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From the 5/7/2021 release of VAERS data:

Found 1,944 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 378001 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Missouri  
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: 390851 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2009-11-19
Onset:2009-12-10
   Days after vaccination:21
Submitted: 2010-06-11
   Days after onset:182
Entered: 2010-06-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 98434P1 / UNK RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Acute respiratory failure, Decubitus ulcer, Gastrostomy tube insertion, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Plasmapheresis, Quadriplegia, Tracheostomy
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-06-11
   Days after onset: 182
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 183 days
   Extended hospital stay? Yes
Previous Vaccinations: GBS~Influenza (Seasonal) (no brand name)~UN~73.00~Patient
Other Medications: ranitidine; lisinopril; verapamil
Current Illness: None
Preexisting Conditions: Hypertension; Diverticulosis; colon resection; peptic ulcer
Allergies:
Diagnostic Lab Data: Lumbar puncture; nerve conductivity test
CDC Split Type:

Write-up: Rapid onset of Guillain-Barre. Quadriplegia, Decubitus Ulcer, tracheotomy acute respiratory failure (has regained partial respiration), Gastrostomy tube IGIV treatment, Plasmapheresis, high dose steroids.


VAERS ID: 390302 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-28
Onset:2009-12-06
   Days after vaccination:8
Submitted: 2010-06-09
   Days after onset:184
Entered: 2010-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aortic arteriosclerosis, Asthenia, Autopsy, Bilevel positive airway pressure, Cardio-respiratory arrest, Cardiomegaly, Computerised tomogram normal, Coronary artery disease, Coronary artery occlusion, Death, Demyelinating polyneuropathy, Depressed level of consciousness, Feeling cold, Guillain-Barre syndrome, Immunoglobulin therapy, Infarction, Laboratory test normal, Left ventricular failure, Left ventricular hypertrophy, Nervous system disorder, Pulmonary congestion, Pulmonary oedema, Respiratory acidosis, Respiratory arrest, Respiratory failure, Swelling
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Demyelination (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-07
   Days after onset: 1
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: Glaucoma; Hypertension; Osteoporosis; Pneumonia; Respiratory problem
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: All kinds of tests (unspecified) came back negative. CT scan head and neck showed no apparent cord compression.
CDC Split Type: A0860663A

Write-up: This case was reported by a consumer (subject''s daughter) and confirmed by a physician and described the occurrence of "couldn''t breathe and was very cold" in a 87-year-old female subject who was vaccinated with AREPANRIX H1N1 (GlaxoSmithKline). Concurrent medical conditions included glaucoma, hypertension and osteoporosis. Initially the case was reported by the consumer. On 28 November 2009 the subject received unspecified dose of AREPANRIX H1N1 (unknown). On 6 December 2009, eight days after vaccination with AREPANRIX H1N1, the subject could not breathe, and was very cold. Her granddaughter called the ambulance and the patient was taken to the hospital at 1000 hours. All kinds of test (not specified) were done and "all came back negative". The patient died at the hospital on 7 December 2009. The subject was independent and perfectly healthy prior to this. An autopsy was performed and the clinical summary in the autopsy report stated that on 6 December 2009, the subject presented with weakness and decreased level of consciousness and was hospitalized. In the hospital, the subject was found to have respiratory acidosis and was kept on bipap. CT scan of the head and neck showed no apparent cord compression. As per the physician, the clinical picture was most consistent with respiratory failure developing from possible GUILLAIN BARRE SYNDROME following vaccination with AREPANRIX H1N1. The subject was treated with intravenous immunoglobulin. The subject was not intubated as per family request; the subject died on 7 December 2009 at 1915 hours. An autopsy, limited to examination of the lungs, heart and central nervous system, was performed on 08 December 2009; however microscopic examination of the brain, spinal cord and portions of skeletal muscle, sural nerve and peroneal nerve were referred to a neuropathologist for expert opinion. The final autopsy diagnosis reported acute demyelinating polyneuropathy, moderate-to-severe coronary artery disease, with 70-75% luminal occlusion of the right coronary and left circumflex arteries and 80% luminal occlusion of the left anterior descending artery, cardiomegaly and left ventricular hypertrophy, pulmonary edema and congestion, with no evidence of pneumonia and moderate atherosclerosis of the proximal aorta. In the summary of autopsy findings, the pathologist reported the most likely cause of death to be cardiopulmonary arrest due to moderate to severe pulmonary edema in a patient with cardiomegaly and left ventricular failure. Subsequently, examination of the brain, spinal cord and portions of peripheral nerves and skeletal muscle was completed by a neuropathologist, who provided a final diagnosis of spinal cord roots and peripheral nerve with areas of axonal swelling and spheroid formation not associated with demyelination, recent central zone ischemic infarction of the cervical/thoracic region (likely a pre-terminal event) and skeletal muscle with mild neurogenic type changes. The comment provided by the neuropathologist states the findings "suggest an autoimmune axonal pathology consistent with the predominantly axonal form of GUILLAIN-BARRE syndrome." An addendum to the autopsy report provided the results of additional testing completed on the spinal cord and revealed involvement of dorsal and ventral roots at multiple levels of the spinal cord, consistent with a mixed sensory motor pattern of involvement and confirmed the absence of any macrophage-mediated demyelination. Follow-up was received from the subject''s daughter on 04 June 2010. On 28 November 2009 the subject was vaccinated with unspecified dose of AREPANRIX H1N1 (unknown), unspecified dose of Flu Shot (Seasonal trivalent Influenza vaccine) and unspecified dose of B12 injection (Cyanocobalamin). Medical history included hospitalization on 21 September 1995 for respiratory problems and pneumonia.


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: 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: 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: 378321 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-12-02
Submitted: 2010-01-25
   Days after onset:54
Entered: 2010-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010021945

Write-up: Report received from a consumer on 22-JAN-2010. A 51 year old male patient received PANVAX H1N1 influenza vaccine in late NOV-2009. The patient''s medical history was unknown as the patient was adopted and had no family history. The patient was noted as previously fit and was an aviation firefighter. The reporter was not aware that the patient was on any medications. The patient was not ill at the time of vaccination. The patient received pertussis vaccination on the same day as receiving PANVAX. On 02-DEC-2009, approximately 1 week after administration with PANVAX, the patient had heart failure at the gym. The patient was resuscitated for 45 minutes which was unsuccessful. The event outcome was fatal on 02-DEC-2009 and currently awaiting Coroner''s report. The case was reported as serious due to fatality. The company considered the event to PANVAX conditional to further information. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Death Date: 02-Dec-2009.


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: 374862 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-27
Onset:2009-11-28
   Days after vaccination:1
Submitted: 2009-12-23
   Days after onset:25
Entered: 2009-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS AFLSA117AA / UNK UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Carbon Dioxide narcosis; decompensation cardiac; respiratory insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0619049A

Write-up: This case was reported by a regulatory authority (# DHH-N2009-49347) and described the occurrence of death in a 67-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline), ALPHARIX. Concurrent medical conditions included 5 carbon dioxide narcosis in one month with cardiac decompensation and terminal respiratory insufficiency. On 27 November 2009, the subject received unspecified dose of PANDERIX H1N1 (unknown route, unknown injection site), unspecified dose of ALPHARIX (unknown route, unknown injection site, lot number not provided). On 28 November 2009, 1 day after vaccination with ALPHARIX and PANDEMRIX H1N1, the subject experienced death without prodromes or symptoms. The subject died during the night of 28 to 29 November 2009, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 473105 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-11-27
Submitted: 2012-10-30
   Days after onset:1067
Entered: 2012-11-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012NL096317

Write-up: Case number PHHY2012NL096317 is an initial literature report received from a health care professional via foreign health authority (NL-LRB-102333) on 24 Oct 2012. The intent of the article was to describe an observational study conducted to describe the methods of processing, analyzing and performing signal detection on the reports of adverse events following immunization (AEFI) with respect to the two pandemic influenza vaccines, FOCETRIA and PANDEMRIX and to provide a summary of the results of the safety monitoring of both vaccines. This report refers to a 2-years-old male patient. The patient''s medical history and concomitant medications were not reported. He was vaccinated with pandemic influenza vaccine (manufacturer and batch number: not reported) 1x1 0.5 ml intramuscularly for immunization on an unknown date. On 27 Nov 2009, the patient died and the cause of death was not provided. The health authority assessed the causality as unlikely. But the authors commented that although a possible relationship could not be excluded, the causal relationship between administration of the vaccine and death was improbable on the basis of what was currently known about the report. The author concluded the article stating that no major safety issues occurred with respect to the type of reported AEFIs or with batches of either vaccine.


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: 374084 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-17
Onset:2009-11-24
   Days after vaccination:7
Submitted: 2009-12-18
   Days after onset:24
Entered: 2009-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Atelectasis, Computerised tomogram abnormal, Death, Electromechanical dissociation, Endotracheal intubation, General physical health deterioration, Multi-organ failure, Pneumonia, Renal failure, Sciatica, Sepsis, Septic shock, Spinal X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Angioedema (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 (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-11-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus type 2; Glaucoma; Metabolic disorder; Myocardial insufficiency
Preexisting Conditions: Urinary bladder carcinoma
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: D0064872A

Write-up: This case was reported by a physician and described the occurrence of basal pneumonia in an 84-year-old male subject who was vaccinated with Seasonal Influenza Vaccine) manufacturer unspecified). According to the vaccinating physician the subject has not received PANDEMRIX H1N1 (GlaxoSmithKline), as reported initially, but has received Influenza vaccine 2009/2010 (manufacturer unspecified). On 17 November 2009 the subject received a dose of PANDEMRIX H1N1 (unknown). Approximately seven days post vaccination with PANDEMRIX H1N1, on 24 November 2009, the subject experienced pneumonia. The subject was hospitalised for 3 days. Approximately eight days post vaccination with PANDEMRIX H1N1, on 25 November 2009, the subject experienced renal failure and needed intubation. Approximately eight days post vaccination with PANDEMRIX H1N1, on 26 November 2009, the subject died. Follow-up information was received on 30 November 2009 from the reporting physician. Approximately seven days post vaccination with PANDEMRIX H1N1, on 24 November 2009, the subject was hospitalised for reduced general condition and lumboischialgia. Thoracic X-ray and computed tomogram showed basal pneumonia with atelectasis. The subject died on 26 November 2009 from electromechanical dissociation and multiorgan failure post septic shock and pneumonia. An autopsy was not performed. The reporting physician considered fulminant course of the events and that the events were possibly related to vaccination with PANDEMRIX H1N1. Follow-up information was received on 07 December 2009 from the reporting physician. The subject''s medical history included urinary bladder carcinomas. Concurrent medical conditions included diabetes mellitus type 2, glaucoma and myocardial insufficiency. On 17 November 2009 the subject received the first dose of PANDEMRIX H1N1 (intramuscular, unknown). Approximately one week post vaccination post PANDEMRIX H1N1, on 24 November 2009, the subject experienced basal pneumonia and sepsis. The subject was hospitalised on 24 November 2009 for three days. The reporting physician considered that the events were life threatening. In hospital the subject experienced remarkable foudroyant coursed of sepsis with multiorgan failure and death. Approximately nine days post vaccination with PANDEMRIX H1N1, on 26 November 2009, the subject died from electromechanical dissociation due to septic shock. An autopsy was not performed. The reporting physician considered that the events were possibly related to vaccination with PANDEMRIX H1N1. On 15 December 2009 the same case was reported by the regulatory authority (# DE-PEI-PEI2009028753). This information was identical to data previously received on 07 December 2009 from the reporting physician. Follow-up information was also received on 15 December 2009 from the reporting physician. The subject has not received PANDEMRIX H1N1 (GlaxoSmithKline), but Influenza Vaccine 2009/2010, (manufacturer unspecified). The vaccinating physician has never vaccinated any subject with PANDEMRIX H1N1. The reporting physician considered that the events were unrelated to vaccination with Influenza virus vaccine 2009/2010. Follow-up information has been requested.


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: 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: 383746 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Arizona  
Vaccinated:2009-11-20
Onset:2009-11-20
   Days after vaccination:0
Submitted: 2010-03-21
   Days after onset:120
Entered: 2010-03-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 10P012 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Death, Dizziness, Dyspnoea, Fatigue, Heart rate increased, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HALDO, any psych except PAXIL x 1 a day
Allergies:
Diagnostic Lab Data: Taken that AM 11/20/09 Blood Test office. Also Hosp 11-18-09 11-19-09
CDC Split Type:

Write-up: Patient received H1N1virus shot late AM 11-20-2009. On the way home she was tired, near lunch I gave her peaches & a little soup. Heart rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up & went to bathroom & died.


VAERS ID: 378725 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-16
Onset:2009-11-20
   Days after vaccination:4
Submitted: 2010-01-29
   Days after onset:70
Entered: 2010-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Autopsy, Bacterial test positive, Blood product transfusion, Death, Histiocytosis haematophagic, Liver function test abnormal, Parasitic test positive, Parvovirus infection, Platelet count increased, Pyrexia, Rash, Serum ferritin increased, Viral test positive, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-21
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nil
Preexisting Conditions: Nil
Allergies:
Diagnostic Lab Data: 50 bacteria and viral/ parasites test with the autopsy shows parvovirus-related hemophagocystic diseases
CDC Split Type:

Write-up: rashes starting from extremities follow with fever up to 39C 4 days later and elevation of WBC/ Platelets/ liver functions/ ferritin/ Antibiotic and antiviral/ IVIG given together with NSAIS''s


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: 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: 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: 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: 620475 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-09-22
Onset:2009-11-13
   Days after vaccination:52
Submitted: 2016-01-24
   Days after onset:2263
Entered: 2016-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3203AA / 7+ LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Complications of transplanted lung, Condition aggravated, Death, Lung transplant, Total lung capacity decreased
SMQs:, Interstitial lung disease (broad), Eosinophilic pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-16
   Days after onset: 183
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Interstitial Lung Disease; Parkinson''s Disease
Preexisting Conditions: Interstitial Lung Disease; Parkinson''s Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My father had interstitial lung disease for about 10 years at this point. He never received a flu shot before, & in the fall of 2009, there was widespread worry about swine flu. Because of his condition, he decided it was prudent to get a flu shot. Within 2 weeks of receiving the flu shot, his lung capacity went from 88% to 44% and he ended up in the hospital on oxygen. His condition continued to downgrade until 1-1-10 when he received a lung transplant (he was in such need at that time, he was placed on the list and called for a transplant in less than a week). I believe he would have died within a week or two of that time. He did eventually die on May 16, 2010 due to complications of the lung transplant.


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: 406577 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2009-10-20
Onset:2009-11-10
   Days after vaccination:21
Submitted: 2010-10-18
   Days after onset:341
Entered: 2010-11-02
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3207AA / 2 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Dysphagia, Gastrointestinal tube insertion, Laboratory test, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-31
   Days after onset: 293
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: LA101002

Write-up: Approximately 3-4 weeks after flu shot began to have tingling of face and arm. Symptoms progressed to lower extremities Experienced sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family states multiple tests were done. 2) Released and went to neurology clinic in another state for second opinion. 3) Admitted to another hospital and then transferred to a rehab facility in another state. 4) Family had him brought back to original hospital.


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: 366648 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-04
Onset:2009-11-07
   Days after vaccination:3
Submitted: 2009-11-10
   Days after onset:3
Entered: 2009-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER AB1CA061A / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Heart rate decreased, Pallor, Respiratory rate decreased, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-07
   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: AMLODIPINE; BUSOPROLOL; VALSARTAN; DICLOFENAC; PANTOPRZOLE
Current Illness: Hyperlipidemia; Hypertension arterial; Polyarthrosis; Reduced physical ability; Renal insufficiency
Preexisting Conditions: Prosthesis implantation; Reduced blood pressure; Strumectomy; Syncope (recurrent)
Allergies:
Diagnostic Lab Data: Heart rate, 07Nov2009, low
CDC Split Type: D0063628A

Write-up: This case was reported by a physician and described the occurrence of death - at present cause unknown - in a 92-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline) and INFLUSPLIT SSW 2009/2010 (GlaxoSmithKline). The subject''s medical history included prosthesis implantation (total endoprosthesis) in 2007 and strumectomy. Relevant recent medical history included recurrent syncope with reduced blood pressure, last episode in May 2009, possibly associated with wrong intake of antihypertensive drug(s). Concurrent medical conditions included hyperlipidemia, arterial hypertension since years, polyarthrosis and renal insufficiency grade I. The subject suffered from reduced physical ability but was mentally fit. The subject lived with her son and was cared for by a nursing service. Concomitant medications included AMLODIPIN, BISOPROLOL, PROVAS, DICLOFENAC and PANTOPRAZOL. On 03 November 2009 the subject received a dose of INFLUSPLIT SSW 2009/2010 (0.5 ml, unknown). On 4 November 2009 the subject received the first dose of PANDEMRIX H1N1 (0.5 ml, unknown). The subject has tolerated both vaccinations well and experienced no adverse events. In the morning of the date of death, on 07 November 2009, the subject was completely well without experiencing any complaints. Approximately three days post vaccination with PANDEMRIX H1N1 and approximately four days post vaccination with INFLUSPLIT SSW 2009/2010, on 07 November 2009, in the afternoon post afternoon nap, the subject was hardly responsive to verbal stimuli and experienced pallor, low pulse rate and decreased respiration rate. The nursing service called for an emergency physician on 07 November 2009 at around 16:00. The subject received no treatment for the event because of living will/advance directive. The subject was transferred to a hospital. Some time later at the hospital, on the same day, on 07 November 2009, the patient died. The cause of death was considered to be unknown. Therefore an autopsy has been ordered by a public prosecutor/district attorney. The results of autopsy were unknown. The reporting physician considered that death and preceding adverse events were unrelated to vaccination with PANDEMRIX H1N1 and/or INFLUSPLIT SSW 2009/2010, because post vaccinations the subject experienced no adverse events at all. Follow-up information has been requested.


VAERS ID: 374505 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-11-06
Onset:2009-11-07
   Days after vaccination:1
Submitted: 2009-12-21
   Days after onset:44
Entered: 2009-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS A81CA067A / UNK UN / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug level increased
SMQs:, Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-07
   Days after onset: 0
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: Phenytoin; Zonisamide; Ipratropium bromide; Salbutamol sulphate; Ramipril; Citalopram
Current Illness: Chronic obstructive pulmonary disease; Epilepsy
Preexisting Conditions: At review in June 2009 he was having 2-3 fits a month and was being treated with Phenytoin and Zonisemide 300mg. His weight (45kg) was recorded in November 2008.
Allergies:
Diagnostic Lab Data: The dose of phenytoin was reduced in September 2009 by 25mg as his phenytoin levels were found to be too high (26).
CDC Split Type: B0603336A

Write-up: This case reported by a regulatory authority (# GB-MHRA-FLU 00026877) and described the occurrence of death unexplained in a male subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline), inactivated influenza vaccine (Sanofi Pasteur). Concurrent medical conditions included epilepsy. The patient had previously received annual influenza vaccine for several years. On 6 November 2009 the subject received unspecified dose of PANDEMRIX H1N1 (1 injection, intramuscular), unspecified dose of Inactivated influenza vaccine. On 7 November 2009, 1 day after vaccination with Inactivated influenza vaccine and PANDEMRIX H1N1, the subject experienced death unexplained. The subject died on 7 November 2009 from death unexplained. At the time of reporting a post mortem had been awaited. Pt given H1N1 PANDEMRIX and inactivated influenza vaccine (sanofi pasteur) on Friday 6/11/09, previously received annual influenza vaccine for several years, history epilepsy pt emergency admission early hours saturday morning 7/11/09 now deceased, currently awaiting post mortem. Case updated 10/11/2009: Brand name updated to PANDEMRIX, dates from text entered and reaction amended to death unexplained. Changes identified at signal detection meeting. Follow-up information received on 14 December 2009: Concurrent medication included Phenytoin, zonisemide, ipratropium, salbutamol, ramipril and citalopram. Concurrent medical conditions included chronic obstructive pulmonary disease. On 07 November 2009, in the early hours, the 52 year-old subject was hospitalised. At review in June 2009 he was having 2-3 fits a month and was being treated with Phenytoin and zonisemide 300mg. The dose of phenytoin was reduced in September 2009 by 25mg as his phenytoin levels were found to be too high (26). His weight (45kg) was recorded in November 2008. The brand of the H1N1 vaccine was confirmed as PANDEMRIX and not CELVAPAN. He was vaccinated with both PANDEMRIX and seasonal flu vaccine on 6th November. Admitted to hospital in the early hours of 7th November where he died. He has a medical history of COPD and epilepsy. At review in June 2009 he was having 2-3 fits a month and was being treated with Phenytoin and zonisemide 300mg. The dose of phenytoin was reduced in September 2009 by 25mg as his phenytoin levels were found to be too high (26). His weight (45kg) was recorded in November 2008. No information on weight since then. Other medications - ipratropium, salbutamol, ramipril and citalopram. Post mortem results are awaited. The patient was taking PANDEMRIX for: Epilepsy.


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: 410690 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-10-20
Onset:2009-11-06
   Days after vaccination:17
Submitted: 2010-11-30
   Days after onset:389
Entered: 2010-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blood test, Death, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging, Paralysis, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-12-19
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 36 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: spinal taps, blood tests, MRI scans, etc
CDC Split Type:

Write-up: Almost 6 weeks in ICU with paralysis, respiritory arrest, death from Guillain Barre Syndrome


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: 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: 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: 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: 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: 371292 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-30
Onset:2009-11-02
   Days after vaccination:3
Submitted: 2009-12-02
   Days after onset:30
Entered: 2009-12-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 092302A / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0688X / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Atrial fibrillation, Blood creatinine increased, C-reactive protein increased, Cerebrovascular accident, Chest X-ray normal, Crepitations, Death, Disorientation, Electrocardiogram abnormal, Eye movement disorder, Febrile infection, General physical health deterioration, Granulocyte percentage, Haematocrit decreased, Haemoglobin normal, Heart rate irregular, Hemiparesis, Lymphocyte percentage decreased, No reaction on previous exposure to drug, Rales, Red blood cell count decreased, Somnolence, Unresponsive to stimuli, Urine analysis normal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (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), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CONCOR; KALINOR; PANTOZOL; REMERGIL; carbimazole; furosemide
Current Illness:
Preexisting Conditions: Multimorbidity
Allergies:
Diagnostic Lab Data: physical examination, 02Nov09, irregular heart beat; physical examination, 02Nov09, crackling pulmonary rales right basal; physical examination, 02Nov09, right sided hemiparesis; physical examination, 02Nov09, mild ocular deviation to the left; chest X-ray, 02Nov09, pneumonia was ruled out; electrocardiogram, 02Nov09, absolute arrhythmia in the scope of atrial fibrillation; WBC count, 02Nov09, 19.7/nl; hematocrit, 02Nov09, 0.343 l/l; hemoglobin, 02Nov09, 11.9 g/dl; lymphocyte count, 02Nov09, 7%; serum C-reactive protein, 02Nov09, 254 mg/l; serum creatinine, 02NOv09, 1.28 mg/dl; urinalysis, 02Nov09, normal results; red blood cell count, 02Nov09, 3.88/pl; blood granulocyte count, 02Nov09, 87%; WBC count, 04Nov09, 10.6/nl; hematocrit, 04Nov09, 0.305 l/l; hemoglobin, 04Nov09, 10.3 g/dl; serum C-reactive protein, 04Nov09, 282 mg/l; red blood cell count, 04Nov09, 3.37/pl
CDC Split Type: WAES0911USA04792

Write-up: Information has been received from a health authority in a foreign country on 23-Nov-2009 (PEI200925841) concerning a multimorbid 90 year old patient with history of previous vaccination with FLUAD on 03-Nov-2009 reported as well tolerated. On 30-OCT-2009 the patient was vaccinated with PNEUMOVAX 23 (Lot # 662312/0688X) (Batch # NJ23660) intramuscularly into her left upper arm. Secondary suspect vaccine included FLUAD (Lot # 092302A) administered intramuscularly into her right arm on the same day. Concomitant therapy included CONCOR, carbimazole, REMERGIL and PANTOZOL, KALINOR and furosemide. (These drugs were listed in the hospital report as "recent medications", no exact indications were provided.) It was reported that in the morning of 02-NOV-2009, the patient was somnolent and did not respond to verbal stimuli, general condition was reduced and the patient was hospitalized the same day. Physical examination showed an irregular heartbeat, crackling pulmonary rales right basal, right sided hemiparesis and mild ocular deviation to the left. The patient was awake but disoriented (recovered from somnolence). Electrocardiography on 02-NOV-2009 showed absolute arrhythmia in the scope of atrial fibrillation. Inflammatory lab parameters were remarkably increased. Relevant laboratory for 02-NOV-2009 included: HB (blood hemoglobin test): 11.9; hematocrit (whole blood hematocrit): 0.343; erythrocytes (red blood cell count): 3.88; leucocytes (white blood cell count): 19.7; CRP (serum C-reactive protein test): 254; creatinine (serum creatinine test): 1.28; granulocytes (blood granulocyte count): 87; lymphocytes (blood lymphocyte count): 7. Cystitis could be ruled out by urinalysis on 02-NOV-2009 which showed normal results. Pneumonia was ruled out by chest x-ray on 02-NOV-2009. Relevant laboratory for 04-NOV-2009 included: HB (blood hemoglobin test): 10.3; hematocrit (whole blood hematocrit): 0.305; erythrocytes (red blood cell count): 3.37; leucocytes (white blood cell count): 10.6; CRP (serum C-reactive protein test): 282. Febrile infection on unknown origin and suspicion of apoplexy was diagnosed. Treatment with AUGMENTIN was started. On 06-NOV-2009 the patient was transmitted to a nursing home for further treatment. On the reporting form outcome of the reaction was reported to be fatal (verbatim PEI: febrile infection, reduced general condition and unknown cause of death). cessation date of febrile infection was reported to be 13-NOV-2009. However, the exact date of death was not reported (NOV-2009). Other business partner numbers include E200910777., A lot check has been initiated. File is closed. No further information is available.


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: 367628 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-28
Onset:2009-10-31
   Days after vaccination:3
Submitted: 2009-11-13
   Days after onset:13
Entered: 2009-11-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED 090201401 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Septic shock, Staphylococcal bacteraemia, Staphylococcal sepsis
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-12
   Days after onset: 12
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: End stage renal failure, home haemodialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021359

Write-up: Report received from a hospital via an adverse event surveillance organisation on 12-Nov-2009. A 48 year-old male patient (initials unknown, date of birth 30-Jan-1961) received PANVAX H1N1 (batch 090201401) on 28-Oct-2009 at 12:30pm. The patient had a medical history of end stage renal failure since March 2009, and was undergoing home haemodialysis. Concomitant medications unknown. On 31-Oct-2009 (3 days post-vaccination), the patient visited the emergency department and presented in septic shock. The patient was admitted to hospital on 2-Nov-2009. A blood culture was positive for Staph aureus and the patient was diagnosed with staph sepsis. The patient died on 12-Nov-2009, 15 days after the suspect drug was administered. Cause of death is unknown. The case was reported as serious because the outcome was fatal. The company considered events to be possibly related to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 391248 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-22
Onset:2009-10-31
   Days after vaccination:9
Submitted: 2010-06-18
   Days after onset:230
Entered: 2010-06-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED 090200402 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myelopathy, Neuropathy peripheral, Pneumonia aspiration
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-03
   Days after onset: 3
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010024405

Write-up: Report received from the Foreign Regulator on 10-Jun-2010 (case: 261905). A 90 year old male patient received a single dose of PANVAX H1N1 vaccine (batch: 090200402) on 22-Oct-2009. On 31-Oct-2009, 12 days after vaccination, the patient was admitted to hospital with peripheral neuropathy. On 03-Nov-2009, the patient died due to aspiration pneumonitis as a result of ascending myelopathy. The reporter considered the event of peripheral neuropathy to be serious due to inpatient hospitalisation and assessed the causality as possible in relation to the suspect drug PANVAX H1N1 vaccine. The company considered the event of peripheral neuropathy to be possibly related to the suspect drug PANVAX H1N1 vaccine, and considered the events of aspiration pneumonitis and ascending myelopathy to be unlikely related. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Death date: 03-Nov-2009.


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: 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: 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: 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: 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: 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: 392671 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2009-10-23
Onset:2009-10-23
   Days after vaccination:0
Submitted: 2010-07-13
   Days after onset:263
Entered: 2010-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 978471P1 / UNK UN / IM
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac valve disease, Congestive cardiomyopathy, Death, Dizziness, Feeling abnormal, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (narrow), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-10
   Days after onset: 48
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: Lupus
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On day of vaccination throat was closing up for about 40 minutes after vaccine, then was dizzy for several days after. Stated she didn''t feel good. On 12/4/09 was diagnosed with heart valve damage both mitral and tricuspid and dilated cardiomyopathy. Was admitted to CCU on 12/10/09 and died. Had H1N1 vaccine on 10/23/09.


VAERS ID: 363731 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-23
Onset:2009-10-23
   Days after vaccination:0
Submitted: 2009-10-29
   Days after onset:6
Entered: 2009-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA502AE / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Computerised tomogram abnormal, Death, Haemorrhagic stroke, Hypertension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-25
   Days after onset: 2
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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 23Oct2009, High; Computerized tomogram, 23Oct2009, Stroke
CDC Split Type: B0599740A

Write-up: This case was reported by a physician and described the occurrence of stroke in a 50-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject was reported to be hypertensive. No information on medication taken. On 23 October 2009 at about 2-4 pm, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). The subject was observed (kept) for 30 minutes. Doctor and nurse did not notice anything wrong with him. Afterwhich, no information on whereabouts of the subject. It was reported that the vaccination was part of vaccination program for employees of a petroleum company. About 40 other patients received the vaccine on the same time. On 23 October 2009 at 5:30 pm, within hours of vaccination with FLUARIX, the subject went to the hospital alone via public transport (motor vehicle/TukTuk). The subject had high blood pressure. He fainted at hospital. He showed signs of stroke and was brought for CT Scan. The subject was admitted at hospital and was diagnosed to have stroke (AVC hemorrhagic) based on CT scan result. On 24 October 2009, condition of subject deteriorated. Family decided to bring him home. The subject died on 25 October 2009 (morning) at home, cause of death was not reported. It was unknown whether an autopsy was performed. The physician considered the events were unrelated to vaccination with FLUARIX.


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: 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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 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: 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: 386360 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2009-10-16
Onset:2009-10-17
   Days after vaccination:1
Submitted: 2010-04-25
   Days after onset:190
Entered: 2010-04-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 07249111A / UNK RA / UN

Administered by: Military       Purchased by: Military
Symptoms: Death, Pyrexia, Toxicologic test abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: TOPAMID; ZENEXTRA; ibuprofen; aspirin
Current Illness: Possible H1N1 in incubation stage
Preexisting Conditions: Obesity; severe insomnia; observed sleep apnea; possible undiagnosed fibromyalgia; arthritis.
Allergies:
Diagnostic Lab Data: Toxicology report showed high ethanol content (0.43%) except she didn''t drink. 8hrs forensic investigation did not turn up any alcohol/containers/ glasses etc.
CDC Split Type:

Write-up: Death - 13 hours after Influenza A administration. Spouse had evidence of febrile event when found. spouse had been exposed to son with H1N1 (swine) continuously for 5 days in preceding 8 days before death. It was unknown at time that son had H1N1 and only became known to us 6 weeks after patient''s death.


VAERS ID: 382997 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-17
Onset:2009-10-17
   Days after vaccination:0
Submitted: 2010-03-17
   Days after onset:151
Entered: 2010-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Facial palsy, Guillain-Barre syndrome, Headache, Paraesthesia, Paralysis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-31
   Days after onset: 106
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: DIABEX (METFORMIN HYDROCHLORIDE)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022225

Write-up: Report received from a consumer on 10-Mar-2010. A male patient (details unknown) received the PANVAX on an unknown date. The medical history and concomitant medication are unknown. On an unknown date after receiving PANVAX, the patient developed a 10 week long illness that was diagnosed as Guillain Barre Syndrome. Subsequently, the patient died recently. No further information was provided. The reporter states that the ''two may not be linked''. This case was reported as serious because of a fatal outcome. The company considered events conditional to the suspect drug, PANVAX until further information is received. Information derived from the AE report does not change the current safety profile of the product. Follow-up information was received from a consumer on 15-Mar-2010. A 60 year old male patient received PANVAX H1N1 influenza vaccine 0.5 ml on 17-Oct-2009. The patient has a medical history of Type 2 diabetes that was only diagnosed a few months earlier. Concomitant medications included unspecified blood pressure medications, cholesterol medications and low dose DIABEX. The patient was also self dosing with anti-flu decongestant (day/night) tablets just prior to the adverse events. Other relevant medical history is not listed. On 17-OCT-2009 at night, the patient experienced headaches. Over the next few days, he also experienced pins and needles in his hands and feet. On 25-NOV-2009, the patient was admitted to the emergency department with total loss of muscle use in the calves of his legs. This progressed upwards to his shoulders on the same day, however he was still able to shrug his shoulders (he was not able to move muscles below shoulders). By 26-Nov-2009, the patient was totally paralysed through to his face. He was transferred to another Hospital on 26-Nov-2009. The patient was put onto a respirator on an unknown date and received INTRAGAM once at one hospital and twice over his weeks at another hospital. The patient died on 31-Jan-2010. Cause of death was reported as related to GBS, respiratory failure and Type 2 diabetes. The reporter consided the case as serious. The company considered events possible to the suspect drug given the time to onset and additional information. Information derived from this AE report does not change the current safety profile of the product. Cause(s) of death due to disease: Type 2 diabetes mellitus, Respiratory failure. Death date: 31-Jan-2010.


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: 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: 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: 362840 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-13
Onset:2009-10-14
   Days after vaccination:1
Submitted: 2009-10-23
   Days after onset:9
Entered: 2009-10-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

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: Unknown
Current Illness:
Preexisting Conditions: Liver transplant
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA02253

Write-up: Information has been received from a health care professional concerning a male patient of unspecified age who had a medical history of liver transplant. The patient received a dose of PNEUMOVAX and a dose of influenza vaccine (manufacturer, batch number, route and site of administration have not been reported). According to the reporter the vaccination may have taken place on 13-OCT-2009. The patient died the day after vaccine administration (it may occurred on 14-OCT-2009). No other information has been reported. Additional information has been requested. Other business partner numbers include E2009-09634.


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: 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: 386863 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2009-10-06
Onset:2009-10-09
   Days after vaccination:3
Submitted: 2010-05-06
   Days after onset:209
Entered: 2010-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR AFLLA285AA / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Culture positive, Death, Influenza, Influenza like illness, Laboratory test, Polymerase chain reaction, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not known; Apparently used home oxygen
Current Illness: Flu like symptoms
Preexisting Conditions: High cholesterol; Diabetes; Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Autopsy - Office of Med Invest - H1N1 by RT-PCR confirmed
CDC Split Type:

Write-up: Apparently had flu-like symptoms starting about 2 OCT 09. He had lab work & flu shot at the Health Clinic, on 6 OCT 09. He had a respiratory arrest at home on 9 OCT 09. H1N1 influenza from lung cultures & Nl Swab at autopsy.


VAERS ID: 363249 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-07
Onset:2009-10-09
   Days after vaccination:2
Submitted: 2009-10-26
   Days after onset:17
Entered: 2009-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ARTERIOSCLEROSIS; DRUNKEN STATE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0598551A

Write-up: This case was reported by a healthcare professional in the frame of an SDE agreement and described the occurrence of death due to acute myocardial infarction in a 59-year-old male subject who was vaccinated with influenza virus vaccine Influenza vaccine (Green Cross Corporation). Concurrent medical conditions included arteriosclerosis. The subject had no concomitant medication. On 7 October 2009 the subject received unspecified dose of Influenza vaccine (intramuscular, unknown injection site). Lot number not provided. On 9 October 2009, 54 hours after vaccination with Influenza vaccine, the subject experienced death due to acute myocardial infarction. The subject was in a drunken state. The subject died on 9 October 2009, cause of death was myocardial infarction. An autopsy was performed and showed serious arteriosclerosis. The healthcare professional and the manufacturer considered the event was unrelated to vaccination with Influenza vaccine. No further information has been requested, the case has been closed.


VAERS ID: 370527 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-09
Onset:2009-10-09
   Days after vaccination:0
Submitted: 2009-11-25
   Days after onset:47
Entered: 2009-11-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain injury, Condition aggravated, Death, Dyspnoea, Hypoxia, Intensive care, Mechanical ventilation, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Morbid obesity; asthma; recent respiratory infection.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009021502

Write-up: Report received from a regulator on 20-NOV-2009. A 59 year old female patient (initials: unknown, DOB: 17-JAN-1950) received PANVAX H1N1 via intramuscular route on 09-OCT-2009. Batch number and expiry for the vaccine is unknown. The patient had a medical history of morbid obesity, asthma and a recent respiratory tract infection. It is unclear if the patient was well at the time of vaccination. The patient''s general practitioner stated that the patient was well at the time of vaccination whilst history from the hospital indicated that she and her husband suffered from cold and flu symptoms in the last few days prior to vaccination. At the time of vaccination, the patient appeared well and stable with no temperature and stated that she was alright. The patient had no immediate local or systemic reactions and was monitored for 15 minutes at the general practitioners surgery and was well when she left the surgery. She also had recently ceased a course of antibiotics. Details of concomitant medications are unknown. On 09-OCT-2009, three and a half hours after PANVAX H1N1 was administered, the patient developed dyspnoea and hypoxia. The patient then suffered respiratory arrest and significant hypoxic brain injury. Resuscitation was performed following hypoxic respiratory arrest. The patient was admitted to the intensive care unit where she was ventilated. These events resulted in a fatal outcome. The patient died on an unknown date after PANVAX H1N1 was administered. Cause of death was reported as possible to the administration of PANVAX H1N1. Investigations into this case are ongoing. The reporter considered events possible to PANVAX H1N1 administration. This case was reported as serious because due to fatal outcome. The company considered events possible to PANVAX H1N1 due to time to onset relationship and other possible confounding factors. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 361119 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-06
Onset:2009-10-08
   Days after vaccination:2
Submitted: 2009-10-15
   Days after onset:7
Entered: 2009-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aneurysm, Back pain, Chest pain, Death
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Atenolol, dosage 25 mg QD, oral; SERITIDE, dosage 250mg BID; SPIRIVA; VENTOLIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009020904

Write-up: Report received from a foreign regulator on 14-OCT-2009. A 77-year old male patient (initials unknown, date of birth: 16/4/1932) received PANVAX H1N1 (batch unknown) intramuscularly on 06-OCT-2009. The patient was taking concomitant atenolol (25 mg daily), Seretide accuhaler (250 mcg twice daily), Spiriva and Ventolin. Approximately 30 hours after vaccination on 08-OCT-2009, the patient had terrible back pain which continued through the night and then commenced chest pains. The patient was advised by the surgery to attend hospital immediately. The patient attended hospital, and died of an aneurysm on 08-OCT-2009. No autopsy results were provided. The regulatory assessed the causality as possible.


VAERS ID: 360751 (history)  
Form: Version 1.0  
Age: 1.04  
Sex: Male  
Location: Michigan  
Vaccinated:2009-10-01
Onset:2009-10-04
   Days after vaccination:3
Submitted: 2009-10-08
   Days after onset:4
Entered: 2009-10-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3178DA / 1 RL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB334BA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF673AA / 4 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0554Y / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0731Y / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-04
   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: Seizure disorder; DANDY WALKER syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was seen on 10/1/09. Death reported on 10/4/09. Pt has seizure disorder along with encephalocele. / DANDY WALKER Syndrome. Had received vaccines on 10/1/09.


VAERS ID: 407253 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Alaska  
Vaccinated:2009-10-03
Onset:2009-10-04
   Days after vaccination:1
Submitted: 2010-11-08
   Days after onset:400
Entered: 2010-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U318AA / UNK RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Cerebrovascular accident, Hemiplegia, Pulmonary congestion
SMQs:, Cardiac failure (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: I do not know if this also included the H1N1 vaccine, but I believe it did. In addition, her doctor may or may not have submitted her to an additional flu vaccination while being hospitalized, within 1-2 weeks of the original vaccine. The
Current Illness: no. (I do not know what time of day the vaccination occurred!)
Preexisting Conditions: She had a permanent enterococcous infection from the hospital hip surgery rec''d four years prior.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: (actual time unk) 1 day after vaccine severe lung congestion. 5 days after vaccine total paralyzation on right side of body, diagnosed as "stroke."


VAERS ID: 359951 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: California  
Vaccinated:2009-10-02
Onset:2009-10-03
   Days after vaccination:1
Submitted: 2009-10-07
   Days after onset:4
Entered: 2009-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97844P2 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Encephalitis, Mental status changes
SMQs:, Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-24
   Days after onset: 52
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 51 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: See report
CDC Split Type:

Write-up: 10/3 - started with mental changes 24 hours after influenza vaccine. Dx with encephalitis.


VAERS ID: 360706 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Virginia  
Vaccinated:2009-10-02
Onset:2009-10-03
   Days after vaccination:1
Submitted: 2009-10-13
   Days after onset:10
Entered: 2009-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 98431P1 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Aricept; Coreg; HCTZ; Lexapro; Lisinopril; Synthroid; Namend; Insulin; Simvastatin
Current Illness: Diabetes; HTN; Dementia; hypothyroidism
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. expired on 10/3/09. Attending MD did not believe immunization was cause of death but reported because of dose temporal proximity. (Pt. expired approx. 24 hrs after receiving the flu vaccine). 10/16/09 Death Certificate: Cardiorespiratory arrest, Diabetes mellitus type 2, Hypertension.


VAERS ID: 360397 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: New York  
Vaccinated:2009-10-02
Onset:2009-10-02
   Days after vaccination:0
Submitted: 2009-10-02
   Days after onset:0
Entered: 2009-10-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 98441P1A / UNK RA / UN

Administered by: Private       Purchased by: Other
Symptoms: Cardiac arrest, Circulatory collapse, Death, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Kidney stones.
Allergies:
Diagnostic Lab Data: None performed
CDC Split Type:

Write-up: Patient to PMD for physical. Was feeling well and received flu vaccine. Upon arriving home minutes later told wife "I don''t feel well" and collapsed. Brought to ED in full cardiac arrest. Unable to resuscitate. 10/19/09 ER records received service date 10/2/09. Assessment: Cardiac Arrest. Patient arrived unresponsive, intubated with CPR in progress. Asystole on monitor with no spontaneous respirations. External trauma to eyes. ICD-9 code 427.5 cardiac arrest. 12/16/09 Death Certificate received. DOD 10/02/09. Cause of Death - Hypertensive and arteriosclerotic heart disease.


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: 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: 361120 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-30
Onset:2009-10-01
   Days after vaccination:1
Submitted: 2009-10-15
   Days after onset:14
Entered: 2009-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cardiac death, Influenza like illness
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: 2009-10-02
   Days after onset: 1
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: cerebral palsy; intellectual disability; epilepsy; foetal alcohol syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009020903

Write-up: Report received from a foreign regulatory on 14-OCT-2009. A 24-year old female patient (initials and date of birth unknown) received PANVAX H1N1 (batch unknown) intramuscularly on 30-SEP-2009. The patient had a history of cerebral palsy, intellectual disability, epilepsy and foetal alcohol syndrome. On 01-OCT-2009, 1 day after PANVAX vaccination, the patient developed flu-like illness. On 02-OCT-2009, the patient developed a cardiac arrest and dies out of hospital. Apart from flu-like illness, pre-arrest clinical information was not known. Full results of a coronial enquiry are expected in 6-12 months. The regulator assessed the causality as possible, and noted the patient was admitted to hospital. The company assessed the event causality as possible in relation to the suspect drug, given the time to onset. However, the company also notes that the patient''s history classified the patient at high-risk of death regardless of vaccine administration and the influenza-like illness may have been indicative of a concomitant viral infection. Information derived from this AE report does not change the safety profile of the product. History of cerebral palsy, intellectual disability, epilepsy and foetal alcohol syndrome. Influenza-like illness may have been indicative of an intercurrent viral infection. No autopsy details available.


VAERS ID: 359602 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2009-09-24
Onset:2009-09-27
   Days after vaccination:3
Submitted: 2009-10-16
   Days after onset:19
Entered: 2009-10-06
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR U3192AA / 2 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Lumbar puncture
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-12
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: kidney stone issues
Preexisting Conditions: hx polio, prostate ca, hyperlipediemia, smokes, emphesema, diverticulitis, hemmroids, ventral hernia, osteoarthritis, skin ca, no allergies. 10/19/09 Physician fax received for date of service 10/12/09.PMH: Post-Polio syndrome. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. PMH: Polio with kyphoscoliosis, atrophy (L) lower extremity and arm. Nephrolithiasis. Carcinoma of prostate. Hyperlipidemia. Diverticulosis / Diverticulitis. Hemorrhoids, tosillectomy, ventral hernia, basal cell carcinoma of skin, osteoarthritis.
Allergies:
Diagnostic Lab Data: LP done. 10/19/09 Physician fax received for date of service 10/12/09. Labs and Diagnostics: EMG: Denervation distally. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. LABS and DIAGNOSTICS: Chest X-ray - Abnormal. EMG - Abnormal. MRI Brain Abnormal. Abdominal US - Abnormal. ECG - Abnormal. CBC - WBC 11.4 (H) RBC 3.47 (L) HGB 11.1 (L) HCT 32.2 (L). CHEM - Glucose 123 (H) Calcium 8.1 (L) ALKPHOSPH 236 (H) AST 171 (H) ALT 287 (H).
CDC Split Type:

Write-up: he had a hard time navigating to the bathroom on 2 separate occasions and is unable to walk on his own. 10/19/09 Physician fax received for date of service 10/12/09. Dx: Death secondary to Guillain-Barre Syndrome. Assessment: Intubated due to GBS. EMG showed denervation distally. Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient. 12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. Assessment: Severe Guillian-Barre Syndrome. Patient developed profound, progressive and generalized weakness over the last 24-36 hours. Numbness toes, feet, fingers. Unable to walk on his own. Peripheral edema. Rhonchi bilateral. Intubated. Subdural hematoma. Hematuria with clots. Gallbladder polyp, Renal cyst. Atrial fibrillation. Sinus Bradycardia. Left ventricular hypertrophy. Nonresponsive to voice / touch. DTR''s absent. IVIG Administered.


VAERS ID: 359582 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2009-09-23
Onset:2009-09-25
   Days after vaccination:2
Submitted: 2009-10-06
   Days after onset:11
Entered: 2009-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97848PIC / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Influenza like illness, Mechanical ventilation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (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: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Psoriasis PMH: psoriasis Allergies: PCN
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: H1N1 (-). Labs: Admission: CBC norm, CMP: Na 127, K-3.2, Albumin-1.9 all Low, Creatinine 2.4, BUN-36, AST-158, ALT-81 all HIgh Viral respiratory panel neg, MRSA screening negative, Urine strep pneumonia antigen negative, Mycoplasma IgM AB negative, Urine Legionella antigen negative, Blood and Urine cultures negative Dx studies/Xrays: CXR multilobar pneumonia , Echocardiogram pericardial effusion
CDC Split Type:

Write-up: Flu like symptoms: Fever, SOB. Was admitted to the hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim autopsy report received with the following findings: Multilobar pneumonia (all lobes severely involved). Post mortem bacterial, fungal, acid fast and viral cultures pending. H1N1 (-). Renal failure probably 2'' to acute tubular necrosis. 10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of fever, malaise. nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and thought to be viral, sx progressed, cough worsened and patient became dyspneic. To hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam, Cleocin, Xigris, Serum Bicarbonate. DC DX''s: Severe Multilobar Pneumonia, Respiratory failure, Renal failure, Metabolic Acidosis. 12/29/09 Autopsy report received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to Legionella, non-pneumophilia species. Additional information abstracted: Patient developed community-acquired bilateral pneumonia causing severe hypoxia and multiorgan system failure.


VAERS ID: 358151 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-09-21
Onset:2009-09-21
   Days after vaccination:0
Submitted: 2009-09-23
   Days after onset:2
Entered: 2009-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA445AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea, Groin pain, No reaction on previous exposure to drug, Resuscitation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-21
   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: Hypertension Arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 150/100mmHg
CDC Split Type: D0062951A

Write-up: This case was reported by an occupational physician via a sales representative and described the occurrence of death - at present cause unknown - in a 54-year-old male subject who was vaccinated with INFLUSPLIT SSW 2009/2010 (GlaxoSmithKline). Concurrent medical conditions included hypertension arterial. Latest value of blood pressure determined was 150/100 mmHg. Otherwise, the subject has no known underlying or concurrent medical conditions or other risk factors. Previous vaccinations included seasonal trivalent influenza vaccine, manufacturer not specified, given annually since years. On 21 September 2009 in the morning the subject received a dose of INFLUSPLIT SSW 2009/2010 (0.5 ml, unknown). Less than one day post vaccination with INFLUSPLIT SSW 2009/2010, on 21 September 2009 at around 22:00, the subject returned from work and was complaining about groin pain and dyspnea. An emergency physician was called. Less than one day post vaccination with INFLUSPLIT SSW 2009/2010, in the night from 21 September 2009 to 22 September 2009, the subject died. At present the cause of death was unknown. Resuscitation, performed by the emergency physician, was without success. It was unknown whether an autopsy was or will be performed. According to information provided by the sales representative the physician considered that the events might be unrelated to INFLUSPLIT SSW 2009/2010. Follow-up information has been requested.


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: 381986 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-09-08
Onset:2009-09-10
   Days after vaccination:2
Submitted: 2010-03-05
   Days after onset:176
Entered: 2010-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 89881 / 2 UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Computerised tomogram, Convulsion, Lumbar puncture normal, Nuclear magnetic resonance imaging, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-20
   Days after onset: 283
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: sinus infection
Preexisting Conditions: tingling in face, began having seizures.
Allergies:
Diagnostic Lab Data: patient has had two lumbar punctures with negative results, numerous MRI''s and CT''s.
CDC Split Type:

Write-up: tin.


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: 386368 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Male  
Location: Foreign  
Vaccinated:2009-04-08
Onset:2009-04-08
   Days after vaccination:0
Submitted: 2010-04-29
   Days after onset:386
Entered: 2010-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090623502 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus test positive, Autopsy, Cough, Death, Feeling hot, Nasopharyngitis, Pathology test, Respiratory disorder, Skin warm, Toxicologic test normal, X-ray normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022518

Write-up: Report received from a foreign regulator on 23-APR-2010 (case: 258197). A 1 year and 3 month old male patient received FLUVAX (batch 0906-23502) on 08-APR-2009. The patient''s medical history and concomitant medications were unknown. The patient had a cough, fever, runny nose and cold like symptoms. for 2 weeks prior to vaccination. On 08-APR-2009, the day of vaccination, the patient had a slight cough, felt warm and was given infant paracetamol. He was found deceased that evening. Autopsy showed evidence of intercurrent respiratory illness (viral swabs identified adenovirus). However, there was no evidence of pneumonia or pneumonitis to account for the death. At autopsy, the infant was found to be a well nourished, normal formed male child. No cause of death was identified. No anatomical, radiological, toxicological, biochemistry or infective cause was found for the death. There were no injuries or other markings to indicate other than natural causes of death. The case was consistent with sudden unexplained death in childhood. The history of vaccination was noted and the pathologist found no evidence at autopsy that the vaccine contributed to death. It was noted that childhood vaccination have been shown in most studies to reduce the incidence of sudden death in childhood. The reporter considered events possible to the suspect drug, FLUVAX. The case was reported as serious due to death. The company considered events possible to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product. Batch review results were received for 090623502 on 23-APR-2010. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot was assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Cause of death is unknown. Death Date: 08-APR-2009.


VAERS ID: 345447 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-17
Onset:2009-04-01
   Days after vaccination:166
Submitted: 2009-05-01
   Days after onset:30
Entered: 2009-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA348A / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-01
   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: Unknown
Preexisting Conditions: Contact dermatitis or other eczema, Hypertension, Other musculoskeletal system and connective tissue disorder.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: R0004010A

Write-up: This female subject was enrolled in a study. On 17 October 2008, she received one dose of FLUARIX or influenza vaccine adjuvanted with half dose of AS03 (FLU NG). This subject received FLUARIX (lot AFLUA348A). On 01 April 2009, five months after the dose of Blinded vaccine, this 82-year-old subject died, cause of death is unknown. It was unknown whether an autopsy was performed. Investigator causality was unknown at the time of reporting. MEDICAL HISTORY AT STUDY START: Contact dermatitis or other eczema, Hypertension, Other musculoskeletal system and connective tissue disorder.


VAERS ID: 340286 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: California  
Vaccinated:2009-01-23
Onset:2009-02-13
   Days after vaccination:21
Submitted: 2009-02-20
   Days after onset:7
Entered: 2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2808AA / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Chest X-ray abnormal, Cough, Influenza serology positive, Pneumonia, Pyrexia, Staphylococcus identification test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-03-21
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 35 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Staph Aureus; Infl B positive; X ray chest diffuse pneumonia LABS: Admit labs: WBC 0.9(L), plts 41K(L) CRP 26.6(H), RA factor 16(H).Drug screen neg. Head CT WNL. Bone marrow biopsy.
CDC Split Type:

Write-up: Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA. 5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions. Autopsy limited to lung only. 4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing. Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia. Pulm, ID, heme consults done. Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG. Progressively declined, extubated per family request & expired shortly therafter.


VAERS ID: 342393 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: New York  
Vaccinated:2008-10-10
Onset:2009-02-13
   Days after vaccination:126
Submitted: 2009-03-23
   Days after onset:37
Entered: 2009-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 27A3EA / UNK UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza serology positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-15
   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:
Current Illness: None
Preexisting Conditions: Ventral Septal Defect 5/20/09-records received-Clinical history of patent ductus arteriosus and ventricular septal defect. Slit-like communication between atria. One of twins.
Allergies:
Diagnostic Lab Data: Flu A cultured; IVP, brain, heart 5/20/09-records received-CXR negative.
CDC Split Type:

Write-up: Possible vaccine failure. Child expired with Flu A cultured. 5/20/09-autopsy report received-COD-cardiopulmonary arrest. Due to: systemic infection with influenza type A/H1. Sudden onset of muscle and leg cramps on 2/14/09, URI symptoms last day or so including sore throat. Suddenly developed tachypnea fever and diaphoresis within 20n minutes of onset of leg cramps. In ED fever of 107, tachycardia and dyspnea, developed flutter then bradycardia. Intubated, v-tach, coded and expired.


VAERS ID: 340925 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Texas  
Vaccinated:2009-01-14
Onset:2009-02-10
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2009-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C2903AA / 3 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2794CA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C83143 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1172X / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-10
   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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died of influenza A on 2/10/09. 3/16/09-preliminary anatomic diagnoses received-Influenza A infection with Staphylococcus aureus superinfection and septic shock. Bilateral hemorrhagic bronchopneumonia. Staphylococcus aureus isolated on postmortem lung culture;antibiotic sensitivity pending. Influenza A virus identified by PCR testing on antemortem tracheal aspirate. Bilateral adrenal hemorrhage Waterhouse-Friderichsen syndrome). Coagulopathy widespread glomerular microthrombi. Congestive organomegaly, lungs, liver, kidneys and spleen. Admitted 2/10/09.


VAERS ID: 338667 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2009-01-27
Onset:2009-01-28
   Days after vaccination:1
Submitted: 2009-01-28
   Days after onset:0
Entered: 2009-01-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2810AA / 2 RL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB274AD / 1 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1369X / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 021052 / 4 RL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1406X / 1 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Autopsy
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-28
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy is being performed
CDC Split Type:

Write-up: Sudden death at home morning of 1/28/09. 6/1/09 Autopsy report states COD as sudden unexpected infant death & manner of death as natural. Report also states patient found dead in crib, tox screens & cultures all neg.


VAERS ID: 336785 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Illinois  
Vaccinated:2008-12-18
Onset:2008-12-19
   Days after vaccination:1
Submitted: 2009-01-07
   Days after onset:19
Entered: 2009-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2792CA / 1 RL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB319AB / 1 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1083X / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1317X / 1 LL / UN

Administered by: Public       Purchased by: Public
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None, healthy
Preexisting Conditions: Extra digit both hands at birth - tied; H/O drugs use in, child was in D 2/17/09-records received-sickle cell anemia trait
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient seen on 12/18/08, received immunizations, had low grade fever next day and then was brought to ER lifeless. 2/17/09-records received COB bacterial sepsis. Other significant conditions contributing to death but not related to terminal conditions:sickle cell anemia trait. krk


VAERS ID: 336129 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Mississippi  
Vaccinated:2008-12-15
Onset:2008-12-17
   Days after vaccination:2
Submitted: 2008-12-22
   Days after onset:5
Entered: 2008-12-29
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3174AA / 1 LL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2797CA / 1 LL / UN
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 1719U / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C52997 / 3 RL / UN

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Autopsy, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-17
   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:
Current Illness: Cough congestion
Preexisting Conditions: Reflux
Allergies:
Diagnostic Lab Data: Autopsy - report showed accidental suffocation as COD.
CDC Split Type:

Write-up: Death - Mom discovered infant''s head wedged between pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive asphyxia. Compressive markings of skin of chest, shoulders and sides of face. Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic junctions, right more than left.


VAERS ID: 359853 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2008-10-16
Onset:2008-12-11
   Days after vaccination:56
Submitted: 2009-10-06
   Days after onset:298
Entered: 2009-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA184AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Leukaemia, Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-01
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Lymphoma
Preexisting Conditions: Chemotherapy; Radiotherapy 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. PMH: Thrombocytopenia, non-Hodgkin''s lymphoma, pacemaker, myelodysplastic syndrome, hyponatremia. 10/15/09 Medical records received for date of service 10/9/08. PMH: None.
Allergies:
Diagnostic Lab Data: Unknown 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. Diagnostics/Labs: CT abdomen and pelvis–RUQ mass, bilateral pleural effusion. CXR-decreased inspiration w/ basilar effusion/atelectasis. US RUQ - cholecystitis. EKG WNL. Platelet 13(L), HGB 9.8(L), HCT 30.8(L), BUN 28(H), urine culture(+) E-coli.10/15/09 Medical records received for date of service 10/9/08. Diagnostics and Labs: None.
CDC Split Type: WAES0910USA00329

Write-up: Information has been received from a consumer concerning his approximately 78 year old wife with lymphoma diagnosed in February 2007. The patient was underwent chemotherapy and radiation. In December 2007 she experienced a recurrent lymphoma and was prescribed oral chemotherapy from January 2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia and experienced recurrence of lymphoma. On an unspecified date she was hospitalized. She received unspecified treatment which was unsuccessful. The patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No further information is available. 10/13/09 Hospital records and DC summary received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in back and both hips. Assessment: Pt found to have fever. Pt treated for current medical conditions and acute conditions and DC to rehab facility. 10/15/09 Medical records received for date of service 10/9/08. Shingles (Zostavax) vaccine administered on 10/9/08. Physician reports that pt. did not call office to report an adverse reaction. 10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic syndrome. Acute myelogenous leukemia. Anemia.


VAERS ID: 334611 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Illinois  
Vaccinated:2008-11-26
Onset:2008-12-08
   Days after vaccination:12
Submitted: 2008-12-10
   Days after onset:2
Entered: 2008-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500569P / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0070X / 3 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2730AA / UNK RA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Headache, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-08
   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: None known. ?? oral contraceptive or an antibiotic for acne.
Current Illness: None.
Preexisting Conditions: Acne. PMH: PCN allergy. Acne. On OCs (Yaz). 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin.
Allergies:
Diagnostic Lab Data: Autopsy performed 12-9-08 was unrevealing per family verbal report to me; no signs of intracranial bleed, meningitis, cardiomyopathy, trauma. Toxicology report still pending at this time. Post-mortem tox screen (-).
CDC Split Type:

Write-up: Patient, a previously healthy 19 year-old female college freshman died suddenly yesterday, approximately 10 days after receiving Gardasil & menningococcal vaccines. Vaccines were administered by a medical provider in her hometown while she was home for the Thanksgiving holiday, sometime around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her death) with the Student Health Service; medical clerk had entered "possible seizure" as the reason for making the appointment. Patient had no history of epilepsy. She complained of a headache and not feeling well in the 24 hours prior to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a roomate. She appeared to still be sleeping the next morning when her roomate left for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with rigor mortis. No history of substance abuse, alcohol intake, or depression or other mental health issues. She was a happy, achieving student. This report is filed by a friend of patient''s parents, who is a physician (board certified internal medicine & geriatrics). Report also filed online today with the FDA. Patient''s mother can be reached at home for additional details. Memorial service & funeral 12-12-08 and 12-13-08. Only known past medical history requiring physician attention was facial acne. 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema, purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment: Probable viral URI with ? sinusitis. Tx: Biaxin. Received from CDC via email: The patient had no previous health problems. She was a freshman and was seen at the college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth control pills and a topical acne medication. After the death, police questioned her roommate who said that the pt did go out on the evening of 12/6/08 and had a few alcoholic drinks, but not an excessive amount. She had a HA the next day and thought it was from the alcohol. She had a PCN allergy and was a non smoker. 12/11/2008 Records received from PCP. HPV#1 1/18/2008. HPV#2 3/28/2008. Vaccines deferred 7/29/2008 2'' to oral prednisone usage for acne (with Bactrim). Seen 8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for vaccines 11/26/2008 in good health with normal exam. Additional record also received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes (one 1 month ago and one on the day of death) of waking up in a cold sweat, having urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt made for ? seizure. Pt did not arrive for appt. 3/3/09 Autopsy report received. COD: Unable to ascertain after autopsy, microscopic, toxicologic and chemical evaluation.


VAERS ID: 334613 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-25
Onset:2008-11-30
   Days after vaccination:5
Submitted: 2008-12-09
   Days after onset:9
Entered: 2008-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR D0632 / UNK UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB192AD / 1 UN / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-11-30
   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:
Current Illness: Dysphagia; Infantile cerebral paralysis; Percutaneous endoscopic gastrostomy; Possible gastroesophageal reflux; Spastic paresis
Preexisting Conditions: Previous vaccinations have been well tolerated.
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: D0059792A

Write-up: This case was reported by a regulatory authority (foreign regulatory authority (vaccines, biologicals) # DE-PEI-PEI2008019287) and described the occurrence of death from an unknown cause in a 4-year-old male subject who was vaccinated with HAVRIX 720 Junior (GlaxoSmithKline). Co-suspect vaccinations MUTAGRIP 2008/2009 (Sanofi Pasteur MSD). Concurrent medical conditions included infantile spastic cerebral paresis, dysphagia, possible gastroesophageal reflux and percutaneous endoscopic gastrostomy tube insertion. Previous vaccinations included seasonal influenza virus vaccine (non-GSK) (MUTAGRIP 2006/2007, Sanofi Pasteur MSD) and seasonal influenza virus vaccine (non-GSK) (MUTAGRIP 2007/2008, Sanofi Pasteur MSD), given on 02 November 2006 and 27 November 2007, respectively. Previous vaccinations have been well tolerated. On 25 November 2008 the subject received the first dose of HAVRIX 720 Junior (0.5 ml, intramuscular, unknown deltoid) and a dose of MUTAGRIP 2008/2009 (intramuscular, unknown deltoid). Approximately five days post vaccination with HAVRIX 720 Junior and MUTAGRIP 2008/2009, on 30 November 2008 at 07:00, the subject died from an unknown cause. An autopsy was not performed. The subject was buried on 03 December 2008. The reporter stated having reported this case only due to timely relationship between death and vaccination with HAVRIX 720 Junior and MUTAGRIP 2008/2009. No further information will be available.


VAERS ID: 333759 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2008-11-21
Onset:2008-11-26
   Days after vaccination:5
Submitted: 2008-11-28
   Days after onset:2
Entered: 2008-12-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B198AA / 3 LL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U22787CA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D03125 / 3 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 09688 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac
Current Illness: Minimal URI
Preexisting Conditions: "Snoring" per ENT; No sleep apnea; GERD 3/9/09-records received-per parent patient suffered from sleep apnea from birth and sometimes snore when sleeping. Antibiotic therapy for recent throat problem. Born 4 weeks premature.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 5 days after vaccines administered pt was found face-down in crib not breathing. Resuscitation not successful. No other signs of illness. Presumed SIDS vs suffocation. 3/9/09-autopsy report received-COD Sudden Infant Death Syndrome.


VAERS ID: 337669 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Michigan  
Vaccinated:2008-11-17
Onset:2008-11-24
   Days after vaccination:7
Submitted: 2009-01-19
   Days after onset:56
Entered: 2009-01-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2788FA / 1 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB213AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF222AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0807U / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C50457 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1517U / 1 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Death, Dyspnoea, Hypotonia, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None - normal
Preexisting Conditions: ? slight allergy 6-10-08; Hx otitis media . PMH: PCP records reveal normal childhood illnesses (OM, URI, bronchits) in 1st yr of life. Excessive wt gain noted at 3 months.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: CXR (+) for R pneumpthorax, pneumomediastinum, and probable L pneumothorax.
CDC Split Type:

Write-up: Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR #1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later "barely breathing"; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-died at local hospital a couple of hours later. 2/12/09 PCP and hospital records received from FDA. Pt with mild fever 11/24/08 put down to nap. Ptfound to be diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160, RR 32 with rhonchi bilaterally R$gL. Dx with severe croup at local hospital with transport planned to higher level of care. In ER unresponsive in severe respiratory distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression- Respiratory Failure. Cardiac arrest. CPR unsuccesful. 3/25/09 Autopsy report received with COD: Community Acquired Pneumonia. Manner of Death: natural. Final DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms purulent multifocal pneumonia. 2) Moderate Cerebral Edema. 3) Serous Pleural and Peritoneal Effusions.


VAERS ID: 350518 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-18
Onset:2008-11-18
   Days after vaccination:0
Submitted: 2009-06-30
   Days after onset:223
Entered: 2009-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA223AA / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER B0445 / UNK UN / UN

Administered by: Other       Purchased by: Other
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: 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0792799A

Write-up: This case was reported by a nurse via a regulatory authority (# V0900342) and described the occurrence of sudden death in a 66-year-old male subject who was vaccinated with FLUVIRAL (GlaxoSmithKline), PNEUMO (non-GSK). On 18 November 2008 the subject received unspecified dose of FLUVIRAL (unknown), unspecified dose of PNEUMO (Non-GSK) (unknown). On 18 November 2008, 5 hours after vaccination with FLUVIRAL and PNEUMO (Non-GSK), the subject experienced sudden death. The subject died from death (unknown cause) (nos). It was unknown whether an autopsy was performed.


VAERS ID: 333284 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Florida  
Vaccinated:2008-11-06
Onset:2008-11-13
   Days after vaccination:7
Submitted: 2008-11-25
   Days after onset:12
Entered: 2008-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA209AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Disorientation, Encephalitis, Intensive care
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-12-20
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 37 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Cozaar, Lipitor, Flomax
Current Illness: None
Preexisting Conditions: Hypertension, hyperlipidemia, benign prostatic hypertrophy PMH: obesity, kidney stones,
Allergies:
Diagnostic Lab Data: LABS: Brain biopsy. CSF: WBC 141( H), lprotein 135(H), glucose 161(H), c/s (+) strep grp B & S. simulu. Initial CT brain scan, MRI brain & CXR WNL. Later CT brain revealed bilateral SDHs. Paracentesis fluid: WBC 1822(H), lymphs 5%(H), polys 95%(H), c/s (+) candida. CBC, ammonia, B12, folic acid, ESR, TSH WNL. LFTs (H). Sodium 133. UA abnormal. Blood c/s (+)E.faecal, E. coli, S. Eeider, candida. Urine c/s (+) E. coli & candida. Sputum c/s(+) psuedomonas & Strep Grp B. EEG c/w diffuse encephalopathy, no seizures. CT abdomen & renal US (+) multiple nonobstructing bladder & kidney stones. US doppler of LEs neg.
CDC Split Type:

Write-up: Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis. Presently in an intensive care unit at Medical Center. 1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated. Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week. Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs. Fever 101.5 in ER. ID, Neuro, Uro, Nephro, Pulmo, Heme consults done. Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress. Admitted ICU & intubated. LP done. Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis. Continued downhill course & transferred to hospice on 12/20/08.


VAERS ID: 362042 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-11
Onset:2008-11-13
   Days after vaccination:2
Submitted: 2009-10-20
   Days after onset:340
Entered: 2009-10-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 098612001 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Influenza like illness
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-01-08
   Days after onset: 56
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: Amlodipine; ASPIRIN ARROW; BIMATOPROST; Bisoprolol; Omeprazole; Simvastatin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2009020947

Write-up: Report received via a regulator. A male patient (patient initials, date of birth and age : unknown) received ENZIRA (influenza vaccine) on 11-NOV-2008. The batch number used was 098612001. Concomitant medications included amlodipine 5 mg taken orally daily for hypertension started on 27-NOV-2008, aspirin 75 mg taken orally daily started on ??-???-2007, bimatoprast for ophthalmic use indicated for glaucoma started on ??-???-2005, bisoprolol, 1.25mg taken orally daily started on ??-???-2007, omeprazole 20 mg taken orally daily for gastric ulcer prophylaxis started on 06-OCT-2008 and simvastatin 40 mg taken orally daily started on ??-???-2007. It is unknown if the patient had any other relevant medical conditions. On 13-NOV-2008, 2 days after ENZIRA was received, the patient developed a flu-like illness. On 28-NOV-2008, 17 days after ENZIRA was administered, the patient developed GUILLAIN BARRE Syndrome. The reaction duration specified for GUILLAIN BARRE Syndrome was 41 days with a recovery time of 58 days. The patient was admitted to hospital. The patient died on 08-JAN-2009, just under two months after vaccination. The patient was treated with amoxycillin 500 mg three times daily and cefadroxil 500 mg twice daily for the flu-like symptoms. The reporter considered this case serious due to death and that the cause of death was due to GUILLAIN BARRE Syndrome. No other details were provided regarding patient death. The company considered events as possible in relation to ENZIRA administration. Information derived from this AE report does not change the current safety profile of the product. Cause(s) of death: GUILLAIN BARRE syndrome. Death Date: 08-Jan-2009.


VAERS ID: 333752 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-11
Onset:2008-11-11
   Days after vaccination:0
Submitted: 2008-12-03
   Days after onset:22
Entered: 2008-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA362BA / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Inappropriate schedule of drug administration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-28
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Handicap; Living in nursing home; Neonatal brain damage; Renal function impairment; Spasticity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: D0059689A

Write-up: This case was reported by a physician and described the occurrence of death due to renal failure in an approximately 43-year-old male subject who was vaccinated with INFLUSPLIT SSW 2008/2009 (GlaxoSmithKline). Concurrent medical conditions included neonatal brain damage, pre-existing renal function impairment and spasticity. The subject was very severely handicapped and was living in nursing home. On 30 September 2008 the subject received the first dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, unknown). On 11 November 2008 the subject received by error the second dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, unknown). This vaccination with the second dose of INFLUSPLIT SSW 2008/2009 was inappropriate. According to initial information, the subject died from renal failure on 26 November 2008, approximately 15 days post vaccination with the second dose of INFLUSPLIT SSW 2008/2009. According to follow-up information, the subject died from renal failure on 28 November 2008, approximately 17 days post vaccination with the second dose of INFLUSPLIT SSW 2008/2009. It was unknown whether or not an autopsy was performed. The reporting physician considered that the event was unrelated to vaccination with INFLUSPLIT SSW 2008/2009 and vaccination with the second dose of INFLUSPLIT SSW 2008/2009. Follow-up information has been requested.


VAERS ID: 422403 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: California  
Vaccinated:2008-11-05
Onset:2008-11-08
   Days after vaccination:3
Submitted: 2011-05-08
   Days after onset:910
Entered: 2011-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 88805 / UNK RA / IJ

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Lumbar puncture abnormal, Malaise, Mechanical ventilation, Paraesthesia, Paralysis, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-05-20
   Days after onset: 192
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: None~ ()~~0.00~Patient
Other Medications: Arthritis Medication (Unknown)
Current Illness: None
Preexisting Conditions: Lumbar area fused in the 1980''s. Metal rod in wrist in the early 90''s due to job related accident.
Allergies:
Diagnostic Lab Data: Spinal Tap revealed Guillain Barre.
CDC Split Type:

Write-up: Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08


VAERS ID: 335268 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-07
Onset:2008-11-07
   Days after vaccination:0
Submitted: 2008-12-12
   Days after onset:35
Entered: 2008-12-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: 07-Nov-2008; Osteoarthritis; Shoulder pain; Spondylosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814428

Write-up: Report received from the agency (No.: GB-MHRA--ADR20347390): An 82-year-old female patient (initials and date of birth unknown) was vaccinated with ENZIRA (CLS influenza vaccine, lot number unknown) 0.5mL by intramuscular injection on 07-Nov-2008. The patient died on the same day as vaccine injection. The death was reported as unexplained. A post mortem report is awaited.


VAERS ID: 416222 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-06
Onset:2008-11-06
   Days after vaccination:0
Submitted: 2011-02-04
   Days after onset:820
Entered: 2011-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Erythema, Rash, Swelling, T-cell lymphoma
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0696393A

Write-up: This case was reported by a consumer and described the occurrence of t-cell lymphoma in a 69-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 6 November 2008, the subject received an unspecified dose of FLUARIX (intramuscular, administration site unknown, batch number not provided). On 6 November 2008, less than one day after vaccination with FLUARIX, the subject experienced swollen, rash and erythema. In May 2010, 18 months after vaccination with FLUARIX, the subject experienced t-cell lymphoma. On an unspecified date, the subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 332152 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-05
Onset:2008-11-05
   Days after vaccination:0
Submitted: 2008-11-12
   Days after onset:7
Entered: 2008-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Condition aggravated, Death
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0545050A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included asthma in stationary phase. On 5 November 2008, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). Lot number not provided. On 5 November 2008, in the evening, less than one day after vaccination with FLUARIX, the subject experienced asthmatic attack and died. The physician considered the events were unrelated to vaccination with FLUARIX. The subject died on 5 November 2008, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 330558 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Maine  
Vaccinated:2008-10-13
Onset:2008-10-25
   Days after vaccination:12
Submitted: 2008-10-27
   Days after onset:2
Entered: 2008-10-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500536P / UNK NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood alkaline phosphatase normal, Blood potassium increased, Blood sodium increased, Eosinophil count increased, Lymphocyte count increased, Neutrophil count decreased, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (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: 2008-10-25
   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: 11/3/08-records received-completed prednisone taper day prior after Flumist.
Preexisting Conditions: Asthma, Nuts 11/3/08-records received- PMH-Multiple allergies. Asthma. Lung disease.
Allergies:
Diagnostic Lab Data: K, 5.2; Na, 150; Cl, 108; Alk phos, 157; Lymp, 45.3; Neut, 35; EOS, 10
CDC Split Type:

Write-up: 515 Child not breathing at home - brought to ED by POV. 525 Arrived in ED, full arrest at that time. Vitals monitor. 0544 ETT placed, Epi. 11/3/08-records received from ED for DOS 10/25/08-presented to ED dyspnea, unresponsive ventricular fibrillation. At home acutely SOB 6/23/09-death certficate and autopsy report received-COD Status asthmaticus. Lymphocytic bronchitis.


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