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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: 549295 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Arizona  
Vaccinated:2014-10-21
Onset:2014-10-22
   Days after vaccination:1
Submitted: 2014-10-22
   Days after onset:0
Entered: 2014-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI194AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levetiracetam ER 500mg; Vimpat 150mg; Escitalopram 20mg
Current Illness: None reported
Preexisting Conditions: Seizure disorder- unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None were reported to the pharmacy. Clinical director wanted it reported for documentation purposes.


VAERS ID: 585031 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Arizona  
Vaccinated:2014-10-15
Onset:2014-10-22
   Days after vaccination:7
Submitted: 2015-07-08
   Days after onset:259
Entered: 2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES UI189AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Central nervous system lesion, Hemiparesis, Hyperaesthesia, Injection site pain, Pain, Pain in extremity
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-06-16
   Days after onset: 237
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 40 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metoprolol,lisinopril,omeprazole,loratadine, aspirin,krill oil,lananoprost eye drops
Current Illness: no
Preexisting Conditions: high blood pressure, high cholesterol
Allergies:
Diagnostic Lab Data: left arm pain sensitive to touch, right side weakness, brain lesions, weakness
CDC Split Type:

Write-up: site of injection burning, severe sensitivity touch,aching


VAERS ID: 549512 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2014-10-17
Onset:2014-10-19
   Days after vaccination:2
Submitted: 2014-10-24
   Days after onset:5
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Death, Dizziness, Fall, Head injury, Hip fracture, Hip surgery, Malaise, Syncope, Ultrasound Doppler, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Osteoporosis/osteopenia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Synthroid, JCTZ, albuterol inh prn
Current Illness: Unknown
Preexisting Conditions: Cardiomegaly, COPD, hypothyroidism
Allergies:
Diagnostic Lab Data: CT scans, x-rays, carotid ultrasound, bloodwork
CDC Split Type:

Write-up: Patient told me that she had not felt well since she got the high dose flu shot last week. She was light headed and experienced syncope. As result of syncope she fell and hit the back of her head and fractured her left hip. Hip surgery ensued and was successfully performed. Upon release from hospital she was moved to a rehabilitation facility where she died the next morning. Patient attributed the syncope to the administration of the flu shot.


VAERS ID: 560802 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Georgia  
Vaccinated:2014-10-15
Onset:2014-10-19
   Days after vaccination:4
Submitted: 2015-01-08
   Days after onset:81
Entered: 2015-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI198AA / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Atrial fibrillation, Cerebrovascular accident, Convulsion, Pneumonia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 41 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/15/14 - received dose. 10/24/14 - admitted hospital - pneumonia, seizures, stroke. 10/29/14 - discharged - diagnosed stroke, AFib, pneumonia. 12/23/14 - admitted - syncope, seizures, stroke. Presently hospital.


VAERS ID: 554987 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Nevada  
Vaccinated:2014-10-17
Onset:2014-10-17
   Days after vaccination:0
Submitted: 2014-11-20
   Days after onset:34
Entered: 2014-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. CH2070 / 1 NS / IN

Administered by: Private       Purchased by: Other
Symptoms: Ataxia, Cardiac arrest, Diarrhoea, Dysarthria, Dysphagia, Enterovirus test positive, Eyelid ptosis, Gastrointestinal tube insertion, Influenza B virus test positive, Polymerase chain reaction, Respiratory failure, Rhinorrhoea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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), Pseudomembranous colitis (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-09
   Days after onset: 23
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: PCR positive for influenza B; PCR positive for enterovirus
CDC Split Type:

Write-up: Per medical records. Per mother, child saw PCP and received FLUMIST on 10/17/14. By the time they arrived home the child developed watery diarrhea and vomiting. Next day child had droopy eyelids and rhinorrhea. Over the course of a few days this progressed to truncal ataxia, dysphagia, ptosis and slurred speech. The child progressed to respiratory failure and cardiac arrest. No treatment, aside from supportive fluids and tube feeding provided.


VAERS ID: 557396 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Vermont  
Vaccinated:2014-10-10
Onset:2014-10-11
   Days after vaccination:1
Submitted: 2014-12-09
   Days after onset:59
Entered: 2014-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 014011A / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, 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: 2014-10-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lantus; Metformin; Citalopram; Lisinopril; Immodium; Gabapentin; Acetaminophen
Current Illness: None evident at time of vaccination, other than pre-existing conditions.
Preexisting Conditions: Diabetes, COPD, arthritis, depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. had diarrhea during nap. Increased Immodium, no other complaints following. Patient was found deceased 9:30 AM 10/22/2014. Was normal with no problems 5 PM previous evening.


VAERS ID: 549876 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Michigan  
Vaccinated:2014-10-08
Onset:2014-10-10
   Days after vaccination:2
Submitted: 2014-10-10
   Days after onset:0
Entered: 2014-10-24
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5042AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
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: 2014-10-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: To date, this is the 5th patient that I am aware of that has died within 6 months of getting high dose flu vaccine in my practice since 2010.
CDC Split Type:

Write-up: Patient had high dose flu vaccine and presented to ER non-responsive less than 2 days later. Date of vaccine 10-8-2014. Date of death 10-10-2014. Patient had underlying COPD and CHF but he was stable when I saw him 10-8-2014.


VAERS ID: 576974 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2014-10-08
Onset:2014-10-09
   Days after vaccination:1
Submitted: 2015-05-01
   Days after onset:204
Entered: 2015-05-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1412301 / 1 AR / SYR

Administered by: Private       Purchased by: Unknown
Symptoms: Autoimmune disorder, Death, Eating disorder, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-03-25
   Days after onset: 167
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Mild rash-new detergent
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Medical records included
CDC Split Type:

Write-up: After flu shot developed autoimmune disease which kept her from eating and eventually her airway which led to her death 3-25-15.


VAERS ID: 575852 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-10-04
Onset:2014-10-04
   Days after vaccination:0
Submitted: 2015-03-13
   Days after onset:160
Entered: 2015-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 28949411A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Atrial fibrillation, Cardiac failure acute, Death, Rash generalised, Vasculitic rash
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (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: 2015-01-20
   Days after onset: 108
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine; aspirin; atorvastatin; nicorandil; ramipril
Current Illness:
Preexisting Conditions: Ischaemic heart disease; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015049393

Write-up: This medically confirmed health authority report (initial receipt 27-Feb-2015) concerns a male patient who had concomitant conditions of ischaemic heart disease and polymyalgia rheumatica (started in 1997). Concomitant medications included amlodipine, aspirin, atorvastatin, nicorandil and ramipril. Amlodipine and ramipril was taken for hypertension and other concomitant medications were taken for ischaemic heart disease. On 04-Oct-2014, the patient received intramuscular AFLURIA (batch number 28949411A) 0.5 mL. On 04-Oct-2014, a few hours following the routine vaccination, the patient developed a generalised rash and joint pains a few hours later. He had a vasculitic type rash. Patient then developed atrial fibrillation and died of acute heart failure on 20-Jan-2015. The outcome was reported as fatal (due to acute heart failure) and not recovered for atrial fibrillation, generalised rash, joint pain and vasculitic rash. Reporter''s comments: The regulatory authority assessed the case as serious (led to hospitalisation and fatal outcome).


VAERS ID: 564361 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2014-10-01
Onset:2014-10-03
   Days after vaccination:2
Submitted: 2015-01-27
   Days after onset:116
Entered: 2015-02-09
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK LA / UN

Administered by: Other       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: 2014-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; Lactulose; ZANAFLEX; SENEKOT; Fentanyl; LEXAPRO; Bisacodyl; NUTREN
Current Illness: None
Preexisting Conditions: Cerebral Palsy; Intellectual Disabilities; COPD; Dysphagia
Allergies:
Diagnostic Lab Data: Negative
CDC Split Type:

Write-up: Client received vaccine at 6pm on 10-1-14. Client was found unresponsive on 10-3-14 at 4:15 AM. Client was pronounced dead at 4:39 AM.


VAERS ID: 548418 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Colorado  
Vaccinated:2014-10-02
Onset:2014-10-02
   Days after vaccination:0
Submitted: 2014-10-16
   Days after onset:14
Entered: 2014-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI196AC / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest discomfort, Chills, Cough, Death, Endotracheal intubation, Eye pruritus, Headache, Hypotension, Laboratory test normal, Malaise, Multi-organ failure, Ocular hyperaemia, Pain, Pyrexia, Septic shock
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Glaucoma (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-15
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No regular meds
Current Illness: None
Preexisting Conditions: Amoxicillin - rash; Osteoarthritis; Thrombocytosis
Allergies:
Diagnostic Lab Data: Labs done day of 10/2/14 physical basically normal
CDC Split Type:

Write-up: Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock.


VAERS ID: 558341 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2014-10-02
Onset:2014-10-02
   Days after vaccination:0
Submitted: 2014-12-15
   Days after onset:74
Entered: 2014-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI189AE / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Cardio-respiratory arrest, Chills, Computerised tomogram, Condition aggravated, Death, Gait disturbance, Pallor, Pyrexia, Rhinorrhoea, Tremor, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (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), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-15
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: Drug allergy; Sulfa allergy; The patient had drainage from the nose prior to vaccination.
Allergies:
Diagnostic Lab Data: CT scan and x-rays performed, results not provided.
CDC Split Type: 2014SA171839

Write-up: Initial unsolicited case received from a consumer, who is the patient''s wife, on 10 December 2014. An 82 year old male patient, with a history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal drainage at the time of vaccination. Three hours after receiving the vaccine, the patient''s right arm began shaking uncontrollably. His fingers were white, and he was weak and needed help to walk. He presented to the emergency department, where he was given fluids. The symptoms of shaking became worse, and progressed to "full body shaking". He underwent a CT scan and x-rays; results were not reported. He experienced chills and fever, and per the reporter had a possible lung infiltrate. He continued to have nasal drainage. He was treated with an antibiotic and admitted to the hospital, where he remained for 13 days. According to the reporter, the patient died from "respiratory cardiac conditions" on an unspecified date. Documents held by sender: None.


VAERS ID: 623724 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Colorado  
Vaccinated:2014-09-16
Onset:2014-09-28
   Days after vaccination:12
Submitted: 2016-02-25
   Days after onset:515
Entered: 2016-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI192AA / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abasia, Coma, Computerised tomogram, Death, Electroencephalogram abnormal, Endotracheal intubation, Fall, Gaze palsy, Generalised tonic-clonic seizure, Intensive care, Malaise, Mechanical ventilation, Paralysis, Seizure, Unresponsive to stimuli
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-10-11
   Days after onset: 13
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations: ~Influenza (Seasonal) (no brand name)~UN~5.00~Patient
Other Medications: Too many to list.
Current Illness: Pt. had multiple long-term, chronic illnesses. They were all stable at this time. Migraine headaches, pain to most of body, Osteoarthritis, RSD bilateral legs L$gR, COPD/Emphsyema, Vulvadynia, Muscle atrophy esp. to LLE, Difficulty voiding, Poor nutrition, GERD, Tachyarrhymias, Chronic constipation R/T narcotic use, MPD.
Preexisting Conditions: Allergies: Most ABX, Gabapentin, Vancomycin, Gentamycin, Medical condition: Debilitated, walked with assistance or used wheelchair, Mentally AA&O x 4, Able to do ADL mostly by self.
Allergies:
Diagnostic Lab Data: SEE CHART
CDC Split Type:

Write-up: 09/28/2014 c/o "BEING SICK". 10/02/2014 AT 7:00 am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA & O, moving all extremities. On the way to CT, she had a localized seizure involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a longer T/C seizure beginning in BLE and then involving all parts of body. Head turned upward and to right. Eyes deviated upward and right but conjugate, Not responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change. No somulent again. Transferred to ICU. Later on during the same evening, she experienced a full T/C seizure lasting $g 30 minutes. Given paralytics to get her intubated and started on Diprovan drip along with other meds. Continued with paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to show seizure wave patterns. When they let her up from her meds, she was now paralysed and comatose. Remained ventilated. After a family conference with Internal Medicine and Pulmonologist, it was decided to extubate her and allow her to die. Which she did after 45-60 minutes. These were her wishes, in her Durable Medical POA.


VAERS ID: 545642 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Ohio  
Vaccinated:2014-09-24
Onset:2014-09-26
   Days after vaccination:2
Submitted: 2014-09-29
   Days after onset:3
Entered: 2014-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. CJ2005 / 1 NS / IN

Administered by: Private       Purchased by: Private
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: 2014-09-26
   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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy report pending
CDC Split Type:

Write-up: Sudden unexplained death during nap; autopsy report pending.


VAERS ID: 550386 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Vermont  
Vaccinated:2014-09-22
Onset:2014-09-25
   Days after vaccination:3
Submitted: 2014-10-17
   Days after onset:22
Entered: 2014-10-28
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1412201 / 1 LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Chest X-ray abnormal, Death, Fungal test positive, Gun shot wound, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intensive care, Intentional self-injury, Pneumonia, Sputum abnormal, White blood cell count increased
SMQs:, Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-26
   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: Multiple see print out
Current Illness: None
Preexisting Conditions: SULFACET-R, Rash; ALEVE, unknown; Bee Sting, anaphylaxis
Allergies:
Diagnostic Lab Data: CXR showed multifocal pneumonia of (R) lung; Sputum light growth yeast; Rapid flu negative for flu A and B; CBC, WBC 14.2
CDC Split Type:

Write-up: Patient ended up hospitalized 3 days later with severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out AMA on 9/26/14 and died of self inflicted gun shot.


VAERS ID: 544978 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: New York  
Vaccinated:2014-09-20
Onset:2014-09-22
   Days after vaccination:2
Submitted: 2014-09-23
   Days after onset:1
Entered: 2014-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U50188A / 6 UN / UN

Administered by: Private       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: 2014-09-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XANAX; ALIGN; PULMICORT; DIASTAT AcuDial; FLONASE; Folic Acid; ATROVENT; PREVACID Solutab; XOPENEX; Levetiracetam; Sulfasalazine liquid
Current Illness: None
Preexisting Conditions: Mental retardation; Cerebral palsy; seizure disorder; ulcerative colitis; global develop. delay; spastic quadriplegia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found unresponsive on 9/22/14 by parents in his bed. 911 called, ACLS protocol initiated, however pt expired and pronounced dead in ED.


VAERS ID: 545039 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2014-09-19
Onset:2014-09-20
   Days after vaccination:1
Submitted: 2014-09-24
   Days after onset:4
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T57105 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-20
   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: SEROQUEL; Sertraline
Current Illness: None
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No adverse events after vaccine, but patient''s mother reported he passed away in sleep.


VAERS ID: 544517 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: Iowa  
Vaccinated:2014-09-18
Onset:2014-09-19
   Days after vaccination:1
Submitted: 2014-09-19
   Days after onset:0
Entered: 2014-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI189AA / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Autopsy to be done
CDC Split Type:

Write-up: Pt received influenza vaccination previous day and passed away from believed to be heart attack the following morning. An autopsy is being performed.


VAERS ID: 546527 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2014-09-19
Onset:2014-09-19
   Days after vaccination:0
Submitted: 2014-10-05
   Days after onset:16
Entered: 2014-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5022BA / UNK RA / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Abasia, Blood pressure increased, Blood test, Computerised tomogram, Dysstasia, Heart rate increased, Neurological examination
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-21
   Days after onset: 124
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metoprolol; Namenda; Flomax; Aspirin; Finasteride; Super B12; Preservision
Current Illness: Dementia
Preexisting Conditions: Dementia
Allergies:
Diagnostic Lab Data: CT scan; blood work, evaluation by neurologist.
CDC Split Type:

Write-up: Could not stand or walk. Blood pressure and heart rate soared.


VAERS ID: 544718 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Washington  
Vaccinated:2014-09-17
Onset:2014-09-18
   Days after vaccination:1
Submitted: 2014-09-23
   Days after onset:5
Entered: 2014-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T56805 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-18
   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:
Preexisting Conditions: Surgery (aortic aneurysm) excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014045210

Write-up: This medically confirmed report (initial receipt 19-Sep-2014) concerns a 63-year-old male patient. The patient recently underwent a surgery for aortic aneurysm excision (exact date unknown). It was unknown whether the patient received any other medications or immunizations. If the patient received anything else, it would have been outside the facility. On 17-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T56805) at 0.5 ml annually. On 18-Sep-2014, approximately 12 hours after vaccination, the patient passed away. The cause of death was unknown. It was believed that no autopsy would be performed. The outcome was reported as ''death''. Reporter''s comments: The reporter assessed the causality as serious and unlikely due to AFLURIA.


VAERS ID: 560118 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-21
Onset:2014-05-21
   Days after vaccination:0
Submitted: 2014-11-25
   Days after onset:188
Entered: 2014-11-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI086AE / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dysphonia, Dyspnoea, Hypotonia, Pyrexia, Somnolence, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-27
   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: Antiinflammatory/Antirheumatic products; Antacids; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Body temperature
CDC Split Type: 2014SA159354

Write-up: This case report is part of a batch of reports associated with several products that was received on 13 November 2014 by our partner who received the report from the ministry of health. Partner forwarded the batch of cases to Sanofi Pasteur on 14 November 2014. A female patient, age reported as 87 years 03 months, with medical history of hypertension, had received single dose of FLUZONE, lot number UI086AE, by intramuscular route, in the right deltoid on 21 May 2014. The patient''s concomitant medications included anti-inflammatory and anti gas. On an unspecified date, the patient experienced dyspnea and hoarseness 5hrs after vaccination, hypotonia 6hrs after vaccination and fever. The reported diagnosis was death. It was reported that death was temporally associated with the use of influenza vaccine. Patient was 87 years old bedridden, with medical history of hypertension, having been suspended medication in a private consultation, using anti-inflammatory and anti gas (not specified products) on purchase through pharmacy. According to the family, the patient presented hoarseness, dyspnea, drowsiness and fever, not being forwarded to medical consultation. On 27 May 2014, she died. It was not tracked the death certificate. We solicited better feedback research from 05 June 2014, not received until the moment. The outcome was reported as death. The patient did not undergo a medical consultation. The case was reported as serious due to death by the regulatory authority.


VAERS ID: 591741 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2013-10-19
Onset:2014-05-04
   Days after vaccination:197
Submitted: 2015-05-21
   Days after onset:382
Entered: 2015-08-24
   Days after submission:95
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Death, Gun shot wound
SMQs:, Suicide/self-injury (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-04
   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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SE51366

Write-up: A report has been received from a Study investigator concerning a 15 year old, female subject, Height: 5.1 inches; Weight: 140.0 Pounds, enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 19-Oct-2013. The patient experienced suicide/intentional self-harm with a firearm which started on 04-May-2014. The patient died from the event of suicide/intentional self-harm with a firearm on 04-May-2014. Assessment of the Serious criteria for the report was as follows: Death. The patient died on 04-May-2014. The cause(s) of death was/were suicide/intentional self-harm with a firearm and gunshot wound of head. The investigator considered that there was no causal relationship between suicide/intentional self-harm with a firearm and FLUMIST QUADRIVALENT.


VAERS ID: 527362 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: Unknown  
Vaccinated:2013-10-29
Onset:2014-03-23
   Days after vaccination:145
Submitted: 2014-04-02
   Days after onset:10
Entered: 2014-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 55A29 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac disorder, Death, Influenza, Influenza B virus test positive, Oropharyngeal pain, Unresponsive to stimuli, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-25
   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: Automatic implantable cardioverter; Congenital heart defect; Heart surgery
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1066974A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of influenza B in a 10-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included automatic implantable cardioverter defibrillator pacer, congenital heart defect repaired by heart surgery. On 29 October 2013, the subject received a dose of FLUARIX (administration site and route unknown). On 23 March 2014, 5 months after vaccination with FLUARIX, the subject experienced sore throat. No test for flu was conducted and no antivirals were given. No swab testing for culture or sensitivity was done. At that time, he was stable from cardiac standpoint. On 25 March 2014, he was found unresponsive. A culture was took around pronouncement of the death which showed positive results for influenza B which was considered as a vaccination failure. The subject died on 25 March 2014 from cardiac complications and influenza B infection.


VAERS ID: 531609 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-19
Onset:2014-03-19
   Days after vaccination:0
Submitted: 2014-05-21
   Days after onset:63
Entered: 2014-05-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Tabularized lab data is appended
CDC Split Type: 2014042543

Write-up: This medically confirmed health authority report (initial receipt 07-May-2014) concerns a 77-year-old male patient. The patient had a medical history of hypertension. On 19-Mar-2014 at 09:00 am, the patient received subcutaneous influenza vaccine injection (manufacturer and batch number not provided). On 19-Mar-2014 at 15:15, the patient experienced sudden cardiac arrest. Resuscitation was attempted. The patient was taken to the hospital via ambulance. His treatment included CP (cardiopulmonary resuscitation), intubation, adrenaline 10 x 1 mg and adrenaline infusion. An ECG-VT (electrocardiogram - ventricular tachycardia) echo was performed which showed global left ventricular dysfunction. On 19-Mar-2014 at 18:22 pm, the patient died. Reporter''s comments: The health authority assessed the causality as possible. The reported Preferred Term was ''ventricular dysfunction''. .


VAERS ID: 522177 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2014-01-28
Onset:2014-01-31
   Days after vaccination:3
Submitted: 2014-02-07
   Days after onset:7
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1340IP / UNK AR / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-31
   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: Spiriva inhaler, Symbicort Inhaler, Furosemide 20mg qd, Ambien 10mg hs, Xanax 1mg bid, Lortab 10 mg tid, Predisone 10 mg, ASA 325mg qd, Albuterol nebulizer
Current Illness: Hx of recent hospitalization for pneumonia
Preexisting Conditions: COPD, Chronic home O2 use, Obstructive sleep disorder, HTN, Hx of skin Ca, Pulmonary Htn., CHF, Chronic back pain, Dyspnea
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 520888 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Texas  
Vaccinated:2014-01-06
Onset:2014-01-22
   Days after vaccination:16
Submitted: 2014-01-27
   Days after onset:5
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13452P / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J006921 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Decreased appetite, Dysgeusia, Hypersomnia, Pain, Pain in extremity, Respiratory tract congestion
SMQs:, Taste and smell disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time
Current Illness: Congestion the next day and hurting all over.
Preexisting Conditions: Diabetes, COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pain and hurting in both arms. Congestion and hurting all over body. Sleeping all the time. Loss of apetite and bad taste in mouth.


VAERS ID: 521877 (history)  
Form: Version 1.0  
Age: 0.54  
Sex: Female  
Location: Indiana  
Vaccinated:2013-12-27
Onset:2014-01-05
   Days after vaccination:9
Submitted: 2014-02-05
   Days after onset:31
Entered: 2014-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS FF723 / 2 RL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4794BA / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G77643 / 3 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J008362 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-05
   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: POLY-VI-SOL with Iron; SYNAGIS
Current Illness: None
Preexisting Conditions: Preterm - 32 weeks
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None.


VAERS ID: 518872 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2013-11-21
Onset:2014-01-04
   Days after vaccination:44
Submitted: 2014-01-10
   Days after onset:6
Entered: 2014-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2156 / 2 NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-04
   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: ADDERALL XR; CELEXA
Current Illness: Anxiety; Attention deficit/hyperactivity disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA002324

Write-up: This spontaneous report as received from nurse refers to a 14 year old female patient with attention deficit disorder and anxiety and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated with first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided), on 25-JUL-2012 patient received second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot number: J007354, expiration date 20-FEB-2016) (dose and route of administration were not provided). Secondary suspect therapy included FLUMIST which was given on 21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported that patient complained of headache on 04-JAN-2014 and she went to bed early that night. It was reported that "she never woke up". Patient died on 04-JAN-2014. Nurse has not been informed of the autopsy result so she could not determinate cause of death. Lab diagnostic studies were not performed. It was also reported that approximately 27 doses of the recalled lot of GARDASIL were also administered at reporter''s facility but she has not heard of any other adverse effects. The outcome of headache was unknown. The relatedness between death, headache and GARDASIL was unknown. Additional information has been requested.


VAERS ID: 552234 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2013-12-20
Submitted: 2014-10-20
   Days after onset:303
Entered: 2014-11-06
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Brain injury, Chest X-ray abnormal, Cough, Croup infectious, Cyanosis, Death, Influenza, Obstructive airways disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-29
   Days after onset: 9
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: Concomitant Drug(s) Not Reported
Current Illness: H1N1 influenza
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Soft-tissue X-ray of upper respiratory system, Upper respiratory system was collapsed
CDC Split Type: 2014SE79865

Write-up: A consumer report has been received concerning a 5 year old male patient. The patient''s concurrent disease included H1N1 virus infection. No concomitant medication was reported. The patient received FLUMIST (intranasal) on an unknown date. During an unspecified year in November he received the flu vaccine and came down with flu on 20-Dec. The patient experienced flu related complications. He was taken to the pediatrician when he developed a barking cough often characterizing croup. He was given doses of steroidal medication, prescribed by his pediatrician to combat the coughing, croup symptoms. His symptoms did not seem to be improving, so he was taken to the emergency room early Christmas morning. Doctors took a soft-tissue X-ray of his upper respiratory system and told it was collapsed a little. After spending the day with the patient, parents felt he needed to go back to the hospital. When his mother was changing his pants patient collapsed right in front of her and turned blue. Paramedics secured an airway. According to the patient''s mother, the patient suffered severe brain damage due to a lack of oxygen from a collapsed airway. The patient died from flu related complications, collapsed airway and brain damage on December 29. It was unknown if an autopsy was performed. The reporter considered the events of flu related complications, collapsed airway and brain damage to be serious based on death and hospitalization criteria.


VAERS ID: 521908 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-01
Onset:2013-12-20
   Days after vaccination:19
Submitted: 2014-02-05
   Days after onset:47
Entered: 2014-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Cardiac arrest, Death, Gait disturbance, Muscular weakness, Myalgia, Polyneuropathy
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-09
   Days after onset: 20
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: Aspirin; Atorvastatin calcium; Carvedilol
Current Illness: Hypercholesterolemia; Ischemic heart disease
Preexisting Conditions: Aortocoronary bypass
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0966136A

Write-up: This case was reported by a regulatory authority and described the occurrence of a fatal cardiac arrest in a 63-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included aortocoronary bypass. Concurrent medical conditions included hypercholesterolemia and ischemic heart disease. Concurrent medications included Cardio aspirin, TORVAST and DILATREND. On 1 December 2013, the subject received 1st dose of FLUARIX (intramuscular, unknown injection site and batch number). On 20 December 2013, 19 days after vaccination with FLUARIX, the subject experienced polyradiculoneuritis, lower limb weakness, myalgia, walking difficulty and ataxia. The subject was hospitalised and he was treated with SOLUMEDROL. At the time of reporting, the events were not resolved. Follow-up information received on 04 February 2014: The subject died on 9 January 2014 from cardiac arrest. It was unknown whether an autopsy was performed.


VAERS ID: 540489 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: California  
Vaccinated:2013-12-02
Onset:2013-12-02
   Days after vaccination:0
Submitted: 2014-08-20
   Days after onset:260
Entered: 2014-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS D43CT / UNK RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Ageusia, Eye movement disorder, Facial asymmetry, Facial nerve disorder, Facial paresis, Headache, Nerve injury, Nuclear magnetic resonance imaging, VIIth nerve paralysis
SMQs:, Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hearing impairment (broad), Ocular motility disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bells Palsy~Influenza (Seasonal) (FluLaval)~UN~55.75~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Several doctor appointments including MRI and reports. No treatment known per four physicians. I have a file that has all information.
CDC Split Type:

Write-up: After vaccine, I had severe headaches for several weeks. By December 6, I had weird facial disfigurement. I went to hospital on December 8 thinking I had stroke. The emergency room diagnosed Bells Palsy with damage to the seven facial nerve. Follow-up appointments with my practitioner, neurologist, and hospital neurology department confirmed I had permanent nerve damage which lead to disfigurement, loss of facial movement on left side of face including, chin, cheek, taste, nose, eye, and forehead. I have regained maybe 30% but symmetry of my face is still not improved.


VAERS ID: 519605 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Ohio  
Vaccinated:2013-10-11
Onset:2013-12-01
   Days after vaccination:51
Submitted: 2014-01-16
   Days after onset:46
Entered: 2014-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4713AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

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? No
Previous Vaccinations:
Other Medications: Information not available. Patient has not filled prescriptions at pharmacy since 9/3/2013.
Current Illness: No
Preexisting Conditions: No indicated on Patient Questionnaire
Allergies:
Diagnostic Lab Data: ADEM
CDC Split Type:

Write-up: On 1/15/14 patient''s daughter informed me that patient was diagnosed with ADEM (acute disseminated encephalomyelitis) secondary to Fluzone HD. He was admitted on 12/1/13 and now is in a hospital.


VAERS ID: 573855 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-12-01
Submitted: 2015-01-19
   Days after onset:414
Entered: 2015-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autopsy, C-reactive protein increased, Computerised tomogram normal, Death, Fibrin D dimer, Glomerulonephritis, Haematocrit decreased, Haemoglobin decreased, International normalised ratio normal, Myocardial ischaemia, Neutrophil percentage increased, Paraparesis, Renal necrosis, Renal vasculitis, Toxicologic test normal, Urinary tract infection, Urine analysis abnormal, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Other ischaemic heart disease (narrow), Vasculitis (narrow), Renovascular disorders (narrow), Chronic kidney disease (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: 2013-12-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NORVASC; LOSEC; RIVOTRIL
Current Illness: Unknown
Preexisting Conditions: Hypertension; Parkinson''s disease; Prostate cancer; Cancer surgery
Allergies:
Diagnostic Lab Data: 12/28/2013, C-reactive protein, 153; 12/28/2013, Haematocrit, 37.3%; 12/28/2013, Haemoglobin, 12.2; 12/28/2013, International normalised ratio, 1.15; 12/28/2013, Neutrophil count, 89%; 12/28/2013, White blood cell count, 12900
CDC Split Type: GR2015005546

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of paraparesis in a 83-year-old male patient who received Influenza vaccine. The patient''s past medical history included hypertension, Parkinson''s disease, prostate cancer and cancer surgery. Concomitant products included NORVASC, LOSEC and RIVOTRIL. In November 2013, the patient received Influenza vaccine. On 1st December 2013, 5 days after receiving Influenza vaccine, the patient experienced paraparesis (serious criteria hospitalization, GSK medically significant and other). On an unknown date, the outcome of the paraparesis was fatal. The patient died on 29th December 2013. The reported cause of death was myocardial ischemia. An autopsy was performed. The autopsy determined cause of death was myocardial ischemia. The reporter considered the paraparesis to be probably related to Influenza vaccine. Regulatory authority verbatim: Case 20130450 [physician, serious]. Initial report: An 83 year old man received an influenza vaccine of unknown brand name on an unknown date. On 1-DEC-2013, the patient presented paraparesis, probable Guillain Barre. The patient died on 29-DEC-2013. Follow up with the physician that reported the event: The patient was hospitalized on 28-DEC-2013 due to vomiting and weakness that had started 3 days earlier. One month earlier he had been vaccinated against influenza (the brand name of the vaccine was not known even to the patient). Five days after the vaccination the patient started to present paraparesis symptoms. On admission to hospital, the patient was subjected to computerized tomography of the lumbar area without any pathological findings of spinal cord compression. Blood test results: HCT: 37.3%, Hgb: 12.2, WBC 12900 (89% Neutrophils), INR 1.15, D-dimers: 1.6, CRP 153, Urine test results: pyosphairia (probably urinary tract infection, afebrile). TAZOCIN treatment was initiated immediately but the patient died on 29-DEC-2013. The physician considered it as outstanding that the patient went to hospital 25 days after the presentation of paraparesis symptoms although these symptoms started 5 days after the vaccination. Concomitant medicines included NORVASC, LOSEC and RIVOTRIL. The patient''s medical history included Parkinson''s disease and hypertension. Forensic autopsy report received: Date of death: 29-DEC-2013, time of death: 06:31 a.m. The death occurred as a result of recent myocardial ischemia on the background of nectrozing kidney vasculitis and glomerulonephritis. Toxicological laboratory results received: without findings. The patient had also a history of prostate cancer surgery. Committee causality assessment received: The reported adverse reaction is probably related to the vaccine.


VAERS ID: 515346 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Texas  
Vaccinated:2013-11-26
Onset:2013-11-28
   Days after vaccination:2
Submitted: 2013-12-02
   Days after onset:4
Entered: 2013-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907ZA / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: Infant was under the care of his Dad - information was obtained from Mom that was not present at the moment of the event. As per mom the infant was as usual in the morning and he went to take his nap from what he never woke up.


VAERS ID: 514980 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Female  
Location: Ohio  
Vaccinated:2013-11-26
Onset:2013-11-26
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:1
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B169BA / 4 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AC / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J007097 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J001177 / 1 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, 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: 2013-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Cardiac arrest < 12 hours following administration. Prelim autopsy with unknown cause of death.


VAERS ID: 527273 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Georgia  
Vaccinated:2013-11-25
Onset:2013-11-26
   Days after vaccination:1
Submitted: 2014-04-01
   Days after onset:125
Entered: 2014-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
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: 2014-01-19
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None that I know of.
Current Illness: Felt weak
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Emergency room. Guillain Barré syndrome.


VAERS ID: 556239 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2013-11-21
Onset:2013-11-23
   Days after vaccination:2
Submitted: 2014-12-02
   Days after onset:374
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Death, Dyspnoea, Mobility decreased, Paralysis
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-08
   Days after onset: 15
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: Diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Paralysis, could not breathe, could not get out of bed, was given antibiotics at emergency room and sent home. Died 10 days later.


VAERS ID: 514607 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2013-11-15
Onset:2013-11-17
   Days after vaccination:2
Submitted: 2013-11-25
   Days after onset:8
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AB / 7+ RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U4502AA / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown, Denied radiation, steroid, or chemo drugs per immunization questionnaire
Current Illness: Recent trauma, Pt reported falling off a ladder sustaining injuries in recent months
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My co-worker told me Sunday evening that patient died Sunday morning. I do not know details only that he passed away.


VAERS ID: 517164 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-12
Onset:2013-11-15
   Days after vaccination:3
Submitted: 2013-12-13
   Days after onset:28
Entered: 2013-12-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 132402 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Acute polyneuropathy, Areflexia, Asthenia, Back pain, Blood bilirubin normal, Blood creatinine increased, Blood folate decreased, Blood glucose, Blood sodium decreased, C-reactive protein normal, Calcinosis, Cardio-respiratory arrest, Cerebellar atrophy, Computerised tomogram abdomen normal, Computerised tomogram abnormal, Cytomegalovirus test, Dysaesthesia, Dysstasia, Echocardiogram abnormal, Electrocardiogram normal, Electromyogram abnormal, Escherichia infection, Facial wasting, Fatigue, Flank pain, Gamma-glutamyltransferase increased, Glomerular filtration rate, Haematocrit decreased, Herpes simplex serology, Hypertension, Immunoglobulins, Lumbar puncture abnormal, Lymphocyte count decreased, Muscle atrophy, Muscular weakness, Neurological examination abnormal, Oedema, Pain, Paraesthesia, Polyneuropathy, Protein total normal, Red blood cell count decreased, Renal pain, Spinal X-ray normal, Spondylitis, Sudden death, Synovial rupture, Urinary tract infection, Vitamin B12, Vomiting, Walking aid user, White blood cell count abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Lipodystrophy (narrow), Chronic kidney disease (broad), Arthritis (narrow), Tumour lysis syndrome (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? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-05
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COTAREG; EUTIROX; Cortisone acetate; Genotropin; DIBASE; BONIVA
Current Illness: Asthenia; Vomiting; Hypertension; Osteoporosis, Under replacement therapy; Hypopituitarism
Preexisting Conditions: 2010, Pathological fracture; Prosthesis implantation; Rehabilitation therapy
Allergies:
Diagnostic Lab Data: 11/23/2013, Blood bilirubin, 0.4; 11/25/2013, Blood bilirubin, 0; 11/26/2013, Blood bilirubin, 0; 11/23/2013, Blood creatinine, 1.6; 11/25/2013, Blood creatinine, 1.7; 11/26/2013, Blood creatinine, 1.5; 11/29/2013, Blood creatinine, 1.3; 12/03/2013, Blood creatinine, 1.6; 11/26/2013, Blood folate decreased, 2.1; 11/23/2013, Blood glucose, 116, Basal glucose; 11/24/2013, Blood glucose, 82, in the cephalorachidian fluid; 11/25/2013, Blood glucose, 107; 11/26/2013, Blood glucose, 300; 11/29/2013, Blood glucose, 109; 11/24/2013, Blood pressure, 130/80; 11/25/2013, Blood sodium, 134; 11/26/2013, Blood sodium, 131; 11/29/2013, Blood sodium, 131; 11/23/2013, C-reactive protein, 0.011; 11/25/2013, C-reactive protein, 0.015; 11/23/2013, EGFR, 30.4; 11/25/2013, EGFR, 28.4; 11/26/2013, EGFR, 32.8; 11/29/2013, EGFR, 38.7; 12/03/2013, EGFR, 30.4; 11/25/2013, Electromyogram, Abnormal, Positive. 11/29/2013, Gamma-glutamyltransferase, 43; 11/29/2013, Haematocrit, 31.8; 12/03/2013, Haematocrit, 30.6; 11/25/2013, Haemoglobin, 1, Significant; 11/26/2013, Haemoglobin, 1, Significant; 11/29/2013, Haemoglobin, 10.5; 12/03/2013, Haemoglobin, 10.4; 11/26/2013, Immunoglobulins, 17.8, Herpes simplex 1 IgG = 27.1, Herpes simplex 2 IgG = 1.64 Ab Anti CMV IgG = 144; 11/24/2013, Oxygen saturation, 95%, in room air; 11/24/2013, Protein total, 80, in cephalorachidian fluid; 11/25/2013, Protein total, 6, Total; 11/25/2013, Red blood cell count, 3.94; 11/26/2013, Red blood cell count, 3.88; 11/29/2013, Red blood cell count, 3.3; 12/03/2013, Red blood cell count, 3.18; 11/26/2013, Vitamin B12, 126; 11/24/2013, Weight, 70; 11/25/2013, White blood cell count, 25; 11/29/2013, White blood cell count, 3.71, Lymphocytes = 0.51
CDC Split Type: PHHY2013IT145251

Write-up: Case number PHHY2013IT145251 is an initial spontaneous report from the health authority received on 10 Dec 2013. This report refers to an 86-year-old female patient. Her medical history included arterial hypertension and pituitary insufficiency. It was reported that her hypopituitarism was diagnosed in 1998 following the onset of asthenia and vomiting, and after a magnetic nuclear resonance (RMN) test of the pituitary gland that had reported a pituitary gland alteration not better specified (the patient excluded the presence of a nodular or expansive pathology). She had concomitant severe osteoporosis with spontaneous fractures of the right femoral bone in 2010, treated with prosthesis. She was ongoing with replacement therapy with EUTIROX and Cortone Acetate 25 mg with the last endocrinological evaluation follow up performed at the Hospital in Sep 2013. Concomitant drugs included COTAREG, EUTIROX 50, Cortone acetate DIBASE, BONVIVA and Genotropin. Her previous vaccinations included FLUARIX vaccine on 23 Nov 2011 and on 29 Nov 2012. She was vaccinated with AGRIPPAL S1 (batch number: 132402, expiry date: 30 Jun 2014) on 12 Nov 2013. On an unknown date, after vaccination she experienced pain at the left flank. The patient got admitted in the emergency department. It was reported that her last visit was performed on 21 Nov 2013 and the patient has been discharged with the diagnosis of lumbar pain and pain at kidney loggia on the left side. A CT scan of the abdomen has been performed that was negative. Treatment with DUROGESIC has been started. Due to the progressive evidence of hyposthenia and dysesthesia at the lower limbs with ingravescent course, characterized by the incapability to walk it has evidenced a diagnostic lumbar tap as far as suspected of Guillain Barre syndrome was concerned. During hospital admission suspected acute polyneuroradiculoneuritis of Guillain Barre type was diagnosed. Her blood pressure was 130/80, heart rate: 84, O2 saturation 95% in room air, body weight: 70 and VAS: 8. Her abdomen was treatable and thoracic examination was within the normal limits. Neurological objective examination at hospital admission showed moderate facial deficit greater on the left side of peripheral type. She had no hyposthenia at the upper limbs, but hyposthenia at the lower limbs, dysesthesia with distal paresthesia up to the umbilical level, osteo-tendon reflexes (ROT) absent at the lower limbs, weak at the upper limbs and cutaneous plantar reflex (RCP) in plantar flexion, GBS disability scale and Erasmus GBS scale filled out as (5/7). On 23 Nov 2013, her basal glucose was 116, creatinine was 1.6, eGFR was 30.4, bilirubine 0.4 and C-reactive protein 0.011. On 24 Nov 2013, the dorsal spine and lumbo sacral spine X-ray showed diffuse reduction of the calcium tone and diffuse spondyloarthritis. No signs of bone fractures and clear somatic collapses can be evidenced. Encephalous CT scab showed notes of cortico-subcortical atrophy, lacunar hypodensity areas due to not recent ischaemic sequels, bilateral, the greater one in the left peri-insular region. Ventricular system regular as far as morphology and content were concerned. On the same date, lab tests showed glucose in the cephalorachidian fluid as 82 and proteins in the cephalorachidian fluid as 80. On 25 Nov 2013, the patient underwent an electromyography examination indicative of symmetrical polyneuropathy at the four limbs, mixed motor-sensitive with predominantly demyelinating characteristics, of marked entity, compatible with the clinical suspect of Guillain-Barre syndrome. Present hospital admission due to suspected acute polyneuroradiculoneuritis of Guillain-Barre. It was reported that the dosage of the RSH has been performed, 0.11 consistent with the primary pituitary deficit sodium 131, potassium 3.5. Integration with dosage of FT3, FT4, prolactine, cortisol, PRA, and aldosterone (to be performed before taking the drugs) would be useful. Cycle of therapy with Ig endovenously at high dosage in slow infusion has then been administered for 5 days from 25 Nov 2013 to 29 Nov 2013. On 25 Nov 2013, the lab tests showed creatinine 1.7, eGfr 28.4, sodium 134, total protein 8, C-reactive protein 0.015, hemoglobin 1, leukocytary esthease 25, RBC 3.94. On the third day the neurological objectivity slightly worsened with reduction of the strength in prension of the hands, peripheral facial deficit bilaterally, but more evident on the left side and the remaining cranial nerves were not compromised. She had persistence of pain symptomatology and para-dysesthesia at the lower limbs of fluctuant intensity and characterized by exacerbations often during the night, despite of the administered analgesic therapies. The dosage of Cortisone acetate has been increased as for endocrinological recommendations. On 26 Nov 2013, creatinine 1.5, eGFR 32.8, sodium 131, immunoglobulins G 17.8, glucose 300, hemoglobin 1, lymphocytes 0.75, Vit B12 126, folic acid 2.1, herpes simplex 1 IgG 27.1, herpes simplex 2 IgG 1.64 and interpretation of previous infection, TSH = 0.118. On 27 Nov 2013, upon endocrinology visit it was reported that the patient had less hyposodiemia, B12 and folates deficit, TSH reduced, compatible with hypopituitarism, fT4 and fT3 not available, IGF1 within the normal limits. The patient was advised to take the steroid therapy switching to Cortisone one tablet half tablet up to hospital discharge or Flebocortid 100 mg that can be repeated every 12 hours and supplementation with B12 folates. The repeated ECG, on 24 Nov 2013 and on 29 Nov 2013 resulted within the normal limits, with sinus rhythm. On 28 Nov 2013 FT3 was 1.31. On 29 Nov 2013, creatinine 1.3, eGfr 38.7, sodium 131, WBC 3.71, gamma-GT 43 and lymphocytes 0.51. On 29 Nov 2013, the patient has started rehabilitation treatment in bed and on 02 Dec 2013 demonstration of the patient capability to control his posture, for this reason the possibility of a subsequent transfer ring to a second level Rehabilitation institution has been taken into account. At the hematobiochemical examination, a mild increase in creatinine has been observed. Since 30 Nov 2013, antibiotic treatment with Amoxicillin/clavulanic acid has been added due to infection of the urinary way due to E. Coli. Thromboembolic prevention therapy with low molecular weight heparin subcutaneously has been performed. Based on physiokinesitherapy evaluation on 29 Nov 2013 and individual rehabilitation plan programmed on 02 Dec 2013, it was reported that the patient was alert, oriented and cooperative. Minimal deficit with difficulty of prension and manipulation at the level of the left upper limb. The patient reported paresthesias at both hands. Recruiting muscle deficit bilaterally at the lower limbs with partial possibility of flexion-extension and abduction-adduction of the hip, extension of the knee was possible (partially even against gravity). Paresthesias, and marked deficit of the sensibility distally. The patient was able to change with a minimal support his own positions while he needed a great support to reach the seated position with his legs outside the bed. The patient was able to control the trunk posture in the seated position. The patient was not able to obtain the standing position even with an intense support. The patient can maintain the standing position with the aid of a deambulator walker but she felt a great fatigue during movements. Neuro-motor rehabilitation treatment was ongoing with mobilization of the lower and upper limbs exercises to improve the offered cooperation and to autonomize the postural changes, propaedeutic exercises to control the trunk with the attempt to recovery the standing position. On 03 Dec 2013, creatinine was 1.6, eGFR 30.4, hemoglobin 10.4, Rbc 3.18 and hematocrit as 30.6. On 04 Dec 2013, the patient underwent Echodoppler examination of the lower limbs, venous and muscle-tendon, with observation of fluid collection in the posterior loggia of the right leg due to probable breaking of a Baker cyst, probable concomitant cause of pain and discrete thickening of the subcutaneous tissue due to edema. On the same date, observation of arterial hypertension, treatment with antihypertensive drug has been withdrawn. Exacerbation of the pain symptomatology at the lower limbs, and some episodes of vomiting have been reported. Feeding orally was possible in autonomy, no dyspnoea, sensorium always not compromised. Treatment received by the patient was reported as Pregabalin, nadroparinum and AUGMENTIN. She also had cardiorespiratory arrest on an unspecified date. She had sudden death in the morning of 05 Dec 2013 at 7.40 a.m with acute, inflammatory polyneuropathy of Guillain-Barre type. The causality of the event Guillain-Barre Syndrome was reported as suspected to be related to vaccination with AGRIPPAL S1. Following an internal review on 13 Dec 2013, a significant correction was done for the information received on 10 Dec 2013: The labeling of the event fatal Guillain Barre syndrome was changed from listed to unlisted.


VAERS ID: 516246 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Florida  
Vaccinated:2013-10-09
Onset:2013-11-13
   Days after vaccination:35
Submitted: 2013-12-04
   Days after onset:21
Entered: 2013-12-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. 1308701 / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COREG; Torsemide; Warfarin
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 518781 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-05
Onset:2013-11-13
   Days after vaccination:8
Submitted: 2014-01-08
   Days after onset:56
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dementia, Epilepsy, Postictal state
SMQs:, Systemic lupus erythematosus (broad), Dementia (narrow), Convulsions (narrow), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diazepam; Levetiracetam; Citalopram; Galantamine hydrobromide
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0956808A

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 22363615) and described the occurrence of epileptic fit in a 61-year-old male subject who was vaccinated with Influenza vaccine unspecified. Concurrent medications included diazepam, levetiracetam, citalopram and GALANTAMINE. On 5 November 2013 the subject received an unspecified dose of Influenza vaccine unspecified (0.5 ml, intramuscular). On 13 November 2013, 8 days after vaccination with Influenza vaccine unspecified, the subject experienced epileptic fit, exacerbation of dementia and postictal state. The subject was hospitalised. At the time of reporting the outcome of the events were was unspecified. On an unknown date the patient died. Verbatim Text: Epileptic seizure. Seizure in known epileptic but postictal worsening of dementia then died. Medically Significant: Associated fit causing worsening of dementia.


VAERS ID: 573824 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-11-11
Submitted: 2015-01-16
   Days after onset:431
Entered: 2015-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT004173

Write-up: Case number PHHY2015IT004173 is an initial spontaneous report received from a consumer via lawyer on 12 Jan 2015. This report refers to an 85 years old female patient. She had a healthy life and followed a very strict diet. Her concomitant medications were not reported. She was vaccinated with AGRIPPAL (batch number: not reported) on an unknown date. It was reported that the patient suddenly died on 11 Nov 2013 after vaccination with AGRIPPAL. She was in good health before death. The health authority assessed the event as serious. The causality of the event was not reported.


VAERS ID: 512092 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Maine  
Vaccinated:2013-11-06
Onset:2013-11-06
   Days after vaccination:0
Submitted: 2013-11-08
   Days after onset:2
Entered: 2013-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS A4K92 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trazodone; Aspirin; Atorvastatin; Atenolol
Current Illness: No
Preexisting Conditions: HTN; Diabetes; Hyperlipidemia; Aortic Valve Disorder; Allergy to Lisinopril
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 578682 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-06
Onset:2013-11-06
   Days after vaccination:0
Submitted: 2015-05-18
   Days after onset:557
Entered: 2015-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory failure, Anaphylactic shock, Autopsy, Cyanosis, Death, Ecchymosis, Epistaxis
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (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 (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Hepatitis B vaccine, 1st dose, Prophylaxis, No adverse event; Hepatitis B vaccine, 2nd dose, Prophylaxis, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK064237

Write-up: This case was reported in a literature article and described the occurrence of acute respiratory failure in a 6-month-old female subject who received Flu seasonal TIV Dresden. On 6th November 2013 11:20, 50 min after receiving Flu seasonal TIV Dresden and Hepatitis B vaccine, the subject developed acute respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included allergic shock on 6th November 2013 11:20 with serious criteria of death and GSK medically significant, cyanosis on 6th November 2013 11:20, ecchymosis on 6th November 2013 11:20 and nasal bleeding on 6th November 2013 11:20. The outcome of acute respiratory failure was fatal on 6th November 2013 12:30. The outcome(s) of the additional event(s) included allergic shock (fatal on 6th November 2013 12:30), cyanosis (unknown), ecchymosis (unknown) and nasal bleeding (unknown). The subject died on 6th November 2013. The reported cause of death was acute respiratory failure and allergic shock. An autopsy was performed. The autopsy determined cause of death was acute respiratory failure and allergic shock. It was unknown if the investigator considered the acute respiratory failure, allergic shock, cyanosis, ecchymosis and nasal bleeding to be related to Flu seasonal TIV Dresden and Hepatitis B vaccine. Additional information received: The female patient received first dose of Influenza Vaccine and third dose Hepatitis B vaccine on 06th November 2013 at 10:30. She experienced cyanosis, multiple site ecchymosis on skin and a little red liquid in nasal cavity at 11:20 on 06th November 2013. She died at 12:30 on 06th November 2013 out of hospital without a clear reason (the patient had received twice Hepatitis B vaccine from the same factory and had no adverse reaction). Autopsy Results: Allergic shock caused acute respiratory failure. This case was 1 of 3 valid cases in this literature article (see case CN2015GSK063737).


VAERS ID: 514648 (history)  
Form: Version 1.0  
Age: 35.0  
Sex: Male  
Location: New York  
Vaccinated:2013-10-04
Onset:2013-11-03
   Days after vaccination:30
Submitted: 2013-11-25
   Days after onset:22
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AGRIFLU) / NOVARTIS VACCINES AND DIAGNOSTICS 1309001 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Biopsy, Blindness
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-05
   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: Novartis - lot 1309001 -exp 4/20/14 only one dose given. not sure about the manufacture or which type was given. His work place administered the shot.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: There has been an autopsy and biopsy performed. Waiting on results.
CDC Split Type:

Write-up: Loss of vision. Admitted to Medical Center @ 7:00 AM.


VAERS ID: 517460 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-31
Onset:2013-10-31
   Days after vaccination:0
Submitted: 2013-12-23
   Days after onset:53
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 2454941117 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Culture positive, Death, Laboratory test abnormal, Pneumonia, Sepsis
SMQs:, Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 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:
Allergies:
Diagnostic Lab Data: Chest X-ray; Culture; Lab test
CDC Split Type: 2013039656

Write-up: This medically confirmed health authority report (initial receipt 13-Dec-2013) concerns a 77 year old female patient. Influenza vaccination had been used yearly and tolerated in the past. On the 31-Oct-2013, the patient received AFLURIA (batch number ''2454941117'') 1 separate dose. On the 31-Oct-2013, the patient developed pneumonia bilaterally and sepsis which lasted for four days. The patient died on an unknown date. It was unknown whether an autopsy was performed. Diagnosis was confirmed by a chest X-ray, laboratory tests and cultures (blood). No outpatient was needed, however inpatient treatment was needed. The outcome was reported as fatal. Cause of death is unknown.


VAERS ID: 509650 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2013-10-24
Onset:2013-10-25
   Days after vaccination:1
Submitted: 2013-10-25
   Days after onset:0
Entered: 2013-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1308501 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: NONE
Preexisting Conditions: CARDIOVASCULAR DISEASE - NOT SPECIFIED
Allergies:
Diagnostic Lab Data: NONE AVAILABLE
CDC Split Type: PR0113

Write-up: PATIENT RECEIVED THE INFLUENZA VACCINE IN 10/24/2013 AT 7:20 PM DURING A MASS VACCINATION. THE FAMILY REFERS THE PATIENT WENT TO SLEEP AND DURING THE MORNING OF 10/25/2013 THE PATIENT''S DAUGHTER FOUND HER DEAD IN HER BED. THE FAMILY INDICATES THAT THEY KNEW THE PATIENT HEART CONDITION HISTORY AND BELIEVE HER DEATH WAS A RESULT OF NATURAL CASUES, STILL A VAERS REPORT WAS CREATED DUE TO THE SHORT TIME BETWEEN THE VACCINATION AND HER TIME OF DEATH.


VAERS ID: 518198 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-23
Onset:2013-10-24
   Days after vaccination:1
Submitted: 2013-12-31
   Days after onset:68
Entered: 2013-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Apnoea, Blood test, Body temperature increased, Chest X-ray, Coma, Computerised tomogram, Condition aggravated, Death, Dyspnoea, General physical health deterioration, Grand mal convulsion, Incontinence, Mobility decreased, Respiratory disorder, Respiratory failure, Respiratory rate increased, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
   Days after onset: 16
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Clonazepam; Lamotrigine; Midazolam; Vitamin B Complex; Thiamine
Current Illness: Unknown
Preexisting Conditions: Lennox-Gastaut syndrome; Seizure; No allergies
Allergies:
Diagnostic Lab Data: Blood test, Unknown; Chest X-ray, Unknown; Computerised tomogram, Unknown; Infection samples taken.
CDC Split Type: B0955305A

Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00107001) and described the occurrence of respiratory rate in a 20-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject''s medical history included Lennox-Gastaut syndrome and seizure. Concurrent medications included Clonazepam, KEPPRA, Lamotrigine, Midazolam, Vitamin B Complex and Thiamine. On 23 October 2013 the subject received unspecified dose of Influenza vaccine (1 IU Axa). On 24 October 2013, 1 day after vaccination with Influenza vaccine, the subject experienced tachycardia, grand mal seizure, rise in temperature, decreased mobility, loss of speech, and incontinence Approximately 7 days later on 30 October 2013 the patient experienced apnea and then 10 days later on 02 November 2013 the patient experienced Irregular respiration and respiratory rate increased. On an unknown date the patient went into a coma and had general physical health deterioration and condition aggravated. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. The subject died on 09 November 2013 from respiratory failure. It was unknown whether an autopsy was performed. I have contacted the vaccine damage unit but they do not include the seasonal influenza vaccine in their investigation schedule. My son had Lennox Gastaut syndrome and as such had frequent seizures. He was doing well and stable. The day following his influenza vaccine he developed a temperature and difficulty with respiration. He became tachycardic and his seizures increased from his base line target of below 10 to 30, then 50 then in the final days over a hundred grand mal seizures. He was admitted to hospital and no chest infection found, and released. His seizures and temperature kept increasing after discharge and he was readmitted later the same week. His seizures were stabilized and he was also treated with anti-retro viral TAMIFLU, because of possible link to vaccine causing serious deterioration of his health. He slipped into a coma and he died of respiratory failure the following day. My son was also treated at home prior to his admissions by various professionals and the visiting general practitioner just said to give him paracetamol to try to lower temperature. His consultant neurologist said this needs investigation. This was the first time my son had had this vaccine, and his deterioration and subsequently, death appears to be a direct consequence of a reaction from this. My son was admitted to hospital by ambulance twice by ourselves, due to concern over massive seizure increase and temperature and general declining state of health since the flu vaccine.


VAERS ID: 509890 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Illinois  
Vaccinated:2013-10-23
Onset:2013-10-23
   Days after vaccination:0
Submitted: 2013-10-28
   Days after onset:5
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13394P / 7+ LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chest pain, Malaise, Pharyngitis streptococcal
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-27
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin 500mg; Nyquil Cold and Flu (per police report)
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: According to police report, strep throat.
CDC Split Type:

Write-up: According to police report, patient c/o "not feeling well since he got his flu shot". Patient went to hospital w/ c/o chest pain on 10/26/13 where he was dx with strep throat, prescribed medication and sent home.


VAERS ID: 514396 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2013-10-21
Onset:2013-10-21
   Days after vaccination:0
Submitted: 2013-11-20
   Days after onset:30
Entered: 2013-11-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH898AB / UNK RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Asthenia, Death, Myocardial infarction, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes; Heart disease
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Client presented at PH office requesting Flu vaccine - came with spouse. Reviewed screening questions - no contraindications. Received phone call at home from spouse at 630. Client had shaking episode and weakness/fever. Went to hospital admitted - had heart attack next day and deceased. Spouse received flu vaccine at same time as client with no adverse events. Same vaccine from same multi-dose vial. Client denied any allergies or problems with any previous vaccines. No egg allergies. He was admitted to the hospital. No confirmation received from attending physician that flu vaccine caused heart attack.


VAERS ID: 522134 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2013-10-09
Onset:2013-10-19
   Days after vaccination:10
Submitted: 2014-02-02
   Days after onset:106
Entered: 2014-02-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4780AA / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Acute respiratory distress syndrome, Angina pectoris, Bronchitis, Candida infection, Chest discomfort, Chest pain, Endotracheal intubation, Haematuria, Haemorrhoid operation, Haemorrhoids, Pain in extremity, Pneumonitis, Scrotal pain, Sleep apnoea syndrome, Urinary retention, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-01
   Days after onset: 105
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NIZORAL; ISORDIL; NITROSTAT; RANEXA; DETROL; LIPITOR; TOPROL; PAXIL; ATIVAN
Current Illness: No
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: Candida albican; Dubliniensis; ARDS after viral prodrome
CDC Split Type:

Write-up: 10/16/13 Urinary retention post-hemorrhoidectomy. 10/19/13 Hemorrhoid prolapse, leg pain, scrotal pain chest discomfort 11/12/13 Angina 11/18/13 Angina 11/22/13 angina 11/24/13 hematuria 11/26/13 sleep apnea 12/12/13 chest pain 12/23/13 acute bronchitis 1/11/14 pneumonitis 1/19/14 intubated.


VAERS ID: 513224 (history)  
Form: Version 1.0  
Age: 1.13  
Sex: Male  
Location: Utah  
Vaccinated:2013-10-18
Onset:2013-10-18
   Days after vaccination:0
Submitted: 2013-11-14
   Days after onset:27
Entered: 2013-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4779AA / UNK RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Culture, Cyanosis, Death, Resuscitation, Toxicologic test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: No lab tests
CDC Split Type: 2013SA108488

Write-up: Initial report was received on 23 October 2013 with additional information received on 03 November from a health care professional. A 13 month-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 18 October 2013 at 1045 AM an intramuscular right thigh injection of FLUZONE QIV, lot number U4779AA and an unspecified amount of time later was found with no chest movement and blue. The patient was put to bed at 9 PM and at 1145 PM or 1245 AM the mother checked on the child who was found with no chest movement and the child was blue. Cardiopulmonary resuscitation (CPR) was performed with no response. An "autopsy done: gross examination unrevealing; no obvious cause of death identified; results of cultures, toxicology pending (will take up to ~6 weeks for results to come back)." No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: none.


VAERS ID: 507897 (history)  
Form: Version 1.0  
Age: 1.66  
Sex: Female  
Location: Colorado  
Vaccinated:2013-10-16
Onset:2013-10-17
   Days after vaccination:1
Submitted: 2013-10-18
   Days after onset:1
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 93HY5 / UNK LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4779AA / UNK LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 5B23A / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G05787 / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received call from coroner 10/17/13 that the patient had "died in the morning".


VAERS ID: 510449 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Utah  
Vaccinated:2013-10-15
Onset:2013-10-17
   Days after vaccination:2
Submitted: 2013-10-30
   Days after onset:13
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH888AB / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Altered state of consciousness, Bacterial test negative, CSF white blood cell count positive, Drug screen, Encephalitis, Full blood count, Lumbar puncture, Malaise, Meningitis, Pyrexia, Urine analysis, White blood cell count normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-11-19
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: LP, drug screen, urinalysis, CBC. CBC showed WBC 6.6. CSF showed WBC but no bacteria. Otherwise lab results not reported to me.
CDC Split Type:

Write-up: Malaise, fever at onset. Sought help in ER 10/20/2013. No dx given. 10/23/2013, altered consciousness, probable meningitis or encephalitis.


VAERS ID: 507228 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Michigan  
Vaccinated:2013-10-04
Onset:2013-10-09
   Days after vaccination:5
Submitted: 2013-10-11
   Days after onset:2
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4779AA / 5 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Bradycardia, Cardiac arrest, Chromaturia, Cough, Nasopharyngitis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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 (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-09
   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: Aldactone; LASIX; ASA; Ranitidine; Iron supplement; Albuterol; PULMICORT
Current Illness: None
Preexisting Conditions: Tricuspid atresia, s/p PA banding with PDA ligation (Nov 4, 2010), s/p hemi-Fontan (April 18, 2011), s/p hemi-Fontan takedown, with right modified Blalock-Taussig shunt (April 21, 2011), elevated mean MPA and LPA pressures, catheterization on (April 4, 2012); Bicuspid aortic valve with mod aortic stenosis (last ECHO 09/03/13); Ventricular septal defect; Atrial septal defect; Acute diastolic heart failure, pulmonary edema needing diuretics; Hypoplastic left heart; DVT with embolic injury to distal extremities (fingers bilaterally) - s/p LOVENOX; Probable bilateral femoral venous occlusion; CVA, left parieto-occipital infarct (December 2010); Right sided seizures - resolved, phenobarbital discontinued in July 2012 by pediatric neurologist - no seizure activity since; Necrotizing enterocolitis, ileal perforation, s/p small bowel resection and colostomy (December 10, 2010), s/p takedown and reanastomosis (March 23, 2011); Pneumoperitoneum (April 29, 2011); C. diff colitis causing prerenal failure, admitted August 1-11, 2011 - dehydration and diarrhea; GERD; Occlusion - left lower pulmonary vein by catheterization (April 4, 2012); Likely obstruction left upper pulmonary vein by catheterization (April 4, 2012); Chronic cyanosis - goal O2 sats $g60% on room air; Iron deficiency anemia; Febrile UTI - no VUR; RSV bronchiolitis (January 10, 2010); Acute bronchiolitis due to human metapneumovirus (admitted December 4-11, 2011); Symmetric IUGR; Neonatal narcotic withdrawal - s/p methadone; Refractive amblyopia bilateral; Hyperopia with astigmatism; Developmental delay - gross and fine motor, along with speech
Allergies:
Diagnostic Lab Data: 09:14 U/S probe cardiac full - no wall motion pronounced 09:16
CDC Split Type:

Write-up: 10/8/13 - cold/cough symptoms. Urine - orangish color. Albuterol neb. 10/9/13 - brachycardia -$g full arrest.


VAERS ID: 514394 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-08
Onset:2013-10-09
   Days after vaccination:1
Submitted: 2013-11-13
   Days after onset:35
Entered: 2013-11-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac death, Cardiac disorder, Cor pulmonale
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Polio; Gastrointestinal disorder NOS; Electrolyte disturbance
Preexisting Conditions: Coronary artery bypass
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE83887

Write-up: A physician report from the Health and Medicines Authority concerns a 78 year old male. His past medical history included polio, gastrointestinal disorder NOS, electrolyte disturbance, and coronary artery surgery. The patient received an unspecified influenza virus vaccination (route and product unspecified) on 08-Oct-2013. According to the police report he was observed after vaccination according to guidelines, so he didn''t die of acute anaphylactic shock. She reported on suspicion alone, and knows not what the patient died of, he might have died of other cause. The patient was not autopsied, but the death certificate stated that the patient died of heart disease. The patient died from the cardiac disorder on 09-Oct-2013. The reporter considered the cardiac disorder to be serious by the criterion of death.


VAERS ID: 504792 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Indiana  
Vaccinated:2013-09-29
Onset:2013-09-30
   Days after vaccination:1
Submitted: 2013-09-30
   Days after onset:0
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4716AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-30
   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: Potassium Chloride; Clopidogrel
Current Illness:
Preexisting Conditions: Heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received FLUZONE high dose 9/29/13. Patient died 9/30/13, family believes the death is due to advanced age, not the vaccination.


VAERS ID: 518725 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Ohio  
Vaccinated:2013-09-25
Onset:2013-09-26
   Days after vaccination:1
Submitted: 2014-01-08
   Days after onset:104
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4759AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Barium swallow, Blood test, Computerised tomogram, Dysphonia, Dyspnoea, Echocardiogram, Electromyogram, Muscular weakness, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-29
   Days after onset: 429
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID, LOSARTIN, TRAZADONE, CITALOPRAM, EYE DROPS, EYE ANTIBIOTIC
Current Illness: NONE
Preexisting Conditions: CODIENE ALLERGY, SELDANE ALLERGY; LEGALLY BLIND AT BIRTH
Allergies:
Diagnostic Lab Data: EMG, XRAYS, SWALLOW TEST, BLOOD TEST, PULMONARY DR, CAT SCAN, ECHO CARDIOGRAM
CDC Split Type:

Write-up: WOKE UP WITH HOARSENESS IN VOICE AND LABORED BREATHING WEAKNESS IN HANDS, ARMS, LEGS & FEET.


VAERS ID: 504693 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2013-09-13
Onset:2013-09-19
   Days after vaccination:6
Submitted: 2013-09-26
   Days after onset:7
Entered: 2013-09-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4759AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Contusion, Death, Haematocrit normal, Haemoglobin normal, Haemoptysis, International normalised ratio decreased, Platelet count decreased, Pyrexia, White blood cell count normal
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADIN; ASA; CELEBREX; PLAQUENIL; SINGULAIR; HTZ; ATIVAN
Current Illness:
Preexisting Conditions: The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201309690

Write-up: Initial report was received from a healthcare professional on 20 September 2013. A 67-year-old female had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4759AA, on 13 September 2013. On 19 September 2013, the patient went to the emergency room (ER) and was seen by her oncologist. She presented with coughing up blood, bruising and a fever. The patient died four hours after arrival to the ER. There was no bleeding or bruising at the injection site after vaccination and a 1 inch, 25 gauge needle was used. Lab data included platelets 88K, hemoglobin 12.9, hematocrit 38, INR 8 and WBC 6.5. Concomitant medication included COUMADIN, acetylsalicylic acid (ASA), CELEBREX, PLAQUENIL, SINGULAIR, hydrochlorothiazide (HTZ) and ATIVAN. The patient had a history of lupus, idiopathic thrombocytopenic purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and nitrofurantoin. The patient received regular FLUZONE in the past without problems. Outcome was fatal. Documents held by sender: None.


VAERS ID: 514744 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Florida  
Vaccinated:2013-09-17
Onset:2013-09-18
   Days after vaccination:1
Submitted: 2013-11-26
   Days after onset:69
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4717AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-22
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel, furosemide, micalcin, tramadol, metoprolol, levothyroxine, lovastatin, terazosin
Current Illness:
Preexisting Conditions: Pulmonary Fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, Chills, Sweating.


VAERS ID: 516391 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-09-17
Submitted: 2013-12-11
   Days after onset:85
Entered: 2013-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA782BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Sepsis, Streptococcus test negative
SMQs:, 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: Dutasteride; Lamotrigine; Tamsulosin HCl; Phenprocoumon
Current Illness: Chronic renal impairment; Deep vein thrombosis; Depression; Nonsmoker; Prostatic hyperplasia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Streptococcus test negative, 19Sep2013, negative
CDC Split Type: D0082141A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2013074192) and described the occurrence of sepsis in a 79-year-old male subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included chronic renal impairment, deep vein thrombosis, depression, non-smoker and prostatic hyperplasia. Concomitant medications included AVODART, lamotrigine, tamsulosin hydrochloride and phenprocoumon. On an unspecified date in fall 2013 the subject received a dose of INFLUSPLIT SSW (0.5 ml, intramuscular, unknown). At an unspecified time post vaccination with INFLUSPLIT SSW, on 17 September 2013, the subject experienced sepsis. Relevant test results included negative Streptococcus test, performed on 19 September 2013. In the further course, the subject died from sepsis on an unspecified date in 2013. According to the reporter an autopsy had not been performed. The foreign regulatory authority has requested further information. At the moment no further information was available.


VAERS ID: 510192 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Alabama  
Vaccinated:2013-09-04
Onset:2013-09-13
   Days after vaccination:9
Submitted: 2013-10-29
   Days after onset:46
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 55D72 / 1 UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Death, Dysstasia, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care, Lumbar puncture abnormal, Nerve conduction studies abnormal, Paraesthesia, Pulseless electrical activity, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-09-27
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: Left elbow pain
Preexisting Conditions: Chronic bronchitis, chronic left shoulder pain, obesity, obstructive sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presents to outside ED for evaultion of new onset weakness with numbness/tingling in hands with progression to feet. He was having difficulty walking. CT and blood work was negative. Sent home with Dilaudid. On 9/16, he presents to his primary care docto. He is now unable to stand or hold objects in his hands. Denies fever, chills sweats or vision changes. He is admitted to hospital for neurologic work up. On 9/19, he is transferred to the MICU. Neurology consulted. based on findings from lumbar puncture and nerve conduction studies, diagnosis most consistent with GBS related to flu vaccine (FLUARIX QUADRIVALENT). Therapy with IVIG started on 9/19. On 9/27, patient became unresponsive with PEA arrest and expired.


VAERS ID: 515469 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: New York  
Vaccinated:2013-09-10
Onset:2013-09-11
   Days after vaccination:1
Submitted: 2013-12-03
   Days after onset:83
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J003806 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood glucose fluctuation, Death, Headache, Oropharyngeal pain, Paraesthesia, Paralysis
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
   Days after onset: 59
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Her physician will have that info.
Current Illness: No
Preexisting Conditions: Diabetes, heart disease, high blood pressure, 2 aortic aneurysms.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, sore throat, tingling of feet and hands, blood sugar unusually fluctuated. Patient had paralysis earlier in the day on day of death.


VAERS ID: 500147 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-08-06
Submitted: 2013-08-21
   Days after onset:15
Entered: 2013-08-22
   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: Autopsy, Death, Dengue fever, Dyspnoea, Headache, Influenza, Lung infiltration, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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? Yes
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: 201308659

Write-up: Initial report was received on 12 August 2013 from lay media via the local affiliate. "This is a spontaneous report of serious adverse events. We collected through lay media, the information about some children of the city that presented suspect of influenza A/H1N1, however, according to the City Hall data, 100% of the children were vaccinated against influenza. On 06/Aug/2013, a boy of eight years old went to the hospital with fever, headache, and body pain. After examination, physicians suspected of dengue, the patient was medicated and sent home. At noon, the child began to present difficulty breathing, and at 16 o''clock, when he returned to the hospital, he had critical situation. According to to the physician, the whole lung was infiltrated and they suspected of influenza A/H1N1. The patient did not resist and died. The result of the autopsy conducted on the body of the patient should be released in 15 days. No additional information was provided." This case is linked to cases 2013-08658 and 2013-08660. Documents held by sender: none.


VAERS ID: 503710 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2013-07-11
Onset:2013-07-21
   Days after vaccination:10
Submitted: 2013-09-23
   Days after onset:64
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK LL / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PER: PERTUSSIS (NO BRAND NAME) / EMERGENT BIOSOLUTIONS - / UNK RL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0505AE / UNK MO / PO
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / -

Administered by: Public       Purchased by: Public
Symptoms: Acute disseminated encephalomyelitis, Brain stem syndrome, Cerebral atrophy, Convulsion, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-08
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 36 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE AT THE MOMENT, AFTER VACCINATIONS NAPRONEX AND PARACETAMOL ONLY.
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: BRAIN STEM DYSFUNCTION - 36 HRS; CORTICAL-SUBCORTICAL ATROPHY - 14 DAYS; Acute disseminated encephalitis- 36 DAYS
CDC Split Type:

Write-up: FEVER, LETHARGIC, CONVULSIONS. TREATMENT: FEBRAX (NAPROXEN AND PARACETAMOL).


VAERS ID: 497558 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-06-16
Submitted: 2013-07-18
   Days after onset:32
Entered: 2013-07-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Coma, Death, Influenza
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: DIOVAN; EXELON Patch
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013AR075728

Write-up: Case number PHHY2013AR075728, is an initial report received from a consumer (daughter of the patient) via patient oriented program on 15 Jul 2013. This report refers to an elderly male patient. The patient received DIOVAN tablets for pressure from 2 years ago (approximately) at a dose of 1 DF (80mg) daily, orally. Also, the patient received EXELON patch for Alzheimer principle from 1 year ago at a dose of 1 DF (4.6mg) daily, transdermal route. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number unknown) on unspecified date and had a very strong flu. On 16 Jun 2013 (five days after vaccination), patient experienced massive stroke; went into coma and was hospitalized. The patient died due to massive stroke and coma. It was unknown whether autopsy was done or not. Seriousness and outcome for strong flu were not reported. Causality for events was not reported.


VAERS ID: 495927 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-06-09
Submitted: 2013-07-01
   Days after onset:22
Entered: 2013-07-05
   Days after submission:4
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, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unspecified respiratory and heart problems.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 201307404

Write-up: Initial report received from the local affiliate on 25 June 2013. The information was collected in lay media by a Sanofi Pasteur spokesperson who sent it to the local affiliate on the same day. This case is not medically confirmed. A 77-year-old male patient (date of birth unknown) had received a dose of Influenza vaccine (manufacturer unknown) on an unspecified date and died on 09 June 2013 due to H1N1. The patient did not present with fever as a symptom, and was hospitalized for 10 days. Corrective treatments and complementary investigations were unknown. The patient had medical history of unspecified respiratory and heart problems. Family history was unknown. No additional information was provided. Additional information has been requested by the local affiliate. Documents held by sender: None.


VAERS ID: 498864 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-30
Onset:2013-04-30
   Days after vaccination:0
Submitted: 2013-08-07
   Days after onset:99
Entered: 2013-08-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090636201 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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:
Preexisting Conditions: Known allergy; Other medical conditions; Acute myocardial infarction, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013037172

Write-up: This health authority report (initial receipt 24-Jul-2013) concerns a 62 year old female patient with known allergy and other medical conditions. The patient had predisposing condition acute myocardial infarction unspecified. On 30-Apr-2013, the patient received influenza virus vaccine (batch 0906-36201) via intramuscular route at a dose of 0.5 ml. On 30-Apr-2013, within 12 hours post vaccination, the patient developed myocardial infarction which was severe. There was no improvement on dechallenge and no rechallenge was performed. The event outcome was fatal - unrelated to drug. Reporter''s comments: The reporter considered events serious as the patient died and unlikely in relation to the suspect drug. Cause(s) of death: Unknown cause of death.


VAERS ID: 489874 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2012-04-01
Onset:2013-04-02
   Days after vaccination:366
Submitted: 2013-04-23
   Days after onset:21
Entered: 2013-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Public       Purchased by: Private
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound scan
SMQs:, 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: 2013-04-02
   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: N/A
Current Illness: NO
Preexisting Conditions: PREGNANCY
Allergies:
Diagnostic Lab Data: ULTRASOUND, DELIVERY
CDC Split Type:

Write-up: FETAL DEATH.


VAERS ID: 489391 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2012-12-01
Onset:2013-03-20
   Days after vaccination:109
Submitted: 2013-04-15
   Days after onset:26
Entered: 2013-04-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cardiac arrest, Chest pain, Death, Dyspnoea, Influenza, Life support, Myocarditis, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-05
   Days after onset: 16
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: 201304714

Write-up: Initial report was received on 08 April 2013 from an electronic lay press article. A 10-year-old female patient had received an injection of INFLUENZA VACCINE (trade name, manufacturer, lot number, route, site and exact date of administration not reported) in December 2012. The patient was diagnosed with strain B flu on 20 March 2013. Three days after the patient was diagnosed with the flu, she was rushed to the hospital after complaining of stomach and chest pains and difficulty breathing. She went into cardiac arrest the following morning, and doctors revived her after performing CPR for about two hours. She was placed on a life support system to restore oxygen to her blood. Doctors also put her on a machine to do the work of her heart while waiting for a transplant. The infection morphed into a serious case of myocarditis. The patient died from flu complications at 10:45 AM on 05 April 2013. Outcome was fatal. Documents held by sender: none.


VAERS ID: 493598 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: New Hampshire  
Vaccinated:2013-02-13
Onset:2013-02-26
   Days after vaccination:13
Submitted: 2013-06-06
   Days after onset:99
Entered: 2013-06-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B370BA / 2 UN / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4482BA / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH689AA / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H0011457 / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0606139

Write-up: ? SIDS (final death cert not avail.).


VAERS ID: 486038 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-26
Onset:2013-02-04
   Days after vaccination:101
Submitted: 2013-03-01
   Days after onset:25
Entered: 2013-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA692DA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza A virus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-02-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: H1N1 Influenza PCR positive, 09Feb2013, positive
CDC Split Type: D0078940A

Write-up: This case was reported by a health professional, via local health authority, via a foreign regulatory authority (# DE-PEI-PEI2013009993) and described the occurrence of influenza A (H1N1) infection in a 75-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included multiple myeloma type IgA. On 26 October 2012 the subject received an unspecified dose of INFLUSPLIT SSW (unknown route and application site). On 4 February 2013, 101 days after vaccination with INFLUSPLIT SSW, the subject experienced influenza A (H1N1) infection. The subject was hospitalised for 6 days since 04 February 2013. The regulatory authority reported that the events were life threatening. Influenza A (H1N1) infection was confirmed by PCR. The subject died on 9 February 2013 from influenza a (h1n1) infection. It was unknown whether an autopsy was performed. Foreign regulatory authority has requested further information.


VAERS ID: 483818 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Texas  
Vaccinated:2013-02-01
Onset:2013-02-02
   Days after vaccination:1
Submitted: 2013-02-04
   Days after onset:2
Entered: 2013-02-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH712AA / 1 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VISTARIL; Temazepam; SEROQUEL; RISPERDAL
Current Illness: None
Preexisting Conditions: Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reported by family that he was found dead on 2/2/13.


VAERS ID: 485004 (history)  
Form: Version 1.0  
Age: 1.86  
Sex: Female  
Location: Utah  
Vaccinated:2013-01-21
Onset:2013-01-28
   Days after vaccination:7
Submitted: 2013-02-20
   Days after onset:23
Entered: 2013-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4547CA / 1 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0532AE / 2 LL / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Influenza A virus test positive, Laboratory test, Respiratory arrest, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PMD''s office reported that child had been recommended to take a multivitamin, unknown if child was taking.
Current Illness: None reported by PMD''s office
Preexisting Conditions: None reported by PMD''s office
Allergies:
Diagnostic Lab Data: Child had been seen at Emergency Room on 01/27/2013 and had positive rapid influenza A testing. No influenza testing through second Medical Center but did have series of testing to determine cardiac related event. Autopsy was declined by family.
CDC Split Type:

Write-up: Per hospital and family reports, child was talking to grandfather when she collapsed and stopped breathing. Grandfather performed CPR until EMS arrived and child was transported via AirMed to Medical Center. Child expired on 01/30/2013.


VAERS ID: 529028 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Florida  
Vaccinated:2013-01-23
Onset:2013-01-24
   Days after vaccination:1
Submitted: 2014-04-16
   Days after onset:446
Entered: 2014-04-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1203901 / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abasia, Cystitis, Death, Dysstasia, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-02
   Days after onset: 343
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin; Colcory; UTORIC; Carvedilol; Bumetanide; Neutontin; Elopidogrel; Losartan; Tramadol
Current Illness: Diabetes; Congestive heart failure
Preexisting Conditions: Diabetes; Congestive heart failure
Allergies:
Diagnostic Lab Data: Was in hospital 7 times the next 12 mo.
CDC Split Type:

Write-up: Took Flu shot in January 2013 - the next day could not walk. Went to hospital was told had bladder infection - Live about 13 months. Could never walk again. Had flu shot in January 2013 - could not walk or stand the next day - was in a wheelchair until her death 1-2-14.


VAERS ID: 483215 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2013-01-16
Onset:2013-01-17
   Days after vaccination:1
Submitted: 2013-02-01
   Days after onset:15
Entered: 2013-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AL2156 / 4 NS / IN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-17
   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:
Current Illness: No
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient deceased.


VAERS ID: 701354 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-01-10
Submitted: 2017-06-29
   Days after onset:1630
Entered: 2017-06-30
   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, Guillain-Barre syndrome
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700017

Write-up: This serious initial spontaneous case, received on 04-APR-2017 was reported by a physician via regulatory (RNF: IT-MINISAL02-189667) concerns a male patient on unspecified age. On an unspecified date, the patient was administered with Influenza vaccine: dose, route of administration and batch number: not reported) for an unknown indication. On 10-Jan-2013, the patient experienced Guillain-Barre syndrome as a result the patient was died on an unspecified date. It was unknown whether autopsy was done. Action taken with Influenza vaccine was not reported. The reporter assessed the causality between Influenza vaccine and Guillain-Barre syndrome as related. Health Authority considered the case as serious (Death). Case correction received on 21-Apr-2017: labelling of the event was done for all the remaining RSI.


VAERS ID: 480899 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Florida  
Vaccinated:2013-01-07
Onset:2013-01-07
   Days after vaccination:0
Submitted: 2013-01-10
   Days after onset:3
Entered: 2013-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4542AA / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Diarrhoea, Viral infection, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-07
   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: Latanoprost eye drops, tamsulosin, possibly other, patient uses other pharmacies also
Current Illness: None reported at time of vaccination
Preexisting Conditions: High blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Neighbor reported that the patient died 1-7-13. Inital cause has been diagnosed as vomiting and diarrhea probably caused by a virus. Due to its close approximation to vaccination I am reporting this incident.


VAERS ID: 563794 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Georgia  
Vaccinated:2012-12-31
Onset:2013-01-01
   Days after vaccination:1
Submitted: 2015-01-29
   Days after onset:758
Entered: 2015-02-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Asthma, Cryptococcosis, Death, Dysphonia, Encephalopathy, Euthyroid sick syndrome, Headache, Hydrocephalus, Hyperkalaemia, Mechanical ventilation, Meningitis, Palpitations, Pleural effusion, Proteinuria, Pyrexia, Renal failure, Sepsis, Shock, Swelling, Toxoplasmosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-30
   Days after onset: 29
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 54 days
   Extended hospital stay? Yes
Previous Vaccinations: Sepsis shock~Influenza (Seasonal) (no brand name)~UN~32.00~Patient
Other Medications: Lansoprazole; ondansetron; pyrimethamine; atovaquone; abacavir; azithromycin; heparin; clindamycin; zidovudine; clonidine; amlodipine; raltegravir; haloperidol; hydrocortisone; leucovorin calcium; omeprazole; morphine; vancomycin; FORTAZ; l
Current Illness: Nov. 20, 2011 was smother with plastic diagnose; toxoplasmosis; HIV pt.
Preexisting Conditions: Nov. 02, 2012 ER, admitted to ICU sepsis shock; pneumonic
Allergies:
Diagnostic Lab Data: Hydrocephalus; encephalopathy; sick euthyroid syndrome; renal failure; mild hyperkalemia; HFV; CNS toxoplasmosis; lung pleural effusion, cryptococcal; asthma; meningitis; proteinuria; shock
CDC Split Type:

Write-up: Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.


VAERS ID: 480310 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: New York  
Vaccinated:2012-12-19
Onset:2012-12-23
   Days after vaccination:4
Submitted: 2013-01-06
   Days after onset:14
Entered: 2013-01-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Bacterial test, Death, Malaise, Pericardial haemorrhage, Viral test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-23
   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: SPIRIVA; Gabapentin; Simvastatin; Diclofenac
Current Illness: None
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Viral and bacterial cultures of pericardial blood pending
CDC Split Type:

Write-up: According to son who was interrogated, decedent received flu vaccine 12/19 at hospital and was not feeling well after that; found dead at home 12/23, hemorrhagic pericarditis.


VAERS ID: 513554 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2012-08-31
Onset:2012-12-20
   Days after vaccination:111
Submitted: 2013-11-15
   Days after onset:330
Entered: 2013-11-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. AJ2024 / 5 NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010649 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiopulmonary bypass, Death, Dyspnoea, Influenza, Oropharyngeal pain, Pulmonary oedema, Pyrexia, Transfusion, Wheezing
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-01-08
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: 2013SA114788

Write-up: Initial report was received on 07 November 2013 from a nonhealth care provider from an unverified internet source. A 14 year-old female patient (date of birth not reported) had received on an unspecified date in August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and five months later on 08 January 2013 "died from complications of infection with Influenza Type A". The patient was evaluated at and urgent care with a bad sore throat, treated with Prednisone and was sent home. The sore throat evolved into a serious fever that included shortness of breath and wheezing. The patient''s lungs filled with fluid and was hospitalized. The patient had a heart and lung bypass with an "ACMO" machine and blood transfusions. Diagnostic and laboratory testing were not reported. The patient''s outcome was fatal. Documents held by sender: none.


VAERS ID: 479777 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2012-12-14
Onset:2012-12-16
   Days after vaccination:2
Submitted: 2012-12-30
   Days after onset:14
Entered: 2012-12-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH734AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Eyelid function disorder, Vaccination complication, Viral infection
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-02
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACIPHEX
Current Illness: None indicated on VAR
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Beginning 12/16/12, 2 days post flu vaccine, pt complained of dizziness which became progressively more severe. It''s more of the eyelids flipping upwards/jumping movement. Per wife, hospital ruled out stroke, aneurysm and are leaning toward viral infection or flu vaccine adverse event as cause. It has not been determined.


VAERS ID: 482446 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-01
Onset:2012-12-01
   Days after vaccination:91
Submitted: 2013-01-24
   Days after onset:54
Entered: 2013-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myelitis, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0078533A

Write-up: This case was reported by a consumer and described the occurrence of complete paralysis in an adult female subject of unspecified age who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). The reporting consumer was the husband of the subject. A physician or other health care professional has not verifired this report. On an unspecified date in September 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, unknown). Approximately three months post vaccination with INFLUSPLIT SSW, on an unspecified date in December 2012, the subject experienced complete paralysis and myelitis. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. The subject died on 00 January 2013 from cause of death. An autopsy was not performed. Follow-up information has been requested.


VAERS ID: 476400 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Florida  
Vaccinated:2012-11-21
Onset:2012-11-21
   Days after vaccination:0
Submitted: 2012-12-04
   Days after onset:13
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4537AA / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Confusional state, Death, Influenza like illness, Malaise, Nausea, Pain, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-22
   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: QUINAPRIL 10 mg tablets, 1 oral dose daily; Simvastatin 10 mg tablets, 1 oral dose daily
Current Illness:
Preexisting Conditions: The patient was a male who smoked, had hyperlipidemia, and hypertension. No known allergies to food or other medications were noted in his medical history.
Allergies:
Diagnostic Lab Data: No autopsy was performed as it appeared at the time to be a natural cause of death due to the patients advanced age.
CDC Split Type:

Write-up: Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been given a flu shot early that day. Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been giving a flu shot early that day. At approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient stating that he was going to the bathroom because he did not feel well. The next morning the patient did not respond to phone calls or knocking on the door by relatives. Upon gaining entry to the home, the patient was found dead on the floor between his bedroom and bathroom hallway. The patient was naked and face down on the floor when found. The patient had no history of heart problems and had never experienced a heart attack.


VAERS ID: 478216 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Male  
Location: Virginia  
Vaccinated:2012-11-19
Onset:2012-11-21
   Days after vaccination:2
Submitted: 2012-12-16
   Days after onset:25
Entered: 2012-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0793510 / 1 LA / ID

Administered by: Unknown       Purchased by: Other
Symptoms: Chest X-ray, Cough, Dizziness, Headache, Increased bronchial secretion, Laboratory test, Pleural effusion, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Aenolol, prednisone Merck Sharpe, & D
Current Illness: No
Preexisting Conditions: High blood pressure
Allergies:
Diagnostic Lab Data: Chest x-rays, emergency room lab tests, extended hospital stage still going on.
CDC Split Type:

Write-up: Fluid in lungs, persistent rattling cough, excess mucous, headache, fever, dizziness, ....


VAERS ID: 475412 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-15
Onset:2012-11-16
   Days after vaccination:1
Submitted: 2012-11-28
   Days after onset:12
Entered: 2012-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER J8336 / UNK UN / ID
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. G009997 / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Productive cough, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-20
   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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211ITA010964

Write-up: Case received from Health Authority (case n. 182595) through agency (local case n. IT614/12). Initial report received on 21-NOV-12. Case medically confirmed. An 87 year old male patient was vaccinated on 15-NOV-12 with one dose of INTANZA (batch n. J8336-1) i.d. and concomitantly with one dose of PNEUMOVAX (batch n. G009997) s.c.. On 16-NOV-12 he presented with febrile increase treated with TACHIPIRINA. On 17-NOV-12 and 18-NOV-12, the patient was afebrile. On 19-NOV-12 in the afternoon, there was a febrile increase with productive cough. He was treated with TACHIPIRINA and ceftriaxone i.m. On 20-NOV-12 at 6:15 am the patient died. The case is closed.


VAERS ID: 498707 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-13
Onset:2012-11-13
   Days after vaccination:0
Submitted: 2013-08-07
   Days after onset:266
Entered: 2013-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA750AB / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest discomfort, Cough, Death, Malaise, Pulmonary function test abnormal, Pyrexia, Rales
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Cardiac arrest, Chronic atrial fibrillation, Chronic obstructive pulmonary disease, Coronary artery disease, Heart failure, Low blood pressure, Surgery, Type II Diabetes
Allergies:
Diagnostic Lab Data: Body temperature, Nov2012, 39.4Deg. C; C-reactive protein, Nov2012, 67; Chest X-ray, Nov2012, no distinct pneu; Pulmonary function test, Nov2012, Rales on the left
CDC Split Type: B0913744A

Write-up: This case was reported by a nurse via a regulatory authority (# FI-FIMEA-20130911) and described the occurrence of death (cause undetermined) in a 80-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included cardiac arrest, chronic atrial fibrillation, chronic obstructive pulmonary disease, coronary artery disease, heart failure, low blood pressure, surgery and type II diabetes. On 13 November 2012, the subject received unspecified dose of FLUARIX (intramuscular, right upper deltoid). On 13 November 2012 (evening), within hours of vaccination with FLUARIX, the subject experienced chest discomfort, malaise and cough. Ague-type fever up to 39.4 Deg. C occurred in the night. The subject was hospitalised. Rales were heard on the left in the lungs on auscultation. No distinct pneumonia was seen in the lung x-ray. The subject was treated with ZINACEF. In the evening of 14 November 2012 the subject was found dead in his bed. It was unknown whether an autopsy was performed but requisition for medicolegal autopsy has been done.


VAERS ID: 476286 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-03
Onset:2012-11-11
   Days after vaccination:39
Submitted: 2012-12-04
   Days after onset:23
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-11
   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: No other medications
Current Illness: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012TW110879

Write-up: Case number PHHY2012TW110879, is an initial spontaneous report received from the consumer via press on 19 Nov 2012: This report refers to a 78-year old male patient. The patient had history of diabetes mellitus. The patient had vaccination (brand name and manufacturer unknown) two years ago and had no adverse event afterward. On 03 Oct 2012, he was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown). On the same day, the patient experienced leg weakness. In the end of Oct 2012, the patient''s health condition deteriorated and was hospitalized. The patient died on 11 Nov 2012. The cause of death was not reported. The case is now under investigation of CDC (Centers of Disease Control). The causality of the events was not reported.


VAERS ID: 478907 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-11-09
Submitted: 2012-12-20
   Days after onset:41
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Hypoxia, Premature baby, Stillbirth, Trisomy 21
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB006492

Write-up: Case number PHFR2012GB006492, is an initial spontaneous report received from a consumer (patient''s father) via health authority (GB-MHRA-ADR 21929657-003) on 17 Dec 2012. This report refers to a stillbirth neonate. The baby''s mother had 4 prior pregnancies resulted in live births with no history of miscarriage or stillbirths in the family. Her pregnancy was normal all the way through, blood pressure and pulse was normal. The baby''s mother was vaccinated with Influenza vaccine (unknown manufacturer and batch number) parenteral and REPEVAX (batch number: unknown) on 01 Nov 2012. The mother had midwife appointment 3 days before vaccination, when the examinations done revealed normal baby movements and strong heartbeat. The mother''s blood pressure and pulse were also normal. The mother was advised by the mid-wife to receive whooping cough vaccination to protect unborn child and was advised that it was safe. Two days later, the mother received vaccination. After vaccination, things started to slow down and 5 days after the vaccinations baby''s movements stopped and the mother lost slight blood (See case: PHFR2012GB006478). On 06 Nov 2012, mother also noticed a decrease in baby''s movements. Over the next days, the baby''s movements had completely stopped but the mother was able to get a midwife appointment only three days later. At the midwife appointment, it was found that the baby had died. On 09 Nov 2012, the mother delivered a still born baby; he measured 47 cm and weighed 3.1 kg for the age 36.5 weeks. The reporter was in strong belief that the whooping cough vaccination caused the death of the child. The baby''s father had contacted the manufacturers of the vaccine to confirm that no clinical tests were carried out on pregnant women and was of opinion that he would not have allowed the vaccination if he had read the leaflet. He added that this was his wife''s fifth pregnancy, all 4 prior resulted in live births, there was no history of miscarriages or stillbirths in the family, and the only thing that has changed with all 5 pregnancies is the whooping cough vaccination. Post-mortem was not done, but the parents agreed for blood tests, testing on cord, placenta and also tissue. The test results revealed Down syndrome, but the parents believed very slightly as there were no visible signs, and added this as put "out of the blue since there was nothing in their blood that could cause a risk to this and that the placenta was in perfect condition and working order". The cause of death was reported as hypoxia. The parents were of belief that Down syndrome was not the cause of death.


VAERS ID: 474460 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2012-11-08
   Days after vaccination:1
Submitted: 2012-11-16
   Days after onset:8
Entered: 2012-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA753AA / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Death
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tamsulosin HCl; Amlodipine
Current Illness: Benign prostate hypertrophy; Bladder carcinoma; Hypertension
Preexisting Conditions: Surgery
Allergies:
Diagnostic Lab Data: Body temperature, 07Nov2012, 38deg.C
CDC Split Type: B0845289A

Write-up: This case was reported by a regulatory authority (# 181257) and described the occurrence of death due to unknown causes in a 79-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included surgery in 2012 for bladder cancer. Concurrent medical conditions included benign prostate hypertrophy (since 10 years), bladder carcinoma with internal stomy not treated with chemotherapy and hypertension (since 15 years). Concurrent medications included OMNIC and Amlodipine. On 7 November 2012, at 7.30 pm, the subject received an unspecified dose of FLUARIX (route unknown, left deltoid). At 8.30 pm, his body temperature was 38 deg.C. On 8 November 2012, 9 hours after vaccination with FLUARIX, the subject died due to unknown causes. The regulatory authority reported that the event was possibly related to vaccination with FLUARIX. The subject died on 8 November 2012 at 4.30 am, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 473512 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-31
Onset:2012-10-31
   Days after vaccination:0
Submitted: 2012-11-06
   Days after onset:6
Entered: 2012-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Breath sounds abnormal, Death, Feeling cold, Snoring
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cardiovascular disorder NOS treated with drugs NOS; Pulmonary oedema twice 2 years prior to this report
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012273372

Write-up: This is a spontaneous report from a contactable pharmacist. The pharmacist reported that his 86-years-old uncle received a dose of PREVENAR 13 at 0.5 ml single dose intramuscularly and a dose of VAXIGRIP at 0.5 ml single dose intramuscularly, both on 31Oct2012 (noon). Medical history included ongoing cardiovascular disorder treated with not specified drugs and two episodes of pulmonary oedema two years prior to this report. In the evening of 31Oct2012 the patient started feeling cold and when he slept he started snoring. Then, he developed abnormal breath sounds and he expired on 31Oct2012. The cause of death was unknown as no autopsy was performed.


VAERS ID: 481816 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-29
Onset:2012-10-30
   Days after vaccination:1
Submitted: 2013-01-17
   Days after onset:79
Entered: 2013-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA713BB / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-08
   Days after onset: 9
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: Atrial Fibrillation; Hypothyreosis-Hashimoto''s; Ischemic heart disease; Pacemaker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0860109A

Write-up: This case was reported by a physician via a regulatory authority (124709) and described the occurrence of death (cause undetermined) in a 92-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, hypothyreosis-Hashimoto''s, ischemic heart disease and pacemaker. On 29 October 2012 the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). On 30 October 2012, 1 day after vaccination with FLUARIX, the subject was feeling unwell. The subject was hospitalised overnight under observation. She was discharged the following day. The discharge summary stated that the malaise was likely to be related to the vaccine and had no cardiac origin. According to her relatives, the subject was feeling unwell since the vaccination. In the evening of 7 November 2012, they spoke to her and everything was as usual. The subject was found dead on 8 November 2012 in the morning lying quietly in her bed. The cause of death was unknown. It was unknown whether an autopsy was performed. Since important medical information was missing in the report, the causality was assessed as unclassifiable. No further information can be obtained from regulatory authority. The case has therefore been closed.


VAERS ID: 496745 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-29
Onset:2012-10-30
   Days after vaccination:1
Submitted: 2013-07-11
   Days after onset:254
Entered: 2013-07-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 20122013A15 / UNK LA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F29673 / 1 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatinine increased, Blood lactate dehydrogenase increased, Blood urea increased, Blood uric acid increased, Bronchitis, C-reactive protein increased, Cardiac arrest, Chest X-ray normal, Condition aggravated, Cough, Death, Dehydration, Electrolyte imbalance, Fatigue, General physical health deterioration, Glomerular filtration rate, Inflammatory marker increased, Renal failure, Renal failure acute, Resuscitation, Sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-23
   Days after onset: 24
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: MARCUMAR
Current Illness:
Preexisting Conditions: Coronary artery disease; Myocardial infarction; Apoplectic fit, status post several insults; Hypertension arterial; Aortic aneurysm repair, Status post aortic aneurysm surgery in 1990; Influenza vaccine; PREVENAR; PNEUMOVAX
Allergies:
Diagnostic Lab Data: 05-NOV-2012, Blood lactate dehydrogenase, 326 IU/l; 07-NOV-2012, Blood lactate dehydrogenase, 258 IU/l; 12-NOV-2012, Blood lactate dehydrogenase, 271 IU/l; 29-OCT-2012, Blood urea, 106 mg/dl; 05-NOV-2012, Blood urea, 180 mg/dl; 07-NOV-2012, Blood urea, 179 mg/dl; 12-NOV-2012, Blood urea, 126 mg/dl; 05-NOV-2012, Blood uric acid, 9.9 mg/dl; 07-NOV-2012, Blood uric acid, 9.9 mg/dl; 12-NOV-2012, Blood uric acid, 7.9 mg/dl; C-reactive protein (05Nov2012): 114; C-reactive protein (07Nov2012): 132; C-reactive protein (12Nov2012): 136; Glomerular filtration rate (12Nov2012): 11.73; Creatinine (29Oct2012): 3.7; Creatinine (05Nov2012): 5.33; Creatinine (07Nov2012): 5.22; Creatinine (12Nov2012): 5.03
CDC Split Type: 2013200913

Write-up: This is a spontaneous report received from the foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2013037811. A male 84-year-old patient was vaccinated on 29Oct2012 with the first dose of PREVENAR 13 (lot./batch no.: F29673), at 0.5 ml single dose into the right upper arm and with GRIPPEIMPFSTOFF RATIOPHARM (lot. 2012/2013 A15; batch A15), at 1 DF single into the left upper arm. Concomitant medication included MARCUMAR. Previous seasonal influenza vaccinations (administered yearly) had been well tolerated. Medical history included coronary artery disease, myocardial infarction, apoplectic fit, arterial hypertension, and aortic aneurysm repair in 1990. Previous vaccinations included influenza vaccine, PREVENAR and in 2005 PNEUMOVAX. On 30Oct2012, the patient experienced general physical health deterioration with tiredness. On 05Nov2012, a deterioration of the preexisting renal insufficiency was detected with elevated creatinine and urea values. In addition, inflammatory parameters (C-reactive protein) were increased. On 14Nov2012, the patient was admitted to hospital where he presented with nonproductive cough as well as increasing deterioration of the general condition with significantly elevated inflammatory and retention parameters. A chest X-ray did not reveal a infiltration of the lung. The patient was diagnosed with a bronchitis infection, exsiccosis and acute on chronic renal failure. Sepsis was suspected, but no pathogenic microorganisms were detected. Thus, it has to be assumed that the patient had been suffering from a systemic inflammatory response syndrome (SIRS). The patient was treated with intravenous fluids as well as ampicillin/sulbactam. Unfortunately, the antibiotic therapy had a bad response. On 23Nov2012 experienced Electrolyte Imbalance. Patient was hospitalized from 14Nov2012 to 23Nov2013. On 23Nov2012, the patient decided to discharge himself against medical advice. Before doing this, the patient experienced a cardiac arrest and required cardiorespiratory resuscitation. When the patient experienced a second cardiac arrest, no further CPR was performed, since the patient had decided in advance to refuse resuscitation and intensive care treatment. The patient died on 23Nov2012 at the clinic. According to the reporting physician, no autopsy was performed. Reporter''s comment as provided by Regulatory Authority: Most likely consistent with bronchitis infection accompanied by exsiccosis and consecutive acute on chronic renal failure. Antibiotic treatment did not take effect. Additional information provided by physician: Event''s outcome was reported as fatal. Exitus letalis due to malignant dysrhythmia in the context of septic infection and electrolyte imbalance. No follow-up attempts needed, follow-up automatically provided by agency.


VAERS ID: 474106 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-24
Onset:2012-10-25
   Days after vaccination:1
Submitted: 2012-11-13
   Days after onset:19
Entered: 2012-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA744AA / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Alendronate sodium; Tramadol hydrochloride; Enalapril maleate; Furosemide; Potassium chloride; Metoprolol succinate
Current Illness: Chronic obstructive pulmonary disea; Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0843273A

Write-up: This case was reported by a physician via a regulatory authority (DK-DKMA-EFO3607) and described the occurrence of sudden death in a 61-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included chronic obstructive pulmonary disease and lung transplant. Concurrent medications included Alendronate sodium, DOLOL, CORODIL, FURIX, KALEORID and SELO-ZOK. On 24 October 2012, the subject received an unspecified dose of FLUARIX (subcutaneous, administration site unknown). On 25 October 2012, 1 day after vaccination with FLUARIX, the subject suddenly died. The subject died on 25 October 2012 from sudden death. It was unknown whether an autopsy was performed.


VAERS ID: 471819 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2012-10-23
Onset:2012-10-24
   Days after vaccination:1
Submitted: 2012-10-26
   Days after onset:2
Entered: 2012-10-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH732AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Cardiac failure congestive, Condition aggravated, Nausea
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: CHF; Aortic aneurysm; Advanced age
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized 10/16-10/21 with CHF exacerbation and increased weakness. Assessment by HH 10/23/12 and vaccine given. Patient developed nausea later in the day. Called EMS morning of 10/24 and patient taken to E.R.


VAERS ID: 474221 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-17
Onset:2012-10-17
   Days after vaccination:0
Submitted: 2012-11-14
   Days after onset:28
Entered: 2012-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 22349421A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Death, Lipase normal, Nausea, Pancreatitis acute, Renal failure, Respiratory failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease; Obstructive airways disorder; Hypertensive heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lipase, 27.67 ukat/L
CDC Split Type: 2012033879

Write-up: This medically confirmed report from foreign health authority (initial receipt 05-Nov-2012) concerns a 77-year-old female patient, who had a medical history of coronary heart disease, hypertensive heart disease and obstructive airways disorder. On 17-Oct-2012, the patient received one separate dose of AFLURIA (batch no. 22349421A) intramuscular. In the evening after the vaccination the patient developed nausea and vomiting. On 18-Oct-2012 the patient was hospitalized and diagnosed with acute pancreatitis (no lithiasis, no alcohol addiction, lipase 27.67ukat/L). In the further course she developed kidney failure along with respiratory and cardiac insufficiency. On an unspecific date the patient died. An autopsy was not performed. Reporter''s comment: The physician considered the adverse events as serious and not assessable to AFLURIA vaccination. Cause of death is unknown.


VAERS ID: 491996 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-16
Onset:2012-10-16
   Days after vaccination:0
Submitted: 2013-05-17
   Days after onset:213
Entered: 2013-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA757AA / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dyspnoea exertional, Feeling abnormal, Hyporeflexia, Multi-organ failure, Nausea, Pneumonia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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: 2012-11-24
   Days after onset: 39
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: Blood pressure, 22Nov2012, 101/67; Heart rate, 22Nov2012, 83; Physical examination, 22Nov2012, see text
CDC Split Type: B0892467A

Write-up: This case was reported by a physician via a regulatory authority (ES-AGEMED-337279340) and described the occurrence of sepsis shock in a 82-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 October 2012, the subject received unspecified dose of FLUARIX (unknown route and injection site). On 16 October 2012, less than one day after vaccination with FLUARIX, the subject experienced hyporexia, nausea and dizziness, unstable feeling and dyspnea during exertion. On 22 November 2012, during a physical exploration subject''s blood pressure was 101/67, heart rate: 83, he had no edema, his heart activity was rhythmic, without murmur, only some basal crackling modified by cough were seen, anodyne abdomen, no hepato-jugular reflux and no jugular swelling. On 24 November 2012, 39 days after vaccination with FLUARIX, the subject suddenly presented septic shock with multiorganic failure secondary to pneumonia. The regulatory authority reported that the events were unlikely to be related to vaccination with FLUARIX. On 24 November 2012, the subject died from sepsis. It was unknown whether an autopsy was performed.


VAERS ID: 476377 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: New York  
Vaccinated:2012-10-02
Onset:2012-10-14
   Days after vaccination:12
Submitted: 2012-12-04
   Days after onset:51
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4489AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Anaemia, Blood culture, Blood test, Candidiasis, Chest X-ray, Computerised tomogram, Culture urine, Death, Echocardiogram, Fatigue, Full blood count, Hyperhidrosis, Malaise, Pyrexia, Ultrasound scan, Urine analysis
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 2012-11-30
   Days after onset: 47
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine 5mg, Metoprolol ER 25mg, Isosorbide mononitrate 60mg, Fluoxetine 20mg, Hydrocodone/APAP 7.5/500, Omeprazole 20mg, ASA 81mg, Lidoderm patch 5%, Pravastatin 40mg.
Current Illness: None specifically known.
Preexisting Conditions: None known.
Allergies:
Diagnostic Lab Data: Blood cultures, blood analysis (CBC, etc), urine cultures and analysis, CT scans, chest x-rays, sonogram, echo-cardiogram, and possibly more tests were given.
CDC Split Type:

Write-up: Fevers (102.6 max), sweating, fatigue, malaise, anemia, thrush. Adverse effects lasted until day of death.


VAERS ID: 472279 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2012-10-11
Onset:2012-10-13
   Days after vaccination:2
Submitted: 2012-10-26
   Days after onset:13
Entered: 2012-10-31
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED P58306 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Recent massive heart attack; Narcolepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012033702

Write-up: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 62-year-old male patient, who had a medical history of recent massive heart attack and narcolepsy. He had no known drug allergy. He was taking ''a lot of medications'' (type unspecified). On 11-Oct-2012 the patient received AFLURIA (batch number: P58306) injection at a dose of 0.5 mL intramuscularly. On the day of vaccination, the patient did not complain of any symptoms and went home without any adverse events. On 13-Oct-2012 the patient was found dead. The cause of death was still being investigated. According to the pharmacist (reporter), the patient had many health problems including a recent massive heart attack (date unspecified).


VAERS ID: 476382 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2012-10-09
Onset:2012-10-12
   Days after vaccination:3
Submitted: 2012-12-04
   Days after onset:53
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4525AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Biopsy, Biopsy bone marrow, Blood test, Computerised tomogram, Nuclear magnetic resonance imaging, Sensory loss, X-ray
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-01
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 34 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vasodec, HTZ/lisinopril
Current Illness: None
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: CT, MRI, (multiple) biopsies, blood tests, bone marrow biopsy, multiple x rays
CDC Split Type:

Write-up: Started losing all feeling in arms and legs. Unable to walk unassisted.


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