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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: 470890 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-10
Onset:2012-10-11
   Days after vaccination:1
Submitted: 2012-10-22
   Days after onset:11
Entered: 2012-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Atrial thrombosis, Autopsy, Blood pressure fluctuation, Carotid artery stenosis, Coronary artery stenosis, Death, General physical health deterioration, Hepatic congestion, Pulmonary oedema, Respiratory distress
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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: 2012-10-12
   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: Chronic gastritis; Coronary arteriosclerosis; Diabetes mellitus Type 2; Generalized arteriosclerosis; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 11Oct2012, fluctuating
CDC Split Type: D0077465A

Write-up: This case was reported by a physician via a regulatory authority (# DE-PEI-PEI2012052261) and described the occurrence of death - at present cause unknown - in an 80-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included arterial hypertension, chronic gastritis, diabetes mellitus type 2, severe coronary arteriosclerosis and generalized arteriosclerosis. It was unknown whether or not previous vaccinations with vaccines not further specified, including or not INFLUSPLIT SSW (GlaxoSmithKline), have been well tolerated. On 10 October 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, subcutaneous, unknown). Approximately one day post vaccination with INFLUSPLIT SSW, on 11 October 2012, the subject experienced blood pressure fluctuation and respiratory distress. In the night between 11 October 2012 and 11 October 2012 the subject died (death - at present cause unknown). The subject was found dead at home sitting in an arm chair by the daughter in law. An autopsy was performed. Additional information was received by the foreign regulatory authority by phone from the reporting physician on 16 October 2012, 17 October 2012 and 18 October 2012. An autopsy was performed on 17 October 2012. Despite autopsy the cause of death remained unknown. The autopsy showed a pulmonary edema, signs of congestion of liver, thrombi in the left cardiac atrium, a generalized arteriosclerosis with high-grade stenosis of the coronary arteries and with high-grade stenosis of internal carotid artery on both sides. Examination of the brain and several histological examinations are planned, but not yet conducted. Therefore the final autopsy result was not yet available. Initially the physician had reported that the subject has experienced worsening of general condition post vaccination with INFLUSPLIT SSW. Later on worsening of general condition was specified and the physician more precisely reported that the subject experienced blood pressure fluctuation and respiratory distress. In additional information was received by the regulatory authority by phone on 18 October 2012 from a general practitioner, the family physician of the subject. This physician has specified that the seasonal trivalent Influenza vaccine used for vaccination on 10 October 2012 had been INFLUSPLIT SSW (GlaxoSmithKline). The foreign regulatory authority has requested further information. At the moment no further information was available.


VAERS ID: 475174 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Unknown  
Vaccinated:2012-09-22
Onset:2012-10-08
   Days after vaccination:16
Submitted: 2012-11-21
   Days after onset:44
Entered: 2012-11-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) / SANOFI PASTEUR UT4466BA / UNK UN / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s past medical history was reported as not applicable (n/a) and illness at time of vaccination was reported as none. The patient used home oxygen.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201210777

Write-up: Initial report was received from a consumer on 14 November 2012, and involves a case of misuse, inappropriate age at vaccine administration. An 88-year-old female patient received an injection of FLUZONE Intradermal, sanofi pasteur Inc., (lot number, route, site, side and dose in series not reported) on 22 September 2012, which is indicated for patients 18 to 64 years of age. On 08 October 2012, 16 days post vaccination, the patient was found dead. The patient''s past medical history was reported as not applicable (n/a) and illness at time of vaccination was reported as none. The patient used home oxygen. It was not reported if an autopsy was done. No other details were provided. The patient''s outcome was reported as fatal on 08 October 2012. Documents held by sender: None.


VAERS ID: 472392 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-04
Onset:2012-10-08
   Days after vaccination:4
Submitted: 2012-10-31
   Days after onset:23
Entered: 2012-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA741AA / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiopulmonary failure, Death, Treatment noncompliance
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Salbutamol sulphate; Beclomethasone dipropion; Amoxicillin trihydrate; Prednisolone
Current Illness: Unknown
Preexisting Conditions: Asthma; Exacerbation of asthma; Patient weight as of 22/11/2011: 41.5kg
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0839603A

Write-up: This case was reported by a physician, via the regulatory authority, and described the occurrence of cardiorespiratory failure in a 15-year-old male subject who was vaccinated with FLUARIX. The subject''s medical history included asthma. The subject was treated for an exacerbation of asthma on 19 September 2012 with amoxicillin and prednisolone. Concurrent medications included VENTOLIN and CLENIL MODULITE. It was reported that the subject had ''probable poor compliance with CLENIL inhaler''. On 4 October 2012 the subject received an unspecified dose of FLUARIX (1 injection, left arm, batch number AFLUA741AA). On 8 October 2012, 4 days after vaccination with FLUARIX, the subject experienced cardiorespiratory failure. The subject died on 08 October 2012 from acute cardiorespiratory failure. An autopsy was not performed. Agency Verbatim Text: Asthmatic patient died with acute cardio respiratory failure four days after receiving influenza vaccination (unexpected). Known asthmatic. Probable poor compliance with CLENIL inhaler. Was treated for exacerbation in September with a course of amoxicillin and prednisolone.


VAERS ID: 480995 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2012-10-03
Onset:2012-10-07
   Days after vaccination:4
Submitted: 2013-01-10
   Days after onset:95
Entered: 2013-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH730AB / UNK LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Pain in extremity
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-18
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes; Coronary artery disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine 10-3-12. To ER 10-12-12 with (L) arm pain. Seen 10-13-12 & transferred to cardiologist at hospital she declined there, was diagnosed with Guillain-Barre, transferred to where she expired.


VAERS ID: 468865 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Ohio  
Vaccinated:2012-10-03
Onset:2012-10-04
   Days after vaccination:1
Submitted: 2012-10-10
   Days after onset:6
Entered: 2012-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1204201 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-04
   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: vitamin D, mirtazapine, omeprazole, hydrochlorothiazide, loratadine, tramadol, docusate
Current Illness: no infectious illnesses at time of vaccination
Preexisting Conditions: NKDA Adult Failure to Thrive Esophageal stricture, HTN, Osteoarthritis, Dementia
Allergies:
Diagnostic Lab Data: Pt had chronic illnesses including being very malnourished, weighing 102# and being 6''2".
CDC Split Type:

Write-up: Per family pt had a good day and eve, no signs of allergic reaction or difficulty. He failed to wake up the next morning. Time of death 10:37 AM.


VAERS ID: 467247 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: New York  
Vaccinated:2012-09-26
Onset:2012-09-27
   Days after vaccination:1
Submitted: 2012-10-02
   Days after onset:5
Entered: 2012-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4482AA / 4 AR / IM

Administered by: Private       Purchased by: Public
Symptoms: Body temperature increased, Death, Moaning, Nasal flaring, Pain, Peripheral coldness, Resuscitation
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-27
   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: Multivitamin Levetiraceta Phenobarbitol Diazepam
Current Illness: None
Preexisting Conditions: MR/CP, seizure disorder, developmental delay
Allergies:
Diagnostic Lab Data: None. Family waived Medical Examiner review.
CDC Split Type:

Write-up: 11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR 82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at hospital.


VAERS ID: 467340 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:2012-09-25
Onset:2012-09-26
   Days after vaccination:1
Submitted: 2012-10-03
   Days after onset:7
Entered: 2012-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1204901 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-27
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US019182

Write-up: Case number PHEH2012US019182 is an initial spontaneous report received from a pharmacist on 28 Sep 2012. This report refers to a 49-years-old male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1204901, expiry date: May 2013) intramuscularly on 25 Sep 2012. On 26 Sep 2012, he felt sick and nauseous. It was reported that he suffered a heart attack at his work site and expired before the ambulance arrived on 27 Sep 2012. No further information was available.


VAERS ID: 467090 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Missouri  
Vaccinated:2012-09-24
Onset:2012-09-24
   Days after vaccination:0
Submitted: 2012-10-01
   Days after onset:7
Entered: 2012-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED P58406 / UNK - / IM

Administered by: Other       Purchased by: Public
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-28
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: None
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data: unknown.
CDC Split Type:

Write-up: Pt daughter reported next day that explosive diarrhea occurred. Recommended ER or urgent care.


VAERS ID: 465916 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Texas  
Vaccinated:2012-09-20
Onset:2012-09-21
   Days after vaccination:1
Submitted: 2012-09-21
   Days after onset:0
Entered: 2012-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4494AA / UNK UN / IM

Administered by: Other       Purchased by: Public
Symptoms: Activities of daily living impaired, Death, Faecal incontinence, Musculoskeletal stiffness, Pain
SMQs:, Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan 50mg daily
Current Illness: No chronic disease noted
Preexisting Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Since flu vaccine was adminstered within such a close timeframe, medical examiner thought that we should be aware and report to VAERS, the possible link of the vaccine to the patient''s death.
CDC Split Type:

Write-up: Patient complained of "achiness" around 2:30 to 3:00 pm. His symptoms progressed to stiffness and soreness by bedtime and needed help with his clothing before bed. Around Midnight, there was a loss of bowel control and he passed away.


VAERS ID: 469713 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Washington  
Vaccinated:2012-09-18
Onset:2012-09-18
   Days after vaccination:0
Submitted: 2012-10-11
   Days after onset:23
Entered: 2012-10-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 12251P / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-18
   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: Recently discharged for CHF exacerbation
Preexisting Conditions: CHF; Peripheral vascular disease; Hyperlipidemia; Atrial fibrillation; Foot amputation
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Resp. Depression, Tachycardia and Cardiac Arrest. Epinephrine 1 MG Other, Dopamine 10 MCG Other.


VAERS ID: 486413 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Georgia  
Vaccinated:2012-09-14
Onset:2012-09-15
   Days after vaccination:1
Submitted: 2013-03-07
   Days after onset:173
Entered: 2013-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1204601 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Abasia, Diarrhoea, Dysstasia, Hypersomnia, Hypokinesia, Intensive care, Lethargy, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-10-01
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: couldnt move without assistance~ ()~~0.00~Patient|couldnt stand~ ()~~0.00~Patient|weakness~ ()~UN~12.75~Patient|~Influenza (Seas
Other Medications: Duonebs, Abilify, Azactam, Carvedilol, Diflucan, Diflucan, Levanquin, Solu-Cortef, Synthroid, Vancomycin. Allergies: Sulfa, Penicillin, Benadryl
Current Illness: After an hour of vaccine, patient was nausea, vomiting, diarrhea and couldn''t move or stand to go to bathroom.
Preexisting Conditions: Received vaccine at dialysis center. Dialysis of kidney, full-blown AIDS, but very active and lively before incident.
Allergies:
Diagnostic Lab Data: Yes. ER & ICU & CCU
CDC Split Type:

Write-up: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn''t move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn''t move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.


VAERS ID: 466326 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2012-09-10
Onset:2012-09-14
   Days after vaccination:4
Submitted: 2012-09-25
   Days after onset:11
Entered: 2012-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AH2140 / 1 NS / IN

Administered by: Unknown       Purchased by: Public
Symptoms: Influenza virus test negative, Intensive care, Nasopharyngitis, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-20
   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: Miralax; Dulcolax; Erythromycin (EES); Iron; Poly-Vi-Sol; Lactulose
Current Illness: Mild URI for 1 day with no fever and no respiratory distress
Preexisting Conditions: Prematurity (31-32 weeks); G-tube dependent; Developmental delay; Atrial Septal Defect; Undiagnosed cause for muscle weakness; Constipation
Allergies:
Diagnostic Lab Data: Negative Influenza test result.
CDC Split Type:

Write-up: Respiratory arrest at home after 4 days of worsening cold symptoms. Driven by family auto to Medical Center and then transfered to PICU at another hospital.


VAERS ID: 473170 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2012-08-01
Onset:2012-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2012-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Demyelination, Myelitis transverse, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-10
   Days after onset: 70
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: MRI consistent of ADEM.
CDC Split Type: HI1205

Write-up: Transverse myelitis. Region of demyelination in right frontal lobe.


VAERS ID: 586909 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-27
Onset:2012-07-27
   Days after vaccination:0
Submitted: 2015-07-22
   Days after onset:1090
Entered: 2015-07-23
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-27
   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: Con Meds =None; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: COPD-Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA106413

Write-up: Initial unsolicited literature report received from a healthcare professional on 16 July 2015. A 47-year-old female patient had received a dose of Influenza vaccine (batch number, route and site of administration were unknown) on 27 July 2012. Patient''s medical history included COPD (chronic obstructive pulmonary disease) and HTN (hypertension). The patient did not receive any concomitant medication. On 27 July 2012, same day unspecified time after vaccination, the patient was found dead, lonely at home, Laboratory investigations were not reported and corrective treatments were unknown. It was unknown if autopsy performed. Patient died of an unknown cause. The causality was reported as not related (unrelated) to vaccine. Documents held by sender: none. Lab tests unknown. Cause(s) of Death: Unknown cause of death.


VAERS ID: 586912 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-27
Onset:2012-07-27
   Days after vaccination:0
Submitted: 2015-07-22
   Days after onset:1090
Entered: 2015-07-23
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-27
   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: Con Meds = None; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Diabetes mellitus; hypertension; COPD; polycythemia
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA106415

Write-up: Initial unsolicited literature report received from a healthcare professional on 16 July 2015. A 49-year-old female patient had received a dose of Influenza vaccine (batch number, route and site of administration were unknown) on 27 July 2012. Patient''s medical history included diabetes mellitus (DM), COPD (chronic obstructive pulmonary disease), HTN (hypertension) and polycythemia. The patient did not receive any concomitant medication. On 27 July 2012, same day unspecified time after vaccination, the patient was found dead. Physician was not able to perform diagnosis as the corpse was not taken to the hospital. Laboratory investigations and corrective treatment were unknown. Autopsy was not performed. Patient died of an unknown cause. The causality was reported as not related to vaccine. Documents held by sender: none.


VAERS ID: 588567 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-07-19
Onset:2012-07-20
   Days after vaccination:1
Submitted: 2015-07-23
   Days after onset:1098
Entered: 2015-07-24
   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, Fatigue, Hyperhidrosis, Peripheral coldness
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds -None; Indomethacin
Current Illness:
Preexisting Conditions: Abdominal pain; flatulence
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA106412

Write-up: A 69 years old male patient who did not take any concomitant medications had received a dose of Influenza vaccine (dose details, batch number, expiry date, route of administration and site of administration were not reported) on 19 July 2012. The patient had a history of abdominal pain with flatulence and was taking Indomethacin regularly. The family history was unknown. On 20-Jul-2012, next day post-vaccination; the patient experienced fatigue and sweating and was found cold bodied and dead at home. Laboratory investigation and corrective treatments were not reported. At the time of report, the outcome of the events fatigue, sweating and body temperature was unknown. Relationship of the suspect vaccine and the events per the reporter was reported as "No". Documents held by sender: none. Lab tests unknown. Cause(s) of Death: death NOS.


VAERS ID: 586911 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-19
Onset:2012-07-19
   Days after vaccination:0
Submitted: 2015-07-22
   Days after onset:1098
Entered: 2015-07-23
   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: Cardiogenic shock, Chills, Death, Dyspnoea, Pneumonia, Pulmonary hypertension, Pyrexia, Right ventricular failure, Septic shock
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds -None; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: hypertension; congestive heart failure; dyslipoproteinemia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA106414

Write-up: Initial unsolicited literature report received from a pharmacist on 16-Jul-2015. A 68 years old female patient, had received a dose of Influenza Vaccine (dose details, batch number, expiry date, route of administration and site of administration were not reported) on 19-Jul-2012. The patient had a history of hypertension, congestive heart failure and dyslipoproteinemia. The family history was unknown. She did not take any concomitant medications. On 19-Jul-2012, same day post-vaccination, the patient was febrile, she developed chills and dyspnea. She died on 19-Jul-2012. The physician had diagnosed that patient had died due to severe pulmonary hypertension, right side heart failure, suspected septic/cardiogenic shock and pneumonia. It was reported that after the death cause evaluation, the result stated that it was not related to the vaccine. Laboratory investigations and corrective treatments were not reported. Relationship of the suspect vaccine and the events per the reporter: No. Documents held by sender: none. Lab tests unknown. Cause(s) of Death: cardiogenic shock, septic shock, pulmonary hypertension, failure right heart, pneumonia.


VAERS ID: 586908 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-14
Onset:2012-07-16
   Days after vaccination:2
Submitted: 2015-07-22
   Days after onset:1101
Entered: 2015-07-23
   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: Asthenia, Cerebrovascular accident, Death, Somnolence
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds = None; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Diabetes Mellitus; Hypertension; dyslipoproteinemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA106411

Write-up: Initial unsolicited report received from literature on 16 July 2015. A 76-year-old female patient had received a dose of Influenza vaccine (batch number, route of administration, site of administration were unknown) on 14 July 2012. Patient''s diabetes mellitus (DM), hypertension (HTN) and dyslipoproteinemia (DLP). The patient did not receive concomitant medication. On 16 July 2012; two day after vaccination, the patient developed symptoms of drowsiness, weakness and patient was diagnosed with stroke disease. On 16 July 2012, two day after vaccination, the patient developed symptoms of drowsiness, weakness and patient was diagnosed with stoke disease. On 16 July 2012, patient was found dead. Laboratory investigations were not reported and corrective treatments were unknown. Special tests or treatment required and their result was reported as not applicable. The causality was reported as non-related (unrelated). Documents held by sender: none. Lab tests unknown. Cause(s) of Death: stroke.


VAERS ID: 465843 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-28
Onset:2012-06-29
   Days after vaccination:32
Submitted: 2012-09-20
   Days after onset:83
Entered: 2012-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR J7051 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Chills, Cough, Dyspnoea, Influenza, Influenza A virus test positive, Lung consolidation, 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), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient has a history of chronic lung disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201208549

Write-up: Initial report was received on 11 September 2012 from a health care professional via the local affiliate, local reference number BR-BT2012-0435. A 79 year-old male patient with a history of chronic lung disease had received on 28 May 2012 VAXIGRIP, batch number J7051 (route and site of administration not reported). On 29 June 2012, the patient presented with flu symptoms of cough, fever, shivers and dyspnea. The patient was hospitalized on 29 June 2012 and a chest radiograph indicated the presence of consolidation. On 06 July 2012, a nasopharyngeal aspirate was completed and the PCR detected pandemic influenza A (H1N1). Treatments included oseltamivir. No further information was available at the time of the report. The patient outcome was fatal. The reporter for this case is the same as case 2012-07585 and 2012-07591. Documents held by sender: none.


VAERS ID: 464524 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-06-04
Submitted: 2012-09-07
   Days after onset:95
Entered: 2012-09-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood bilirubin, Blood culture negative, Blood product transfusion, Death, HIV test negative, Haemoglobin, Hepatitis B test negative, Hepatitis C test negative, Immunology test normal, International normalised ratio decreased, Platelet count decreased, Thrombotic thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hb, 94 g/l; INR, 1.1; Platelet, 10x10^9/l; T Bilirubin, 81 micromol/l
CDC Split Type: 2012033271

Write-up: This health authority report (initial receipt 29-Aug-2012) concerns a 28-year-old female patient. On an unspecified date the patient received influenza vaccine (manufacturer and batch no. not specified) 1 dose unspecified. On 04-Jun-2012 the patient developed thrombotic thrombocytopenic purpura (TTP). Laboratory results revealed platelet count of 10x10^9/l, haemoglobin (Hb) was 94 g/l, international normalized ratio (INR) was 1.1 and total (T) bilirubin was 81 micromol/l. A peripheral film revealed multiple fragmented cells consistent with TTP. A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13 activity) was 1 ng/ml. Human immunodeficiency virus (HIV), hepatitis B and C, urine and blood cultures and immunology tests were all negative. She was treated with plasma exchange. On 06-Jun-2012 the patient died as a result of the event. Reporter''s comment: On 05-Aug-2012, the health authority considered the events as possible in relation to influenza vaccine.


VAERS ID: 457040 (history)  
Form: Version 1.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-16
Onset:2012-05-18
   Days after vaccination:2
Submitted: 2012-06-08
   Days after onset:21
Entered: 2012-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza like illness, Pneumonia, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-28
   Days after onset: 10
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: B0805826A

Write-up: This case was reported by a consumer (subject''s granddaughter) and described the occurrence of pneumonia in a 100-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. On 16 May 2012, the subject received 1st dose of FLUARIX (unknown route, unknown arm, batch number not provided). On 18 May 2012, 2 days after vaccination with FLUARIX, the subject experienced flu-like symptoms described as running nose and sneezing which according to the reporter evolved in pneumonia. No hospitalisation was required following the responsible physician''s recommendation. The subject died on 28 May 2012, cause of death was not reported. It was unknown whether an autopsy was performed. Follow-up information was not expected.


VAERS ID: 457355 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-10
Onset:2012-05-12
   Days after vaccination:2
Submitted: 2012-06-11
   Days after onset:30
Entered: 2012-06-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1203501 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Blood gases, Cardio-respiratory arrest, Chest X-ray, Death, Decreased appetite, Dyspnoea, General physical health deterioration, Hyperhidrosis, Intensive care, Malaise, Productive cough, Pyrexia, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), 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), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012CO048429

Write-up: Case number PHHY2012CO048429 is an initial spontaneous report received from a hospital nurse and health authority through a Norvatis employee on 06 Jun 2012. This case refers to a 93-year-old female patient. The patient''s medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1203501, expiration date: Dec 2012) on 10 May 2012. On 12 May 2012, she experienced fever, cough with secretions, sweating, malaise, difficulty in breathing, loss of appetite. She received medical treatment, management of symptoms with acetaminophen, and respiratory therapy. The patient''s history was discussed with the caregivers (not specified). The patient was diagnosed with respiratory distress syndrome secondary to lymphangitic spread vs. post-vaccine reaction on 12 May 2012 by a physician. On 14 May 2012 physician referred the patient to the emergency room where chest radiography and arterial blood gases were performed. On 14 May 2012 the patient was admitted in ICU in bad general condition, with drowsiness, dyspnea, and fever. She was given treatment with normal saline solution, furosemide 5 mg every 12 hours, methylprednisolone, morphine, ranitidine, enoxaparin and 30% oxygen. On 16 May 2012 the patient experienced a cardiopulmonary arrest and died. The outcome of the events fever, difficulty breathing/dyspnea, loss of appetite, respiratory distress syndrome, bad general condition and drowsiness were reported as death. Agency consider that FLUVIRIN treatment was suspected to be related with events.


VAERS ID: 482742 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-07
Onset:2012-03-09
   Days after vaccination:93
Submitted: 2013-01-28
   Days after onset:325
Entered: 2013-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 66116279 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Aspartate aminotransferase normal, Aspiration tracheal abnormal, Basophil count normal, Bladder catheterisation, Blood albumin, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood cholesterol normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood culture positive, Blood glucose normal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactate dehydrogenase normal, Blood potassium normal, Blood sodium normal, Blood triglycerides normal, Blood urea normal, C-reactive protein increased, CSF cell count abnormal, CSF glucose, CSF protein, CSF protein normal, CSF white blood cell count negative, Cardiac arrest, Chest X-ray normal, Coma scale, Complement factor C3, Complement factor C4, Complement factor normal, Culture urine positive, Death, Delirium, Diet refusal, Dysarthria, Dysphagia, Dysphonia, Electromyogram abnormal, Electroneurography, Eosinophil percentage decreased, Eyelid function disorder, Gamma-glutamyltransferase normal, Globulin, Guillain-Barre syndrome, Haematocrit normal, Haemoglobin normal, Heart rate increased, High density lipoprotein normal, Hypertension, Immunoglobulin therapy, Intensive care, International normalised ratio normal, Keratitis, Klebsiella test positive, Laboratory test abnormal, Lipase increased, Loss of consciousness, Low density lipoprotein normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Mechanical ventilation, Monocyte count normal, Muscular weakness, Nasopharyngitis, Neutrophil percentage increased, Paraesthesia, Paralysis, Platelet count normal, Protein total normal, Prothrombin time normal, Pseudomonas test positive, Pupillary light reflex tests normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red blood cells CSF positive, Red cell distribution width normal, Reflexes abnormal, Respiratory arrest, Respiratory failure, Sepsis, Speech disorder, Staphylococcus test positive, Tracheostomy, Urinary tract infection, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Corneal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular infections (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-09
   Days after onset: 0
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: PIRAMIL
Current Illness: Hypertension; Epididymitis; Prostatic adenoma
Preexisting Conditions: Surgery; Eyelid ptosis; Bladder catheterisation; Mechanical ventilation; 01/11/2012, Tracheostomy
Allergies:
Diagnostic Lab Data: Aspiration tracheal, Positive, Significant, Pseudomonas aeroginosa; Blood albumim, 26.9 g/dl, Low; Blood alkaline phophatase, 51 U/l, Low; Blood creatinine, 61 umol/l, Low; Blood culture, Positive, Significant, Pseudomonas aeuroginosa and coagulase negative Staphylococcus species; Blood pressure, 170/110, High; C-reactive protein, 56.6 mg/l, High; CSF cell count, Abnormal, Significant, RBC 50, WBC 2; CSF glucose, 3.7, Not Applicable; CSF protein, 0.6, Not Applicable; Culture urine, Positive, Significant, Klebsiella pneumoniae ESBL; Eosinophil count, 0.3%, Low; Heart rate, 90 per minute, High; Lipase, 19 g/dl; High; Lymphocye count, 7%, Low; Neutrophil count, 85.1%, High; Red blood cell sedimentation rate, 80 mm/3.6 ks, High
CDC Split Type: PHHY2013HR006498

Write-up: Case number PHHY2013HR006498 is an initial spontaneous report received from a consumer via health authority (HA reference number: 2012-01906) on 23 Jan 2013. This report refers to a 78-years-old male patient. His medical history included surgery on both eyelid due to eyelid ptosis and current conditions included arterial hypertension and inflammation of the left epididymis and prostate adenoma. His concomitant medications included RAMIPRIL 10 mg. He was vaccinated with FLUIMUN (batch number: 6/6 116279) on 07 Dec 2011. On 05 Jan 2012 around 4 pm he felt weakness in his legs and after that in his arms. He also had speech disturbance. He was taken to emergency room around 7 pm where it was concluded that the event was due to high pressure and he was sent home. The weakness got worse when he reached home. It was reported that on 06 Jan 2012, it was identified that he had Guillain Barre syndrome. He was hospitalized at the neurology ward due to the events. On the date of admission, at around 2 pm, he felt tingling in his legs and arms. It was difficult for him to get up from the table after lunch. During that day, by the evening the weakness got worse, with difficulties in speaking and swallowing. A few days previously he had had a cold. Physical status at admission was reported as follows: He was cardio-circulatory and respiratory compensated. He was hemodynamically stable. His blood pressure was 170/110 mmHg and pulse rate was 90/ minute. He was afebrile, rhythmic and had normal auscultatory findings on heart and lungs. His abdomen was soft and painless and there was no palpable organomegalles or pathological resistances. His peripheral arterial pulsations were normally palpitated, peristalsis was audible, extremities were symmetrical and there was no edema. Neurological status was reported as follows: He was conscious and Glasgow Coma Scale (GCS) was 15. There was no meningism. Speech was dysarthric and dysphonic. His right upper eyelid was disceetly lowered. Pupils were round and isochoric and had normal reactions to light. All extremities were brought to antigravity position limply falling on the surface. Own reflexes were not stimulated. Plantar reflex was bilaterally physiological. There was no signal of loss of feeling. Vascular status of the neck physically was with no special findings. It was reported that he had permanent urinary catheter placed. Results of tests were reported as follows: HDW was 27.8; Globulins was 45-1; CSF was clear and colorless. Pandy''s test was negative. Heart and lung X-ray performed revealed radiologically compensated heart, normal configuration of hila, lungs of normal airiness and no fresh infiltrates. Diaphragm was of normal position and form. Control heart and lung X-ray on 06 Jan 2012: Asymmetry of the imaging position. Lungs well ventilated with no pathological shadows. Tip of central venous catheter was in the shadow of the superior vena cava. Diaphragm and lateral phrenicocostal sinuses were of normal appearance. Laboratory test results were reported as follows: red blood cell count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width, platelet count, mean platelet volume, white blood cell count, glucose, urea, sodium, potassium, bilirubin total, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, protein total, lactate dehydrogenase, creatinine kinase, prothrombin time, international normalized ratio (INR), Complement factors C3 and C4, Immunoglobulin A, M and G, activated partial thromboplastin time (APTT) was reported as normal. Neutrophils was 85.1 percent, lymphocytes were 7 percent, eosinophil was 0.3 percent and monocytes and basophil were normal. Erythrocyte Sedimentation Rate (ESR) was 80, creatinine was 61, alkaline phosphatase was 51, lipase was 19, albumin was 26.9, C-reactive protein (CRP) was 56.6 mg/l, creatinine kinase was 79 U/l (normal value: 177U/l), Cerebrospinal fluid examination was as follows: RBC: 50, WBC: 2, protein: 0.6 and glucose: 3.7. Tracheal aspiration showed Pseudomonas aeuroginosa and urine culture yielded Klebsiella pneumoniae ESBL (extended spectrum beta lactamase). Hemoculture was positive for Pseudomonas aeuroginosa and coagulase negative Staphylococcus species. On 07 Jan 2012, in the morning hours he stopped breathing on his own, had respiratory insufficiency and was put on a ventilator. He was unconscious. The immunoglobulin (Ig) therapy was commenced immediately upon admission to hospital and lasted for 5 days. On 11 Jan 2012, tracheostomy was done. He was conscious on 17 Jan 2012 and the first indications appeared of a recovery of the facial musculature. Over the next few days the facial and neck musculature largely recovered. On 24 Jan 2012, the doctors decided to reinstitute lg therapy to which he did not respond (some muscle contractions on arms were noted, but there was no attempt to breathe on his own, and he continued to be paralyzed from the neck down). Even on 31 Jan 2012, there was no change in his condition. On 07 Feb 2012, he experienced urinary tract infection and sepsis. It was reported that he continued to be on ventilator and other machines by mid Feb 2012. Control heart and lung X-ray was performed on 20 Feb 2012 and the result was as follows: Lungs were well ventilated. Tip of the central venous catheter was in the projection of the superior vena cava. There was no differentiated pathological infiltrates. Diaphragm and lateral phrenicocostal sinuses were of normal appearance. Electromyography: ''in m. tibialis ant. dex.et sin.; m. ext. dig. brevis dex et sin; m. vastus lat. Dex.'' No willful or spontaneous activity was registered (eight days from the onset of neurological deficit). Neurography: for ''n. medianus sin.; n. ulnaris sin.; n. tibialis dex. et sin. muscle potential was not evoked''. For n. peroneus dex. extended terminal latency registered and low CMAP amplitude, from the proximal point of stimulation, muscle potential was not stimulated (condition block?). On an unknown date at the end of Feb 2012, he started to breathe on his own, managed to move his legs and arms and was sent to medical spa; since he had to wait for his turn to start therapy at the spa, he continued to lie in the neurosurgery ICU. Improvement occurred and he started to drink and take food by mouth, recovered his ability to swallow and speech returned to a certain degree but was made difficult by a cannula. On an unknown date in 2012, he had keratoconjunctivitis. It was reported that on 08 Mar 2012, after the visit everything was normal, but in the evening hours of the same day he got a fever, refused to eat and was delirious all night. On 09 Mar 2012, around noon he was still conscious, later he lost consciousness. He had a cardiac arrest and he finally died at 7 pm on 09 Mar 2012. The causality of the event was not assessed. No further information was provided.


VAERS ID: 514629 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2012-03-01
Onset:2012-03-06
   Days after vaccination:5
Submitted: 2013-11-25
   Days after onset:629
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 637BA / UNK LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Diplegia, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Respiratory disorder
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-14
   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: Aricept, Klonopin, Namenda, Mobic, and Tenormin.
Current Illness: Administered at discharge. Patient has been admitted to hospital with nausea, vomiting, diarrhea. Diagnosed with severe gastroenteritis and diverticulosis.
Preexisting Conditions: Hypertension, dementia, arthritis, hypothyroidism. Allergies: penicillin, erythromycin, codeine, hydrochlorothiazide.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient became very weak on 3/06/12 at home. Presented to ED with paralysis of lower extremities on 3/07. Neurology diagnosis: Guillain-Barre Syndrome. Treated with IVIG. Patient quickly developed respiratory issues and required ventilatory support.


VAERS ID: 450453 (history)  
Form: Version 1.0  
Age: 1.07  
Sex: Male  
Location: Maine  
Vaccinated:2012-02-07
Onset:2012-02-08
   Days after vaccination:1
Submitted: 2012-02-22
   Days after onset:14
Entered: 2012-02-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4003AA / 4 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4149CA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0852AA / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F17155 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found unresponsive by babysitter. EMS called to scene. Patient transported to ER at Medical Center. Time of death noted to be 20:48 on 2/8/12 by ER.


VAERS ID: 450086 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2012-02-06
Onset:2012-02-07
   Days after vaccination:1
Submitted: 2012-02-22
   Days after onset:15
Entered: 2012-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ADEN_4_7: ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME) / TEVA PHARMACEUTICALS 348000018 / UNK UN / UN
FLUN3: INFLUENZA (SEASONAL) (FLUENZ) / MEDIMMUNE VACCINES, INC. 04949221AA / UNK UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB221AA / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4256AA / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B075BA / 1 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Bacterial test negative, Blood culture negative, CSF culture negative, Cold agglutinins negative, Culture urine negative, Death, Diarrhoea, Dizziness, Drug screen negative, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intensive care, Laboratory test abnormal, Legionella test, Lung infiltration, Mechanical ventilation, Multi-organ failure, Mycoplasma test, Pyrexia, Respiratory arrest, Respiratory syncytial virus test negative, Sputum culture, Streptococcus test negative, Treponema test negative, Treponema test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Interstitial lung disease (narrow), 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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-10
   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: ADENOVIRUS VACCINE 06 FEB 2012
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: SHE HAD A POSITIVE RPR. ALL OF THE FOLLOWING WERE NEGATIVE: RESP - FLU A/B, H1N1, RSV, M PNEUMONIA, SPUTUM CX; BLOOD - CX, MHA-TP, COLD AGGLUTININS; CSF - BACT AND VIRAL CX, GRP B STREP, STREP PNEUMO, HIB, NEISSERIA MEN A/C/Y/W135, NEISSERIA MEN B/E COLI K1-0 AGS; URINE - CX, LEGIONELLA AG, DRUG SCREEN
CDC Split Type:

Write-up: PATIENT PRESENTED WITH VOMITING AND DIARRHEA ON 8 FEB. AAS SHOWED PULM INFILTRATE. PT STARTED ON PO ABX. PT STARTED FEELING FEVERISH ON THE EVENING OF 8 FEB. 9 FEB WOKE UP FEELING LIGHTHEADED AND DIZZY. TAKEN BY AMBULANCE TO ED, WHERE SHE SUFFERED RESP ARREST. CODED 3 TIMES. ADMITTED TO ICU ON VENT. DEVELOPED MULTI-ORGAN SYSTEM FAILURE. DIED ON 10 FEB.


VAERS ID: 448544 (history)  
Form: Version 1.0  
Age: 0.97  
Sex: Male  
Location: West Virginia  
Vaccinated:2012-01-25
Onset:2012-01-27
   Days after vaccination:2
Submitted: 2012-02-01
   Days after onset:5
Entered: 2012-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4231BB / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-27
   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: amoxicillin-potassium clavulanate 600 mg-42.9 mg/5 mL Oral Susp, 1/2 Teaspoon(s), PO, BID, 10 days, for a total of 50, start on January 18, 2012 and end on January 27, 2012.
Current Illness: NASAL CONGESTION
Preexisting Conditions: ATRIAL SEPTAL DEFECT AT BIRTH PLANNED TO RECHECK AT 1 YEAR OF AGE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: UNKNOWN- ADVERSE EVENT ONSET TIME IS UNKNOWN.


VAERS ID: 504441 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-27
Onset:2012-01-17
   Days after vaccination:82
Submitted: 2013-09-25
   Days after onset:616
Entered: 2013-09-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Chills, Convulsion, Cough, Death, Pain in extremity, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 06/2011 Pyrexia; Hypertension
Preexisting Conditions: Meningitis when the patient was child; Disability when the patient was child
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013IT106423

Write-up: Case number PHHY2013IT106423, is an initial spontaneous report received from a consumer (lay press) on 20 Sep 2013. This case refers to a 53-year-old female patient. She was invalid due to meningitis when she was child. Since Jun 2011, she was suffering from mild fever every day and current condition included hypertension. On 27 Oct 2011, she was vaccinated with seasonal influenza vaccination (manufacturer and batch number: unknown) by her general practitioner even when she had fever. A few hours after the vaccination, she developed cough, shivering, severe pain at leg and increasing body temperature. The general practitioner suggested therapy with paracetamol. On 07 Nov 2011, she developed respiratory failure followed by seizure and pneumonia with multiple foci. She was hospitalized in resuscitation ward and then transferred to another structure. On 09 Jan 2012, she was re-hospitalized in resuscitation ward due to worsening of condition. On 17 Jan 2012, she died. The cause of death was not reported. It was unknown if an autopsy was performed. It is reported that, the forensic physician appointed by patient''s relatives assessed the relationship as suspected to the vaccination performed when the patient had fever.


VAERS ID: 519375 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Unknown  
Vaccinated:2011-12-14
Onset:2011-12-18
   Days after vaccination:4
Submitted: 2014-01-15
   Days after onset:759
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Acute respiratory failure, Coma, Condition aggravated, Death, Diabetic ketoacidosis, Dyspnoea, Endotracheal intubation, Mechanical ventilation, Pneumonia, Respiratory distress, Sepsis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-02
   Days after onset: 684
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 1 diabetes mellitus
Preexisting Conditions: 12/14/2011, Diabetic ketoacidosis; 12/13/2011, Diabetes mellitus inadequate control, hospitalization
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA004836

Write-up: Information was received regarding a case in litigation concerning a 26 year old female who suffered from Type 1, Juvenile Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with ketoacidosis (DKA). The patient was treated with an insulin drip and met with a dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the hospital the patient was diagnosed with pneumonia, acute respiratory failure and diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically ventilated. Shortly after admission, the patient went into acute respiratory distress and became septic. The patient fell into a coma for approximately one month. The patient was hospitalized for a total of two months and was discharged on or about 09-FEB-2012. The patient never fully recovered from this hospitalization and spent the remainder of her life in and out of hospitals. The patient passed away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia, sepsis, respiratory distress/failure, coma and death which were a direct and proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review, coma, sepsis, and diabetic ketoacidosis were determined to be medically significant events. Additional information has been requested.


VAERS ID: 448396 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-13
Onset:2011-12-12
   Days after vaccination:2251
Submitted: 2012-01-30
   Days after onset:49
Entered: 2012-01-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0092R / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test normal, Death, Intensive care, Laboratory test, Medical induction of coma, Multi-organ failure, Pneumonia
SMQs:, 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), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, 05Dec11, there was nothing in the results that would indicate a possible catastrophic event
CDC Split Type: WAES1201USA03483

Write-up: This case was received from a consumer (the patient''s husband) on 18-JAN-2012. The case was not medically confirmed. A female patient of unknown age received dose one of PNEUMOVAX 23 (batch number NB26520, lot number 650909/0092R) on 13-OCT-2005. It was administered at the same time as the patient had an influenza vaccine (manufacturer and batch number not reported). On 12-DEC-2011, 6 years post vaccination, the patient died in intensive care of total organ failure brought on by pneumonia. The patient had blood tests (unspecified) on 05-DEC-2011 but the reporter stated that the general practitioner said there was nothing in the results that would indicate a possible catastrophic event. The patient was put into a induced coma during the night of 06-DEC-2011 and she died whilst still in the coma. The reporter stated that nobody had tole him why his wife died, only what she had died from. Other business partner numbers include E2012-00374. A lot check has been initiated. No further information is available.


VAERS ID: 445447 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2011-12-05
Onset:2011-12-06
   Days after vaccination:1
Submitted: 2011-12-14
   Days after onset:8
Entered: 2011-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AD / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-09
   Days after onset: 3
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: Unknown
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown at this time
CDC Split Type: MA1103

Write-up: PT became ill and reported to have gone to the ER.


VAERS ID: 457319 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:2011-12-01
Onset:2011-12-06
   Days after vaccination:5
Submitted: 2012-06-12
   Days after onset:188
Entered: 2012-06-13
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012032567

Write-up: This social media report (initial receipt: 04-Jun-2012) concerns a 7-year-old female patient. On ??-Dec-2011 the patient received her fatal dose of flu vaccine (manufacturer, brand name and batch number were not reported) and was pronounced dead about 92 hours later on 06-Dec-2011. The cause of death was not reported.


VAERS ID: 444950 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Vermont  
Vaccinated:2011-12-02
Onset:2011-12-03
   Days after vaccination:1
Submitted: 2011-12-08
   Days after onset:5
Entered: 2011-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AD / UNK LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Autopsy, Culture negative, Death, Dyspnoea, Influenza like illness, Lethargy, Microscopy, Pain, Pyrexia, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-06
   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: None
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: Gross Autopsy negative. Preliminary cultures negative Pending Microscopic examination
CDC Split Type:

Write-up: Went for well child check 12/2 no issues flu vaccination given. Next day developed flu like illness with fever 102.3, body aches lethargy, treated with Tylenol and Motrin, symptoms waxed and waned got significantly worse Tuesday 12/6/11 with dyspnea. Patient went unresponsive on way to pediatrician emergent resuscitation and died 12/6/11.


VAERS ID: 444965 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Female  
Location: Idaho  
Vaccinated:2011-11-30
Onset:2011-12-02
   Days after vaccination:2
Submitted: 2011-12-08
   Days after onset:6
Entered: 2011-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4147CA / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Breath sounds abnormal, Cardiac failure congestive, Condition aggravated, Dyspnoea, Oedema peripheral, Rales
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix, aldactone, Lanoxin, valproic acid, Senocot, Miralax
Current Illness: End-stage CHF- health declining
Preexisting Conditions: No known allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Exacerbated CHF x 6 weeks with multiple changes in medications. ON continuous O2. 12/2 Extremely dyspnic with anxiety. Crackles right lung, diminished breath sounds. Increased peripheral edema.


VAERS ID: 452383 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Ohio  
Vaccinated:2011-11-03
Onset:2011-12-02
   Days after vaccination:29
Submitted: 2012-03-25
   Days after onset:113
Entered: 2012-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH475AB / UNK LA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-12-02
   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: 1. September 18, 2011 - Sick with cold/flu 2. October 9, 2011 - vomited through nose, dry heaves 3. October 19, 2011 - diagnosed with sinus infection; dizzy; short of breath; labwork - prescribed calcium awaiting urinalysis results for f
Current Illness: IN-PATIENT STAY 11/1-6/2011
Preexisting Conditions: DIABETES DIAGNOSED 5/2011
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: DEATH.


VAERS ID: 446332 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Male  
Location: Georgia  
Vaccinated:2011-11-18
Onset:2011-11-20
   Days after vaccination:2
Submitted: 2011-12-22
   Days after onset:32
Entered: 2011-12-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH505AA / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Aphagia, Death, Headache, Malaise
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-11-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a medical history of increased blood pressure and "Dbj". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient''s concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201112429

Write-up: Initial report was received on 19 December 2011 from a consumer who is also the patient''s parent and additional information was received from a health care professional. A 43-year-old male patient received an injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc. lot not reported, on 17 November 2011 (also reported as 18 November 2011). The patient had a medical history of increased blood pressure and "Dbj". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient''s concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines. The parent stated that the patient was seen by her on 18 November 2011 and he had been sick after receiving the influenza vaccine and was having a severe headache and could not eat. The patient had called 911 on Sunday and was taken to a hospital. The patient died on 21 November 2011. The outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 489802 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-11-18
Submitted: 2013-04-19
   Days after onset:517
Entered: 2013-04-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure congestive, Chronic myeloid leukaemia, Nausea, Right ventricular failure
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TASIGNA
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011JP102270

Write-up: Case number PHHY2011JP102270 is a combined spontaneous report initially received from physician on 18 Nov 2011 and 21 Nov 2011 and a follow up report received from the physician on 02 Oct 2012 with a follow up report from physician received on 26 Nov 2012 and a follow up literature report received on 09 Apr 2013. This report refers to a 79-year-old female patient. The patient received TASIGNA for the treatment of chronic myeloid leukemia from 10 Jun 2011 at a dose of 600 mg daily orally. On 18 Nov 2011, 162 days after starting TASIGNA therapy, the patient who did not have bad cardiopulmonary function so much, experienced cardiac failure congestive and right heart failure. TASIGNA dosage was reduced to 400 mg daily orally on an unknown date. About 1 month later, the patient recovered. Seriousness of cardiac failure congestive and right heart failure was reported as non-serious. Outcome of cardiac failure congestive and right heart failure was reported as recovery on an unspecified date in Dec 2011. On an unspecified date, after starting treatment with suspect drug, the patient experienced nausea. The event outcome was reported as resolved. The author concluded that nilotinib can be administered to patients on hemodialysis with renal failure at any stage. Causality of cardiac failure congestive and right heart failure was reported as not related to TASIGNA. The physician commented that the "patient had received an Influenza vaccine injection (manufacturer unknown, batch no: unk) on an unspecified date, which possibly had an effect". As of this report, treatment with TASIGNA was ongoing with no problems at all. Follow up report received from the physician on 02 Oct 2012: The action taken with the drug, outcome, seriousness, causality, treatment received and the physician''s comment were updated. Follow up report from physician received on 26 Nov 2012: Updated patient''s initials, TASIGNA therapy details and start date of the events. Follow up literature report received on 09 Apr 2013: The case PHHY2012JP068351 was identified as duplicate of the case PHHY2011JP102270. All the information from the case PHHY2012JP068351 was merged with this case PHHY2011JP102270 and the case PHHY2012JP068351 will be deactivated. The merged information is report type, TASIGNA dosage, suspect drug, event, outcome were updated.


VAERS ID: 506610 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-10
Onset:2011-11-10
   Days after vaccination:0
Submitted: 2013-10-08
   Days after onset:697
Entered: 2013-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA666AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchitis, Chills, Convulsion, Cough, Death, Pain in extremity, Pneumonia, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-17
   Days after onset: 68
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oxygen; Paracetamol; Ice
Current Illness: Disability; Hypertension; Low grade fever
Preexisting Conditions: Meningitis
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0927916A

Write-up: This case was reported by an article via another manufacturer via a regulatory authority (#218842) and described the occurrence of death-unknown cause in a 53-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included meningitis. Concurrent medical conditions included disability due to meningitis and hypertension. Since June 2011, the subject also presented with low grade fever (37.2-37.3 Deg. C) sometimes reaching up to 38 Deg. C. Concurrent medications included oxygen therapy, in the night at home, paracetamol and ice pack. On 10 November 2011, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). On 10 November 2011, less than one day after vaccination with FLUARIX, the subject experienced respiratory failure, cough, fever, chills, leg pain, bronchitis, pneumonia and seizure. The subject was hospitalised in several departments. After her condition improved, she was transferred to a different structure until 9 January 2012 when she was hospitalised again. The subject died on 17 January 2012, cause of death was not reported. It was unknown whether an autopsy was performed. There were some inconsistency between the information received by the authority and information received from the article. Clarification has been requested. The fact that vaccine was administered when the subject presented with fever could have triggered a worsening of her condition leading to her death.


VAERS ID: 457541 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2011-11-02
Onset:2011-11-05
   Days after vaccination:3
Submitted: 2012-06-13
   Days after onset:221
Entered: 2012-06-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA676AA / UNK AR / UN

Administered by: Private       Purchased by: Private
Symptoms: Cardiac failure congestive, Death, Dialysis, Immunosuppression, Mixed connective tissue disease, Neuropathy peripheral, Pneumonia primary atypical, Polymyositis, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-23
   Days after onset: 200
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 65 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN; Arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Began with bilateral neuritis type symptoms both arms. Proceeded to "walking pneumonia", CHF polymyositis, mixed connective tissue disease, kidney failure & death. Tx- 2 inj of steroids, long term high dose steroids, immune suppression, dialysis & death.


VAERS ID: 446303 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Idaho  
Vaccinated:2011-10-26
Onset:2011-11-03
   Days after vaccination:8
Submitted: 2011-12-27
   Days after onset:54
Entered: 2011-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA651AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Diplopia, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal, Nerve conduction studies abnormal, Ophthalmoplegia, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-04-18
   Days after onset: 167
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Peripheral neuropathy History of Bells palsy 2009
Allergies:
Diagnostic Lab Data: Nerve conduction test and lumbar puncture consistent with diagnosis. Pls note pt is now in acute care hospital setting.
CDC Split Type:

Write-up: Facial weakness, double vision, numbness tingling of extremities. Progressed to ophthalmoplegia, severe weakness, DX as Guillain Barre syndrome pt hospitalized.


VAERS ID: 446850 (history)  
Form: Version 1.0  
Age: 0.56  
Sex: Female  
Location: New York  
Vaccinated:2011-10-31
Onset:2011-11-01
   Days after vaccination:1
Submitted: 2011-12-20
   Days after onset:49
Entered: 2012-01-05
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4176BA / 1 RL / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-11-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nebulizers; Diuretics; Antireflux meds; Pain mgmt
Current Illness: Vent dependent; BPD
Preexisting Conditions: Former 24 week premature infant - in hospital NICU throughout her life.
Allergies:
Diagnostic Lab Data: All radiographic/laboratory data unable to explain fever or death
CDC Split Type:

Write-up: Infant developed very high fever (sepsis ruled out) hours after vaccine. Despite maximal medical support, infant died. No explanation for fever could be found.


VAERS ID: 441125 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Male  
Location: New Hampshire  
Vaccinated:2011-10-28
Onset:2011-10-31
   Days after vaccination:3
Submitted: 2012-11-25
   Days after onset:391
Entered: 2012-12-03
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B136BB / 1 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4118CA / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBC263BA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916617 / 4 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-31
   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: Sodium fluoride
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: See medical examiner''s report
CDC Split Type:

Write-up: Was seen for 15 mo well child visit 10/28/2011 received DTaP, HIB, PCV 13 and influenza vaccines approximately 5pm exam was normal. Patient was at daycare 10/31/11 and found to be unresponsive after being put down for a nap. Brought to ER, pronounced dead after unsuccessful resuscitation attempt.


VAERS ID: 441422 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Texas  
Vaccinated:2011-10-17
Onset:2011-10-21
   Days after vaccination:4
Submitted: 2011-11-04
   Days after onset:14
Entered: 2011-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH455AD / 5 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Cardiac disorder, Condition aggravated, 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: 2011-10-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: DENIED
Preexisting Conditions: PER REPORTS CHILD HAD UNDISCLOSED HEART CONDITION
Allergies:
Diagnostic Lab Data: UNKNOWN
CDC Split Type: TX20110081

Write-up: PT WAS VACCINATED ON 10/17. NO DISTRESS IMMEDIATELY FOLLOWING VACCINATION. PER REPORT FROM SCHOOL NURSE, PT COLLAPSED ON PLAYGROUND ON 10/21. REPORTEDLY, CHILD HAD UNDISCLOSED HEART CONDITION.


VAERS ID: 440919 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: California  
Vaccinated:2011-10-10
Onset:2011-10-20
   Days after vaccination:10
Submitted: 2011-10-25
   Days after onset:5
Entered: 2011-11-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4184BB / UNK RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBC291BA / UNK LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0047AA / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916922 / UNK RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0338AA / 1 RL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Brain herniation, Brain oedema, CSF test, Diarrhoea, Endotracheal intubation, Hydrocephalus, Posturing, Pyrexia, Rash, Unresponsive to stimuli, Ventricular cisternostomy, Viral test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (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: 0000-00-00
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:
Current Illness: None
Preexisting Conditions: Seckel syndrome or osteodysplastic primordial dwarfism
Allergies:
Diagnostic Lab Data: California encephalitis panel; CSF
CDC Split Type:

Write-up: Patient with likely osteodysplastic primary dwarfism began to have vomiting, diarrhea, rash, fever on 10/20, became progressively weaker. Seen in urgent care clinic 10/23, became very weak after home on BENADRYL, came to ER. Found to have hydrocephalus (more than previous MRI), decorticate posturing, intubated, ventriculostomy perform, no longer responsive, cerebral edema and herniation.


VAERS ID: 440529 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2011-10-17
Onset:2011-10-18
   Days after vaccination:1
Submitted: 2011-10-28
   Days after onset:10
Entered: 2011-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA685AA / UNK RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Intensive care, Multi-organ failure, Septic shock
SMQs:, 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-10-27
   Days after onset: 9
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: None.
Preexisting Conditions: Unknown.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Reported to us that patient received Flu shot on 10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ failure.


VAERS ID: 439269 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-19
Onset:2011-10-16
   Days after vaccination:27
Submitted: 2011-10-17
   Days after onset:1
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CHF; A fib; CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 439267 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-20
Onset:2011-10-14
   Days after vaccination:24
Submitted: 2011-10-17
   Days after onset:3
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CAD; HTN; Arthritis; Confusion/delirium
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 450832 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2011-10-04
Onset:2011-10-14
   Days after vaccination:10
Submitted: 2012-02-29
   Days after onset:138
Entered: 2012-02-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED N57307 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Diarrhoea, Fatigue, Influenza like illness, Myocarditis, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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: 2011-10-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma (None listed on consent form at time of vaccination)
Allergies:
Diagnostic Lab Data: Autopsy performed that concluded pt had myocarditis in Rt ventricle/AV node.
CDC Split Type:

Write-up: Patient started feeling flu-like symptoms (nausea, diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later passed away while playing Squash/handball on 10/19/11.


VAERS ID: 438770 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Illinois  
Vaccinated:2011-10-13
Onset:2011-10-13
   Days after vaccination:0
Submitted: 2011-10-14
   Days after onset:1
Entered: 2011-10-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA609AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Atrial fibrillation, Confusional state, Death, Dehydration, Fall, Mental status changes, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOSAMAX; CALTRATE D; RELAFEN
Current Illness: Rapid H.R.; Weakness; Paleness
Preexisting Conditions: Asthma; Osteoporosis; Prosthetic eye; Osteoarthritis; Breast CA; Allergy = strawberries.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. had emesis that she vomited on the floor, she then tried getting up & fell. Resident was confused, weak, & had pale color. Sent to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib, dehydration, rapid ventricular response, & mental status changes.


VAERS ID: 438416 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Washington  
Vaccinated:2011-10-12
Onset:2011-10-12
   Days after vaccination:0
Submitted: 2011-10-14
   Days after onset:2
Entered: 2011-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA678AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Crepitations, Death, General physical health deterioration, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Novolin 70/30 insulin 13 u sq QPM Novolin 70/30 insulin 45 u sq QAM Celexa 30 mg QD Fosamax 70 mg 1x/wk. Levoxyl 100 mcg QAM Lanoxin 0.125 mg QAM Prilosec 20 mg QD ASA 325 mg QD Lasix 80 mg QD Calcium w/Vit D 600/400 BID KCL 20 meq QD Benad
Current Illness: None
Preexisting Conditions: Diabetes, Hypothyroidism, GERD, Hypercholestrolemia, A. Fib., CHF, COPD, HTN, Vascular Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden onset of decline. Audible, course crackles upper airways. O2 sats 88% on 4L O2, BP 112/70, P90, R24, T98.6. Elevated HOB, nebulizer given. MD immediately informed w/orders, if no improvement w/PRN neb tx or worsening sx''s, transfers to ER for eval. Guardian notified & in agreement w/MD orders. During neb tx, O2 sats decreased to 84% w/audible course crackles, BP 102/78, P89, R34. Ambulance called, arrived & during assessment per ambulance crew, rt. expired at 2145. Ambulance crew informed Co. Sheriff of death. No concerns re: death. Guardian & MD informed of rt.''s passing. Funeral home notified.


VAERS ID: 441679 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Virginia  
Vaccinated:2011-10-04
Onset:2011-10-11
   Days after vaccination:7
Submitted: 2011-11-07
   Days after onset:27
Entered: 2011-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT425AA / UNK UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Abdominal distension, Adenovirus test, Alanine aminotransferase increased, Antibody test negative, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood pH increased, Blood phosphorus increased, Borrelia test negative, Brain natriuretic peptide increased, C-reactive protein increased, Carbon dioxide decreased, Cardiac failure, Cardiomegaly, Chest X-ray abnormal, Chills, Cytomegalovirus test, Cytomegalovirus test negative, Death, Dialysis, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Epstein-Barr virus antibody positive, Extracorporeal membrane oxygenation, Fatigue, Feeling abnormal, Fibrin D dimer, General physical health deterioration, HIV test negative, Headache, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Influenza, Influenza A virus test negative, Influenza B virus test, Intensive care, Jaundice, Left ventricular dysfunction, Lung consolidation, Myalgia, Myocarditis, Neutrophil percentage increased, PO2 decreased, Pericardial effusion, Pleural effusion, Protein urine present, Pulmonary arterial pressure normal, Pulmonary hypertension, Pulmonary oedema, Red blood cell sedimentation rate increased, Renal impairment, Respiratory syncytial virus test negative, Streptococcus test negative, Toxoplasma serology, Toxoplasma serology negative, Troponin I increased, Ventricular assist device insertion, Weight increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-10-27
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASACOL; omega 3s; mvi
Current Illness: Ulcerative colitis well controlled and asymptomatic at the time
Preexisting Conditions: Ulcerative colitis; mild glaucoma
Allergies:
Diagnostic Lab Data: CRP, 25.92 (15 Oct); ESR, 79; 18 Oct labs: WBC, 24.4/87 neuts; Troponin I 12.40; BNP, 55321; CKMB, 63.8; CK, 501; ALT/AST, 2587/3549; creatinine, 2.7; phosphate, 7.9; ABG pH/ PO2CO2, 7.48/63/16.1; Antibody panels: Epstein-Barr virus nuclear Ab IgG serum, $g5.00; Epstein -Barr virus capsid Ab IgG serum, 2.7; Epstein-Barr virus capsid Ab IgM serum, <0.2; Epstein-Barr virus nuclear Ab IgG, $g8.0; Hepatitis B virus surface Ab serum Non reactive; Hepatitis B virus surface Ag serum Non reactive; Hepatitis B virus Core Ab IgM serum Non Reactive; Hepatitis C virus Ab serum Non reactive; nasopharyngeal swab 21 Oct: NO INFLUENZAE A/B, PARAINFLUENZA 1-3, adenovirus, or RSV isolated; HIV negative; Cytomegalovirus Ab IGG/IGM negative; Toxoplasma Ab IGG/IGM negative; Streptolysin O Ab negative; Lyme disease total ab screen negative; ECHO 18 Oct, - overall left ventricular systolic function severely reduced EF < 20%, - small circumferential pericardial effusion present, -mild pulm hypertension w/PA systolic pressure estimated at 40mmHg, - No cardiac tamponade, left ventricular wall thickness normal, LV cavity dimensions normal; CXR as above
CDC Split Type:

Write-up: 61 y/o stated he received injectable INFLUENZA vaccine on 4 Oct 2011. States he has received the flu shot every year with no problems as well as no adverse events with any other vaccinations in his career. PMH includes ulcerative colitis for which he took ASACOL. He developed this condition in the late ''90''s and it has been under good control with no active symptoms. Took ASACOL up until the time of hospitalization but was not given it after admitted. Pt was healthy and active, worked full time and ran 3-4 miles 5x/week and ran the 10 miler on Sunday 9 Oct''11. On Tues, 11 Oct he developed chills in the evening. He went to work the next day but by evening "wasnt feeling right". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache, abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He got weighed and found he had gained 7 pounds. He continues to feel badly and went into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital: creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to develop pleural effusion, clear evidence of pulmonary edema, and continued cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2, piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to receive dialysis due to worsening renal function, but also due to potential need for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO, receiving steroids, unable to do heart biopsy due to worsening condition. Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct. Titers/PCR pending on myocardial tissue. Path report returned yesterday showed giant cell myocarditis, no eosinophils. Additional labs pending from hospital to include parvo and coxackie abs.


VAERS ID: 449283 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2011-10-04
Onset:2011-10-11
   Days after vaccination:7
Submitted: 2012-01-23
   Days after onset:104
Entered: 2012-02-09
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR IU465AA / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Anion gap increased, Aspartate aminotransferase increased, Basophil percentage decreased, Bilirubin conjugated, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride decreased, Blood creatinine increased, Blood glucose increased, Blood magnesium decreased, Blood phosphorus, Blood potassium decreased, Blood sodium decreased, Blood urea increased, Blood urea nitrogen/creatinine ratio, Carbon dioxide decreased, Death, Eosinophil percentage decreased, Feeling cold, Globulins increased, Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Immunoglobulins, Laboratory test, Livedo reticularis, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume increased, Monocyte percentage, Platelet count decreased, Protein total decreased, Protein total normal, Pulse absent, Red blood cell count normal, Red cell distribution width increased, Respiratory arrest, Resuscitation, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-11
   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: Amiloride HCl 5mg tab; Cetirizine HCl 10mg tab; Epinephrine 0.3mg auto injector ea; Flunisolide, 0.025% 200D nasal inh spray; Ketotifen fumarate, 0.025% oph soln; Magnesium Cl 535mg (64mg mag) SR tab; Mometasone 200mcg inh; Omeprazole 20mg
Current Illness: None noted
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/11/2011, Na, 122 mmol/L L; K, 3.7 mmol/L; Cl, 62 mmol/L L; CO2, 20.0 mmol/L L; Glucose, 493 mg/dL H; BUN, 78 mg/dL H; Creat, 7.3 mg/dL H; AST, 197 U/L H; ALT, 79 U/L H; ALP, 71 U/L; T. Bil, 1.0 mg/dL; D Bili mg/dL; Alb, 2.5 G/dL L; Calcium, 6.9 mg/dL L; PO4, mg/dl; Mg, 0.9 mEq/L L; Ani Gap, 40.0 mmol/L H; BUN/Cr, 10.7; Glob, 3.6 G/dL; T Prot, 6.1 G/dL; WBC, 19.3 K/cu mm H; RBC, 4.21 M/cu mm; Hgb, 14.9 g/dL; Hct, 40.8%; MCV, 96.9 fL; MCH, 35.4 pg H; MCHC, 36.5 g/dL, RDW, 14.4%; Plt, 134.0 K/cu mm L; MPV, 14.1 fL H; Lymph, 12.7% L; Mono, 5.9%; Gran, 64.5%; Eos, 0%; Baso, 0%; IM, 1.0%; Ly, 1.67 K/cu mm; 10/04/2011, Na, 134 mmol/L; K, 2.8 mmol/L L; Cl, 98 mmol/L; CO2, 22.2 mmol/L; Glucose, 93 mg/dL; BUN, 4 mg/dL L; Creat, 0.5 mg/dL; AST, 133 U/L H; ALT, 79 U/L; ALP, 71 U/L; T. Bil, 0.6 mg/dL; Alb, 3.2 G/dL; Calcium, 8.7 mg/dL; Ani Gap, 14.0 mmol/L; BUN/Cr, 7.5 L; Glob, 3.3 G/dL; T Prot, 6.5 G/dL; WBC, 8.0 K/cu mm; RBC, 3.61 M/cu mm L; Hgb, 12.7 g/dL; Hct, 38.0%; MCV, 105.3 fL H; MCH, 35.2 pg H; MCHC, 33.4 g/dL; RDW, 15.4%; Plt, 200.0 K/cu mm; MPV, 10.1 fL; Lymph, 20.8%; Mono, 7.0%; Gran, 70.3%; Eos, 0.5%; Baso, 0.4%
CDC Split Type:

Write-up: Patient was found down by significant other and brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of resuscitation, time of death was called.


VAERS ID: 439266 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-12
Onset:2011-10-10
   Days after vaccination:28
Submitted: 2011-10-17
   Days after onset:7
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Gastric adenocarcinoma; CAD; COPD; Afib; HTN; AVR; Dementia; Seizure disorder; CHF
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 441149 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-10
Onset:2011-10-10
   Days after vaccination:0
Submitted: 2011-11-02
   Days after onset:23
Entered: 2011-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA643AA / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nutritional supplement
Current Illness: Unknown
Preexisting Conditions: Dementia; Frailty; Pressure sore; No known drug allergies.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0757933A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 21310327) and described the occurrence of unexplained death in a 78-year-old female subject who was vaccinated with FLUARIX. The subject''s medical history included dementia, frailty and pressure sore. Concurrent medications included unspecified nutritional supplement (Dietary supplement). On 10 October 2011 the subject received an unspecified dose of FLUARIX (0.5 ml, subcutaneous, Batch number AFLUA643AA). On 10 October 2011, on that same day after vaccination with FLUARIX, the subject experienced pallor and was unresponsive to stimuli. It was reported this was not a typical anaphylaxis reaction. Approximately 6 hours after vaccination with FLUARIX, the patient died from an unspecified cause. An autopsy was performed. At the time of reporting the results of the post-mortem examination were unknown. Verbatim Text: Flu jab administered. Family reported patient became pale and lifeless following this. Died 6 hours later. Not typical anaphylaxis reaction. Awaiting results of post-mortem examination to identify definite cause of death.


VAERS ID: 439265 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Florida  
Vaccinated:2011-09-21
Onset:2011-10-07
   Days after vaccination:16
Submitted: 2011-10-17
   Days after onset:10
Entered: 2011-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH444AB / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Rectal carcinoma; Delirium
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 437570 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Michigan  
Vaccinated:2011-10-06
Onset:2011-10-06
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:5
Entered: 2011-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH438AB / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Alanine aminotransferase increased, Antiphospholipid antibodies, Arrhythmia, Aspartate aminotransferase increased, Atelectasis, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium increased, Blood chloride increased, Blood count abnormal, Blood creatinine increased, Blood gases, Blood glucose normal, Blood lactic acid normal, Blood magnesium increased, Blood pH decreased, Blood phosphorus normal, Blood potassium normal, Blood sodium increased, Blood urea increased, Bradycardia, Breath sounds abnormal, C-reactive protein, Carbon dioxide decreased, Cardiac arrest, Central venous catheterisation, Chest X-ray abnormal, Clostridium test negative, Compression fracture, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Condition aggravated, Cyanosis, Death, Electrocardiogram P wave abnormal, Electrocardiogram abnormal, Endotracheal intubation, Eye movement disorder, Femoral pulse decreased, Gastrointestinal sounds abnormal, Haematocrit normal, Haemodilution, Haemoglobin normal, Heart rate decreased, Hypertension, Hypotension, International normalised ratio normal, Ischaemic hepatitis, Loss of consciousness, Mean cell volume normal, Mechanical ventilation, Mental status changes, Merycism, Neuropathy peripheral, Neutrophil percentage increased, Nodal rhythm, Occult blood positive, Ocular hyperaemia, Oliguria, Osteoporosis, PCO2 normal, PO2 increased, Peripheral coldness, Platelet count normal, Pneumothorax, Protein total decreased, Prothrombin time normal, Pulseless electrical activity, Radial pulse abnormal, Red blood cell sedimentation rate normal, Renal failure acute, Renal tubular necrosis, Resuscitation, Rhonchi, Rib fracture, Sepsis, Septic shock, Somnolence, Spinal compression fracture, Syncope, Troponin normal, Ultrasound Doppler, Ultrasound pelvis abnormal, Unresponsive to stimuli, Urinary sediment present, Urine analysis abnormal, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Lactic acidosis (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Supraventricular tachyarrhythmias (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Osteoporosis/osteopenia (narrow), Renovascular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEDICATIONS: The patient is on the following medications at home. - Oxycodone one capsules orally p.r.n.. - Voltaren 75 mg orally twice a day. - Gabapentin 400 mg four times a day. - Digoxin 0.125 mg orally every other day. - Amlo
Current Illness: None noted
Preexisting Conditions: PAST MEDICAL HISTORY: Hypertension, neuropathy, atrial fibrillation. Chronic kidney disease stage 3. Depression, anxiety, chronic iron-deficiency anemia, COPD, stable, osteoarthritis and chronic pain syndrome, and history of recurrent falls.
Allergies:
Diagnostic Lab Data: 10/6/11: WBC 21.4, Scr-1.8, BUN-39, LA-7.9, ABG-7.16, troponin-0.01 10/7/11: Wbc-12.2, Neuts-71.1%, scr-2.2, BUN-47, LA-4.6, ABG-7.20, CRP-1.8, sed rate-10mm/hr
CDC Split Type:

Write-up: DATE OF EXAM: 10/07/2011 at 08:20. SUBJECTIVE: The patient is an 80-year-old lady who was brought in to the Emergency Room last night unconscious. I reviewed the reviewed the history in the system as well as reviewed the history from the patient''s family at bedside. The patient''s daughter saw the patient during lunchtime and had lunch with her. She was in her usual state of health. She has not had any fever or chills. No productive cough, no chest pain, no abdominal pain and no diarrhea. She was in her usual state of health without any evidence of an infectious process. After lunch time, the patient was supposed to get her flu shot and was on her way to get her flu shot. The patient''s family believes that she has gotten her flu shot. They were not told otherwise. It is presumed that the patient has received her flu shot. We are at this time unsure of the route it was given if indeed she received it. At around 6:00 after work, the same daughter came to visit the patient to cook her dinner. She was noted to be unconscious, sitting up in her electrical wheelchair. The patient does have episodes of syncope and has had multiple episodes in the past. Normally this is associated with "bowel movement" vasovagal syncope). At this time, the patient was not on the toilet bowl. The patient''s daughter did not smell or see any evidence of bowel or bladder incontinence or any sign that she had tried to move her bowels. The patient''s daughter tried to pick her up, thinking that this was one of her usual episodes of syncope. She asked the nursing staff to help her wake the patient up, but when they could not wake up the patient, EMS was called. When EMS arrived, the patient was noted to have low blood pressure. The patient''s daughter believes that she had taken all of her morning medications since her medication dispenser for that day was empty. The only thing that they are not sure of is whether or not the patient took her "fibromyalgia pill". The patient was then brought to the emergency room. The patient remained unconscious and had to be intubated to protect her airway. She was given IV fluid boluses without good response and started on vasopressor initially with dopamine and subsequently changed to Levophed. While the patient was in the emergency room, the patient was noted to have a pulseless electrical activity. They were not sure how long the patient had pulseless electrical activity and so CPR was performed. The patient sustained some broken ribs as well as mild pneumothorax. I have counseled the patient''s family regarding this and they are aware. The patient remains unresponsive on the vent. Occasionally, she tried to move her upper extremities. She is noted to have some movements of the lower extremity, but is not necessarily consistent with stimulation and not necessary purposeful. Occasionally, she will bite down on her ET tube. She is also noted occasionally to be "ruminating". The patient has guaiac positive stools, but there is no evidence of active bleeding or GI bleed. Blood count remains stable despite aggressive IV fluid hydration. There is some decrease in blood count, but mainly secondary to hemodilution. OBJECTIVE: GENERAL: The patient is mainly unresponsive, intubated, on vent support and vasopressor support. VITAL SIGNS: Most recent vital signs showed blood pressure 114/90, heart rate of 98, respirations of 15-22, temperature 35.4 degrees centigrade. Temperature minimum was 34.7 degrees early this morning. HEENT: Normocephalic and atraumatic. ET and OGT noted. Pupils were 4-5 mm bilaterally and minimally reactive to 3-4 mm bilaterally. Doll''s eyes were equivocal. There is some eye movements, but not entirely consistent with doll''s eye movement. Pink conjunctivae, no icterus. I was unable to fully evaluate the patient''s oral mucosa. NECK: Supple. CHEST: Lungs are symmetrical with good chest expansion. Diminished breath sounds at the bases with occasional scattered rhonchi noted, otherwise no significant wheezing. CARDIOVASCULAR: Normal rate, regular rhythm, S1, S2 noted. I do not appreciate any rubs or gallops. PMI is difficult to palpate secondary to the patient''s low blood pressure. No significant JVD noted. GASTROINTESTINAL: The abdomen is globular very hypoactive bowel sounds, soft, no grimace to palpation, no rebound tenderness. MUSCULOSKELETAL: There is no significant edema of bilateral lower extremities. Pedis pulses are significantly diminished. The patient''s extremities are cold to touch and the left upper extremity appears to be somewhat cyanotic. SKIN: Cool to touch as noted above. No other rash or skin breakdown noted. I am not able to detect any injection site on both of the patient''s deltoid areas. NEUROLOGIC AND PSYCHIATRIC: Examination severely limited secondary to the patient''s mental status. Babinski are equivocal. There are some occasional movements of both upper extremities and left lower extremity as noted above. DIAGNOSTIC RESULTS: Laboratories obtained this morning showed WBC 12.2, hemoglobin 12.5, hematocrit 36.5, MCV of 93, and platelet count 243. PT 11.6, INR 1.1. Sodium 151, potassium 3.6, chloride 113, CO2 18, BUN 47, creatinine 2.2, calcium 7.3, magnesium 3.8, phosphorus 4.4. Lactic acid 4.6, alk phos is 614, total bilirubin 1.6, AST 213, ALT of 84, total protein 5.3, albumin 2.8, glucose of 166. PH is 7.20, pCO2 42, pO2 of 109, CO2 17, oxygen saturation 95% at 60% FIO2. Stools for guaiac came back positive. Stools for Clostridium difficile back negative x2. CT of the abdomen and pelvis obtained, preliminary reading, showed multiple findings without definite evidence of bowel obstruction, left-sided pneumothorax with left-sided rib refracture of the left transverse process at L1-L2. Compression fracture of T12 of indeterminate age with marked compression deformities in retropulsion noted. ASSESSMENT AND PLAN: * Hypotension with mental status change presumed to be secondary to severe sepsis with septic shock. Unclear source at this time. Urinalysis obtained did show some evidence of possible infection; however, this was a contaminated urine with a lot of squamous epithelial cells. So far there is really no other definitive infectious source. We will continue vasopressor support. We will continue IV antibiotics with vancomycin and Zosyn. We will need to ascertain whether the patient did receive a flu vaccine and what route it was given. We might need to know the lot number. I personally spoke with Dr. from Infectious Disease. I recommend continuing IV antibiotics and this might need to be reported, especially once we are certain that the patient did receive a flu vaccine. I will also order a rapid flu test. We will follow the results of blood cultures and urine cultures. * Status post cardiac arrest with pulseless electrical activity requiring chest compression. Initial troponin did come back negative. I will not order further troponins since it is likely this will be elevated secondary to the CPR that was performed at the Emergency Room. We will check digoxin level. The patient was intubated for protection of her airway and from my understanding she did not have any respiratory arrest. * Acute renal failure. I believe this is secondary to acute tubular necrosis (ATN) from the patient''s hypotension. I will repeat urinalysis. We will monitor the patient''s I''s and O''s closely. At this time, it appears that the patient is starting to be oliguric. We will continue IV fluid hydration and will obtain ultrasound of the abdomen. * Probable shocked liver secondary to hypotension with mental status change and hypertension. Continue supportive care. We will continue to monitor the patient''s kidney function including PT and INR. * Osteoarthritis. * Neuropathy. * Hypertension. The patient''s blood pressure is low and needs vasopressor support, so we will hold the patient''s amlodipine and benazepril. Given the patient''s acute renal failure, benazepril is not a good medication for this patient at this time. We will try to obtain old records from the patient''s primary care doctor. * Positive guaiac stools. No evidence of acute bleeding. Hemoglobin and hematocrit remain stable. * GI and DVT prophylaxis. We will continue IV Protonix, but I will increase the dose to q.12 hours given the guaiac positive stools. I will discontinue Lovenox, but I will give low-dose heparin subcutaneous injections instead given the patient''s kidney function and guaiac positive stools. It is easier to reverse the heparin than Lovenox if you do end up needing to reverse it. * Condition is very guarded. Prognosis is poor. * Pending patient''s clinical course and at this time, I will obtain EEG for altered mentation will hold off any sedation until after the EEG done. The patient already has p.r.n. Ativan ordered as well as fentanyl. DISPOSITION: Pending the patient''s clinical course. At this time, I will obtain EEG for the altered mentation. We will hold off any sedation until after the EEG is done. The patient already has p.r.n. Ativan ordered as well as fentanyl. Total critical time spent was 60 minutes including discussion with the patient. The patient''s family has been made aware of the critical nature of their mother''s condition. All of their questions were answered to their satisfaction. DATE OF EXAM: 10/07/2011 at 11:15. SUBJECTIVE: I was called to the bedside because of a rhythm change. I looked at the tele monitor and I was unable to see P-waves. EKG has been ordered. I was unable to find radial pulses right away. Femoral pulses were very faint and were not necessarily correlating with electrode activity on telemetry monitor. Doppler ultrasound was used to monitor the patient''s pulse. The patient''s pulse was noted to be 35 beats per minute, but heart rate on the telemetry monitor showed 70 beats per minute. EKG obtained showed a junctional rhythm. Because of this 1 amp of atropine was given. Prior to this, blood pressure was also in the 70s systolic. The patient''s blood pressure, telemetry heart rate and palpable pulse improved. Repeat blood pressure obtained showed systolic in the 110s. Repeat EKG done after atropine still showed accelerated junctional rhythm with a rate of 75. OBJECTIVE: The patient remains intubated with altered mentation and unresponsive. DIAGNOSTIC RESULTS: New laboratories obtained since the earlier visit with the new ABG obtained showed a pH of 7.27, pCO2 31, pO2 80, and CO2 15. Oxygen saturation 93% at 60% FIO2. Digoxin level 0.7. Repeat chest x-ray, 1 view, obtained today showed bibasilar subsegmental atelectasis. There is a left-sided central venous catheter seen with its tip apparently having been retracted now with appearance in the region opposing the medial clavicle head on the left. No obvious pneumothorax was detected. Reactive CRP was 1.8. ASSESSMENT AND PLAN: * Electrical impulse dissociation presently with a junctional rhythm. The dissociation improved with atropine. At this time, blood pressures are acceptable and heart rate is acceptable. Because of the low pH and electrical rhythm and pulse disassociation, 1 amp of bicarb was given even though pH was only 7.27. Cardiology consultation would be obtained. Echocardiogram has been ordered. * Hypotension. The patient''s Levophed drip was titrated to 27 mcg per minute. * Presumed severe sepsis with septic shock. Again, no focus can be found aside from questionable urinary tract infection, which was contaminated/colonized. Inflammatory CRP is only 1.8, which does not really correlate with a person in septic shock. Continue IV antibiotics for now. * Acute renal failure with acute tubular necrosis. The patient is becoming more and more oliguric. The patient was given 500 mL of normal saline bolus. The patient remains on fluid resuscitation. Kidney ultrasound has been ordered. * Please refer to the previously dictated progress note as well as diagnoses for further details. * Prognosis remains poor. Condition is very critical. * Total critical time spent was another 40 minutes. DATE OF EXAM: 10/07/2011 at 1355 hours. SUBJECTIVE: The case was discussed with cardiologist who recommended the patient will need to be transferred since she might need a pacemaker to be placed. Transfer was arranged. The case was discussed with the intensivist at another Medical Center who accepted the patient in transfer. Medevac was informed, but arrived at approximately 1356 hours, the patient was noted to have a rhythm change and became bradycardic and suddenly asystole. Code blue was called, aside from me 2 other doctors responded. Dr. ran the code according to ACLS protocol. The patient was given 3 rounds of epinephrine and atropine. Rhythms checks were made intermittently. Despite aggressive progressive attempt, the patient remained in asystole. The patient was coded for approximately 15 minutes and the code was called off at 1411 hours. The patient''s family was informed. They were aware when the code blue was called. I spoke to them during the middle of the code, informed them that we will continue to try cardiac resuscitation, will continue on for 15 minutes. They agreed with the plan. They were also notified after the code was called. Patient''s family was informed about the outcome of the code. Because the patient has not been in the hospital for less than 24 hours, the cause of death cannot be ascertain at this time. The case will be forwarded to the medical examiner. Noncritical time spent was 15 minutes.


VAERS ID: 446452 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-10-06
Submitted: 2011-12-29
   Days after onset:84
Entered: 2011-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Gestational hypertension, Intra-uterine death, Maternal exposure during pregnancy
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0770833A

Write-up: This retrospective pregnancy case was reported by the Agency (# GB-MHRA-EYC 00077010) and described the occurrence of intrauterine death in a neonate subject of unspecified gender whose mother was vaccinated with influenza virus vaccine during pregnancy. On an unspecified date the subject''s 29 year old mother received unspecified dose of Influenza virus vaccine. The date of the mother''s last menstrual period was 2 January 2011; the estimated date of delivery was unknown. The neonate was exposed to Influenza virus vaccine at an unknown number of week''s gestation. On 6 October 2011, at an unspecified time after exposure to Influenza virus vaccine, the subject experienced intrauterine death. It was reported that the neonate was "slightly small for gestational age". It was also reported that the neonate was "term". The regulatory authority reported that the event was congenital anomaly. The neonate died, cause of death is not specified. It was stated that post mortem showed gestational hypertension. Verbatim Text: Patient raised this as a possible cause for her stillbirth. The baby was at term, was slightly small for gestational age and the mother had mild gestational hypertension. Serious consequences for the parents.


VAERS ID: 437391 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Maine  
Vaccinated:2011-10-04
Onset:2011-10-05
   Days after vaccination:1
Submitted: 2011-10-07
   Days after onset:2
Entered: 2011-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH463AB / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; ASA; AMBIEN; Tramadol; LIPITOR; Anagrelide
Current Illness: None
Preexisting Conditions: HTN; Elev. Lipids
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Police reported to us that patient was found dead in her home the day after flu vaccine was administered. We had no communication w/ pt after office visit 10/4.


VAERS ID: 438876 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: New York  
Vaccinated:2011-10-03
Onset:2011-10-03
   Days after vaccination:0
Submitted: 2011-10-18
   Days after onset:15
Entered: 2011-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH462AC / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Activities of daily living impaired, Blood culture positive, CSF protein increased, Culture urine positive, Dysstasia, Endotracheal intubation, Escherichia urinary tract infection, Guillain-Barre syndrome, Hypoaesthesia, Hypokinesia, Immunoglobulin therapy, Lumbar puncture, Mechanical ventilation, Paraesthesia, Plasmapheresis, Sensory loss, Sputum culture positive, Staphylococcal infection, Streptococcal bacteraemia, Walking aid user
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-10-23
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: LP- positive for protein
CDC Split Type:

Write-up: Pt had numbness and tingling of his finger tips on same evening as recieving flu shot that morning. On next day, Tuesday, he started same numbnes and tingling in his toes. Pt went to family doctor on Wednesday and needed walker to assist him in walking. (Prior to this event the pt was able to ambulate without assistance of any devices, drive a car long distances and grocery shop on own) pcp- sent pt to the ER for evaluation. Pt was diagnosed as having Guillain Barre syndrome from the flu shot. By 9 pm that Wednesday evening he was not able to stand and pt had limited use of his arms. Pt was admitted to hospital. By 9am on Thursday pt had little movement and no feeling in legs. He had very little movement of his arms and was not able to lift his arms to his mouth to feed himself. By Thursday night pt was intubated and placed on ventilation support. By Friday am he was not able to move any extremities and only had movement of his head, mouth and shoulder shrugs. Immunoglobulin administration was started on Wed afternoon and continued for 5 or 6 doses (one each day). No improvement was seen. Pt subsequently developed several infectious processes-e-coli in urine, staph (not MRSA) in his sputum, and strep in his blood. Plasmaphoresis was started every other day times 5 exchanges. (Was have finished 3 exchanges up to this time with no movement of extremities seen.


VAERS ID: 438031 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Unknown  
Vaccinated:2011-10-01
Onset:2011-10-01
   Days after vaccination:0
Submitted: 2011-10-11
   Days after onset:10
Entered: 2011-10-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Death, Diabetic coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-03
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2011US06146

Write-up: Case number PHEH2011US06146 is an initial spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot raised his blood sugar to a diabetic coma that he did not wake up. The patient received care at hospital. The critical team worked on him for 12-hours and he expired on 03 Oct 2011. No other information was provided.


VAERS ID: 441165 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Alabama  
Vaccinated:2011-09-22
Onset:2011-09-30
   Days after vaccination:8
Submitted: 2011-11-02
   Days after onset:33
Entered: 2011-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH468AB / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Aphasia, Asthenia, Encephalopathy, Fatigue, Gait disturbance, Hypersomnia, Nuclear magnetic resonance imaging brain abnormal, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (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: 2011-11-13
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zinc; Vit D; MICARDIS; Levothyroxine; Vitamin C; PERICOLACE; MVI; Glucosamine; Calcium; PROTONIX
Current Illness: Reflux
Preexisting Conditions: Allergies: ALDOMET, VASOTEC, ZANTAC, MIRALAX, DEXILANT, Sulfa, Mycins; Hypertension; Arthritis; Stroke
Allergies:
Diagnostic Lab Data: MRI - head - possibility of encephalitis could be considered MD diagnosed: Acute post vaccine encephalopathy
CDC Split Type:

Write-up: Pt. admitted to hospital 10/27/11. About 4 wks prior had begun feeling weak, stumbling, fatigued. Has lost 15-20 pounds over past mo. Past 3-4 days family reported no verbal responses. Sleeping 16 or more hrs/day. Treated with Acyclovir IV.


VAERS ID: 435707 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Washington  
Vaccinated:2011-09-22
Onset:2011-09-25
   Days after vaccination:3
Submitted: 2011-09-26
   Days after onset:1
Entered: 2011-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501096P / 3 NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Chest pain, Death, Malaise, Resuscitation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data: Autopsy has been ordered
CDC Split Type:

Write-up: Member was given the Flumist on 09/22/2011. On 09/25/2011, member was feeling chest pain and not feeling well after dinner and going to the Club. Mamber was found down face in vomit by his friends. CPR was started and 911 activated. Paramedics arrived and continued CPR en route to Hospital where CPR was continued unsuccesfully. Member was pronounced dead at 0215 by Dr.


VAERS ID: 436743 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Male  
Location: Minnesota  
Vaccinated:2011-09-22
Onset:2011-09-23
   Days after vaccination:1
Submitted: 2011-10-04
   Days after onset:11
Entered: 2011-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT4176BA / UNK RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0404AA / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916598 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0819AA / 1 LL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: Cold/URI/ear infection
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Parents found patient blue and not breathing at home. Code Blue to hospital.


VAERS ID: 438638 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-21
Onset:2011-09-22
   Days after vaccination:366
Submitted: 2011-10-17
   Days after onset:25
Entered: 2011-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011DE90135

Write-up: Case number PHHY2011DE90135 is an initial spontaneous report received from a health care professional via a foreign Health Authority (reference number: DE-PEI-PEI2011032831) on 11 Oct 2011. This case refers to a 46-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on 21 Sep 2010. She developed septicemia on 22 Sep 2011 and died (exact date of death not reported). The event lasted for 3 days. An autopsy was performed. The reporter stated that according to the autopsy report the cause of the death was septicemia, a causal relationship to the vaccination could not be excluded, and poisoning was excluded as cause for the death. The foreign authorities stated that they requested follow up information.


VAERS ID: 439084 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Michigan  
Vaccinated:2011-09-09
Onset:2011-09-10
   Days after vaccination:1
Submitted: 2011-10-06
   Days after onset:26
Entered: 2011-10-19
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UH4398A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Chest pain, Dysphonia, Hypokinesia, Pain, Swollen tongue, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None (see above dx.)
Preexisting Conditions: (See above)
Allergies:
Diagnostic Lab Data: Heart Disease (CHF); Thyroid; Kidney (4% operating)
CDC Split Type:

Write-up: Received High dose flu shot 9/9/11 within 12 hr had chest pain, hoarseness, wheezing, decreased movement arm/shoulder, decreased movement in face, body ache, tongue swelling. Daughter reporting.


VAERS ID: 435354 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2011-08-31
Onset:2011-09-07
   Days after vaccination:7
Submitted: 2011-09-23
   Days after onset:16
Entered: 2011-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1100201 / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Autopsy, Death, Livedo reticularis, Peripheral coldness, 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: 2011-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no c/o illness by patient
Preexisting Conditions: Hypertension Type 1 diabetes
Allergies:
Diagnostic Lab Data: I dont have results of postmortum as of today. Still pending.
CDC Split Type:

Write-up: At 12:30 PM patient laid down for a nap he offered no co at that time, at 2 PM I (wife) found patient unresponsive no pulse no respiratory effort. His skin was cold and moteled I dailed 911 and began chest compressions as instructed by 911 operator. I never got a pulse first responders and also worked on patient and transfered him to hospital he was pronounced dead at 2:08 pm on 09/07/2011.


VAERS ID: 436253 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Maryland  
Vaccinated:2011-08-26
Onset:2011-08-26
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:34
Entered: 2011-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3944AA / 5 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH476AC / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G1083 / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1644Z / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1046AA / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-08-26
   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: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found dead in bathroom after no obvious reaction.


VAERS ID: 434755 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-06-07
Onset:2011-06-07
   Days after vaccination:0
Submitted: 2011-09-16
   Days after onset:101
Entered: 2011-09-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death
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: 2011-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CHF (chronic heart failure) with LV (left ventricule) dysfunction
Allergies:
Diagnostic Lab Data: No data
CDC Split Type: 201108593

Write-up: Initial report received from the Health Authorities on 13 September 2011 through the company under the reference number GPO-MBP-11-007. Case linked with case 2011-08595, case 2011-08596 and 2011-08598 (same source reporter, INFLUENZA vaccine). A 70-year-old female patient with a medical history of chronic heart failure with left ventricule dysfunction died on 07 June 2011, the day she had received a seasonal INFLUENZA vaccine (manufacturer unknown, batch number, route and administration site not reported) on 07 June 2011. No information was provided on the origin of the seasonal flu vaccine. However, the INFLUENZA vaccine manufactured by GPO-MBP was routinely used in the national vaccination programme. On 07 June 2011, the patient was found lying dead. The physician diagnosed a sudden cardiac arrest. This case was investigated by the regional AEFI committee and was concluded as unlikely related to the vaccine.


VAERS ID: 436109 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-12
Onset:2011-05-18
   Days after vaccination:6
Submitted: 2011-09-26
   Days after onset:131
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3960AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abscess, Cellulitis, Death, Local reaction, Localised infection, Pain, Septic shock, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-22
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; The patient had underwent an uneventful cardiac catheterization 10 days prior to the vaccination.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108841

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local case reference number BR-BT2011-3791). A 77-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U39601AA, route and anatomical site of administration not reported) on 12 May 2011. The patient had underwent an uneventful cardiac catheterization 10 days prior to the vaccination. On 18 May 2011, the patient experienced severe local reaction with local pain, progressing to local abscess and cellulitis (intensity classification: severe). She developed then septic shock and died on 22 May 2011. The patient initially only received pain medication. When her symptoms worsened, she also received oral antibiotics. This case was still under investigation at the time of the report. A probable local contamination was evoked. Sudden unexpected death was also mentioned. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 450488 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-06
Onset:2011-05-08
   Days after vaccination:2
Submitted: 2012-02-24
   Days after onset:292
Entered: 2012-02-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 090629801 / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myocardial infarction, Pneumonia, Renal failure acute, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisolone; Roxithromycin; Oxybutynin; Multivitamin and mineral supplement
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031208

Write-up: This health authority report (initial receipt: 14-Feb-2012) concerns a 86 year old female patient. Concomitant medications included prednisolone, roxithromycin, oxybutynin and nutritional supplements. On 06-May-2011 the patient received 0.5mL dose of influenza virus vaccine inactivated (batch number: 090629801) intramuscular. On the same day she also received 0.5 mL dose of PNEUMOVAX-23 intramuscularly. On 08-May-2011 the patient developed pneumonia, sepsis, acute renal failure and myocardial infarction. The event outcome was death. Predisposing condition was chronic obstructive pulmonary disease. Upon dechallenge the events did not show improvement. No rechallenge was performed. The suspect drugs were not reduced. The reporter considered events to be serious (due to death) and unlikely in relation to the suspect drugs. The reporter stated that the death was "unrelated to drug". Cause of death is unknown.


VAERS ID: 435253 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-28
Onset:2011-05-05
   Days after vaccination:7
Submitted: 2011-09-21
   Days after onset:139
Entered: 2011-09-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3785AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Alanine aminotransferase increased, Anuria, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Bronchospasm, Cough, Dyspnoea, Full blood count, Nausea, Ocular icterus, Pneumonia, Pyrexia, Respiration abnormal, Respiratory failure, Sepsis, Sudden death, Swelling, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108735

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3685). A 09-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U3785AA, route and anatomical site of administration not reported) on 28 April 2011. On 05 May 2011, i.e. 7days post-vaccination, the patient experienced sudden unexpected death (intensity classification: severe). The patient presented with dry cough, bronchospasm, chest indrawing, abdominal pain, nausea, fever ($g38 degrees C), difficulty in breathing, "total swelling", conjunctival jaundice and anuria (SIC). The report did not present any information from before or after the vaccination, only about three days before the patient''s death, which occurred in the hospital. Transaminase exams showed GOT 86, GPT 129 and Alkaline Phosphatase 88. Further tests (complete blood count) and X-Ray report were awaited at the time of the report. This event was temporally associated to the vaccine. The death diagnoses were respiratory Failure + Pneumonia + Sepsis. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The Ministry of Health classified the adverse events on Coincidence (temporal association). The "causality classification" was inconclusive (the Ministry of Health assessed the causal relationship to the vaccine as unknown). Documents held by sender: none.


VAERS ID: 436104 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-03
Onset:2011-05-04
   Days after vaccination:1
Submitted: 2011-09-26
   Days after onset:145
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3960AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Arthralgia, Completed suicide, Conjunctivitis, Death, Depression, Eye irritation, Face oedema, Headache, Pain in extremity
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Suicide/self-injury (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Corneal disorders (broad), Depression (excl suicide and self injury) (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108827

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3795). A 62-year-old male patient (born on 08 December 1948), whose medical history and concomitant therapies were not reported, had received his dose of FLUZONE (batch number U3960AA, route and anatomical site of administration not reported) on 03 May 2011. On 04 May 2011, i.e. 24 hours post-vaccination, the patient experienced anaphylaxis with facial oedema, joint pain in the left upper limb, burning eyes, conjunctivitis and moderate headache (intensity classification: not severe). Improvement was seen after receiving antihistamines. On 09 June 2011, the patient''s wife stated that the patient had depression and committed suicide. The Ministry of Health assessed this case as serious. The patient was not hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification) was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 436272 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-04
Onset:2011-05-04
   Days after vaccination:0
Submitted: 2011-09-28
   Days after onset:147
Entered: 2011-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3829AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Malaise, 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: 2011-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Vaccination records showed "7 doses of vaccines (not specified) and one dose of influenza H1N1 vaccine", with no report of adverse reactions. The patient had a medical history of severe arterial hypertension without medical supervision.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201108746

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3712). A 65-year-old male patient (born on 20/01/1946), whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number U3829AA, route and anatomical site of administration not reported) on 04 May 2011. Vaccination records showed "7 doses of vaccines (not specified) and one dose of influenza H1N1 vaccine", with no report of adverse reactions. The patient had a medical history of severe arterial hypertension without medical supervision. On 04 May 2011, one hour post-vaccination, the patient experienced severe malaise and was taken to hospital. He arrived without life. The autopsy was performed but unfortunately "the material could not be analyzed because it arrived contamined" (the Death Verification Service). The cause of death was diagnosed as sudden death of natural causes. The case was assessed as serious by the Ministry of Health. The patient was not hospitalized. The Ministry of Health classified the adverse events as Coincidence (temporal association). The "causality classification" was inconclusive (the Ministry of Health assessed the causal relationship to the vaccine as unknown). Documents held by sender: none.


VAERS ID: 422660 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-09-03
Onset:2011-04-18
   Days after vaccination:227
Submitted: 2011-05-10
   Days after onset:22
Entered: 2011-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Balance disorder, Blood pressure decreased, Botulism, CSF glucose increased, Computerised tomogram head, Computerised tomogram normal, Death, Dizziness, Headache, Intensive care, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Protein total normal, Quadriparesis, Quadriplegia, Respiratory paralysis, Spinal myelogram
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Unknown
Preexisting Conditions: Hyperlipidaemia; Breast cancer
Allergies:
Diagnostic Lab Data: 04/18/2011, Blood pressure dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance imaging brain revealed moderate microvascular disease, abnormal.
CDC Split Type: PHHO2011US07292

Write-up: Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject''s medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on ''JV'' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient''s protein was normal. In the subject''s CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject''s condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient''s sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.


VAERS ID: 430780 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: California  
Vaccinated:2011-03-28
Onset:2011-04-11
   Days after vaccination:14
Submitted: 2011-08-23
   Days after onset:134
Entered: 2011-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3741AA / 1 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0565Z / 3 LA / UN

Administered by: Public       Purchased by: Public
Symptoms: Arrhythmia, Autopsy, Blood culture positive, Body fluid analysis, Cardiac failure, Cardiomyopathy, Death, Drug screen negative, Microscopy, Streptococcus test positive, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Mildly overweight; concern for idiopathic scoliosis
Allergies:
Diagnostic Lab Data: Autopsy, including microscopy slides. Heart blood culture showed alpha streptococcus (not Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and vitreous humor samples showed no drugs on complete drug screen. Vitreous panel (Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium - 15.2 mmol/L, Chloride - 124 mmol/L, Urea Nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL)
CDC Split Type:

Write-up: Found dead in bed in a.m. by family. Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.


VAERS ID: 688490 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-16
Onset:2011-03-17
   Days after vaccination:1
Submitted: 2017-03-23
   Days after onset:2198
Entered: 2017-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLUA589AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: 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: 2011-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: oxycodone; alendronate; furosemide; acetylsalicylic acid; cholecalciferol
Current Illness: Nephropathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK040393

Write-up: This case was reported by a regulatory authority and described the occurrence of dyspnea in a 83-year-old female patient who received Influenza vaccine (batch number AFLUA589AB, expiry date unknown). Concurrent medical conditions included renal disease. Concomitant products included alendronate, furosemide, acetylsalicylic acid, Cholecalciferol and oxycodone. On 16th March 2011, the patient received Influenza vaccine (intramuscular) .5 ml. On 17th March 2011, 1 days after receiving Influenza vaccine, the patient experienced dyspnea (serious criteria death). On an unknown date, the outcome of the dyspnea was fatal. The patient died on 17th March 2011. The reported cause of death was dyspnea. The reporter considered the dyspnea to be possibly related to Influenza vaccine. Additional details were provided as follows: The case was received via regulatory authority in the form of line listing from 1st January 2007 to 31st December 2016. The primary reporter was not provided; therefore no further information would be available. The patient had pre existing renal disease and had no known allergy. The age at vaccination was not provided. The patient had other medical conditions and also received nutritional supplements. This was 1 of the 12 cases reported by the same reporter. No further information was provided.


VAERS ID: 688574 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-15
Onset:2011-03-17
   Days after vaccination:2
Submitted: 2017-03-28
   Days after onset:2203
Entered: 2017-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA589AD / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: 2011-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK040395

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 64-year-old female patient who received FLUARIX (batch number AFLUA589AD, expiry date unknown). On 15th March 2011, the patient received FLUARIX (subcutaneous) . 5 ml. On 17th March 2011, 2 days after receiving FLUARIX, the patient experienced sudden death (serious criteria death and GSK medically significant). On 17th March 2011, the outcome of the sudden death was fatal. The patient died on 17th March 2011. The reported cause of death was sudden death. It was unknown if the reporter considered the sudden death to be related to FLUARIX. Additional information as provided as follows: This case was received via regulatory authority in the form of line listing involving GSK Influenza vaccine covering 1st January 2017 to 31st December 2016. The primary reporter was not provided, therefore no further information would be available. The patients had other medical conditions however no further information was provided. The patient medical conditions including pre-existing renal disease, pre-existing hepatic disease, recent surgery, transfusion and X-ray with contrast media, known allergy, familial, other chemicals and nutritional supplements were unknown. The events lasted for less than a week. Autopsy results were unknown. No further details was provided. This is one of the 12 linked cases reported by the same reporter.


VAERS ID: 420013 (history)  
Form: Version 1.0  
Age: 0.84  
Sex: Male  
Location: Unknown  
Vaccinated:2010-10-12
Onset:2011-03-15
   Days after vaccination:154
Submitted: 2011-03-30
   Days after onset:15
Entered: 2011-03-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C368AA / 2 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3575DA / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB24CA / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 914274 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardiac arrest, Cardiomegaly, Convulsion, Culture tissue specimen positive, Death, Meningitis pneumococcal, Neurological infection, Pyrexia, Viral myocarditis, Vomiting, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray (14-MAR-2011) results: showed he had an enlarged heart; Autopsy - brain tissue culture (15Mar2011) revealed: pneumococcal meningitis
CDC Split Type: 2011066068

Write-up: This is a spontaneous report from a Pfizer sales representative on behalf of a contactable physician. A 15-month-old male (at the time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010 at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against pneumococcal disease. Relevant medical history was unknown. The relevant concomitant medications were unknown. The infant had only been administered two doses of PREVNAR 13 instead of four doses. On 11MAR2011, he was taken to the Emergency Room and diagnosed with neural infection. Treatment was not reported. On 13MAR2011, the patient was taken to the Emergency Room again, but did not see the doctor came back home. On 14MAR2011, the patient was taken to the physician''s office, where he presented with fever, vomiting, and neural infection, because of which he was hospitalized. On 14MAR2011, while in the hospital, he had seizures. An x-ray was performed which revealed an enlarged heart. The patient then had cardiac arrest. On 14MAR2011, the patient was transferred to a hospital where they have found viral myocarditis. Treatments in response to the events were not reported. On 15MAR2011, the infant died. An autopsy was performed on brain tissue culture on 15MAR2011, which showed that he died due to pneumococcal meningitis. The clinical outcome of the reported event of pneumococcal meningitis (per autopsy results) was fatal, and the outcome of the other events was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.


VAERS ID: 688495 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-25
Onset:2011-03-04
   Days after vaccination:7
Submitted: 2017-03-24
   Days after onset:2211
Entered: 2017-03-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA589AD / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-04
   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: No other medications
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK040394

Write-up: This case was reported by a regulatory authority and described the occurrence of pneumonia in a 75-year-old male patient who received FLUARIX (batch number AFLUA589AD, expiry date unknown). Concurrent medical conditions included chronic obstructive pulmonary disease. On 25th February 2011, the patient received FLUARIX (subcutaneous) .5 ml. On 4th March 2011, 7 days after receiving FLUARIX, the patient experienced pneumonia (serious criteria death and GSK medically significant) and sepsis (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal and the outcome of the sepsis was unknown. The patient died on 4th March 2011. The reported cause of death was pneumonia. The reporter considered the pneumonia and sepsis to be unlikely related to FLUARIX. Additional details were provided as follows: This case was received via regulatory authority in the form of line listing involving GSK Influenza vaccine for the period of 1st January 2007 to 31st December 2016. The primary reporter was not provided. The age at vaccination was not reported. The patient''s pre-existing renal disease, pre-existing hepatic disease, recent surgery, transfusion, X-ray with contrast media, known allergy, familial, other chemicals and nutritional supplements were unknown. The events lasted for less than a week. The outcome was provided as died (unrelated to drug). The cause of death was not specified that due to which event the patient has died. Autopsy results were unknown. No follow up would be available. This is one of the 12 linked cases reported by the same reporter.


VAERS ID: 447405 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2011-02-19
Submitted: 2012-01-13
   Days after onset:328
Entered: 2012-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA592AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Cough, Death, Hypotension, Incorrect storage of drug, Increased upper airway secretion, Influenza, Influenza A virus test positive, Lung disorder, Mechanical ventilation, Pyrexia, Sepsis, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebral palsy; Inability to move; Inability to speak; Intellectual disability; Neurological impairment
Preexisting Conditions: Aspiration pneumonia
Allergies:
Diagnostic Lab Data: Body temperature, 19Feb2011, 38.4deg.C; Chest x-ray, 19Feb2011, lung opacities; Oxygen saturation, Feb2011, 88%; Respiratory rate, Feb2011, 24bpm
CDC Split Type: B0774395A

Write-up: This case was reported in a literature article and described the occurrence of influenza A in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). This case corresponds to patient A in the literature article. The subject''s medical history included aspiration pneumonia and history of abnormalities noted on chest radiography. Concurrent medical conditions included inability to move, inability to speak, cerebral palsy, intellectual disability and neurological impairment. Between October and November 2010, the subject received an unspecified dose of FLULAVAL (administration site and route unknown) which was incorrectly stored: the vaccine refrigerator temperature was considerably below optimal temperature during the investigation. On 19 February 2011, within months of vaccination with FLULAVAL, the subject experienced fever (38.4 deg.C). His oxygen saturation was 88% on room air. On illness day 2, the subject developed mild cough and wheezing. On day 3, he became tachypneic and required increased respiratory suctioning. On day 5, the subject was hospitalised with fever (38.5 deg.C) and respiratory rate of 24 bpm. On day 6, he was tested positive for influenza A and developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On day 7, the chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. The subject was treated with ciprofloxacin, Piperacillin, Tazobactam, vancomycin, Oseltamivir, oxygen, mechanical ventilation and vasopressor. The subject died in February 2011 on day 8, the cause of death was not reported. It was unknown whether an autopsy was performed. Summary of the literature article: Children with neurological and neurodevelopmental conditions are at increased risk for severe outcomes from influenza, including death. In April 2011, the state Department of Health and CDC investigated an influenza outbreak that began in February 2011 in a residential facility for 130 children and young adults with neurologic and neurodevelopmental conditions. This report summarizes the characteristics and clinical courses of 13 severely ill residents with suspected or confirmed influenza; 10 were hospitalized, and seven died. Diagnosis is challenging in this population, and clinicians should consider influenza in patients with neurologic and neurodevelopmental conditions who have respiratory illness or a decline in baseline medical status when influenza is circulating in the community. The findings in this report are subject to at least two limitations. First, a broad case definition was used to identify suspected cases, and not all ill residents underwent diagnostic testing; thus, respiratory pathogens other than influenza might have contributed to this outbreak. Second, residents of this facility are considerably more medically fragile than subjects with mild neurologic and neurodevelopmental conditions; therefore, this report is not generalizable to all patients with neurologic and neurodevelopmental conditions or all patients in residential-care centers. The authors'' conclusion stated that prompt testing, early and aggressive antiviral treatment, and antiviral chemoprophylaxis are important for these subjects. When influenza is suspected, antiviral treatment should be given as soon as possible after symptom onset, ideally within 48 hours. Treatment should not wait for laboratory confirmation of influenza. During outbreaks, antiviral chemoprophylaxis should be provided to all residents of institutional facilities (e.g., nursing homes and long-term care facilities), regardless of vaccination status. Residential facilities for subjects with neurologic and neurodevelopmental conditions are encouraged to vaccinated all eligible residents and staff members against influenza.


VAERS ID: 458458 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2011-02-19
Submitted: 2012-06-29
   Days after onset:495
Entered: 2012-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Cough, Death, Hypotension, Influenza A virus test positive, Mechanical ventilation, Oxygen saturation decreased, Pyrexia, Sepsis, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Neurodevelopmental disorder; Nervous system disorder; Physical disability, Unable to speak or move; Cerebral palsy; Mental disability
Preexisting Conditions: Pneumonia aspiration, Multiple hospital admissions.
Allergies:
Diagnostic Lab Data: Body temperature, 38.5 degrees C, High; Chest X-ray, Abnormalities, Significant, Abnormalities noted on chest radiography; Chest X-ray, Lung opacities, Significant, On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. Influenza A virus test positive, Positive, Significant, He tested positive for influenza A by rapid influenza diagnostic test. Oxygen saturation decreased, 88%, Low
CDC Split Type: PHHY2012US054673

Write-up: Case number PHHY2012US054673 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient''s medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations. With his neurologic impairment, he was able to make sounds but unable to speak or move on his own volition. He had multiple prior admissions for aspiration pneumonia and a history of abnormalities noted on chest radiography. He was vaccinated with season influenza vaccine 2010/2011 (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was initiated. On illness day 2, he developed mild cough and wheezing and was given supplemental oxygen. On illness day 3, he became tachypneic and required increased respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F (38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated with oseltamivir (60 mg twice daily). On the same day, he developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. He died on illness day 8, Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.


VAERS ID: 421334 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: New Hampshire  
Vaccinated:2010-12-09
Onset:2011-01-27
   Days after vaccination:49
Submitted: 2011-04-19
   Days after onset:81
Entered: 2011-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3732AA / 3 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3645AA / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E80083 / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 04192011

Write-up: None stated.


VAERS ID: 482751 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-01-08
Submitted: 2013-01-25
   Days after onset:748
Entered: 2013-01-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Autopsy, Biopsy bone, Death, Influenza, Pneumonia legionella, Polycythaemia
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Diabetes mellitus; Obesity; Pancytopenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013HR006928

Write-up: Case number PHHY2013HR006928 is an initial spontaneous report received from a physician via health authority (reference number: 2011-00047) on 23 Jan 2013. This case refers to a 46-year-old male patient. His medical history included of diabetes mellitus since long period, obesity (weight: 150 kg) and was suffering from pancytopenia that was diagnosed after arrival at the hospital. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. On 08 Jan 2011, a month after vaccination he developed swine flu. On the same day he developed severe clinical picture caused by the H1N1 virus. The patient was hospitalized in the clinic for infectious diseases, after admission to the hospital he was diagnosed with polycythemia which set suspicion on the hematological disease that could cause non development of protective antibodies. Within 24 days after hospitalization a severe clinical picture of acute respiratory distress syndrome (ARDS) was developed and the patient died from complications on 09 Jan 2011. It was also reported that he got over the legionnaire''s disease. Bone biopsy was taken during the autopsy for further diagnosis of causes of complications from influenza H1N1 virus. The final diagnosis was reported as inefficacy for the seasonal vaccine. The cause of death was reported as acute respiratory distress syndrome. The causality of the event inefficacy of the seasonal vaccine was reported as possibly related to seasonal influenza vaccine.


VAERS ID: 414096 (history)  
Form: Version 1.0  
Age: 0.97  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-12-30
Onset:2010-12-31
   Days after vaccination:1
Submitted: 2011-01-04
   Days after onset:4
Entered: 2011-01-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3574CA / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Robinol; Hydrocortisone; Phenobarbital; KEPPRA; PREVACID; ATIVAN PRN; TYLENOL
Current Illness:
Preexisting Conditions: Holoprosencephaly; Diabetes Insipidus; seizure; adrenal insufficiency; FT
Allergies:
Diagnostic Lab Data: Coroner performing autopsy 1/4/11
CDC Split Type:

Write-up: Details unknown. I was notified by agency that pt expired 12/31/10.


VAERS ID: 414974 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Illinois  
Vaccinated:2010-09-22
Onset:2010-12-26
   Days after vaccination:95
Submitted: 2011-01-19
   Days after onset:24
Entered: 2011-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U3602AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-06
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per patients daughter, he developed Guillain Barre Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away on 1/6/2011.


VAERS ID: 414691 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-12-20
Onset:2010-12-22
   Days after vaccination:2
Submitted: 2011-01-13
   Days after onset:22
Entered: 2011-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 098618802 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-22
   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: Bendroflumethiazide; BETACAP; Calcium carbonate; COCOIS; Isopropyl myristate; Levothyroxine; Nitrofurantoin; Simvastatin;
Current Illness: Osteopenia; Essential hypertension; Hypothyroidism; Melaena
Preexisting Conditions: Hysterectomy; Respiratory arrest
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011027341

Write-up: This regulatory report (initial receipt 04-JAN-2011) concerns a 75 year old female patient, who had a relevant medical history of hysterectomy and respiratory arrest (which caused admission in NOV-2009). At the time of the event the patient concomitantly suffered from essential hypertension, hypothyroidism, melaena and osteopenia. Concomitant medications included bendroflumethiazide, betamethasone valerate, calcium carbonate, coal tar solution; precipitated sulphur; salicylic acid combination, isopropyl myristate; liquid paraffin combination, levothyroxine, nitroflurantoin and simvastatin. On 20-DEC-2010, the patient received ENZIRA (batch number: 098618802) as routine measure. She had not previously had swine flu vaccine last year but did have routine vaccinations annually. On 22-DEC-2010, 3 days after vaccination, the patient was found unconscious in bed. Paramedics failed to resuscitate her and she was certified dead at home. The reporter considered events to be serious (medically significant). Cause of death is unknown. Death Date: 22-DEC-2010.


VAERS ID: 413836 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2010-11-01
Onset:2010-12-20
   Days after vaccination:49
Submitted: 2011-01-02
   Days after onset:13
Entered: 2011-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased appetite, Full blood count normal, Haemoglobin decreased, International normalised ratio decreased, Melaena, Nausea, Platelet count decreased, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-07
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril; Aspirin; Omeprazole; Diltiazem
Current Illness: None
Preexisting Conditions: Hypertension; Chronic kidney disease; Neurogenic bladder; Allergies: codeine, sulfa
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: May of 2010, CBC plt were normal. Dec of 2010, WBC count of 2.5 - hemoglobin = 7.0 - plt = 14 - no schistocystes or RBC fragments to suggest consumptive coagulopathy, no teardrop cells, plts appear nl, INR = 1.29. Patient complaining of melanic stools, abdominal pain, nauseam decreased appetite, for since December 20, 2010.


VAERS ID: 414511 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-11-08
Onset:2010-12-19
   Days after vaccination:41
Submitted: 2011-01-11
   Days after onset:23
Entered: 2011-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501013P / UNK NS / IN

Administered by: Private       Purchased by: Private
Symptoms: Acute disseminated encephalomyelitis, Coma, Confusional state, Death, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, Subacute sclerosing panencephalitis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-02
   Days after onset: 14
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: Peg Infron; Isoprinosine
Current Illness: SSPE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI & LP at Clinic and Hospital
CDC Split Type:

Write-up: ADEM secondary to agency from administration of live virus flu vaccine to patient following interferon confusion, fever, coma, death. Contact hospital doctor for details.


VAERS ID: 413092 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Nevada  
Vaccinated:2010-12-17
Onset:2010-12-18
   Days after vaccination:1
Submitted: 2010-12-18
   Days after onset:0
Entered: 2010-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 713639DA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown manufacturer, report completed by ED doctor. Detailed vaccine information unavailable. Please contact family
Current Illness: uk
Preexisting Conditions: Sickle Cell
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: respiratory and cardiac arrest resulting in death


VAERS ID: 414753 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: Utah  
Vaccinated:2010-12-13
Onset:2010-12-16
   Days after vaccination:3
Submitted: 2011-01-15
   Days after onset:30
Entered: 2011-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA595AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Abdominal distension, Cardiac arrest, Death, Depressed level of consciousness, Dyspnoea, Headache, Hyperhidrosis, Increased bronchial secretion, Nasopharyngitis, Nausea, Pain, Pulse abnormal, Resuscitation, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-20
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fentanyl patch 100 mcg 1 patch every 2 days Oxycodone 30 mg 1 q 3 hrs prn pain Midodrine 10 mg 1 q d Captopril 12.5 mg 1/2 tab q 8 hrs Fludrocortisone 0.1 mg 1 q d Omeprazole 40 mg 1 q d Paxil 40 mg 1 q d Clonazepam 1 mg 1-2 q hs prn insomn
Current Illness: Cellulitis, abdomen, at PEG tube site. Afebrile
Preexisting Conditions: Chronic illnesses: Muscular Dystrophy, Limb girdle type Quadriplegia Dysphagia requiring feeding tube Chronic respiratory failure requiring ventilator support. Chronic hypoxemia. Chronic right pleural effusion. History of recurrent pneumonia. Congestive heart failure Chronic pain requiring chronic Chronic anemia Chronic depression and anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 12/16/2010. Patient''s wife called to report that he developed nausea, headache, sweats, aching, cold two days ago (1 day after the flu vaccine was administered). On 12/15/10 he had more difficulty breathing but didn''t mention this on 12/16/10 although he still had body aches. I recommended that he receive ibuprofen 800 mg tid until the symptoms subsided. Go to ER for increased difficulty breathing. 12/20/10. Hospital ED physician called to report that patient was found by his wife in the morning to be difficult to arouse. His abdomen was distended and he had nausea with increased secretions. 911 was called. They found his pulse to be thready and while being transported to the ER went into ventricular fibrillation and then asystole. A full code was done in the ER but they were unable to resuscitate him and he died.


VAERS ID: 415118 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-06
Onset:2010-12-12
   Days after vaccination:6
Submitted: 2011-01-20
   Days after onset:39
Entered: 2011-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Death, Dyspepsia
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 12Dec2010, normal; Oxygen saturation, 12Dec2010, normal
CDC Split Type: D0070000A

Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2010037292) and described the occurrence of unknown cause of death in a 65-year-old male subject who was vaccinated with seasonal trivalent Influenza vaccine (Influenza vaccine (unspecified) manufacturer unspecified). Concurrent medical conditions included chronic bronchitis. On 06 December 2010 the subject received a dose of Influenza vaccine (unspecified) (0.5 ml, intramuscular, unknown). Approximately six days post vaccination with Influenza vaccine (unspecified), on 12 December 2010, the subject experienced chest pain and heartburn. An emergency physician was called. Blood pressure and oxygen saturation were normal. The emergency physician has not given any medication for the events. Ambulatory follow-up treatment was not necessary. On the next day, on 13 December 2010 at 05.55 in the morning, the subject was found dead. The police have been called. The subject died from unknown cause of death. It was unknown whether an autopsy was performed. At the moment no further information will be available.


VAERS ID: 413215 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Virginia  
Vaccinated:2010-11-01
Onset:2010-12-06
   Days after vaccination:35
Submitted: 2010-12-20
   Days after onset:14
Entered: 2010-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501049P / 2 NS / IN

Administered by: Public       Purchased by: Public
Symptoms: Blindness, Death, Headache, Intensive care, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-12-16
   Days after onset: 10
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: VA10020

Write-up: On 12/6/10, developed fever & headache. Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10.


VAERS ID: 547973 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-12-01
Submitted: 2014-10-14
   Days after onset:1412
Entered: 2014-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-aquaporin-4 antibody negative, Blood brain barrier defect, Blood test abnormal, CSF oligoclonal band present, Cardiac arrest, Central nervous system inflammation, Convulsion, Death, Dry mouth, Immunoglobulin therapy, Interleukin level increased, Monoparesis, Muscular weakness, Myelitis transverse, Neck pain, Necrosis, Neurogenic bladder, Neuromyelitis optica, Nuclear magnetic resonance imaging abnormal, Oral herpes, Paraplegia, Paresis, Plasmapheresis, Quadriparesis, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Demyelination (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood-brain barrier disruption, oligoclonal band and highly elevated interleukin 6 were found in cerebrospinal fluid. Aquaporin 4 and MOG-Ab (Myelin Oligodendrocyte Glycoprotein (MOG)) were repeatedly tested negative.
CDC Split Type: DE2014GSK006175

Write-up: This case was reported in a literature article and described the occurrence of neuromyelitis optica in a 9-year-old male patient who received Influenza vaccine. In 2010, the patient received Influenza vaccine. In December 2010, less than a year after receiving Influenza vaccine, the patient experienced neuromyelitis optica (serious criteria GSK medically significant), transverse myelitis (serious criteria GSK medically significant), left leg paresis and possible infection. In 2013, the patient experienced midbrain inflammation (serious criteria GSK medically significant), dry mouth and neck pain. In July 2013, the patient experienced weakness of upper extremities, oral herpes infection and hand paresis. In September 2013, the patient experienced respiratory failure (serious criteria death and GSK medically significant), seizure (serious criteria death and GSK medically significant) and cardiac arrest (serious criteria death and GSK medically significant). On an unknown date, the patient experienced tetraparesis (serious criteria GSK medically significant), paraplegia (serious criteria GSK medically significant) and neurogenic bladder disorder. The patient was treated with Steroids, cyclophosphamide and Immunoglobulins. In September 2013, the outcome of the midbrain inflammation was unknown. On an unknown date, the outcome of the neuromyelitis optica, transverse myelitis, tetraparesis, paraplegia, left leg paresis, neurogenic bladder disorder, weakness of upper extremities, oral herpes infection, hand paresis, dry mouth, neck pain and possible infection were unknown and the outcome of the respiratory failure, seizure and cardiac arrest were fatal. The patient died in September 2013. The reported cause of death was respiratory failure, seizure and cardiac arrest. The reporter considered the neuromyelitis optica, transverse myelitis, tetraparesis, paraplegia, midbrain inflammation, respiratory failure, seizure, cardiac arrest, left leg paresis, neurogenic bladder disorder, weakness of upper extremities, oral herpes infection, hand paresis, dry mouth, neck pain and possible infection to be possibly related to Influenza vaccine. Additional information received: This case was reported in a literature article and described the occurrence of seronegative atypical neuromyelitis optica (NMO) in a 9-year-old boy following flu vaccination [route and dosage not stated and manufacturer unknown]. The patient''s medical history, concurrent medical conditions or concomitant medications were unknown. On an unspecified date the patient received flu vaccination [route and dosage not stated and manufacturer unknown]. In December 2010, following flu vaccination, the patient presented with paresis of his left leg. Longitudinal extensive transverse myelitis (LETM) with areas of beginning necrosis was diagnosed. Blood-brain barrier disruption, oligoclonal band and highly elevated interleukin 6 were found in cerebrospinal fluid (CSF). Clinically, the entire spinal cord was affected with tetraparesis and inverted breathing. The patient was treated with steroids, plasmapheresis, cyclophosphamide (CPM), and immunoglobulins. Paraplegia starting from Th9 and a neurogenic bladder disorder persisted. Antibodies to Aquaporin-4 (AQP4) and myelin oligodendrocyte glucoprotein (MOG), which are characteristic serological findings, were repeatedly tested negative. There was no evidence of optic neuritis during the follow-up period. In July 2013, the patient experienced a first relapse with weakness of the upper extremities following oral herpes infection. CSF, blood, and magnetic resonance images showed identical findings to the first episode. After treatment with steroids, plasmapheresis and CPM he showed no clinical improvement and lost his hand function. After 27 days, application of CPM again following oral herpes infection he experienced a second relapse with tetraparesis, sensibility loss starting at Th2, dry mouth, and neck pain. Lumbar puncture was no longer possible. The patient showed no improvement to steroids and plasmapheresis, but the inflammation progressed to the midbrain. In September 2013, the patient finally experienced respiratory failure, seizures and cardiac arrest. The authors considered NMO-spectrum disorder (high-risk NMO), possibly triggered by infection or vaccination without NMO and MOG-Ab nor optic nerve involvement. The clinical picture is characterized by a polyphasic course with late relapses and poor prognosis. This case demonstrates an unusual clinical course of LETM and should open discussion about the variable clinical picture of NMO in childhood.


VAERS ID: 418006 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Idaho  
Vaccinated:2010-11-30
Onset:2010-11-30
   Days after vaccination:0
Submitted: 2011-03-01
   Days after onset:91
Entered: 2011-03-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3773BA / 4 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none at present time
Preexisting Conditions: COPD; Reflux; HTN; Gout; Allergy to salmon
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID11003

Write-up: Pt. came into clinic for annual flu shot. Was non-ill appearing. Wife received same flu shot at the same time with no adverse rxn. Pt. then went home and later passed away in house (residence).


VAERS ID: 502563 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Maryland  
Vaccinated:2010-10-18
Onset:2010-11-26
   Days after vaccination:39
Submitted: 2013-09-05
   Days after onset:1013
Entered: 2013-09-16
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-04
   Days after onset: 373
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Past away. 12-4-2011.


VAERS ID: 413389 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Alabama  
Vaccinated:2010-10-21
Onset:2010-11-23
   Days after vaccination:33
Submitted: 2010-12-21
   Days after onset:28
Entered: 2010-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3730AA / UNK LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Balance disorder, Bradyphrenia, Feeling abnormal, Gait disturbance, Irritability, Mobility decreased, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-17
   Days after onset: 1881
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling~Pneumo (no brand name)~UN~0.00~Patient|Injection site mass~Pneumo (no brand name)~UN~0.00~Patient
Other Medications: Prednisone; blood pressure pill; Vitamin B12
Current Illness:
Preexisting Conditions: History of increased blood pressure, and temporal arteritis (3 years). Additionally, the patient reported that 5 years earlier she had experienced "swelling and a hard knot" following vaccination with pneumonia vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201007010

Write-up: This case was initially reported by a consumer, who is also the patient, on 15 December 2010. A 79-year-old female patient received an INFLUENZA VACCINE (manufacturer reported as "possibly Sanofi Pasteur", lot not reported) in the left arm on 22 November 2010. The patient had a history of increased blood pressure and temporal arteritis (for past 3 years); she had previously experienced swelling and a hard knot at the site of a pneumococcal vaccine, and had received numerous influenza vaccines in the past. Concomitant medications included prednisone, a blood pressure pill, and Vitamin B12 1000mg. According to the patient, approximately 6 hours post-vaccination she began experiencing fever, nausea, vomiting, and difficulty in moving. Approximately 12 hours post-vaccination, she had a fever of 103 degrees and was unable to get out of bed. She was seen by a physician the day after vaccination, at which time she complained of difficulty walking and "brain function problem", described as fuzziness, slow thinking process, and balance problems when walking. The patient noted that she had been seen by a "brain doctor". Outcome was not reported.


VAERS ID: 410080 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Idaho  
Vaccinated:2010-11-19
Onset:2010-11-21
   Days after vaccination:2
Submitted: 2010-11-24
   Days after onset:3
Entered: 2010-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3574BA / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Death, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives, pucking, then DEATH


VAERS ID: 411968 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Texas  
Vaccinated:2010-10-20
Onset:2010-11-21
   Days after vaccination:32
Submitted: 2010-12-07
   Days after onset:16
Entered: 2010-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 501057P / UNK NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Activities of daily living impaired, Atelectasis, Chills, Computerised tomogram abnormal, Cough, Dyspnoea, Insomnia, Pleural effusion, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-30
   Days after onset: 9
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: Unfortunately, no vaccine information available
Current Illness: Unknown
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: Bilateral pneumonia versus atelectasis with associated pulmonary effusion shown on chest CT; no PE seen.
CDC Split Type:

Write-up: Pt states shortness of breath started 2 weeks ago when he received Flu mist. symptoms mild at that time. he began to have activity limiting symptoms on 19Nov, unable to take a deep breath or sleep because of symptoms. He becomes very SOB with ambulation. Has cough that is only present when he takes a deep breath (nonproductive). Fever and chills over the last 2 weeks, had fever of 102.2 on presentation to emergency room, and satting 91% on room air.


VAERS ID: 416456 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2010-10-18
Onset:2010-11-20
   Days after vaccination:33
Submitted: 2011-02-09
   Days after onset:81
Entered: 2011-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3579BA / UNK LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Abasia, Electromyogram, Hypoaesthesia, Laboratory test, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Scan, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fish oil, Centrum silver, Baby aspirin, Decadron, Testosterone, folic acid, lasix, Nexium, Toprol-XL, Zocor, Ambien, Levaquin, Neurontin, Rephresh eyedrops, Colace Lortab, coumadin, IVIG
Current Illness: peripheral vascular disease
Preexisting Conditions: colon polyps, Benign prostatic hyperplasia, osteoarthritis, atherosclerotic peripheral vascular disease, history CVA, pituitary adenoma with right partial third nerve palsy, hyperlipidemia, hypertension, peripheral neuropathy, organic health disease with atrial fibrillation and cardiomegaly
Allergies:
Diagnostic Lab Data: Was sent to Nursing Home after discharge from hospital. MRI, scans, lumbar puncture, EMG, xray, lab
CDC Split Type:

Write-up: 6 wks after receiving the vaccine began having progressive weakness and numbness in legs and fingertips. Few days prior to admission to hosptial 1/26/2011 unable to walk.


VAERS ID: 413664 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2010-11-03
Onset:2010-11-17
   Days after vaccination:14
Submitted: 2010-12-28
   Days after onset:41
Entered: 2010-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA622AA / UNK LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Asthenia, Cerebrovascular accident, Death, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-02
   Days after onset: 15
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
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No record available.
CDC Split Type:

Write-up: After 2 weeks SP immunization Resid - Began to c/o increased weakness & numbness. Sat -$g MD. Apt with MD. Started on neurontin 11/20. Sat on floor. L/T increased weakness. 11/21 -$g hosp with signs & sx of CVA.


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