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VAERS ID: 360985 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Wisconsin  
Vaccinated:2009-10-01
Onset:2009-10-05
   Days after vaccination:4
Submitted: 2009-10-08
   Days after onset:3
Entered: 2009-10-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3427AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D05882 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1358X / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Bradycardia, Death, Diarrhoea, Pyrexia, Resuscitation, Thirst, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: DOWN Syndrome; VSD; CHF
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient with hx of DOWN Syndrome, VSD, CHF developed loose stools and low grade fever within 12 hrs of receiving vaccines. Mom noted increase fluid demand and gave child extra water. Noted wheezing 10/4/09. Bradycardia alarm @ 0307 on 10/5/09. CPR no response.


VAERS ID: 361101 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Michigan  
Vaccinated:2009-10-15
Onset:2009-10-15
   Days after vaccination:0
Submitted: 2009-10-16
   Days after onset:1
Entered: 2009-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3211AA / 4 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Post procedural haemorrhage, Tracheostomy malfunction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-15
   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: Received Tylenol during clinic visit to prevent fever
Current Illness: mild URI
Preexisting Conditions: ex 27 week prematurity, bronchopulmonary dysplasia, asthma, subglottic stenosis, tracheostomy-dependent, GERD, congenital hip dysplasia with absence of left femoral head, Grade 1 intraventricular hemorrhage. Bronchoscopy with laser treatment of subglottic granulation tissue 10/13/2009
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Patient pulled out trach (witnessed by family members), unable to replace trach, trach site began gushing blood, patient coded. Temperature in ER was 36.9 at the time of arrival at 8:22 p.m. Pronounced dead at 8:47 p.m.


VAERS ID: 361215 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: New York  
Vaccinated:2009-10-01
Onset:2009-10-02
   Days after vaccination:1
Submitted: 2009-10-16
   Days after onset:14
Entered: 2009-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA256AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Chest X-ray normal, Death, Respiratory rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin, Fosamax, Vit. D, Zocor, Amiodarone HCL, Finasteride F/C, Prednisone, Multivitamin, Vit. C, Xalatan eye drops, Calcium Antacid, Demeclomycin, Brimonidine Tartrate eye drops
Current Illness: no
Preexisting Conditions: other disorders of neurohypophysis 253.6, history of TIA/CVA, Polymyalgia Rheumatica
Allergies:
Diagnostic Lab Data: Chest x-ray negative for active disease. 10/19/09 Nursing Home medical records received service dates 10/1/09 to 10/5/09. LABS and DIAGNOSTICS: Chest X-ray - cardiomegaly.
CDC Split Type:

Write-up: Temp 103.2 at 0240 AM, rapid respirations began approx 12 hours later. 10/19/09 Death Certificate DOD 10/5/09 - Complications / effects of Influenza Vaccine. 10/19/09 Nursing Home medical records received service dates 10/1/09 to 10/5/09. Patient develops elevated temperature. Tylenol given, blankets removed and cool cloths applied. Oxygen via face mask. Respiration rate increased, mouth breathing. Appetite poor, not eating. Lethargic. Coughing. Unable to swallow. Unresponsive to voice or painful stimuli. Unable to obtain BP or radial pulse. Labored respirations. Stopped breathing. Death. Concurrent Illness: Toe has red flat area.


VAERS ID: 361282 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: California  
Vaccinated:2009-10-09
Onset:2009-10-12
   Days after vaccination:3
Submitted: 2009-10-16
   Days after onset:4
Entered: 2009-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3198AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-12
   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: Reglan, Calcium
Current Illness: None
Preexisting Conditions: NKDA, Medical conditions are Benign Hypertension, Osteoporosis, Sleep Disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown. 11/6/09 Autopsy report received. DOD 10/12/09. Anatomic Diagnosis: 1. Coronary artery disease. 2. Cardiac rupture with cardiac tamponade. 3. Pleural effusion. 4. Status post cholecystectomy and appendectomy. 11/12/09 Coroner - Final Cause of Death: Severe coronary atherosclerosis.


VAERS ID: 361353 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: California  
Vaccinated:2009-10-08
Onset:2009-10-14
   Days after vaccination:6
Submitted: 2009-10-16
   Days after onset:2
Entered: 2009-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3203AA / 3 LA / IM
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500751P / 1 NS / IN

Administered by: Private       Purchased by: Unknown
Symptoms: Blood alkaline phosphatase normal, Blood glucose normal, Death, Full blood count abnormal, Haematocrit decreased, Haemoglobin decreased, Immunohistochemistry, Neisseria test positive, Pupil fixed, Red blood cell sedimentation rate increased
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-14
   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: None
Current Illness: Limping
Preexisting Conditions: H/O Leukemia 2002; Down''s Syndrome. 1022/09 PCP /Nursing medical records received, service dates 11/11/03 to 10/14/09. Down Syndrome. Cough, fever. Frequent colds. Discharge from eyes. Vomiting and diarrhea. Lymphadenopathy. Foot pain. CBC abnormal.
Allergies:
Diagnostic Lab Data: CBC: 2.5, 7.5, 21.3, 207; Sed rate 125. 10/20/09 ER records received service date 10/14/09. LABS and Diagnostics: EEG - Asystole. CHEM - Glucose 107 mg/dL (H) Calcium 3.5 mg/dL (L) Albumin 3.4 g/dL (L) Alk Phos 170 U/L (L). CBC - WBC 2.5 Thou/uL (L) RBC 2.57 Mill/uL (L) HGB 7.5 g/dL (L) HCT 27.3% (L) RDW 16.4% (H) Neut ABS 565 cells/uL (L) Mono ABS 33 cells/uL (L) Eosin 3 cells/uL (L)
CDC Split Type:

Write-up: None Stated. On 10/19/09, the PCP stated that coroner called him and told him that he found consolidation of the lungs on autopsy. Autopsy report is not complete yet. 10/20/09 ER records received service date 10/14/09. Assessment: Cardiac arrest. CPR initiated. Pupils fixed and dilated. Apnea, pale. Rigor, lividity. 1022/09 PCP /Nursing medical records received, service dates 11/11/03 to 10/14/09. Assessment: Death. Office staff unable to contact patient''s family, eventually visited patient''s home. learnd that patient was found dead at home and taken to ER. 11/3/09 Additional ER records received for service date 10/14/09. Found supine on floor at home apneic and pulseless. Cardiac arrest. CPR initiated. 12/8/09 Autopsy received. Pronounced dead on 10/13/2009 Final cause of death: Pneumococcal Pneumonia. Pandemic Influenza A. Additional Information Abstracted: Other contributing conditions - Leukopenia, history of leukemia, Down syndrome. Drug Screen Heart Blood: Dextromethorphan <0.10 ug/ml, Promethazine 0.11 ug/ml. /ksk 12/28/09 Pathology report received. Receipt date 10/23/2009. Sign out date 12/21/2009. Diagnosis: Lung - Diffuse alveolar damage and bronchopneumonia. Immunohistochemical and molecular evidence of novel influenza A H1N1. Immunohistochemical and molecular evidence of Streptococcus pneumoniae. Immunohistochemical evidence of Neisseria meningitidis without molecular confirmation. No immunohistochemical evidence of Group A Streptococcus or Haemophilus influenzae. All follow-up attempts have been completed per company SOPs. No further information available.


VAERS ID: 361579 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Washington  
Vaccinated:2009-10-12
Onset:2009-10-15
   Days after vaccination:3
Submitted: 2009-10-19
   Days after onset:4
Entered: 2009-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 06349111A / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no illness reported
Preexisting Conditions: chronic kidney failure, heart failure, ischemic cardiomyopathy, gastroesophageal reflux, h/o TIA.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: patient found dead in the morning by his son. presumed cardiac cause of death, although flu vaccine given 10/12/09 seems unlikely as a cause, it can not be excluded. Autopsy is not planned. 12/31/09 Death Certificate received. DOD 10/15/09. Cause of Death: Unknown. Other conditions: End Stage Kidney Failure. Cardiomyopathy.


VAERS ID: 361585 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Alabama  
Vaccinated:2009-09-11
Onset:0000-00-00
Submitted: 2009-10-19
Entered: 2009-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3191AA / UNK LA / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: alcohol abuse, coronary artery disease, peripheral vasular disease, cirrhosis, stroke.
Allergies:
Diagnostic Lab Data: LABS and DIAGNOSTICS: POINT OF CARE - Na 152 mMol/L (H) K 3.1 mMol/L (L) Glu 242 mg/dL (H) Ca 102 mMol/L (L) HGB 8.8 g/dL (L) HCT 26% (L). AST 115 U/L (H) ALT 286 U/L (H) Creatinine Kinase U/L 1536 (H) CK MB ng/mL 14.5 (H). Urinalysis - Bacteria many, Amorph many, yeast moderate. Urine Culture - Staph coag neg (+) Enterococcus faecalis (+) Yeast (+). Broch Wash Culture / Tracheal aspirate - Serratia marcescens (+). CSF - Albumin Ser 2140 mg/dL (L) Albumin CSF 16.6 mg/dL WNL, CSF IgG 7.63 mg/dL (H). CBC - WBC 18.41 10^3/cmm (H) RBC 2.33 10^6/cmm (L) Platelets 102.3 10^3/cmm (L) RDW 19.7% (H) Neutrophils 87% (H) Lymphocytes 3% (L) Monocytes 16% (H). COAG - PT 28.4 sec (H) PTT 41 sec (H) Fibrinogen 75 mg/dL (L) D-Dimer 7580 (H). IMMONOLOGY - CH50 146 u/mL (H) IgA 679 mg/dL (H). Chest X-ray - Abnormal. Alveolar edema and left pleural effusion,sludge gallbladder. Abdominal Ultrasound - Abnormal, acites, cirrhotic liver, portal vein thrombosis. MRI Brain - Abnormal, old infarct. Ultrasound chest - pleural effusion. Nerve Conduction Study - Abnormal. Echocardiogram - Abnormal. ECG - Abnormal.
CDC Split Type:

Write-up: Pt reported to be at hospital on vent since Oct 2 2009 with Guillain-Barre syndrome. 10/21/09 Hospital records DC summary received service dates 10/2/09 to 10/20/09. Assessment: Death due to sepsis, respiratory failure, disseminated intravasular coagulopathy, acute renal failure, cirrhosis. Patient presented with hx of lower extremity weakness progressing to all four extremities. Was admitted to another facility where he became short of breath and hypoxic, intubated and developed ARDS. Neurological exam - areflexia severe axonal senserimotor polyneuropathy.Tranferred to MSU service for plasma exchange. Multiple infections including ventilator aquired pneumonia. DIC. Bloody stools. Metabolic acidosis, DNR, death.


VAERS ID: 361629 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-10-19
Entered: 2009-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA00269

Write-up: Information has been received from an office manager and a consumer who reported that she had seen reports of deaths following GARDASIL on television. This is one of two cases from the same source. This is a hearsay report in the absence of an identifiable patient. All telephone attempts to obtain follow up information have been unsuccessful.


VAERS ID: 361716 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2009-09-16
Onset:2009-09-20
   Days after vaccination:4
Submitted: 2009-10-08
   Days after onset:18
Entered: 2009-10-20
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3198AA / UNK UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Death, No adverse event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-20
   Days after onset: 0
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: No acute illness
Preexisting Conditions: See attached. 11/17/09: Discharge Summary and Medical Records received for date of service 9/20/09: PMH: CAD with CABG surgery. Hyperlipidemia, PAD s/p carotid endarterectomy.
Allergies:
Diagnostic Lab Data: 11/17/09: Discharge Summary and Medical Records received for date of service 9/20/09: Labs and diagnostics: EKG-ventricular fibrillation. CPK 3000 (H). WBC 21,000 (H), Hct 54 (H), glucose 250 (H), BUN 21 (H), Sodium 149 (H). BNP 395 (H). CK 82 (H).
CDC Split Type:

Write-up: Pt had no obvious reaction to the vaccine. 10/23/09 Death certificate received. DOD 9/20/09. Cardiogenic shock, Hypoxic encephalopathy. Ventricular fibrillation. 11/17/09: Discharge Summary and Medical Records received for date of service 9/20/09: Final Dx: Out of hospital cardiac arrest, ventricular fibrillation, cardiogenic shock, severe hypoxic encephalopathy, respiratory failure. Assessment: Experienced sudden onset severe chest pain at home. Ambulance arrived and found pt. in ventricular fibrillation. Received 2 shocks en route to hospital and upon arrival was intubated with additional CPR and defibrillations. Major vasopressors were administered for support of blood pressure. CPK was 3000. Admitted to ICU and maintained on maximal support for 12 hours including ventilation, temporary pacemaker and major vasorpressors at high doses. No urinary output. Pupils fixed and unresponsive. Pt. eventually experienced cardiac arrest and died after DNR was signed.


VAERS ID: 362090 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Washington  
Vaccinated:2009-10-14
Onset:2009-10-18
   Days after vaccination:4
Submitted: 2009-10-21
   Days after onset:3
Entered: 2009-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3304AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB610AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D46875 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0321Y / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-18
   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: Nystatin oral suspension
Current Illness: thrush
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant was found dead.


VAERS ID: 362178 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Virginia  
Vaccinated:2009-07-30
Onset:2009-08-02
   Days after vaccination:3
Submitted: 2009-10-21
   Days after onset:80
Entered: 2009-10-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0198Y / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Death, Intensive care, Pancreatitis, Septic shock
SMQs:, Acute pancreatitis (narrow), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-08-04
   Days after onset: 2
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: Unknown 10/30/09-Concomitant medications: Diovan, HCTZ, Protonix, Effexor XR, Lotrel, Zocor, Prednisone, Pulmacort, Combivent, Nasonex, Albuterol, Estradiol, Atrovent, and vitamin & calcium supplements
Current Illness: chronic obstructive pulmonary disease; Pancreatitis chronic; Smoker
Preexisting Conditions: 10/30/09-Concurrent conditions: hypertension, osteoporosis, allergic rhinitis, severe GERD, moderate to severe COPD, asthma, hypercholesterolemia, hyperglycemia, chronic pancreatitis since November 2000; previous drug reaction to Fosamax & Actonel (caused abdominal pain)
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA02142

Write-up: Information has been received from a physician concerning a 60 year old female smoker with severe chronic obstructive pulmonary disease (COPD), chronic pancreatitis who on 30-JUL-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, on an unspecified date the patient experienced septic shock and cardiac disease. The patient was admitted to the intensive care unit (ICU). On 04-AUG-2009 the patient died eight hours after admission. The physician did not think death was related to ZOSTAVAX (Merck). The physician felt the patient died of cardiac reasons, but her documents said that the cause of death was septic shock and pancreatitis. Additional information has been requested. reported the following additional information: No other vaccines were administered at the time of the ZOSTAVAX Hospital records not received by the office, but a copy of a cardiac consult done on admission on 02-AUG-2009 showed renal insufficiency and DIC (consumptive coagulopathy); patient was intubated due to decreased mental status changes; consult also shows that patient went into cardiac arrest on 03-AUG-2009; onset of AEs was within 48 hours of death Death certificate showed the immediate cause of death as septic shock with the underlining cause of death as pancreatitis; no autopsy was performed.


VAERS ID: 362855 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Female  
Location: Oregon  
Vaccinated:2009-10-22
Onset:2009-10-25
   Days after vaccination:3
Submitted: 2009-10-26
   Days after onset:1
Entered: 2009-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500765P / 1 NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Influenza like illness
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none known
Current Illness: spherocytosis, hemolitic onemica
Preexisting Conditions: none. /27/09 ER and hospital records received service date 10/25/09. Splenectomy. Appendectomy. 11/02/09: Primary Care Records received for date of service 10/9/09. PMH: Heriditary spherocytosis with splenectomy, D&C, L ACL Repair, L arthroscopic knee surgery.
Allergies:
Diagnostic Lab Data: /27/09 ER and hospital records received service date 10/25/09. LABS and DIAGNOSTICS: ECG - Abnormal, sinus tachycardia, Nonspecific ST and T wave abnormality. Arterial Blood gases: pCO2 50 mmHg (H) O2 Sat 83% (L) Bicarb 8.0 mmol/L (L) Base Excess -26.0 mEq/L (L) pH 6.8 (L). CHEM - Potassium 3.0 mmol/L (L) Glucose 27 mg/dL (L) Creatinine 2.42 mg/dL (H) AST 121 IU/L (H) Bilirubin Total 1.6 mg/dL (H). GFR 28 mL/min/1.73 m2 (L). CBC - RDW 15.0% (H) PLT 91 10^9/L (L) Neutrophils 20.0% (L) Bands 20% (H) Metamyelocytes 3% (H) Lymph 55.0% (H) Lymphs Atyp 1% (H) Anisocytosis slight, Howell Jolly Body few, Vacuolated Polys moderate. Blood culture (+) for Streptococcus pneumoniae. Chest X-ray - Abnormal. 10/29/09 Hospital lab report. Blood Culture Final Report Verified on 10/28/09 - (+) for Streptococcus pneumoniae. 11/02/09: Primary Care Records received for date of service 10/9/09. Labs and diagnostics: WBC 12.5 (H), Lymph # 7.9 x 10 (H), RBC 3.7 (L), HCT 33.0 (L), MCH 32.2 (H), MCHC 36.1 (H), RDW 15 (H), PLT 493 (H), Lymph % 63 (H), Gran 28 (L). IDPB Test results: Lung section shows increased interstitial inflammatory infiltrates. Heart section shows focal interstitial edema and extravasation. No evidence of myocarditis. Liver section shows increased portal infiltrates and dilated sinusoids with Kupffer cell hyperplasia. Special stains: Scattered gram-positive cocci in lung, heart and liver. Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver. (-) for influenza virus. PCR Assays: Negative for 2009 pandemic H1N1 influenza A virus. PCR for penumoniae pending.
CDC Split Type:

Write-up: Patient got sick with flu like symptoms on 10/24 around 1PM, went to hospital with trouble breathing around 9PM, was pronounced deceased at 1AM on 10/25. 10/27/09 ER and hospital records received service date 10/25/09. Assessment: Death due to septic shock secondary to infection of unknown source. Asplenia. Patient had nausea, vomiting, chills, stomach cramping, diarrhea, tachypnea, hypotension, diaphoresis for one day. Limited oral intake. Became cyanotic around lips, fingernails, and toenails. Presented to ER hypotensive, hypoxic, no longer breathing. Tachycardia. Cardiac arrest presenting as pulseless electrical activity (PEA). Hyperacidemia. Resusitation. Intubated and transported to ICU. Bilateral infiltrates consistent with acute respiratory distress syndrome. End-organ damage including kidneys and brain. Repeated PEA. No pulse. Mottling of head and extremities. Overwhelming sepsis and septic shock. Patient expired. 11/02/09: Primary Care Records received for date of service 10/9/09. Seasonal flu vaccine record received VAERS updated. Assessment: Presented with vaginal bleeding x 3 weeks, had hx. of D&C in 08 2/2 heavy vaginal bleeding. Also presented with a cold that started 5 days prior, afebrile at visit. Seasonal Flu vaccine given. 11/05/09 Diagnostic/lab results received. IDPB Test results: Lung section shows increased interstitial inflammatory infiltrates. Heart section shows focal interstitial edema and extravasation. No evidence of myocarditis. Liver section shows increased portal infiltrates and dilated sinusoids with Kupffer cell hyperplasia. Special stains: Scattered gram-positive cocci in lung, heart and liver. Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver. (-) for influenza virus. PCR Assays: Negative for 2009 pandemic H1N1 influenza A virus. PCR for penumoniae pending. 12/14/09 Autopsy Records receivedI. DOD 10/25/09. Final Cause of Death: Streptococcus Pneumonia Sepsis. II. Hemolytic Anemia with Splenectomy. Additional information abstracted: Arteriovenous malformation of brain. Cholecystectomy remote. Blood cultures (+) for streptococcus pneumonias.


VAERS ID: 363458 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Florida  
Vaccinated:2009-10-26
Onset:2009-10-27
   Days after vaccination:1
Submitted: 2009-10-28
   Days after onset:1
Entered: 2009-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP004AA / 1 UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-28
   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: Metoprolol 50mg BID; HYZAAR 100mg/25mg QD; ASA 81 mg chew 1 QAM
Current Illness:
Preexisting Conditions: Obesity; Hypertension; Hyperlipidemia etc. 10/29/09 PCP medical records received service dates 10/26/09 to 10/28/09 Hypertension, hyperlipidemia, pulmonary embolism, impaired fasting glucose, obesity, DVT, hydradenitis supurative, skin grafting.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client contacted Dr.''s office on 10/27/09 approximately equal to 0900 c/o feeling lightheaded and was not sure whether it was due to low BP or having received an H1N1 injection the day prior (10/26/09). Position: ESE Paraprofessional (worked with special needs children). An autopsy will be performed. 10/29/09 PCP medical records received service dates 10/26/09 to 10/28/09 includes vaccine records. Assessment: URI, low blood pressure, fatigue. On 10/27/09 Patient presents with low blood pressure and fatigue. Slight sore throat and post nasal drainage. Weak, ''woozy''. Weight loss of 38 lbs since 2/08. On 10/28/09 notified that patient had expired. 12/28/09 Note from Medical Examiner. DOD 10/28/09. Patient found unresponsive in bed at home. History of recurring deep vein thrombosis. Autopsy results show saddle embolus resulting in death. Local Health Department requested this office''s assistance in regards to possible infection with H1N1. 1/5/09 Autopsy Report received. DOD 10/28/09. Final Cause of Death: Pulmonary Thromboembolism Due To Recurrent Lower Extremity Deep Vein Thrombosis. Additional Information Abstracted: Contributing - Morbid Obesity, Uterine Leiomyomata.


VAERS ID: 364511 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2009-03-03
Onset:2009-03-08
   Days after vaccination:5
Submitted: 2009-10-19
   Days after onset:224
Entered: 2009-11-02
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Death, Fatigue, Muscle spasms, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-07-05
   Days after onset: 118
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Good Health
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 1wk. from vaccination, she began to have pain & tingling in her feet. She stayed tired all the time. She had gout in her feet before and thought it was gout. She went to the Dr. and he gave her QUININE for her legs cramping. This helped a little but kept getting worse, went to hospital on 5-25-09 Died 7-5-09. 11/5/09 Death Certificate received DOD 7/5/09 Cause of Death: Respiratory Failure consistant with Adult Respiratory Distress Syndrome.


VAERS ID: 365165 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2009-10-30
Onset:2009-11-02
   Days after vaccination:3
Submitted: 2009-11-04
   Days after onset:2
Entered: 2009-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP009AA / 1 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0509Y / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Identified
Preexisting Conditions: aspirin Steriods Augmentin.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: UNKNOWN.


VAERS ID: 365381 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Virginia  
Vaccinated:2009-11-03
Onset:2009-11-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2009-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UU013AA / 1 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Death, International normalised ratio, Myocardial infarction, Prothrombin time
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADIN; GLYPIZIDE; LIPITOR; AVODART
Current Illness: None
Preexisting Conditions: NKDA; Afib; Lung CA. PMH: Small cell Lung CA, lobectomy x2 2006, 4 month hospitalization, aspiration, tracheostomy, failure to thrive, PEG tube. Hypertension, inguinal hernia, GERD, hyperlipidemia, diabetes, secondary heart block, Wenckebach, chronic constipation, urinary retention (Foley 2005), DVT R leg recurrent, atrial fib, past smoker, family h/o heart disease and CA.
Allergies:
Diagnostic Lab Data: PT/INR, 2.1.
CDC Split Type:

Write-up: 77 y/o with Afib and lung cancer given H1N1 (Sanofi) on 11/3/09- Died. 11/5/09-prob. heart attack. 11/06/09 Medical records received. DOS 08/21/08-03/24/09. PCP office notes. Visits note looked well, unremarkable PEs with well healed surgical scars, clear bronchial to minimal wheeze, CBCs WNL w/some low 02 sats (92% on R/A). Extrems trace PTE, until 03/24/09. DX bad cold w/ white mucus and cough. Nausea, low grade fever. Lung sounds benign. Mild leukocytosis, possible infection. Tx Levaquin. 4/28/09 Congestion continued, thick mucus, worse since pneumonia. Bronchial w/minimal wheezes. CBC WNL. EKG sinus rhythm, systolic murmur. Subsequent visits showed 02 sat 91%, weight loss. 11/03 occasional SOB, H1N1 vaccine given. Labs & Diags EKG- normal, sinus mechanism, bradycardia 48. 12/17/09 Death Certificate received. DOD 11/05/09. Cause of Death. Myocardial infarction. Other information abstracted: Other medical conditions - lung cancer, atrial fibrillation.


VAERS ID: 365416 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Michigan  
Vaccinated:2009-09-07
Onset:0000-00-00
Submitted: 2009-11-05
Entered: 2009-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 05849111A / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Aphasia, Asthenia, Death, Dysstasia, General physical health deterioration, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol #3, Namenda, Aspirin 81mg, Ranitidine
Current Illness:
Preexisting Conditions: Patient had Alzheimers, high functioning. History of hip replacements in past 15 years.11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. PMH: Alzheimers dimentia, HTN, arthritis, hypothyroidism, scoliosis, sundowners.
Allergies:
Diagnostic Lab Data: 11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. Labs and Diagnostics: Blood cultures, Urinalysis, urine culture, CXR- all normal.
CDC Split Type:

Write-up: Patient showed a marked decline in functioning starting about 12 hours after the vaccine was administered. Pt was shaky, weak, could not put words together. Pt''s doctor was contacted on Sept 8, ruled out UTI. Seen by doctor on Sept 24. Pt was unable to stand or use legs, so she was taken to the hospital on Oct 8. Pt was admitted to hospital Oct 8 at Hospital, admitted to hospice on Oct. 13, and passed away Oct 17. 11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. Dx: End stage Alzheimers Dimentia, dysphagia, HTN, arthritis, hypothyroidism, scoliosis, and sundowners. Assessment: Presented unable to ambulate that morning, not able to communicate. Pts. baseline is to ambulate using walker, toilet and converse but over past 3-4 weeks she has steady decline and is no longer lucid and has no insight. Urine, blood work and CXR all used to rule out infectious process. Patient unable to improve in any way, palliative care discussed and hospice home decided on by family for comfort care measures only.


VAERS ID: 365428 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Montana  
Vaccinated:2008-10-16
Onset:2008-11-05
   Days after vaccination:20
Submitted: 2009-11-05
   Days after onset:365
Entered: 2009-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B153BA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D05881 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA681A / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Choking, Death, Irritability
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-05
   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: Patient was on Amoxicillan since birth due to slight hydronephrosis in his left kidney
Current Illness: None, the week prior he had a viral outbreak of sores in his mouth/ throat, physician thought he would be fine to vaccinate the next week
Preexisting Conditions: He had hydronephrosis in his left kidney, was on amoxicillan for it
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was fussy on 11/04/2009, he was hard to calm down in the morning at approx 4 am I awoke to sounds of him choking, I picked him up and then he was fine, I took him to daycare that morning and received the phone call at 4:30 pm that he was being rushed to the ER. 12/22/09 Death Certificate Received, DOD 11/05/08, Cause of Death: Sudden Infant Death Syndrome (SIDS) at daycare. 12/22/09 Autopsy received. Cause of Death: Sudden Infant Death Syndrome (SIDS). Additional information abstracted: Had been fussy and more congested lately. Chronic inflammation in the large airways likely due to viral infection.


VAERS ID: 365786 (history)  
Form: Version 1.0  
Age: 1.41  
Sex: Male  
Location: California  
Vaccinated:2009-11-05
Onset:2009-11-06
   Days after vaccination:1
Submitted: 2009-11-06
   Days after onset:0
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UT014AA / 1 UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR UT3178CA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D50003 / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0681Y / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seizures PMH: hx of seizure 7/2009. Allergies: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient Died.


VAERS ID: 365979 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-11-06
Entered: 2009-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Inappropriate schedule of drug administration
SMQs:, Medication errors (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: Unknown
Current Illness:
Preexisting Conditions: Hospitalisation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA00425

Write-up: Information has been received from a registered nurse concerning an elderly patient who on an unspecified date was vaccinated with a second dose of PNEUMOVAX 23 (lot#, route and site of administration not reported). The first and second doses were reported to be given "approximately 6 months apart". On an unspecified date, the patient died but many months after receiving the second vaccination. The nurse stated that the patient was administered PNEUMOVAX 23 vaccine prior to discharge from a local hospital. The reporting nurse insisted that it had nothing to do with PNEUMOVAX 23 vaccine and death was from old "age". This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 366004 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: New York  
Vaccinated:2009-08-12
Onset:2009-09-01
   Days after vaccination:20
Submitted: 2009-11-06
   Days after onset:66
Entered: 2009-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1580X / 1 RA / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39016 / 4 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0043Y / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Death, Pneumonia, Polymerase chain reaction, Rash, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2009-11-02
   Days after onset: 62
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 57 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Ferrin-sol; Poly-vi-sol; NYSTATIN PRN; Bactroban PRN
Current Illness: See 19, Had mild cough, otherwise well
Preexisting Conditions: Milk protein allergy; Chromosomal abnormality; Hypotonia (abnormal muscle biopsy); Disordered feeding; Aspiration pneumonia (recurrent); Anemia; G-tube feed 12/9/09 Received records. PMH: RAD, GERD, type 2 muscle atrophy, anemia, multiple hospitalizations for aspiration pneumonia, RSV, G-tube, otitis media, varicella
Allergies:
Diagnostic Lab Data: DOH did evaluation; PCR (+) for vaccine strain (isolated from fluid from skin lesions). 11/13/09 Death Certificate received DOD 11/2/09 Cause of Death: Multisystem Organ Failure, Acute Respiratory Distress Syndrome, Varicella Pneumonitis. 12/9/09 Received records. Diag/Labs: CBC abnormal, CXR(-), chemistry abn, CRP 1(H), sed rate 35(H), blood cult(-), tracheal aspirate cult (+)gram neg bacilli, pseudomonas aeruginosa 1/4/09 Additional diag/labs received from date 9/5/09 to 10/29/09. Diag/Labs: CBC w/ diff abnormal, blood culture(+)pseudomonas aeruginosa, urine cult(+)candida albicans, Immune tests: abs T cells 223(L), abs suppressor 46(L), abs helper 169(L), IGG subclass 1-4(L), CXR (+)rt side pneumothorax, abdominal US(-), brain US(-).
CDC Split Type:

Write-up: Patient given vaccine on 8/12/09. Hospitalized for respiratory illness/pneumonia 8/27-9/1, given steroids during hospitalization. Rash developed on 9/1/09, day of discharge. Saw patient on 9/2/09, started on oral acyclovir. DOH and hospital notified. 11/13/09 Death Certificate received DOD 11/2/09 Cause of Death: Multisystem Organ Failure, Acute Respiratory Distress Syndrome, Varicella Pneumonitis. 12/9/09 DC summary received for dates 8/27/09. DX: respiratory difficulty, bronchospasms, hypotonia. Chief c/o respiratory distress, URI x1day, fever, tachypnea, retractions. Caretaker reports pt having difficulty breathing, fever, irritable. Assessment, (+)fever, grunting, retractions, hypotonia, O2 sat 91% on 3LNC. Speech and swallow eval: oropharyngeal dysphagia. Pt improved over 3 days, stable at dc. ER/hospital 9/5/09 to 10/29/09. DX: muscular weakness disorder, viral pneumonitis, varicella. Resp distress, fever. Parent states varicella vax 8/12/09. Varicella skin rash formed 8/31/09.EMS presented pt. to ER. Assessment: stridor, rash, fever, mild distress. Pt admitted and following day resp distress increased, grunting, increase in fever 103F, pt found to be irritable, O2 sats 92% w/ O2 therapy. Tylenol given, within 30 min temp 104.5F. One hr later pt HR 220-240bpm. Pt later stabilized but prognosis guarded.


VAERS ID: 366035 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Female  
Location: Connecticut  
Vaccinated:2009-09-09
Onset:2009-09-10
   Days after vaccination:1
Submitted: 2009-11-06
   Days after onset:57
Entered: 2009-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 057303 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt received her 1st PCV vaccine on 9/9/09 and passed on 9/10/09. The circumstances surrounding her demise are unclear at moment. Dx as SID. 12/18/09 Autopsy Received. DOD 9/20/09. Cause of Death: Sudden Explained Infant Death. Additional Information Abstracted: Final Other Significant Conditions - Bed Sharing With Adult.


VAERS ID: 366680 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-10-30
Onset:2009-11-08
   Days after vaccination:9
Submitted: 2009-11-10
   Days after onset:2
Entered: 2009-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3479AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. AHBVB370AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D88185 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0319Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-08
   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: None
Preexisting Conditions: Born 37 wks; IUGR; inguinal hernia; choroid plexus cyst
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient died in sleep. presumptive diagnosis is "SIDS".


VAERS ID: 366686 (history)  
Form: Version 1.0  
Age: 1.76  
Sex: Male  
Location: New York  
Vaccinated:2009-11-04
Onset:2009-11-09
   Days after vaccination:5
Submitted: 2009-11-10
   Days after onset:1
Entered: 2009-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR UT3179EA / 3 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Lethargy, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-10
   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:
Current Illness: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt lethargic, with non custodial parent out of town. Febrile 11-8-09 -$g 11-9-09. Found unresponsive. Died in AM 11-9-09. ? foul play.


VAERS ID: 366608 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2009-11-06
Onset:2009-11-07
   Days after vaccination:1
Submitted: 2009-11-11
   Days after onset:4
Entered: 2009-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 100923 / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hypotension, Malaise, Nausea, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-11
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: patient was in car accident on 10/07/2009
Current Illness: Friday c/o bronchitis symptoms and recieved Zpac
Preexisting Conditions: allergy to Phenergan and Elavil. ESRD. Hx of a-fib. 11/13/09: Dialysis Notes received for date of service 11/4/09: Dx: Renal failure 2/2 HTN. secondary hypothyroidism (of renal origin), unspecified chest pain, unspecified deficiency anemia, unspecified peritonitis, hyperparathyroidism, phosphorous disorder, atrial fibrillation, hyperkalemia, nasopharyngitis, depression. 11/13/09: Discharge Summary received from dates of service 10/07/09 to 10/11/09. DX: Lacerated spleen, fractures of cervical 5 and 6. Assessment: Involved in an MVA on 10/7/09 in which she suffered a lacerated spleen and fractures of cervical 5 and 6. Discharged to home on 10/11/09. PMH: Anemia in Chronic Renal Disease, Chronic Renal Failure, ESRD due to HTN, Iron deficiency anemia, RLS, seborrheic dermatitis, secondary hypothyroidism (of renal origin), unspecified chest pain, unspecified deficiency anemia, unspecified peritonitis, hyperparathyroidism, phosphorous disorder, atrial fibrillation, hyperkalemia, nasopharyngitis, depression.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: General malaise, nausea, hypotension. 11/13/09: Medical record for date of correspondence 11/13/09: Assessment: Received H1N1 vaccine 11/6/09 at a dialysis appointment and did not feel well, c/o nausea and malaise on 11/7 & 11/8/09, according to pt''s husband, she continued to feel unwell on 11/10/09. On the morning of 11/11/09 the patient was found to have died in her sleep. 11/13/09: Hospital discharge summary(hospitalizaton prior to vaccine), hemodialysis clinic records and correspondence of case summary received. On 11/09/09, patient received out-patient dialysis. The patient had gained four pounds since her previous dialysis appointment. 12/21/09 Death Certificate received. DOD 11/11/09. Cause of Death: Hypertensive cardiovascular disease.


VAERS ID: 366976 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-10-28
Onset:2009-10-29
   Days after vaccination:1
Submitted: 2009-11-12
   Days after onset:14
Entered: 2009-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP013AA / UNK LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Death, Dyspnoea, Feeling cold, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-10
   Days after onset: 12
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: AMBIEN; amiodarone; Bayer Aspirin; clonidine HCl; COLACE; DULCOLAX; FERRLECIT; FLOMAX; heparin sodium (porcine); hydroxyzine HCl; LEVOXYL; NEPHROCAPS; normal saline; oxygen; PEPCID; PERCOCET; PhosLo; PROAMATINE; TRILEPTAL; TYLENOL; ZEMPLAR;
Current Illness:
Preexisting Conditions: Allergies: Nitrous oxide; Novacaine; PMH: see below *. PMH: Severe peripheral vascular disease. Amputation of left leg. hypertension, hypertensive cardiovascular disease, diabetes mellitus, cerebrovascular accident in the past, End-stage renal disease on hemodialysis, coronary artery disease, chronic obstructive coronary disease, seizure disorder.
Allergies:
Diagnostic Lab Data: obtained at our medical center. LABS and DIAGNOSTICS: Chest X-ray - Abnormal, nodule left lung. CBC - RBC 3.21 Mill/uL (L) HGB 11.2 g/dL (L) HCT 32.2% (L) MCV 102.0 fL (H) MCH 35.0 pg (H) RDW 21.2% (H) Platelets 67 Thou/uL (L). CHEM - Chloride 96 mmol/L (L) CO2 33 mmol/L (H) Creatinine 3.6 mg/dL (H) BUN CREAT Ratio 9.3 (L) Glucose 138 mg/dL (H) eGFR 17 mL/min (L).
CDC Split Type:

Write-up: Pre dialysis on 10/30/09 complained of achiness (generalized), feeling cold, difficulty breathing. Lungs were clear (oxygen administered w/ ease of breathing), BP 129/41, HR 81 - regular temp 98.38. TYLENOL given for pain #7/10 on pain scale. Patient 3.4 kg $g EDW. Edema +2 pitting in right leg. Reported patient condition to Nephrologist. Hemodialysis treatment initiated and completed without complication. Patient refused to be evaluated at ER and discharged home in stable condition. 11/13/09 Medical records received. Dialysis records for DOS 10/28-10/30. C/o fainting x3 at home. Can''t stay awake. Vaccine given same day (10/28). Admits he had called 911 x2 looking for help that day. Seen 2 days later and c/o coldness, hurting all over. Can''t breath. Kept asking for help. Staff offered to call 911. Refused. Afebrile. No flu like sx noted by staff other than achy. Dialysis tx given. D/C to home. Follow-up call made. Pt OK. Went to bed. 11/16/09 Two discharge summaries received, hospital records. Service dates 10/30/09 to 11/10/09. Assessment: Dehydration, swine flu reaction, Patient presented with fevers, generalized aches, and pains. Very weak and sick. Headache. Non-healing ulcer on right heel. While in hospital became lethargic and difficult to arouse. Developed high fever (105.5), more confused and lethargic. Bradycardic, patient intubated, lost peripheral pulses, resusitation not sucessful, pronounced deceased. 0/04/2010 Death Certificate received. DOD 11/10/2009. Cause of Death: Coronary artery disease, severe peripheral vascular disease, chronic obstructive pulmonary disease, septicemia. Other significant conditions: Status post left below knee amputation, depression, diabetes.


VAERS ID: 367270 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2009-11-05
Onset:2009-11-05
   Days after vaccination:0
Submitted: 2009-11-13
   Days after onset:8
Entered: 2009-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UT014FA / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Cardiac arrest, Cardioversion, Death, Endotracheal intubation, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonazepam; Clonidine; PREVACID; REBETOL; ibuprofen; Phenobarbital; MIRALAX; TOPAMAX
Current Illness: None Known except those noted in 19
Preexisting Conditions: Status encephalopathy; control apnea; seizure disorder; GERD; S/P Nissen EG-Tube; traumatic brain damage; NKA. 11/17/09 PCP medical records and ED records received service date 11/5/09. Traumatic brain damage, feeding tube in abdomen. Heart murmur. 11/20/09 Extensive PCP, ED, Hospital, rehabilitation, and consultation records received documenting a complex past medical history. Service dates 6/1/07 to 11/5/09. Profound developmental delay and neurologic compromise. Seizures. Cortical visual impairment. Pneumonia, hydropneumothorax, nonaccidental trauma s/p left subdural hematoma, right occipital skull fracture, cystic encephalomalacia, gastroesophageal reflux disease, central apnea, gastroscopy tube placement, Nissen fundoplication.
Allergies:
Diagnostic Lab Data: Autopsy report pending. 11/17/09 PCP medical records and ED records received service date 11/5/09. LABS and DIAGNOSTICS: ECG - Abnormal.
CDC Split Type:

Write-up: Arrived to ED at 1214 via EMS. In asystole and CPR in progress. Intubated and defibrillated in field. Interosseous IV started in ED. Epinephrine, bicarb, and glucose administered. Code stopped at 1236. 11/17/09 PCP medical records and ED records received service date 11/5/09. Assessment: Cardiopulmonary arrest. Child presented for H1N1 vaccination with nasal congestion and oxygen via nasal cannula. No mention from mother of concerns, no noticeable distress from child. Later at home grandmother heard O2 Oximeter beep, found child unresponsive and not breathing. Mother performed CPR. EMS started ACLS, intubated, and defibrillated. Interosseous IV. Pupils on admission Fixed and dilated. No spontaneous respirations. No cardiac activity - asystole. No pulse. No blood pressure. Skin cyanotic and cool. Code terminated. Deceased.


VAERS ID: 367379 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Alabama  
Vaccinated:2009-10-28
Onset:2009-10-28
   Days after vaccination:0
Submitted: 2009-11-14
   Days after onset:17
Entered: 2009-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP003AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: none known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Killed in a car accident while pulling out of the street where the clinic was located. Was turning left onto a divided highway when the driver''s side door was hit by an oncoming vehicle. Died on impact.


VAERS ID: 367386 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-10-31
Onset:2009-10-31
   Days after vaccination:0
Submitted: 2009-11-14
   Days after onset:14
Entered: 2009-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP008AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood gases, CD4 lymphocytes decreased, Dyspnoea, General physical health deterioration, Headache, Intensive care, Mechanical ventilation, X-ray
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-11-19
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: no other vaccine adminstered
Current Illness: none
Preexisting Conditions: HIV POSTIVE 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Previous suicide attempts, substance abuse, depression, coronary artery disease with stenting, HIV(+), COPD, hypertension, skin cancer. Smoker, alcohol use. 12/3/09 Hospital discharge summary for service dates 8/23/09 to 8/26/09. Suicide attempt using Neurontin and baclofen. Substance abuse.
Allergies:
Diagnostic Lab Data: blood gases, xrays, spending more time on the HIV aspect but he was healthy HIV status person before the shot... never been hospitalized before this incident, and his cd4 count was above 200 and his viral load un-detected, his cd-4 count as of now is 94... too coincidental for me... 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. LABS and DIAGNOSTICS: Sputum Smear Gram Stain - Gram (+) Cocci, Gram (-) Diplococci, Gram (+) Bacilli, Gram (-) Bacilli. CBC - RBC 3.23 Mill/uL (L) Hematocrit 34.3% (L) Hemoglobin 11.9 G/DL (L), Lymphs 13.0% (L) Granulocytes 81.1% (H) WBC Morphology 1+ Toxic Granulation. HIV 1 IGG (+). CHEM - Creatinine 0.84 MG/DL (L) BUN/CREAT Ratio 23.8 (H) Calcium 8.8 MG/DL (L) Total Protein 5.9 G/DL (L) Albumin 2.8 G/DL (L) B-Type Natriuretic Peptide 458 PG/ML (H). Blood Gases - Abnormal. MI Screen - CK 418 IU/L (H) Myoglobin Serum/Plasma 143 NG/ML (H). Chest X-ray - Abnormal, bilateral pulmonary edema.
CDC Split Type:

Write-up: Begin with headache, shortness of breath followed, ended up in ICU on ventilator on 11/08/09, doing very poor at this time. 12/03/09 Hospital records and discharge/death summary received, service dates 11/09/09 to 11/19/09. Deceased Diagnosis: Acute respiratory failure secondary to bilateral pneumonia, hemoptysis, AIDS, history of coronary artery disease, status post coronary stent, previous history of myocardial infarction, history of chronic obstructive pulmonary disease. Patient had ingested 18 Percocet, called EMS because of fever, coughing, shortness of breath and pain in back. Presented at ED complaining of shortness of breath and hemoptytsis. Intubated, ICU. Bilateral pneumonia, hypoxic. Placed on ventilator and IV antibiotics. DNR order signed, consent for tracheostomy denied, placed on morphine drip. Stopped breathing, heart rate dropped to flat line. No muscle tone, pupils dilated, pronounced dead.


VAERS ID: 367469 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Alabama  
Vaccinated:2009-10-22
Onset:2009-10-23
   Days after vaccination:1
Submitted: 2009-11-16
   Days after onset:24
Entered: 2009-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Death, Dyspnoea, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-11-09
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: diabetic,impaired renal function, chf. PMH: CAD w/CABG, carotid disease, htn, DM, hyperlipidemia, past smoker Allergies: Lopid
Allergies:
Diagnostic Lab Data: Labs & Diags: CXR- mildly enlarge enlarged and congestive changes, bil pleural effusions. MRA abd -atherosclerotic disease of aorta. EKG - aortic sclerosis w/mild aortic insuff, moderate pulmonary htn. WBC 13.8 (H), RBC 2.7 (L), HGB 7.9 (L), HCT 24 (L), RDW 15.3 (H), NEUTR 90.7 (H). LYMPH 4 (L). K 5.7 (H), UREA N 113 (H). CREAT 2.5 (H), ALB 2.5 (L), PHOSPHOROUS 4.9 (L), GLUC 228 (H), CHLORIDE 114 (H), ALK PHOS 229 (H), NA 134 (L), SPUTUM CX GRAM + COCCI. U/A LARGE LEUKS, STOOL OCCULT BLD +, URINE PROT 11.0 (H)
CDC Split Type:

Write-up: difficulty breathing, unable to talk, was taken to hospital via ambulance, O2 sat 88% later died. 12/7/09 Death Certificate recieved. DOD 11/9/09. Cause of Death: Chronic Obstructive Lung Disease. Additional information abstracted - Other significant conditions: ASHD; GI bleed. 11/25 and 12/4 Medical records and discharge summary received. DOS 10/23/09 Final DX: Acute on chronic congestive heart failure likely s/to a combination of diastolic dysfunction, severe HTN and valvular heart disease. COPD, New onset of atrial fibrillation, CAD s/p coronary artery bypass grafting 2006. PVD with h/o moderate carotid disease, HTN, DM type 2, Valvular heart disease w/moderate to severe mitral regurgitation and moderate pulmonary hypertension by echocardiogram. C/O fatigue, SOB, dizziness, edema. Lethargy. Breathless. Bil carotid bruits. ICU. D/C. Poor prognosis. DOS 11/02 Final DX: Acute renal failure, suspect patient was prerenal azotemia w/eleveated blood urea nitrogen to creatanine ratio related to diuretics, poor oral intake, and congestive heart failure. Hypokalemia related acute renal failure in setting of medications which can increase potassium. Bradycardia likely related to hypokalemia in addition to medication which can slow heart rate. Now s/p pacemaker placement. Hypotension r/to symptomatic bradycardia, anemia, underlying CHF w/ bil pleural effusions, respiratory failure w/adequate gas exchange. Admit for malignant hypertension and COPD, improved and was D/C to home. Prognosis poor. 5 days later c/o lethargy, hypotension, bradycardia, intubated. BP 90/60. Decreased breath sounds bil. 3rd degree AV block, acute renal failure. Hypokalemia. Multiorgan failure. Acute resp failure. UTI.


VAERS ID: 367792 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2009-11-03
Onset:2009-11-03
   Days after vaccination:0
Submitted: 2009-11-16
   Days after onset:13
Entered: 2009-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500781P / UNK NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Chest X-ray abnormal, Death, Resuscitation
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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-03
   Days after onset: 0
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: gingivitis. dental care provided 10/29/2009
Preexisting Conditions: PMH: loose teeth, gum pain and bleeding, hit head when young.
Allergies:
Diagnostic Lab Data: OMI results not available at this time however chest xray showed enlarged heart, no pulmonary effusion
CDC Split Type:

Write-up: Patient had sudden cardiac arrest and had CPR from onset, was picked up by EMS and transported to hospital and pronounced dead at approx 11:30 PM. 12/16/09 Report of death received for 11/03/09. Decedent fell on the floor while in a social gathering. No pulse, CPR performed by school nurse for 10 mins until EMS came. Decedent had emesis while compressions were performed. EMS started ACLS, intubation, 3 IV lines, 4 Epi, 3 Atropine and 1 amp Bicarb. Sinus rhythm established 1 time, but lost. CPR unsuccessful. Decendent pronounced dead. 12/16/09 Autopsy results revealed no visible internal signs of trauma. All systems autopsy: normal. Teeth in poor condition. Cardiovascular system: myocardium: focal areas of fibrosis, atrial; bulges in atrial and ventricular muscular fee walls, interventricular septum 3cm thick. Pathologist opinion: Hypertrophic cardiomyopathy (790gr). Heart severely congested and lungs heavy with possible aspiration. 12/24/09 Toxicology report received. This report showed that no drugs were used. 01/04/09 Medical/dental record received for DOS 10/29/09. Debridement performed. Anesthesia used. Moderate to heavy generalized bleeding. Tx: Chlorhexidine gluconate oral rinse. DX: Gingivitis, periodontal disease.


VAERS ID: 368647 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2009-09-07
Submitted: 2009-11-18
   Days after onset:72
Entered: 2009-11-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021423

Write-up: Report received on 17-NOV-2009 from a daughter of a patient regarding a claim in litigation. The female patient (date of birth unknown) received the "flu shot" (manufacturer and lot # not provided) on an unspecified date in 2009. On 07-SEP-2009, the patient died possibly due to the flu shot. No further information was provided.


VAERS ID: 368648 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Missouri  
Vaccinated:2008-11-22
Onset:2008-11-23
   Days after vaccination:1
Submitted: 2009-11-17
   Days after onset:359
Entered: 2009-11-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test negative, Anxiety, Autopsy, Biopsy skin abnormal, Bradycardia, Brain herniation, CSF glucose increased, CSF lymphocyte count normal, CSF monocyte count negative, CSF neutrophil count negative, CSF protein normal, CSF test abnormal, CSF white blood cell count negative, Cardiac enzymes normal, Chest pain, Computerised tomogram normal, Condition aggravated, Death, Dehydration, Differential white blood cell count abnormal, Drug screen negative, Dysphagia, Electrocardiogram normal, Encephalitis, Full blood count normal, Histology abnormal, Hypoaesthesia facial, Hypotension, Intracranial pressure increased, Lactic acidosis, Lumbar puncture, Meningitis, Metabolic function test, Metabolic function test normal, Oliguria, Panic attack, Polymerase chain reaction, Pruritus, Rabies, Red blood cells CSF positive, Renal failure acute, Saliva analysis abnormal, Virus serology test positive, Withdrawal of life support
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic leukopenia (broad), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-30
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin human antirabies
Current Illness:
Preexisting Conditions: The patient had been bitten by a bat on the left ear four to six weeks prior to symptom onset. The patient had a history of chronic neck and back pain that occasionally featured numbness. Three days prior to the event, the patient had a history of pruritus on his left ear, face and arm (19/nov/2008), mild chest pain (21/Nov/2008), and panic attacks and anxiety associated with swallowing water (22/Nov/2008).
Allergies:
Diagnostic Lab Data: 21/Nov/2008: Electrocardiogram and cardiac enzymes (negative for myocardial infarction); 24/Nov/2008: Lumbar puncture (CSF) - glucose 78 mg/dL, protein 39 mg dL, six red blood cells/mm3, and one white blood cell/mm3; differential showed lymphocytic predominance of 68%, 26% monocytes, and 6% neutrophils; Complete blood cell count; metabolic panel; drug screen; and computerized tomography scan of the head were unremarkable; Serum CSF; nuchal skin biopsy; and saliva were collected and submitted to CDC, where a rabies diagnosis was confirmed on November 26th; Viral antigen nd RNA were detected by CDC in the skin biopsy by direct fluorescent antibody testing and reverse transcription polymerase chain reaction (RT-PCR), respectively; Viral RNA also was detected in the patient''s saliva by RT-PCR; Serum was positive for neutralizing antibodies against rabies by rapid fluorescent focus inhibition test (RFFIT), and CSF was negative by RFFIT and indirect fluorescent antibody; Rabies viral RNA amplified by RT-PCR was typed as variant common to silver-haired bats (Lasionycteris noctivagans); Autopsy (report not provided): confirmed suspected cerebellar tonsillar herniation and moderate bilateral uncal herniation; On histological examination, multiple neurons had eosinophilic cytoplasmic inclusion bodies, particularly in specimens from the hippocampi, nucleus basalis, and Purkinje cells.
CDC Split Type: 200904838

Write-up: Initial report received 09 November 2009 from a literature citation which involves a case of misuse (i.e., inappropriate schedule of drug administration). On 24 November 2008, the Centers for Disease Control and Prevention was notified about suspected rabies in a 55-year-old male patient who had been bitten by a bat four to six weeks prior to symptoms onset. Family members reported that they saw a bat in the rafters of the front porch for several days before it flew into the house. The patient caught the bat and allowed it to crawl up his arm and neck and was bitten on the left ear. The patient did not report the incident to public health authorities or seek medical evaluation. The patient left the bat unrestrained in the house for two days, and when the bat appeared to be well after that period, he released it outside. On 26 November 2008, infection with rabies virus variant associated with silver-haired bats was confirmed and the patient subsequently died on 30 November 2008. The following report summarizes the patient''s treatments and clinical course. A 55-year-old male patient developed pruritus on 19 November 2008 on his left ear that spread to his left face and arm. Two days later on 21 November 2008, he began experiencing mild chest pain and reported to the emergency department. Testing included an electrocardiogram and cardiac enzymes which were negative for acute myocardial infarction and the patient was discharged with instructions to return if symptoms worsened. On 22 November 2008, the patient returned to the emergency department with panic attacks and anxiety associated with swallowing water. At that time, the patient reported that he had been bitten by a bat on the left ear lobe four to six weeks earlier. He received corrective treatment with rabies post-exposure prophylaxis consisting of 15.4 mL of rabies immune globulin (manufacturer, lot number not reported) and 1 mL of rabies human diploid vaccine (manufacturer and lot number not reported), and a tetanus-diphtheria vaccine booster (manufacturer and lot number not reported), and was released. The patient reported to a second emergency department on 23 November 2009 due to new numbness of the left ear and face, continuing chest pain and difficulty swallowing water. The patient also reported a history of chronic neck and back pain that occasionally featured numbness. He also informed the physician about his prior bat exposure and the PEP treatment he received the previous day. The physician explained that the PEP treatment the patient received was appropriate, but explained that treatment might not be helpful if administered late in the course of rabies disease. The patient was released from the emergency department and advised to seek medical attention if his symptoms progressed. Later that same day, the patient returned to the emergency department complaining of dehydration and he became anxious when he tried to drink fluids. On 24 November 2008, the patient was transferred to a tertiary care facility. The differential diagnosis on admission included rabies and other causes of infectious meningitis and encephalitis. A lumbar puncture yielded cerebrospinal fluid (CSF) with glucose 78 mg/dL (normal 50-80 mg/dL), protein 39 mg dL (normal 15-45 mg/dL, six red blood cells/mm3 (normal 0), and one white blood cell/mm3 (normal 0-3 cells/mm3); differential showed lymphocytic predominance of 68%, 26% monocytes, and 6% neutrophils. Complete blood cell count, metabolic panel drug screen, and computerized tomography scan of the head were unremarkable. Serum CSF, nuchal skin biopsy and saliva were collected and submitted to CDC on 24 November 2008, where a rabies diagnosis was confirmed on 26 November 2008. Viral antigen and RNA were detected by CDC in the skin biopsy by direct fluorescent antibody testing and reverse transcription polymerase chain reaction (RT-PCR), respectively. Viral RNA was also detected in the patient''s saliva by RT-PCR. Serum was positive for neutralizing antibodies against rabies by rapid fluorescent focus inhibition test (RFFIT), and CSF negative by RFFIT and indirect fluorescent antibody. Rabies viral RNA amplified by RT-PCR was typed as a variant common to silver haired bats (Lasionycteris noctivagans). On 25 November 2008, the patient began rabies treatment using protocol, which included coma induction and administration of amantadine. The following day, the patient became bradycardic and hypotensive and was administered atropine and dopamine. On 28 November 2008, dopamine was replaced with norepinephrine and persistent hypotension and bradycardia. Diuretics were administered because of signs of increased intracranial pressure. On 29 November 2008, hypotension worsened and the patient developed oliguric acute renal failure with lactic acidosis and was placed on dialysis. When signs of increased intracranial pressure herniation were detected on 30 November 2008, his family elected to withdraw life support, and the patient died shortly thereafter. The autopsy (report not provided) confirmed the suspected cerebellar tonsillar herniation and moderate bilateral uncal herniation. On histological examination, multiple neurons had eosinophilic cytoplasmic inclusion bodies, particularly in specimens from hippocampi, nucleus basalis, and Purkinje cells. Documents held by sender: None.


VAERS ID: 369139 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: West Virginia  
Vaccinated:2009-11-17
Onset:2009-11-17
   Days after vaccination:0
Submitted: 2009-11-20
   Days after onset:3
Entered: 2009-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B204AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF753AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66586 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High birth score for SIDS.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death - cause of death not confirmed by medical examiner.


VAERS ID: 369428 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2009-10-16
Onset:2009-10-21
   Days after vaccination:5
Submitted: 2009-11-14
   Days after onset:24
Entered: 2009-11-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR V8003AA / 1 RA / IJ
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR V3176DA / 7+ LA / IJ

Administered by: Private       Purchased by: Unknown
Symptoms: Acute respiratory failure, Chest X-ray abnormal, Cough, Death, Dyspnoea, Intensive care, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-25
   Days after onset: 4
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:
Current Illness:
Preexisting Conditions: Retts Syndrome (Spasticity); Reflux; G Tube; Wheel chair bound; Scoliosis; 12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to 10/25/09. Breathing abnormality, drooling, endometriosis, mental retardation, pressure ulcer, hip surgery, Rett syndrome vs Angelman, scoliosis, seizure, sleep disorder, spasticity. Allergic reaction to Suprax. Adhesive bandage reaction.
Allergies:
Diagnostic Lab Data: CXR severe bilateral pneumonia. LABS and DIAGNOSTICS: CBC - WBC 8.4 k/mm3 (L) Hgb 10.4 Gm/dL (L) Hct 30.3% (L). APTT 33.3 sec (H). CHEM - Sodium 120 mmol/L (L) Potassium 3.3 mmol/L (L) Chloride 83 mmol/L (L) Glucose 165 mg/dL (H) Creatine-Blood 0.3 mg/dL (L) C-Reactive Protein 33.4 mg/dL (H). Chest X-ray - Abnormal. 12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to 10/25/09. LABS and DIAGNOSTICS: RBC 3.31 M/MM3 (L) Neut 90.0% (H) PLT 147 K/MM3 (L) Neut 7.5 K/MM3 (H) Lymph 0.4 K/MM3 (L) Mono 0.0 K/MM3 (L). Arterial Blood Gases - Abnormal. Prealbumin 8.0 MG/DL (L).
CDC Split Type:

Write-up: 10/22/09 fever, cough, SOB: healthy 14 yo sib with clinical H1N1. TAMIFLU began 75 BID. 10/23/09 seen in office & at home resp decompensation admitted to PICU: BiPAP. DNI order. Bilateral severe pneumonia died approx. 1pm 10/25/09. 12/14/09 Death Certificate received. DOD 10/25/09. Cause of death: Pneumonia. Additional information abstracted: Rett Syndrome. 12/14/09 Hospital records received, service dates 10/23/09 to 10/25/09. Assessment: Medically frail with hypovolemia, respiratory distress, ABG concerning for ARDS, likely due to H1N1 infection w/ bacterial superinfection. Patient presents with increasing work of breathing, fever, and cough. O2 Tamiflu at home. Tachypnea. Wheeze, shortness of breath. Crackles, rhonchi, flaring, retractions. Decreased responsiveness. Admitted to ICU. Mechanical ventilation. Edema of feet. Expired. 12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to 10/25/09. Assessment: Pneumonia present on admission, respiratory distress present on admission.


VAERS ID: 370052 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2009-11-10
Onset:2009-11-13
   Days after vaccination:3
Submitted: 2009-11-24
   Days after onset:11
Entered: 2009-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102045P1 / UNK UN / UN
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA285AA / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-23
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Obesity; Diabetes; Hypertension; Schizophrenia. 11/25/09 Hospital records received service dates 11/13//09 to 11/22/09. Diabetes mellitus, hypertension, morbid obesity, paranoid schizoprenia, sleep apnea, GERD, IBS, anal fissure, hyperthyroidism, dysfunctional uterine bleeding / post endometrial oblation, phlebitis left lower extremity, hyperlipidemia, osteoarthritis. Allergies to penicillin, sulfa, Symbicort. Pickwickian syndrome. Smoker. 1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to 11/23/09. Schizophrenia, hypertension, morbid obesity, diabetes mellitus type 2, sleep apnea.
Allergies:
Diagnostic Lab Data: 11/25/09 Hospital records received service dates 11/13//09 to 11/22/09. LABS and DIAGNOSTICS: Pulse Oximetry 79% O2. Chest x-ray - abnormal. Sputum Culture (+) for gram-positive bacillus. Blood cultures (+) for gram-positive cocci, gram positive bacillus. CHEM - Sodium 147 (H), Potassium 3.9 WNL, Chloride 109 (H), bicarbonate 37 (H), glucose 216 (H), BUN 53 (H), Creatinine 1.1 WNL, Albumin 2.3 (L). CBC - WBC 23. (H), Hemoglobin 9.2 (L), Hematocrit 36.5% (L). Urinalysis - RBCs $g50 (H), WBC 3-4 (H). 1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to 11/23/09. LABS and DIAGNOSTICS: CT Angiogram Chest - Abnormal.
CDC Split Type:

Write-up: Admitted to hospital 11/13/09. Expired 11/23/09. Doctor''s note state pt received H1N1 and Seasonal flu vaccine 3 days prior to admission. 11/25/09 Hospital records received service dates 11/13//09 to 11/22/09. Assessment: Pneumonia, diphtheria Patient presents with cough and shortness of breath. Body aches, yellow sputum, right-sided chest pain with deep inspiration. Sore throat. Fever. Intubated and mechanically ventilated. 1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to 11/23/09. Assessment: Severe bilateral pneumonia with adult respiratory distress syndrome. Respiratory failure with hypoxemia, sepsis, diarrhea, acute renal failure, hypernatremia, hypoalbuminemia. Patient seen at ED and diagnosed with pneumonia. Seen at PCP office later that day and admitted to hospital. Intensive care, intubation, ventilator. High fever, hypotension, resusitation. Patient expired.


VAERS ID: 370081 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2009-11-23
Onset:2009-11-23
   Days after vaccination:0
Submitted: 2009-11-25
   Days after onset:2
Entered: 2009-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 100814 5PA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: NO
Preexisting Conditions: None known. 12/7/2009 PCP visits for 9/27 and 10/16/2009, patient dx''d with MS, sx of rt leg weakness. Initially Tx''d with IV Solu-Medrol, now on maintenance meds. Labs from 3/2009 CBC, CMP and UA wnl. No dx studies noted PMH: Asthma, High cholesterol 12/22/09 ED records received. Service dates 11/23/09 to 11/24/09. Chest Pain.
Allergies:
Diagnostic Lab Data: 12/22/09 ED records received. Service dates 11/23/09 to 11/24/09. LABS and DIAGNOSTICS: ECG - Abnormal.
CDC Split Type:

Write-up: Pt went to the gym and died from a heart attack/stroke?? within 24hrs of obtaining H1N1 injection. 12/22/09 ED records received. Service dates 11/23/09 to 11/24/09. Assessment: Cardiac arrest. EMS called because of chest pain, arrested on route to ED. Intubation. Resusitation. Ventricular Fibrillation. Patient presents in cardiac arrest. Radial pulses absent. Pupils fixed and dilated. Skin mottled, clammy, temperature is cool. Pronounced expired


VAERS ID: 370216 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Missouri  
Vaccinated:2009-11-11
Onset:2009-11-12
   Days after vaccination:1
Submitted: 2009-11-25
   Days after onset:13
Entered: 2009-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3264DA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Chest pain, Death
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-12
   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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Family reports that he came into the house from outdoors c/o chest pain and abdominal pain. 11/30/09 Coroner Report Received. DOD 11/12/09. Cause of Death: Probable Myocardial Infarction, due to seasonal flu, with other significant conditions of Diabetes.


VAERS ID: 370257 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2009-10-16
Onset:2009-11-03
   Days after vaccination:18
Submitted: 2009-11-25
   Days after onset:22
Entered: 2009-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP001AA / 1 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Pathology test, Toxicologic test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known.
Preexisting Conditions: Alleged history of seizure disorder.
Allergies:
Diagnostic Lab Data: Toxicology and frozen specimen results are pending.
CDC Split Type:

Write-up: The patient received her H1N1 vaccine at her place of work on October 16, 2009. On 11/3/2009 she died at home. The cause of death is unknown. The autopsy results were unremarkable. Labs and frozen sections are pending. She is alleged to have had a seizure disorder and neurologic records are being subpoenaed by the Coroner.


VAERS ID: 370514 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2009-11-18
Onset:2009-11-19
   Days after vaccination:1
Submitted: 2009-11-24
   Days after onset:5
Entered: 2009-11-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102124P1 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Death, Influenza like illness, Pain, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-20
   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: Atenolol 50 MG 1 qhs; minoxidil 2.5 mg 2 qhs; NEURONTIN 100 mg 1 qhs; COLACE 100 mg 1 BID; MIRALAX 1 scoop q day; NEPHPLEX RX 1 q day; PANCREASE 3 TID with meals; RENVELA 800 mg TID with meals
Current Illness: ESRD
Preexisting Conditions: ESRD; AKA; BKA; Hx CVA; blind; pancreatitis; diabetic; anemia; hypertension 12/2/09 Medical records received w/PMH: on dialysis, Chronic low back pain Allergies: NKDA
Allergies:
Diagnostic Lab Data: WBC, 12.7 bil/L 12/2/09 Medical records received w/Labs: CBC, Hgb, Hct, Lymphs and Monos all low, WBC high, CMP noted Cl low and Creatinine and Glucose high
CDC Split Type:

Write-up: Patient reported to ER 1 day after receiving H1N1 vaccine with "flu like symptoms", "hurting all over". VS and lab stable - treated for lower back pain. Sent home with instructions to report back if problems continue. Patient reported to ER on 11-20-09. Report is not available. Sister states pt. was treated and sent home. Boyfriend discovered pt. dead at home after returning home from store. 12/2/2009 ED record for 11/19/2009 and 11/20/2009 and dialysis records for 11/13, 11/16 and 11/18/2009. Patient presented to ED with c/o''s flu-like sx: "aching and pain all over", no other sx noted. PE was negative. Tx: IM pain meds Morphine and Dilaudid, po Zofran. Dc''d with Rx for Lortab On 11/20/2009 presented to another ED with c/o''s "hurting all over and with c/o''s nausea/vomiting. Tx: Demerol and Vistaril Dc''''d with dx of chronic back pain. Notes state that later on 11/20/2009 patient expired at home. 1/7/2010 Death Certificate received. DOD 1120/09. Cause of Death: Acute Myocardial Infarction. Additional information abstracted: Other Significant Conditions - Diabetes.


VAERS ID: 370596 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2009-11-24
Onset:2009-11-25
   Days after vaccination:1
Submitted: 2009-11-30
   Days after onset:5
Entered: 2009-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP042AA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Death, Malaise, Pyrexia, Somnolence, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Digoxin 250mg QD PO; Geodon 40mg BID PO; ASA 325mg QD PO; Zyrtec 10mg QD PO; Cardizem CD 120mg BID PO; Aricept 5mg QD PO; Flomax 0.4mg QHS PO; Zantac 300mg BID PO; Advair Diskus 500/50 BID Inh.; Spiriva 1 Inh QD; Albuterol Unit Dose Neb. Q4
Current Illness:
Preexisting Conditions: Chronic Illnesses COPD, atrial fib, macular degeneration and incontinence. 12/2/2009 PCP records received, service dates 6/2/09 to 9/4/2009. Progress notes. Past medical history: COPD, Inguinal hernia, Irregular heartbeat, Dementia, Blind, TIA, CVA, Pneumonia, Psychosis, Dyspepsia.
Allergies:
Diagnostic Lab Data: He was pronounced dead at his residence by the coroner and no post mortem workup was done.
CDC Split Type:

Write-up: Wife called home health and said pt wasn''t feeling well, was more drowsy than usual. HH Aide visited at 9:15 AM. He was afebrile and respirations were 36. Skin was cold and clammy. Aide encouraged daughter to take him to ER. Daughter stated she thought he might get to feeling better and that if he didn''t get better or if he seemed worse, she would take him. RN talked to wife later in afternoon around 3:00 PM and wife reported he had eaten some and seemed to be feeling a little better. When his wife went to wake him early Thursday AM , she could not arouse him and she called 911. When they responded the coroner was called. 12/3/09 Death Certificate received. DOD 11/26/09. Final Cause of Death: Myocardial Infarction, NOS & Chronic Pulmonary Disease, Dementia, Stroke (CVA).


VAERS ID: 370733 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2009-11-20
Onset:2009-11-24
   Days after vaccination:4
Submitted: 2009-11-30
   Days after onset:6
Entered: 2009-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3141AA / 4 RL / IM
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP010AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF565AA / 4 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D48928 / 4 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anticonvulsant drug level therapeutic, Blood magnesium, Blood phosphorus, Blood selenium, Blood thyroid stimulating hormone, Blood zinc, Chest X-ray, Death, Differential white blood cell count, Full blood count, Metabolic function test, Prealbumin, Renal function test, Thyroxine free, Vitamin D
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0.00~Patient
Other Medications: APAP with Codeine prn, Diastat prn, Ibuprofen prn, Ativan prn, Kepra, Phenobarbital, Pulmicort Respules, Klonopin, Robinul, Albuterol, Miralax
Current Illness: none
Preexisting Conditions: NKDA, chronic lung disease, s/p GBS meningitis at 7 weeks of age resulting in static encephalopathy, generalized convulsive epilepsy with intractable epilepsy, congenital anomalies of larynx, trachea, & bronchus, feeding difficulties, cerebral palsy. On 9/29/09 he had left hip open reduction, adductor tenotomy, left femoral varus osteotomy and left iliac osteotomy. 12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. PMH: GBS meningitis, SZ disorder, laryngomalacia s/p suprahottoplasty, subluxation of L hip, multiple pneumonias. Allergies: NKDA
Allergies:
Diagnostic Lab Data: CXR AP view 10/2/09, Selenium, Magnesium, Phosphorous, Zinc, CMP, CBC, T4 free, TSH 3rd generation, Vitamin D, phenobarbital, prealbumin on 10/2/09; renal function panel with EGFR, and CBC on 10/8/09; renal function panel with EGFR & CBC on 10/15/09; CMP & CBC with diff on 10/29/09; phenobarital level on 11/6/09. 12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. Lab and DX tests: HR 149-193, BP: 67-122/30-48; BUN/creatinine: 56/2.25; INR 2.3; Culture: gram + cocci.
CDC Split Type:

Write-up: respiratory distress resulting in death 12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. DX: Cardiopulmonary arrest. Pt presented with s/p cardiopulmonary arrest on 11/23/09 with MOF, hypotensive, coarse bs. Kidneys not functioning, coagulopathy, metabolic acidosis. tx: epinephrine, diuretics, vasopressors, bicarbonates, antibiotics. Pt condition worsened despite ICU tx. Pt expired. 12/29/09 Death Certificate Received. DOD 11/24/09. Cause of Death: Methicillin-Resistant Staphylococcus Aureus Pneumonia.


VAERS ID: 370987 (history)  
Form: Version 1.0  
Age: 1.69  
Sex: Male  
Location: Colorado  
Vaccinated:2006-11-22
Onset:2006-11-30
   Days after vaccination:8
Submitted: 2009-11-23
   Days after onset:1089
Entered: 2009-12-01
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0522F / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Blood test, Convulsion, Electroencephalogram, Encephalitis viral, Lumbar puncture, Nuclear magnetic resonance imaging, 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), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-10-07
   Days after onset: 1041
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations: Long lasting crying and lump near shot~DTaP (no brand name)~1~0.00~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: 12/04/09 DC summary for DOS received for DOS 09/09/09 ? 10/07/09. PMH: SZ disorder. Allergies: NKDA
Allergies:
Diagnostic Lab Data: EEG; MRI; Lumbar puncture; Blood work 12/04/09 DC summary for DOS received for DOS 09/09/09 ? 10/07/09. Lab and DX tests: ICP: 40-50; brain biopsy: negative; skin biopsy as part of autopsy.
CDC Split Type:

Write-up: Fever, seizure approximately 8 days after vaccines. Diagnosed with viral encephalitis at hospital. 12/03/09 Vac record received for DOS 11/22/09 12/22/09: Provisional Autopsy report received for date of exam 10/9/09. Findings: Clinical history of seizures; presented with status epilepticus and Influenza A (H1N1) positivity. A. Heavy lungs. B. Clinical hx. of encephalitis and brain herniation. C. Other findings: Heavy heart, pericardial effusion, hepatosplenomegaly. 12/04/09 DC summary for DOS received for DOS 09/09/09 ? 10/07/09. Final DX: Hypoxic ischemic encephalopathy Pt presented with seizure, rigors, tonic-clinic seizures. On neurological exam: febrile seizure, developed blown R pupil, diffuse cerebral edema, increased ICP; tx: hypertonic saline, pentobarbital, Tamiflu, Ativan, Dilantin, Manitol, serum sodium; Pt''s condition worsened and Pt was not responsive. Physician related cerebral edema to H1N1 influenza related encephalitis or metabolic disorders. Pt expired on 10/07/09.


VAERS ID: 371039 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Arizona  
Vaccinated:2009-08-12
Onset:2009-08-13
   Days after vaccination:1
Submitted: 2009-12-02
   Days after onset:111
Entered: 2009-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3301AA / 2 LL / IJ
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39015 / 2 RL / IJ
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1695X / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Loss of consciousness, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-13
   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: None.
Current Illness: None.
Preexisting Conditions: None. 12/3/09 PCP, cardiology consultation, and hospital records received. Service dates 4/1/09 to 8/13/09. Premature - 36 weeks. Jaundice. Benign pulmonary flow murmur, tiny collateral vessel originating from the descending thoracic aorta. Seborrheic dermatitis. Plagiocephaly, decreased upper body strength. Circumcision. Fussy, gas, vomiting, diarrhea.
Allergies:
Diagnostic Lab Data: None. 12/3/09 PCP, cardiology consultation, and hospital records received. Service dates 4/1/09 to 8/13/09. LABS and DIAGNOSTICS: Postmortem Skeletal Survey - No evidence of acute or healing fractures.
CDC Split Type:

Write-up: On August 12, 2009, 11:39 AM, infant had four-month checkup and was found to be well. At 12:00 PM, he was given five immunizations (DTaP/DT, IPV, Hib, PCV7, Rotovirus). The following morning at 8:00 AM (20 hours later), he was found unconscious by his parents. Cardiopulmonary resuscitation was initiated. Emergency medical services found the infant in full code. He was transported to the hospital where he was essentially dead on arrival. 12/10/09 Autopsy report received. Cause of Death: Undetermined. Manner of Death: Undetermined. Additional infomation abstracted: Pathological Diagnosis - Well baby by clinical history. Overlay cannot be excluded. 12/3/09 PCP, cardiology consultation, and hospital records received. Service dates 4/1/09 to 8/13/09. Assessment: Not breathing. Child was sleeping with parents, not breathing this AM. EMS called.


VAERS ID: 371206 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: New York  
Vaccinated:2009-11-24
Onset:2009-12-01
   Days after vaccination:7
Submitted: 2009-12-02
   Days after onset:1
Entered: 2009-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2471AA / 4 RA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UT75AA / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0620Y / 4 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66586 / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac arrest, Death, Resuscitation
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: 2009-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: History of several febrile seizures 1 year ago. Normal EEG then. No seizures since then.
Allergies:
Diagnostic Lab Data: Unsuccessful resuscitation by EMS and Vassar Hospital ER. Was asystolic when EMS arrived.
CDC Split Type:

Write-up: Unexpected death. Patient was asymptomatic except for skipping lunch. Took his usual afternoon nap but expired during sleep. Autopsy today did not reveal a cause. 01/07/2010. Autopsy received. DOD 1201/2009. Cause of Death: 1. Undetermined. Manner of Death: Undetermined. Additional Information Abstracted: I. [History of Febrile Seizures]: Cerebral Edema and Congestion. II. Pulmonary Edema and Congestion. II. Postmortem Toxicology Results: A. Blood: 1. Atropine = 870 NG/ML. B. Vitreous Humor: 1. Sodium = 137 MEQ/L. 2. Potassium = 17.8 MEQ/L. 3. Chloride = Creatinine = 0.8 MG/DL. 5. Urea Nitrogen = 7 MG/DL. 6. Glucose = <20 MG/DL.


VAERS ID: 371498 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: Nevada  
Vaccinated:2009-10-28
Onset:0000-00-00
Submitted: 2009-11-12
Entered: 2009-12-04
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP005AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death, Diabetes mellitus, Myocardial infarction
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-09
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: Diabetic; had a pacemaker; other but unk
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unk. Pt. deceased unattended. 11/23/09 Sheriff officer said her doctor ruled heart attack and diabetes as cause of death. 12/10/09 Coroner''s report received. Pronounced dead 11/09/09. Died of Natural Causes related to diabetes, irregular heart rate - had pacemaker, COPD - asthma, high blood pressure, thyroid disease, reflux disease, arthritis. 12/16/09 Death Certificate received. DOD 11/09/09. Cause of Death: Cardiopulmonary Arrest, Chronic Obstructive Pulmonary Disease, Hypertension, Diabetes.


VAERS ID: 371508 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Unknown  
Vaccinated:2006-01-04
Onset:2006-05-29
   Days after vaccination:145
Submitted: 2009-11-23
   Days after onset:1274
Entered: 2009-12-04
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood HIV RNA increased, CD4 lymphocytes, CD4 lymphocytes increased, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-29
   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: None.
Current Illness:
Preexisting Conditions: HIV infection. The participant was not hospitalized during the study.
Allergies:
Diagnostic Lab Data: 12/28/2005: HIV viral load: greater than 227,000 copies/mL. 02/01/2006: CD4 cell count: 2,724 cells/mm^3.
CDC Split Type:

Write-up: The subject was a 3-year-old, HIV-infected enrolled in a study on 03/04/2006. The subject reportedly expired and the date of death is unknown. On 12/28/2005, the subject''s HIV viral load was greater than 227,000 copies/mL. On 02/01/2006, the subject''s CD4 cell count was 2,724 cells/mm^3. On 01/04/2006, 01/18/2006, and 02/28/2006, the subject received the study agent, Pneumococcal 7-valent Conjugate Vaccine. The participant was last seen at the clinic for the week 8 study visit on 02/28/2006. On 05/12/2006, telephonic contact was attempted with the participant''s mother on numerous occasions but none of these attempts were successful and eventually the cell phone number was not in use any longer. A formal letter requesting the participant to come to the clinic was sent to the participant''s home: however this also did not yield any response. On 03/18/2009, one of the study nurses telephonically contacted the subject''s mother. She was very rude and said the her child had died and that the site should never attempted to contact her again. She then hung up the phone without providing any further information regarding the cause or date of death. Please note that the participant''s death is considered unconfirmed as the mother did not come to the clinic to provide further details. This death has also not been confirmed at the Death Registry. The agency has been informed of this case and has allowed Independent Committee to review it. Note that discovery of this case was the result of a request of the study team to actively pursue these lost to follow-up. It is not expected that further information on the cause will be found. The site Principal investigator has assessed the event of presumed death, unconfirmed, as probably not related to the study agent, Pneumococcal 7-valent Conjugated Vaccine. The Medical Officer has assessed the event of presumed death, unconfirmed, as not related to the study agent, Pneumococcal 7-valent Conjugated Vaccine.


VAERS ID: 372029 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Washington  
Vaccinated:2009-11-20
Onset:2009-11-21
   Days after vaccination:1
Submitted: 2009-12-02
   Days after onset:11
Entered: 2009-12-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 10127806 / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOZARIL; glyburide; metformin; ACTOS; enalapril; atenolol; NEURONTIN
Current Illness: Pt denied.
Preexisting Conditions: Schizophrenia; DM
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine administered 11/20/09. Found deceased unknown cause 11/21/09.


VAERS ID: 372134 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-12-03
Onset:2009-12-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2009-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3273AA / 5 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Body temperature increased, Chest X-ray, Death, Respiratory arrest, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-04
   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: Multiple meds
Current Illness: Persistent vegtv state
Preexisting Conditions: Cerebral contus.; deep coma; chronic infiltrates; pneumonia
Allergies:
Diagnostic Lab Data: 10/7/09 CXR
CDC Split Type:

Write-up: 12/03/09 Temp. 98.9-Flu vaccine given (Influenza) on 7-3 shift. 8:45 PM 12/3/09 Temp. 102.9, pulse 145-Dr. notified-CIPRO 500 mg via GT given as an order BID. Change to ROCEPHIN 1 gm IM x 7 days, TYLENOL given, cold compresses. 12:20 AM 12/04/09 resident ceased to breathe. 12/9/2009 Death certificate received. DOD 12/4/09. Cause of Death: Pneumonia. Traumatic Encephalopathy.


VAERS ID: 372288 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: California  
Vaccinated:2009-12-01
Onset:2009-12-01
   Days after vaccination:0
Submitted: 2009-12-07
   Days after onset:6
Entered: 2009-12-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97843P1 / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Body temperature increased, Death, Dyspnoea, Hospice care, Immediate post-injection reaction, Parkinsonism
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Numerous pain, anxiety and Parkinsons rx.
Current Illness:
Preexisting Conditions: NKDA; End Stage Parkinson''s
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine given 12/1 at 10:30 AM. Pt immediately reacted with increased temp and SOB. BENADRYL given 25mg stat and q 8 hours. Pt alert/oriented. 12/2 At 1:55 AM, pt temp 102.7, TYLENOL given. 12/3 Temp 99, pulse 110 at 1000 AM, oriented to self only. 12/4 At 0500 pt died. * Pt on hospice; dx: Parkinson''s. 12/9/09 Death certificate received. DOD 12/4/2009. Cause of death: Respiratory Failure. Cardiac Failure. Parkinsons Disease.


VAERS ID: 372790 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: Unknown  
Vaccinated:2009-11-18
Onset:2009-11-30
   Days after vaccination:12
Submitted: 2009-12-11
   Days after onset:11
Entered: 2009-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Caesarean section, Death, Drug exposure during pregnancy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-30
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/30/09 ED records summary received. Service date 11/30/09. LABS and DIAGNOSTICS: Ultrasound to abdomen. 1/6/09 ED records received. Service date 11/30/09. LABS and DIAGNOSTICS: ECG - Abnormal.
CDC Split Type: MA20095712

Write-up: We received via agency, and Norvartis Pharmaceuticals, from a healthcare professional the following information on 01 DEC 2009: A 34-year-old female patient, born on 01 SEP 1975, pregnant for the third time in 27 weeks gestation, was vaccinated i.m. with seasonal FLUVIRIN, batch no. unknown) on 18 NOV 2009. The patient was also vaccinated with pandemic FLUVIRIN (batch no. unknown) on the same day (please see MA2009-5711 for reference). The patient also had a medical history of blighted ovum. On 30 NOV 2009 the patient collapsed and died on 30 NOV 2009. Autopsy was pending at time of report. A male male infant was delivered by C-section. Agency Ref. no: NA09-008971. Norvartis Pharmaceuticals ref. no.: S2009US27919. 12/30/09 ED records summary received. Service date 11/30/09. Assessment: Collapsed, unresponsive, asystolic rhythm. EMS found patient unresponsive, collapsed on floor, in asystolic rhythm. Presented at ED unresponsive, no spontaneous respirations, asystolic rhythm. Cental cyanosis, prior intubation, oxygen, epinephrine. Fixed dilated pupils, no corneal reflex. Pale. No spontaneous cardiac sounds. Fetal heart tones noted. Emergency C-Section, premature infant delivered and resusitated. 1/6/09 ED records received. Service date 11/30/09. Assessment: Cardiac arrest, expired. Pregnant patient arrived in full cardiac arrest. Asystole/Pulseless. Reflexes absent. Emergency low transverse cesarean. Male fetus delivered.


VAERS ID: 373122 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2009-11-25
Onset:0000-00-00
Submitted: 2009-12-14
Entered: 2009-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500829P / 1 NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Smoking; Cardiac condition
Preexisting Conditions: Per patient''s co-worker, patient has hx of smoking and cardiac condition. 12/16/09 PCP medical records received. Service dates 3/8/08 to 11/18/08. Cough, shortness of breath, low back pain, dizziness, essential hypertension, atherosclerosis, anxiety. Alcohol dependence, alcoholic gastritis, chronic insomnia, depression, erectile dysfunction, hip pain, loss of weight.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Notified by patient''s co-worker that patient had passed away. 12/15/09 Death Certificate received. DOD 12/08/2009. Cause of Death: Myocardial Infaction. Atherosclerotic Coronary Vascular Disease.


VAERS ID: 373189 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: New York  
Vaccinated:2008-09-16
Onset:0000-00-00
Submitted: 2009-12-11
Entered: 2009-12-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3355AA / 1 UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Varicella post vaccine
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-28
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: Medical history included HIV. The patient had received VARIVAX on 20 August 2008 and subsequently developed chickenpox.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200905439

Write-up: Initial case received from a health care professional on 10 December 2009. An 11-year-old male patient developed chickenpox and died after receiving ADACEL (lot not reported) and VARIVAX (Merck, lot number 0630X410). The patient, who was HIV positive, received VARIVAX on 20 August 2008 and developed chickenpox (start date reported as August 2008). On 16 September 2008 he received ADACEL, and developed chickenpox again. He was seen in his physician''s office on 28 November 2008 and was admitted to the hospital at that time. He later died (date of death not reported). No additional information was reported. Documents held by sender: None.


VAERS ID: 373314 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-14
Entered: 2009-12-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA00907

Write-up: Information has been received from a consumer who saw a report on the internet about a 23 year old patient who was vaccinated with 3 doses of GARDASIL. Subsequently the patient died, the cause of the death was unknown. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 373315 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-14
Entered: 2009-12-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA01166

Write-up: Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of GARDASIL (dates were not reported). Subsequently the patients died, the cause of death was unknown. This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients. Additional information has been requested.


VAERS ID: 373347 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-15
Entered: 2009-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Blood product transfusion, Cerebral haemorrhage, Condition aggravated, Death, Diarrhoea haemorrhagic, Glomerulonephritis, Lung neoplasm, Purpura, Skin ulcer, Vasculitis cerebral
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (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: cyclophosphamide; MEPREDNISONE; azathioprine; methotrexate; corticosteroid; gusperimus
Current Illness: Glomerulonephritis; vasculitis; WEGENER''S Granulomatosis
Preexisting Conditions: Crescentic glomerulonephritis; hematuria; proteinuria
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0607925A

Write-up: This case was reported in a literature article and described the occurrence of fatal exacerbation of glomerulonephritis in an adult male subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). At the age of 12 years, the subject was diagnosed with PR3-ANCA-associated glomerulonephritis due to Wegener''s granulomatosis. He was treated with CYCLOPHOSPHAMIDE, METHYLPREDNISONE and AZATHIOPRINE. During the follow-up from 1999 to 2004, the subject suffered from several relapses that were treated with CYCLOPHOSPHAMIDE or METHOTREXATE in combination with CORTICOSTEROIDS. In 2004, the subject developed a biopsy-proven renal relapse. DEOXYSPERIGUALIN, an antiproliferative drug with effects on lymphocytes and macrophage function and neutrophil production, was started in combination with high doses of steroids. During the 1st three cycles, a partial remission was induced. Because hematuria and proteinuria persisted, the kidney was re-biopsied and showed persistently active glomerulonephritis with new necrotizing and and crescentic lesions. The 4th and 5th cycles went uncomplicated. In the 6th cycle, the subject received unspecified dose of Influenza virus vaccine (unknown route and injection site), lot number not provided. Shortly after vaccination, a severe relapse occurred with purpura, arthralgias, new nodular lung lesions and active glomerulonephritis. DEOXYSPERGUALIN was stopped and MYCOPHENOLATE MOFETIL in combination with high-dose CORTICOSTEROIDS and plasma exchange was given. Despite this therapy, the subject developed a severe ulceration of the legs, abdominal pain with bloody diarrhea and intercerebral haemorrhage due to cerebral vasculitis, resulting in death. The vaccination was done while the subject had an active glomerulonephritis suggestion that activation of the vasculitic process after influenza vaccination was caused by so-called bystander activation in which the vaccination resulted in activation of antigen presenting cells expressing the autoantigen proteinase 3. The author considered the events were possibly related to vaccination with Influenza virus vaccine. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 373484 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Michigan  
Vaccinated:2009-10-23
Onset:2009-10-28
   Days after vaccination:5
Submitted: 2009-12-10
   Days after onset:43
Entered: 2009-12-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 007AA / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-01
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pulmonary hypertension; Ulcerative colitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: H1N1 injection administered on 10.23.09. Patient became ill 5 days later with pneumonia. History of pulmonary hypertension. PICU.


VAERS ID: 373547 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-12-03
Onset:2009-12-04
   Days after vaccination:1
Submitted: 2009-12-16
   Days after onset:12
Entered: 2009-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500804P / 1 NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Laboratory test, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-06
   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: Unknown.
Current Illness: Screening questions were asked prior to vaccination by school nurse, screener, and vaccinator and no illness reported.
Preexisting Conditions: Birth Defect: Spina Bifida. 12/17/09 PCP past medical records received. Service dates 9/27/99 to 10/25/07 History of spina bifida, paraplegia, wheelchair use. Decubitis ulcer. UTI. Hyperlipidemia. Hearing deficit, tinnitus. Sinus infection. URI. Allergy to Bactrim. Epigastric pain. Headache.
Allergies:
Diagnostic Lab Data: Autopsy performed. Cause of death pending results of various labs sent out.
CDC Split Type:

Write-up: Per co-workers, patient reported "not feeling well" on 12/04/09. 12/29/09 Autopsy received. DOD 12/06/2009. Cause of Death: Long-term Sequelae of Spina Bifida. Additional information abstracted: Contributory - Associated Chronic and Acute Urinary Tract Infection. Summary of Autopsy Findings: I. Spina bifida - A. Large puckered lower lumbar scar. B. Chronic lower extremity atrophy with bilateral foot deformities. C. Indurated scars and large scarring - buttock and legs. D. Chronic and acute urinary tract infections. E. Posterior absence of corpus callosum. F. Ventriculoperitoneal shunt. G. Congested, dusky leptomeninges with associated cerebral edema. II. Other findings - A. Moderate atherosclerotic coronary artery disease. B. Minimal to moderate cardiac hypertophy. C. Acute visceral adhesions. D. Old abdominal adhesions. E. Status-post cholecystectomy.


VAERS ID: 373588 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-15
Entered: 2009-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA01512

Write-up: Information has been received from a female consumer concerning her child who "over 10 years ago" was vaccinated with a dose of MMR II. The patient died after being given the vaccine. No further information is available.


VAERS ID: 373830 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-10-12
Onset:2009-10-17
   Days after vaccination:5
Submitted: 2009-12-11
   Days after onset:55
Entered: 2009-12-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3386AA / 1 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB730AA / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D81704 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 03184 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Death, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 35 wk. preemie, NICU x5 days
Allergies:
Diagnostic Lab Data: Results of autopsy not available. 12/17/09 ED record received. Service date 10/17/09. LABS and DIAGNOSTICS: EKG - Abnormal, asystole.
CDC Split Type:

Write-up: Patient seen for well visit/immunized on 10/12/09. No problems found. Child found unresponsive in crib on 10/17/09 & taken to ER. CPR unsuccessful. 12/17/09 ED record received. Service date 10/17/09. Assessment: SIDS, Suffocation. Mother fell asleep in bed with baby. Awoke to find baby unresponsive. Patient presents unresponsive, no spontaneous respirations, no pulse. Vomitus, blood, in airway. Purple color. Resusitation attempted, intubation.


VAERS ID: 373905 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2009-11-02
Onset:2009-11-18
   Days after vaccination:16
Submitted: 2009-12-16
   Days after onset:28
Entered: 2009-12-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP 008AA / 1 RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Chest pain, Death, Myocardial infarction, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-18
   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: Cholesterol med.
Current Illness: None
Preexisting Conditions: Hyperlipidemia; Hypertension; Hypothyroidism. 12/21/09 ER records received, service date 11/18/09. Kidney stones - lithotripsy. Hypothyroidism. High cholesterol. Allergy to iodine. 12/24/09 PCP medical notes received. Prior hx of palpitations, chest pain, headache, dizziness, blackouts.
Allergies:
Diagnostic Lab Data: None. 12/21/09 ER records received, service date 11/18/09. LABS and DIAGNOSTIS: ECG - Abnormal. CHEM - Glucose 342 MG/DL (H) Creatinine 1.8 MG/DL (H) GFR 43.02 (L) Potassium 3.0 MMOL/L (L) CO2 19.9 MMOL/L (L) AST 561 U/L (H) ALT 748 U/L (H) Total Protein 5.2 G/DL (L) Albumin 2.7 G/DL (L). Prothrombin Time 16.1 sec (H). CBC - RBC 3.94 M/UL (L) HGB 12.6 G/DL (L) HCT 37.2% (L) MCH 32.1 (H) PLT Count 130 K/UL (L) Seg Neut 10% (L) Lymph 75% (H) Basophil 1.0% (H) Bands 4% (H) Anisocytosis slight, Giant Platelets present.
CDC Split Type:

Write-up: Pt. had c/o chest pain x 1 d. Approx. 4 pm on 11/18/09, pt collapsed in parking lot at MD office. Resuscitation attempted at office, during EMS transport and hospital. Pt. died of MI. 12/21/09 Death Certificate received. DOD 11/18/09. Cause of death: Myocardial infarct due to High Cholesterol, Hypertension, Hypothyroidism. Additional information abstracted: Had c/o of chest pain at doctor''s office, nurse found in cardiac arrest. EMS upon arrival found patient pulseless and apneic, CPR being performed. Resusitation including IV meds and defibrillation. Transported to hospital. 12/21/09 ER records received, service date 11/18/09. Assessment: Cardiopulmonary resusitation unsuccessful. Patient had C/O of chest pain. Found unresponsive, no respirations, no pulse, cyanotic, pupils fixed and dilated.


VAERS ID: 374023 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Arizona  
Vaccinated:2009-11-05
Onset:2009-12-05
   Days after vaccination:30
Submitted: 2009-12-17
   Days after onset:12
Entered: 2009-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP019AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death, Pneumonia viral, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-16
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown. 12/23/09 Discharge Summary, hospital records received. Service dates 12/11/2009. Depression, arthritis. Degenerative joint disease. Hysterectomy, breast reduction surgery.
Allergies:
Diagnostic Lab Data: 12/23/09 Discharge summary, hospital records received. Service dates 12/5/09 to 12/11/09. LABS and DIAGNOSTICS: CAT Scan Chest - Abnormal. Chest X-ray - Abnormal. Echocardiogram - Abnormal. CBC - WBC 19.4 K/UL (H) RBC 3.39 M/UL (L) HGB 10.9 G/DL (L) HCT 32.2% (L) MCH 32.1 PG (H)Neutrophils 92.0% (H) Lymphs 6.3% (L) Monos 1.0% (L). Creatine Kinase 136 U/L (H). CHEM - Glucose 119 MG/DL (H) BUN 22 MG/DL (H) Protein Total 5.4 GM/DL (L) Albumin 1.8 GM/DL (L) ALP 131 U/L (H) AST 77 U/L (H) Chlorine 113 MMOL/L (H). Complement C3 65 MG/DL (L). NT-PROBNP 3340 pgmL (H). Arterial Blood Gases Abnormal. Urinalysis - Protein (1+) RBCs 2 (H) WBC 13 (H) Squamous Epithelial Cells few (H). Urine Bacteria - E. coli. 12/23/09 Discharge Summary, hospital records received. Service dates 12/11/2009. LABS and DIAGNOSTICS:CBC - WBC 14.6 1000/uL (H) Platelets 142 100C/uL (L). Creatinine 2.1 mg/dL (H). Glucose 25 mg/dL (L). ALT 1222 U/L (H) AST 4210 (H). C-Reactive Protein 13.3 mg/dL (H). LDH 6637 IU/L (H). Magnesium 3.1 mg/dL (H) Phosphorus 8.5 mg/dL (H). Plasma Hemoglobin 17.8 mg/dL (H). D-Dimer $g20 (H) Prothrombin Time 97.8 Sec (Abnormally High) INR 11.7 (Very Abnormally High) Partial Thrombolastin 101.1 Sec (Abnormally High).
CDC Split Type:

Write-up: Client admitted to hospital for respiratory symptoms. Diagnosis - pneumonia - diagnosed with viral pneumonia. Cause or type unknown at time of death. 12/23/09 Discharge summary, hospital records received. Service dates 12/5/09 to 12/11/09. Assessment: Bilateral extensive pneumonia/acute respiratory distress syndrome. Acute hypoxia, respiratory failure. Anxiety/depression. Chronic anemia. Pulmonary hypertension. Right ventricular dysfunction. Patient developed acute onset of fevers, chills, shortness of breath, productive cough. Decreased breath sounds. Patient admitted to ICU. On ventilator. Acute renal failure. Discharged to higher level facility. 12/23/09 Discharge Summary, hospital records received. Service dates 12/11/2009. Assessment: ARDS, multiorgan failure, thrombocytopenia, multiple arterial and deep venous clots right upper and left upper extremities, right-sided pneumothorax, hemodynamic instability, possible heparin-induced thrombocytopenia. Patient transferred from another facility intubated with left lower lobe pneumonia. Small pupils, nonreactive. Crackles left chest. Hypotension. Bladder infection. Developed shock liver and acute renal failure with oliguria. Patient expired.


VAERS ID: 374073 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:2009-12-16
Onset:2009-12-18
   Days after vaccination:2
Submitted: 2009-12-18
   Days after onset:0
Entered: 2009-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 102042P1 / 1 LA / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3366AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Death, Nausea, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-18
   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: Novologmix 70/30 insulin 35 u am 15 u pm
Current Illness: Pharyngitis Rx Z pack. 12/24/09 PCP records received. Service dates 12/9/08 to 12/16/09. On day of immunization diabetic patient c/o ''sugar is up'', thrush in throat.
Preexisting Conditions: diabetes. 12/24/09 PCP records received. Service dates 12/9/08 to 12/16/09. Depressed, multiple drug overdose, traumatic stress disorder. Hysterectomy, diabetes, migraine headaches, neuropathy of lower extremities.
Allergies:
Diagnostic Lab Data: 12/23/09 ED records and Hospital Record of Death received. Service date 12/18/09. LABS and DIAGNOSTICS: EKG - Abnormal. CBC - WBC 15.4 K/mm3 (H) Neutrophils 23.7% (L) Lymphocytes 70.7% (H) Lymphocytes 10.9 k/mm3 (H). CHEM - Glucose 450 mg/dl (H) Total Protein 4.4 g/dl (L) Albumin 2.4 g/dl (L) AST 165 IU/L (H) ALT 160 IU/L (H). Brain Natriuretic 200 pg/ml (H).
CDC Split Type:

Write-up: Nausea/vomiting became unresponsive went into cardiopulmonary arrest and died - was unable to be resuscitated by emergency department staff.


VAERS ID: 374336 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-18
Entered: 2009-12-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Varicella post vaccine
SMQs:, Opportunistic infections (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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA01977

Write-up: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (route and lot # unknown). On an unspecified date the patient developed varicella lesions after receiving the vaccine. The patient was hospitalized in and on an unspecified date the patient died. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 374643 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Female  
Location: Michigan  
Vaccinated:2009-12-14
Onset:2009-12-15
   Days after vaccination:1
Submitted: 2009-12-22
   Days after onset:7
Entered: 2009-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3083AA / 4 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF730AA / 4 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66586 / 4 RL / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Yes, runny nose, no fever
Preexisting Conditions: Blindness r/t optic nerve hypoplasia. Possible DeMosier''s Syndrome. (MRI scheduled, not done at time of death) Developmental delay.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death, SIDS


VAERS ID: 374649 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Iowa  
Vaccinated:2009-12-16
Onset:2009-12-16
   Days after vaccination:0
Submitted: 2009-12-21
   Days after onset:5
Entered: 2009-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP051AA / 1 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Blood culture positive, Cardiac arrest, Death, Diarrhoea, Endotracheal intubation, Meningococcal infection, Mental status changes, Pyrexia, Rash, Streptococcus identification test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-12-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Runny nose
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Rapid Strep Test - Negative; Blood Cultures - Neisseria Meningitidis. 12/31/09 ED consultation records received. Service date 12/17/09. LABS and DIAGNOSTICS: Blood Gases - Abnormal. Lactate 12.0 mmol/L (H). CHEM - Creatinine 1.4 mg/dL (H) Postassium 3.4 mmol/L (L) Anion Gap 26 mmol/L (H) Glucose 133 mg/dL (H) Calcium 7.2 mg/dL (H). CBC - WBC 4.8 x10e/uL (L) HGB 10.4 g/dL (L) HCT 31.7% (L) Platelets 12.0 x10e3/uL (L) Mono# 0.0 x10e3/uL (L) Anisocytosis slight, Microcytosis slight. Chest X-ray - Abnormal. ECG Abnormal.
CDC Split Type: IA090030

Write-up: 12/16 2130. Presented to ED 12/16 with fever 104.8. Treated with TYLENOL and discharged to home. Returned to ED on 12/17-0615 - altered Mental Status, diarrhea, Rash, T 99.8 - Cardiac arrest - Intubation, code Meds, ROCEPHIN, Vancomycin, acyclovir. Transferred. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. /ksk 12/31/09 ED consultation records received. Service date 12/17/09. Assessment: Thrombocytopenia, purpuric rash, cardiopulmonary respiratory arrest, shock with septic and hypovolemic metabolic acidosis, hematemesis, screen for meningococcemia. Child presented to the ED the previous evening with a temperature of 104.8 F was medicated for fever and discharged. This AM presents with a purpuric rash all extremities. Diarrhea, lethargic. Decreased level of consciousness. Intubated and attempted to stabilize for air transport. Abdominal distention. Blood-tinged mucus fluid from nose and mouth. Full CPR. Pulseless electrical activity.


VAERS ID: 374692 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: New York  
Vaccinated:2009-12-11
Onset:2009-12-18
   Days after vaccination:7
Submitted: 2009-12-22
   Days after onset:4
Entered: 2009-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP0068A / 2 LA / UN

Administered by: Other       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-18
   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. ``` albuterol.
Current Illness: None
Preexisting Conditions: None.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Heart stop beating, past away.


VAERS ID: 375144 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2009-12-23
Onset:2009-12-27
   Days after vaccination:4
Submitted: 2009-12-28
   Days after onset:1
Entered: 2009-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102131P1 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dizziness, Malaise, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: sick sinus syndrome,coronary artery disease, type 2 diabetes, hyperlipidemia, chronic anemia, hypertension,
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Resident complained of being dizzy and not feeling well, went unresponsive and passed away at 9:30 PM. Resident was a comfort care only resident no medical attention was necessary. 01/12/2010 Death Certificate received. DOD 12/27/09. Cause of Death: Congestive Heart Failure as a consequence of CAD. Additional information abstracted: Contributing factors - Diabetes mellitus.


VAERS ID: 375507 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Maryland  
Vaccinated:2009-12-09
Onset:2009-12-10
   Days after vaccination:1
Submitted: 2009-12-30
   Days after onset:20
Entered: 2009-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP008AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; ENALAPRIL; GLYBURIDE; VIAGRA; METOPROLOL; SIMVASTATIN; VIT D
Current Illness: Congestion; Sneezing.
Preexisting Conditions: Allergies: coated aspirin; history of diabetes - type II; coronary artery disease; HASCVD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported cold-like symptoms (congestion and sneezing) and was seen for that and for blood in his semen. He was given H1N1 vaccine and was released. The next morning he was found dead of a suspected heart attack.


VAERS ID: 375527 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Illinois  
Vaccinated:2009-12-04
Onset:2009-12-11
   Days after vaccination:7
Submitted: 2009-12-30
   Days after onset:19
Entered: 2009-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 10127803 / UNK LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Blood product transfusion, Electromyogram abnormal, Endotracheal intubation, Fatigue, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies abnormal, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-31
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unfortunately the vaccination took place at an outside facility, and information regarding the vaccine and lot number has not been available. Medications prior to admission on 12/13/09 include: alendronate carbidopa-levodopa diltiazem enta
Current Illness: Parkinson''s disease, atrial fibrillation, neurogenic bladder, Ig A deficiency
Preexisting Conditions: Penicillins - rash Blood products that contain E antigen - transfusion reaction/hemolysis since the patient has alloantibody anti-E.
Allergies:
Diagnostic Lab Data: EMG / NCV from 12/17/09: Impression: Findings are abnormal, widespread, consisting of segmental demyelination, distal and proximal conduction blocks-a pattern typically seen in Guillain Barre Syndrome
CDC Split Type:

Write-up: Patient presented to the emergency department on 12/13/09 with 2-3 days of fatigue and lower extremity weakness. The patient was admitted to the hospital and experienced progressive ascending paralysis with subsequent respiratory distress which required intubation on 12/15/09. Per the immunology physicians note on 12/17, diagnosis was Acute Inflammatory Demyelinating neuropathy consistent with Guillain-Barre Syndrome. The patient received a course of five plasmapheresis treatments, followed by one treatment of IVIG.


VAERS ID: 376066 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Arizona  
Vaccinated:2009-12-12
Onset:2009-12-14
   Days after vaccination:2
Submitted: 2010-01-06
   Days after onset:23
Entered: 2010-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102133P1 / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Dyspnoea, Endotracheal intubation, Gastrostomy, Plasmapheresis, Renal failure acute
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (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 (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-09
   Days after onset: 26
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA, Diabetes, HTN, Hx CVA.
Allergies:
Diagnostic Lab Data: LABS and DIAGNOSTICS: Troponin - Elevated. Chest X-Ray - Abnormal. ECG - Abnormal. CT Head - Abnormal. CT Thorax - Abnormal. EEG - Abnormal. CBC - WBC 17.5 K/MM3 (H) RBC 3.76 K/MM3 (L) HGB 11.2 g/dL (L) HCT 33.4% (L) Segs 88% (H) Lymphs 5% (L) Neut# 15.4 X10^9/L (H). CHEM - Glucose 182 mg/dL (H) BUN 34 mg/dL (H) Creatinine 0.55 mg/dL (L) BUN/Creat Ratio 62 (H) Potassium 3.0 mmol/L (L) Albumin 2.5 g/dL (L) Alb/Glob Ratio 0.7 (L). Arterial Blood Gases - Abnormal. Sputum Culture (+) for Alpha Hemolytic Streptococci. Sputum Gram stain (+) for Gram Positive Cocci and Gram Negative Rods. Vancomycin-Trough 27.8 ug/mL (H).
CDC Split Type:

Write-up: Weakness, Shortness of breath, elevated troponins, acute renal failure - Diagnosis per neurology Guillane Barre 2'' vaccination? - Patient received plasmaphoresis x5 days, required intubation and subsequent trach and PEG and discharge to SNF.


VAERS ID: 376078 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Virginia  
Vaccinated:2009-12-22
Onset:2009-12-24
   Days after vaccination:2
Submitted: 2010-01-04
   Days after onset:11
Entered: 2010-01-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3501AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1274Y / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D65510 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cough, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Mild URI
Preexisting Conditions: 36 wk. premature infant; hx RDS; jaundice at birth
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child seen in office 12/22/09, side visit - cough; congested no fever. Child behind on immunizations, had only had 1 Hep B. Immunizations given at this visit, no other contact from parent until 12/28/09 - parent called office to inform us of death of child.


VAERS ID: 376329 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Georgia  
Vaccinated:2009-11-11
Onset:2009-11-14
   Days after vaccination:3
Submitted: 2010-01-08
   Days after onset:55
Entered: 2010-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP004AA / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Caesarean section, Death, Drug exposure during pregnancy, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-15
   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:
Current Illness: No
Preexisting Conditions: PT was 38wks 3days pregnant. Pt was morbidly obese and was diagnosed with Pregnancy Induced Hypertension.
Allergies:
Diagnostic Lab Data: Autopsy performed
CDC Split Type:

Write-up: Pt died of Hemorrhagic shock within minutes of non-emergent c/section.


VAERS ID: 376388 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2009-10-21
Onset:0000-00-00
Submitted: 2010-01-07
Entered: 2010-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500756P / UNK NS / IN

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Fatigue, Influenza like illness, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron pills; Prenatal vitamins; Lisinopril
Current Illness: INFLUENZA
Preexisting Conditions: Iron deficiency anemia; Dysfunctional uterine bleeding; Hypertension.
Allergies:
Diagnostic Lab Data: No autopsy performed, apparently no recent influenza tests performed.
CDC Split Type:

Write-up: Seen in clinic 10/21/09 with cough, congestion, and "feels hot". Prescribed TAMIFLU on 10/21/09 and given intranasal H1N1 vaccine on 10/21. Subsequently apparently had flu-like symptoms and tiredness for unspecified period of time and apparently found unresponsive in home. Resuscitation unsuccessful.


VAERS ID: 376499 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2009-12-14
Onset:2009-12-17
   Days after vaccination:3
Submitted: 2010-01-11
   Days after onset:25
Entered: 2010-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP050AA / 1 LA / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR U3377AA / 2 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF457AA / 1 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown.
Allergies:
Diagnostic Lab Data: unknown.
CDC Split Type: ND0938

Write-up: Unknown if symptoms occured following vaccination but patient passed away 3 days later.


VAERS ID: 376710 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Male  
Location: New York  
Vaccinated:2010-01-08
Onset:2010-01-11
   Days after vaccination:3
Submitted: 2010-01-12
   Days after onset:1
Entered: 2010-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3431AA / UNK UN / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3167FA / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39016 / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Death, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: According to mother, mom called office stated that she walked into baby room he was unresponsive, she called EMS and baby was taken to local ER where he was pronounced dead. Have not spoken to mother, she called office and spoke with nurse.


VAERS ID: 376969 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:2010-01-06
Onset:2010-01-09
   Days after vaccination:3
Submitted: 2010-01-14
   Days after onset:5
Entered: 2010-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP035BA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Coagulopathy, Death, Drug interaction, International normalised ratio increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-11
   Days after onset: 2
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: COUMADIN
Current Illness: NonHodgkins Lymphoma
Preexisting Conditions: lymphoma; chronic DVT
Allergies:
Diagnostic Lab Data: Increased INR
CDC Split Type:

Write-up: Suspect H1N1 caused interaction with COUMADIN/coagulation.


VAERS ID: 376990 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2010-01-08
Onset:2010-01-10
   Days after vaccination:2
Submitted: 2010-01-14
   Days after onset:4
Entered: 2010-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 500805P / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: unknown


VAERS ID: 377459 (history)  
Form: Version 1.0  
Age: 1.69  
Sex: Male  
Location: Colorado  
Vaccinated:2009-12-29
Onset:2009-12-31
   Days after vaccination:2
Submitted: 2010-01-20
   Days after onset:20
Entered: 2010-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UT030EA / 2 LL / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Autopsy, Brain death, Death, Life support, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: Seizure~Pneumo (Prevnar)~3~0.50~Patient|Seizure~Influenza (Seasonal) (Fluzone)~1~0.50~Patient|Seizure~DTaP + IPV + Hib (Pentacel
Other Medications:
Current Illness: Some preceding gastroenteritis in the couple weeks prior to immunization. O/W no known significant illnesses.
Preexisting Conditions: Very serious neurological syndrome (Dravet''s Syndrome) involving intractable poorly controlled frequent seizures and poor prognosis. (Dx had been confirmed by DNA Probe).
Allergies:
Diagnostic Lab Data: Prelim autopsy results inconclusive for cause of death. Tentative dx is SUDEp. (Sudden Unexpected Death of Epilepsy).
CDC Split Type:

Write-up: DEATH. (Toddler was napping in crib during day. Parent found child in full arrest. (Unclear if he''d be seizing prior.) CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.


VAERS ID: 377577 (history)  
Form: Version 1.0  
Age: 1.83  
Sex: Male  
Location: D.C.  
Vaccinated:2009-10-19
Onset:2009-10-20
   Days after vaccination:1
Submitted: 2010-01-20
   Days after onset:92
Entered: 2010-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR U3211AA / 3 LL / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time prolonged, Autopsy, Bacteria stool test, Bacterial test negative, Blood bicarbonate normal, Blood creatinine increased, Blood culture negative, Blood lactate dehydrogenase increased, Blood potassium increased, Blood sodium decreased, Blood urea increased, Blood urine present, C-reactive protein increased, Colitis, Culture stool negative, Culture throat positive, Death, Diarrhoea, Gastroenteritis, Haematocrit normal, Haemoglobin increased, Inflammation, Influenza serology negative, Intensive care, International normalised ratio increased, Necrosis, Platelet count decreased, Polymerase chain reaction, Protein urine present, Prothrombin time prolonged, Renal failure, Respiratory distress, Respiratory syncytial virus test negative, Shock, Urine analysis abnormal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (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), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-10-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Seen at PMD for URI symptoms. Diagnosed with acute otitis and antibiotics prescribed.
Preexisting Conditions: Prematurity (27 weeks gestational age) with h/o medical necrotizing enterocolitis. Also with chronic lung disease.
Allergies:
Diagnostic Lab Data: Admission: WBC 37.9, H/H15/39.5, platelets 65, Na 127, K 6.2, HCO3 17, BUN 35, Cr 1.2 In PICU: LDH 1779, CRP 22.93PT 16.3, PTT 37. INR 1.43, UA 4+protein and 3+blood Blood cultures negative, tracheal cultures positive for non-antracis bacillus(thought to be contaminant by pathology), Flu and RSV PCR (NP swab) negative, stool culture negative, stool c.diff negative. Autopsy significant for diffuse colitis wth patchy necrosis, chronic inflammation
CDC Split Type:

Write-up: Parents report onset of diarrhea and abdominal pain in AM on day following vaccination. He presented to the ED 3 days following vaccination with acute gastroenteritis, renal failure, repiratory distress and shock. He was admitted to the PICU from the ED with a diagnosis of acute gastroenteritis +/- HUS. He died later that evening in the PICU.


VAERS ID: 377750 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:2010-01-14
Onset:2010-01-16
   Days after vaccination:2
Submitted: 2010-01-21
   Days after onset:5
Entered: 2010-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102148P1 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-16
   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: ASA; Lisinopril 20mg; PLAVIX; Simvastatin 40mg; NITROQUICK; Metoprolol 25mg; albuterol
Current Illness: F/up HTN
Preexisting Conditions: HTN; Hyperlipidemia; Coronary atherosclerois
Allergies:
Diagnostic Lab Data: scheduled CMP, Lipid panel - Not done
CDC Split Type:

Write-up: Death apparent heart attack 1/16/10. Pt. w/ CAD/ angioplasty 7/09 w/ stent placement. On multiple meds, smoker, denied symptoms 1/14/10.


VAERS ID: 378001 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Kansas  
Vaccinated:2009-12-09
Onset:2009-12-10
   Days after vaccination:1
Submitted: 2010-01-24
   Days after onset:45
Entered: 2010-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP037DA / 1 LA / IM
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB167DA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Condition aggravated, Hepatic encephalopathy, Osmotic demyelination syndrome, Unresponsive to stimuli
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-02
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Liver and Kidney Disease
Preexisting Conditions: Liver and Kidney Disease
Allergies:
Diagnostic Lab Data: Numerous on medical record at hospital.
CDC Split Type:

Write-up: Increased hepatic encephalopathy and non-responsiveness followed by a coma for about eight days. Diagnosis was later rendered that patient had suffered central pontine myelinolysis.


VAERS ID: 378027 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Virginia  
Vaccinated:2010-01-12
Onset:2010-01-15
   Days after vaccination:3
Submitted: 2010-01-21
   Days after onset:6
Entered: 2010-01-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP074AA / 1 LA / IM

Administered by: Other       Purchased by: Public
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-15
   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: Unknown
Current Illness: None reported
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: No adverse reactions within first hour after vaccination administered. Notified of client''s death on 01/15/2010.


VAERS ID: 378186 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: New York  
Vaccinated:2009-09-18
Onset:2009-10-17
   Days after vaccination:29
Submitted: 2010-01-26
   Days after onset:101
Entered: 2010-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER AF1U1A48CA / 3 UN / IJ

Administered by: Private       Purchased by: Other
Symptoms: Areflexia, Blood product transfusion, Death, Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness, Neuropathy peripheral, Protein total, Protein total abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-12-07
   Days after onset: 51
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE KNOWN
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: PT HAD AN LP PERFORMED ON 10/31/09 AND SHOWED AN ELEVATED PROTEIN VALUE
CDC Split Type:

Write-up: PT PRESENTED TO ER WITH NEUROPOTHY AND LEG WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT. FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG.


VAERS ID: 378368 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Male  
Location: Michigan  
Vaccinated:2010-01-21
Onset:2010-01-21
   Days after vaccination:0
Submitted: 2010-01-26
   Days after onset:5
Entered: 2010-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3496AA / 3 - / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3209AA / 1 RL / IJ
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1251Y / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D84740 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0318Y / 3 MO / PO

Administered by: Other       Purchased by: Public
Symptoms: Death, Intensive care, Meningitis, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Noninfectious meningitis (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: diagnosis: meningitis.
CDC Split Type:

Write-up: upper respiratory complaints - admitted to ICU.


VAERS ID: 378423 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Ohio  
Vaccinated:2009-12-14
Onset:2009-12-14
   Days after vaccination:0
Submitted: 2010-01-27
   Days after onset:44
Entered: 2010-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102141P1 / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Death, Diarrhoea, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: He took Lasix each night but I am not sure if he took them during the week after having the diarrhea. I had told him on other occassions not to take them when he was having a bought of diarrhea. He took Motrin as needed for pain but not e
Current Illness: Patient was overweight but relatively in good health.
Preexisting Conditions: Patient as far as we have learned had not seen a doctor in many years. He was taking Lasix, which we found that he was ordering abroad by mail. He retained fluid and had told me he was seeing a doctor for the pills but we have learned that he was not.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He had diarrhea many times throughout the night and all day the next day. I live an hour and a half from him and he traveled home on Tuesday having to stop to go to the bathroom twice. He got home and had diarrhea all day on Tuesday 12/15/2009. He also told me all week that he was feeling very weak. He was even having trouble walking. I had told him all week to go to the emergency room and he kept telling me he would be ok. Finally on Friday 12/18/2009 he agreed to call the emergency squad after I told him I would meet him at the Hospital. The emergency squad arrived and being a big man he decided to walk to the squad. He went down the first of two steps and died. They tried to bring him back but was unsuccessful.


VAERS ID: 378896 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2008-10-09
Onset:2008-10-11
   Days after vaccination:2
Submitted: 2010-01-31
   Days after onset:477
Entered: 2010-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C2900AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C25655 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0302X / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-11
   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: Dr. gave my baby a host of different vaccines and neglected to inform or give me a copy of what all she gave my baby on 10/09/2008
Current Illness: NONE.
Preexisting Conditions: NONE.
Allergies:
Diagnostic Lab Data: Still do not Know the cause of her death. My baby was healthy before I brought her in to get her routine vaccines including the administered oral vaccine Rotavirus, given to her two days before her death by Dr.
CDC Split Type:

Write-up: She Died. I was not informed of anything other than her death. Hospital records are conflicting. Tried to obtain medical records of shots given to my baby, but the doctor''s office said "They don''t have it".


VAERS ID: 379004 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Oklahoma  
Vaccinated:2010-01-20
Onset:2010-01-21
   Days after vaccination:1
Submitted: 2010-02-01
   Days after onset:11
Entered: 2010-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB762BA / 2 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Death, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-21
   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: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: well child check 1-20-2010. Infant received Hepatitis B vaccine on 1-20-2010. Aunt found infant ,on the morning of 1-21-2010, dead in the bed with mother,who was asleep. suspect SIDS or accidental suffocation.


VAERS ID: 379008 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2009-09-28
Onset:2009-10-12
   Days after vaccination:14
Submitted: 2010-02-01
   Days after onset:112
Entered: 2010-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR U3191AA / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abasia, Asthenia, Death, Electromyogram abnormal, Guillain-Barre syndrome, Lumbar puncture abnormal, Paraesthesia, Plasmapheresis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-01
   Days after onset: 81
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Receiving chemotherapy for non-hodgkins lymphoma
Preexisting Conditions: Receiving chemotherapy for non-hodgkins lymphoma.
Allergies:
Diagnostic Lab Data: Lumbar puncture and EMG both suggest GBS.
CDC Split Type:

Write-up: Tingling in extremities followed by weakness and inability to walk. Hospitalized and received plasmapheresis for GBS. D/c to nursing home for rehab therapy.


VAERS ID: 379119 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Florida  
Vaccinated:2010-01-13
Onset:2010-01-30
   Days after vaccination:17
Submitted: 2010-02-02
   Days after onset:3
Entered: 2010-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3261AA / 1 LL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBHB730AA / UNK RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D48928 / 1 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DA802A / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-30
   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: NYSTATIN oral soln.
Current Illness: Thrush
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 379398 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Iowa  
Vaccinated:2009-12-30
Onset:0000-00-00
Submitted: 2010-01-27
Entered: 2010-02-04
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3565AB / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E06427 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA963A / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ear infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 379507 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Indiana  
Vaccinated:2010-01-21
Onset:2010-01-21
   Days after vaccination:0
Submitted: 2010-02-04
   Days after onset:14
Entered: 2010-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102135P1 / UNK - / IJ

Administered by: Other       Purchased by: Public
Symptoms: Death, Eating disorder, Hypotonia, Lethargy, Parkinson's disease
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro tab 10 mg Amitiza Caps 24mcg Nasonex Scent Free Ns Spr 17g 50mcg Omeprazole Caps 20mg Requip Tabs 0.25mg Xalatan Opth Soln 2.5ml 0.005% Carbidopa/levodopa Tabs 25/100mg Megestrol Oral Susp 40mg/ml
Current Illness: Parkinson''s Disease
Preexisting Conditions: Parkinson''s Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lethargic, stopped drinking, stopped eating on the 21st. On the 22nd his arms layed limp at his sides when previously they were rigid and locked from the Parkinson''s. He would not eat or drink on the 22nd.


VAERS ID: 379514 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-12-11
Onset:2009-12-12
   Days after vaccination:1
Submitted: 2010-02-05
   Days after onset:55
Entered: 2010-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR - / 1 UN / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-12
   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: metformin 500 mg Tums Lantus Humalog
Current Illness: Yes; hyperglycemia; BS 300 on 12/11/09
Preexisting Conditions: IDMM newly diagnosed. Admitted on 12/7/09 in DKA coma and hyperosmolar state.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient unresponsive at home after being discharged on 12/12/09 at 9:15pm. Patient arrested, brought to hospital and pronounced dead at 11:40 PM.


VAERS ID: 379725 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Virginia  
Vaccinated:2010-01-08
Onset:2010-01-12
   Days after vaccination:4
Submitted: 2010-02-08
   Days after onset:27
Entered: 2010-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3433AA / 1 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHAVB359AA / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D84740 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0181Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-12
   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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: SIDS 1/12/09
CDC Split Type:

Write-up: Child given PENTACEL, ROTATEQ, and ENGERIX on 1/8/09. Child with apparent SIDS 1/12/09. I am not sure what the final ME report stated.


VAERS ID: 380175 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-11
Entered: 2010-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: B-cell lymphoma, Blood product transfusion, Death, Prostate cancer
SMQs:, Prostate malignant tumours (narrow), Malignant lymphomas (narrow), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had received prior yellow fever vaccinations in 1959 and 1965; however it was not reported whether any adverse events were experienced after those vaccinations.
Allergies:
Diagnostic Lab Data: Pre-mortem specimen not available for serologic evaluation testing.
CDC Split Type: 201000826

Write-up: Initial case retrieved via the scientific literature on 01 February 2010. This involves a case of misuse (drug administration error). Summary of article: On 27 March 2009, blood products were collected from 89 active duty military donor/trainees during a blood drive. On 10 April 2009, a routine record review in connection with a subsequent blood drive learned of breach in the deferral protocol for blood products collected from 89 donor/trainees. Further investigation revealed that the blood obtained from the donor/trainees was from donor/trainees who had been vaccinated with yellow fever vaccine 4 days prior to donating blood. All the blood products had already been processed and incorporated into the inventory at the hospital blood bank. Additional investigation showed that, between 31 March and 09 April 2009, 5 patients had received a total of 6 blood products (3 platelets, 2 fresh frozen plasma, and 1 packed red cell unit) from 6 of the 89 donor/trainees. One of 5 blood recipients had underlying diffuse large B cell lymphoma and prostate carcinoma, and died 20 days after receiving the blood product. Of the other 4 surviving blood recipients, 3 had VFV-IgM antibodies confirmed by plaque reduction neutralization test. This case contains information for 1 of the 5 blood product recipients. Information regarding the other 4 blood recipients is reported in cases 2010-00827, 00841, 00842, and 00843. Information regarding the 6 blood donor/trainees is recorded in case 2010-00844. An 82-year-old male patient was discharged to inpatient hospice for terminal prostate cancer and end-stage, transfusion dependent, B-cell lymphoma, and received on an unspecified date, 1 unit of irradiated platelets that was from blood products that had been donated by one of the active duty military donor/trainees who had received yellow fever vaccination 4 days prior to donating blood. The blood donor/trainee had no previous history of vaccination or travel history consistent with exposure to wild-type YFV. Testing for pre-transfusion serologic status of the patient could not be performed because banked sera were not available. The patient died (death not related) 20 days after receiving the blood transfusion of irradiated platelets. It was noted the patient had previously been vaccinated with yellow fever vaccine in 1959 and again in 1965. No autopsy was performed on the patient; and cause of death was not provided. No pre-mortem blood specimens were available for testing, and residual blood products from the patients transfusion was discarded. Documents held by sender: None.


VAERS ID: 380328 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2010-01-06
Onset:2010-01-14
   Days after vaccination:8
Submitted: 2010-02-05
   Days after onset:22
Entered: 2010-02-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED 102123P1 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Confusional state, Death, Decreased appetite, Laboratory test normal, Lethargy, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Excess uric acid feet
Preexisting Conditions: Cardio/Artery disease; Hypertension
Allergies:
Diagnostic Lab Data: Negative
CDC Split Type:

Write-up: Loss of appetite, confusion, lethargy, excessive mucus. Patient did not want to be hospitalized. Jan 14 thru Jan 18, 4 AM.


VAERS ID: 380740 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Washington  
Vaccinated:2009-08-25
Onset:2009-10-01
   Days after vaccination:37
Submitted: 2010-02-18
   Days after onset:140
Entered: 2010-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500673P / UNK NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0671Y / 1 AR / IJ

Administered by: Private       Purchased by: Other
Symptoms: Death, Decreased activity, Fall, Headache, Hypoaesthesia, Loss of control of legs, Menstruation irregular, Oedema peripheral, Paraesthesia, Peripheral coldness, Sensory loss, Unresponsive to stimuli
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trileptol and Keppra
Current Illness: My daughter had a seizure disorder that came on with her periods.
Preexisting Conditions: Patient had a pre-existing seizure disorder which she was on trileptol and Keppra to control the seizures.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received the HPV as well as the flu nasal spray on Aug 25th. I first declined getting her the vaccination but her doctor ensured me that it was safe. I had declined the same vaccination a year earlier at the downtown public health center. Patient was getting ready for school and was standing by her closet, and all of a sudden she fell, she lost total control of her legs. She went to school and could not engage in any of the activities because of the numbness in her legs and the swelling of her foot. She also, started to get a really bad headache. Days later she woke up out of her sleep complaining of a severe headache, which usually she gets if she has a seizure but she hadn''t had a seizure this night. She continued to say she had not feeling in her foot and tingling feeling in her leg. After I examined her foot I noticed it was swollen. The next morning I called her doctors office and made her doctors appointment for Oct 23rd. During the month of October she had irregular periods. My daughter never made it to Oct 23rd, which as also her birthday. She passed on Oct. 17th, I found her cold unresponsive in her room at 7am, which I went in to wake her up to take her morning pills.


VAERS ID: 381102 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Alabama  
Vaccinated:2009-10-20
Onset:2009-10-21
   Days after vaccination:1
Submitted: 2010-02-23
   Days after onset:125
Entered: 2010-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS ALLA255AA / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death, Diplegia, Dysphagia, Fall, Monoplegia
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-13
   Days after onset: 84
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BP, diuretic, patient also received flu vaccinations in prior years
Current Illness: none
Preexisting Conditions: high blood pressure, anemia, CHF.
Allergies:
Diagnostic Lab Data: none.
CDC Split Type: AL1006

Write-up: Fell at home 10/21/2009. By weekend began paralysis of arms and legs. Had trouble eating and swallowing. 10/24/2009 to ER Hospitalized 2-3 days. Discharged and returned to hospital for two additional visits, nursing home placement for 3 weeks. Returned home mid December 2009 with nurses and hospice care. MD told family he thought she had Guillain Barre but would not put it in writing.


VAERS ID: 381128 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2010-02-22
Onset:2010-02-23
   Days after vaccination:1
Submitted: 2010-02-23
   Days after onset:0
Entered: 2010-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 104044P1A / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-23
   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:
Current Illness: None
Preexisting Conditions: HTN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt died suddenly within 24 hrs of administration. Clinically suspect unrelated.


VAERS ID: 381178 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2010-02-10
Onset:2010-02-11
   Days after vaccination:1
Submitted: 2010-02-18
   Days after onset:7
Entered: 2010-02-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3260AA / 2 RL / IM
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500824P / 1 NS / IN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB349AA / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Cough, Croup infectious, Death
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-11
   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: Dexamethasone one dose
Current Illness: Viral croup
Preexisting Conditions: 30 weeks gestation at birth --$g respiratory distress
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 28 month old (ex - 30 week preemie) male was seen in pediatric clinic for outpatient evaluation of croup. Examining attending physician described barking cough but no stridor at rest. Given dexamethasone 9 mg and vaccines. Child put to bed "fine". Found dead next morning. Unsuccessful resuscitation.


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