 207832 (history)  
Form: Version 1.0  
Age: 0.14  
Sex: Female  
Location: Florida  
Vaccinated:2003-08-05
Onset:2003-08-06
   Days after vaccination:1
Submitted: 2003-08-11
   Days after onset:5
Entered: 2003-08-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21881E9 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0255N / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492856 / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-06
   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:
Current Illness: NONE
Preexisting Conditions: Thrush
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Impression: SIDS. 9/3/03 Per review of autopsy report, final COD was confirmed as SIDS.


VAERS ID: 207834 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: California  
Vaccinated:2002-11-14
Onset:0000-00-00
Submitted: 2003-08-11
Entered: 2003-08-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UB245AA / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Military       Purchased by: Unknown
Symptoms: Bacterial infection, Cough, Drug ineffective, Dyspnoea, Laboratory test abnormal, Pharyngitis, Rash maculo-papular, Respiratory distress, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Lack of efficacy/effect (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), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Diagnostic Laboratory: PCR was positive for Neisseria Meningococcal infection serogroup C.
CDC Split Type: 200301574

Write-up: From initial information received on 8/7/03 from a medical professional, regarding an adverse event occurring in the US, it was reported that an 18year old male patient received MENOMUNE, lot number UB245AA, FLUZONE (lot number not reported), TUBERSOL (lot number not reported), HEPATITIS A VACCINE (lot number and manufacturer not reported, HEPATITIS B VACCINE (lot number and manufacturer not reported), MMR (lot number not reported), and PNEUMOVAX (lot number not reported) administered on 11/14/02. All vaccines were administered on the same date. The patient died on 12/15/02. The CDC investigation confirmed that the patient was positive for serogroup C, Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed, however, results were not available at the time of this report. Follow-up information: Information has been received from a health professional concerning an 18 year old male patient who was healthy with no adverse entry who on 11/14/2002 was vaccinated with a dose of MMRII (Lot # not reported). Concomitant therapy on 11/14/2002 included a dose of hepatitis A vaccine (inactive) (manufacturer unknown) (Lot # not reported), a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (Lot # not reported), a dose of pneumococcal vaccine 23 polyvalent (MSD) (Lot # not reported), a dose of tuberculin in purified protein derivative (TUBERSOL) (Lot # not reported), a dose of influenza virus vaccine (FLUZONE) (Lot # not reported) and a dose of meningococcal polysaccharide vaccine (MENOMUME-A/C/Y/W-135) (Lot # UB245AA). Subsequently the patient died on 12/15/2002. It was confirmed that the patient was positive for serogroup C Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed; however, the results were not available at the time of the report. From additional information received on 08/12/2003 from a pathology department, it was reported that the patient presented with an acute onset of a rash on his feet that spread to his face over a period of a few hours, after a 3 day history of a cough and sore throat. The symptoms progressed rapidly to severe respiratory distress and shock. The patient was treated with advanced cardiac life support in the ICU (intensive care unit) and died within three hours of presenting to the hospital. The patient died at 1:01 pm on 12/15/2002; the autopsy was done the following day and showed that the cause of death was Neisseria Meningitidis Septicemia (Meningococcemia). Gross autopsy findings included evidence acute shock syndrome with diffuse petechia and hemorrhage to multiple organs, visceral congestions, shock kidneys, and a blothcy erythematous rash to the organs and a few scattered foci of acute inflammation within the myocardium and meninges. The clinical presentation, autopsy findings, and laboratory PCR results were consistent with Neisseria Meningitidis (meningococcal) Septicemia (special pathogens branch # M10158). The manner of death was natural. The CDC confirmed that the patient was positive for serogroup C Meningococcal infection. Final anatomical diagnosis from the autopsy report included: Diffuse discrete petechiae and small hemorrhages involving multiple organs, serosa and mucosal surfaces (intestines, mesentery, epicardium, myocardium, renal cortex, adrenals, lungs, pharynx, bronchi, skeletal muscle and conjuctica), pulmonary edema and visceral congestion, bilateral pleural and pericardial effusions, blotchy erythematous rash on face, trunk, arms and legs, shock kidneys with diffuse pale cortices. there was no purulent meningeal exudates present. The PCR results were positive for Neisseria Meningitidis Serogroup C. Microscopic findings included: Numerous fibrin micro thrombi in heart, lungs, liver, glomeruli, brain and oropharynx and scattered small foci of acute inflammation in meninges and myocardium associated with hemorrhage and focal myocyte necrosis. Microscopic descriptions included: Trachea-diffuse mucosal and submucosal hemorrhage without inflammation. Lung-diffuse alveolar damage with numerous scattered fibrin and conspicous granulocytes present in red pulp. Liver-sinusoidal congestion with sinusoids distended by granulocytes and scattered fibrin micro thrombi. Prostate and bladder-mucosal and glandular autolysis, no pathologic diagnosis. There were no radiographs taken. Toxicology results included: Volatiles-the blood and vitereous fluid were examined for the presence of ethanol at a cutoff of 20 mg/dl. No ethanol was detected. The following drugs were detected: Positive Lidocaine-Lidocaine was detected in the liver by gas chromatography and confirmed by gas chromatography/mass spectrometry. Positive Atropine-Atropine was detected in the liver by gas chromatography/mass.


VAERS ID: 207946 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-08-14
Onset:2003-08-15
   Days after vaccination:1
Submitted: 2003-08-15
   Days after onset:0
Entered: 2003-08-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0856CA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA821AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0704 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492405 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Agitation, Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-15
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Child was vaccinated in our office on 8/14/03. Received call from coroner on 8/15/03, that child had expired this morning. Reported was that grandmother heard child cry went into room and found child unresponsive. No further info available at time of completion of report. Autopsy Report received on 11/07/2003 states COD is SIDS.


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: 207987 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Cough, Diarrhoea, Dysphonia, Dyspnoea, Fatigue, Feeling cold, Lung disorder, Nasal congestion, Pharyngolaryngeal pain, Pneumonia, Productive cough, Pyrexia, Respiratory disorder, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), 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: 2003-07-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Duoneb, Flovent, Zoloft, Guaifenesin, Ativan, Tylenol Extra strength, Inhaled gentamicin
Current Illness:
Preexisting Conditions: COPD, O2 Dependent, CHF, Aortic Stenosis, Osteoarthritis, Angioplasty 1996. Relevant history from previous hospitalizations: On 12/20/2002 the patient was cultured for illness 65 days after vaccination. On 12/23/2002 he went to MD and was placed on Zithromax. Patient was recultred and placed on Levaquin 12/27/2002. On 12/31/2002 the patient went to visit MD (scheduled visit), and was admitted to the hospital, 76 days after vaccination, with initial symptoms of a sore throat, hoarseness, nasal stuffiness, cough, tiredness. Patient became short of breath as cold progressed. He had a chest x-ray done twice with a diagnosis of Pneumonica-Sputum culture-pseudomonas. He was treated with one dose of Ciprofloxacin and a course of Levaquin and required supplemental oxygen. Outcome-Recovered with Residual Effects on 01/10/2003. Patient never fully returned to baseline. Investigator assessed the event as unrelated to the study product. He was admitted to the hospital again on 04/08/2003. On 02/19/2003, 126 days after vaccination, he was cultured for respiratory illness. He complained of increased sputum, cough with chills and feverishness, while on antibiotics per MD. He did not get better after 2 courses of antibiotics, became increasingly SOB and was admitted to the hospital on 03/08/2003 (143 days after vaccination) due to increased shortness of breath. He was placed on increased oxygen, ahd 2 chest x-rayx and was started on inhaled Gentamicin. While in the hospital had ORSA (Oxacillin Resistant Staph Aureaus) and Pneumonia was diagnosed. Patient had 3 chest x-rayx, MRI, CAT scan. He was released from hospital after 7 days on inhaled Gentamicin and Prednisone, home oxygen and use of Acapella flutter valve. The investigator assessed the event as unrelated to the study products. Date Discharged 03/14/2003. The third hospitalization occurred on 04/04/2003, 170 days after vaccination. He experienced vomiting, diarrhea, abdominal pain, a temperature of 103 F, oxygen saturation of 82% and was admitted to the hospital. Questionable ischemic bowel or diverticulitis. Patient transferred to ICU for observation. Thought to be septic. NG tube placed. Received multiple blood transfusions. The investigator assessed the event as unrelated to the study product.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301313

Write-up: An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt''s obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt''s death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: "Additional information received 09/08/2003. Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease. Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia." Death Certificate received on 9/12/2003 states COD was COPD.


VAERS ID: 208160 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Unknown  
Vaccinated:2003-04-09
Onset:2003-04-22
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2003-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0769M / 2 LL / SC

Administered by: Military       Purchased by: Military
Symptoms: Bacterial infection, Decreased appetite, Dysphagia, Dyspnoea, Lethargy, Musculoskeletal stiffness, Pneumonia
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-22
   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: Bilateral bacterial bronchopneumonia
CDC Split Type:

Write-up: Lethargy, stiffness in limbs, inability to swallow, labored breathing, spitting white foam, lack of appetite. Autopsy Report received on 12/10/2003 states COD was bronchial pneumonia.


VAERS ID: 208170 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Unknown  
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: 208171 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Unknown  
Vaccinated:2002-10-10
Onset:0000-00-00
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: Bronchitis, Cardiac failure, Condition aggravated, Lung disorder, Polyp, Weight decreased
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix, Theophylline, Combivent, Oxygen, Aerobid, Guaifenesin, Rabeprazole, Prednosone
Current Illness:
Preexisting Conditions: Emphysema, Chronic Obstructive Pulmonary Disease, Additional information received 08/22/2003. Previous history: Discharge Summary: 04/24/2002. Date of Admission: 04/15/2002. Date of Discharge: FINAL DIAGNOSIS: 1) Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2) Gastrointestinal bleed secondary to polyps. PLAN: He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h, Ventolin metered dose inhaler two puffs p.o. q6h. Theophylline 300 mg p.o. three times daily, Ceftin 500 mg p.o. three times daily for the next five days and Prednisone 6 mg p.o. once a day to be tapered as an outpatient. Diet and activity can be as tolerated. He will follow up with myself and with MD. HOSPITAL COURSE: He was admitted for exacerbation of COPD. He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids. He showed a steady improvement as his medication was tapered on the final hosptial day. He was back to his baseline and did not have dyspnea on exertion. While in the hospital, he had an episode of GI bleeding. MD was consulted. Colonoscopy was done. He had noted to have a rectal mass and multiple colon polyps and anal stenosis. Biopsies were done. H&H remained stable. At this time, no further in-hospital management is planned and he can be followed as an outpatient. H&P: Chief complaint: Dyspnea. HISTORY: A 76 year old male who developed several days of increasing shortness of breath with chills. He had not been keeping up with his medications. He presented to the ER where treatment there did not resolve his symptoms and he was referred to me for exacerbation of chronic obstructive pulmonary disease with probable underlying bronchitis. He has had a productive cough. MEDICATIONS: Emphysema, Theophylline, Combivent, Albuterol. PAST MEDICAL HISTORY: Emphysema, Back pain. FAMILY HISTORY: Non contributory. SOCIAL HISTORY: He is a former smoker but has not smoked in several years. REVIEW OF SYSTEMS: Chiefly remarkable for the chronic back pain, otherwise not remarkable. PHYSICAL EXAMINATION: General: appeared well. Vital signs: Pulse 136, Respirations 36, blood pressure 160.82. Temperature: 98.6. HEENT: Not remarkable. Neck: No JVD or bruit. Heart: Had a regular rate and rhythm. Abdomen: soft, good bowel sounds. Lungs: Crackles an wheezing in all fields. Neurological: not remarkable. Extremities: no edema.
Allergies:
Diagnostic Lab Data: First CPK was negative. Blood gas revealed hypoxia. However, he was not acidotic. Chem-7 was okay. CBC and elevated white blood count of 17. Theophylline was 10.
CDC Split Type: 200301625

Write-up: This subject is a 76 year old male who died on 7/24/03 due to his emphysema while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/10/02. The subject died 287 days post immunization. The subject''s family phoned on 8/15/03 to notify the investigator that the subject expired from emphysema on 7/24/03. The event was reported by the investigator as unrelated to the study product. A 15-day follow up report received 8/26/03 adds: Additional info received 08/22/2003. Previous medical history received and available in source documents. Discharge Summary: 04/24/2002. History and Physical: 04/24/2002. Progress Notes: 1/4/00, 1/25/00, 3/6/00, 3/1/01, 6/29/02, 7/8/02. Final diagnoses: 1. Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2. Gastrointestinal bleed secondary to polyps. He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h. Ventolin metered dose inhaler two puffs spo q6h. Theophylline 300mg po bid, Ceftin 500mg po bid for the next five days and Prednisone 6mg po once a day to be tapered as an outpatient. Diet and activity can be as tolerated. He will follow-up with myself and with Dr. Hospital Course: He was admitted for exacerbation of COPD. He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids. He showed a steady improvement as his medication was tapered on the final hospital day. He was back to his baseline and did not have dyspnea on exertion. While in the hospital, he had an episode of GI bleeding. Dr. was consulted. Colonoscopy was done. He had noted to have a rectal mass and multiple colon polyps and anal stenosis. Biopsies were done. H&H remained stable. At this time, no further in-hospital management is planned and he can be followed as an outpatient. Impression: 1. Severe COPD. 2. Weight loss. Maintain Prednisone at 20mg per day. Continue on Pulmicort, Atrovent, and Albuterol. Follow-up again in one month. Death certificate states congestive heart failure. Additional info received 9/19/03. Follow up report. Diagnosis: Emphysema, chronic obstructive pulmonary disease, congestive heart failure. Progress notes: 9/19/03. Patients certificate of death received and noted. Immediate cause linked as COPD and congestive heart failure. Review reveals no evidence of cong. failure in this facility. Pt received his injection of RSV vaccine in Oct. 2002. Deceased July 24, 2003. Death certificate received. Cause of death: End stage chronic obstructive pulmonary disease, congestive heart failure. The investigator assessed the events as unrelated to the study products. Follow up on 09/17/2003: "Additional information received 09/05/2003. Family reports death certificate states: A-End stage of chronic osbructive pulmonary disease. B-Congestive heart failure. Copy pending. Diagnosis: Chronic Obstructive Pulmonary Disease, Emphysema. The death was reported by the investigator as not related to the study product."


VAERS ID: 208279 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Colorado  
Vaccinated:2002-11-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cor pulmonale, Hypertension, Pneumonia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Pulmonary hypertension (narrow), Hypertension (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: 2003-07-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV, Placebo, Micronase, Glucophage, Inderal, Prinivil, Combivent, Mobic, Celexa, vicodin, Oxybutynin, Estring, oxygen
Current Illness:
Preexisting Conditions: COPD, hypertension, diabetes type II, neuropathy, depression, obesity, spinal stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301742

Write-up: This subject is a 73 year old female who died at home 240 days post immunization on 7/11/03 while enrolled in the RSV 11 study. The subject received the RSV vaccine or Placebo and influenza vaccine on 11/13/02. The subject was diagnosed with pneumonia a few days before her death. Subject was not admitted to hospital and was found in her home on 7/11/03. The death was reported by the investigator as not related to the study product. Death certificate states cause of death as "Probable complications of hypertensive heart disease." Other significant conditions, chronic obstructive pulmonary disease, obesity. No autopsy performed. Additional documents received and with source documents: Certificate of Death: 8/20/03.


VAERS ID: 208853 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2003-08-27
Onset:2003-08-27
   Days after vaccination:0
Submitted: 2003-09-04
   Days after onset:8
Entered: 2003-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 1 UN / SC

Administered by: Military       Purchased by: Military
Symptoms: Chest pain, Dyspnoea, Oedema, Pericardial effusion, Sarcoma
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Systemic lupus erythematosus (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-02-25
   Days after onset: 182
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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown Discharge summary states sarcoma.
Allergies:
Diagnostic Lab Data: Extremely bloody pericardial fluid. Initial tests inconclusive. A 60-day follow up report received 11/24/03 adds: (Not recovered) The pt has been diagnosed with a cardiac sarcoma, which was excised. His prognosis is not good as the condition is probably fatal. It seems unlikely given the timeframe that there is a correlation between the vaccine and the sarcoma; but it is still worthy of documenting.
CDC Split Type:

Write-up: Received hepatitis A and typhoid vaccine on 8/22/03. Received PPD and anthrax vacicne on 8/27/03. On 8/27/03 was admitted for profound pericardial effusion requiring drainage and pericardial window. Patient currently still admitted and improving. Nurse follow up on 05/19/04 states: Per review of hospital d/c summary, diagnosis of cardiac sarcoma (cancer) again confirmed and has already been coded. (This was a case that resulted in the death of the patient and was followed by nurse as well. Case was complete, but this d/c summary from the patient''s last hospitalization just arrived.) Discharge summary states dyspnea, edema, chest pain.


VAERS ID: 209010 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: California  
Vaccinated:2003-08-06
Onset:2003-08-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2003-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 590A9 / 1 LL / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5373A2 / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0869 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492408 / 1 RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Apnoea, Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-12
   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:
Current Illness:
Preexisting Conditions: Undescended left testicle
Allergies:
Diagnostic Lab Data: Autopsy and toxicology results pending.
CDC Split Type:

Write-up: Infant found unresponsive, not breathing while at daycare. Taken to ER; resuscitation unsuccessful. Autopsy report received on 12/04/2003 states COD was SIDS.


VAERS ID: 209109 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Mississippi  
Vaccinated:2003-08-14
Onset:2003-08-14
   Days after vaccination:0
Submitted: 2003-09-08
   Days after onset:25
Entered: 2003-09-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 596C9 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1215M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0907 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491571 / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Oliguria, Oral candidiasis, Pyrexia, Rash, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-17
   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: Tylenol
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: MS03066

Write-up: Shots given at approximately 11AM, several hours later parents called because of Rash. They were refered to MD. received info that child was seen in ER on 8/16/03. Hospital discharge states vomiting, decreased urinary output, fever and thrush.


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: 209178 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Unknown  
Vaccinated:2002-10-31
Onset:2003-08-13
   Days after vaccination:286
Submitted: 0000-00-00
Entered: 2003-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Atrial fibrillation, Cardiac failure congestive, Coronary artery embolism, Intestinal gangrene, Nausea, Pain, Pleural effusion, Vomiting, White blood cell count increased
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Coumadin, Restoril, Remeron, Protonix, Lasix, Lisinopril, Coymadin
Current Illness:
Preexisting Conditions: Surgery a few years ago for a small bowel obstruction, chrome atrial fibrillation , CHF, recurrent pleural effusions, open cholecystectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301863

Write-up: This subject is an 82 year old male who was admitted to the hospital on 8/13/03 and died 2 days later on 8/15/03 while enrolled in RSV 11 study, with RSV vaccine or Placebo and Influenza vaccine. The subject received study vaccine on 10/31/02. Subject developed nausea, vomiting, abdominal distention and pain 286 days post immunization and was admitted to the hospital 286 days later on 8/13/02. Subject was diagnosed with gangrene of small bowel, congestive heart failure, chronic atrial fibrillation, embolus of the superior mesenteric artery. Treatment included the medication, Restoril, Remeron, Protonix, Lasix, Lisinopril and IV antibiotics. Subject died 2 days later on 8/15/03. The causality has not been assessed by the investigator as of yet, additional information has been requested. On examination, he was mentally alert. He was complaining of quite a bit of pain. His abdomen was distended. At first, bowel sounds were absent. Note, he gave a history of passing flatus on the day prior to admission and having a bowel movement, but none on the day of admission. The patient was given IV fluids. He was not given antibiotics at first. His Coumadin was discontinued. His other medications continued were appropriate. On the morning of 8/14/03, the patient had had nasogastric suction overnight, which was fairly profuse. He was still complaining of abdominal pain but stated that he had passed some flatus during the night. His white count became elevated. He was therefore placed on broad spectrum antibiotics. We discussed the possibility of proceeding with surgery with him. He said he wanted to avoid this if at all possible. A CT of the abdomen was obtained, and this suggested proximally dilated bowel and collapsed distal bowel. Our impression at this time was on of an incomplete small bowel obstruction, particularly in view of the fact that he recently passed flatus, and there was a considerable amount of gas in the colon. The patient was treated overnight. On the morning of 8/15/03, however, his white count had dropped only minimally. He was still complaining of pain. His abdominal distention had not decreased. His nasogastric suction was quite profuse. We recommended surgery. He discussed this with his daughter in some detail and considered not giving permission but finally relented. He was aware that he was at high risk and that even offered his comment that he thought he would not survive the surgery. He was taken to the surgical area where an A line and a Swan-Ganz catheter was placed. He already had a Foley catheter in situ. He was taken to surgery. At the time of surgery, ischemia of the entire bowel was found in the distribution of the superior mesenteric artery. The bowel was clearly not viable. The abdomen was therefore closed. The patient returned to recovery room where he was kept on large doses of vasopressors but was maintaining inadequate blood pressure. He was kept on a ventilator. Later, after discussion with his daughter and on our advice, we discontinued the vasopressor, and within just a few minutes, he developed cardiac asystole. He was pronounced dead as 2:30 pm on 8/15/03. An autopsy was declined by the family. A 15-day follow up report received 09/30/2003 adds: Final Diagnosis: 1. Gangrene of the small bowel. 2. Probable embolus of the superior mesenteric artery. 3. Chronic atrial fibrillation. 4. Congestive heart failure. 5. Recurrent pleural effusions.


VAERS ID: 209245 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: California  
Vaccinated:2003-01-14
Onset:2003-02-01
   Days after vaccination:18
Submitted: 2004-08-19
   Days after onset:564
Entered: 2003-09-16
   Days after submission:338
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0812AA / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490901 / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-01
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301892

Write-up: This subject is a three month old female, who suffered a fatal head injury while enrolled in a comparative post marketing safety study of Daptacel (diptheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the US standard of care. The subject received one dose of study vaccine: the last dose prior to the event was given on 01/14/2003. The subject "expired instantly due to blunt head injuries in motor vehicle accident described as "auto vs. fixed object, ejected," 18 days post immunization and expired the same day. No other information was reported. Death Certificate has been received. Autopsy has been performed but report not yet received. The event of fatal head injury was reported by the investigator as unrelated to the study product. The autopsy report states accident automobile, death. Follow up on 09/30/2003: "Autopsy Report received by medical affairs on 09/16/2003. This three-month-old female is a victim of an apparent accidental death. "Auto (passenger) vs. F/O, rollover, ejected". The base portion of the car seat strapped in the center of the back seat. The car seat carrier was facing rear, however it was behind the passengers seat of the vehicle (not locked in the base) with the seat belts in use. The car seat canopy was found with the descedent. She was about 100 feet north of the vehicle, face down with her head against a rock. There was a blanket covering her. Death is probably instant and is clearly from crushing blunt injuries to the head. Other injuries also listed in the autopsy report include a crushed head and multiple severe abrasions and probable compressed chest event due to collapsed lungs and areas of hemorrhagic discoloration on lungs. This can happen in infants without fractures of the ribs, etc. Other injuries included fracture of the left femur as well as crushed and avulsed toes of the right foot. There was no signs of internal torso injuries except for the lungs. No further information is anticipated, this case is considered closed.


VAERS ID: 209326 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: California  
Vaccinated:2003-08-25
Onset:2003-08-27
   Days after vaccination:2
Submitted: 2004-09-17
   Days after onset:387
Entered: 2003-09-17
   Days after submission:366
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21895A2 / 1 RL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1736J / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA841AC / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492410 / UNK RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Insomnia, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-27
   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:
Current Illness:
Preexisting Conditions: The pt received a previous dose of Hep B vaccine, number 1736J, in the right thigh on 17May03.
Allergies:
Diagnostic Lab Data: Toxicology results and other labs are still pending. From additional information received on 9/13/04 from the coroner''s autopsy report: 8/28/03 Autopsy findings: Petechial hemorrhages on the pleura surfaces of the lungs. Occasional petechial hemorrhages on the thymus gland. There is no evidence of recent trauma. Opinion as to the cause of death: Sudden unexplained death in an infant. Manner of death: natural. 8/26/04: Blood cultures negative; Viral cultures: no virus isolated. Peritoneal swab - scant growth bacillus species not otherwise specified.
CDC Split Type: 200301891

Write-up: This subject was a 15 week old male, who died while enrolled in a Comparative post-marketing safety study of Daptacel administered with other recommended vaccines according to the US standard of care, Protocol number P3T08. The subject received first series of vaccines on 8/25/03. This case was discovered when telephone interviewers attempted to complete a second interview. The coroner''s office findings as of yet are inconclusive and not suggestive of an obvious cause of death. The toxicology results and other labs were still pending. The parents completed their first interview approximately two hours prior to the time of death and reportedly only some restless sleep on day of vaccination and the next day, loss of appetite on day of vaccination and next day. Otherwise, parents reported no symptoms. The subject died two days after vaccination. Autopsy results are pending. The causality is pending, awaiting cause of death. From additional info received on 9/18/03. The subject''s initials were previously reported incorrectly and through email correspondence received on this date, the correct info was reported. The VAERS number was also reported as 209326. Follow up on 10/01/2003: "This subject is a 15 week old male, who died while enrolled in a Comparitive post-marketing safety study of Daptacel (Diphtheria and Tetanus toxoids and Acellular Pertissis Vaccine Adsorbed) administered with other recommended vaccines according to the US standard of care, Protocol number P3T08. The subject received first series of vaccines on 08/25/2003. This case was discovered when telephone interviewers attempted to complete a second interview. The coroner''s office findings as of yet are inconclusive and not suggestive of an obvious cause of death. The toxicology results and other labs were still pending. The parents completed their first interview approximately two hours prior to the time of death and reported only some restless sleep on day of vaccination and the next day, loss of appetite on day of vaccination and next day. Otherwise, parents reported no symptoms. The subject died two days after vaccination. Autopsy results are pending. The causality is pending, awaiting cause of death. From additional information received on 09/18/2003. The subjects initial were previously reported incorrectly and through e-mail correspondence received on this date, the correct information was reported. The VAERS number was also reported as 209326. From additional information received on 09/24/2003 from the site, the date of death was reported as 19:15, a corrected date of injection for the Hep B vaccine was reported as 05/17/2003, and the lot number for Pediarix was reported as 21895A2. No other information was provided. From additional information received on 09/25/2003 from VAERS (209326) it was reported that the Deputy Coroner, who contacted VAERS, stated that she thought there was a preliminary cause of death listed as SIDS. Additional details provided were that the child was put to sleep by his father at 13:30, he was wrapped in a comforter. five and a half hours later the father found the baby, cold and blue. He called 911 and they instructed him to start CPR. Upon arrival of the ambulance, they found the baby to have lividity and rigor and he was pronounced dead. VAERS stated that they would call us back after their conversation with the coroner." Follow up on 10/10/2003: "Follow up information indicated that the "date" of death was 19:15. The deputy coroner stated that she thought there was a preliminary cause of death listed as SIDS. It was reported that the child was put to sleep by his father at 13:30, he was wrapped in a comforter. Five and a half hours later the father found the baby cold and blue. He called 911 and they instructed him to start CPR. Upon irrival of the ambulance, they found the baby to have lividity and rigor and he was pronounced dead. Additional details to be provided after a conversation with the coroner. At this time, relationship of the adverse experiences to study therapy is unknown. Other business partner numbers include 2003-01891. Additional information is expected." A follow up report received 10/15/2003 adds no new info. Follow up on 12/19/03: "From additional information received 12/04/03, no updated information regarding this subject has been obtained. Preliminary information is still indicating SIDS, per the coroner''s office, who will give candid information via voice, but will not provide anything in writing until finalized. Per the interview with the father (scheduled call back at 48 hours post immunization, as per protocol) on 08/27/03 at 17:00, it was not known if the infant had a temperature. The infant had been given an antipyretic after the vaccination (product frequency or dose not reported). ACTHIB Lot # UA841AC/W1254-2." Medical assesment: File to be completed. Follow up on 05/24/04 states: "From additional information received on 05/20/04 from the study site, it was reported that the autopsy reports are pending. Preliminary autopsy information shows no unusual findings. Update of 05/18/04; still incomplete findings howevere, a verbal confirmation of SIDS was provided. The event of SIDS was reported as unrelated to the vaccines. This subject did not receive the study vaccine." From additional information received on 9/13/04 from the coroner''s autopsy report, it was reported that the patient was pronounced deceased on 8/27/03 at 1915 hours by the fire chief. At the time the coroner arrived at the scene he observed that the infant was on the floor next to the parent''s bed. His clothes had been cut off and were under his body. The infant was wearing a white diaper, which appeared to be wet. Fixed lividity was present to his back, head and bottom of his feet. The coroner observed no visual trauma. On 8/25/03, the patient had received Polio, DtaP/DTP, HIB, Hepatitis B and Pneumococcal immunizations and had a check up. On the day of his death, he was crying al ot and not eating too much. Nothing else out of the ordinary was noted. According to the autopsy findings: Petechial hemorrhages on the pleural surfaces of the lungs. Occasional petechial hemorrhages on the thymus gland. There is no evidence of recent trauma. Opinion as to the cause of death: sudden unexplained death in an infant. Manner of death: natural. Per the investigator the adverse event of sudden unexplained death in an infant is considered unrelated to the study vaccine. The serious adverse event report list the immunizations given on 8/25/03 as PEDIARIX, PRP-T, and PREVNAR. No further information is anticipated, this case is considered as closed.


VAERS ID: 209397 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Kentucky  
Vaccinated:2003-08-28
Onset:0000-00-00
Submitted: 2003-09-12
Entered: 2003-09-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21912A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA774AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493259 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diflucan, lactose syrup
Current Illness: Mild URI
Preexisting Conditions: Laryngomalacia, thrush, constipation
Allergies:
Diagnostic Lab Data: Per coroner preliminary autopsy no pathology, preliminary diagnosis.
CDC Split Type:

Write-up: SIDS.


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: 209532 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Arkansas  
Vaccinated:2003-09-17
Onset:2003-09-18
   Days after vaccination:1
Submitted: 2003-09-22
   Days after onset:4
Entered: 2003-09-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0853CA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0047N / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA842AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0816 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490702 / 1 LL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Apnoea, Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-18
   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: NONE
Current Illness: NONE
Preexisting Conditions: None recalled by mother during screening.
Allergies:
Diagnostic Lab Data: Autopsy - pending results. Autopsy report received on 12/17/03 states SIDS.
CDC Split Type:

Write-up: Call received on 911 at about 6:50 AM 9/18/03. CPR attempted by ambulance personnel. Per mother, child well and without fever when she put child down for evening. Found lying on stomach without response and without breathing at about 6:50 AM by mother. The autopsy report received on 12/17/03 states SIDS.


VAERS ID: 209550 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Texas  
Vaccinated:2003-09-09
Onset:2003-09-12
   Days after vaccination:3
Submitted: 2003-09-12
   Days after onset:0
Entered: 2003-09-24
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1387AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5384A2 / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA838AB / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0363 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492817 / 1 LL / -

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Cyanosis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-12
   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: Amokicillin initiated 09/09/2003
Current Illness: Right otitis media; URI
Preexisting Conditions: Maternal Hepatitis C positive; not confirmed in infant.
Allergies:
Diagnostic Lab Data: Unknown at this date. Autopsy results pending.
CDC Split Type: TX03119

Write-up: Infant was found cyanotic, lifeless by mother morning of 9/12/03. Mother attempted CPR then called EMS. Patient transported to hospital. By mothers report, infant was in twin bed where sleeping with mother and another adult overnight.


VAERS ID: 209788 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-09-26
Entered: 2003-09-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0309USA02133

Write-up: Information has been received from a company representative concerning a 15 month old patient, who in 1995, was vaccinated with a dose of varicella virus vaccine live (lot number unknown). The company representative heard from a certified midwife about the patient who in 1995 received the varicella virus vaccine live shot and two weeks later developed encephalitis, was hospitalized, and died two weeks later. It was noted this occurred at a different clinic than where the nurse midwife is currently working. It was noted the patient''s gender was reported unknown (also reported as she). The cause of death was reported unknown. No additional information was provided. There was no product quality complaint reported. The encephalitis was considered to be immediately life threatening and disabling. Additional information has been requested. A 15-day follow report received 10/02/2003 adds: This is an amended report. The reporter has been changed, and the narrative has been updated to reflect the info. This report has been corrected as amended. Follow-up info was received, which reported that the certified nurse midwife, who was the original reporting source, indicated she had taken care of a mother, who tole her she had a child who received varicella virus vaccine live, experienced encephalitis and died two weeks later. The nurse midwife indicated she now worked at another practice and was unable to remember the name of the mother or the child. She did not know whether an autopsy had been done, and indicated that she had previously reported everything she knew. The case was considered closed, since no new info would be forth coming. The encephalitis was considered to be immediately life-threatening and disabling. A 15-day follow up report received 10/15/2003 adds no new info. Follow up on 11/25/2003: "No further information is available, since the reporter no longer had access to the patient''s records, nor could any details be remembered."


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: 209988 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Georgia  
Vaccinated:2002-11-01
Onset:2003-09-13
   Days after vaccination:316
Submitted: 0000-00-00
Entered: 2003-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-13
   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: Digoxin; Simethicone; Simvastatin; Polyvinyl alcohol; Spironolactone; Losartan; Pyridoxine HCL; Folic Acid; Cyanocobalamin; Insulin Glargine; Isosorbide Dinitrate; Torsemide; Insulin Glargine; Rabeprazole
Current Illness:
Preexisting Conditions: Patient has history of myocardial infarction, valvular heart disease, congestive heart disease, hypertensive heart disease and diabetes mellitus. On 12/10/02 the patient was admitted to the hospital for chest pain that worsened on ambulation. The patient was diagnosed with angina pectoris (atypical), unknown etiology and was discharged the following day 12/11/02. Patient recovered as of 12/22/02.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302207

Write-up: This subject is a 67 year old male who died at home from Ateriosclerotic Cardiovascular Disease while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 11/1/02. The subject died from Arteriosclerotic Cardiovascular Disease on 9/13/03, 316 days post immunization. Death Certificate 9/17/03: The cause of death was Arteriosclerotic Cardiovascular Disease. No autopsy was performed. The death was reported by the investigator as unrelated to the study vaccine. A 15-day follow up report received 10/22/2003 adds: Additional info received 10/09/2003. Pt, 67 year old male seen 08/12/2003 in cardio clinic reporting doing well overall, blood sugars were stable, CHF stable with medications. Echocardiography performed on 09/03/2003 revealing marked concentric LVH, marked left atrial enlargement, mild mitral regurgitation, mild tricuspid regurgitation with normal pulmonary pressure. No other info is available as pt died at home and no autopsy performed. Diagnosis: Arteriosclerotic Cardiovascular disease. List of additional info received and available with source file: Death certificate: 9/22/2003. Medication Record: 10/16/2002-08/12/2003. Doctors notes: 08/12/2003. Echocardiography report: 09/03/2003. A 15-day follow up report received 10/23/2003 adds no new info.


VAERS ID: 209989 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Georgia  
Vaccinated:2002-10-31
Onset:2003-08-08
   Days after vaccination:281
Submitted: 0000-00-00
Entered: 2003-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ascites, Neoplasm malignant, Pleural effusion
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: 2003-08-08
   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: Clopidogrel; Aspirin Enteric Coated; Carvedilol; Furosemide; Nitroglycerin; Amlodipine; Albuterol Inhalor; Enalapril Maleate; Spironolactone; Megestrol Acetate; Ipratropium Bromide.
Current Illness:
Preexisting Conditions: Other significant conditions of COPD, anorexia/malnutrition. History of myocardial infarction, CHF, and HTN. Relevant history from previous hospitalizations: On 1/5/03 patient was admitted with dyspnea and chest discomfort associated with CHF 66 days after vaccination. He recovered and was discharged one day later.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302206

Write-up: This subject is a 76 year old male, who died at home of carcinoma of unknown primary origin while enrolled in RSV11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/31/02. The subject died of carcinoma of unknown primary origin on 8/8/03, 281 days post immunization. Death Certificate 8/17/03: The cause of death was carcinoma of unknown primary with ascites and pleural effusion. Approximately interval between onset and death: 5 months. Other significant conditions were COPD, anorexia/malnutrition. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested. A 15-day follow report received 10/23/2003 adds: Additional info received 10/09/2003. Death occurred at home. Upon researching recent history, 4 additional hospitalizations, SAE''s found unreported to site with some medical history and relevance to this will be forthcoming. Reference hospitalization SAE of 7/17-7/23/03 as last medical info available. Pt released in stable condition in care of hospice on 7/23/03. No further data available other than Discharge Summary of 7/23/03. Diagnosis: Carcinoma of UNK primary with ascites and pleural effusion. Cross Reference SAE hospitalization for CHF symptoms 01/05/2003. Hospital Discharge Summary: 07/17-07/23/2003. The pt presented to the Emergency Dept with mental status changes after taking 0.5 mg of Ativan also with a concomitant increase in his Duragesic patch to 50 micrograms. He was admitted for evaluation and continued treatment of his mental status changes and also due to some increase in his shortness of breath and dysphagia type symptoms. A therapeutic paracentesis was performed x2. Due to his dysphagia, speech therapy was consulted for a swallowing evaluation. A barium swallow showed a normal swallowing mechanism. Computed tomographic scan showed air in the esophagus, which was consistent with some sort of mass lesion in the mediastinum, although this was not apparent on the computed tomographic scan done previously. An esophagogastroduodenoscopy was consistent with mild esophagitis, otherwise was WNL without strictures or other obstructions seen. The pt continued to be at his baseline during his hospital stay with no definite etiology of the globus sensation, his dysphagia and swallowing difficulties that the pt was having. He was given no apparent etiology from an esophagogastroduodenoscopy, barium swallow or computed tomographic scan. After discussing the risks and benefits of total parental nutrition and ventral line, the pt declined that therapy at this time. The pt''s medications were changed to add Megace, Morphine Sulfate as needed and the pt was instructed to call his Primary Care Provider if his symptoms returned for a repeat therapeutic paracentesis as well as other interventions as needed. Additional info received and available in source file: Medication Record: 10/29/2002-07/24/2003. Death Certificate: 08/17/2003. Discharge Summary: 07/17-07/23/2003.


VAERS ID: 210048 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Washington  
Vaccinated:2003-10-02
Onset:2003-10-02
   Days after vaccination:0
Submitted: 2003-10-06
   Days after onset:4
Entered: 2003-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1093AA / UNK RA / -

Administered by: Private       Purchased by: Public
Symptoms: Difficulty in walking, Dizziness, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Site redness~Influenza (Seasonal) (Fluzone)~~54.00~In Patient
Other Medications: Tegretol; Cough medicine; Phenobarbital; Dilantin
Current Illness: NONE
Preexisting Conditions: Severe mental handicap; Obesity; Seizure disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/02 vaccine administered. 10/02 Evening: patient began running fever. 10/03 Patient unable to walk due to dizziness; dyspnea on and off since 10/02. 10/05 Mother thought bloated; gave suppository and he died.


VAERS ID: 210188 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2003-10-02
Onset:2003-10-02
   Days after vaccination:0
Submitted: 2003-10-03
   Days after onset:1
Entered: 2003-10-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1271AA / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Nausea, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-04
   Days after onset: 2
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: cancer, severe anemia
Preexisting Conditions: see 18
Allergies:
Diagnostic Lab Data: na
CDC Split Type: MS 03 077

Write-up: Wife called clinic 10/03/03. Reports 2 and half hours after flu vaccine patient c/o, n/v, bpv. Symptoms not improved next day, instructed patient to see PMD ASAP. Patient went to hospital from residence 10/4/03 via ambulence, expired that night.


VAERS ID: 210190 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Arizona  
Vaccinated:2002-10-22
Onset:2003-07-25
   Days after vaccination:276
Submitted: 0000-00-00
Entered: 2003-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Dehydration, Hyponatraemia, Laboratory test abnormal, Oral intake reduced, Pyrexia, Renal failure, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-28
   Days after onset: 65
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: Potassium Hydralazine; Ranitidine; Isosorbide mononitrate; Macrobid; Atenolol; Quinine sulfate; Sinemet; Lasix; Insulin; Imdur; ASA; Synthroid
Current Illness:
Preexisting Conditions: Patient has a history of congestive heart failure, hypertension, angina, coronary heart disease, stent placement and angioplasty, left ventricular dysfunction, hyperlipidemia, diabetes type II, chronic renal failure, mild anemia, degenerative joint disease, hypothyroidism. Allergies: Penicillin, Sulfa.
Allergies:
Diagnostic Lab Data: Glucose 245, BUN 27, Sodium 127, Potassium 3.8, Chloride 93, Bicarbonate 26, Creatinine 1.8. The rest of the comprehensive metabolic profile is within normal range. Complete blood count revealed white blood cell count 11.2, Hemoglobin 10.9, Hematocrit 32.2, MCV 94, and Platelets 243,000. Urinalysis with micro is normal. Basic metabolic profile on discharge, glucose 151, blood urea nitrogen 21, sodium 134, potassium 4.0, chloride 104, total bicarbonate 26, creatinine 0.3, calcium 8.0, and magnesium 1.6. Prior to her discharge, the subject on 2g of magnesium sulfate IV infusion). CBC: WBC 11.2, hemoglobin 10.9, hematocrit 33.2, mean corpuscular volume 94, platelet 243. Cardiac enzymes were negative. Urinalysis, protein +2 and nitrates and leukocyte esterase are negative. White blood cell is only 224.
CDC Split Type: 200302227

Write-up: This subject is an 83 year old female, who was admitted to hospital due to acute renal failure while enrolled in RSV11 study. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 10/22/02. The subject developed generalized weakness, low grade fevers, low intake and decreased urinary output for 24 hours and was brought to the emergency room by the family on 7/25/03, and was admitted to hospital on 7/25/03, 276 days post immunization. She was diagnosed with renal failure which was thought to be superimposed on an underlying chronic renal failure. Treatment included IV fluid with infusion of normal saline and put on oral fluid restriction to one liter per day and Lasix was hold. The subject''s hyponatremia recovered and dehydration was resolve with IV infusion. During her admission it was suspected that she had Parkinsonism. She was started on a low dose Sinemet to be followed up by the primary care physician. Discharge diagnosis: Hyponatremia recovering, Suspicion of Parkinsonism, History of coronary artery disease, stable, Acute renal failure secondary to dehydration superimposed on chronic renal failure, Dehydration, resolved, Diabetes Mellitus, on insulin, Hypertension controlled, Mild chronic anemia of chronic disease. After subject was stable she was discharged home for hospice home care visits. While at home she got a severe upper respiratory infection. Subject and family only wanted good comfort interventions. The subject expired on 9/28/03 at home. The event was reported by the Investigator as unrelated to the study vaccine. Additional information received and available in the source file: History and Physical for admission 7/25/03, Discharge Summary for 7/25 to 7/27/03, Summary of Lab tests from 5/31/02 to 7/27/03, Chest X-ray 7/25/03, Hospital Discharge Notification, Hospice Plan of Care 9/1/03, Hospice Physician Admission Orders 9/1/03. A 15-day follow up report received 10/22/2003 adds no new info. A 15-day follow up report received 10/23/2003 adds: Additional info received 10/07/2003. Subject was a hospice pt. No autopsy was done. Confiemed that pt wasn''t hospitalized on 09/08/2003. 10/17/2003: No further info is anticipated, case is closed.


VAERS ID: 210330 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2003-10-03
Onset:0000-00-00
Submitted: 2003-10-13
Entered: 2003-10-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Arrhythmia, Gastritis, Hypertension, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-07
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:

Write-up: Had flu vaccine 100303. C/O N & V after vaccine. Deceased 100703 AM cause of death not known. The autopsy report states cardiac arrhythmia and hypertensive heart disorder. Medical Record received on 10/20/2003 states gastritis.


VAERS ID: 210423 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2003-10-08
Onset:2003-10-09
   Days after vaccination:1
Submitted: 2003-10-14
   Days after onset:5
Entered: 2003-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765705 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-09
   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: lisinopril
Current Illness: none
Preexisting Conditions: hypertension h/o pneumonia diet controlled diabetes smoker
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient came into clinic 10/8 for follow up of hypertension, diabetes. No symptoms reported. Agreed to take influenza vaccine. Medical resident who saw her was call by the medical examiner the next day. she was found dead in bed by family. Apparently c/o soreness at injection site; no other symptoms. Medical examiner signed case out as hypertensive cardiovascular disease, but only did external exam, not full autopsy. The autopsy states hypertensive cardiovascular dx.


VAERS ID: 210427 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Female  
Location: Tennessee  
Vaccinated:2002-06-25
Onset:2002-08-18
   Days after vaccination:54
Submitted: 2003-10-10
   Days after onset:418
Entered: 2003-10-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1700K / UNK - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA696AB / UNK - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1189 / UNK - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485993 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bradycardia, Cardiac arrest, Gastrointestinal haemorrhage, Hydrocephalus, Hypertension, Lethargy, Neoplasm, Paralysis, Pneumonia, Torticollis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-02
   Days after onset: 168
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: Ibuprofen; Tylenol; Motrin; Amoxicillin; Nystatin; Albuterol; Debrox; Pediapred; Decadron; Mannitol
Current Illness:
Preexisting Conditions: Relevant medical history significant for ependymoma with mestastasis and has experienced several surgeries as a result and many complications. The subject was taken to surgery on 8/23/03 because of an acute development of the left sixth-nerve palsy and agonal respirations. The subject was given chemotherapy since this hospitalization and has had to be re-hospitalized several more times due to complications of the underlying ependymoma.
Allergies:
Diagnostic Lab Data: An MRI showed a 4x4cm, posterior-fossa mass to the right of the midline. There was marked compression of the fourth ventricle with marked hydrocephalus of the lateral and third ventricles and the pons and medulla were markedly shifted to the left. A spine series showed an extension of this enhancing mass with sugar coating down to the level of C7, T1 and T2. A CT of the head was done and showed hydrocephalus and posterior-fossa tumor. The subject also exhibited bradycardia and hypertension.
CDC Split Type: 200302044

Write-up: This subject is an eight month old female, who was admitted to the hospital due to right cerebellar mass and 3rd and bilateral ventricular enlargement while enrolled in a Safety, Immunogenicity and Lot Comparability of CPDT Vaccine Absorbed When Administered with Other Recommended Vaccines at 2, 4, 6, and 15 to 16 months of age, Protocol Number P3T06. The subject received three doses of study vaccine; the last dose prior to the event was given on 6/25/02. The subject developed vomiting and became lethargic and was admitted to the hospital 54 days post immunization. She was found to have right cerebellar mas and 3rd and bilateral ventricular enlargement. The event of right cerebellar mass and 3rd and bilateral ventricular enlargment was reported by the investigator as unrelated to the study vaccine. Discharge summary and reports from the investigations done in the hospital have been requested by PPD. From additional information received on 12/11/02 from PPD, it was reported that this patient was hospitalized secondary to vomiting and was later diagnosed with ependymoma. The treatment options for this child are systemic chemotherapy. On 8/18/02, the subject was admitted to the hospital after three weeks of vomiting, lethargy, and progressive head tilt. Treatment included ventriculostomy with externalized drain for decompression. The subject was taken to surgery on 8/23/02 because of an acute development of the left sixth-nerve palsy and agonal respirations. Since surgery, the course has been complicated by a failed swallowing study, therefore, a Gastro-tube was placed without a Nissen fundoplication. The subject developed aspiration pneumonia on 9/1/02 and the treatment included clindamycin and Reglan. The subject has also experienced a small gastrointestinal bleed. The subject was given chemotherapy since this hospitalization and has had to be re-hospitalized several more times due to complications of the underlying ependymoma. From additional information received on 2/5/03 from PPD it was reported that this 13 month old subject who was previously diagnosed with ependymoma recently expired secondary to aspiration. This subject had been on experimental chemotherapy and was given a very poor prognosis. From additional information received on 2/13/03 via a MedWatch from PPD it was reported that this 14 month old subject experienced aspiration requiring hospitalization. On 2/2/03, the subject aspirated at home. Paramedics were called to the home. The subject was taken to the hospital where she was pronounced dead on arrival. On 10/9/03: As per investigator''s site, no additional information is expected, therefore this case is considered closed. Follow up on 10/22/2003: "On 10/09/2003: As per investigator''s site, no additional information is expected, therefore this case is considered closed. On 10/14/2003 a new version was created to correct latest received date to 10/09/2003." Discharge Summary received on 10/22/2003 states cardiac arrest. Medical records received on 10/22/2003 states hydrocephalus.


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: 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: 210764 (history)  
Form: Version 1.0  
Age: 0.78  
Sex: Female  
Location: California  
Vaccinated:2003-10-07
Onset:2003-10-08
   Days after vaccination:1
Submitted: 2003-10-20
   Days after onset:12
Entered: 2003-10-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI078AA / 1 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac arrest, Lung disorder, Pneumonia
SMQs:, Torsade de pointes/QT prolongation (broad), 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), 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: 2003-10-08
   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: Albuterol; Lasix; Pulmicort; KCL; Iron
Current Illness: NONE
Preexisting Conditions: Chronic lung disease; Recurrent pneumonia; Microcephaly; Developmental delay
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received influenza .25cc on 10/7/03 and also received Synagis same day. No illness/fever reported. Patient put to bed; last checked at 3AM 10/08. Found dead in crib on 10/8 about 9 AM. No autopsy done. Hospital discharge summary received on 11/21/03 states cardiopulmonary arrest. Death Certificate received on 10/29/2003 states pneumonia and chronic lung disease.


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: 210959 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Iowa  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-10-23
Entered: 2003-10-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung disorder, Lung neoplasm malignant
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-09
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: Reported cause of death: mesothelioma.
CDC Split Type: HQWYE341520OCT03

Write-up: Information regarding poliovirus vaccine was received from an attorney regarding a male pt who experienced mesothelioma and cancer. The pt received vaccine. Relevant medical history was not provided. Indication for poliovirus vaccine was immunization. Product was administered between 1974 and 1977. Dose regimen was not provided. Concomitant medications were not reported. The attorney alleges that the decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, including but not limited to breathing difficulties, asbestosis, lung and/or other cancer (carcinoma NOS), mesothelioma, and/or other lung damage. Decedent died of esothelioma on 9/9/02. Decedent was diagnosed with mesothelioma on or about November 2002. No additional info was available at the time of this report.


VAERS ID: 211044 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: California  
Vaccinated:2003-10-17
Onset:2003-10-19
   Days after vaccination:2
Submitted: 2003-10-23
   Days after onset:4
Entered: 2003-10-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1260AA / UNK 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: 2003-10-19
   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: Hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302675

Write-up: From initial info received on 10/22/03, from a health care professional, regarding a death occurring, it was reported that a 79 year old female pt died of a "heart attack" on 10/19/03, two days after receiving a dose of Fluzone SV ''2003-''2004, lot number U1260AA, given IM in the left deltoid on 10/17/03. The reporter stated that the case of death indicated on the death certificate was cardiac arrest. A 15-day follow up report received 11/04/2003 adds: From additional info obtained on 10/27/2003, from a telephone conversation with the reporter, it was stated that the responsible physician is waiting for follow-up documents. The reporter also stated that she was not sure if there will be an autopsy report and that they had not yet received any hospital records or test results. The correct spelling of the responsible physician''s last name was also provided. A 15-day follow up report received 11/13/2003 adds: From additional info received on 11/06/2003 from faxed correspondence from the reporter, it was reported that the pt had pre-existing conditions of hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson''s disease. The pt received the influenza vaccine on 10/17/2003 and expired on 10/19/2003 at 9:31 AM. Per the reporter, the pt''s death was not caused by the vaccine. The death certificate was also provided and the "immediate cause" of death was listed as cardiac arrest . Both hypertension and hyperlipidemia were listed as "underlying cause". No other info was reported. Case is closed.


VAERS ID: 211046 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Arizona  
Vaccinated:2002-10-21
Onset:2003-08-21
   Days after vaccination:304
Submitted: 0000-00-00
Entered: 2003-10-28
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, Renal failure acute
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (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), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-22
   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: RSV/Placebo, Celexa, Aspirin, Prevacid, Nephrocap, Amiodarone, Coreg, Metoclopramide, Miralax, Alphagan, Lumigan, Flonase
Current Illness:
Preexisting Conditions: Information received October 17, 2003 regarding previous hospitalizations: Discharge Summary: 5/29/03-6/4-03. The subject developed respiratory distress and wheezing 220 days post immunization and was admitted to the hospital on 5/29/03. He was diagnosed with possible pneumonia or bronchitis along with reactive airways disease and also volume overload state. The pt received dialysis with fluid removal as tolerated. he was hypotensive on dialysis and received dialysis several days in a row. The pt was treated with IV antibiotics along with oral Biaxin and has been maintained on oral Biaxin. Also, the pt has received supplemental oxygen and small volume nebulizer bronchodilator therapy. His respiration status has improved significantly throughout the hospitalization. Repeat chest x-ray showed interval decreases in the bilateral perihilar opacities, with a small pleural effusion. Dialysis will be continued 3 times a week. Subject''s condition is ongoing and he was discharged from hospital to a nursing facility 7 days later on 4/6/03. The event was reported by the investigator as not related to the study vaccine. Admission/ Discharge Summary 7/22/03-7/25/03. The subject developed increased shortness of breath over the last five days and was admitted 274 post immunization on 7/22/03 with SOB, CHF, fluid overload and pleural effusion. Treatment underwent a thoracenteses of the right pleural effision. The fluid studies were consistent with a transudative effusion likely secondary to fluid overload with this end-stage renal disease and congestive heart failure. He continued on hemodialysis during the hospital course and his fluid status improved as well as his respiratory status. After undergoing hemodialysis the pt experienced some episodes of hypotension but remained asymptomatic without any chest pain, shortness of breath, lightheadedness or dizziness. He was started on Proamatine 2.5mg po bid to be increased as needed. Pt also experienced some diarrhea. A c. diff stool study done on the 6/25/03 was noted to be positive for C. diff. He was started on Flagyl 500mg po tid for 10 days. Pt was discharged to a nursing home 3 days later on July 25. He was comfortable at rest and ambulated with oxygen 2 liters nasal cannula. The pt will continue on hemodialysis on a three times a week basis and will continue on his medications including Coreg and Amiodarone. Labs include a white count of 10.3, hemoglobin of 11.7, platelets of 230,000, sodium 136, potassium 3.9, chloride 98, bicarb 28, BUN 43, creatinine 4.5, glucose 123, calcium 8.9, total bilirubin 1, AST 37, ALT 47, Alk phos 135, CK 34, Troponin 0.07, chest x-ray shows a right-side pleural effusion as well as bilateral perihilar consistent with CHF. The EKG shows sinus rhythm with ST depression findings in the lateral leads and inferior leads. C. diff stool study done on the 6/25/03 was noted to be positive for C. diff. The event was reported by the investigator as not related to the study vaccine. Admission/ discharge 8/4/03. Hx-CHF, pneumonia, pleurisy, pleural effusion, RAD, ESRD, prostate surgery, quit smoking 20 years ago. The subject developed SOB and a productive cough 287 days post immunization and was admitted to the hospital on 8/4/03. Pt apparently had been having similar problems which had cleared up after a course of treatment, however symptoms resumed over the next couple of days. Treatment included oxygen, SVN and IV antibiotics and he was placed on IV Invanz. Chest x-ray revealed diffuse infiltrates and bilateral pleural effusions. Cocci serology report is pending. CPK 27l, sodium 136, potassium 4.5, chloride 99, CO2 29, glucose 137, BUN 23, creatinine 4.4, SGOT 83, SGPT 124, alkaline phosphatase 208, Troponin negative, white count 7.5, hemoglobin 12.3, platelets 531. No manual differential available. EKG shows sinus rhythm without any acute ischemic changes. The subject''s condition is ongoing and he was discharged the same day. The event was reported by the investigator as not related to the study vaccine. Admission/ Discharge 8/11-8/15-03. The subject developed SOB 294 days post immunization and was admitted to the hospital on 8/11/03 with chronic obstructive pulmonary disease exacerbation. He was started on Solu-Medrol 120mg IV, then 60mg IV q. 12H, SVN. Treatments of Albuterol and Atrovent were started q. 4h. while awake. Pulmonary consultation was arranged. He was started on his home medication as well as Flagyl 500mg one po tid x 5 days which had been started prior to admission. He was seen in consultation and assessment was respiratory insufficiency, mental status change, right pleural effusion and COPD. At this point his medications were continued as previously ordered. He was seen by a Nephrologist for continued dialysis. On the 13th he remained stable. Speech evaluation is ordered for evaluation of his swallowing. CT scan of his chest was noted to show possible right upper lobe mass. CT scan of head show atrophy, with nothing acute. At this point there are no further plans for further evaluation of the mass. On the 15th Dr. did discuss the mass at length with the family and they decided on a hospice evaluation. The subject''s condition is ongoing and he was discharged with hospice to the nursing home 4 days later on 8/15/03 to hospice. Lab: sodium 138, potassium 5.0, chloride 101, CO2 30, glucose 147, BUN 27, creatinine 4.8, albumin 2.5, alkaline phosphatase 125, white count 6.6, hemoglobin 11.6, platelet count 362,000, blood gases 7.46/43/76 four liters. The event was reported by the investigator as unrelated to the study vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302461

Write-up: This is a 83 year old male who died on August 21, 2003 while enrolled in RSV S and I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/02. The subject died 304 days post immunization while in hospice care. The event was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 10/31/2003 adds: The subject died 305 (corrected) days post immunization while in hospice care. Additional info received 10/24/2003: Date of death is 08/22/2003, changed from 08/21/2003. Diagnosis: Pt died at hospice on 08/22/2003 from CHF and ESRD.


VAERS ID: 211047 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Georgia  
Vaccinated:2003-10-09
Onset:2003-10-10
   Days after vaccination:1
Submitted: 2003-10-23
   Days after onset:13
Entered: 2003-10-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21893B9 / 2 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1170M / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494303 / 2 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: There were no adverse events following the initial dose of vaccines.~ ()~~0.00~Patient
Other Medications: NONE Palivizumab; Sodium chloride
Current Illness: NONE Unknown
Preexisting Conditions: Prematurity birth; Apnea; Birth twin; Bradycardia; Cough with exposure to cigarette SM, Decreased oxygen saturation; Hyperbilirubinemia; Hypoglycemia; Nasal congestion; Passive smoker; Staphylococcal infection, Tachycardia; Maternal history of 33 year old female smoker with insufficient prenatal care; complications during pregnancy included maternal GUILLAIN-BARRE syndrome, premature labor, and multiple gestation; medications during pregnancy included prenatal vitamins and antiemetics.
Allergies:
Diagnostic Lab Data: NONE Autopsy listed cause of death as Sudden Infant Death Syndrome (report not available). The patient was born by urgent cesarean delivery and was one of a twin pregnancy; infant had first cry was at 23 seconds then apnea. The patient was admitted to neonatal intensive care unit following delivery for indications including possible sepsis and prematurity; sepsis was ruled out (treatment with ampicillin and gentamicin) and diagnoses while hospitalized included prematurity (32 weeks three days gestation), hyperbilirubinemia, twin gestation, and hypoglycemia; the patient was hospitalized for thirteen days following delivery for respiratory and nutritional support and two days of phototherapy.
CDC Split Type: A0499473A

Write-up: Unknown. Died in sleep. The autopsy report received on 3/9/04 states SIDS. This report was received from the Center for Disease Control (CDC) in response to a request by GSK. This case was reported by the Center for Disease Control (VAERS number 211047) and described the occurrence of sudden death in a 4-month-old female patient who had received PEDIARIX. Medical history included premature birth at 32 weeks three days gestation to a 33-year-old gravida 4 para 4 female. The mother had a previous premature delivery and used tobacco. During this pregnancy, there was no prenatal care until three days prior to delivery. Pregnancy was complicated by twin gestation, premature onset labor, had untreated group B streptococcal infection. The patient was a twin delivered by urgent cesarean section with a birth weight of 1.835 kilograms. The patient''s first cry was at 23 seconds and was followed by apnea; the "initial heartrate was less than or equal to 60 beats per minute. The apnea and bradycardia responded immediately to positive pressure ventilation and supplemental oxygen, which were discontinued within two minutes thirty seconds. Apgar scores were 4 and 9 at 1 and 5 minutes, respectively. The patient was admitted to the neonatal intensive care unit (NICU) with diagnoses of prematurity and possible sepsis. The 13-day NICU course was complicated by: 1) blood cultures that grew coagulase negative Staphylococci; this was treated with ampicillin and gentamicin; sepsis was subsequently ruled out. 2) hyperbilirubinemia (maximum serum total bilirubin 10.3 mg/dL) which was treated with two days of phototherapy. 3) Hypoglycemia, treated with intravenous fluids (04 through 08 June 2003), and gavage feedings (08 through 13 June 2003). The infant was discharged home on 16 June 2003. The infant was reported healthy when seen by the pediatrician for well-child care on 23 June 2003. On 25 July 2003, the neonate was examined for cough and several nasal congestion that had persisted for three days duration, and had improved following nasal suctioning. It was noted that both parents smoked and that the patient''s symptoms were attributed to second-hand smoke. On 01 August 2003, the patient was reportedly improved. It was noted that, during the previous visit on 25 July 2003, the physical examination revealed tachycardia (heart rate of 212 without color changes) and decreased oxygen saturation (pulse oximetry in the "low eighties"), with subsequent improvement (heart rate to 180''s and pulse oximetry of 100). It was noted that the parents had been counselled about not smoking in the house or car, and the importance of back sleeping was discussed "as babies have several risk factors for SIDS". The patient received initial vaccinations with PEDIARIX, PRENAR, and haemophilus influenza type b vaccination. Assessment included prematurity, passive smoking, and tachycardia with referral to cardiology for first available appointment for evaluation. On the afternoon of 09 October 2003, the patient received her second dose of PEDIARIX (lot number 21893B9). At the time of vaccination, the patient''s heartrate was 136 beats per minute, respiratory rate of 32 per minute, temperature 97.3 degrees Fahrenheit, weight 15.88 pounds. The patient was noted to be "smiling, playful, no distress". Co-administered vaccinations on that date included PREVNAR (Lederle Labs) and PEDVAXHIB (Merck). One day after vaccination, on the morning of 10 October 2003, the patient died in her sleep. Autopsy reported the cause of death as Sudden Infant Death Syndrome. (report not available). Further information about the circumstances of death are not available.


VAERS ID: 211159 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Virginia  
Vaccinated:2003-10-22
Onset:2003-10-23
   Days after vaccination:1
Submitted: 2003-10-23
   Days after onset:0
Entered: 2003-10-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1386AA / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR VA874AA / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1624 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493472 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-23
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death in crib within 24 hours; infant was prone in crib.


VAERS ID: 211160 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Washington  
Vaccinated:2002-10-22
Onset:2003-09-29
   Days after vaccination:342
Submitted: 0000-00-00
Entered: 2003-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Coma, Condition aggravated, Deep vein thrombosis, Fluid overload, Mental impairment, Pulse absent
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/Placebo, Allopurinol, Atenolol, Furosemide, Simvastatin, ASA, insulin, Mirtazapine, Doss, Loperamide, Simethicone
Current Illness:
Preexisting Conditions: DM, CHF, CAD, PVD, gout, UTI (recurrent). Above the knee amputation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302676

Write-up: This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 9/29/03. He was transferred from ICU post AKA for decrease MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Pt showed bilateral DVT''s and was placed on Heparin and then Lovenox the same day. He remained stable until October 1, 2003 in the evening when he was found unresponsive and pulseless. Subject expired more than 30 minutes of unsuccessful resuscitation. Diagnosis: DVT with presumed PE, cardiopulmonary failure secondary to DVT, CHF exacerbation, DM, GRI, and altered MS. The death was reported by the investigator as not related to the study vaccine. Follow up on 11/26/03: "Initial SAE report received on 10/22/03. This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 09/29/03. He was transferred from ICU post AKA for decreased MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Patient showed bilateral DVT''s and was placed on Heparin and then Lovenox the same day. He remained stable until 10/01/03 in the evening when he was found unresponsive and pulseless. Subject expired after more than 30 minutes of unsuccessful resuscitation. Diagnosis: 1) DVT with presumed PE. 2) Cardiopulmonary failure secondary to #1. 3) CHF exacerbation. 4) DM. 5) GRI. 6) Altered MS. The death was reported by the Investigator was not related to the study vaccine. Additional information received 11/18/03. Death certificate: Cause of death: Pulmonary Embolism due to deep vein thrombosis due to congestive heart failure. The pulmonary embolism secondary to deep vein thrombosis secondary to congestive heart failure was reported by the investigator as not related to the study vaccine."


VAERS ID: 211341 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: New Mexico  
Vaccinated:2003-07-25
Onset:2003-08-16
   Days after vaccination:22
Submitted: 2003-10-30
   Days after onset:75
Entered: 2003-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR 13 / 2 - / -
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / 2 - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 2 - / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Irritability, Pyrexia, Sudden infant death syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: very high fever~DTP + IPV (no brand name)~1~0.20~In Patient
Other Medications:
Current Illness: none
Preexisting Conditions: She was born a month premature.Had to drink lactos free milk
Allergies:
Diagnostic Lab Data: the medical examiner said it was SIDS
CDC Split Type:

Write-up: She had gotten really high fevers around 104 and she was really fussy and was vomiting really bad. She also had dirrea almost everyday scince she had recivied the vaccine we took her to the emercancy once and the doctor just told us that it was the normal reaction the the vaccines she hsd recieved and just to give her alot of fluids. About a week later she died. The autopsy states SIDS.


VAERS ID: 211326 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Washington  
Vaccinated:2002-10-17
Onset:2003-07-28
   Days after vaccination:284
Submitted: 0000-00-00
Entered: 2003-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-10
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Trachy Brady Syndrome; A-fib; CAD; CHF; COPD; Sprain; Actinic Keratosis; Gastroesophageal Reflux Disorder; Colonic Polyps; Iron Deficiency Anemia; Obstructive Lung Disease; Hypertension; Glaucoma; Cataract; Hypothyroidism; Renal insufficiency; Anticoagulation assoc bleeding; Allergy;
Allergies:
Diagnostic Lab Data: Information received from previous hospitalization 11/25/02-11/28/02: The subject developed back and shoulder pain, 36 days post-immunization and 3 days prior to admission into hospital. The pain increased and became associated with chest pressure and radiation of pain down his left arm. NTG did not relieve the pain. Subject did not want to go to the hospital until the evening of 11/25/02 when pain became very severe with associated nausea. He was admitted to hospital on 11/25/02 and started on NTG gtt, morphine and b-blocker and when stabilized was transferred to another hospital. At transfer subject was pain free, enzymes were essentially negative and EKG had no new changes. He was unable to tolerate a nuclear stress test secondary to claustrophobia. Physical exam was within normal limits except for decreased breath sounds at lung bases. Renal U/S showed no hydronephrosis or renal calculi w/in either kidney with mild parenchymal thinning. Initial troponin was 0.1. ECG showed RBBB with ST seg depression in V1 and V2, left axis deviation and sinus tachycardia. Chest x-ray showed cardomegaly with no infiltrates. Reported labs were HCT 31.8, platelets 203, creatinine 3.2, BUN 43, CPK 101, CKMB 4.6, and troponin 0.15. Creatinine increased from 3.2 to 3.5. Urine protein/creatinine ratio and renal U/S were both obtained and were normal. Subject was started on ASA and continued on digoxin, dilitiazem and started low dose of carvedilol and continued on outpt inhalers for severe COPD based on PFT''s. UTI was diagnosed by U/A with $g30 WBC HPF and treated w/ Levofloxacin. A sudden onset of pain and swelling on the lateral left ankle was treated with Tylenol. He was discharged home w/diagnosis of atypical chest pain in setting of known CAD on ASA and b-blocker. Symptoms/Diagnosis: Chest pain, intermittent A-fib, CHR class II-III, Acute Renal Failure, UTI. The subject recovered. He has a follow up appointment with cardiology in 1-2 months. Information received from previous hospitalization 05/05-08/03. Subject was hospitalized 200 days post immunization for diaphoresis, with chest pressure, palpitations, nausea, diaphoresis, tachycardia. He has had difficulty with variable heart rates in a fib/flutter/jxnal since 04/03. On digoxin/carvedilol for a fib rate control and heart failure. Developed bradycardia with apparent accelerated jxnal rhythm when seen in clinic by doctor on 04/10/03. He has been off and on his digoxin and carvedilol since, with alternating episodes of tachycardia and bradycardia. Stopped Digoxin 04/27/03. Continued on carvedilol 3.125 mg bid. Plan for OP permanent pacer to treat bradycardia assoc with tx of atrial tachycardia. EKG-aflutter, rate about 150, extreme LAD, RBBB, info Q, Q V3-4 after 10 mg Diltiazem-rate 102, freq PVC''s o/w unchanged. CxR 05/05-Although the left lung base was excluded in the image, there may by opacity obscuring left hemidiaphragm possibly atelectasis or pneumonia. Cardiomegaly unchanged w/out sign of interstitial edema. 05/06-Cardiomegaly and pulmonary vascular engorgement w/out overt failure. New cardiac pacer in satisfactory position. 05/07-PA/LAT-continued satisfactorypostoperative appearance following single-lead left transvenous pacemaker placement, w/pacemaker components in customary position. No pneumothorax of other complication is seen, and no change observed from yesterday''s film Moderate to severe cardiomegaly is again noted, w/out evidence of CHF. Hospital course: 1) Tachy/Brady Syndrome: patient admitted to tele for monitoring and rate control. Diltiazem boluses brought rate from 140s to 90s readily. Initially increased long acting Diltiazem to 240mg qd from 180mg qd in rsponse. Also increased Carvedilol from 3.125 mg bid to 6.125 mg bid. However, patient became relatively hypotensive on these med increases with SBP 80s-90s on hosp day #2. Thus decreased back to OP doses of Carvedilol and Diltiazem and restarted Digoxin with IV load as rate had been in 40s as OP on this regimen. Subject received pacemaker on 05/06/03 w/out complication. Pacing appropriately below rates of 70. 2) NSTEMI-patient admitted with CP assoc w/tachycardia. Had small bump in troponin to 0.43 from baseline of 0.18 or so. Experienced no further CP in house. Thought that small NSTEMI was rate related. Patient was continued on CAD risk modification meds, including ASA, Carvedilol, Losartan. Patient rqstd to PharmD on d/c that ASA be discontinued. 3) Ischemic Cardiomyopathy-EF 35-40% 04/01. No signs of volume overload on CxR or exam and osygenation fine, thus diuresis was not pursued. CO likely worsened by tachycardia, causing worsening renal function and acidosis, but improved with rate control. Continued Losartan, Carvedilol, ASA, Lasix 40mg qd restarted on d/c. 4) Renal failure-Experienced worsening of Cr from recent baseline of 2.8-2.9 to 3.7 recently, likely due to tachycardia resulting in worsened cardiac output. Decreased to and stabilized at 3.1 on discharge. Following with Renal as outpatient to determine when and whether to start dialysis. Continued on Losartan. 5) Gap metabolic acidosis-subject presented with bicarb of 18 and AG 16, resolved over hospital stay. Presumed due to decreased CO and lactic acidosis and better now that rate is better controlled Bicarb 24 on d/c.
CDC Split Type: 200302677

Write-up: This subject is an 81 year old male who according to his wife was admitted to the hospital due to an acute myocardial infarct while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. Subject was admitted to the hospital 284 days post immunization and died 13 days later. Investigator has requested a discharge summary. The myocardial infarction was reported by the investigators as not related to the study vaccine. The death certificate received on 11/20/03 states cardiomyopathy. Follow up on 11/26/03: " Additional information received 11/18/03. Death Certificate: Date of death: 08/10/03. Cause of death: PEA arrest due to Global Dilated Cardiomyopathy. The PEA arrest secondary to Global Dilated Cardiomyoptahy was reported by the Investigator as not related to the study vaccine."


VAERS ID: 211358 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2001-02-12
Onset:2001-02-12
   Days after vaccination:0
Submitted: 2003-10-30
   Days after onset:990
Entered: 2003-10-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474736 / 1 LL / ID

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Congenital anomaly, Convulsion, Encephalopathy, Hypoxia, Pneumonia, Pyrexia, Status epilepticus
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-11-01
   Days after onset: 262
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Flovent; Atrovent; Zantac; Feosol; Albuterol; PRN
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT and MRI: hypoxic ischemic encephalopathy - no change; EEG after seizure stopped; No seizure activity on EEG; Elevated LFT''s.
CDC Split Type:

Write-up: Child developed fever to 102 ax (103.7 pr later). At 5:30, given Tylenol. At 1 AM 2/13/01, the child was found in status epilepticus. EMS called. Patient given 4 different anticoagulants, intubated. Given dopamine; ICU care. Depressed neuro function persisted. The death certificate received on 11/21/03 states pneumonia, pulmonary failure, and CP.


VAERS ID: 211457 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2003-07-21
Onset:2003-07-21
   Days after vaccination:0
Submitted: 2003-10-31
   Days after onset:102
Entered: 2003-11-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Acidosis, Cardiac arrest, Coma, Dyspnoea, Encephalopathy, Pneumonia, Renal failure acute, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Lactic acidosis (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), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-07-22
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, ESRD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt went to hospital earlier that day and received a Pneumovax. During lunch time she complained of shortness of breath, became unresponsive and 911 was called. ACLS performed, pt brought to hospital and intubated. Dx: cardiac arrest-shock. The hospital discharge states end stage renal dx, encephalopathy, acidosis, and aspiration pneumona.


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: 211535 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: New York  
Vaccinated:2003-10-15
Onset:2003-10-15
   Days after vaccination:0
Submitted: 2003-10-29
   Days after onset:14
Entered: 2003-11-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765874 / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1212M / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1001AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Coronary artery disease
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-15
   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: Hyzaar, Advair
Current Illness: NONE
Preexisting Conditions: HTN, probable emphysema
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death approx 6 to 7 hrs after vaccine administration. The death certificate state cardiopulmonary arrest and CAD.


VAERS ID: 211550 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: New York  
Vaccinated:2003-10-15
Onset:2003-10-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2003-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Herpes zoster
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norflex, Aspirin, Diltiazem, Zocor, Vioxx, folic acid, Actonel, Prednisone, Nystatin
Current Illness:
Preexisting Conditions: COPD, pulmonary fibrosis-end stage-diagnosed 6/2003. Angioplasty and stent 2001.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302804

Write-up: This subject is a 72 year old male who died while enrolled in the RSV11 study. Subject received RSV vaccine or Placebo and influenza vaccine on 10/15/2003. The subject developed shingles 10/19/03, 4 days post immunization and 7 days later, on 10/26/03 he had increasing shortness of breath and died while on the way to the hospital. The death was reported by the investigator as possibly related to the study vaccine. Follow up on 12/10/03: "Additional info received 12/01/03. Death cert received with the date of death being 10/28/03 not 10/26/03 as stated in the initial report . Cause of death was CHF w/approximate interval of 2 weeks between onset and death. Due to or as a consequence of CAD w/appropriate interval of years between onset and death. Due to or as a consequence of Idiopathic Pulmonary Fibrosis w/approximate interval of months between onset and death." Follow up on 02/09/04: "The causality has been changed by the investigator from possible relationship to "unrelated"."


VAERS ID: 211692 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Missouri  
Vaccinated:2003-10-14
Onset:2003-10-23
   Days after vaccination:9
Submitted: 2003-11-04
   Days after onset:12
Entered: 2003-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1255AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-31
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Type 2 Diabetes, COPD, Hypertension, Hyperlipidemia, Peripheral Vascular Disease, TIA, osteoarthritis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Guillain-Barre Syndrome. The hospital discharge summary received on 12/15/03 states apnea/respiratory failure.


VAERS ID: 211782 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Male  
Location: Georgia  
Vaccinated:2003-10-05
Onset:2003-10-07
   Days after vaccination:2
Submitted: 2003-03-07
   Days after onset:213
Entered: 2003-11-04
   Days after submission:242
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV078 / 1 RA / IM
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UB233AA / 1 - / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020071 / 2 LA / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR W1344 / 1 - / IM

Administered by: Military       Purchased by: Military
Symptoms: Arteriosclerosis, Cardiovascular disorder, Coma, Coronary artery occlusion, Malaise, Stomach discomfort
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-07
   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: Deconamine SR
Current Illness: FEVER
Preexisting Conditions: High blood pressure; 15-year smoking history, new heart murmur 1/6 systolic. Preliminary autopsy findings: ASCVD w/ left main coronary artery occluded 90%, left anterior descending coronary artery occluded 85%. Diagnosed wit URI on 9/30/03 and treated with Deconamine SR BID x 10d.
Allergies:
Diagnostic Lab Data: PPD skin test applied on 10/5/03
CDC Split Type:

Write-up: Patient did vigorous physical training session just before dinner, went to dinner, didn''t feel well (upset stomach), went to barracks, apparently fell out of top bunk, was unresponsive. CPR started promptly with physician assistant attending. EMS arrived, patient was in asystole with no response to ACLS protocols. Transported to ER and ACLS continued with no response. Post-mortem x-ray showed no skeletal fracture or dislocation. Well known to unit PA; high blood pressure; 15-year smoking history, new heart murmur 1/6 systolic. Preliminary autopsy findings: ASCVD w/ left main coronary artery occluded 90%, left anterior descending coronary artery occluded 85%. Final autopsy report awaits tissue and toxicology findings. Add''l medical records will be provided once available. Pt did vigorous physical training session just before dinner, went to dinner, didn''t feel well (upset stomach), went to baracks, apparently fell out of top bunk, was unresponsive. CPR started promptly with physician assistant attending. EMS arrived, pt was in asystole with no response to ACLS protocols. Transported to ER and ACLS continued with no response. Post-mortem x-ray showed no skeletal fracture or dislocation. Well known to unit PA; high blood presure; 15-year smoking history, new heart murmur 1/6 systolic. Diagnosed with URI on 09/30/2003 and treated with Deconamine SR BIDx 10d. Preliminary autopsy findings: ASCVD with left main coronary artery occluded 90%, left anterior descending cornonary artery occluded 85%. Final autopsy report awaits tissue and toxicology findings. Nurse follow up on 11/08/04 states: "Severe Atherosclerotic Cardiovascular Disease."


VAERS ID: 211721 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Female  
Location: Missouri  
Vaccinated:2003-10-21
Onset:2003-10-22
   Days after vaccination:1
Submitted: 2003-11-04
   Days after onset:13
Entered: 2003-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 616A2 / 4 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4020017 / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 494759 / 4 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, Cholangitis, Grunting, Laboratory test abnormal, Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-10-23
   Days after onset: 1
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; Vasotec; Lasix
Current Illness:
Preexisting Conditions: Polycystic Kidney Disease; Hypertension; Previous E. Coli bacteremia
Allergies:
Diagnostic Lab Data: Blood cultures; Autopsy report; Pseudomonas sepsis (possible infected liver cyst).
CDC Split Type:

Write-up: Fever day after immunization. Gone that night, but then developed moaning and grunting. Went to ER; looked shocky and then arrested. Died several hours later despite repeated resuscitation efforts. The autopsy received on 11/11/03 states pseudomomas sepsis. The autopsy report received on 2/4/04 states shock and cholangitis.


VAERS ID: 211864 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Illinois  
Vaccinated:2003-10-22
Onset:2003-10-22
   Days after vaccination:0
Submitted: 2003-11-05
   Days after onset:14
Entered: 2003-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1281AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA825AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0907 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492397 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE KNOWN
Allergies:
Diagnostic Lab Data: RECIEVED REPORT OF PENDING PROBABLE SIDS.
CDC Split Type:

Write-up: INFANT SAW DR ON 10-22-03. ULTRASOUND OF HEAD ORDERED FOR 10-23-03, JUST TO BE SURE NOTHING WAS IRREGULAR AS BABY''S HEAD WAS SLIGHTLY LARGER THAN SCALE. NO IMMUNIZATION CONTRAINDICATIONS. IMMUNIZATIONS GIVEN 10-22-03 AT HEALTH DEPARTMENT. 2 1/2 HOURS LATER BABY FOUND UNRESPONSIVE IN PLAYPEN. RECIEVED REPORT OF PENDING PROBABLE SIDS. Follow up: Autopsy to be mailed upon receipt of payment.


VAERS ID: 211829 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2002-10-31
Onset:2003-10-19
   Days after vaccination:353
Submitted: 0000-00-00
Entered: 2003-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Choking, Dyspnoea, Pulse absent
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-19
   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: Imdur; Buspar; Mobic; ASA; Protonix; Pulmicort; Norvasc; Astelin; Atrovent; Advair; Cardura
Current Illness:
Preexisting Conditions: Angina; Asthma; GERD; Anxiety; BPH; HTN: Arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302580

Write-up: This subject is a 82 year old male who died from a choking episode while enrolled in RSV 11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/31/2002. The subject died 353 days post immunization on 10/19/03. The subject choked on some food and 911 was called. Subject was taken to the hospital and pronounced dead on arrival. The subject''s death 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 on 11/3/03: Diagnosis: Cardiac arrest. According to discharge summary, pt was gasping for air more than choking. When intubated by the paramedics they did not see any food obstructing his airway. Resuscitation attempted in ER, but arrived there pulseless and remained pulseless. Family reported pt complained of intermittent chest pain over the past week. Etiology suspected arrythmia related. Cause of death: Cardiac arrest/pulseless electrical activity/idioventricular rhythm. Additional documents available with source file: ER note: 10/19/2003.


VAERS ID: 211877 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Michigan  
Vaccinated:2003-10-29
Onset:2003-11-03
   Days after vaccination:5
Submitted: 2003-11-04
   Days after onset:1
Entered: 2003-11-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21897A9 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE054AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494310 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-03
   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: NONE
Current Illness: NONE
Preexisting Conditions: Newborn rash on cheeks
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was seen for well check on 10/29/03. She received vaccines and per parents tolerated them very well. She was well over the following days but found dead on 11/03/2003 AM.


VAERS ID: 212153 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Unknown  
Location: California  
Vaccinated:2002-10-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lung disorder, Pneumonia, Pulmonary hypertension
SMQs:, Pulmonary hypertension (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: 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; Prednisone; Lasix; Spironolactule; Arpamil, Fosamax, Septha
Current Illness:
Preexisting Conditions: Emphysema, CHF, COPD, interstitial lung fibrosis, diabetes type 2.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302839

Write-up: This subject is a 79 year old male who died while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 10/25/02. Investigator is waiting for medical records. The death was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 11/13/2003 adds no new info. The hospital discharge summary received on 11/20/03 states pneumonia, and pulmonary hypertension. A follow-up received 11/20/2003 adds: Acute pneumonia, pulmonary HTN.


VAERS ID: 212170 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Indiana  
Vaccinated:2003-11-07
Onset:2003-11-08
   Days after vaccination:1
Submitted: 2003-11-11
   Days after onset:3
Entered: 2003-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765797 / 4 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coronary artery atherosclerosis
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-09
   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: Insulin Oral diabetic agents Calcium Channel blocker?
Current Illness: None reported
Preexisting Conditions: Diabetes Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired 11/9/03 Cause of death following autopsy: Fatal Heart Disease (Athero- sclerotic heart disease) Fatal Arrythmia Diabetic Related


VAERS ID: 212277 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2003-10-22
Onset:0000-00-00
Submitted: 2004-10-01
Entered: 2003-11-14
   Days after submission:321
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1123AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Respiratory failure, Stevens-Johnson syndrome, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), 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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amoxicillin, two neurological medications
Current Illness:
Preexisting Conditions: The patient was a teacher and received the vaccine at her school. At the time of vaccination, the patient was reportedly taking amoxicillin and two new neurological medications however, the indications for each were not specified.
Allergies:
Diagnostic Lab Data: No autopsy was performed.
CDC Split Type: 200302904

Write-up: It was reported that a 43 year old female pt received Fluzone on 10/23/03. An unspecified amount of time later, the pt developed a fever of 104 deg F and was taken by ambulance to the hospital. She was diagnosed with Stevens-Johnson syndrome. The pt died on 11/3/03. The reporter stated that the death certificate lists the cause of death as "toxic epidermal necrolysis and severe respiratory failure." No other info was reported. A telephone call was placed to the reporter on 11/7/03, to request copies of the death certificate and autopsy report if available and any additional info. Later that day, the reporter provided the lot number info. The product was administered IM in the left deltoid on 10/22/03. The pt was admitted to the hospital on 10/25/03. The primary physician''s info and vaccine supplier were also provided. On 11/7/03, during telephone contact with the primary physician, it was reported that the pt was on several other medications at the time of vaccination, including amoxicillin and two new neurological medications. He could not provide any additional info at this time. Follow up on 11/17/2003: "From additional information received on 11/10/2003 from the initial reporter, it was reported that the patient died at a university medical center on 11/03/2003 at 8:38AM. A copy of the death certificate was provided and the causes of death are listed as toxic epidermal necrolysis and Stevens-Johnson Syndrome. The approximate interval between the onset of symptoms and death was noted to be one week. No autopsy was performed. The vaccine administrator and responsible physician''s information were also provided, as well as the attending physician''s name and contanct information from the hospital where the patient was treated. The patient received the influenza vaccine on 10/22/2003 in the left deltoid. E-mail correspondence with the attending physician at the hospital that same day stated that he felt that the physicians who were part of the original attending team admitting the patient to the hospital would best be able to answer requests for additional information. He provided the names of the doctors and stated that the forwarded the request from AP, Inc. to these same physicians. No other information was provided." Follow up on 05/18/04 states: "Despite several attempts to obtain follow up information, no additional information was provided. This case is considered closed."


VAERS ID: 212445 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Texas  
Vaccinated:1997-09-11
Onset:0000-00-00
Submitted: 2003-11-14
Entered: 2003-11-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-12
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: Cetirizine hydrochloride, Immunotherapy
Current Illness: UNK
Preexisting Conditions: Adenoidectomy, Alcohol consumption, Allergy to Biaxin, Allergy to Cedar, Allergy to Molds, Appendectomy, dust allergy, elevated creatinine, environmental allergy, ex-smoker, hemorrhoids, hypercholestoerolemia, hypothyroidism, xyphosis, polymyalgia rheumatica, preseyopia, restless
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0439341A

Write-up: This report described the occurrence of renal insufficiency in an adult female patient who received ENGERIX B vaccine. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient''s medical history, concurrent conditions, and concurrent medications were not reported. On 11/5/03, the plaintiff''s attorney alleged that on an unspecified dates the patient received vaccinations of ENGERIX B vaccine and experienced medical problems, including severe renal disease and compromise, and Plaintiff''s resulting death. These events required hospitalization. Follow up on 11/26/03: "Staphlococcal endocarditis."


VAERS ID: 212685 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2003-09-30
Onset:2003-10-08
   Days after vaccination:8
Submitted: 2004-03-05
   Days after onset:149
Entered: 2003-11-20
   Days after submission:106
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 1 - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 5452460029N / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Abscess, Apnoea, Cardiac valve disease, Chills, Confusional state, Cough, Cyanosis, Diarrhoea, Endocarditis, Hyperhidrosis, Neck pain, Pharyngolaryngeal pain, Pneumonia, Pyrexia, Renal failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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 (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (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: 2003-10-09
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin Lipito aspirin acetaminophen
Current Illness:
Preexisting Conditions: Coronary bypass surgery; Aortic valve replacement; Lumbar vertebral fracture; Aortic aneurysm; Cardiac murmur; Haemorrhoids; Smoker; Iodine allergy; Hyperlipidaemia; social alcohol drinker; hearing loss
Allergies:
Diagnostic Lab Data: Blood pressure 10/8/03, little low, Blood pressure, 10/9/03, 91 7:37AM, Blood pressure, 10/9/03, 101 8:25AM, Diagnostic laboratory, 10/8/03 normal, Chest x-ray 10/8/03 normal, Blood pressure 10/09/03, 80 10:41AM. Body temp 10/8/03 fever, Complete blood cell 10/8/03 unknown. INR, 06/23/03, 2.3 Prothrombin time, 06/23/03, 24.4 seonds 12.2-14.8 High Serum alanine, 05/12/03, 42U/L, 21-72 SCPT Serum creatinine, 05/12/03, 1.0mg/dL, 0.5-1.5 Serum cholesterol/HDL-C, 05/12/2003, 2.9, 1.7-6.7 Low Serum cholesterol, 5/12/03, 150mg/dL, 120-200 Serum chloride, 05/12/03, 103mmol, 98-110 Serum calcium, 05/12/03, 9.4mg/dL, 8.4-10.2 Serum blood urea, 05/12/03, 15mg/dL, 9-20 Serum aspartate, 05/12/03, 37U/L, 15-46, GOT Serum alkaline, 05/12/03, 92U/L, 38-126 Serum albumin, 05/12/03, 3.7g/dL, 3.6-5.0 Total serum protein, 05/12/02, 7.2g/dL, 6.3-8.2 Total serum carbon, 05/12/03, 30mmol, 22-32 Total serum bilirubin, 05/12/03, 0.8mg/dL, 0.2-1.3 Temperature measurement, 10/9/03, 96, 7:37AM Serum VLDL-C, 05/12/03, 11mg/dL, 5-51 Serum triglyceride, 05/12/03, 55mg/dL, 40-160 Serum sodium, 05/12/03, 137mmol, 137-145 Serum prostate specific, 05/12/03, 1.66ng/mL, 0.0-4.0 Serum potassium, 05/12/03, 4.4mmol, 3.5-5.3 Serum LDL-C calculated, 05/12,03, 87mg/dL, 0-135 Serum HDL-C, 05/12/03, 52mg/dL, 30-90 Serum glucose, 05/12/03, 85mg/dL, 75-115 Serum glucose, 05/12/03, 85mg/dL, 75-110 PT control, 06/23/2003, 13.5 second Serum direct bilirubin, 05/12/03, 0.1mg/dL, 0.0-0.5 Body temp, 10/08/2003, afebrile; normal Body temp, 10/07/03, 103 Blood drug screen, 10/02/03, 3.3, Coumadin level Body temp, 10/08/03, fever Blood glucose, 10/08/03, 104
CDC Split Type: WAES0311USA00578

Write-up: Information has been received from a health professional and a physician concerning a 61 year old male with a history of coronary bypass surgery who on 9/30/03 was vaccinated with a dose of penumococcal 23v polysaccharide vaccine (645246/0029N). Concomitant therapy included influenza virus vaccine and Coumadin. For several days after the vaccine the pt had a fever and chills. On 10/8/03 the pt was brought to the ER with chills, sweats and a fever. The report indicated that they "did tests." It was also reported that he had a chest x-ray and CBC and was given an injection of Rocephin and Phenergan. He was diagnosed with mild renal failure. He was discharged with a prescription for Keflex and went home. The next day, on 10/9/03, the pt died of pneumonia. The reporter expressed a concern with the lot. There was no product quality complaint involved. Pneumonia was considered to be immediately life-threatening and disabling. Additional info has been requested. The autopsy report states septic endocarditis. Follow up on 12/04/03: "The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information from a physician and medical records indicated that the pt had open heart surgery on 23Dec2002 which consisted of one by-pass and a valve replacement. It was reported that the operation went well and the pt had a remarkable recovery. He first had a heart murmur which felt to be benign. He followed up with his primary who ordered an echodardiogram and the problem with his heart valve was discovered. He was sent for a cardiac cathaterization and they recommended immediate replacement of his aortic valve together with a repair of the aneurysm. On 30Sep2003 the pt was seen by a physician and reported to be in good health, and would probably live to be 100. His physical exam was negative at that time. That day he received te pneumococcal 23v polysaccharide vaccine and the influenza virus vaccine. On 02Oct2003 the pt had his monthly labwork done for a a warfarin sodium level. The result was 3.3 and he was instructed to stay on the same dose. On 04Oct2003 the pt was feeling a bit under a the weather, was coughing and did not act up to par. On 05Oct2003 the pt felt the same way, but he had a slight cough and was hoarse. By 07Oct2003 the pt began to run a temperature of 103 and was having uncontrollable chills, sweating, vomiting and diarrhea. The symptoms were only temporary and he took acetaminophen which broke the fever. He had a good appetite and was eating three meals a day. On 08Oct2003 the pt felt good, but had a bout with uncontrollable chills and reported that he was so cold he couldn''t get warm. He took two acetaminophen and felt better, but later had the sweating, vomiting and diarrhea. At 8:30PM he was again having uncontrollable chills and the lobes of his ears looked blue. He was not running a temperature. He was seen in the ER and was told he had symptoms of pneumonia. His temperature was normal and his blood pressure was a little low. He was told by a physician that this was because he was sick. A chest x-ray and bloodwork were done and were reported to be normal, however his blood sugar was 184. He was told that this may make him a little confused. His wife reported that he was confused after taking it. It was reported that the doctor also ordered an injection of something for nausea and an injection of an antibiotic. The pt''s wife was assured by the nurse that these medications would not interact with anything the pt was currently taking. He was given IV to replace body fluids since his blood presure was low. While he was on the IV he had to go to the bathroom with diarrhea and vomiting. It was reported that he was very weak and almost fell off the commode. The pt was released from the ER with a diagnosis of a viral infection and was given prescriptions for dicyclomin hydrochloride 10mg capsule, cephalexia 500mg capsule and diphen/atrop 2.5mg tablet. It was reported that he rested well that night, but did a lot of night sweating. He felt better than the day before, but was still experiencing diarrhea and vomiting. ON 09Oct03 at 7:37AM the pt''s blood pressure was 91-56-117 and his temperature was 96. He tried to eat and drink and his blood pressure at 8:25 was up to 101-54-112. The pt indicated that he would be ok so his wife left the house. She found him at 10:30AM sitting on the floor. He had gotten up to go to the bathroom, but felt sick so he sat there to vomit in the trash can. His wife put him in bed, he took his medications and drank some water and reported that his throat burned. At 10:41AM his blood pressure was 80-44-68 and his nails were blue so the pt''s wife called 911. The pt reported that his neck hurt, so his wife removed pillows and the pt turned his head and stopped breathing. The wife started CPR. With no reponse after a few minutes, she ran out and screamed to a neighbor. The neighbors gave CPR until the ambulence arrived. The pt was taken to the ER where the family was told the pt passed away. An autopsy was performed and the cause of death was listed as septic paravalvular leak due to dehiscence of prosthetic aortic valve due to prosthetic valve endocarditis with ring abscess. The death was reported as natural. Pneumonia, sepsis, endocarditis, abscess and leakage were considered to be immediately life-threatening and disabling. Additional information is not expected."


VAERS ID: 212767 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2003-10-22
Onset:2003-11-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2003-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Circulatory collapse, Laboratory test abnormal
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: 2003-11-12
   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: Bumez; Zaroxolyn; Coreg; Zocor; Zestril; Bufferin; Salsalate; Doxycycline; Milk of Magnesia; Dimetapp; Albuterol, Atrovent; Zocor; Lasix; Lanoxin; K-lor; Colace; ASA; Toprol; Amoxicillin; Antivert; Hydrodiuril; Lortab; Quinine; Pepcid; Ativ
Current Illness:
Preexisting Conditions: CHF, bronchitis, COPD, leg cramps, gout, acute renal failure. Information from previous hospital admissions. Admission February 19-23/2003. Subject was admitted for bilateral knee replacement 96 days post-immunization. Reported labs were as follows: postop day one-PCV 35.9, INR 1.27, BUN 50 and creatinine 1.7. Day two INR was 2.41. Day three urine output was 550cc in 8 hrs, BUN 54, creatinine 1.8, PCV 34.8 and INR 2.55. He also had 1+ pitting pedal edema. Post operative day four room air sat was 93% and INR was 2.22. Treatment post surgery included infusion of two units packed red blood cells. The subject recovered and was discharged on 2/23/03 and continued in the trial. The event of bilateral knee replacement surgery was reported by the investigator as unrelated to the study vaccine. Past medical history includes use of quad cane for ambulation, arthritis, leg cramps, gout, COPD, renal insufficiency, HTN, CHF with cardiomyopathy, hyper cholesterolemia, obesity, rotator cuff tear, back surgery and chronic bronchitis. Past radiography demonstrated advanced arthritis in both knees. Concurrent medications include Bufferin, SAlmalate, Doxycycline, milk of Magnesia, Dimetapp, Albuterol, Atrovent, Zocor, Lasix, Zestril, Lanoxin, K-Lor, Colace, ASA, Toprol, Amoxicillin, Antivert, Hydrodiuril, Lortab, Quinine, Pepcid, Ativan, Colchicine, vitamin E, One a day multi vitamin, Selenium, Lorazepam and Bextra. Admission 6/25-27-2003. Over the last two months the subject experienced intermittent severe dyspnea, peripheral edema and paroxysmal nocturnal dyspnea which became progressively worse and on 3/25/03, 223 days post immunization he was admitted to the hospital. Subject underwent a right heart catheterization on the day of admission and was found to have a right atrial pressure of 16 and a wedge pressure of 25. Subject was aggrressively diuresed with IV Lasix with symptomatic improvement and was discharged from hospital 2 days later on 6/27/03. The event was assessed by the investigator as unrelated to the study vaccine. Previous history: Diagnosed with dialated cardiomyopathy in 1992. In 1995, the ejection fraction was 15% to 25%. He underwent cardiac catheterization in February 1999, and was found to have an ejection fraction of 20% and no significant coronary disease. Over the last two years, he had intermittent severe dyspnea and peripheral edema. Admission 7/10-13/03. Subject was admitted 238 days post immunization for congestive heart failure and acute renal insufficiency. This subject had been admitted approximately two weeks prior secondary to volume overload, was diuresed and sent home on Bumex and Zaroxolyn of which the pt took both q.d. Despite previous advised to take Zaroxolyn on a prn basis per his weight. During this time he had also been on escalated doses of Neurontin for his peripheral neuropathy. Just prior to be being admitted his dose was 3600mg q.d. He presented at the clinic for evaluation with a one week history of increasing fatigue, sleepiness, increasing tremor and shakiness, difficulty walking, swelling in his feet bilaterally. It was felt he had Neurontin toxocity. Subject had his Neurontin held and neurological symptoms improved. Routine labs demonstrated that his initial creatinine was 4.0 with a BUN of 137 and a potassium of 5.4 indicating acute renal insufficiency likely secondary to volume depletion and he had become toxic on his Neurontin doses. A renal ultrasound was obtained which was normal. Post multiple 500cc fluid boluses, his renal function returned to his baseline. At the time of discharge he was reinstituted on his ACE inhabitor and beta-blocker, continued on Digoxin, Zocor and his diuretic was changed to Bumex 3mg p.d. without Zaroxolyn. He was placed on fluid restriction for his peripheral neuropathy, which he continued to complain about. He was started on Elavil at 25mg p.o q.d. Medications Bumex 2mg p.o. q.d., potassium chloride 30mEq p.o. q.d., Zestril 5mg p.o. bid, Lanoxin 0.25mg p.o. q.d., Metoprolol extended release 50mg p.o. q.d., sublingual Nitroglycerin prn., Zocor 4mg p.o. q.d., Enteric coated aspirin 325mg p.o. q.d., Pepcid 20mg p.o. bid, vitamin E and C q.d., Elavil 25mg p.o. q.d. Albuterol and Atrovent metered-dose inhalers. Subject was discharged 3 days later on 7/13/03. The event was assessed by the investigator as unrelated to the study vaccine.
Allergies:
Diagnostic Lab Data: Admission: 2/19-23/2003. Reported labs were as follows: postop day one-PCV 35.9, INR 1.27, BUN 50 and creatinine 1.7. Day two INR was 2.41. Day 2: BUN 54, creatinine 1.8, PCV 34.8 and INR 2.55. Post operative day four room air sat was 93% and INR was 2.22. Admission on July 10-13/2003. Creatinine 4.0 BUN 137, potassium 5.4. Post treatment: creatinine 1.2, BUN 71.
CDC Split Type: 200302974

Write-up: This subject is a 66 year old male who was taken to the emergency dept after collapsing in his home while enrolled in RSV11 study. The subject received his second dose of RSV vaccine or Placebo and influenza vaccine on 10/22/03. Subject collapsed at home on 11/12, 21 days post immunization. Subject''s wife and stepson attempted CPR. An ambulance was called and subject was taken to the emergency dept. There was little EKG activity on arrival and subject died in the ER on 11/12/03. Cause of death was not reported. The death was reported by the investigator as not related to the study vaccine. Follow up on 12/16/2003: "Additonal information received 12/01/2003, CIF and ER report. CIF: Cause of death-cardiac arrest w/secondary underlying cardiac disease. Additional information received 12/03/2003. Subject attempted to get out chair at home in the AM of 11/12/2003, and collapsed, hit a wall and landed on the cough. EMS notified and responded. Subject in asystole, CPR was started, IV fluids, intubated and sent to ER for further management, but remained asystole. Cause of death, cardiac arrest with secondary underlying cardiac disease. The cardiac arrest with secondary underlying cardiac disease was assessed by the investigator as unrelated to the study vaccine. Additonal information available with source documents. ER report


VAERS ID: 212768 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: California  
Vaccinated:2003-02-20
Onset:2003-09-13
   Days after vaccination:205
Submitted: 2003-11-18
   Days after onset:66
Entered: 2003-11-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0725AA / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UA775AB / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490901 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Chromosome abnormality
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-13
   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: Patient diagnosed with Gangliosidosis, a progressive terminal illness in January 2003.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200303026

Write-up: This subject is a one year old male, who died while enrolled in a Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the US standard of care. The subject received three doses of study vaccine; the last dose prior to the event was given on 2/20/03. Subject also given PRP T and Prevnar on 2/20/03, lot numbers not reported. The subject expired, 205 days post immunization. The subject was diagnosed with Gangliosidosis, a progressive terminal illnes in January 2003 and expired at home. No autopsy was performed. The events of Gangliodosis and Cardiopulmonary arrest were reported by the investigator as unrelated to the vaccine. Vaccine lot numbers if available, were requested from the investigator. Follow up on 11/26/03: "From additional info rec''d on 11/18/03 the lot numbers of the suspect products were providec. ActHib AvP UA775AB/W0522, DAPTACEL C0725AA & PREVNAR LEDERLE 490-901."


VAERS ID: 212882 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2003-10-30
Onset:0000-00-00
Submitted: 2003-11-24
Entered: 2003-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765955 / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aneurysm, Anorexia, Fatigue, Malaise, Thinking abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Per patient, denied any illness at the time of administration of Flu vaccine.
Preexisting Conditions: Patient denied any allergy to eggs or Thimerisol. No other medical information available.
Allergies:
Diagnostic Lab Data: none known
CDC Split Type:

Write-up: Patient expired on 11/18/03 due to ruptured Aorta. Presented at ER 11/14/03 after "not feeling well", for a few days, complaining of tiredness and loss of appetite. Discharge Summary received on 12/01/2003 states change in mental status.


VAERS ID: 213046 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Virginia  
Vaccinated:2003-10-04
Onset:2003-10-06
   Days after vaccination:2
Submitted: 2003-11-20
   Days after onset:45
Entered: 2003-11-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1196M / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Drug ineffective, Ear pain, Hypotension, Laboratory test abnormal, Otitis media, Pneumonia, Pyrexia, Shock, Sinusitis
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-08
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Norvasc, clonidine, Allegra, Flonase, Avapro
Current Illness:
Preexisting Conditions: Lymphoma; Pneumococcal sepsis; Asplenia, Penicillin allergy, Hypersensitivity, Blood pressure high.
Allergies:
Diagnostic Lab Data: Chest xray 11/06/03: possible pneumonia. Diagnostic laboratory 11/07/03: Positive culture for pneumococcus 4 plus.
CDC Split Type: WAES0311USA01084

Write-up: Information has been received from a physician concerning a 60 year old male with history of lymphoma (in remission since 1996), pneumococcal septicemia (2001 "treated successfully") and asplenia who in 1998 and on 11/4/03 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (645249/1196M), respectively. Concomitant therapy included clonidine, amlodipine besylate and irbesartan for high blood pressure. Other therapy included fexofenadine hydrochloride and fluticasone propionate for allergies. It was noted that the pt was initially vaccinated with pneumococcal 23v polysaccharide vaccine due to the lymphoma and asplenia. It was also reported that the pt was in routine follow-up with oncologist who "recommended a pneumococcal 23v polysaccharide vaccine this year." The reporting physician reported that the patient was seen on 11/4/03 and was asymptomatic. On 11/6/03 the patient presented to the emergency room of the hospital with symptoms of high fever, and pain in one ear. There was a questionable otitis or sinusitis. The oncologist reported that his findings were not that impressive. On 11/7/03 the patient was admitted to the hospital by the oncologist. There were reported to be "four blood cultures positive for pneumococcus" also reported as "positive culture for strep pneumonia." The patient later became hypotensive, went into shock, and was sent to the intensive care unit. The physician reported that the patient was intubated and that the pulmonary physician that had resumed care for the patient reported that there was a lot of stuff in the patient''s lungs while intubating him. The patient had a chest x-ray resulted as possible pneumonia. On 11/8/03 the pt died. The cause of death was not provided. There was no product quality complaint involved. Additional info has been requested. Follow up: The reporting physician reported that the patient was seen on 04NOV2003 and was asymptomatic. On 06NOV2003 the patient presented to the emergency room of the hospital with symptoms of high fever, and pain in one ear. There was a questionable otitis or sinusitis. The oncologist reported that his finding were "not that impressive." On 07NOV2003 the patient was admitted to the hospital by the oncologist. There were reported to be "four blood cultures positive for pneumococcus" also reported as "positive culture for strep pneumonia." The patinet later became hypotensive, went into shock, and was sent to the intensive care unit. The physician reported that the patient was intubated and that the pulmonary physician that had resumed care for the patient reported that there was a lot of "stuff" in the patient''s lungs while intubating him. The patient had a chest xray resulted as possible pneumonia. On 09NOV2003 the patient died. The cause of death was not provided. It was reported to be unknown if serotyping was done. The physician reported that he knew an autopsy was not done. It was noted that the reporter expressed a concern for the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.


VAERS ID: 213146 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: California  
Vaccinated:2003-08-05
Onset:2003-09-19
   Days after vaccination:45
Submitted: 2004-02-12
   Days after onset:146
Entered: 2003-12-01
   Days after submission:73
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21883B2 / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR W0602 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492929 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-19
   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: Acylcarnitine Profile and Congenital Adrenal Hyperplasia-within normal limits.AP and lateral skull x-rays-there is an apparent endotracheal tube extending to the midchest. There is no evidence of a fracture. There are no metallic foreign bodies. Complete drug screen-no common acidic, neutral or basic drugs detected. No blood ethyl alcohol or other alcohols or acetone detected. No barbiturates or benzodiazeprines detected by specific drug assay.
CDC Split Type: 200303060

Write-up: This subject is a 3 month old male, who died while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants as a booster to toddlers, Protocol number P3T08. The subject received one dose of Pediarix vaccine, ACTHIB, PRevnar. The last dose prior to the event was given on 8/5/03. The subject died 45 days post-immunization. The event of SIDS was reported by the investigator as not related to the study vaccine. The pathology report states that the subject was pronounced dead at 2346 hours of 9/19/03. The disease or condition directly leading to death is consistent with sudden infant death syndrome. Anatomical diagnoses: 1) Petechial hemorrhages, heart, lungs. Thymus; 2) No congential anomalies; 3) Pulmonary congestion and edema and 4) Visceral organ congestion. The autopsy report states body appearing the stated age of 3 months. Evidence of medical therapy is present: 1) an interosseous needle present in the left thigh. At the time of the autopsy exam, the needle has come out of the thigh. In addition, there is a second apparent needle puncture mark in the same location; 2) an oral tracheal tube secured around the neck by tape; 3) an electrical monitoring device taped to the right big toe; and 4) multiple cardiac monitoring pads over the torso. There are no blunt injuries to the body. Fontanelles are flat. Statures are moveable. Present in the right occipital area about two inches above the ear, is a 1/2 inch red defect consistent with a hemangioma. Pupils are round. Irides are brown. Sclerae are white. No petechial hemorrhages are noted. Ears, nose and lips are non remarkable. Neck is normal. Chest is flat. The breasts are consistent with an infant male. The umbilicus is well-healed. The abdomen is flat. The external genitalia are non remarkable. Legs and feet are normal. Each foot and hand has five digits. No simian folds are present. The back is non remarkable. The anus is perforated and surrounded by yellow-brown fecal material. Internal examination: Body cavities-the pleural cavities, pericardial cavity and peritoneal cavity are lined by smooth, glistening surfaces and contain no fluid. Ribs and diaphragms are intact. No traumatic injuries are present. Oragns are in their proper locations. Heart-a small number of petechial hemorrhages are present on the epicardial surface. No areas of necrosis are present. Chambers and valves are normal. The coronary system is normal. The ventricular septum is completely formed. The foramen ovale is closed. Thymus-a small number of petechial hemorrhages are present on the surface. Trachea and bronchi-No T-E fistula is present. Lungs-a small edematous. No consolidation or infarcts are present. Airways of both lungs are normal. Liver-the parenchyma is brown and congested. Spleen-no trauma is present. Adrenal glands-normal size, no hemorrhages or tumors present. Neck-the hyoid bone and laryngeal structures are intact. Soft tissue about the larynx is normal. The larynx is free of obstructing material. The oral cavity, esophagus, stomach, intestines, gallbladder, pancreas, kidneys, bladder, prostate, musculoskeletal system and central nervous system are all normal. Microscopic examination: Lungs-sections show non remarkable airways and alveolar spaces. No inflammatory infiltrates are identified. Heart-sections show non remarkable appearing myocardial muscle cells. No inflammation or scarring is identified. Brain-sections show no histological abnormalities. Pancreases-sections show non remarkable exocrine and endocrine structures.


VAERS ID: 213167 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: California  
Vaccinated:2003-06-26
Onset:2003-08-08
   Days after vaccination:43
Submitted: 2003-11-24
   Days after onset:108
Entered: 2003-12-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Condition aggravated, Sepsis, White blood cell count increased
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-08
   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:
Current Illness:
Preexisting Conditions: Per MD, pt had severe anomalies since birth. Reason for hospitalisation. The patient is a 16 month old female who was eight months old when she was admitted on 31/Jan/2003. SHe has a history of unbalanced atrioventricular canal. She previously had multiple palliations for her cardiac disease including placement of a pulmonary artery band, placement of a bilateral canal pulmonary shunt, and coiling up of her main pulmonary artery. She was admitted on 31/Jan/2003 with shortness of breath, a widening mediastinum, and thrombocytopenia. The mediastinal hematoma was evacuated on 02/Feb/2003. Her bilateral canl pulmonary shunt was taken down on 04/Mar/2003. She remained hospitalized secondary to severe lymphedema and respiratory failure secondary to her underlying cardiac condition. Physicial examination: Vital signs: She was intubated when she was admitted. Skin: She had significant petechiae and purpura on her chest and subcutaneously throughout her body. Heent: She did have a nasogastric tube in place and a 4.0 endotrachael tube in place. Lungs: Slightly course to auscultation bilaterally. Chest: Significant lymphedema thoughout her trunk. Abdomen: Nondistended. Gastric tube was noted. Normal active bowel sounds. Extremities: Warm and well perfused with mild-to-moderate lymphedema present throughout her upper and lower extremities. Peripheral pulses were 1-2 bilaterally in the upper and lower extremities. Neurologic: She had no focal neurologic deficits at the time of admission.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200303029

Write-up: This subject is a one and half year old female who was admitted to the hospital due to complications from congenital anomalies she has had since birth; AV canal with severe coarctation, severe clotting disorder probable factor 13 mutation. She was enrolled P3T08, a Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the standard of care. The subject received three doses of Infanrix for primary series and last dose of DTaP on 6/26/03. Also given on same date was IPV, HboC, hep B and Prevnar. Per the pt''s medical doctor, the subject had severe congenital anomalies since birth. The pt was born with AV canal with severe coarctation which was repaired in the first week of life. Volvulus was repaired in May 2002. Subject had Glenn operation in January 2003 which failed and was hospitalized in the pediatric ICU from January 2003 until expiration. The subject likely had a factor 13 mutation/ severe clotting disorder. During hospitalization the subject had repeated elevated white counts probably secondary to sepsis. The pt expired due to congestive heart failure. Autopsy was done and the records have been requested. These events were reported by the investigator as unrelated to the study vaccine. A 15-day follow up report was received 12/29/2003 and adds no new info except for the 4th vaccine reported to be Prevnar. Follow-up information 14 April 2004: After a medical reveiw of the case, a new version of the report has been generated to add the adverse event "condition aggravated" including lymphedema, since due to her progressively worsening status and her potential long-term outcome, the decision was made by the family to move the patient to the care suite and to withdraw the support from the patient. Also, the date of onset for Factor X111 disorder was corrected from 6 April 2003 to 6 APril 2002.


VAERS ID: 213168 (history)  
Form: Version 1.0  
Age: 1.42  
Sex: Male  
Location: California  
Vaccinated:2003-06-30
Onset:2003-07-14
   Days after vaccination:14
Submitted: 2003-11-24
   Days after onset:133
Entered: 2003-12-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 530A2 / 4 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1236M / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0975M / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain neoplasm malignant, Collapse of lung, Neuroblastoma, Pleural effusion, Pneumonia, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-01
   Days after onset: 49
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: Chest x-rays: 7/28/03: at 21:48 hrs-show bilateral extensive pleural effusions and areas of pulmonary edema or pneumonia. 7/28/03 at 22:34 hrs-show bilateral pleural effusions and progressive diffuse pulmonary opacification, consistent with pulmonary edema, pulmonary hemorrhage, ARDS or severe diffuse pneumonia. Feeding tube is in the stomach. Tube is in the trachea. Broviac catheter is in the right atrium. 23:33 hrs-indicatiosn: respiratory failure. Status post drainage of bilateral pleural effusions with pigtail catheters. Continued diffuse pulmonary disease.
CDC Split Type: 200303028

Write-up: This subject is a 17 month old male, who was noted to have vomiting and an abdominal mass while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received four doses of Infanrix. The last dose prior to the event was given on 6/30/03. Other vaccines given on the same date were IPV, PRP-T, MMR and VZV. The subject developed vomiting and an abdominal mass was found, 14 days post-immunization. The subject underwent a tumor biopsy on 7/25/03, along with bone marrow aspirations and biopsies. The pt was diagnosed as a stage 4 Neuroblastoma and was started on the COG A3973 protocol. According to the protocol, the pt was due to have a stem cell harvest after two cycles of chemotherapy. The subject was to have a future autologous stem cell transplant if enough stem cells were harvested and other requirements of the protocol has been completed. There was unanimous agreement among the transplant committee that this subject was a candidate for a stem cell transplant assuming the subject remained on the COG protocol, and the subject met transplant criteria. The subject died on 9/1/03. The event of neuroblastoma, secondary brain/ spine cancer, anoxic brain damage, pneumonia, and pulmonary collapse was reported by the investigator as not related to the study vaccine. Autopsy is pending. A 15-day follow up report received 12/19/2003 adds no new info.


VAERS ID: 213169 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Indiana  
Vaccinated:2002-08-28
Onset:2002-08-31
   Days after vaccination:3
Submitted: 2003-11-26
   Days after onset:452
Entered: 2003-12-01
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-08-31
   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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0440252A

Write-up: This report described the occurrence of sudden infant death syndrome in a two month old female pt who received DTaP and hep B vaccine for prophyalxis. This report was received from the pt''s mother and has not been verified by a physician or other health care professional. The pt''s medical history, concurrent conditions, and concurrent medications were not reported; however, the reporter stated that a younger sibling had "severe sleep apnea." The reporter stated that the pt received the first dose of hep B vaccine at the time of birth without incident. On 8/28/02, the pt received the first dose of DTaP and second dose of hep B vaccine. On the same date, the pt also received injections of IPOL, and HIB vaccines. Approximately 72 hrs post-immunization, on 8/31/02, the pt died at her residence. The reporter stated that the autopsy indicated that the pt had died due to SIDS. Additional info has been rerquested.


VAERS ID: 213203 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: California  
Vaccinated:2003-04-15
Onset:2003-08-14
   Days after vaccination:121
Submitted: 2004-02-11
   Days after onset:181
Entered: 2003-12-01
   Days after submission:72
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21883B2 / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR W1005 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491168 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-14
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Specimen: heart blood sample. 0.28mg/L of Atropine was detected in a heart blood sample. No other common acidic, neutral or basic drugs were detected. No blood Ethyl Alcohol or other alcohols or acetone were detected. No analgesics or barbiturates were detected by specific immunoassay.
CDC Split Type: 200303053

Write-up: This subject is a 6 month old female, who was pronounced dead due to sudden infant death syndrome while enrolled in a Comparative post-marketing study of CPDT Vaccine Absorbed administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received one dose of Pediarix on 4/15/03. Other vaccines received on the same day were PRP T and Prevnar. THe subject was pronounced dead at 18:26 hours on 8/14/03. The condition directly leading to death was consistent with sudden infant death syndrome. Anatomical diagnoses reported included pulmonary congestion and edema as well as visceral congestion. There were no congenital anomalies. 0.28mg/L of Atropine was detected in a heart blood sample. No other common acidic, neutral or basic drugs were detected. No blood Ethyl Alcohol or other alcohols or acetone were detected. No analgesics or barbiturates were detected by specific Immunoassay. According to the autopsy report, there were no blunt injuries to the body. The outcome of this event is fatal. The event of sudden infant death syndrome was reported by the investigator as unlikely/not related to the study vaccine.


VAERS ID: 213214 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Iowa  
Vaccinated:2003-11-30
Onset:2003-11-30
   Days after vaccination:0
Submitted: 2003-12-01
   Days after onset:1
Entered: 2003-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765705 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Apnoea, Cyanosis, Dyspnoea, Hypotonia, Shock
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-30
   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: Toprol XL
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Anaphylactic reaction and subsequent shock. ACLS Protocol: Epi, Benadryl, Solu-cortef, Atropine, Sod. Bicarb, Cricothyrotomy. The hospital discharge summary received on 1/28/04 states cyanotic, dyspnea, apneic and limpness.


VAERS ID: 213215 (history)  
Form: Version 1.0  
Age: 0.56  
Sex: Male  
Location: Michigan  
Vaccinated:2003-11-26
Onset:2003-11-27
   Days after vaccination:1
Submitted: 2003-12-01
   Days after onset:4
Entered: 2003-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 9610A2 / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1089AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1440 / 3 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493265 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), 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: 2003-11-27
   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:
Current Illness: NONE
Preexisting Conditions: Joubert Syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: DOA 11/27/03. The autopsy states cardiorespiratory arrest.


VAERS ID: 213219 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-10-10
Onset:2003-10-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2003-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765180 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-15
   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: Bextra; Glucotrol; Metformin; Zesteretic; Felodipine
Current Illness: NONE
Preexisting Conditions: Hypertension; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: An 82 year old male with past history of hypertension and diabetes but no prior cardiac history. He had no previous documented allergies. He had previously received flu vaccine in my office in 2001 and in 2002. He received the Fluvirin on 10/10/03. He was found at home expired with a presumed sudden cardiac death on 10/15/03. The death certificate received on 12/3/03 states cardiac arrhythmia and myocardial infarction.


VAERS ID: 213220 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Unknown  
Vaccinated:2003-10-02
Onset:2003-10-20
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2003-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765180 / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arrhythmia, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-20
   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: HCTZ; KCL
Current Illness: NONE
Preexisting Conditions: Hypertension; Hypercholesterolemia; Allergy to PCN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A 68 year old female with a past history of hypertension and hypercholesterolemia but no prior cardiac history. She had a documented allergy to PCN. She had also received flu vaccine in my office in 2001 and in 2002. She received her Fluvirin dose on 10/02/03. The pt was found dead at home of a presumed sudden cardiac death on 10/20/03. The death certificate received on 12/3/03 states cardiac arrhythmia and cardiac arrest.


VAERS ID: 213221 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-11-18
Onset:2003-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2003-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765180 / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), 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: 2003-11-20
   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: NONE
Preexisting Conditions: Allergy to Iodine; Diabetes Melitus Type 2; Colon Cancer 1998; Early Alzheimer''s
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: An 84 year old male with a past history of diabetes but no other medical problems, no lipid abnormalities and no prior cardiac history. He had a documented allergy to Iodine. This pt had received flu shots in my office every year since 1997. He received his Fluvirin dose this year on 1/18/03. He was found dead at home of a presumed sudden cardiac death on 11/20/03. The death certificate received on 12/3/03 states sudden cardiac death.


VAERS ID: 213450 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: New Hampshire  
Vaccinated:2003-01-15
Onset:2003-01-21
   Days after vaccination:6
Submitted: 2003-12-01
   Days after onset:314
Entered: 2003-12-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 575A2 / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA765AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0555 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 490897 / 2 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-21
   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: NONE
Current Illness: Hear rash under chin
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0326

Write-up: SIDS.


VAERS ID: 213451 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: New Hampshire  
Vaccinated:2003-08-11
Onset:2003-09-14
   Days after vaccination:34
Submitted: 2003-11-25
   Days after onset:72
Entered: 2003-12-04
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 600A2 / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UB489AA / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0906 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493242 / 2 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-14
   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: Premarin cream
Current Illness: NONE
Preexisting Conditions: Labial adhesion; Premie
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0325

Write-up: SIDS


VAERS ID: 213493 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Wisconsin  
Vaccinated:2003-10-08
Onset:2003-10-11
   Days after vaccination:3
Submitted: 2003-12-01
   Days after onset:51
Entered: 2003-12-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 602A2 / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0366N / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR W1440 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493476 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-11
   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: NONE
Current Illness: UNK
Preexisting Conditions: GE Reflux
Allergies:
Diagnostic Lab Data: Autopsy-SIDS.
CDC Split Type:

Write-up: Patient received 4 vaccines on 10/08/2003 and was found dead in her crib on 10/11/2003. The autopsy report received on 3/24/04 states SIDS.


VAERS ID: 213599 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: New Hampshire  
Vaccinated:2003-07-09
Onset:2003-07-14
   Days after vaccination:5
Submitted: 2003-11-25
   Days after onset:134
Entered: 2003-12-08
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 598A9 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA826AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0906 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491563 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (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: Over the counter medications
Current Illness: R otitis media, URI
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0327

Write-up: SIDS.


VAERS ID: 213643 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-11-09
Onset:2003-11-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2003-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765855 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Diarrhoea, Dyspnoea, Hypoxia, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Respiratory rate increased, Rhinorrhoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-11-18
   Days after onset: 2
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: Ativan, Trazodone, seroquel, atenolol, Lasix, Zantac, Hytrin, Zestril, Asavalproic acid, sinemet 10/100
Current Illness:
Preexisting Conditions: Alzheimers disease; Congestive heart failure; Hypertension; History of ethanol abuse; MI; Dementia with psychosis; Insomnia; Arteriosclerotic heart disease; Anxiety; Respiratory distress (before 31Dec1998)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200301129

Write-up: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, sore throat, and was hospitalized and died 8 days after receiving Fluvirin on 11/9/03. On an unspecified date, 2 to 3 days after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. The vaccinee was treated with antibiotics on commencing on 11/13/03. The vaccinee was transferred to hospital on 11/15/03 and subsequently intubated. The vaccinee died on 11/17/03. The cause of death was not reported. There was insufficient information to determine the reporter''s causality assessment. Follow up pending. Follow up on 12/10/2003: "Update 1, 11/26/03: A follow up report was received from a health care professional indicating that an 84 year old male vaccinee experienced respiratory failure 8 days after, with mild cough, vomiting, fever of 100 degrees F, occurring 4 days after receiving Fluvirin, and diarrhea occuring an unspecified length of time after vaccination. The vaccinee has a history of respiratory distress, Alzheimer''s disease, congestive heart failure, hypertension, alcohol abuse and dementia with psychosis since 12/31/1998. The vaccinee also has a history of MI, arteriosclerotic heart disease, anxiety and insomnia from an unspecified date. Concomitant medication taken included lorazepam, trazodone, quetiapine, atenolol, furosemide, and ranitidine hydrochloride. On 11/13/03 the vaccinee experienced a mild cough with congestion, vomiting and a fever of 100 degrees F. The vaccinee also experienced diarrhea on an unspecified date. The vaccinee was treated with levofloxacin on 11/31/03. At this point the vaccinee''s respiration was rapid. The vaccinee was admitted to hospital on 11/15/03 and on an unknown date was placed on a ventilator. On 11/17/03 the vaccinee died due to respiratory failure. A post mortem report is not available. "Update 2, 18February2004": A follow up report was received from a healthcare professional indicating that the vaccinee had received Fluvirin on 10 November 2003 and not on 9 November 2003 as previously reported. The vaccinee received Influenza vaccine (brand unspecified) previously on 25 November 2002. Additional concomitant medication included terazosin hydrochloride and lisinopril. The reporter indicated that the vaccinee had a history of respiratory distress, congestive heart failure, hypertension, myocardial infarction, moderate pulmonary hypertension and bi-ventricular failure prior to 31 December 1998. In addition to the events reported previously the reporter indicated that the vaccinee was also feeling week and lethargic on 13 November 2003. The reporter also indicated that the vaccinee died from respiratory collapse on 18 November 2003 and not on 17 November 2003 as previously reported. "Update 3, 27 April 2004": A follow up report was received from a health care professional indicating that the vaccinee had received Fluvirin on 9 November 2003 as initially reported. The vaccinee had received a prior influenza vaccination on an unspecified date in November 2002. Additional concomitant medications reported included acetylonlicylic acid, valproic acid and levodopa in combination with carbidopa. The vaccinee also has a history of severe tricupsid regurgitation before 31 December 1998, and Parkinson''s disease. The reporter indicated that the vaccinee was treated with levofloxacin and quoifenesin after 3 days with no improvement. The vaccinee was also treated with paracetonol for fever. The vaccinee''s level of consciousness began to decrease and the vaccinee was experiencing shortness of breath. The vaccinee was treated with oxygen. The vaccinee was admitted to the hospital on 15 November 2003, where he was on a ventilator which was removed 2 days later. The vaccinee died on 18 November 1003. No follow up pending, all information received. Cross reference with: PJP-2003-01118, PJP-2003-01119, PJP-2003-01120, PJP-2003-01121, PJP-2003-01122, PJP-2003-01123, PJP-2003-01124, PJP-2003-01125, PJP-2003-01126, PJP-2003-01127, PJP-2003-01128, PJP-2003-01117."


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