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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: 332724 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Utah  
Vaccinated:2008-10-23
Onset:2008-10-23
   Days after vaccination:0
Submitted: 2008-11-18
   Days after onset:26
Entered: 2008-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2805AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hypersensitivity, Oedema peripheral, Rash, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-13
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: liptor, spironolactone, lanoxin, allopurinol, macrobid, plaquinil, hydrochlorthiazide, quinapril
Current Illness:
Preexisting Conditions: Rheumatoid arthritis, osteoperois, gout, chronic UTI, hyperlipid, chf. 12/29/08-records received-PMH: rheumatoid arthritis. status post mitral valvle replacement. status post left mastectomy for breast cancer. chronic UTI. osteoporosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: she presneted 10/23 for a blood pressure check up and in the course of that we did an annual flu shot for her. See the flu shot note: 10/23/08 The following questions were answered by the patient: Are you currently ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No Have you ever had a severe allergic reaction after getting the flu vaccine? (difficulty breathing, aiway swelling, hives, etc.) No Patient was given the opportunity to ask questions prior to immunization and have them answered to their satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009 Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08 Dose: 0.5 ml Site: left deltoid She then reproted on 10/31 with swelling in hands and feet and rash. It looked like allergic reaction. she was not ill so we treated her as an out patient. she called a few days later and was getting worse. I had her admitted to hospital. I have not received a formal report. One of the diagnosis that was on the top of the list was influenza vaccine vasculitis. she was not getting better. The Dr. that was caring for her reported that her dau, a hospice nurse talked to her about what was going on and patient decieded to not have any more needle pokes or evaluation. She was sent to nursing home and died the next day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis. acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated. Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate states COD as acute renal failure with vasculitis & immunologic reaction as contributing factors.


VAERS ID: 330148 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Male  
Location: Colorado  
Vaccinated:2008-10-21
Onset:2008-10-22
   Days after vaccination:1
Submitted: 2008-10-27
   Days after onset:5
Entered: 2008-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UA2828AA / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted at well child check done at time of visit.
Preexisting Conditions: Previous UTI, VCUG done with normal results, and hernia (resolved)
Allergies:
Diagnostic Lab Data: Per pathologist unsure of cause of death at this time, lab work being done ? SIDs, also noted no erythemia or swelling at injection site.
CDC Split Type:

Write-up: Patient received Fluzone on Monday 10.21.08, and died on Tuesday pm on 10.22.08 12/18/08 Autopsy report states COD as sudden unexplained infant death. Manner of death is undetermined. Report also states patient getting over cold w/runny nose & cough, no fever, on day of vaccination. Had been put to sleep on back & found on stomach in crib.


VAERS ID: 331269 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Maryland  
Vaccinated:2008-10-21
Onset:2008-10-22
   Days after vaccination:1
Submitted: 2008-11-04
   Days after onset:13
Entered: 2008-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA181AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Malaise, Mechanical ventilation, Pneumonia
SMQs:, Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-11-13
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Multivitmin
Current Illness: Upper respiratory symptoms, fatigue
Preexisting Conditions: HX OF MACROCYTIC ANEMIA/1988/SEEN BY HEMATOLOGIST 2002/WAS TO HAVE BONE MARROW BX HX OF SMOKING/1 PPD X 44 YEARS/WEARING PATCH HX OF (L) HIP PAIN ASSOCIATED WITH PRIOR TORN LIGAMENT WHICH HAS CALCIFIED/S/P PT AND CORTISONE INJECTIONS #2 2001 HX OF FATIGUE WEARS H/F RESPIRATOR APPROX. 2 X PER YEAR WHEN WORKING WITH AIRHANDLER''S EXHAUST FUMES HX OF LOW HDL''S S/P LUMBAR LAMINECTOMIES 3/25/03 (L3,4,5) S/P THORACIC NERVE PROBLEM 12/03/SENT FOR MRI/DDD AND SPURS FOUND/SEES PT 2 X PER WEEK (1 1/2 MONTHS)/WILL CONTINUE WITH HOME EXERCISES Quit smoking entirely 12/2005 Full cardiac workup in 2006 including Cardiolyte Stress Test - normal, CXR. Workup done d/t mild intermittent chest symptoms, fatigue PMH: COPD, DM type 2, GERD, spinal stenosis s/p laminectomy, squamous cell carcinaoma of ear. NKDA
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: Chest CT (+) for opacity superimposed on severe pulmonary fibrosis, later (+) for PE. Doppler (+) for DVT. Head CT (-). HIT antibody (+). Bonchoscopy (+) for diffuse alveolar hemorrhage and severe pulmonary fibrosis. CT abd/pelvis suggestive of inflammatory or infectious colitis.
CDC Split Type:

Write-up: Employee presented in the occupational Health clinic on 10/21/08 for a influenza vaccination. He told the RN that he had a mild URI illness but no fever and he consented to getting Flulaval after a brief discussion about postponing it until he felt well. The following day he was admitted to Hospital from home with possible pneumonia. Within days he was transferred by helicopter to Medical System where he remains in treatment. The information we have comes via his supervisor. He is reportedly on a ventilator and receiving steroids. We have provided the hospital with the employee medical record. 12/22/2008 MR received for DOS 10/24-11/13/2008 with D/C DX: Acute interstitial pneumonitis, respiratory failure, pulmonary embolism, acute renal failure and death. Pt transferred from local hospital (admitted 10/22/08)for hypoxemic respiratory failure following 6 months of progressive dyspnea and evaluation for lung transplant. On admission T=96.5''F, intubated and sedated with O2 sat of 96%, coarse bilateral breath sounds and tachycardic. Tx for pneumonia but developed DVT with PE which was symptomatic on 11/10/08. Started on heparin but unable to be aroused from sedation. Platelet count dropped. Pt suffered a PEA arrest on 11/13/08 with restoration of BP and heartrate with CPR however BP difficult to maintain despite high dose pressors. Life support withdrawn and pt died at 10:41 on 11/13/08. Autopsy reports COD as Pulmonary Fibrosis due to a combination of acute pneumonia and organizing diffuse alveolar damage superimposed on a background of chronic interstitial lung disease and emphysema.


VAERS ID: 335622 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Kansas  
Vaccinated:2008-10-16
Onset:2008-10-18
   Days after vaccination:2
Submitted: 2008-12-18
   Days after onset:61
Entered: 2008-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 2761AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy brain abnormal, Death, Demyelination, Gait disturbance, Hemiparesis, JC virus infection, Laboratory test abnormal, Nuclear magnetic resonance imaging brain abnormal, Progressive multifocal leukoencephalopathy, Speech disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-11
   Days after onset: 54
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 34 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Albuterol-2 puffs QID, Flovent-1 puff QD, Avapro 150mg PO QD, Calcium Carbonate 1 tablet PO QD, Lasix 40mg PO QD, Asprin 81mg PO QD, Fish Oil 1000mg PO QD, Plavix 75mg PO QD, Prandin 2mg PO QD, Zocor 40mg PO QD.
Current Illness: None
Preexisting Conditions: COPD- well controlled, Diabetes Type 2, wel controlled. PMH: DM, Dyslipidemia, COPD, HTN, ? CHF, Allergies to sulfa, PCN, doxycycline, yellow dye #2.
Allergies:
Diagnostic Lab Data: 11/10/08 MRI: Acute Inflamatory process in both frontal lobes crossing the Corpus Callosum, consistent with encephalitis. On 11/24/08, open brain biopsy showed demyelination consistent with progressive multifocal leukoencephalopathy. On 12/08/08, testing showed the presence of JC Virus. Labs and Diagnostics: MRI brain (+) for possible subacute R frontal stroke, later determined to be acute inflammatory process. Repeat showed progression. MRA (+) for severe focal stenosis. LP showed no sign of infection. Myelin basic protein elevated. Neuron specific enolase (+). EEG (+) for background slowing. PCR and viral tests for HSV, CMV, HZV, West Nile, enterovirus, EBV, Lyme all (-). CXR (+) for atelectasis and possible pleural effusion. Brain bx (+) for JC virus.
CDC Split Type:

Write-up: Pt initally presented to hospital on 10/20-10/26/08 with gait instability, garbled speech and Left sided weakness. Pt was re-admitted to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal Leukoencephalopathy. Pt''s neurological status deteriorated until pt expired on 12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008. Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt presented to local hospital 10/20-26/08 with respiratory distress and admitted for COPD exacerbation and CHF. Also having sx of L sided weakness attributed to possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued to progress with worsening psychomotor retardation. Pt transferred to rehab for several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative bilateral frontal lobe process, extending into the brain stem, possible postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN, DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09 Death Cert received. COD: Progressive Multifocal Leukoencephalopathy.


VAERS ID: 359066 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: D.C.  
Vaccinated:2008-10-13
Onset:2008-10-14
   Days after vaccination:1
Submitted: 2009-10-01
   Days after onset:352
Entered: 2009-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 08132 / 5 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Anaphylactic shock, Angioedema, Blood glucose increased, Death
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOVOLOG; Insulin; Glypizide; Benazepril, etc.
Current Illness: Diabetes; Hyperlipidemia
Preexisting Conditions: Hypertension; Arteriosclerosis; Anemia; Glaucoma, etc.
Allergies:
Diagnostic Lab Data: Blood sugar - Accucheck 444/424
CDC Split Type:

Write-up: Anaphylaxis shock. Angioedema. Death.


VAERS ID: 328577 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Texas  
Vaccinated:2008-10-13
Onset:2008-10-13
   Days after vaccination:0
Submitted: 2008-10-15
   Days after onset:2
Entered: 2008-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2802AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Post Knee replacement
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was vaccinated on 10/13/2008 in the AM. He ate lunch then went to Physical Therapy for rehabilitation following knee replacement surgery. He died during his PT appointment. 5/5/09-death certificate received-Final COD cardio pulmonary arrest.


VAERS ID: 329902 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-13
Onset:2008-10-13
   Days after vaccination:0
Submitted: 2008-10-23
   Days after onset:10
Entered: 2008-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0986K009 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: 13-Oct-2008; The patient had a history of hypertension.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814197

Write-up: Report received from the foreign regulatory authority via a foreign license partner on 20-OCT-2008. A 70 year old male patient (initial S, DOB unknown) received KV FLUKOVAX PF Ini. (CSL influenza vaccine from bulk no: 0980K009) (KV batch no: PI080801; expiry date: 31-JUL-2009) on the morning of 13-OCT-2008. The patient had a history of hypertension. No details of concomitant medications were provided. On 13-OCT-2008 at 13:10 the patient collapsed. At 13:30 (twenty minutes later) the patient was unconscious. The patient died at 15:10 on 13-OCT-2008. The company considered events as unassessable/unclassifiable in relation to the suspect drug. The authority has assessed these events as unrelated to the vaccine. Information derived from this AE report does not change the current safety profile of CSL influenza vaccine (FLUVAX). This case was reported as serious because of death. Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided.


VAERS ID: 330032 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: California  
Vaccinated:2008-10-10
Onset:2008-10-10
   Days after vaccination:0
Submitted: 2008-10-17
   Days after onset:7
Entered: 2008-10-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Pneumonia, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-13
   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:
Current Illness:
Preexisting Conditions: PMH: atherosclerosis; chronic kidney disese; allergic rhinitis; temporal arteritis syndrome, giant cell arteritis, chronic renal insufficiency, osteoporosis, HTN, nephrolithiasis, B12 deficiency due to pernicious anemia; peripheral neuropathy, GERD, remote oral cancer, psoriasis. Allergy: penicillin & quinine. Ex-smoker.
Allergies:
Diagnostic Lab Data: LABS: ESR peak 137 down to 51 on 10/10. CT chest revealed ground glass opacification. Echocardiogram revealed bicuspid aortic valve, mitral aortic insufficiency, LVH & normal ejection fraction. ABG: pO2 62(L), pCO2 38, pH 7.35. ECG abnormal. WBC 8.8, H/H 8.7/26(L), plts 86K. Sodium 132(L), BUN/creatinine 30/2.2. Troponin 0.12.
CDC Split Type:

Write-up: Friday 10/10/2008: Patient was in good shape when I took him to MD - for a review of his blood test results. He was advised to get a flu shot. They were available in the lobby with a paper from the Dr. He got the flu vaccines shot. Saturday 10/11/2008: He sounds as if he has a hard time breathing. -7 P.M. - Saturday 10/11/2008: Patient goes to hospital via ambulance. 911. Sunday 10/12/2008: Patient called me to advise me that he is in the hospital. Monday 10/13/2008: I visit patient in hospital and he is non-responsive and barely alive. Monday 10/13/2008: Patient died from pneumonia. Prior to the flu vaccine he was in good health. I believe the vaccine should not have been advised as it killed him. 10/28/08 Death certificate states COD as respiratory failure w/pneumonia & myelodysplasia as contributing causes. 10/28/08 Reviewed hospital medical records of 10/12-10/13/2008. FINAL DX: CHF; A-fib w/RVR; acute respiratory failure; acute exacerbation of COPD; acute exacerbation of chronic renal insufficiency & failure; malnutrition. Records reveal patient experienced SOB, bilateral leg edema, atrial fibrillation w/rapid ventricular response. Cardioverted & admitted to ICU. Developed acute respiratory failure, agitation, confusion worsened & placed on BiPAP. Tx w/IV antibiotics. Pt was DNR, no intubation. 11/25/08 Reviewed PCP medical records Office record of 8/20/08 reveals pt disoriented s/p ER visit for visual disturbance, HA & temporal arteritis. Had been started on steroids. RTC 9/19/08 s/p ER visit after fall w/o sequelae. RTC 9/29 w/fatigue. RTC 10/10 stating felt better. No record of flu shot, was given by unknown company in lobby of physician office building.


VAERS ID: 329901 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-07
Onset:2008-10-07
   Days after vaccination:0
Submitted: 2008-10-23
   Days after onset:16
Entered: 2008-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0986K009 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: 08-Oct-2008; The patient had a past medical history of chronic pain and leukocytopenia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814198

Write-up: Report received from the foreign regulatory authority via a foreign license partner on 20-OCT-2008. A 69 year old female patient (initial: K; DOB: unknown) received influenza vaccine, HV: FLukovax PF Ini (CSL bulk no: 0980K009) (KV batch no: PI080801; expiry: 31-JUL-2009), on 07-OCT-2008 at 10:00. The patient had a past medical history of chronic pain and leukocytopenia. No details of concomitant medication were provided. On 07-OCT-2008, at 12:00 (two hours after influenza vaccine administration) the patient vomited. Between 19:00 and 20:00 (9 or 10 hours after influenza vaccine administration), the patient developed shock and arrhythmia. The patient died at 15:40 on 08-OCT-2008. The patient''s doctor diagnosed sepsis as the cause of death and stated that there was no relation between the cause of death and the injected vaccine. The company considered events as unassessable/unclassifiable in relation to suspect drug. The authority assessed these events as unrelated to the vaccination. This case was reported as serious because of death. Information derived from this AE report does not change the current safety profile of CSL influenza vaccine (FLUVAX). Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided.


VAERS ID: 331785 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-07
Onset:2008-10-07
   Days after vaccination:0
Submitted: 2008-11-06
   Days after onset:30
Entered: 2008-11-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0980K009 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: 08-Oct-2008
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814283

Write-up: Report received from the foreign regulatory authority via a foreign license partner on 20-Oct-2008. A 69 year old female patient (initial: K; DOB: unknown) received influenza vaccine, *KV: FLUKOVAX PF INI (CSL bulk no: 0980K009) (KV batch no: PI080801; expiry: 31-JUL-2009), on 07-OCT-2008 at 10:00. The patient had a past medical history of chronic pain and leukocytopenia. No details of concomitant medication were provided. On 07-OCT-2008, at 12:00 (two hours after influenza vaccine administration) the patient vomited. Between 19:00 and 20:00 (9 or 10 hours after influenza vaccine administration), the patient developed shock and arrhythmia. The patient died at 15:40 on 08-OCT-2008. The patient''s doctor diagnosed sepsis as the cause of death and stated that there was no relation between the cause of death and the injected vaccine. The company considered the events as unassessable/unclassifiable in relation to the suspect drug. The authority assessed these events as unrelated to the vaccination. This case was reported as serious because of death. Information derived from this AE report does not change the current safety profile of CSL FLUVAX. Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided. This case is identical a previous case number KP-BEH-200814198, which had to be inactivated due to inaccurate country coding. The country code in this new case KR-BEH-200814283 is now correct with ''foreign''.


VAERS ID: 328445 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2008-10-03
Onset:2008-10-04
   Days after vaccination:1
Submitted: 2008-10-14
   Days after onset:10
Entered: 2008-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Cold sweat, Heart rate increased, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-10-04
   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: Lorazepam; Fluoxetine hydrochloride; Lortab; Omeprazole; Sucralfate
Current Illness: Atrial fibrillation, CVA, Dementia
Preexisting Conditions: The subject has no known drug or food allergies. She has previously received flu vaccines and has no history of reactions following previous flu or other vaccines.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0751873A

Write-up: This case was reported by a healthcare professional and described the occurrence of death-unknown cause in a 89-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, cva and dementia. Concurrent medications included ATIVAN, PROZAC, LORTAB, PRILOSEC and CARAFATE. On 3 October 2008 at 17:15 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. On 4 October 2008, approximately 21 hours after vaccination with FLULAVAL, the subject felt cool and clammy, had increased pulse and low blood pressure. Within 5 minutes, the subject experienced death-unknown cause. She was DNR (do not resuscitate). The healthcare professional considered the events were life threatening. The subject died on 4 October 2008, cause of death was not reported. It was unknown whether an autopsy was performed. 1/6/09-records received-Cause of Death-Sudden Cardiac Death. Cerebrovascular Disease. No autopsy performed.


VAERS ID: 355396 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2008-09-09
Onset:2008-10-01
   Days after vaccination:22
Submitted: 2009-08-25
   Days after onset:328
Entered: 2009-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA155AA / 1 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Cardiac failure, Death, Hypoaesthesia, Intensive care, Mobility decreased, Muscular weakness, Pain in extremity, Paralysis, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Peripheral neuropathy (broad), Parkinson-like events (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), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-10-21
   Days after onset: 20
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: FLOMAX; ASPIRIN; LOPID; TORSEMIDE; LYRICA; QUINAPRIL; DIOVAN; ZOCOR; CLONIDINE; ZEMPLAR; HUMULIN; Fish oil; Calcium
Current Illness: Diabetes; Renal failure
Preexisting Conditions: Diabetes; Diabetic neuropathy; Renal disease; Stroke. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Known history of recent myocardial infarction. Type 2 Diabetes Mellitus. Diabetic neuropathy and retinopathy. Diabetic nephropathy. Hyperlipidemia. Bilateral ankle surgery. Immobility. History of lumbar degenerative disk disease. Hypertension.
Allergies:
Diagnostic Lab Data: See med. records - too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. LABS and DIAGNOSTICS: CD4/CD8 Ratio - Normal. CSF Oligoclonal Bands (IEF) - Total Protein 133 mg/dL (H) IgG 11.20 mg/dL (H) Albumin 77.7 mg/dL (H) Synthesis Rate 11.3 (H). Serum - IgG 558 mg/dL (L) Albumin 2200 mg/dL (L). No evidence of IgG bands in CSF or serum. CSF - Glucose 94 mg/dL (H) Sodium 146 mmol/L (H) Potassium 5.1 mmol/L (H). CHEM - Potassium 7.5 mmol/L (H) Chloride 113 mmol/L (H) BUN 104 mg/dL (H) Creatinine 3.84 mg/dL (H) Glucose 247 mg/dL (H) ALKPHOS 525 U/L (H) ALT 901 U/L (H) AST 3348 U/L (H) Amylase 191 U/L (H) Bilirubin Direct 1.0 mg/dL (H) LDH 560 U/L (H) Phos 14.1 mg/dL (H) SGGT 189 U/L (H) Uric Acid 9.5 mg/dL (H) CK 73311 U/L (H) CKMB 172.4 ng/mL (H) Troponin 6.38 ng/mL (H). CRP 24.27 mg d/L (H). D-DMR $g1000 ng/mL (H). PT 23.6 drc (H). Parathroid PTH 426.2 pg/mL (H). Thyroid Profile abnormal. HGB A1C 8.2% (H). CBC - HGB 7.4 g/dL (L) HCT 22.5% (L) RBC 2.51 M/mm3 (L) RDW 18.5% (H) Platelets 143 Thou/mm3 (L) Neut 13.7 Thou/mm3 (H) WBC 22.0 Thou/mm3 (H) Sed Rate 110 mm/HR (H). Culture (R) foot - Positive Coagulase Negative Staph. Fecal Occult Blood (+). Urinalysis - Orange, Turbid, Sp Grav 1.033 (H), Protein (+) Glucose (+) Acetone (+) Occult Blood (+) WBC (+) RBC (+) Renal Epith (+). Segnmental BP LE - Abnormal.
CDC Split Type:

Write-up: On 10-01-08 he complained of soreness and unusual weakness and numbness in legs (after physical therapy). Had to have help to & from wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08. Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure 10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure. Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis. Patient transfered to facility after noticing weakness in upper and lower extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia. Extubated per patient''s desire. Quickly expired. 10/5/09 Death Cert received with COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre Syndrome


VAERS ID: 336403 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-09-29
Onset:2008-09-29
   Days after vaccination:0
Submitted: 2008-12-23
   Days after onset:85
Entered: 2009-01-05
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 42762AA / 4 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest discomfort, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-29
   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: LEVAQUIN; LOPRESSOR; NEURONTIN; ELAVIL
Current Illness: No acute illness
Preexisting Conditions: Pernicious anemia; CAD; MI; Lumbar disc disease; Peripheral neuropathy; Hypothyroidism; Cardiomyopathy; GERD; Cervical disc disease; Nonunion R hip fx-repaired; AODM; BPH; MOTRIN; MYCARDIS; PREVACID; FLOMAX; trimethoprim 1/7/09-records received-PMH: CHF, pancreatitis, UTI, Diabetic, coronary stents. Stroke.
Allergies:
Diagnostic Lab Data: 1/7/09-records received-Chest x-ray infiltrate at left lung base and possible infiltrate right upper lobe.
CDC Split Type:

Write-up: Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus. Expired 9/29/08. 2/9/09-COD-pulmonary embolism.


VAERS ID: 328446 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-09-23
Onset:2008-09-24
   Days after vaccination:1
Submitted: 2008-10-14
   Days after onset:20
Entered: 2008-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS ASLUA362BA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-24
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: D0058995A

Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority (vaccines, biologicals) # DE-PEI-PEI2008015729) and described the occurrence of death- at present cause unknown- in a 73-year-old male subject who was vaccinated with INFLUSPLIT SSW 2008/2009 (GlaxoSmithKline). Previous vaccinations included INFLUSPLIT SSW 2007/2008 (GlaxoSmithKline). On 23 September 2008 the subject received a dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, intramuscular, unknown gluteal). Approximately one day post vaccination with INFLUSPLIT SSW 2008/2009, on 24 September 2008, the subject died. At present the cause of death was unknown. An autopsy has been ordered. The autopsy results have not been provided. No further information will be available.


VAERS ID: 325795 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-18
Onset:2008-09-18
   Days after vaccination:0
Submitted: 2008-09-22
   Days after onset:4
Entered: 2008-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA360AD / UNK LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0058780A

Write-up: This case was reported by a physician and described the occurrence of acute cardiovascular failure in a 78-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). This was received as a product complaint. Concurrent medical conditions included arterial hypertension. On 18 September 2008 the subject received unspecified dose of INFLUSPLIT SSW (unknown route and application site). On 18 September 2008, 3 minutes after vaccination with INFLUSPLIT SSW, the subject experienced acute cardiovascular failure. Reanimation was without success. Cardiac infarction was suspected. The physician considered the events were unlikely to be related to vaccination with INFLUSPLIT SSW. The subject died on 18 September 2008 from possible cardiac infarction. It was unknown whether an autopsy was performed. Follow-up information has been requested.


VAERS ID: 308661 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-11-19
Onset:2008-02-01
   Days after vaccination:74
Submitted: 2008-04-01
   Days after onset:59
Entered: 2008-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20080504

Write-up: We received on 12 FEB 2008 from a healthcare professional the following information: A 7-year-old male patient, born on 21 JUN 2000 was vaccinated with FLUVIRIN (batch no. unknown) on 19 NOV 2007. The patient was killed in an automobile traffic accident on 01 FEB 2008. The subject had participated in a clinical trial sponsored by MedImmune. FLUVIRIN was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the FLUVIRIN, but other than that has not been involved. Although the event did not occur during the duration of the trial, and the investigator did not see any causal relationship to the vaccination with FLUVIRIN, he reported the event to the IRB and NVD because the child had died.


VAERS ID: 304711 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2008-01-25
Onset:2008-01-25
   Days after vaccination:0
Submitted: 2008-02-01
   Days after onset:7
Entered: 2008-02-11
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2514AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Chest pain, Dyspnoea, Pain, Speech disorder
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-26
   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: Hormones; High BP Pills
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LA080203

Write-up: 01/25/08 11:00 PM Couldn''t breathe or talk at fist. Then c/o pain in chest - then all over. 11:06 Ambulance called. 11:35 Ambulance arrived. Transported to hospital. 09/08 Had problems with SOB to ER - "Test did not show anything" (info given by daughter). 2/12 /08-myocardial infarction per coroner''s office. no autopsy performed. 4/7/08-ER records received for DOS 1/26/08-cardiac arrest. Prounced 0054.


VAERS ID: 309594 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Colorado  
Vaccinated:2008-01-11
Onset:2008-01-20
   Days after vaccination:9
Submitted: 2008-04-10
   Days after onset:80
Entered: 2008-04-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500490P / 1 NS / IN

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Ataxia, Congenital anomaly, Dyspnoea, Expired drug administered, Fall, Gait disturbance, Gene mutation identification test, Mitochondrial encephalomyopathy, Nuclear magnetic resonance imaging abnormal
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-04-05
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Weak prior to vaccination. Two months of respiratory problems at night when asleep described as sudden inspiratory gasp and suddenly relieved.
Preexisting Conditions: 5/1/08-records received- PMH: born at 29 weeks on ventilator for pneumonia. Hospitalized for 3 months. Strabismus repair, PE tubes and adenoidectomy. Rotavirus and hospitalization. Developmental delay. Did not receive 5 year old vaccinations.
Allergies:
Diagnostic Lab Data: Abnormal MRI; Genetic mutation 8993 T-C for mitochondrial disease 5/1/08-records received-EEG negative. MRI 2/08 showed abnormal basal ganglia. Sleep study 3/19/08-hyperventilation and obstructive sleep apnea. G-tube insertion on 3/21/08-Repeat MRI shows further note of worsening of lesions in brain consistent with Leigh syndrome. Blood and wound culture positive for staph.
CDC Split Type:

Write-up: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh''s disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh''s syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh''s encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.


VAERS ID: 302826 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Louisiana  
Vaccinated:2007-12-20
Onset:2007-12-22
   Days after vaccination:2
Submitted: 2008-01-07
   Days after onset:16
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B137AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2514AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54016F / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1195U / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Anoxic encephalopathy, Apnoea test, Autopsy, Brain death, Brain scan normal, Cardiac arrest, Computerised tomogram normal, Corneal reflex decreased, Crying, Dyspnoea, Electroencephalogram abnormal, Hypotension, Intensive care, Intubation, Mechanical ventilation, Oxygen saturation decreased, PCO2 increased, Poor peripheral circulation, Pupil fixed, Respiratory disorder, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Corneal disorders (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Unremarkable. There were no previous hospitalizations. She has received the six month immunizations two days before this happened and has been told the baby needed tummy time to develop the trunk tone and that is what she was doing when this happened.
Allergies:
Diagnostic Lab Data: A CT scan done at the emergency room showed no bleeding or edema with normal ventricles. The next day, repeat CT scan still did not show any brain edema or hemorrhage. An EEG was nearly flat that day with no significant cortical activity. Over the next 24 hours, the agonal respirations disappeared. The EEG became completely flat and there were no signs of any brain activity. an apnea test which showed the patient to have no spontaneous respirations despite the PCO2 going up to 77 and the oxygen saturation dropping to below 70. Also, at that point, there was no corneal reflex. The ocular vestibular reflex was negative. There was no gagging or coughing reflex, and there was no response to deep pain in any form including unchanged heart rate and blood pressure. The baby had a brain flow scan shortly after she came to the PICU, and it showed blood flow to the brain. After the apnea test and the rest of the examination for brain death was done, the mother requested a second brain flow study. The brain flow study was equivocal but still showed flow. Despite that, I explained to the mother that the criteria was still met for brain death, especially if the patient had not received any narcotics or any medications that could be impairing the cortical brain stem activity. An autopsy was performed.
CDC Split Type:

Write-up: This is a 6-month old white female who was transferred from the emergency room when she came into cardiac arrest on full code, asystole and was resuscitated and the heart rate was brought back after several minutes. According to the mother, she left the child prone over a blanket that had the four ends secure so it would not fold and left the room. She had heard the baby cry because, according to her, she didn''t like to be prone. She heard the baby cry 5 minutes before she went back into the room and found her completely unresponsive. She started CPR and called the paramedics who arrived in another 5 minutes according to her. They intubated the baby and transferred to the emergency room. From there, the patient was sent to this PICU. The physical examination showed the baby to be unresponsive to stimuli with gasping rhythmic chest movements with no effective ventilation. The pupils were at 5 mm and fixed. The patient was on the respiratory oxygenating well. The capillary refill was fair to poor approximately 4-5 seconds. Air entry was good and the heart was rhythmic with no murmur. The abdomen was soft. There were no bruises on the body or head of the infant. There was no gag reflex. A CT scan done at the emergency room showed no bleeding or edema with normal ventricles. The patient was placed on mechanical ventilation. A femoral line was placed. The baby was also started on Dopamine and Dobutamine for low blood pressure and poor perfusion and responded well to it. The baby also received albumin 5%. Due to the fact there was no cerebral edema, no Mannitol or 3% saline was given. The venous blood gases showed normal oxygenation and ventilation. The next day, repeat CT scan still did not show any brain edema or hemorrhage. An EEG was nearly flat that day with no significant cortical activity. Over the next 24 hours, the patient had at one point, according to some nurses, some very sluggish pupil reaction and even very mild response to deep pain in the lower extremities only. In my examination, basically the pupils were nonreactive and there was no response to pain. Over the next 24 hours, the agonal respirations disappeared. The EEG became completely flat and there were no signs of any brain activity. At that point, the situation was discussed with the parents and they agreed to an apnea test which showed the patient to have no spontaneous respirations despite the PCO2 going up to 77 and the oxygen saturation dropping to below 70. Also, at that point, there was no corneal reflex. The ocular vestibular reflex was negative. There was no gagging or coughing reflex, and there was no response to deep pain in any form including unchanged heart rate and blood pressure. The baby had a brain flow scan shortly after she came to the PICU, and it showed blood flow to the brain. After the apnea test and the rest of the examination for brain death was done, the mother requested a second brain flow study. The brain flow study was equivocal but still showed flow. Despite that, I explained to the mother that the criteria was still met for brain death, especially if the patient had not received any narcotics or any medications that could be impairing the cortical brain stem activity. At that point, I placed a call to another doctor who came and examined the patient and concurred there was brain death. The mother discussed the case with organ donation personnel and decided to donate the daughter''s organs. The care was then transferred to organ donation on 12/24/07. Final diagnosis: 1. acute life threatening event, 2. anoxic encephalopathy, 3. brain death. 9/9/06 Autopsy report states COD as probable apneic event w/history of anoxic encephalopathy, unresponsiveness, resuscitation & hospitalization, neuro delay & no evidence of trauma or injury.


VAERS ID: 313132 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2007-11-29
Onset:2007-12-14
   Days after vaccination:15
Submitted: 2008-05-21
   Days after onset:158
Entered: 2008-05-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dizziness, Herpes zoster, Myocardial infarction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-12
   Days after onset: 29
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:
Preexisting Conditions: High blood pressure. 6/18/08-records received-PMH: dementia, hypertension. osteoporosis, left hip fracture 11/05.
Allergies:
Diagnostic Lab Data: 6/18/08-records received-Sodium 130, BNP 2460. Troponin 0.04. CXR no acute finidng. Echocardiogram normal. blood culture negative.
CDC Split Type: 200801534

Write-up: This case was received from a consumer in the United Stated on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was "heart attack" according to the patient''s son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia. 7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales. 9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration.


VAERS ID: 302595 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Michigan  
Vaccinated:2007-12-12
Onset:2007-12-12
   Days after vaccination:0
Submitted: 2007-12-31
   Days after onset:19
Entered: 2008-01-14
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2525AA / 1 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Burning sensation, Computerised tomogram normal, Dysphagia, Feeling abnormal, Muscular weakness, Pain, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-01-16
   Days after onset: 401
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Prednisone, metoprolol, aspirin, Vicodin, Lasix, lisinopril, K-DUR
Current Illness: None
Preexisting Conditions: Rheumatoid arthritis, degen. disk disease-cerv. neck PMH: RA, spinal deformities, steroid dependent. Polymyalgia rheumatica. HTN. HOH. Compression fx of c-spine. CAD, mitral regurgitation, CHF, cardiomyopathy w/CABG. Ejection fraction 35%.
Allergies:
Diagnostic Lab Data: CAT scan neg. for tumor or bleed LABS: head CT essentially WNL. MRI c-spine revealed severe stenosis w/cord compression
CDC Split Type:

Write-up: 8 hrs after vaccine admin., sudden onset of weakness bilateral arms & legs. Difficulty with speech, swallowing & ineffective cough. Overall sensation of feeling "wet" and "burning" flesh pain & paralysis. Not recovered but some improvements seen. 2/8/08 Reviewed hospital medical records which reveal patient experienced arm & leg pain, slurred speech & right facial droop. Admitted 12/13-12/29/2007. Progressed to paresthesias & then paralysis. Swallowing & urination compromised. Neuro consult done & felt non reversible. Transferred to hospice. FINAL DX: cervical cord compression 2nd to severe spinal stenosis; neuropathic pain in upper & lower extremities 2nd to cord compression. Annual Follow-up Information 18-FEB-2009: There was partial paralysis of the lower extremities that remained - unable to rehab pt. after receiving vaccine. Pt died approx 5 weeks ago (Jan 16) Sepsis due to bladder infection, being bedridden at nursing home and advanced age. Pt. passed away 35 days after receiving this vaccine (Jan 16th 09). His residual symptoms were lower extremity (partial) paralysis. The upper extremity paralysis. Resolved shortly after initial onset but unable to rehab the lower lungs. Spots from bilateral infection had to hi.sdeath


VAERS ID: 382226 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: California  
Vaccinated:2007-10-29
Onset:2007-12-10
   Days after vaccination:42
Submitted: 2010-03-08
   Days after onset:819
Entered: 2010-03-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 79898 / 7+ RA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1085U / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Body temperature normal, Cardio-respiratory arrest, Condition aggravated, Glycosylated haemoglobin increased, Low density lipoprotein normal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), 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: 2007-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus; Hypertension; Hyperlipidaemia; Coronary artery disease; Chronic back pain
Preexisting Conditions: Myocardial infarction; Obesity; Oedema peripheral; Angina pectoris; Herniotomy
Allergies:
Diagnostic Lab Data: blood pressure, 10/29/07, 94/50 mmHg; diagnostic laboratory, 10/29/07, 7.8%, Hga1c; total heartbeat count, 10/29/07, 71; temperature measurement, 10/29/07, 97.6 degrees F; serum LDL-C, 10/29/07, 159
CDC Split Type: WAES1003USA00551

Write-up: Information has been received from an investigator and medical records as part of a study concerning a 72-year-old, widowed male with type 2 diabetes mellitus and a 10 year history of coronary artery disease. The patient had additional medical history of a prior myocardial infarction (1998), obesity (per measurement at patient''s last medical visit weight was in "normal weight" range (ht 6''3", wt 199) as recently as 2005 weight was 306), hypertension, hyperlipidaemia, chronic mechanical low back pain (2006), surgery for herniated disc (2006), peripheral edema (August 2007), angina (August 2007). On 23-OCT-2007 the patient had routine lab work done. Based on results, patient''s physician sent a letter indicating "both your diabetes and cholesterol are poorly controlled" and the physician requested an appointment. This appointment was the patient''s last medical visit and day of vaccination (29-OCT-2007). According to the medical records the patient was diagnosed with hyperlipidaemia, type 2 diabetes and coronary artery disease. On 29-OCT-2007 the patient was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (lot# 658209/1085U). Concomitant therapy given on the same date included the dose number twelve of FLUVIRIN (lot # 79898), given intramuscularly into the right deltoid. The patient expired suddenly on 10-DEC-2007, according to the coroner''s report the immediate cause of death was cardiopulmonary arrest with secondary cause of 10 year history of Coronary Artery Disease. Diabetes Mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done. During the last medical visit, on 29-OCT-2007, the patient''s physical examination was within normal limits; his blood pressure was 94/50, his pulse was 71 and temperature 97.6 degrees F. The patient started therapy with metformin 500 mg oral bid, famotidine (manufacturer unknown) 40 mg oral bid, metoprolol tartrate 100 mg bid, glipizide, 10 mg bid, captopril 100 mg TID, lovastatin 40 mg daily and furosemide 40 mg daily. The patient was also on therapy with simvastatin (MSD) 40 mg on 29-OCT-2007. The patient had a LDL was 159 and the Hga1c was 7.8%. At that time the patient was discharged with the following instructions: take 4 units NPH insulin in the morning, aim for a blood sugar of 140 or less before meals; stop lovastatin start simvastatin (MSD), check a 12 hr fasting blood test after 6 weeks of taking simvastatin (MSD), check a fasting blood test for diabetes/cholesterol. At this time, relationship of cardiopulmonary arrest to study therapy is unknown. A lot check has been initiated. Additional information is expected. All available medical records will be provided upon request.


VAERS ID: 299871 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New York  
Vaccinated:2007-11-30
Onset:2007-12-03
   Days after vaccination:3
Submitted: 2007-12-14
   Days after onset:11
Entered: 2007-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA282DA / 2 LA / IM

Administered by: Public       Purchased by: Public
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: 2007-12-03
   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: celiac disease
Preexisting Conditions: Aortic stenosis; Hyprtension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died suddenly while snowblowing. 12/18/07 Reporter states no autopsy done. Received vax record which confirms lot # as reported. 2/29/08 Received death certificate which states COD as cardiac arrest w/CAD as contributing factor.


VAERS ID: 300933 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2007-12-03
Onset:2007-12-03
   Days after vaccination:0
Submitted: 2007-12-10
   Days after onset:7
Entered: 2007-12-26
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2509AA / UNK - / IM

Administered by: Public       Purchased by: Private
Symptoms: Death, Pulse absent, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-03
   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: Unknown
Current Illness: No acute - cleared for vaccine
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: At 10:30, patient assessed for contraindications for vaccine. No contraindications, consent signed, vaccine given. No s/d of reaction. 13:50, patient found by staff, unresponsive, no pulse, no respiration''s. MD notified. Stated patient expired due to disease and secondary diagnosis. 6/3/08 Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial fibrillation, CHF & cerebrovascular disease.


VAERS ID: 308620 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2007-10-18
Onset:2007-12-01
   Days after vaccination:44
Submitted: 2008-03-27
   Days after onset:116
Entered: 2008-03-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFUA05288 / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Abasia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Lymphoma, Mechanical ventilation
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Malignant lymphomas (narrow), Respiratory failure (broad), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-05-16
   Days after onset: 166
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: CSF - 153 protein on 2/25/08
CDC Split Type:

Write-up: Patient had influenza vaccine on 10-18-07. Complaints on 1/9/08 of numbness for 1-2 wks in arms/feet. 2/22/08 unable to ambulate. 3/2 Placed on vent. (1/21/08 had malignant lymphoma removed from tonsil). MD diagnosis Guillain barre, 2 lymphoma. 6/24/08 Death certificate states COD as respiratory failure with Guillain-Barre Syndrome & lymphoma. as underlying cause. 6/13/08 Reviewed hospital medical records for 2/23-5/16/2008. FINAL DX: diffuse large B cell lymphoma Records reveal patient experienced paresthesias of hands/feet, sore throat. Had lump on tonsils removed & found to have diffuse large B cell lymphoma. Weakness & paresthesias worsened & dx w/GBS. Had very prolonged extensive hospital course complicated by multiple issues: chronic ventilator dependent respiratory failure; tracheostomy; PEG feeding tube; multiple septic episodes; pulmonary embolism; chemotherapy. Condition worsened, developoed MRSA septicemia, became unresponsive. Family requested comfort measures only, patient was extubated & expired 5/16/2008. Patient had cancer and was undergoing chemo and radiation. This was cause of death.


VAERS ID: 889126 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Michigan  
Vaccinated:2007-12-01
Onset:2007-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Device related infection, Paralysis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2020SA276156

Write-up: paralyzed from neck down; fever; an infection related to catheter; Initial information was received on 05-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (caregiver). This case involves an 89 years old male patient who was paralyzed from his neck down (paralysis), had a fever (pyrexia) and died due to an infection related to catheter (device related infection), while he received INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date in Dec-2007, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) once via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient was paralyzed from neck down (paralysis) 5 hours following the administration of INFLUENZA VACCINE. He was taken to the hospital for 2 days and got back the use of everything but his legs, and then the hospital discharged him to a rehabilitation center that was more reactive, than preventative. The event paralysis was assessed as medically significant. Case details: The family (2 nurses in the family) felt that the patient had Guillen''s Barre, however this was never officially diagnosed. The patient died in the rehabilitation center within a week due to an infection related to his catheter (device related infection) even though he was not running a fever. At the very end he ran a fever (pyrexia, non-serious event), but they did not put him on the appropriate antibiotics. No autopsy was completed. The event device related infection was assessed as medically significant and led to death. No laboratory data was provided. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of paralysis and pyrexia was unknown while the event device related infection was fatal. The cause of death was reported as device related infection. Information on lot number was requested.; Sender''s Comments: This case involves an 89 years old male patient who had paralysis, pyrexia and died due to device related infection after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: an infection related to catheter


VAERS ID: 301390 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2007-11-29
Onset:2007-11-29
   Days after vaccination:0
Submitted: 2007-12-31
   Days after onset:32
Entered: 2008-01-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Diarrhoea, Dyspnoea, Influenza like illness, Malaise, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: autopsy confirmed MI
CDC Split Type: WAES0712USA08345

Write-up: Information has been received from a health authority concerning a 69 year old patient (gender not reported) with no relevant medical history (not known if concomitant medications were being taken) who on 29-NOV-2007 was vaccinated intramuscularly (site not reported) with a dose of Pneumovax 23 (lot# not reported). The patient was concomitantly intramuscurlary vaccinated (site not reported) with an Split Viron (Sanofi Pasteur). On the evening of 29-Nov-2007, the patient developed diarrhoea, shortness of breath, felt unwell and experienced flu-like symptoms. The patient died 3 days later due to myocardial infarction. An autopsy was performed and the cause of death was confirmed as myocardial infarction. Both the reporter and the health authority considered this to be a serious reaction but it is not known if the death was related to the suspected vaccine. The cause of death was myocardial infarction was considered to be immediately life-threatening and disabling. Other business partners numbers include E2007-09353 (0). Additional information is not expected, case is closed.


VAERS ID: 304198 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-29
Onset:2007-11-29
   Days after vaccination:0
Submitted: 2008-02-01
   Days after onset:64
Entered: 2008-02-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 3001252 / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Dyspnoea, Influenza like illness, Malaise, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-01
   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:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05154

Write-up: Information has been received from a health authority concerning a 69 year old female with no relevant medical history reported who on 29-NOV-2007 was vaccinated intramuscularly with a dose of Pneumovax 23 (batch reported as "NB26580") and influenza virus vaccine (manufacturer not reported) (lot 3001252). On 29-NOV-2007, on the evening of vaccination, the patient experienced diarrhea, then flu-like symptom, felt unwell, and had shortness of breath. On 01-DEC-2007, the patient died. The reported cause of death was myocardial infarction. The post mortem report is awaited. The patient had not recovered from other events prior to her death. The health authority and the reporter considered the events to be serious. Other business partner numbers E2008-00549. Additional information has been requested.


VAERS ID: 304418 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2007-11-28
Onset:2007-11-28
   Days after vaccination:0
Submitted: 2008-01-30
   Days after onset:63
Entered: 2008-02-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR AFLUA316AA / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Intensive care, Malaise, Mechanical ventilation
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-01-17
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Many PMH: depression & anxiety, under psychiatric care. Type 2 DM; recurrent UTIs; hyperlipidemia; LBP w/multiple surgeries; thyroid disease; obesity; memory loss. Hx of pneumonia. Secondhand smoke exposure. Family hx of DM & cardiac disease. Allergy: Multiple meds including PCN, sulfa & vancomycin.
Allergies:
Diagnostic Lab Data: LABS: Admit CBC w/WBC 7/9 (N), H/H 11.2/32.7 (L), neutros 82.1% (H), lymphs 6.9% (L), eos 6.7 (H). Admit Chem: Na 134 (L)CT chest scan revealed bilateral nodular lung inflitrates. CT chest angio r/o pulmonary emboli. Bronchoscopy revealed hemorrhagic secretions. Transbronchial biopsy. Lung biopsy via thoracotomy revealed interstitial pneumonitis. FANA (+) w/titer speckled pattern 1:160 (H). Neut cyto aby IgG <1:20 (H). EKG abnormal. Echocardiogram abnormal w/RV dilation & dysfunction.
CDC Split Type:

Write-up: She was immediately sick. Very sick for 4 more days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27 respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which included clinic visit & vax record of 11/28/07. Database updated. Patient w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over past several months since the death of parent. H&P indicates patient experienced sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted 12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed. Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired 1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med records. Death certificate requested from funeral home. 2/21/08 Reviewed death certificate which states COD as respiratory failure with pneumonia as underlying cause.


VAERS ID: 298905 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Virginia  
Vaccinated:2007-11-26
Onset:2007-11-27
   Days after vaccination:1
Submitted: 2007-11-30
   Days after onset:3
Entered: 2007-12-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2474CA / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-27
   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: Also received Synagis at the same time
Current Illness: URI
Preexisting Conditions: Pulmonary atresia s/p VP shunt/HIV exposure PMH: chronic hypoxia. Had cardiac cath done 11/20/07.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient collapsed while eating breakfast at home. He was taken to the ER and pronounced dead. 12/18/07 Reviewed hospital ER records which reveal patient in usual state of health on 11/27 when coughed & then collapsed at home. Was unresponsive in ER & resuscitation unsuccessful. ER COD stated as sudden cardiac death. 1/21/08 Reviewed autopsy report which states COD as complication from congenital cardiac disease (probable arrhythmia.


VAERS ID: 305043 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Colorado  
Vaccinated:2007-11-16
Onset:2007-11-21
   Days after vaccination:5
Submitted: 2008-02-13
   Days after onset:84
Entered: 2008-02-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2454AA / 3 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Confusional state, Death, Demyelination, Disorientation, Headache, Memory impairment, Muscular weakness, Myalgia, Mydriasis, Pupil fixed, Unresponsive to stimuli
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-28
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time of vaccination
Current Illness: Had pneumonia 2 weeks prior and then had a viral illness one week prior.
Preexisting Conditions: Hypertension, dermatitis, pre-diabetes; Allergic to codeine, sulfa, neosporin, and penicillin Capillaritis, post inflammatory hyperpigmentation of LEs, sinusitis, constipation, impaired glucose metabolism. Allergies: congestac, Vioxx, ASA, codeine, bactrim, neosprin.
Allergies:
Diagnostic Lab Data: LABS: CT of head & MRI of brain c/w ADEM. CSF WBCs 789(H), polys 89%. Repeat CT scan revealed worsening demyelination. Blood & CSF c/s neg. Brain biopsy revealed ADEM. WBC 15,500. CT abdomen/pelvis revealed fatty liver & gallbladder distension, both mild. CXR WNL.
CDC Split Type:

Write-up: On 11/21 the husband noticed that patient was having confusion and forgetting little things. The husband notified the PCP who advised him to take the patient to the hospital. Prior to this the patient was treated on 10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the patient recieved the influenza vaccine in the clinic. The morning of 11/21 the patient woke up with a headache and progressively became disoriented with muscle weakness and by 4pm that day could not talk. Once at the hospital the patient was given steroids, antibiotics, and antifungals. The patient improved for two days and then got progressively worse each day after that. The patient became completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on 11/28. Diagnosis was unclear. Patient with definite demylinating process and encephalopathy, so vaccine reaction was in the differential. However some of the symptoms did start prior to receiving the vaccine. 8/26/08 Death certificate states COD as acute disseminated encephalomyelitis. 2/19/08 Reviewed hospital medical records of 11/21-11/28/2007. FINAL DX: acute disseminated encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient experienced confusion, disorientation & loss of speech x 1 day Admitted 11/21-11/28/2007 when she expired. Exam revealed inability to speak but was able to mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact. Tx w/antibiotics, steroids, antivirals & prophylactic antiseizure meds. Received IVIG x 2. By hospital day #4, conditioned worsened & was unresponsive w/left side weakness. C/S neg & antibiotics/antivirals were d/c. Continued to deteriorate & on vent. Family decision to withdraw tx as condition contined to worsen & pt expired. 5/2/08 Reviewed pcp medical records which included vax record that confirms as reported. Office note of 11/16/07 was for flu shot only, no pcp note. 10/24 vs for URI s/s x approx 1 week. Runny nose, facial tenderness, lightheadedness, cough, LBP, poor appetite. Apouse had been ill w/viral syndrome. CXR that day revealed patchy RUL infiltrate; CBC WNL. 10/29 visit reveals patient seen in f/u for pneumonia, dermatitis & pain in left shoulder. She had less cough & improved appetite but was still tired. CXR that day revealed near resolution of pneumonia. Records also included some hospital medical records. Neurosurgery & neurology consults done. Patient w/fever on admission.


VAERS ID: 300791 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-16
Onset:2007-11-19
   Days after vaccination:3
Submitted: 2007-12-21
   Days after onset:32
Entered: 2007-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA336AA / UNK UN / IM

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: 2007-11-19
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0500508A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 56-year-old male subject who was vaccinated with Fluarix for prophylaxis. On 16 November 2007 the subject received unspecified dose of Fluarix (.5 ml, intramuscular). At an unspecified time after vaccination with Fluarix, the subject experienced sudden death. The subject was hospitalized and the regulatory authority reported that the event was . The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. Verbatim Text: Died at home sudden death 3 days after vaccination with Fluarix although waiting by pass operation as well before injection died suddenly 3 days later - possible connection? Reporter Comment: Another patient who had heart disease died following administration fluarix - possible connection?


VAERS ID: 311987 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2007-10-16
Onset:2007-11-18
   Days after vaccination:33
Submitted: 2008-05-09
   Days after onset:172
Entered: 2008-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 80685 / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blindness, Death, General physical health deterioration
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-01-21
   Days after onset: 64
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none
Preexisting Conditions: none PMH: cranial atherosclerosis, distant history of melanoma excised 15 yrs ago; erectile dysfunction; DJD. Bell''s palsy s/p swine flu shot, resolved. Tennis elbow/bursitis, resolved. Dysuria. Diabetes.
Allergies:
Diagnostic Lab Data: unknown LABS: MRI of orbits revealed bilateral optic nerve enhancement (prechiasmal). Sed rate, CRP, ANA & CBC WNL.
CDC Split Type:

Write-up: information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death. 05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain). Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08. Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema. 9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process. Failed high dose steroids & plasma exchange. Tx w/mitoxantrone treatment & second course of high dose steroids in ICU. Mental & respiratory status deteriorated, significant muscle spasms & pain. Mechanical ventilation. Brain lesions continued to grow & new lesions appeared. Developed decerebrate posturing. Comfort care only decided & transferred to hospital closer to family home. 5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day. Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck. Referred to neuro-ophthal. 6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day. Had used Cialis & noted difficulty reading next AM w/HA. Then developed blurry vision, decreased vision & pain over 3 days. Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve. Admitted for stat MRI & IV steroids. No improvement & D/C to home on continued tapering steroids. 7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis


VAERS ID: 297565 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-31
Onset:2007-11-13
   Days after vaccination:13
Submitted: 2007-11-22
   Days after onset:9
Entered: 2007-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA043AA / UNK UN / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0964U / UNK UN / SC

Administered by: Private       Purchased by: Private
Symptoms: CSF culture negative, CSF protein increased, Miller Fisher syndrome, 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), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-29
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Pemphigus Vulgaris. PE (+) for Pemphigus lesions, and thrush. Of note, CBC on date of vax with WBCs of 16.4 (low Eos 0.10%, lymph 4.0%, monos 4.40% and high neu 90.9%).
Preexisting Conditions: PMH: Pemphigus vulgaris on long-term steroids.
Allergies:
Diagnostic Lab Data: CSF; Protein/negative cxs. Labs and Diagnostics: CBC with WBCs of 16.1. PT/INR WNL. Head CT with no acute pathology on 11/18/07. MRI brain 11/19/07 with no evidence of acute pathology. CT brain scan 11/26/07 shows subarachnoid hemorrhage with diffuse cerebral edema, possible cerebellar tonsil herniation. Dopplar studies of the lower extremities WNL. Initial Chemistry with low Na+, Cl-, and Albumin 3.1 and glucose of 183. LFTs WNL on admission elevated by 11/25/07 (AST 67, ALT 120, Alk Phos 137, Total Protein 9.0 and Albumin 2.2). Sed rate 38. CSF protein 75.4. CSF Bacterial antigens (-). Initial Blood cultures (-). Later blood cultures (+) for Enterococcus fecalis.CSF cultures (-). UC (-). Cardiac enzymes unremarkable. ANA (-). Lyme and VDRL (-). CXR initially WNL later showed a L pleural reaction. EEG showed no cerebral activity.
CDC Split Type:

Write-up: Miller - Fisher Syndrome. Respiratory failure. 12/07/2007 MR received for DOS 11/18-29/2007 with DX: Miller-Fisher Syndrome. Pt expired on 11/29/2007. Progress note 11/28/07 states " diagnosis of brain death due to massive intracranial hemorrhage". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness. Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R$gL, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult 11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination. PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator. On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity. On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above. Final DX: Massive cerebrovascular accident with subarachnoid hemorrhage. Brain dead with flat EEG and (+) apnea test. Bactermia with enterococcus faecalis and coagulase-negative staphylococcus. S/P comatose state. Miller Fisher Syndrome on admission. pemphigus vulgaris. S/P respiratory failure. 01/11/2008 Death Cert received. Immediate COD: Cerebrovascular Accident-Approximate interval:onset to death-hours. Ascending Polyneuropathy-onset to death: days. Pemphigus-onset to death: years.


VAERS ID: 309447 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Alabama  
Vaccinated:2007-11-07
Onset:2007-11-13
   Days after vaccination:6
Submitted: 2008-04-14
   Days after onset:152
Entered: 2008-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Chest pain, Dizziness, Headache, Palpitations, Pharyngeal oedema, Restlessness, Stomach discomfort
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal allergic conditions (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-06
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Death~Influenza (Seasonal) (no brand name)~~76.30~Patient
Other Medications:
Current Illness: COPD/Emphysema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Palpitations, restlessness, stomach discomfort pharyngeal edema, headache, dizziness, chest pain, decreased blood pressure. 7/28/08-death certificate received; COD:respiratory failure. Chronic obstructive pulmonary disease.


VAERS ID: 300790 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-11-02
Onset:2007-11-13
   Days after vaccination:11
Submitted: 2007-12-21
   Days after onset:38
Entered: 2007-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA290AE / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Immunisation reaction
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: CVA, Heart Failure
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0500512A

Write-up: This case was reported by a regulatory authority and described the occurrence of death nos in a 80-year-old male subject who was vaccinated with Fluarix for prophylaxis. The subject''s medical history included cva and heart failure. On 2 November 2007 the subject received unspecified dose of Fluarix (.5 ml, intramuscular). On 13 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced death nos. The regulatory authority reported that the event was life threatening. The subject died on 13 November 2007, cause of death was not reported. It was unknown whether an autopsy was performed. Verbatim Text: Delayed reaction to Flu vaccine. Died suddenly found dead in chair after going for his morning newspaper. Possible connection to flu jab as sudden death.


VAERS ID: 295504 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Maine  
Vaccinated:2007-11-02
Onset:2007-11-02
   Days after vaccination:0
Submitted: 2007-11-05
   Days after onset:3
Entered: 2007-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2502AA / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-02
   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: Arthritis; HTN
Preexisting Conditions: Arthritis; HTN
Allergies:
Diagnostic Lab Data: ? Possible adverse reaction vs. M.I. LABS: EKG revealed acute inferior STEMI
CDC Split Type: ME01207

Write-up: On 11-02-2007 during routine office visit for arthritis and HTN, Flu vaccine given. Pt left the office with no c/o any. She went to shop and few hours later she was brought back in lethargic condition. O2 - 4 Epipen - applied, 911 - called, and she was transported by ambulance to Emergency Room. 12/11/07 Reviewed hospital ER records & death summary which reveal patient experienced severe substernal chest pain & collapsed while shopping 11/2/2007. EMS took to ER where she developed complete heart block & bradycardia. Tx w/meds, pacemaker & intubation. Resuscitated & taken for cardiac cath. In cath lab, arrested & CPR started. Developed ventricular fibrillation non responsive to defibrillation & meds & pronounced. 1/11/08 Received death certificate which states COD as ventricular fibrillation, acute MI & ateriosclerotic heart disease.


VAERS ID: 295195 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Michigan  
Vaccinated:2007-10-31
Onset:2007-11-01
   Days after vaccination:1
Submitted: 2007-11-01
   Days after onset:0
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2459LB / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Fetal Omphalocele
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client passed away today. Cause of death unknown at this time. An autopsy is to be performed down state. 8/18/09 Autopsy report 11/02/06. Additional information abstracted: Medical complications of omphalocele. History of repair of congenital omphalocele. Severe abdominal adhesions with extensive dilation of loops of small and large intestine. Status post gastrostomy tube placement. Acute proximal and distal convoluted tubular necrosis of kidneys. Extensive intersitial calcification of kidneys.


VAERS ID: 296231 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: California  
Vaccinated:2007-10-17
Onset:2007-11-01
   Days after vaccination:15
Submitted: 2007-11-06
   Days after onset:5
Entered: 2007-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500486P / UNK NS / IN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2758AA / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200703735

Write-up: A 25-year-old patient, with no reported concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a left deltoid (route not provided) dose of Adacel (lot number C2758AA), and a dose (route not provided) of FluMist (manufacturer MedImmune) (lot number 500486P) on 17 October 2007. Fifteen days post-vaccinations, on 01 November 2007, the patient expired in his sleep. At the time of the report, the autopsy was not complete. No cause of death has been determined at this time. 12/14/07 Received vax record from provider which confirms lot #s as reported. 1/18/08 Reviewed autopsy report which states COD as idiopathic mitral prolapse. Findings at autopsy included: enlarged dilated heart w/LVH & clean coronaries; parachute deformity w/hooding of anterior mitral cusp & lengthening of the chordae tendineae w/mild white thickening of the septal endocardim behind mitral valve; hyperinflated lungs; pneumomediastinum; enlarged liver/spleen/hepatic portal lymph nodes.


VAERS ID: 294848 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-10-28
Onset:2007-10-29
   Days after vaccination:1
Submitted: 2007-10-30
   Days after onset:1
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA062AA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: omeprazol 20 mg daily, Zyprexa 2.5mg evening, ativan 0.25mg po twice daily, remeron 15mg po qhs
Current Illness: See # 19.
Preexisting Conditions: chronic ischemic heart disease. HTN, depression, A-fib. no known allergies. 11/2/07 Received medical records from reporter which reveal patient experienced a PMH: anxiety, depression, dementia, recurrent UTIs, CAD, atrial fib, MI, cataracts.
Allergies:
Diagnostic Lab Data: lot # aflla062aa
CDC Split Type:

Write-up: patient was not acutely ill but was found dead in her chair within 24 hours of flu vaccine. 1/15/08 Death certificate states COD as acute myocardial infarction w/chronic ischemic heart disease as contributing factor.


VAERS ID: 294850 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2007-10-26
Onset:2007-10-28
   Days after vaccination:2
Submitted: 2007-10-30
   Days after onset:2
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA062AA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-28
   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: atenolol 12.5mg po daily, HCTZ 12.5mg po daily, omeprazole 20mg daily, glyberide 5mg twice daily, aggrenox sa 1 cap twice daily, hydralizine 10mg four times daily, lipator 20mg every pm, lasix 40mg daily. remeron 15mg po in pm, namenda 10 m
Current Illness: see # 19.
Preexisting Conditions: diabetes, HTN, SDAT, collitis PMH: Alzheimer''s, lipid disorder, BPH, TURP, prostate cancer, polypectomy, HTN, DM, bowel neoplasm, CVA 2004 requiring craniotomy & evacuation, CHF, ejection fraction 60% in 2003, first degree AV blockdiverticulosis, side branch IPMN, prostate cancer.
Allergies:
Diagnostic Lab Data: LABS: Sodium 131, BUN 45, creatinine 2.9. CXR pulmonary edema. KUB distended bowel loops. Amylase 108, lipase 31
CDC Split Type:

Write-up: Patient found dead in his chair 36 hours after vaccine. Had not been acutely ill prior to vaccination. 11/02/07 Received medical records from reporter which reveal patient w/extensive medical hx. H&P of 5/07 indicates had recent diarrhea, apple core lesion in mid to distal sigmoid colon, severe dementia, SOB & extremely poor appetite who had been admitted to hospital then transferred to LTC due to lethargy, fatigue & falls. Had cellulitis & inflammation of lower leg but afebrile on day of vax. Next day had congested productive cough w/green phlegm & vomiting. 10/28 had increased congestion, unresponsive w/dusky color. BP 89/66 & placed on O2 due to sats of 50-60%. Taken to hospital. 11/16/07 Received hospital ER medical records of 10/28/2007. FINAL ER DX: respiratory failure, sepsis Records reveal patient experienced fever, lethargy altered mental status & abdominal guarding. Exam revealed bilateral diffuse rhonchi, increased respiratory rate, diffuse abdominal tenderness & guarding, decreased bowel sounds, pitting edema of LE''s & tachycardia, temp 101.3. Patient was DNR & comfort measures provided until expiration. ME declined case.


VAERS ID: 294842 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Michigan  
Vaccinated:2007-10-18
Onset:2007-10-24
   Days after vaccination:6
Submitted: 2007-10-30
   Days after onset:6
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA294CA / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: restoril 30 mg q HS, avadart 1 qD, ASA 81 mg q day, remeron 45 mg q HS, oxycodone ER 20 mg bid, magic cup 1-2 q day (nutritional supp given by oncology)deptestosterone 200 mcg IM biweekly, augmentin 875 mg bid
Current Illness: lung ca rul, chronic pneumonia rul due to partial obstruction
Preexisting Conditions: HTN, COPD, CAD, RUL lung CA, depression PMH: HTN, CAD, RUL SCCA of lung.
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 1 week after administration found dead at home. History of COPD and squamous cell lung cancer RUL with obstruction of airway and s/p palliative treatment. Daughter felt he became more lethargic 24 hours after vaccination and requested we report this. No autopsy performed by medical examiner and death certificate pending. 11/27/07 Reviewed death certificate which states COD as right lung pancoast tumor due to chronic obstructive pulmonary disease. 1/4/08 Reviewed medical records which reveal patient experienced cough, recurrent RUL infections which responded to antibiotic tx, RUE pain s/p brachial plexus involvement, poor appetite on 10/18/07. Dx w/RUL lung Pancoast squamous cell carcinoma, stage B & tx w/chemo & radiation tx.


VAERS ID: 296073 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-10-23
Onset:2007-10-23
   Days after vaccination:0
Submitted: 2007-11-09
   Days after onset:17
Entered: 2007-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 78478 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071247

Write-up: We received from a health care professional via the agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL 1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The patient died shortly after the vaccination after he left the facility and walked down the hall. Caller felt that individual was properly screened, reported no allergies to any component, and filled out the waiver for the vaccine prior to administration, and had prior flu vaccinations. The reporter felt the death was coincidental based on the age and history of the patient. Company assessment: Seriousness criterion: death. Causality: insufficient data. Expectedness assessment according to manufacturer label: Death after Fluvirin is not expected. No change in benefit-risk-ratio. No measure necessary. Addendum We received from a health care professional via the medical agencies additional information on 29 OCT 2007: The batch-no. was 78478 (and not 78428 as previously reported). No change in assessment. NA07-005622


VAERS ID: 295043 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2007-10-22
Onset:2007-10-22
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:9
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2489MA / UNK RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cyanosis, Death, Irritability
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-22
   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: Albuterol (2.5mg/3ml-Bullets) 3 ml BID or TID & PRN; Robinul (0.2mg/ml) 2 ml TID Prevacid SoluTab (15mg/tab) 1 tab BID(am & hs) Glycolax 2 tsp QD Children''s Tylenol 4ml Q4 hours PRN increased Temperature
Current Illness:
Preexisting Conditions: This child was in a program. He had a multitude of diagnoses and problems including interrupted development of white matter of the brain, seizures, arthryogryposis of CNS origin, cyanotic spells, apneic events, problems with thermoregulation, reflux, aspiration. He had a pacemaker implanted about a year ago and had been doing much better since then. Parents report he has not have a respiratory or cardiac arrest since then. He did still have seizures monthly. He had posturing and tics on a daily basis. He had an uncoordinated swallow and was at high risk for aspiration. I am the child''s nurse case manager and I have only been working with the family for about 4 months (the family was transferred to me due to internal staff reassign-ments). I reported his death to the State as required. I don''t know who administered the immunization. I don''t know if nurse filed a VAERS. Dr. was not in the office due to his father being in intensive care. The family reports patient had flu shots in the past without difficulty. I spoke with Dr. because I felt a VAERS was warranted. She gave me information and the website info and I am submitting this form today. I will be out of my office for about 3 weeks starting Sunday, November 4. In my absence, you may speak with my program''s director. She is aware that I have filed this report. PMH: early ROM w/decreased amniotic fluid & subsequent joint contractures. Medically fragile w/multiple conditions including severe GERD. Multiple malformations of brain with developmental delay. Recurrent episodes of apnea & structural compromise of airway.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child had flu shot @ about 10 am. Waited in office for 20 minutes. Went home w/mother and private duty nurse. Nurse reported he was fussy after the immunization. She held him until he went to sleep. They put child to bed in parental bedroom upstairs. Nurse went to kitchen to get g-tube feeds ready. Apnea alarm went off shortly thereafter. When RN got to the child, he was face down in the bed and blue. They administered CPR, called 911. He was airlifted to hospital, where he was pronounced dead approximately two hours after receiving the flu shot. 11/13/07 Received autopsy report which reveals COD as complications of cerebral dysgenesis of indeterminate etiology; arthrogryposis multiplex congenita was a significant contributing factor. Had been placed on side for nap but was found prone. Disabilities rendered unable to lift head/body to protect airway. 11/16/07 Received vax records from pcp. VAERS database updated w/same.


VAERS ID: 296120 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2007-10-09
Onset:2007-10-21
   Days after vaccination:12
Submitted: 2007-11-08
   Days after onset:18
Entered: 2007-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2464AA / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Blood pressure increased, Body temperature increased, Electromyogram abnormal, Guillain-Barre syndrome, Intubation, Lumbar puncture, Muscular weakness, Plasmapheresis, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-25
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 32 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Nexium, Ambien, Lisinopril, Hydrochlorothiazide, Taztia XT, Aspirin, Doxazosin, Alprazolam, Tylenol #3.
Current Illness: none 12/17/07-records received-Headache which lasted over the last few weeks.
Preexisting Conditions: Hypertension, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis, Atrial Fibrilation. 12/17/07-records received-PMH: coronary artery disease. Hypertension. Atrial fibrillation. Gastroesophageal reflux disease. Osteoarthritis. Insomnia.
Allergies:
Diagnostic Lab Data: Contrast MRI, Spinal tap, prolonged F wave response 12/17/07-records received- Lumbar puncture showed cyto-albuminic disassociation, elevated protein and enhancement of lumbar roots on MRI. D-dimer elevated at 766. Increased segmented neutrophils 72%. Abdominal and pelvic CT normal. CT head showed small possible meningioma in left occipital parietal area not causing any of his problems. EMG F waves consistent with Guillain-Barre syndrome.
CDC Split Type:

Write-up: Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.


VAERS ID: 294274 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2007-10-20
Onset:2007-10-20
   Days after vaccination:0
Submitted: 2007-10-24
   Days after onset:4
Entered: 2007-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 78476 / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Death, Syncope, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-22
   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: This was a Public Health Mass Immunization clinic. This patient does not come here for routine care. We know that he had had flu vaccine in the past, has a GI upset reaction to eaten eggs, but still eats them, and reported no febrile illness in the 48 hours prior to vaccination and was not allergic to thimerisol
Preexisting Conditions: Discussion with cardiologist listed above revealed that the patient was under his care for "a significant heart condition" and that the doctor does not believe that the immunization contributed to the patient''s demise. He stated that if the patient had been in his office, his risk factors would have warranted vaccination with influenza vaccine. PMH: ischemic cardiomyopathy, ejection fraction 20%; CHF class 2-3; ventricular tachycardia; chronic renal insufficiency; multiple CVAs; COPD; PVD; chronic pain. PMH: MI, HTN, CABG x 5, cardiac stents, pacemaker. Abdominal aneurysm.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s daughter called after the event and reported that patientexperienced wheezing, cough and syncope "later that day" after he returned home from flu clinic. She did not indicate which, if any, hospital he was taken to, but that she had called his physician. Cardiologist. She reported that her father died on Sunday 10-21-2007 11/6/07 Received hospital clinic & cardiology medical records which reveal patient experienced CAD, s/p CABG (1982 & 1990) & severe LVD s/p ICD biventricular deployment; chronic back problems; hyperlipidemia; diabetes type 2; & controlled HTN. Cardiac cath of 4/2006 revealed patent left internal mammary arter to LAD bypass graft w/other grafts being occluded. Had been hospitalized 7/07 for pacemaker device discharge. Had DOE at that time. Pacer rate was increased due to myocardial ischemia. Developed chest pain, nausea & additional DOE. Dx w/unstable angina 7/11/07 & admitted to hospital. 1/18/08 Reviewed ER records of 10/22/07 which reveal patient fell & had witnessed cardiac arrest at home 50 min prior to arrival in ER. Had been intubated & IV access placed in field. ECG revealed V-fib & then asystole & patient expired 10/22/07. 1/29/08 Cardiac arrest per death certificate.


VAERS ID: 293594 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2007-10-18
Onset:2007-10-18
   Days after vaccination:0
Submitted: 2007-10-18
   Days after onset:0
Entered: 2007-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 78995 / 7+ RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-18
   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: unknown
Current Illness:
Preexisting Conditions: PMH: COPD on home O2. ASCVD, s/p CABG. Recent hx of hemoptysis & URI
Allergies:
Diagnostic Lab Data: CXR right pneumothorax.
CDC Split Type:

Write-up: Client presented to drive through flu exercise for influenza vaccination. Gave history of having had flu shots in past without incident. No contraindications to vaccinations identified. Client was vaccinated and returned home. At some time after returning home client went to Hospital emergency room where he coded and expired. 10/23/07 Reviewed hospital medical records which reveal patient experienced weakness & decreased respirations upon arriving home s/p flu shot. Collapsed in seat of pickup truck. EMS intubated, started CPR & transported to hospital. CXR revealed right pneumothorax & chest tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with atherosclerotic cardiovascular disease & CHF as contributing factors.


VAERS ID: 293120 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-15
Onset:2007-10-15
   Days after vaccination:0
Submitted: 2007-10-15
   Days after onset:0
Entered: 2007-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA300BA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-15
   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: unknown
Current Illness: unknown; code team contacted his supervisor who reports that he was well the morning of 10/15/2007.
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient received influenza vaccine at 1105 AM 10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM. Resuscitative efforts were unsuccessful.


VAERS ID: 296690 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-10-10
Onset:2007-10-15
   Days after vaccination:5
Submitted: 2007-10-27
   Days after onset:12
Entered: 2007-11-14
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / PFIZER/WYETH AFLLA037AA / UNK LA / -

Administered by: Private       Purchased by: Other
Symptoms: Cardiac failure, Death, Vaccination complication, Viral infection
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-27
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UPPER RESPRITORY VIRAL INFECTION
Preexisting Conditions: PMH: mitral valve replacement 1996 w/recent coumadin change, rheumatic fever, CVA x 2-3, HTN, Type 2 DM, CHF, mitral valve stenosis allergy to phenobarbital.
Allergies:
Diagnostic Lab Data: LABS: WBC 18.3 (H), segs 81%(H), monos 3% (L), lymphs 16% (L), platelets 482 (H). CK 24, CKMB 17.8, troponin neg. AST 37, LDH 234. PT/PTT 17.6/26l6, INR 2.0. Dig level 1.0. Blood glucose 451(H), K 5.4 (H), BUN 28 (H), creat 1.3, Cl 93 (L), CO2 16.7 (L), NA 130 (L). CXR revealed cardiomegaly, mild failure w/minimal bilateral perihilar infiltrates. Repeat CXR revealed increased failure w/diffuse pulmonary edema & bilateral infiltrates suggesting aspiration pneumonia.
CDC Split Type:

Write-up: oct.28.2007 treated for upper respritory viral infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral infection complecated by influensa vaccine.oct.27 2007died heart failer complecated by virial infection 11/16/07 Reviewed vaccine record from pcp & VAERS database updated w/same. 11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital medical records which reveal patient experienced chest & left arm pain, cold & clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived. EMS rhythm strip revealed BBB w/ST segment depression. In ER, vomited & had diarrhea. EKG revealed atrial fib w/rapid ventricular response. DX w/acute bronchitis & atrial fib w/RVR. Became unresponsive & developed cardiac arrest. Resuscitated & intubated. While being tansferred to higher level of care via helicopter, coded again. Returned to ER & unable to resuscitate. 3/7/2008 Judge states he signed death certificate as directed by state law when patient is not in hospital & only seen in ER but paper copy no longer available. States COD as undetermined & manner of death natural. 3/11 Death certificate reviewed & states COD as undetermined & manner of death as natural.


VAERS ID: 345053 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-10
Onset:2007-10-11
   Days after vaccination:1
Submitted: 2009-04-28
   Days after onset:565
Entered: 2009-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA037AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamictal - 100 mg/day as of 9/14/07; Zocor 20 mg/day; also on Vytorin 10/20 p.o. daily ?
Current Illness: none
Preexisting Conditions: artherosclerosis, obesity, mild epilespy, CAD with mildly elevated calcium score
Allergies:
Diagnostic Lab Data: Coroner''s report conludes he died as the result of artherosclerotic and hypersensitive-type cardiovascular disease, with obesity as a contributory condition.
CDC Split Type:

Write-up: Patient (68 year old male) received a flu shot on 10/10/07. He died that night in his sleep of a massive heart attack, presumably in the early morning hours of 10/11/07. Although previously diagnosed with mild artherosclerosis, he had never had a prior heart attack. He had just visited his doctor the previous day and been given a clean bill of health. 5/6/09 Autopsy report states COD as artherosclerotic & hypertensive-type cardiovascular disease w/obesity as contributing condition. Manner of death natural. Report also states 40-50% stenosis of LAD by calcified atherosclerotic plaque; atherosclerosis of aorta; cardiomegaly; obesity, BMI 34; hx of hypercholesterolemia; mild pulmonary edema/congestion; prostatic nodular hyperplasia; hx of seizure disorder.


VAERS ID: 296240 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-10-03
Onset:2007-10-06
   Days after vaccination:3
Submitted: 2007-11-06
   Days after onset:31
Entered: 2007-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 79489 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Unknown 11/16/07 Reviewed death certificate which reveals COD as liver cancer.


VAERS ID: 297029 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-06
Onset:2007-10-06
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:39
Entered: 2007-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pyrexia, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-08
   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:
Preexisting Conditions: Associated ''pneumological'' disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200707757

Write-up: Case received from Sanofi Pasteur MSD on 06-Nov-2007 under the reference number RA-011-2007: This case was not medically confirmed and was received from a patient''s relative. An elderly female patient with a history of associated ''pneumological'' disease received the booster dose of (Imovax polio, batch number not reported) on 06-Oct-2007. On 06-Oct-2007 she experienced tremor, vomiting and fever. She died on 08-Oct-2007.


VAERS ID: 335764 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Georgia  
Vaccinated:2007-06-25
Onset:2007-09-26
   Days after vaccination:93
Submitted: 2008-12-19
   Days after onset:450
Entered: 2008-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR UNK / UNK UN / UN
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM AHAVB139CA / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1D302 / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2236AA / UNK UN / UN
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1962AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Serology abnormal
SMQs:, Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-27
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture positive for Neisseria meningitis serogroup C on 9/26/07.
CDC Split Type:

Write-up: Patient vaccinated with Menactra on 6/25/07 (lot U2236AA). Culture confirmed meningococcal disease on 9/26/07. Blood culture was positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on 9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status, blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem blood culture positive for neisseria meningitidis, serogroup C. Bilateral hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae, scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace infiltration consistent with terminal ventilator dependence. Bilateral pleural effusions.


VAERS ID: 291678 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Connecticut  
Vaccinated:2007-09-24
Onset:2007-09-25
   Days after vaccination:1
Submitted: 2007-10-01
   Days after onset:6
Entered: 2007-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B056CA / 4 LA / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2456BA / 1 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0700F / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0823U / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: mild febrile rxn~Vaccine not specified (no brand name)~UN~0.00~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: Febrile seizure 3/07 - nl EEG 5/07
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Healthy 18 mo male with history of febrile seizure in 3/07 given MMR II, VZV, DTaP & Flu vaccine on 9/24/07. Child discovered by mother deceased in bed approx 9/25/07. 11/30/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined. Anatomic diagnoses: pulmonary congestion & edema, sudden of unknown etiology. Patient was found unresponsive face down on mattress in crib.


VAERS ID: 314499 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2007-08-21
Onset:2007-08-24
   Days after vaccination:3
Submitted: 2008-05-30
   Days after onset:280
Entered: 2008-06-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 17001 / 2 UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. NE44070 / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-24
   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: Unknown
Current Illness: Down''s syndrome; Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, inconclusive
CDC Split Type: WAES0805AUS00199

Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 17 month old male with a history of Down''s syndrome and cardiac condition who on 21-AUG-2007 was vaccinated with VARIVAX (Batch No. NE44070, Invalid). Other suspect therapy included FLUVAX. On 24-AUG-2007 the patient had unexplained death 3 days after receiving VARIVAX together with a second dose of FLUVAX. The child had no ill health before passing away. Autopsy was performed with inconclusive findings. The agency considered that death was possibly related to VARIVAX and FLUVAX. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 288133 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-08-03
Onset:2007-08-04
   Days after vaccination:1
Submitted: 2007-08-15
   Days after onset:11
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute myocardial infarction, Death, Hyperglycaemia, Myocardial infarction, Nausea, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-04
   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: CEREBROVASCULAR INCIDENT (STROKE), HYPERTENSION, INSULIN DEPENDENT DIABETES
Current Illness: CEREBROVASCULAR INCIDENT (STROKE), HYPERTENSION, INSULIN DEPENDENT DIABETES, SENILE DEMENTIA
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0482727A

Write-up: This case was reported by a physician and described the occurrence of myocardial infarction in a 81-year-old female subject who was vaccinated with Fluarix for prophylaxis. Concurrent medical conditions included cerebrovascular stroke sequelae, hypertension, insulin controlled diabetes and senile dementia. On 3 August 2007 the subject received unspecified dose of Fluarix (intramuscular). On 4 August 2007, 1 day after vaccination with Fluarix, the subject experienced hyperglycemia, vomiting, nausea, finally she developed an acute myocardial infarction and, respiratory distress. The subject died at 21:00. The physician considered the events were unrelated to vaccination with Fluarix.


VAERS ID: 390401 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2007-05-01
Submitted: 2010-06-09
   Days after onset:1135
Entered: 2010-06-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Disability, Guillain-Barre syndrome, Hypertension, Hypoaesthesia, Lung infection, Paralysis, Septic shock, Tracheostomy
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Hypertension (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-26
   Days after onset: 148
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 120 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Drug for pressure control
Current Illness:
Preexisting Conditions: Personal medical history of 3 cardiac saphenous surgeries. Unknown family medical history. Unknown previous history of adverse reaction to a vaccine or a drug. Concomitant therapy for "pressure control". The patient had received influenza vaccine in the previous years. He was in a good health condition otherwise.
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: 201003063

Write-up: Case received from a consumer (patient''s son) through the Sanofi Pasteur on 28 May 2010 under the local reference number BR2010-157. An 81-year-old male patient, with a personal medical history of 3 cardiac saphenous surgeries, had received his booster dose of Influenza vaccine (manufacturer not reported, batch number, route and anatomical site of administration unknown) on an unspecified date between March and April 2007. The patient had an unknown family medical history and an unknown previous history of adverse reaction to a vaccine or a drug. He had a concomitant therapy for "pressure control". The patient had received influenza vaccine in the previous years. He was in a good health condition otherwise. Probably in May 2007, the patient developed numbness in the lower limbs while driving. He drove to the hospital and was admitted due to numbness in the lower limbs which evolved to paralysis. The diagnosis was GUILLAIN-BARRE SYNDROME. He stayed in the hospital for 4 months. During this time, he developed complications and remained with tracheotomy. Complementary investigations performed and corrective treatment were unknown. The patient died on 26 September 2007. According to the death certificate, the causes of death were septic shock and pulmonary infection. According to the reporter, the patient''s symptoms led to persistent disability/incapacity. List of documents held by sender: none.


VAERS ID: 272954 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Unknown  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2007-02-12
Submitted: 2007-02-20
   Days after onset:8
Entered: 2007-02-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had unspecified underlying health problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200700441

Write-up: Initial report received on 14 February 2007 from a health care provider who has acquired the information from a newspaper article. Per the newspaper article, it has been reported by the state department of health that an eight year old child, who had received a flu vaccination and had unspecified underlying health problems, died from the disease influenza on 12 February 2007. Additional information was not provided related to this case. (The firefighter that was also reported in the title of the article had not been vaccinated.


VAERS ID: 271683 (history)  
Form: Version 1.0  
Age: 1.21  
Sex: Male  
Location: Indiana  
Vaccinated:2007-01-26
Onset:2007-01-28
   Days after vaccination:2
Submitted: 2007-01-29
   Days after onset:1
Entered: 2007-02-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2292AA / 1 RL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1203F / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 308682D / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-28
   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: Ibuprofen, previously Pedicare
Current Illness: URI
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Seen on 1/26/07 and received ProQuad, Prevnar, and Flu vaccine. According to grandmother died on Sunday. 4/17/2007 Received Autopsy Report which reveals COD as sepsis with bronchopneumonia & tracheobronchitis. Anatomic findings include: small abrasions on central forehead; marked congestion & edema of bilat lungs; enlarged heart; small contusion on right forhead; skin lesions around mouth & nares & dried mucous around nares.


VAERS ID: 271299 (history)  
Form: Version 1.0  
Age: 0.68  
Sex: Female  
Location: Michigan  
Vaccinated:2007-01-24
Onset:2007-01-26
   Days after vaccination:2
Submitted: 2007-01-26
   Days after onset:0
Entered: 2007-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2200KA / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: History of mild left facial paralysis at birth - resolved
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found dead at home 1/26/07. 5/1/07 Received Autopsy Report which reveals COD as probable SIDS.


VAERS ID: 270156 (history)  
Form: Version 1.0  
Age: 1.54  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-29
Onset:2006-12-31
   Days after vaccination:2
Submitted: 2007-01-08
   Days after onset:8
Entered: 2007-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2176AA / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cough, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), 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: 2006-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: runny nose, temp 100.5~DTaP (no brand name)~4~1.00~In Patient
Other Medications: Poly Vi Flor drops 0.25 mg
Current Illness:
Preexisting Conditions: PMH: PDA treated with meds; 4 mos premature, 1.5 lbs at birth with normal growth & development now, in 96th percentile.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mild clear nasal drainage, slight cough, temp 100.7 2/20/07 Received autopsy report which reveals COD as complications of pneumonitis.


VAERS ID: 269826 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2006-12-20
Onset:2006-12-21
   Days after vaccination:1
Submitted: 2006-12-28
   Days after onset:7
Entered: 2006-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2174KA / 2 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-22
   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: None
Current Illness:
Preexisting Conditions: 5/9/08 Had hx of being in same ER on 1/12/06, 2/9/06 & 4/6/06, all for flu like s/s w/acute febrile illness & abdominal pain.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt found unresponsive at home and brought to ED - unable to resuscitate; pronounced dead. 5/9/08 Autopsy report states COD as changes c/w viral pneumonia, bilateral & manner of death as natural. Autopsy report states patient arrested while at home & transported to ER.


VAERS ID: 268521 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Ohio  
Vaccinated:2006-12-02
Onset:2006-12-02
   Days after vaccination:0
Submitted: 2006-12-02
   Days after onset:0
Entered: 2006-12-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Syncope
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-12-17
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Several
Current Illness: N/A
Preexisting Conditions: Prior history of intracerebral hemorrhage, status post aneurismal surgery PMH: MVA in 1998 in which she experienced a myocardial infarction. CVA followed with a balance disorder. Cerebral aneurysm which was repaired. CHF with an ejection fraction of 35% in 2003. After CVA and aneurysm repair the patient had decrease in peripheral vision and peripheral neuropathy, dysphagia and hyperlipidemia.
Allergies:
Diagnostic Lab Data: MRSA from sputum culture. CXR: cardiomegaly with interstitial edema. CT of head no evidence of acute cortical bleeding. Subsequent CT showering of emboli into the posterior circulation and cerebellar area were noted. EKG: wide QRS complex, left bundle branch block. EEG:record is abnormal and demonstrates generalized disturbances of cerebral functioning manifested by slowing of the background and is compatible with metabolic encephalopathy or other cause of diffuse neural dysfunction.
CDC Split Type:

Write-up: My mother collapsed in the dr office about 10 seconds after the flu shot and went into cardiac arrest. She is currently in ICU. 01/22/07-records received and reviewed. DC DX for DOS 12/02-12/16/06- Acute witnessed cardiopulmonary arrest with resuscitation Ventricular fibrillation Acute respiratory failure Anoxic encephalopathy Prior history of intracerebral hemorrhage, status post aneurismal surgery Methicillin resistant Staphylococcus aureus pneumonia Hypokalemia Cardiomyopathy. HX: Became syncopal and collapsed in physician''s office after receipt of flu vaccine. She immediately came to and was aware of her surrounding. Ambulated to car, as son was driving out of parking lot, patient had a sudden cardiac arrest.. Found to be in ventricular fibrillation and after 4 cardioversions procedures converted into a slow sinus rhythm. Seen in ER required intubation and dopamine drip and dobutamine. PMH: MVA in 1998 in which she experienced a myocardial infarction. CVA followed with a balance disorder. Cerebral aneurysm which was repaired. CHF with an ejection fraction of 35% in 2003. After CVA and aneurysm repair the patient had decrease in peripheral vision and peripheral neuropathy, dysphagia and hyperlipidemia. PE: Did not respond to verbal or painful commands, eye movement was random, at times seemed to have purposeful eye movement but would not move her extremities or reposition her body. Remained obtunded. Ventilator and life support withdrawn. Hospice management. Comfort measures. Transferred to hospice unit. Spoke with hospice unit, patient expired on 12/17/06. 1/25/07 Received Death Certificate which reveals COD as anoxic encephalopathy, cardiopulmonary arrest & CAD.


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

Administered by: Private       Purchased by: Private
Symptoms: Blood test, Convulsion, Electroencephalogram, Encephalitis viral, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

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

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


VAERS ID: 267913 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-11-13
Onset:2006-11-27
   Days after vaccination:14
Submitted: 2006-11-28
   Days after onset:1
Entered: 2006-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2258AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-27
   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: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: NONE


VAERS ID: 268248 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Michigan  
Vaccinated:2006-11-15
Onset:2006-11-26
   Days after vaccination:11
Submitted: 2006-12-04
   Days after onset:8
Entered: 2006-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 2S601211 / UNK UN / -

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Pyrexia, Respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glycopyronium bromide, Fexofenadine hydrochloride, Atenolol, Calcium carbonate, Efloraithine, Risedronic acid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: body temperature 26Nov2006 102 Fahrenheit
CDC Split Type: A0630100A

Write-up: This case was reported by a healthcare professional and described the occurrence of respiratory infection in a 32-year-old male subject who was vaccinated with Influenza virus vaccine trivalent (FluLaval) for prophylaxis. The subject had no pre-existing medical conditions. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Glycopyrronium bromide (Robinul), Fexofenadine hydrochloride (Allegra), Atenolol (Tenormin), Calcium carbonate (Oscal), Eflornithine (Vaniqa) and Risefronic acid (Actonel). On 15 November 2006 the subject received a dose of FluLaval. The reporting healthcare professional follow-up with the subject approximately one week later and the subject had " no side effects to report". On 26 November 2006, 11 days after vaccination with FluLaval, the subject experienced a fever of 102 degrees Fahrenheit and a respiratory infection. On 28 November 2006 the subject was taken to the emergency room. The healthcare professional reported that on 28 November 2006 the subject had "stopped breathing and they (the emergency room) were unable to resuscitate". The subject died on 28 November 2006. It was unknown whether an autopsy was performed.


VAERS ID: 270348 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Illinois  
Vaccinated:2006-11-04
Onset:2006-11-17
   Days after vaccination:13
Submitted: 2007-01-10
   Days after onset:54
Entered: 2007-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA210AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dehydration, Fracture, Lethargy, Oral intake reduced, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-19
   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: unk
Current Illness: 78 y/o in long-term-care facility. Spoke with infectious control nurse, at the facility who states from record that client temp at time of vaccination 98.7.
Preexisting Conditions: Diabetes, immobility-related to previous leg fractures.
Allergies:
Diagnostic Lab Data: 78 year old female with diabetes. Client living in long-term-care facility due to complications from several falls resulting in leg-knee fractures and poor recovery.
CDC Split Type:

Write-up: 78 y/o female who was a resident of a long-term-care facility for 3+ years, rec''d influenza vaccine on 11/4/06. On aprox 11/17/06 patient''s husband stated that the patient became lethargic, refusing food. 11/19/06 patient expired. Patient''s huband stated "she died of dehydration and kidney failure".


VAERS ID: 268453 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2006-11-14
Onset:2006-11-15
   Days after vaccination:1
Submitted: 2006-12-06
   Days after onset:21
Entered: 2006-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 2F601711 / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Blood pressure decreased, Dysphonia, Dyspnoea, Heart rate increased, Pallor, Pharyngolaryngeal pain, Pneumonia, Renal failure, Respiratory arrest, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-22
   Days after onset: 7
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: UNKNOWN
Current Illness:
Preexisting Conditions: BRAIN INJURY HIV REPORTED BY MOTHER NO KNOWN ALLERGIES
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: MOTHER STATES SYMPTOMS STARTED ON THE 15TH OR 16TH. HE COMPLAINED OF SORE THROAT. MOTHER STATES HE HAD DIFFICULTY BREATHING, HOARSENESS, WHEEZING, PALENESS, WEAKNESS, A FAST HEART BEAT AND DIZZINESS. DENIES HIVES. HE WAS TAKEN TO ER ON 11/19. SHE SAID HIS HEART RATE IN ER WAS 152 AND HIS BP VERY LOW. HE WAS DIAGNOSED WITH PNEUMONIA. HE HAD A RESPIRATORY ARREST AND THEN LATER KIDNEY FAILURE. PARENTS CAME AND REPORTED THIS TO FIRST DISTRICT BECAUSE THE CLINIC HAD TOLD THEM TO. THEY WERE RELUCTANT TO GIVE THEIR ADDRESS AND THEIR NAMES. "WE HAVE BEEN THROUGH ENOUGH." 12/8/06 Received medical records from 1st hospital which reveal patient admitted 11/19/06. Patient had 4 days of sore throat, fever, dry cough & diarrhea. Patient continued to deteriorate, coded & expired on 11/22/06. No autopsy was done. LABS: CXR hazy infiltrates in bilateral lung bases. CT of abdomen & pelvis WNL. US of kidney was WNL. CK 11, 046 & troponin 0.24. Bone marrow biopsy done was WNL. WBC 9.21, plts 99, Na 131, elevated liver enzymes. Final Dx: acute tubular necrosis; chronic renal failure likely secondary to HIV nephropathy; HIV positive; COPD, thrombocytopenia; culture negative sepsis; hypotension; respiratory failure/hypoxia; alcoholism; tobacco abuse; seizures secondary to head trauma; depression; s/p LS operation; hypothyroidism; insomnia; and anxiety. 1/5/07 Received Death Certificate from funeral home which reveals COD as HIV/AIDS with rhabdomyalysis as a contributing factor.


VAERS ID: 269930 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2006-10-13
Onset:2006-11-12
   Days after vaccination:30
Submitted: 2007-01-02
   Days after onset:51
Entered: 2007-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2216AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-12
   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: UNK
Current Illness: Diabetes
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11-12-06 Cardiac Arrest 3/26/07 Received Death Certificate which reveals COD as cardiac dysrhythymia & myocardial infarction with contributing factor of diabetes.


VAERS ID: 266512 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Colorado  
Vaccinated:2006-11-04
Onset:2006-11-07
   Days after vaccination:3
Submitted: 2006-11-10
   Days after onset:3
Entered: 2006-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2255AA / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Malaise, Platelet count decreased, Renal failure, Respiratory failure, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-10
   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:
Current Illness:
Preexisting Conditions: Pre diabetes, Hyperlipidemia.
Allergies:
Diagnostic Lab Data: WBC 44.2, Platelets 51,000, ALT 698, AST 1596, Sodium 132, Creatine 3.7.
CDC Split Type:

Write-up: Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06. 11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome. Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit. Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics. ID & resp consults done. No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion. WBC 12.2, plts 40. Rapid influenza test was neg. Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.


VAERS ID: 294689 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-06
Onset:2006-11-07
   Days after vaccination:1
Submitted: 2007-10-29
   Days after onset:355
Entered: 2007-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS SAA0753 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-07
   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: Alendronate sodium; Co-codamol; Diazepam; Frusemide
Current Illness: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HEART DISORDER, HYPERTENSION, OSTEOPOROSIS, PERIPHERAL VASCULAR DISEASE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0493060A

Write-up: This case was reported by a regulatory authority (foreign) # GB-MHRA-ADR 20172206 and described the occurrence of myocardial infarction in a 77-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). Concurrent medical conditions included chronic obstructive pulmonary disease, heart disorder, hypertension, osteoporosis and peripheral vascular disease. Concurrent medications included Alendronate sodium (Alendronate), Co-codamol, Diazepam and Frusemide (Furosemide). On 6 November 2006 the subject received an unspecified dose of Influenza vaccine (0.5 ml, intramuscularly). On 7 November 2006, 1 day after vaccination with Influenza vaccine, the subject experienced myocardial infarction. The subject died on 7 November 2006 from myocardial infarction. An autopsy was not performed. Verbatim text received: One day post vaccination, the patient was found dead.


VAERS ID: 267616 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Georgia  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2006-11-21
   Days after onset:15
Entered: 2006-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Private       Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yes
Current Illness: High blood pressure/diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My mother had a doctor''s appointment with MD for a flu shot 10:00 am on November 6, 2006. Immediately after the shot at approximately 11:00 am as they were driving away from the office she started gasping for breath, the paramedics were called and they never revived her.


VAERS ID: 268102 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2006-12-01
   Days after onset:25
Entered: 2006-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Gastrooesophageal reflux disease, Myocardial infarction, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-07
   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:
Preexisting Conditions: Brachial plexus palsy, depressive troubles, diabetes mellitus, fibromatous uterus, gonarthrosis, hysterectomy, R mastectomy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0447856A

Write-up: This case was reported by the regulatory authority and described the occurrence of myocardial infarctus in a 79 year old female subject who was vaccainted with Fluarix for prophylaxis. The subjects medical history included fibromatous uterus followed by an hysterectomy in 1979 and a right mastectomy. Concurrent medical conditions included right brachial plexus paralysis, depressive troubles, diabetes mellitus and gonarthrosis. Co-suspect medications included diltiazen (monotildiem LP), piribedil (Trivastal LP), insulin lispro (Insulin Humalog Mix) and semisodium valproate (Depakote). On 11/6/06, the subject received an unspecified dose of Fluarix (batch number not available), SC. The same day, she presented with gastroesophageal reflux and nausea. It was uncertain if these events appeared before or after the vaccination. In the evening, she began a treatment with Mopral and Vogalene. The subject died on 11/7/06 at 8:30, one day after vaccination with Fluarix, from a massive myocardial infarctus. It was unk whether an autopsy was performed. Myocardial infarctus was dubiously related to the vaccination with Fluarix and to co suspects medications. Causality relationship for the other events was not assessed. No more information will be available. This case has been closed.


VAERS ID: 271797 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: New York  
Vaccinated:2006-10-31
Onset:2006-11-03
   Days after vaccination:3
Submitted: 2007-01-30
   Days after onset:88
Entered: 2007-02-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Computerised tomogram, Intubation, Tracheostomy, Vaccination failure, Vocal cord paralysis
SMQs:, Angioedema (broad), Lack of efficacy/effect (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-01-23
   Days after onset: 81
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 50 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Digoxin, Atenolol, Tylenol, Nexium, Coumadin
Current Illness: Compression fraction - lower lumbar
Preexisting Conditions: Rheumatoid arthritis, lung disease, congestive heart failure PMH: MI, atrial fib, defibrillation, HTN, GERD, hiatal hernia, severe rheumatoid arthritis, losteoporosis, umbar compression fx, severe kyphoscoliosis w/restrictive lung disease, constipation, COPD, pulmonary fibrosis, bronchiectasis, SIADH, recurrent aspiration, sleep apnea, chronic anemia, hyponatremia.
Allergies:
Diagnostic Lab Data: CT scan - Bilateral vocal cords not due to stroke or tumor.
CDC Split Type:

Write-up: Three days after Influenza vaccine, my mom''s vocal cords were both paralyzed. She had to be intubated and given a tracheostomy. She never recovered. 2/12/07 Received medical records from hospital which reveal patient experienced SOB & abdominal pain on 11/2/06. ENT consult revealed fixed vocal cords & required emergency entubation then tracheostomy. G-tube placed for nutrition. Throughout hospitalization, had intermittent a-fib & nonsustained v-tach. Patient was noted to be depressed & was evaluated by psych. Pt was transferred to SNF unit for rehab. 2/15/07 Received Death Certificate from daughter which reveals COD as cardiopulmonary arrest; COPD; & CAD.


VAERS ID: 265901 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-10-31
Onset:2006-11-02
   Days after vaccination:2
Submitted: 2006-11-02
   Days after onset:0
Entered: 2006-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 2F601311 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril, Thyroid, Protonix, Detral, Premarin, Colestid
Current Illness:
Preexisting Conditions: Allergies: Penicillin, Tetracycline. Medical Conditions: Several
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown. Patients husband came pharmacy at ~ 12pm 11/02 mentioning that his wife had passed away in the evening. Pharmacist manager is a friend of the family and relayed on information on to myself that was running a flu clinic at that location today. 11/9/06 Received Death Certificate which reveal COD as ischemic heart disease and HTN with insomnia, hypothyroidism and chronic bronchitis as contributing factors.


VAERS ID: 266205 (history)  
Form: Version 1.0  
Age: 1.09  
Sex: Male  
Location: Texas  
Vaccinated:2006-11-02
Onset:2006-11-02
   Days after vaccination:0
Submitted: 2006-11-07
   Days after onset:5
Entered: 2006-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2196AA / 1 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER C0806 / 3 - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0950F / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Respiratory failure, White blood cell count increased
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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-11-03
   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: Patient reportedly was given Versed by EMT approximately 45 minutes before respiratory arrest
Current Illness: none reported
Preexisting Conditions: child was born at 34-35 gestation. Is a fraternal twin; sister received same immunizations at same visit on 11/2/06.
Allergies:
Diagnostic Lab Data: WBC 44,800, Potassium 3.3; rectal temp in ER 101.8
CDC Split Type:

Write-up: Apparently healthy 13 montly old fraternal male twin received vaccines (see below) at approximately 9AM on 11/2/06. Approximately 12 hours later child experienced seizure at home. EMT came to home and gave Versed to patient at about 10:30PM and child was brought to ER. Temp at ER 101.8 (rectal). At about 11:15PM child experienced respiratory failure, attempte was made to intubate; child pronounced dead at approximately 12:02AM on 11/3/06. 2/22/07 Received autopsy report which reveals COD as complications of midazolam administration following a s/p vaccination benign febrile seizure.


VAERS ID: 269911 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Illinois  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2006-12-21
   Days after onset:50
Entered: 2007-01-02
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA215BA / UNK RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Dyspnoea, Emphysema, Feeling cold, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-02
   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: UNK
Current Illness: COPD
Preexisting Conditions: COPD with emphysema.
Allergies:
Diagnostic Lab Data: No autopsy. Death certificate lists 1 cause of death as emphysema per daughter.
CDC Split Type:

Write-up: 90 minutes after receipt of flu vaccine, pt complained of SOB and felt cold. Pt with prior diagnosis of COPD. Refused medical treatment. Took breathing Rx as prescribed for chronic condition. Next day had fever 100.2 F and persistent complaints of SOB. Refused to seek medical treatment. Expired later in day approximately 29 hours after immunization.


VAERS ID: 305507 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812934

Write-up: Report received from a literature article on 19-FEB-2008. An 88-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned). The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 305508 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812933

Write-up: Report received from a literature article on 19-FEB-2008. A 80-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned.) The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 305509 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812932

Write-up: Report received from a literature article on 19-FEB-2008. A 58-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned). The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 305510 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2006-11-01
Onset:2006-11-01
   Days after vaccination:0
Submitted: 2008-02-20
   Days after onset:476
Entered: 2008-02-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: ??-Nov-2006
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200812930

Write-up: Report received from a literature article on 19-FEB-2008. A 53-year-old patient (gender unknown) received influenza vaccine (brand unknown) in November 2006. On the same day as receiving the influenza vaccine, the patient died suddenly. No details were provided with regard to medical history or concomitant medications. This was one of four deaths cited by the article. The vaccines given to the four deceased people had been produced by two different producers and were from different batches. The authors comment that the option of a quality defect in the product was considered to be ruled out (however, the brands of vaccine involved and the batches were not mentioned). The authors also comment that medical review concluded that it was highly unlikely that there was a causal association between the deaths and the vaccinations. The authors also mention that three of the four deceased were men.


VAERS ID: 268775 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-12-01
   Days after onset:35
Entered: 2006-12-12
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 2F601011 / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Cardiac failure congestive, Cerebrovascular accident, Coronary artery disease, Dysarthria, Dyspnoea, Hyperlipidaemia, Hypertension, Myocardial infarction, Orthopnoea, Pain, Transient ischaemic attack, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Other ischaemic heart disease (narrow), Lipodystrophy (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-04-15
   Days after onset: 536
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Altace, Topril XL, Lexapro , Hydrochlorothiazide, Dynacric CR, Aspirin
Current Illness:
Preexisting Conditions: She had a stroke and 5 bypass surgery about 7 years ago.
Allergies:
Diagnostic Lab Data: She had a stroke and heart attack. She continued having same types of illnesses for the next 15 months and heart attacks until 4-15-08 when she passed away after having a brain annurism.
CDC Split Type: NC06102

Write-up: Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.


VAERS ID: 265563 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2006-10-25
Onset:2006-10-26
   Days after vaccination:1
Submitted: 2006-10-26
   Days after onset:0
Entered: 2006-10-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 69425 / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Blood glucose increased, Cerebrovascular disorder, Computerised tomogram abnormal, Death, Facial palsy, Hemiparesis, Hemiplegia, Neurological examination abnormal, Somnolence, Transient ischaemic attack
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lasix, ASA, Toprol, Nitro Furitoin, KU.
Current Illness: UTI
Preexisting Conditions: PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN.
Allergies:
Diagnostic Lab Data: Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. Blood sugar 144. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulent. Assessment: TIA versus CVA. CT scan without contrast: prominent deep white matter changes. Compared to study of 3/28/05: significant degree of decreased density in subcortical and perventricular deep white matter regions bilaterally suggesting chronic small vessel ischemic changes. No evidence of mass, hemorrhage or definite areas of acute ischemia.
CDC Split Type: ND0614

Write-up: Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant. Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius. At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.


VAERS ID: 265325 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-10-21
Onset:2006-10-24
   Days after vaccination:3
Submitted: 2006-10-24
   Days after onset:0
Entered: 2006-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 70385 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Milk of Magnesia 20 cc every bedtime; Tegretol 400 mg every am, 400 mg every pm and 600 mg every bedtime; Diflocenac 50 mg twice a day, Zantac 150 mg twice a day, Actonel 35 mg once weekly, Oxycodone/APAP 5/325 at 12 am, 6 am, noon and 2 at
Current Illness: Significant Chronic Conditions and Diagnosis list: Mental Retardation, profound (level) 318.2, (Etiology) Unknown etiology, (Seizures) Generalized Tonic/Clonic 345.1, (Vision) Legally blind; optic atrophy, bilaterally. Old retinal detachments, Cataracts, OU, per doctor name reported 7/26/1993; Cataracts both eyes, per doctor name reported 1-6-00; Exophthalmos right eye, long standing; extropia, left eye, 2-27-02. Episcleritis, right eye 3-03. (Hearing) Hearing is normal in both ears, 8-02. (Chronic Pain) Chronic pain syndrome 733.90, 5-31-01: possibly secondary to Ostoarthritis or symptomatic scoliosis. (Dental) Bruxism severe 9-25-98, (GI) Constipation 564.00, (G-Tube) Status/Post Nissen Fundoplication with Gastrostomy tube 10-04-88. (GYN) History of Dysmenorrhea and irregular periods 625.3; Fibrocystic breasts 610.1, biopsy 4 mm mass of left breast, benign, 10-19-01. (Ortho) Severe lumbar scoliosis 737.30, Spastic quadriplegia 343.2; Fracture right proximal Femur 11-27-00 with open reduction internal fixation (ORIF); refractured 3-18-01 and repeat ORIF. (ORTHO) Osteoporosis 733.0, 3-19-02, (Other) Local reaction to IV Morphine Sulfate 11-27-00; Athetoid Movement Disorder 333.90, Right sided nodular Thyroid neoplasm 193, (Respiratory) Pneumonia, 3/01, (Surgery) Abscess, left axilla, incised and drained, doctor name reported, 9-18-99; resolved, 10-4-99
Preexisting Conditions: Significant Chronic Conditions and Diagnosis list: Mental Retardation, profound (level) 318.2, (Etiology) Unknown etiology, (Seizures) Generalized Tonic/Clonic 345.1, (Vision) Legally blind; optic atrophy, bilaterally. Old retinal detachments, Cataracts, OU, per doctor name reported 7/26/1993; Cataracts both eyes, per doctor name reported 1-6-00; Exophthalmos right eye, long standing; extropia, left eye, 2-27-02. Episcleritis, right eye 3-03. (Hearing) Hearing is normal in both ears, 8-02. (Chronic Pain) Chronic pain syndrome 733.90, 5-31-01: possibly secondary to Ostoarthritis or symptomatic scoliosis. (Dental) Bruxism severe 9-25-98, (GI) Constipation 564.00, (G-Tube) Status/Post Nissen Fundoplication with Gastrostomy tube 10-04-88. (GYN) History of Dysmenorrhea and irregular periods 625.3; Fibrocystic breasts 610.1, biopsy 4 mm mass of left breast, benign, 10-19-01. (Ortho) Severe lumbar scoliosis 737.30, Spastic quadriplegia 343.2; Fracture right proximal Femur 11-27-00 with open reduction internal fixation (ORIF); refractured 3-18-01 and repeat ORIF. (ORTHO) Osteoporosis 733.0, 3-19-02, (Other) Local reaction to IV Morphine Sulfate 11-27-00; Athetoid Movement Disorder 333.90, Right sided nodular Thyroid neoplasm 193, (Respiratory) Pneumonia, 3/01, (Surgery) Abscess, left axilla, incised and drained, doctor name reported, 9-18-99; resolved, 10-4-99
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client found deceased approximately 53 hours after administration of vaccine. She had no fevers or other apparent systemic effects. She had congenital developmental delay, epilepsy, spastic quadriplegia, dysphagia, thyroid cancer. This report is submitted for the unexpected death of a patient 2 days later receiving 2006 Influenza vaccination. Client was a 43-year-old female with profound mental retardation and severe developmental disability from unknown prenatal factors. She had been a resident of a residential long term care facility since she was age 2 years. She was born at full term after an uncomplicated pregnancy except for very little fetal movement. She had an uncomplicated delivery, breathed spontaneously, weighted 8 pounds, 7 ounces but demonstrated poor tone and flaccidity during the neonatal period with no improvement. She subsequently demonstrated further profound developmental disabilities, a generalized tonic/clonic seizure disorder, spastic quadriplegia, severe lumbar scoliosis, osteoporosis, osteoarthritis, dysmenorrhea, dysphagia and episodes of aspiration pneumonitis. She had been diagnosed with a thyroid tumor in 2005, most consistent with thyroid carcinoma but her guardians had elected to not submit her for treatment of this condition. She had a diffuse, chronic pain syndrome, possibly related to neuromuscular disorders. She was legally blind and non-verbal. She was NPO and had a G-tube for all nutrition and medications. She was severely disabled, dependent on others for all ADL and had no effective means of communication. She had an Advance Directive and a DNR order. Her guardians are her parents. Client had been in a general decline in health for several years and was being treated for her acute and chronic conditions but with an emphasis on comfort measures and measures to maximize her quality of life. She received influenza vaccinations annually due to being a high risk individual resident of a long term care facility with no recorded adverse reactions. On 10-17-06 she had a routine medical evaluation and was found to be in her usual state of compromised health, with no change in treatment recommended. She was given an influenza vaccine on 10-21-06 at her residence by a facility nurse and appeared to be in stable health at that time. On daily follow up by nursing she did not appear to be in ill health or have any adverse reaction to the vaccine, with no fever, apparent pain or other discomfort, no abnormal vital signs or rash. She was last observed during a bed check by her residential staff at 3:30 am on 10-24-06, about 53 hours after the vaccination was given and was observed to be sleeping comfortably in prone position and in no distress. The staff neither heard nor witnessed anything unusual but when they checked her one hour later at 4:30 am she was found to be unresponsive, cyanotic, with no respiratory effort and no pulse. Since she had a legal DNR in effect no resuscitation effort was made. She was pronounced dead at 4:50 am on 10-24-2006 by doctor name given. The Coroner was contacted, the death was determined to be of natural causes and the body was released to Mortuary. 11/13/06 Received Death Certificate which revealed COD as cardiopulmonary arrest; generalized tonic/clonic seizure disorder; with contributing factors of congenital developmental disability.


VAERS ID: 266544 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-17
Onset:2006-10-24
   Days after vaccination:7
Submitted: 2006-11-06
   Days after onset:13
Entered: 2006-11-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 70707 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-02
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxygen 2 liters, nebulizer four times a day, singular 10mg every morning, spiriva every morning, albuterol inhaler twice a day, advair 100/50 twice a day, Ibuprofen 200 mg as needed, Xanax 25 mg 1/2 tab by mouth as needed, B12 500mg liquid
Current Illness:
Preexisting Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt admitted to medical center 10/24/2006 for SOB and resp distress. No documented fever. Long standing H/O COPD. Pt expired 11/2/06 no autopsy done.


VAERS ID: 268863 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Ohio  
Vaccinated:2006-09-26
Onset:2006-10-18
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2006-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2166AB / UNK RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Cerebral atrophy
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestion
Preexisting Conditions: CP Pontocerebellar atrophy, brain stem atrophy.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child passed away 10/18/06. Patient was chronically ill with pontocerebellar atrophy, had shortened life expectancy 1/11/07 Received medical records from hospital which reveal patient admitted 10/13/06 secondary to cardiopulmonary arrest. Apparently had been in usual state of health & was riding in car w/parent when suddenly became pale with circumoral cyanosis & stopped breathing. Parent initiated rescue breathing & called EMS who then initiated CPR, intubated & gave epi during transport to outlying hospital before transfer to this Hospital. Made DNR & expired on 10/18/06. PMH: undefined degenerative neurologic disorder, feeding tube, salivary gland removal. Hx of previous arrest from respiratory secretions. Had otitis media 10 days prior to admit tx w/antibiotics. Birth HX: Adopted. Normal development till 9 mos of age when lost milestones. Currently, eyes open spontaneously, non verbal, sits only with support. unable to grasp. Joint contractures of all extremities. LABS: MRI revealed hypoxic/ischemic event to putamen/caudate (some new), cerebral atrophy & cerebellar degenerative changes. Trach c/s grew pan susceptible pseudomonas. Blood & urine c/s all neg. WBC 12.8 on admit, max of 26.8 on 10/16. CXR showed LLL density due to atelectasis & collapse. FINAL DX: None provided. 4/6/07 Received Death Certificate which reveals COD as upper airway obstruction; hypoxic ischemic encephalopathy; cerebral atrophy; and neuromuscular disease (unspecified).


VAERS ID: 264669 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-03
Onset:2006-10-11
   Days after vaccination:8
Submitted: 2006-10-12
   Days after onset:1
Entered: 2006-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69240 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flonase, Zocor, Premarin, Synthroid, Prevacid, Disaleral
Current Illness:
Preexisting Conditions: Allergic rhinitis, hypercholesterolemia, hypothyroidism, RA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found by her son, expired. He states it looked like "she went in her sleep". 10/19/06 Received Death Certificate which states COD as Found Dead, CAD s/p angioplasty, and hypercholesterolemia with contributing factors of HTN, PVD and hypothyroidism.


VAERS ID: 392054 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-01-24
Submitted: 2010-07-05
   Days after onset:1622
Entered: 2010-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, Nervous system disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-24
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IT43054

Write-up: Initial report received from a consumer''s lawyer by legal service on 30 Jun 2010: This patient received AGRIPPAL S (batch number unknown), unknown dose on an unknown date. The patient developed severe neurological disorders on unspecified date and on 24 Jan 2006, the patient died. Cause of death was not reported. No autopsy information was provided. The causality was provided as suspected.


VAERS ID: 249821 (history)  
Form: Version 1.0  
Age: 1.61  
Sex: Female  
Location: Illinois  
Vaccinated:2005-12-06
Onset:2005-12-12
   Days after vaccination:6
Submitted: 2005-12-28
   Days after onset:16
Entered: 2005-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1788FA / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None Stated Autopsy Report received 3/16/06 revealed COD as bronchopneumonia.


VAERS ID: 252693 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2005-11-18
Onset:2005-11-28
   Days after vaccination:10
Submitted: 2006-03-13
   Days after onset:105
Entered: 2006-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Fatigue, Injection site pain, Laboratory test abnormal, Myocarditis, Pulmonary oedema, Pyrexia, Shoulder pain, Sleep disorder, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (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: 2005-12-04
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN 10 MG QD PRN (DISPENSED 12/1/05) MOTRIN 800 MG TID PRN PAIN (DIPSENSED 12/01/05) LIDEX CREME 0.05% (DISPENSED 12/1/05).
Current Illness: NONE
Preexisting Conditions: MEDICAL CONDITIONS: ASTIGMATISM, FLAT FEET NKDA
Allergies:
Diagnostic Lab Data: 1)URINE TOXICOLOGY IS NEGATIVE FOR DRUGS OF ABUSE. 2)AUTOPSY SERUM TOXICOLOGY IS NEGATIVE FOR DRUGS OF ABUSE. 3)CBC IS NEGATIVE FOR SIGNS OF ACUTE BLOOD LOSS WITH A NORMAL HEMOGLOBIN AND HEMATOCRIT.
CDC Split Type:

Write-up: RECEIVED BOTH SMALLPOX AND INACTIVATED INFLUENZA VACCINES ON 11/18/2005. HE PRESENTED TO THE VACCINE HEALTHCARE CENTER ON 12/01/05 FOR EVALUATION OF FATIGUE, FEVERS, POOR SLEEP, LEFT SHOULDER PERSISTENT PAIN, AND CONCERNS REGARDING HIS INOCULATION SITE. THE PATIENT WAS EXAMINED AND FOUND TO HAVE AN ORAL TEMPERATURE OF 99.2F. HE DID APPEAR FATIGUED. HE WAS DIAGNOSED AS HAVING A ROBUST REACTION AND SENT HOME ON CLARITIN, MOTRIN, AND LIDEX CREME. THE PATIENT CONTINUED WITH FATIGUE ON THE FOLLOWING TWO DAYS BUT NEVER COMPLAINED OF CHEST PAIN OR SHORTNESS OF BREATH. THE PATIENT WAS FOUND DECEASED IN HIS BARRACKS BED ON THE MORNING OF 12/04/05. ACLS PROTOCOL WAS INITIATED IN THE FIELD AND CONTINUED IN THE HOSPITAL EMERGENCY ROOM TO NO AVAIL. THE PATIENT WAS PRONOUNCED DEAD AT 0933 HOURS. THE PATIENT''S INITIAL AUTOPSY WAS NEGATIVE FOR ANY SIGNS OF FOUL PLAY, FRACTURE, ACUTE INJURY, TRAUMA, ALCOHOL OR ILLICIT DRUG INTOXICATION OR OVERDOSE. 8/3/06 Received medical records & autopsy report which stated COD as hypersensitivity myocarditis. Final autopsy diagnoses also include sudden death in apparent healthy 26 year old; history of recent smallpox & flu vax; lymphocytic eosinophilic myocarditis, pulmonary edema.


VAERS ID: 248538 (history)  
Form: Version 1.0  
Age: 1.07  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2005-11-22
Onset:2005-11-23
   Days after vaccination:1
Submitted: 2005-11-25
   Days after onset:2
Entered: 2005-12-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1787DA / 1 - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1072P / 1 - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0418R / 1 - / -

Administered by: Unknown       Purchased by: Public
Symptoms: Apnoea, Malaise, Upper respiratory tract infection
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.


VAERS ID: 247750 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Arizona  
Vaccinated:2005-11-17
Onset:2005-11-17
   Days after vaccination:0
Submitted: 2005-11-18
   Days after onset:1
Entered: 2005-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 61501 / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Cardiac arrest, Hypersensitivity, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-11-17
   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: Prazosin 2mg;Ditropan XL; 10mg;Cozaar 50mg;Namenda 10mg;Zoloft 50mg;Diovan 160
Current Illness:
Preexisting Conditions: No allergies, Alzheimer''s, HTN, increased Prostate Specific Antigen, asbestos exposure, cardiomegaly, high cholesterol, anemia, lung asbestosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: While watching wife had severe allergic Rxn to flu shot ( and 10 min after her flu shot) Pt vasovagal syncope on chair and progressed to full arrest. No additional information from Medical Record rec''d 01/25/2006/sr


VAERS ID: 257084 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-07
Onset:2005-11-14
   Days after vaccination:7
Submitted: 2006-05-31
   Days after onset:197
Entered: 2006-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-02
   Days after onset: 18
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: B0425016A

Write-up: This case was reported by the regulatory authority and described the occurrence of encephalitis in a 56 yr old female subject who was vaccinated with influenza virus vaccine (manf unspecified) for prophylaxis. On 7Nov05 the subject received unspecified dose of influenza vaccine. On 14Nov05, 7 days after vaccination with Influenza vaccine, the subject experienced encephalitis. The subject died on 02Dec05, cause of death was not reported. An autopsy was performed and showed encephalitis. Verbatim text received: Autopsy showed autoimmune non herpetic acute limbic encephalitis following influenza vaccination. The reporter considered the reaction to be serious for the following reason: pt died due to reaction.


VAERS ID: 247362 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2005-11-10
Onset:2005-11-11
   Days after vaccination:1
Submitted: 2005-11-14
   Days after onset:3
Entered: 2005-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1864AA / 7+ LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dyazide; Enablex; Tegretol; Norvasc; Procardia; Fosamax
Current Illness:
Preexisting Conditions: CVA, HTN, GERD, Intracerebral aneurysm, Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Expired while sleeping approximately 12 - 18 hours after Flu vaccine administered. Coroner''s case. Additonal term added from autopsy report: Atheroscleric CAD/sr


VAERS ID: 249021 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: New Jersey  
Vaccinated:2005-11-03
Onset:2005-11-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2005-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1904AA / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0347R / UNK LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A25962H / UNK RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cardiac failure, Irritability, Myocarditis
SMQs:, Cardiac failure (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-10
   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: Pulmicort, Zantac, Singulair, Albuterol, AccuNeb
Current Illness: History of RAD
Preexisting Conditions: Premie, asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received vaccine 11/03/2005, admitted in heart failure, myocarditis 11/10/2005, Died 11/10/2005. Increasingly cranky for 2 days procedding admission to hospital.


VAERS ID: 247944 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2005-11-04
Onset:2005-11-08
   Days after vaccination:4
Submitted: 2005-11-21
   Days after onset:13
Entered: 2005-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1803AA / 6 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Asthma, Cardiac failure, Cough, Glomerulonephritis, Haemoptysis, Hypoxia, Lung disorder, Obesity, Pyrexia, Renal failure, Respiratory arrest, Sepsis, Shock, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-19
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Influenza vaccine administered 11/4/05. Recipient life flighted to pediatric intensive care 11/8/05 and placed on ventilator and dialysis. Dx with GoodPasture Syndrome and died 11/19/05. Terms added from Discharge summary rec''d 01/08/2006: shock, anemia, cardiac failure, menoptysis, fever, hypoxia, cough, lung infiltrate, tachypnea. Terms added to pre-existing conditions: Obesity, asthma, depression, hypertension, amenorrhea./sr


VAERS ID: 254832 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Alabama  
Vaccinated:2005-11-03
Onset:2005-11-07
   Days after vaccination:4
Submitted: 2006-04-24
   Days after onset:167
Entered: 2006-05-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1830AA / UNK RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Asthma, Cardiomegaly, Cerebral ischaemia, Encephalopathy, Hepatic necrosis, Hypoxia, Pneumonia, Pyrexia, Status epilepticus, Subdural haematoma
SMQs:, Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Accidents and injuries (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent; Singulair
Current Illness: Asthma
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: WBC 28,500.
CDC Split Type:

Write-up: Child developed fever early morning of Monday 11/7/06, then status epilepticus. Was brought to ER, was intubated and ventilated. Suffered hypoxic insult. Died 11/8/06. 7/6/06 Received medical records & autopsy report from hospital which reveal COD as status epilepticus with subsequent severe hypoxic/ischemic encephalopathy; cerebral edema with bilateral cerebellar tonsillar herniation; subdural hematoma, small, right lateral cerebellum & asthma (by clinical history). Stated that status epilepticus possibly related to URI (MRSA). Temp max 105.8


VAERS ID: 247278 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2005-11-02
Onset:2005-11-04
   Days after vaccination:2
Submitted: 2005-11-11
   Days after onset:7
Entered: 2005-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 61503 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Coma, Pain, Pulmonary embolism
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-05
   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: had UTI diagnosed 11-1-05
Preexisting Conditions: Bactrim Augmentin Flagyl
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11-4-05 C/o pain rt side rt lower lobe crackles 11-5-05 rt rib pain in morning. 5pm clammy unresponsive went to ER died at hospital. Hospital reports died from pulmonary embolism. Have not received death certificate at this time. 11/18/05 Death certificate received which revealed COD as pulmonary emboli.


VAERS ID: 249312 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2005-11-02
Onset:2005-11-04
   Days after vaccination:2
Submitted: 2005-12-15
   Days after onset:41
Entered: 2005-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1802FA / 7+ LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Arrhythmia, Blood pressure increased, Bronchiolitis, Cardiomegaly, Cough, Dyspnoea, Hyperglycaemia, Hypoxia, Ileus, Laboratory test abnormal, Leukocytosis, Pneumonia, Pneumothorax, Respiratory failure
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-02
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: synthroid 75 mcg qd; lopressor 200 mg BID; lasix 40 mg daily; norvasc 5 mg daily; pulmicort inhaler BID
Current Illness: non-productive cough, nasal drainage, afebrile
Preexisting Conditions: HPD, hypothyroidism, anxiety, reflux disease, S/P laryngeal cancer
Allergies:
Diagnostic Lab Data: ABG, CBC, chemistry, lung biopsy
CDC Split Type:

Write-up: Developed marked dyspnea on exertion with SOB at rest and occasional cough productive of red sputum. Condition deteriorated despite intervention. Additional terms added from Discharge Summaries rec''d 12/28/2005: Hypoxia, lab test abnorm, leukocytosis, Inc. BP, Hyperglycemia, atrial fib, anemia, dyrhythmia, resp failure, cardiomegaly, pneumothorax, ileus, broncholitis, pneumonia/sr


VAERS ID: 248329 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-11-03
Onset:2005-11-04
   Days after vaccination:1
Submitted: 2005-11-29
   Days after onset:25
Entered: 2005-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Malaise, Pericarditis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (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: 2005-11-04
   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: Bendrofluazide, Ramipril, Diclofenac, Orlistat
Current Illness: Gastric ulcer, hypertension, obesity, proteinuria.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0401650A

Write-up: This case was reported by a regulatory authority and described the occurrence of pericarditis in a 67 year old male subject who was vaccinated with influenza virus vaccine, manufacturer unspecified, for prophylaxis. Concurrent medical conditions included gastric ulcer, hypertension, obesity and proteinuria. Concurrent medications included bendrofluazide, ramipril, diclofenac and orlistat. On Nov 3 2005 the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced pericarditis, pulmonary edema and feeling unwell. Relevant test results included lab results hospital investigations. The events were unresolved. The subject died on Nov 4 2005, cause of death was not reported. An autopsy was performed and showed pericarditis and pulmonary edema. Verbatim text received. After receiving the flu vaccine he complained of feeling unwell and confined himself to bed, He was found on his bed and was unresponsive-dead. Post portem results showed cloudy fluid around the heart, acute inflammation around the surface the heart, acute pericarditis and pulmonary edema. Autopsy revealed acute pericarditis. An inquest in being arranged.


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