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From the 4/30/2021 release of VAERS data:

Found 1,936 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: 666730 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2016-09-30
Onset:2016-10-08
   Days after vaccination:8
Submitted: 2016-11-16
   Days after onset:39
Entered: 2016-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 9K7E4 / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abasia, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-11-16
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 39 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEXIUM; FLONASE; Levothyroxine; NEURONTIN; XYZAL; Indomethacin
Current Illness: Low back pain
Preexisting Conditions: IV Dye; Hypothyroidism; Gout; Arthritis; GERD; ED; Hypertriglyceridemia; Hiatal hernia; Allergic rhinitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10-9-16 Pt unable to walk, ascending paralysis. Went to ER was admitted with Guillain-Barre.


VAERS ID: 669339 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-06
Onset:2016-10-06
   Days after vaccination:0
Submitted: 2016-11-29
   Days after onset:54
Entered: 2016-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Blood disorder, exclusively liquid black corpse blood, blood richness of the inner organs; Hypertension; Pulmonary hypertension; Coronary artery disease; Angiosclerosis, high-grade; generalised; Nephroangiosclerosis, beginning; both sides; Emphysema, age-related; Benign prostatic hyperplasia; Cholelithiasis; Inguinal hernia, with displacement of
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK171887

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden arrhythmic death syndrome in a 77-year-old male patient who received Influenza vaccine. Concurrent medical conditions included hypertension, pulmonary hypertension, triple vessel disease, angiosclerosis (high-grade; generalised), nephroangiosclerosis (beginning; both sides), emphysema (age-related), hyperplasia of prostate, cholelithiasis, inguinal hernia (with displacement of) and blood disorder (exclusively liquid black corpse blood, blood richness of the inner organs). On 6th October 2016, the patient received the 1st dose of Influenza vaccine .5 ml. On 6th October 2016, several hours after receiving Influenza vaccine, the patient experienced sudden arrhythmic death syndrome (serious criteria death and GSK medically significant). On 6th October 2016, the outcome of the sudden arrhythmic death syndrome was fatal. The patient died on 6th October 2016. The reported cause of death was sudden arrhythmic death syndrome. An autopsy was performed. It was unknown if the reporter considered the sudden arrhythmic death syndrome to be related to Influenza vaccine. Additional details were reported as follows: The patient received the Influenza vaccine on the left deltoid. It was unknown that the patient had been suffering from hypertension. Concomitant medication was not provided. In the morning, the patient received Influenza vaccine (manufacturer unspecified; trade name and batch number were not known or not reported). On the very same day, after vaccination, during the noon hours, the patient was found lifeless in the stairwell of the multifamily house. An emergency physician was called who could only determine the patient''s death. No cardiopulmonary resuscitation was done. An autopsy was performed. Significant findings were found in the autopsy. It was found that anterior wall of the heart was spotted callus and brightened areas in the posterior wall of the heart. The patient had triple vessel disease, severe generalised angiosclerosis, signs of pulmonary hypertension, suspicion of emphysema of old age, exclusively liquid black corpse blood and blood richness of the inner organs. The beginning nephroangiosclerosis of both sides, nodular hyperplasia of the prostate, cholelithiasis was observed. No signs of recent bone fractures, and recent injection site at the left upper arm without signs of inflammation were noted. No signs of external force by a third party were found. On the basis of the autopsy findings and regarding the patient''s pre-existing cardiac disease it could be assumed that the patient died from sudden arrhythmic death syndrome. Autopsy determined and reported cause of death was sudden arrhythmic death syndrome. The physicians performing autopsy reported that death from sudden arrhythmic death syndrome was temporally related to vaccination but considered that a causal relationship could not be easily established. The regulatory authority requested further information.


VAERS ID: 661060 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-01
Onset:2016-10-01
   Days after vaccination:0
Submitted: 2016-10-21
   Days after onset:20
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER N2A301M / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Influenza, Immunisation, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2016152926

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of blackout in a 51-year-old male patient who received Influenza vaccine unspecified (batch number N2A301M, expiry date unknown). Previously administered products included Influenza Virus with an associated reaction of no adverse event. On 1st October 2016, the patient received Influenza vaccine unspecified (unknown). On 1st October 2016, less than a day after receiving Influenza vaccine unspecified, the patient experienced blackout (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the blackout was fatal. The reported cause of death was loss of consciousness. An autopsy was not performed. It was unknown if the reporter considered the blackout to be related to Influenza vaccine unspecified. Additional information: The batch number reported for Influenza vaccine N2A301M does not matching with any GSK lot number. RA verbatim: Case received from a other health professional on 03-Oct-2016. A 51-year-old male adult patient with underlying health conditions received influenza vaccine (batch number N2A301M) on 01-Oct-2016. The patient experienced Collapsed on 01-Oct-2016. It was reported that he was Ok in surgery but was found collapsed in the car in the car park of the surgery. Practice nurse gave CPR and the ambulance was called. Paramedics took over CPR and the patient was taken to hospital where he died. Post mortem to take place later this week. The patient was admitted to hospital on 01-OCT-2016. Corrective actions/drugs used to treat: CPR (cardiopulmonary resuscitation). The patient had received Flu vaccines (Received for a number of years and no incidents occurred). The patient''s outcome was reported a Fatal. The patient died on unspecified date.


VAERS ID: 660133 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2016-09-28
Onset:2016-09-28
   Days after vaccination:0
Submitted: 2016-10-18
   Days after onset:20
Entered: 2016-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI669AA / 4 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-29
   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: Unknown
Current Illness: None
Preexisting Conditions: HTN, hyperlipidemia, chronic bronchial Asthma, anxiety disorder, depression, rt shoulder rotator cuff 2005, smoker
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Unknown. It was reported to us 2 days later that patient went to the hospital and died 9/29/2016.


VAERS ID: 665843 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: New York  
Vaccinated:2016-09-27
Onset:2016-09-28
   Days after vaccination:1
Submitted: 2016-10-28
   Days after onset:30
Entered: 2016-11-14
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 13449211A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-09
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Many-contact facility (nursing home)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was elderly in nursing home but developed a high fever after shot was administered. She had numerous preexisting conditions prior to shot, but I was told by staff she developed, for sure, a high fever and was sent to local hospital a few days after it was given.


VAERS ID: 772577 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Arizona  
Vaccinated:2016-09-22
Onset:2016-09-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED WT56007 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Coma, Gait inability, Imaging procedure abnormal, Intraventricular haemorrhage, Skull fractured base, Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-09-24
   Days after onset: 2
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Contact hospital - too many to list
Current Illness: Arteriovenous malformations; Colitis with colon ulcers
Preexisting Conditions: Refractory ITP with dangerously low platelet counts.
Allergies: sulfa drugs; dapsone; oxycodone; romiplostim
Diagnostic Lab Data: Rapid response called. Patient taken to ED. Imaging revealed subarachnoid and intraventricular hemorrhage with non-displaced longitudinal fracture of the occipital bone extending into the left temporal bone. No response at all to commands. Coma state. Patient had a DNR.
CDC Split Type:

Write-up: Patient drove himself to the facility for an appt. for a blood draw. His appt. was the next week....so while he was there he decided to get the Influenza vaccine (9:49 a.m. on Sept. 22, 2016). At 10:18 a.m. he had collapsed outside the double doors as he was exiting the hospital and hit the concrete. He was seen sitting and scooting on his walker after receiving the shot which was unusual. When he reached the exit doorway, he stood up, walked out to drive home and collapsed.


VAERS ID: 682141 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Georgia  
Vaccinated:2016-09-13
Onset:2016-09-13
   Days after vaccination:0
Submitted: 2017-01-31
   Days after onset:140
Entered: 2017-02-10
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1618901 / 1 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Abdominal discomfort, Cerebrovascular accident, Coma, Death
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), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-31
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Heart medication
Current Illness: No
Preexisting Conditions: Rheumatoid arthritis and A-fib (heart)
Allergies:
Diagnostic Lab Data: Normal physical, well developed and nourished
CDC Split Type:

Write-up: 9-13-16 Doctor appt. - within hours patient had some stomach discomfort that got worse over the week. She had the stroke on 9/20/16. The stroke in the patient''s brain was inoperable, in coma for a while, 6 weeks and 4 days later death.


VAERS ID: 673626 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-08
Onset:2016-09-08
   Days after vaccination:0
Submitted: 2016-09-13
   Days after onset:5
Entered: 2016-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0000467322 / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-08
   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: No other medications
Current Illness: Living in residential institution
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609JPN005840

Write-up: Information has been received from a physician referring to a 94 years old female patient living in a group home. The patient''s medical history and concomitant medication were not provided. On 08-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX NP (dose, lot number and expiration date were not reported, route: parenteral). At the same date, the patient was died after vaccinated with PNEUMOVAX NP. At the time of the report, the cause od death and information on autopsy were not reported. The reporter''s comments: the reporter did not think it was a side effect of PNEUMOVAX NP and was afraid that death happened within 35 minutes to one hour after the vaccination. This was a patient with a poor condition originally and was scheduled for care in the facility. The reporting physician did not assess the relationship of death to PNEUMOVAX NP. Upon internal review, the event death was considered to be medically significant. Additional information has been requested.


VAERS ID: 655683 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: Michigan  
Vaccinated:2016-08-27
Onset:2016-08-28
   Days after vaccination:1
Submitted: 2016-09-16
   Days after onset:19
Entered: 2016-09-27
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-08
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He got flu shot on 8/27/16. According to family members he was admitted in hospital on 8/28/16 and passed away on 9/8/16.


VAERS ID: 641010 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-16
Onset:2016-06-01
   Days after vaccination:16
Submitted: 2016-06-29
   Days after onset:28
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, CSF glucose, CSF lactate, CSF test abnormal, Culture negative, Death, Endotracheal intubation, Formication, Full blood count normal, Glucose urine present, Guillain-Barre syndrome, Hyporeflexia, Immunoglobulin therapy, Myalgia, Protein urine present, Pyrexia, Red blood cells urine positive, Renal function test normal, Retching
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; GLIBENCLAMIDE; LOSARTAN POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20160612; Test Name: body temperature; Result Unstructured Data: 40 Celsius temperature; Test Date: 20160607; Test Name: complete blood count; Result Unstructured Data: NORMAL; Test Date: 20160608; Test Name: renal function test; Result Unstructured Data: NORMAL
CDC Split Type: BRSA2016SA114813

Write-up: Initial unsolicited report received from a health care professional (nurse) via Institute on 14-JUN-2016. This case involves a 46-year-old male patient who was vaccinated with a single dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, site of administration were not reported), intramuscularly on 16-May-2016. It was unknown if the patient presented any reaction with this vaccine before. The patient had a medical history of hypertension, diabetes and obesity. Concomitant medications included metformin 850 MG 2 tablets/day, glibenclamide 5 MG one tablets/day and losartan potassium 50 MG for all route of administration was oral. On 07-Jun-2016, 22 days following the vaccination, the patient experienced formication, myalgia, loss of muscular strength in the left upper member, gagging and underactive in some reflex (It was reported that these symptoms started on the next month of vaccination). On 08-Jun-2016, 23 days after vaccination, the patient also experienced worsening of the clinical condition. On 12-Jun-2016, 27 days after vaccination, the patient experienced episodes of high fever with maximum of 40 degree Celsius (the pick of 40). On an unspecified date in Jun-2016, the patient developed Guillain-Barre syndrome (hypothesis of a diagnosis of Guillain-Barre syndrome). It was reported that on 12-Jun-2016, the patient was intubated. On 07-Jun-2016, patient was admitted on the emergency room and hospitalized. The duration of hospitalization was reported as 07-Jun-2016 to13-Jun-2016. Lab data included 07-Jun-2016, CSF collection (Results: glucose and lactate levels altered), Complete CBC Result: Normal and on 08-Jun-2016, besides unspecific exams of monitoring, a renal function test was performed with normal results. On 13-Jun-2016, some unspecific cell cultures with normal results and turbid urine with high levels of proteins, glucose and erythrocytes. The patient received corrective treatment with Immunoglobulin human intravenous for "worsening of the clinical condition". The patient died (passed away) on 13-Jun-2016. Cause of death: Possible related to Guillain-Barre syndrome post-immunization (No conclusion). It was unknown if the autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: In this case, the reported symptoms and the investigation results (especially CSF) are consistent with the diagnosis of Guillain-Barre syndrome. Guillain-Barre Syndrome is listed with both INFLUENZA SPLIT TRITON THIOMERSAL LOWER CONTENT VACCINE and INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but not severe to that extent which resulted in death. Complementary investigation results including etiological infectious work-up as GBS is often preceded by an infection, the most frequent being Campylobacter jejuni, patient''s medical history and autopsy results confirming the cause of death, etc. are needed to further assess this case. Based on the available information, no conclusion on a role of the vaccine can be drawn. Reported Cause(s) of Death: Guillain-Barre syndrome.


VAERS ID: 638393 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-19
Onset:2016-05-19
   Days after vaccination:30
Submitted: 2016-06-07
   Days after onset:19
Entered: 2016-06-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, H1N1 influenza, Nasopharyngitis, Pathology test, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2016, Pathology test, results were provided
CDC Split Type: BR2016GSK080258

Write-up: This case was reported by a physician via sales rep and described the occurrence of H1N1 influenza in a adult male patient who received FLUARIX TETRA. On 19th April 2016, the patient received FLUARIX TETRA. In May 2016, 30 days after receiving FLUARIX TETRA, the patient experienced weight loss. On 19th May 2016, the patient experienced H1N1 influenza (serious criteria death) and cold (serious criteria hospitalization). On an unknown date, the outcome of the H1N1 influenza was fatal and the outcome of the cold and weight loss were not reported. The patient died on 1st June 2016. The reported cause of death was H1N1 influenza. It was unknown if the reporter considered the H1N1 influenza, cold and weight loss to be related to FLUARIX TETRA. Additional details were provided as follows: On 19th May 2016, the patient developed cold and was hospitalized for 3 days. On 22nd May 2016, the patient had hospital discharge. The patient was well but did not specify very much. Approximately 1 month after the vaccination, the patient suffered from weight loss of 20 kilograms. On 1st June 2016, the patient died but the reporter did not know the exact cause of the death. The patient underwent pathology test but further details were not specified. No further information was provided.


VAERS ID: 636174 (history)  
Form: Version 1.0  
Age: 1.18  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-06
Onset:2016-05-07
   Days after vaccination:31
Submitted: 2016-05-18
   Days after onset:11
Entered: 2016-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA127AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Drug administered to patient of inappropriate age, Off label use
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-07
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2016GSK068650

Write-up: This case was reported by a nurse via sales rep and described the occurrence of unknown cause of death in a 14-month-old male patient who received FLUARIX TETRA (batch number AFLBA127AA, expiry date unknown). On 6th April 2016, the patient received FLUARIX TETRA. On 6th April 2016, an unknown time after receiving FLUARIX TETRA, the patient experienced off label use and inappropriate age at vaccine administration. On 7th May 2016, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and outcome of the off label use and inappropriate age at vaccine administration were unknown. The patient died on 7th May 2016. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death, off label use and inappropriate age at vaccine administration to be related to FLUARIX TETRA. Additional information was provided as follows: The patient received FLUARIX TETRA at the age of 14 months which led to inappropriate age at vaccination and off label use. The autopsy was performed but results were not provided. This case is 1 of the 5 case reported by same reporter.


VAERS ID: 823798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-04-02
Submitted: 0000-00-00
Entered: 2019-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Influenza A virus test positive, Polymerase chain reaction, Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20160404; Test Name: Influenza A virus subtype H1N1 test positive; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Date: 20160404; Test Name: Human respiratory syncytial virus test positive; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Date: 20160404; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2019GS

Write-up: Respiratory distress; Fever; Cough; Vaccination failure; Influenza A(H1N1)pdm09 infection; human respiratory syncytial virus infection; Severe acute respiratory infection; This case was reported in a literature article and described the occurrence of vaccination failure in a 14-month-old female subject who received Influenza vaccine for prophylaxis. On 2nd April 2016, 266 days after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included h1n1 influenza on 2nd April 2016 with serious criteria of death and hospitalization, respiratory syncytial virus infection on 2nd April 2016 with serious criteria of death and hospitalization, severe - grade 3 acute respiratory tract infection on 2nd April 2016 with serious criteria of hospitalization and GSK medically significant, fever on 2nd April 2016 with serious criteria of hospitalization, cough on 2nd April 2016 with serious criteria of hospitalization and respiratory distress with serious criteria of hospitalization and GSK medically significant. The subject was treated with antibiotics nos and oseltamivir. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included h1n1 influenza (fatal), respiratory syncytial virus infection (fatal), acute respiratory tract infection (unknown), respiratory distress (unknown), fever (unknown) and cough (unknown). The reported cause of death was h1n1 influenza and respiratory syncytial virus infection. The investigator considered that there was a reasonable possibility that the vaccination failure, h1n1 influenza, respiratory syncytial virus infection, acute respiratory tract infection, fever, cough and respiratory distress may have been caused by Influenza vaccine. Relevant Tests: 2 days after onset of symptoms, the patient''s nasopharyngeal swab sample was collected for the detection of etiological agent. Real time-polymerase chain reactions (RT-PCRs) were conducted using Centers for Disease Control and Prevention (CDC) protocols for influenza A and B and human respiratory syncytial virus (hRSV) detection. The patient was found positive for influenza A(H1N1)pdm09 and hRSV pathogens. [In this study, the genetic sequencing steps were performed for influenza and hRSV positive samples with a cycle threshold (CT) lower than 32 in the real time RT-PCR protocols]. Diagnostic results (unless otherwise stated, normal values were not provided): On 4th April 2016, Influenza A virus test positive result was positive unknown, Pneumovirus test positive result was positive unknown and Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the vaccination failure in a patient of 1.2-year-old female, who was vaccinated with an unspecified trivalent influenza vaccine (TIV) (manufacturer unknown) for prophylaxis. The patient was a part of birth cohort study, which presented the clinical-epidemiological and molecular characteristics of the first documented influenza outbreak in indigenous peoples that occurred from 30th March to 14th April 2016. Acute respiratory infections were prospectively investigated [In this study, a trained health team visited the households weekly to allow early identification of ARI cases. In the last epidemiological week (EW) of March 2016 (EW 13/2016), a rapid increase in the number and severity of ARI cases was observed beyond the target birth cohort study population. The fieldworkers were supported by the technical section of the Agency, the municipal epidemiological surveillance service and by the research group in order to actively search for cases in all households, collect information on disease and laboratory samples, and help to control the outbreak.]. No information on patient''s medical history and family history or concurrent condition or concomitant medication were provided. On an unspecified date in 2015, the patient received unspecified TIV vaccine (administration route and site unspecified; dosages unknown, batch number not provided). The age at vaccination was not reported. On 2 April 2016, 266 days after vaccination, the patient developed severe acute respiratory infection (SARI). [In this study, SARI defined as the patient experienced Influenza-like illness (ILI) case plus respiratory distress with or without hospitalization. ILI cases were defined as fever measured or reported plus cough and/or sore throat, with onset within the last 7 days during an outbreak]. Subsequently, the patient was hospitalized. On 4th April 2016, 2 days after onset of symptoms, the patient''s nasopharyngeal swab sample was collected for the detection of etiological agent. Real time-polymerase chain reactions (RT-PCRs) were conducted using Centers for Disease Control and Prevention (CDC) protocols for influenza A and B and human respiratory syncytial virus (hRSV) detection. The patient was found positive for influenza A(H1N1)pdm09 and hRSV pathogens. [In this study, the genetic sequencing steps were performed for influenza and hRSV positive samples with a cycle threshold (CT) lower than 32 in the real time RT-PCR protocols]. The patient received antibiotic, oseltamivir with symptomatic treatment. On an unspecified date, the patient died. The clinical outcome of the patient was death. It was unknown if an autopsy was performed. This case has been considered as vaccination failure case. This case has been considered as serious due to death, vaccination failure, hospitalization. The author did not comment on the relationship between the event of SARI and unspecified TIV. However, the authors stated, "Contrary to expectation, the village group has permanent contact with the surrounding non-indigenous population, so is probably not naive for influenza A (H1N1)pdm09 infection and other influenza strains. Additionally, the trivalent influenza vaccine (TIV), which has contained the influenza A(H1N1)pdm09 strain since 2010, is part of the Immunization Program, and had 86.3% vaccination coverage in the 2015 seasonal campaign. These findings revealed the susceptibility of the village to a respiratory outbreak, even though they are not isolated and have high vaccination coverage, and suggests that the population might have attenuated immunity against seasonal influenza, possibly due to influenza antigenic drifts and/or loss of vaccine-induced immunity over time. The A/California/07/2009-like (H1N1)pdm09 strain was integrated in the influenza vaccine for the southern hemisphere from 2010 to 2016. Since the emergence of the influenza A (H1N1)pdm09 strain in 2009, some mutations in HA and NA were gradually incorporated by the virus population over the seasons. This culminated in the emergence and spread of the genetic group 6B.1, characterized by the HA substitution S84N, S162N with the addition of a glycosylation site, and I233T, in the northern hemisphere during the 2015-2016 epidemic season. This genetic group, with important changes in antigenic sites in the HA protein, was introduced in 2016 and may be responsible for the severe epidemic season of this year and for the outbreak in the specific population." The authors concluded, "The results have shown an early arrival of the influenza season before the 2016 influenza vaccination campaign. At the same time, it was confirmed the emergence and spread of a new influenza genetic group not covered by the 2015 vaccine and an overlapping with the hRSV season. The confluence of those circumstances in an indigenous village where several risk factors for infection and severity are highly prevalent can explain the high attack rate of ARI even with a high rate of influenza vaccination, confirming the vulnerability of indigenous peoples to acute respiratory infections. Thus, effective surveillance of respiratory viruses, timely vaccination and controlling risk factors for infection and severity of ARI in the indigenous populations are key public health measures for monitoring and preventing disease and related deaths, particularly in children. Establishing sentinel units in strategic villages with greater demographic mobility can help to identify influenza, hRSV and other virus circulation, and also genetic virus mutations. Influenza vaccination of pregnant women, caregivers and household contacts of children too young to receive vaccine seems to be a reasonable preventive strategy for younger children, since a severe laboratory-confirmed case of influenza A(H1N1)pdm09 was seen in children under the vaccination age. Further studies on pathogen circulation in indigenous villages, and on maternal-infant passive protection, immune response to vaccination and vaccination effectiveness could bring new and robust evidence for indigenous health policy making and decisions regarding optimal timing for vaccination delivery." This is 1 of the 12 valid cases reported in the same literature article. Lab Comments: 2 days after onset of symptoms, the patient''s nasopharyngeal swab sample was collected for the detection of etiological agent. Real time-polymerase chain reactions (RT-PCRs) were conducted using Centers for Disease Control and Prevention (CDC) protocols for influenza A and B and human respiratory syncytial virus (hRSV) detection. The patient was found positive for influenza A(H1N1)pdm09 and hRSV pathogens. [In this study, the genetic sequencing steps were performed for influenza and hRSV positive samples with a cycle threshold (CT) lower than 32 in the real time RT-PCR protocols].; Reported Cause(s) of Death: H1N1 influenza; Respiratory syncytial virus infection


VAERS ID: 691319 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Washington  
Vaccinated:2015-12-08
Onset:2016-03-28
   Days after vaccination:111
Submitted: 2017-04-19
   Days after onset:387
Entered: 2017-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U1431AB / 1 LA / SYR
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 294X9 / 1 RA / SYR
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER L014415 / 1 RA / SYR
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U5020AA / 1 LA / SYR
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 9496S / 1 RA / SYR
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. L020002 / 2 LA / SYR

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Generalised tonic-clonic seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-08
   Days after onset: 376
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: First Grand Mal Tonic-Clonic Seizure (3/28/2016). Second Grand Mal Tonic-Clonic Seizure 1/20/2017. Third/Fourth Grand Mal Tonic-Clonic Seizure 3/10/2017. Fifth/Final Grand Mal Tonic-Clonic Seizure leading to death: 4/8/2017.


VAERS ID: 624988 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: New York  
Vaccinated:2016-02-16
Onset:2016-02-22
   Days after vaccination:6
Submitted: 2016-03-02
   Days after onset:9
Entered: 2016-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5310DA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-22
   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: Keppra, Robinul, Pediasure, vitamin B6
Current Illness: None.
Preexisting Conditions: Anoxic brain injury at birth, resulting in chronic encephalopathy, microcephaly, global developmental delay, seizure disorder, central vision impairment, and cerebral palsy. Also had history of bilateral metatarsus adductus, mild intermittent asthma, excessive salivation, and neuromuscular hip dislocation
Allergies:
Diagnostic Lab Data: Autopsy was performed by county medical examiner.
CDC Split Type:

Write-up: Pt was found deceased in bed by parent.


VAERS ID: 625336 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-25
Onset:2016-02-21
   Days after vaccination:119
Submitted: 2016-03-04
   Days after onset:12
Entered: 2016-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI425AC / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cough, Diarrhoea, General physical health deterioration, Influenza, Influenza A virus test positive, Pneumonia, Polymerase chain reaction, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), 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: 0000-00-00
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: 7 YEARS OF EVOLUTION (2009, EXACT DATE WAS NOT PROVIDED)
Preexisting Conditions: Medical History/Concurrent Conditions: WITH 7 YEARS OF EVOLUTION (2009, EXACT DATE WAS NOT PROVIDED)
Allergies:
Diagnostic Lab Data: 2009, blood pressure, Normal; 20160221, Influenza A virus test, Positive; 20160221, body temperature, 38.5 Celsius temperature
CDC Split Type: MXSA2016SA037122

Write-up: Initial unsolicited report received from a physician on 22-Feb-2016. This case involves an 83-years-old female patient who was vaccinated with a 0.5 ml dose of Fluzone Quadrivalent (batch number: UI425AC, expiry date: 03-Jun-2016) via intramuscular route in the left deltoid on 25-Oct-2015. The patient had medical history of angina heart disease with 7 years of evolution (2009, exact date was not provided) in treatment with several unknown drugs. It was reported that, on an unspecified date it was fitted with a permanent pacemaker as corrective treatment for the heart disease and history of arterial hypertension with 7 years of evolution (2009, exact date was not provided) in treatment with several unknown drugs. It was reported that during the treatment patient''s blood pressure levels were unknown. Concomitant medications were not reported. On 21-Feb-2016, 119 days after the vaccination, the patient experienced Pneumonia for type A influenza, cough, fever (38.5 degree Celsius), diarrhea, stomachache and overall decrease. On 21-Feb-2016, the patient was hospitalized. Laboratory investigations included blood pressure (results were unknown), rapid test for confirmation of influenza was positive to type A influenza and confirmatory PCR results were pending. Patient was prescribed 1 oral capsule 75 mg of Tamiflu every 12 hours and Avelox (route of administration, concentration and dose not provided). On 22-Feb-2016 the patient''s physician increased the dose of Tamiflu from 75 mg to 150 mg every 12 hours and added to the pretreatment ciprofloxacin and Fotamicin as a measure to reduce the exacerbation of pneumonia symptoms. At the time of this report the patient had not recovered from any adverse event. The duration of the hospitalization was 2 days approximately. Upon internal review, the case was considered as serious due to important medical events Pneumonia for type A influenza and Influenza. List of documents held by sender: none. Sender''s Comments: The events Pneumonia for type A influenza and diarrhea are unlisted, while other event is listed for INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible. In this particular case, information about relevant medical history, allergies or concomitant medications, if any, are not provided. The suspected product is used as prophylaxis for type A influenza. Hence, considering this factor causality for Pneumonia for type A influenza with the suspect product can be excluded.


VAERS ID: 641781 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Texas  
Vaccinated:2016-01-25
Onset:2016-02-18
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2016-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI524AA / UNK LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27555 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Brain injury, Cardiac arrest, Chest X-ray abnormal, Coma, Death, Dyspnoea, Electrocardiogram normal, Malaise, Oxygen saturation decreased, Pleural effusion, Pneumonia bacterial, Pneumonia fungal, Resuscitation, Staphylococcal infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-08
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: See attached
Current Illness: None
Preexisting Conditions: Hypertensive under control w/med
Allergies:
Diagnostic Lab Data: See attached chest x-ray 2/3/16 was clear
CDC Split Type:

Write-up: Patient did not feel well at all within 1 hr of receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of feeling like he had fluid on his lungs, went to emergency room. They did EKG was ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues, but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital lungs so full of fluid his heart could not beat. Was resuscitated but due to already depleted oxygen level irreparable brain damage occurred, was in coma 2 weeks and passed. I know him being given the flu vaccine and the PREVNAR 13 vaccines at the same time killed my husband. This practice has to stop! He was transferred from one hospital to another. While in hospital we were advised of bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no signs of problems. Testosterone usage was not understood by doctor, at all. He used 1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no relation to his condition. Once pneumonia found CHF and COPD dismissed.


VAERS ID: 654370 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-11-07
Onset:2016-02-14
   Days after vaccination:99
Submitted: 2016-09-20
   Days after onset:218
Entered: 2016-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cyanosis, Drug ineffective, H1N1 influenza, Malaise, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2016SE96940

Write-up: A spontaneous report has been received from a consumer concerning an 8 year old, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST QUADRIVALENT (intranasal) on Nov-2015, 0.2 millilitres, unknown for prevent H1N1 and flu vaccination. It was reported that the patient received FLUMIST QUADRIVALENT vaccination in November-2015, but fell ill in February. Patient woke up on 14-February-2016 with a stomachache and had fingers and toes turned blue (preferred term: skin discolouration) and patient died suddenly from H1N1 (Preferred Term: H1N1 influenza), also known as swine flu both versions of FDA-approved FLUMIST QUADRIVALENT were supposed to prevent H1N1. CDC voted against using FLUMIST QUADRIVALENT this winter after studies found no protective benefit could be measured (Preferred Term: Drug ineffective) with three percent effectiveness CDC recommends traditional flu shot instead, which had an estimated effectiveness of 63 percent for children between the ages of two and 17. Patient''s parents are stunned by the CDC''s vote, saying they trusted their doctor''s recommendations. It was not known if this was the only dose she received. On 14-Feb-2016 the patient woke up with a stomach ache and died hours later (Preferred Term: Abdominal pain upper). Cause of death were H1N1, woke up with a stomach ache and died hours later/ stomachache and no protective benefit could be measured. It was unknown if autopsy was performed. The outcome of the event of fingers and toes turned blue was unknown. The company physician considered the events H1N1, no protective benefit could be measured and woke up with a stomach ache and died hours later/ stomachache to be serious due to fatal outcome. The reporter considered the event fingers and toes turned blue to be non-serious. The company physician suggested to not capture ill as an event. Corrected report 15-Sep-2016: Suspect product was corrected. Country of case and country of reporter was corrected. Narrative corrected. Summary of follow-up information received by AstraZeneca/MedImmune on 12-Sep-2016 from consumer: Event verbatim updated from woke up with a stomach ache and died hours later/ stomachache to stomachache. Seriousness criteria updated for event woke up with a stomach ache and died hours later/ stomachache to died from non serious. Indication added. Dosing regimen updated. Reporter details updated. Associated case ID added. Patient date of birth added. Narrative corrected. Sender''s Comments: Fatal events of H1N1 influenza and Abdominal pain upper are not listed in the company core data sheet for FLUMIST QUADRIVALENT. Drug ineffectiveness was also reported. No vaccine is 100% effective, so occasional vaccine failures may be expected. Drug ineffectiveness could contribute to H1N1 influenza. However there is insufficient information on patient''s relevant medical history, concurrent diseases, concomitant medication, diagnostic workup and autopsy results which makes causal relationship difficult to assess.; Reported Cause(s) of Death: H1N1; NO PROTECTIVE BENEFIT COULD BE MEASURED; WOKE UP WITH A STOMACH ACHE AND DIED HOURS LATER/ STOMACHACHE.


VAERS ID: 661663 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2015-12-03
Onset:2016-01-26
   Days after vaccination:54
Submitted: 2016-10-23
   Days after onset:270
Entered: 2016-10-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5C2L4 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Anxiety, Arthralgia, Asthenia, Catheter placement, Chest pain, Cystitis, Death, Decreased appetite, Dehydration, Diplopia, Dyspnoea, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immobile, Insomnia, Intensive care, Kidney infection, Laboratory test, Nausea, Nightmare, Paraesthesia, Paralysis, Pneumonia, Sepsis, Stress, Urinary tract infection, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-09-05
   Days after onset: 222
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Listed on patient record
Current Illness: Chronic cough; Dyspnea
Preexisting Conditions: No allergies; No birth defects
Allergies:
Diagnostic Lab Data: Numerous. Relevant tests began at hospital on 1/26/16. Diagnosis of Guillain-Barre Syndrome made at hospital after extensive testing on 1/30/16.
CDC Split Type:

Write-up: Blurred vision, double vision, severe headache, nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet, numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16 (onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital confinement, intensive care unit, and rehabilitation centers provided testing, medications, and physical therapy.


VAERS ID: 619994 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-25
Onset:2015-12-25
   Days after vaccination:30
Submitted: 2016-01-12
   Days after onset:18
Entered: 2016-01-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 152701 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute pulmonary oedema, Atrial fibrillation, Breath sounds abnormal, Bronchitis, Cough, Death, Dyspnoea, Dysstasia, Heart sounds abnormal, Lower respiratory tract infection, Pallor, Rales, Tachyarrhythmia, Troponin increased, Vasoconstriction, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-25
   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: COUMADIN; TRIATEC; GLICOREST; LASIX
Current Illness: Hypoglycaemia, The glycemic compensation was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning); Hyperglycaemia, The glycemic compensation was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning); Nutritional condition abnormal; Atrial fibrillation; Hypertension; Type 2 diabetes mellitus; Cognitive disorder; Cerebrovascular disorder; Parkinsonism; Diabetes mellitus inadequate, The glycemic compensation was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning)
Preexisting Conditions: Oxygen Therapy
Allergies:
Diagnostic Lab Data: 12/17/2015, Heart sounds, Abnormal, Significant, Poor; 12/17/2015, Troponin, Abnormal, Significant, Increase
CDC Split Type: PHHY2016IT002060

Write-up: Case number PHHY2016IT002060, is an initial and follow up spontaneous report received from a physician via Agency received via pharmaceutical company on 04 Jan 2016 and from Agency on 08 Jan 2016 (combined report). This report refers to an 82-year-old male patient. Vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) in the previous years and did not report any immediate reaction. The patient''s current conditions included glycemic compensation which was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning). However, according to the physician opinion, it was due to a poorly corrected nutrition. Hypokinetic syndrome (domiciliary visits every 15 days) and the patient was in good hemodynamic compensation (no signs of pulmonary stasis, no peripheral edema and good oxygen saturation in room air). Concomitant medications included GLICOREST for type 2 diabetes mellitus, COUMADIN for atrial fibrillation, TRIATEC for arterial hypertension of mild degree and LASIX 25 mg tablet. The patient was vaccinated with AGRIPPAL S1 (batch number; 152701, expiration date: 31 Jul 2016) intramuscularly into the right shoulder at a dose of 0.5 ml on 25 Nov 2015 at 12:50 PM. On 03 Dec 2015, the patient experienced cough and difficulty in maintaining the standing position. At about 12:45, when the physician arrived the patient was in bed. The patient was apyretic and had normal blood pressure. The patient presented with humid rumors and whistles at both pulmonary fields and the patient maintained good oxygen saturation in room air. It was reported that a heart rhythm due to atrial fibrillation (AF) was present; however, the heart rate was within the normal limits. The physician suspected bronchial infection and prescribed Levofloxacin 500 mg one tablet daily and the physician withdraw the therapy with LASIX tablet. After about two days, the patient''s clinical conditions worsened and the patient was hospitalized. On 15 Dec 2015 in the afternoon, the patient was discharged from the hospital. The patient was visited by the colleague of the physician late in the morning of 16 Dec 2015 and reported that the patient still had some rales at both pulmonary fields. On 17 Dec 2015 at 08:15, the patient experienced episode of vomiting and was dyspneic (rasping breath). The physician immediately went to the patient''s home and the patient was pale, tachydyspneic, almost soporous; not evaluable the oxygen peripheral saturation due to the presence of vasoconstriction; the patient''s blood pressure was normal and presented with important diffuse humid rumors, tachyarrhythmia, and poor cardiac sounds. The physician suspected acute pulmonary edema and the patient was administered LASIX two vials intramuscularly (unfortunately, the physician could not find any peripheral venous access). The physician called the first aid service. It was reported that upon the arrival of the colleagues of the emergency department, the patient was stabilized by broncho aspiration; oxygen therapy. The patient''s discharge letter read the diagnosis as infection of the low respiratory ways. The patient was directed to the local therapy. The patient''s discharge letter read the diagnosis as infection of the low respiratory ways. The patient was directed to the local town hospital. At hour 12:00, approximately, the patient had a discrete increase in the troponin value and the diagnosis of acute pulmonary edema was confirmed and the patient manifested the intention to get admitted in the hospital. On 22 Dec 2015, the patient''s daughter reported to the physician that her father''s conditions were very severe. The outcome of the events was not reported. The patient died on 25 Dec 2015 (physician supposed) and the physician was not aware of the causes that lead to the patient''s death. The physician considered it was appropriate to report the case taking into account the close temporal relation (suspected causality) between the anti-flu vaccination AGRIPPAL S1 (performed at patient''s home after a clinical visit) and the onset of the cardio-respiratory pathologies lead to the patient''s death.


VAERS ID: 616930 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: South Carolina  
Vaccinated:2015-12-16
Onset:2015-12-24
   Days after vaccination:8
Submitted: 2015-12-31
   Days after onset:7
Entered: 2015-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5344AA / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: White forelock syndrome/Piebaldism; No allergies; Had GERD as infant
Allergies:
Diagnostic Lab Data: Autopsy was performed.
CDC Split Type:

Write-up: According to parents, child developed some fever and runny nose 2 days after vaccine. Was doing OK - had a bottle at 3 AM on 12-24-2015 and was put back to bed and found dead in crib in morning. Autopsy by County coroner found no cause.


VAERS ID: 616336 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: California  
Vaccinated:2015-12-14
Onset:2015-12-15
   Days after vaccination:1
Submitted: 2015-12-23
   Days after onset:8
Entered: 2015-12-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI519AA / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nitroglycerin; ramipril
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient suffered sudden death based on his wife''s statement. The event occurred 24 hours after the vaccine administration. There has been no medical examination to determine the cause of death or to establish relation to vaccine.


VAERS ID: 615815 (history)  
Form: Version 1.0  
Age: 0.63  
Sex: Male  
Location: California  
Vaccinated:2015-12-02
Onset:2015-12-05
   Days after vaccination:3
Submitted: 2015-12-21
   Days after onset:16
Entered: 2015-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4887AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5344AA / 1 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 732ZD / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L63037 / 3 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial test, CSF culture negative, CSF test abnormal, Death, Fungal test, Viral test
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: None reported
Allergies:
Diagnostic Lab Data: Cloudy cerebrospinal fluid on autopsy, without growth on bacterial culture. Repeat bacterial studies, in addition to viral, fungal, and mycobacterial testing planned or in process.
CDC Split Type:

Write-up: Child died while sleeping. No reported evidence of illness prior to death.


VAERS ID: 613837 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: New York  
Vaccinated:2015-12-03
Onset:2015-12-03
   Days after vaccination:0
Submitted: 2015-12-08
   Days after onset:5
Entered: 2015-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS 7DTZY / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Cerebrovascular accident, Computerised tomogram, Culture, Electroencephalogram, Hand-eye coordination impaired, Incontinence, Laboratory test, Lethargy, Mobility decreased, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Visual impairment
SMQs:, Anticholinergic 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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-01-08
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 38 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amLODIPine 5 MG tablet, acetaminophen 325 MG tablet, aspirin 81 MG tablet, cholecalciferol 1000 UNIT capsule, Cranberry 250 MG Caps, loperamide 2 MG capsule, psyllium 95 % packet, pyridoxine 100 MG tablet, sertraline 25 MG tablet, levothyro
Current Illness: Recovering from urinary tract infection
Preexisting Conditions: Dementia; allergy to sulfa drugs; COPD
Allergies:
Diagnostic Lab Data: MR, MR-A, CT Scan, EEG, cultures, many others
CDC Split Type:

Write-up: Patient reports "vertically misaligned" vision; unable to touch nose with finger with or without eyes open; other stroke-like symptoms; incontinence; extreme lethargy; very impaired mobility.


VAERS ID: 618329 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2015-12-01
Onset:2015-12-02
   Days after vaccination:1
Submitted: 2016-01-11
   Days after onset:40
Entered: 2016-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI427AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Asthenia, Dizziness
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins, low-dose diuretic
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Upset stomach, weakness, dizziness. Patient drank fluids--broth and Gatorade. Symptoms continued for three days, with severe dizziness reported on third day.


VAERS ID: 637187 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-01
Onset:2015-12-01
   Days after vaccination:0
Submitted: 2016-05-25
   Days after onset:175
Entered: 2016-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA874CB / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute kidney injury, Anaemia, Atrial flutter, Blood creatinine increased, C-reactive protein increased, Death, Dehydration, Escherichia infection, Fatigue, General physical health deterioration, International normalised ratio increased, Metastases to lung, Prothrombin time shortened, Renal cancer, Urinary tract infection, Vasculitic rash
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Supraventricular tachyarrhythmias (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), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-02
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX; Ramipril
Current Illness: Unknown
Preexisting Conditions: Atrial fibrillation; Cardiac failure chronic; Pulmonary hypertension; Cardiac pacemaker insertion; Atrioventricular block complete; Haematuria; Benign prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Unknown date: Creatinine: 138 mcmol/L; Unknown date: International Normalized Ratio: 3 and above 8; Unknown date: Prothrombin time: 5 and above 8; Unknown date: C-reactive protein: 15-20 and 307.
CDC Split Type: SE2016072260

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of vasculitis in a 89-year-old male patient who received FLUARIX (batch AFLUA874CB, expiry date unknown). The patient''s past medical history included atrial fibrillation, cardiac failure chronic, pulmonary hypertension, cardiac pacemaker insertion, third degree AV block, hematuria and benign prostatic hyperplasia. Concomitant products included LASIX and Ramipril. In December 2015, the patient received FLUARIX. In December 2015, less than a month after receiving FLUARIX, the patient experienced vasculitis (serious criteria death) and acute renal failure (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vasculitis and acute renal failure were fatal. The patient died on 2nd January 2016. The reported cause of death was vasculitis and renal failure. An autopsy was performed. The autopsy determined cause of death was renal cancer. The reporter considered the vasculitis and acute renal failure to be possibly related to FLUARIX. RA Verbatim: Report from a hospital physician concerning an 89-year-old male with atrial fibrillation, chronic heart failure, pulmonary hypertension, pacemaker due to AV-block III, clinical hematuria and benign prostatic hyperplasia. The patient had been vaccinated with FLUARIX (vaccine against flu) in December 2015 and had afterwards developed deteriorated general condition. On 15-17 December, the patient was admitted with anamnesis of decreased condition since ten days which was according to records was consistent with a switch to atrial flutter. Chest x-ray showed some signs of failure with progress of pleural fluid bilaterally. At the hospital, the patient had an elevated PT/INR value of 5.3 and rising creatinine to 138 micromoles/L (ref creatinine 60-105 micromoles/L) which was connected to that the patient was dehydrated. The patient is discharged home when he still is very tired and exhausted, according to the records. Upon a home visit later on, the PT/INR value is above 8 and the patient has a reduced general condition and is referred to the geriatric department on December 28. CRP as in the previous admission had been somewhat elevated to 15-20 was now rising to 307. UTI was suspected and CLAFORAN was initiated. Urine culture showed growth of E. coli. Blood culture was without remarks. The patient had gradually rising creatinine to 416 and poor diuresis 100-150 ml/day. It was previously, in May 2014, seen a "decimeter large" cystic change that was now considered as a left-sided kidney tumor. It was also assessed metastases to the left lung plus pneumonia. The patient died after a few days. Autopsy showed that the kidney cyst was a kidney cancer that grew over towards the adrenal gland, pancreas, hardly had anything to do with the death since it had been present for a long time, according to the reporter. According to the reporter, vasculitis with kidney failure is described after vaccination and has entered vasculitis and acute renal failure as suspected adverse events of FLUARIX. Concomitant medication with LASIX Retard and Ramipril. SPC: "Vasculitis is in very rare occasions associated with transient renal involvement".


VAERS ID: 619281 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-25
Onset:2015-11-25
   Days after vaccination:0
Submitted: 2015-12-01
   Days after onset:6
Entered: 2015-12-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood gases, Blood test, Cardiac massage, Cardio-respiratory arrest, Cardiogenic shock, Death, Endotracheal intubation, Loss of consciousness, Pulmonary embolism, Pulseless electrical activity, Resuscitation, Syncope, Thrombolysis, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-25
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: 11/25/2015, Cardiac massage; 11/25/2015, Endotracheal intubation; 11/25/2015, Thrombolysis; 11/25/2015, Resuscitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT156466

Write-up: Case number PHHY2015IT156466, is an initial spontaneous report received from a health care professional via agency on 26 Nov 2015. This report refers to an 85-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with AGRIPPAL S1 (batch number: 152801, expiration date: 31 Aug 2016) intramuscularly into the left shoulder at a dose of 0.5 ml on 25 Nov 2015 at 11:30 AM. On the same day after vaccination, the patient collapsed with loss of consciousness. The patient was referred for a paramedical intervention for cardio respiratory arrest and pulseless electrical activity. Cardiac massage was performed and the patient was transferred to emergency room. In the emergency room blood tests were performed (results not reported) and the patient had cardiology and anesthesiology visits Intubation was performed. Thrombolysis was performed during cardiopulmonary resuscitation with the following drugs: three vials of epinephrine, heparin 5000 IU, ACTYLISE 20mg and SOLU-CORTEF. Also blood gas analysis was performed; however there was no response to resuscitation maneuvers. The outcome of the events was fatal and the patient died with the diagnosis of cardiogenic shock due to pulmonary thromboembolism. Causality was suspected to AGRIPPAL S1.


VAERS ID: 695957 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-11-25
Submitted: 2017-05-15
   Days after onset:536
Entered: 2017-05-23
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cervical radiculopathy, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700575

Write-up: This spontaneous case, initially received on 09-May-2017 was reported by other health professional (physician) via health authority (HA reference number: IT-MINISAL02-344293) and concerns a female patient of an unspecified age. Administration of Company suspect drug: On an unspecified date, the patient received Influenza vaccine, dose, batch number, expiry date, anatomical location and route of administration: not reported). Indication not reported. Adverse reactions/events and outcomes: On 25-Nov-2015, the patient experienced cervical spine polyradiculopathy. On an unknown date, the patient died. The cause of death was not reported. It was unknown whether autopsy was done or not. Action taken with the suspect vaccine was not applicable. Reporter''s Assessment: The reporter did not provide the causality of the event in relation to the INN Flu Vaccine Seasonal. Health Authority considered the event cervical spine polyradiculopathy as serious (death and hospitalization).


VAERS ID: 622755 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-18
Onset:2015-11-20
   Days after vaccination:2
Submitted: 2016-02-12
   Days after onset:84
Entered: 2016-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 154702 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: APIDRA; LANTUS; TAREG; LASIX; LOBIVON; PEPTAZOL; Cardioaspirin; Furosemide; Valsartan; Bisoprolol; Nifedipine; KCl; Aspirin; Pantoprazole; Allopurinol; Insulin
Current Illness: Diabetes mellitus; Hypertension; Chronic kidney disease; Cardiac valve prosthesis user; Cholelithiasis
Preexisting Conditions: Recent episodes of heart failure; Glaucoma; Coronary artery bypass, double bypass; Essential tremor; Ischaemic cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT153455

Write-up: Case number PHHY2015IT153455, is a spontaneous report initially received from a health care professional (reference number: 335741) on 21 Nov 2015. This report refers to an 82 year old female patient. Historical conditions included recent episodes of heart failure, glaucoma, essential tremor, ischemic-hypertensive cardiopathy, double aorto coronary bypass and aortic valve bioprosthesis. Current conditions included diabetes mellitus, hypertension and chronic renal failure and cholelithiasis. The patient was hospitalized on an unknown date due to her multiple diseases and she was under the treatment of furosemide (manufacturer unknown), valsartan (manufacturer unknown), bisoprolol (manufacturer unknown), nifedipine (manufacturer unknown), KCl (manufacturer unknown), aspirin, pantoprazole (manufacturer unknown), allopurinol (manufacturer unknown), insulin (manufacturer unknown). The patient was discharged from the hospital on 16 Oct 2015 and she was able to do activities of daily living. Concomitant medications included APIDRA, LANTUS, TAREG, LASIX, LOBIVON, PEPTAZOL and cardioaspirin. The patient was vaccinated with FLUAD (batch number: 154702, expiry date: Jun 2016) intramuscularly on 18 Nov 2015 after the physician evaluated the persistence of good general health conditions in particular cardiorespiratory conditions. On 19 Nov 2015, in the morning, the patient experienced mild hyperpyrexia, and nausea accompanied by some vomiting episodes. The physician went to patient''s home at around hour 00:30 pm and detected only nausea, increase in the tremor and probable reduction in the diuresis during the clinical examination. The patient was prescribed tachypirine tablets and PLASIL vials intramuscularly, as needed, physiological solution endovenously. In the afternoon, the patient''s daughter contact the physician again reporting that the nurse could not find a vein to administer the infusion and the conditions of patient appeared to be worsened. The physician suggested to call the first aid service to carry the patient to the emergency department. At 01:00 pm, the patient had no signs of heart failure. Later in the evening the patient was taken to the emergency room The patient died of heart failure on 20 Nov 2015 and autopsy was not performed. The outcome of the events mild hyperpyrexia, nausea, vomiting, increase in the tremor and probable reduction in the diuresis was not reported. Causality was suspected to FLUAD. Batch review report (reference number 1009329) received from quality assurance department on 31 Dec 2015: Based on the document review, it was stated that the concerned [FLUAD] batch number [154702] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from Quality Assurance Department (QA, reference number: 1009329) on 27 Nov 2015: updated QA reference number. Follow up report received from physician and health care professional (reference number: 335741) on 02 Dec 2015: Added new events (increase in the tremor and probable reduction in the diuresis), updated history, current condition, concomitant medication and expiry date of FLUAD, updated the event coding from mild fever to mild hyperpyrexia. Follow-up information from quality assurance department received on 31 Dec 2015: Added investigation summary.


VAERS ID: 622750 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-16
Onset:2015-11-17
   Days after vaccination:1
Submitted: 2016-02-12
   Days after onset:87
Entered: 2016-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 155001A / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Atrial fibrillation, Blood pressure increased, Death, Diarrhoea, Dyskinesia, Hyperpyrexia, Hypotension, Malaise, Psychomotor hyperactivity, Shock, Somnolence
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypertension (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTIROX; LANOXIN; Clopidogrel; Cortisone acetate
Current Illness:
Preexisting Conditions: Lymphocytic hypophysitis; 1990, Thyroid adenoma treated with metabolic radiotherapy; 1993, Hypothyroidism treated with levothyroxine; Myocardial ischaemia; Atrial fibrillation; 1993, Hypothyroidism; 1990, Radiotherapy; Adenoma benign; 2008, Polyglandular autoimmune syndrome type II; 2008, Blood cortisol decreased; 2011, Atrial fibrillation; Fall; 2004, Rib fracture; 2013, Humerus fracture; 03/2014, Lumbar vertebral fracture; Diverticulitis; Diarrhoea
Allergies:
Diagnostic Lab Data: Blood pressure measurement, 100/50 mmHg, Low; Blood pressure measurement, 130/70 mmHg, High
CDC Split Type: PHHY2015IT154263

Write-up: Case number PHHY2015IT154263, is an initial spontaneous report received from a health care professional (reference number: 335985) on 23 Nov 2015. This case also contains QA reference number 1009285. This report refers to an 88 years old male patient. Historical conditions included chronic ischaemic heart disease, unspecified and chronic atrial fibrillation, autoimmune hypopituitarism and the patient whose anamnesis had been characterized by hypothyroidism due to toxic adenoma and thyroid adenoma treated with metabolic radiotherapy in 1990. In 1993 hypothyroidism has occurred (at that time the hypothyroidism has been classified as iatrogenic, due to sequels of radiotherapy), for this reason replacement therapy with levothyroxine had been started. In 1993 hypothyroidism was treated with levothyroxine. In 2008 diagnosis of type 2 autoimmune polyglandular syndrome had been formulated with involvement of the cortical region of the adrenal gland and of the thyroid gland, for this reason replacement therapy with cortisone acetate has also been introduced in order to compensate the deficiency of endogenous cortisol. In 2011 onset of atrial fibrillation about that had been decided not to undergo electrical cardioversion taking into account the patient''s age and the general health condition of the patient. Antiaggregant therapy with clopidogrel (manufacturer unknown) had been started in the meanwhile because the patient and his relatives did not accept oral anticoagulant therapy. In 2004, for the same pathology LANOXIN had also been added. It is important to notify that the patient underwent many traumatic falls causing bone fractures: in 1999 fracture of the distal extremity of the radius bone on the left side, in 2004 fracture of the X rib of the right hemi chest, in 2013 fracture of the surgical neck of the right humeral bone, in March 2014 fracture of the L lumbar spine. The patient, in addition, suffered from a marked diverticulitis of the colon with very frequent diarrheic episodes also very intense. Concomitant medications included clopidogrel (manufacturer unknown), LANOXIN and cortisone acetate (manufacturer unknown), EUTIROX. The patient was vaccinated with FLUAD (batch number: 155001A) intramuscularly on 16 Nov 2015. The physician would like to anticipate that from the data on his or her hands the patient underwent antiflu prophylaxis on a constant basis in these last years. The patient had arrived at his or her surgery accompanied by his wife on Monday morning 16 Nov 2015 asking for the repetition of the prescriptions of the drugs that he was taking in a chronic manner. The patient''s wife underwent anti flu vaccination, however, taking into account that the patient had declared that he would like to be vaccinated by his son in law who is a physician. The physician gave him the vaccine, a dose of FLUAD batch number: 155001A, urging him to have the vaccine injected as soon as possible, without interrupting the cold chain, and the physician discharged him. On 17 Nov 2015, the patient experienced hyperpyrexia, hypotension and psychomotor hyperactivity. On Wednesday, 18 Nov 2015 in the morning, the physician received a telephone call by the patient''s wife that reported to the physician that during the night the patient presented with very high hyperpyrexia and diarrhea. The treating physician suggested her to administer that patient with paracetamol that she had available at home, and loperamide, in case of persistence of the diarrhea, as she usually did, and to keep treating physician informed. In the first part of the afternoon treating physician received another telephone call by the patient''s wife that reported to treating physician the presence of very high hyperpyrexia, for this reason treating physician went to the patient''s home to visit him At the objective examination the patient was sleepy, however reactive, he could answer the questions, and, although with the usual difficulty in the movements he was cooperative as far as the procedures of the visit were concerned. No dyspnoea, no sweating, no agitation. The heart rhythm was chaotic due to atrial fibrillation, at the chest and at the abdomen no other relevant signs. The patient''s heart pressure of 130/70 mmHg, oxygen saturation within the normal limits, measured with the pulsimeter. Because treating physician could not detect any emergency symptoms, treating physician suggested continuing the treatment with paracetamol and to keep him informed On Thursday, 19 Nov 2015, around hour 05:15 p.m. approximately, the patient''s wife called to treating physician at his or her surgery and she reported in an agitated way that her husband suddenly had shown signs of severe malaise. After no more than ten minutes (treating physician surgery is located at a very short distance from the domicile of my patient) treating physician arrived and treating physician found that the patient was in a severe state of agitation. Even that time, no dyspnoea, no sweating was noted and oxygen saturation was within the normal limits, measured with the pulsimeter, blood pressure of 100/50, however, the treating physician was more focused on some movements almost rhythmic of the upper limbs and of the head, that almost could be configured as coreic movements that where accompanied by a verbal complaint. The patient answered only if he was called by his name with very high voice, however with syllables or complaints. Treating physician therefore, immediately called the first aid service. In the meanwhile also the patient''s son in law, who is a physician, arrived, who discharged current treating physician. On Friday, 20 Nov 2015 around 00 30 pm, the patient''s son in law called treating physician telling him that his father in law had died during that morning due to irreversible shock. It was unknown whether an autopsy was performed or not. The outcome and seriousness of the events diarrhea, sleepy, blood pressure increased, malaise, agitation and blood pressure decreased was not reported. The causality of the events hyperpyrexia, hypotension and psychomotor hyperactivity was reported as suspected. The reporter stated that the suspect drug may have contributed to death of the patient. Follow up information received from other health care professional on 24 Nov 2015 along with QA reference number on 26 Nov 2015. Added information included medical history: hypothyroidism from an unknown date in 1993, toxic adenoma, type 2 autoimmune polyglandular syndrome from an unknown date in 2008, deficiency of endogenous cortisol from an unknown date in 2008, atrial fibrillation from an unknown date in 2011, traumatic falls down, bone fractures/fracture of the distal extremity of the radius bone on the left side, from an unknown date in 1999, X rib of the right hemi chest from an unknown date in 2004, fracture of the surgical neck of the right humeral bone from an unknown date in 2013, fracture of the L lumbar spine from an unknown date in Mar 2014, diverticulitis and very frequent diarrheic episodes also very intense. Concomitant medication and adverse events: diarrhea, sleepy, heart rate abnormal, blood pressure increased, malaise, agitation and blood pressure decreased. Updated narrative accordingly. Follow up report received from a health care professional (reference number: 335985) on 07 Dec 2015: Updated past medical history (thyroid adenoma, hypothyroidism and its treatment).


VAERS ID: 673760 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Utah  
Vaccinated:2015-10-29
Onset:2015-11-10
   Days after vaccination:12
Submitted: 2016-12-05
   Days after onset:391
Entered: 2016-12-20
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI481AA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-14
   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:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 622770 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-07
Onset:2015-11-08
   Days after vaccination:1
Submitted: 2016-02-12
   Days after onset:96
Entered: 2016-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 155001 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Basophil percentage decreased, Blood creatinine increased, Blood uric acid increased, Cerebrovascular accident, Death, Eosinophil percentage increased, Glomerular filtration rate decreased, Haematocrit decreased, Lymphocyte percentage, Neutrophil percentage, Red cell distribution width increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-08
   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: CLEXANE; EUTIROX; PEPTAZOL; LASIX; FOLINA; Heparin
Current Illness: Hypertension; International normalised ratio fluctuation, supervening difficulty to maintain INR within the range; Congestive cardiomyopathy, fibrillating heart dilated; Dementia Alzheimer''s type; Chronic kidney disease; Nephroangiosclerosis; Embolism arterial; Hypothyroidism; Cardiac fibrillation, fibrillating heart dilated
Preexisting Conditions: Shock haemorrhagic; Arrhythmia; Palpitations; 2012, Cerebrovascular accident; 2012 Cerebral ischaemia, cerebral ischemic events; 2012 Hemiparesis; 2012, Aphasia; COUMADIN/warfarin sodium; 2012, Endotracheal intubation; Leg amputation; Angiopathy; Intra-abdominal haematoma; Cognitive disorder
Allergies:
Diagnostic Lab Data: Basophil count, 0.4%, low; Blood creatinine, 1.26 mg/dl, high; Blood uric acid, 7.5 mg/dl, high; Eosinophil count, 5.8%, high; Glomerular filtration rate, 37 ml/min, low; Haematocrit, 36.8%, low; Lymphocyte count, 23.1%, low; Neutrophil count, 63.2%, high; Red cell distribution width, 52.9 fL, high, red cell distribution width-corpuscular volume (RDW CV); Red cell distribution width, 17.0%, high, red cell distribution width- standard deviation (RDW-SD).
CDC Split Type: PHHY2015IT147840

Write-up: Case number PHHY2015IT147840, is a spontaneous report initially received from a health care professional via Agency (reference number: 333607) on 09 Nov 2015 and 10 Nov 2015 (combined report). This report refers to a 91 years old female patient. The patient had vascular disease and suffered from cognitive impairment. The patient suffered from the outcomes of several previous stroke episodes as a result of frontal left ischemia (cerebral ischemic events)with aphasia and right hemiparesis in 2012. Nasogastric tube was placed in 2012. The patient''s medical history included thromboembolic or hemorrhagic shock, arrhythmias, palpitations. Current condition included hypertension. The patient had been suffering from fibrillating dilated cardiomyopathy for several years and of arterial thromboembolism with outcome of previous left leg amputation above the knee, mild chronic renal failure from angiosclerosis and Alzheimer''s disease. Her vaccination history included administration of FLUAD (batch number: not reported) in the previous years. The patient had been in therapy with anticoagulant therapy for years with COUMADIN that was changed with low molecular weight heparin due to supervening difficulty to maintain INR within the range. The dosage of heparin was reduced in Jul 2015 due to the hospitalization for abdominal hematoma. Concomitant medications included CLEXANE, EUTIROX, PEPTAZOL, LASIX, FOLINA and "Nutrison Standard" (dietary foods for special medical purposes). The condition of the patient at the time of vaccination was precarious. On the day of vaccination the patient was relatively clinically stable with normal vital signs (body temperature, blood pressure, heart rate and oximetry). The patient was vaccinated with FLUAD (batch number: 155001, expiry date: 31 Jul 2016) intramuscular on 07 Nov 2015 at 09:30 AM. The laboratory data included as red cell distribution width- corpuscular volume (RDW CV)- 17.0 percentage (11.5-14.5), red cell distribution width- standard deviation (RDW-SD)-52.9 fL (39.0-48.0), neutrophils 63.2 percentage, lymphocytes 23.1 percentage, eosinophils 5.8 percentage, basophils 0.4 percentage, serum/plasma creatinine 1.26 mg/dl (0.50 - 1.00), estimated glomerular filtration rate (eGFR) 37 mL/min/1.73m2 and Uric acid 7.5 mg/dl (2.4 - 5.7) and hematocrit was 36.5% (37.0-47.0). On 08 Nov 2015 at 10:30 AM the patient died due to cerebral stroke. It was reported that an autopsy was not performed. Seriousness, outcome and causality of the other events were not reported. The reporter stated that there was only temporal relation with vaccination as death occurred 24 hours after vaccination with FLUAD on random circumstance. The Centre assessed the relationship between the reaction and the vaccine as not related according to WHO''s algorithm. Batch review report reference number (1008846) received from quality assurance department on 08 Dec 2015: Based on the document review, it was stated that the concerned FLUAD batch number (155001) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up information from health care professional via Agency received on 12 Nov 2015: Medical history, vaccination history, concomitant medication and other clinically relevant information updated in the narrative. Non significant follow up received from quality assurance department (QA reference number: 1008846) received on 17 Nov 2015: Updated QA reference number only. Follow-up information from health care professional via Agency received on 30 Nov 2015: Added medical history (thromboembolic or hemorrhagic shock, arrhythmias, palpitations and hypertension) and laboratory data. Following internal review done on 14 Dec 2015 for the data received on 30 Nov 2015: Case follow up significant box was checked in the general tab as the correction (outcome and reported seriousness of the event Hematocrit decreased which was mentioned in the narrative) was done on 11 Dec 2015 inadvertently as non significant. Follow up information received from quality assurance department on 08 Dec 2015: Added expanded investigation summary. Follow-up information from health care professional via Agency received on 28 Jan 2016: Added Centre assessment.


VAERS ID: 605991 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2015-10-29
Onset:2015-10-30
   Days after vaccination:1
Submitted: 2015-10-30
   Days after onset:0
Entered: 2015-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI450AA / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac arrest, Chest X-ray normal, Death, Fibrin D dimer increased, Myocardial necrosis marker increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (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: 2015-10-30
   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: Daily Aspirin, Daily calcium supplement, Daily fish oil supplement, Gaviscon daily for reflux, Lisinopril/ HCTZ 20-12.5, daily multivitamin, vitamin C daily
Current Illness: No
Preexisting Conditions: NKDA, history of heart murmur, cataract surgery in January 2015, hyperlipidemia, hypertension, squamous cell carcinoma of lip removed with no return of cancer.
Allergies:
Diagnostic Lab Data: Labs done in ER with elevated cardiac enzymes and elevated D-dimer. Chest xray was negative.
CDC Split Type:

Write-up: Cardiac Arrest at home while in bed sleeping next to wife. Brought in to ER in Cardiac Arrest. Coded for 20 minutes until time of death was called at 1:30am.


VAERS ID: 614067 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2015-10-14
Onset:2015-10-28
   Days after vaccination:14
Submitted: 2015-12-09
   Days after onset:42
Entered: 2015-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1515301 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, Dizziness, Dysarthria, Laboratory test normal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-20
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CALCIUM, ACYCLOVIR, METOPROLOL, MAG64
Current Illness: Multiple myeloma
Preexisting Conditions: Multiple myeloma
Allergies:
Diagnostic Lab Data: UNSURE
CDC Split Type:

Write-up: DIZZINESS, SLURRED SPEECH, WEAKNESS TO THE POINT OF NEEDING ASSISTANCE. UNBALANCED, HOSPITALIZATION, TESTS ALL NEGATIVE.


VAERS ID: 626920 (history)  
Form: Version 1.0  
Age: 1.05  
Sex: Male  
Location: Indiana  
Vaccinated:2015-10-19
Onset:2015-10-23
   Days after vaccination:4
Submitted: 2016-03-14
   Days after onset:143
Entered: 2016-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5319DA / 1 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9CJ5Y / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. K002528 / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K008824 / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No, child was well at the visit
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy report
CDC Split Type:

Write-up: Child found deceased.


VAERS ID: 609508 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-16
Onset:2015-10-22
   Days after vaccination:6
Submitted: 2015-11-12
   Days after onset:21
Entered: 2015-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER BJ14T / UNK AR / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K009223 / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Brain injury, Death, Hepatic failure, Intestinal ischaemia, Multiple organ dysfunction syndrome, Renal failure, Sepsis, Septic shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Ischaemic colitis (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 10/15/2013, Pneumococcal vaccine, no adverse event; 10/2014, Influenza virus vaccine (unspecified), no adverse event; 10/2013, Influenza virus vaccine (unspecified), no adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511DEU005522

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DE-1577272925-E2015-12322) as a part of a business agreement on 09-NOV-2015. Case of fatal outcome was received from the Health Authority on 02-Nov-2015 (reference no. PEI2015066426). Case is medically confirmed. A 71-year-old female patient received a dose of PNEUMOVAX 23, lot-no. K009223, expiration date was not reported) IM into the upper arm and a dose of XANAFLU, Abbott, lot-no. BJ14T IM into the upper arm on 16-Oct-2015. One day later, on 17-Oct-2015, the patient was diagnosed with sepsis of unknown origin, multiorgan failure, kidney and liver failure, suspected mesenterial ischemia, and septic shock. Diagnosis was confirmed by laboratory tests, clinical picture, computerized tomography of chest and abdomen. Perforation of the intestine, cholecystitis, pneumonia, ischemia, and cerebral hemorrhage were excluded. On 18-Oct-2015, hypoxic brain damage occurred which was ascribed to a delayed start of therapy. The patient died on 22-Oct-2015. It was not reported whether the autopsy was performed. Medical history: Previous immunization with unspecified seasonal influenza vaccine administered in Oct-2014, unspecified influenza vaccine administered in Oct-2013, and pneumococcal vaccine (manufacturer unknown) administered on 15-Oct-2013 had been well tolerated.


VAERS ID: 633973 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-17
Onset:2015-10-22
   Days after vaccination:35
Submitted: 2016-05-03
   Days after onset:194
Entered: 2016-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 30349421A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Autopsy, Biopsy brain abnormal, Death
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-11-11
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBBEH2016061724

Write-up: This medically confirmed health authority report (initial receipt 20-Apr-2016) concerns a 40 year-old male patient. On 17-Sep-2015, the patient received Enzira vaccine (batch number 30349421A) via the subcutaneous route for flu vaccination. On 22-Oct-2015, the patient experienced acute disseminated encephalomyelitis. The diagnosis of acute disseminated encephalomyelitis was confirmed on the brain biopsy and subsequent post mortem. The patient was initially treated with antivirals/antibiotics, then immunosuppression when the diagnosis of acute disseminated encephalomyelitis was more secure. Prior to the admission, the patient was well. The patient died on 11-Nov-2015. The outcome was fatal. Reporter comments: The health authority assessed the case as serious (life threatening, fatal and medically significant). It was difficult to prove acute disseminated encephalomyelitis directly secondary to vaccine. The vaccination predisposed to acute disseminated encephalomyelitis. May have contributed to acute disseminated encephalomyelitis which eventually resulted in the patient''s death. Sender''s Comments: Seriousness: Serious. Fatal outcome. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, acute disseminated encephalomyelitis is unlisted (encephalomyelitis is listed as per the CCDS and unlisted as per the AFLURIA PI). Causality: Possible. Time to onset is approximately 5 weeks following vaccination. The case meets level 1 diagnostic certainty for ADEM as the diagnosis was made on brain biopsy. Encephalomyelitis is considered a class effect of Influenza vaccines in general and proposed pathomechanism is immune-mediated damage myelin due to viral or vaccine-associated products. The illness is generally monophasic with complete recovery; hence an outcome of fatal as in this case is unusual and other factor such as concomitant medical condition and clinical course that caused fatal outcome were not specified. Causality is considered possibly related to CSL IVV due to the plausible temporal association, absence of other risk factors (not specified)such as other vaccination and viral infection. Reported Cause(s) of Death: Acute disseminated encephalomyelitis; Autopsy-determined Cause(s) of Death: Acute disseminated encephalomyelitis.


VAERS ID: 627859 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Iowa  
Vaccinated:2015-10-19
Onset:2015-10-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2016-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI475AA / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Ear pain, Malaise, Paralysis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-11-25
   Days after onset: 35
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:
Current Illness: None
Preexisting Conditions: See medical records
Allergies:
Diagnostic Lab Data: See medical records
CDC Split Type:

Write-up: 10/21/15 Malaise. Symptoms continued until hospitalized on 11/10/15 with high fever. 11/17/15 Went to doctor - still having low fever, malaise and ear pain. Hospitalized 11/18/15 weakness, paralysis.


VAERS ID: 604906 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2015-09-30
Onset:2015-10-20
   Days after vaccination:20
Submitted: 2015-10-26
   Days after onset:6
Entered: 2015-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 25L53 / UNK LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: COPD, STAGE 3 KIDNEY DISEASE, hx lung ca, anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death - pt had co-morbities at the time, poss pneumonia, pneumothorax. Death occurred on a subsequent admission not the same as Prevnar 13 administration.


VAERS ID: 608222 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Washington  
Vaccinated:2015-10-20
Onset:2015-10-20
   Days after vaccination:0
Submitted: 2015-11-09
   Days after onset:20
Entered: 2015-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI440AB / 2 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Asthma, Condition aggravated, Death, Decreased appetite, Disorientation, Dizziness, Flushing, Hallucination, Hyperhidrosis, Incontinence
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-06
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; Potassium chloride; Simvistatin; Morphine; Albuterol sulfate; QVAR; Hydrochlorothiazide; Ipratropium Ativan; Metoprolol Tartrate
Current Illness: No
Preexisting Conditions: Asthma, COPD, Depression, high blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flushing, dizziness, sweating and disoriented. Then he had an asthma attack. Was put on steroids. They helped minimally. Within the next few days he lost appetite, started hallucinating, lost continence and 17 days after his vaccination, he died.


VAERS ID: 609504 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2015-10-20
Onset:2015-10-20
   Days after vaccination:0
Submitted: 2015-11-08
   Days after onset:19
Entered: 2015-11-13
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 66521011802 / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Death, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vomiting; Loss of appetite
Preexisting Conditions: He had sepsis in April of 2015
Allergies:
Diagnostic Lab Data: Autopsy denied at hospital by medical examiner
CDC Split Type:

Write-up: Patient received Flu shot on October 20 and became ill the same day. He was vomiting and shivering. He died the day after receiving Flu shot.


VAERS ID: 604092 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Georgia  
Vaccinated:2015-10-19
Onset:2015-10-19
   Days after vaccination:0
Submitted: 2015-10-22
   Days after onset:3
Entered: 2015-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-10-19
   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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions: Cardiac operation; Heart disease congenital
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510USA009311

Write-up: This spontaneous report as received from a physician via a company representative refers to an approximately 2.5 year old male patient. The patient''s medical history included "hyperplastic left heart" and multiple unspecified heart surgeries. There was no information about the patient''s concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30, the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and expiration date were not reported), a dose of VARIVAX (Merck) (route of administration, lot # and expiration date were not reported) and a dose of an unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to the provider''s office, apparently in cardiac arrest. The reporter stated they began performing cardiopulmonary resuscitation (CPR) on the patient and called for an ambulance. The ambulance took the patient to an emergency room. The reporter stated they received a call from the coroner''s office at 15:00, and was informed that the child died (on 19-OCT-2015). The event of cardiac arrest was reported as life threatening. The outcome of cardiac arrest was reported as fatal, however the cause of death was not provided. The relatedness between the adverse event and suspect therapies was not reported. Upon internal review, the event of cardiac arrest was considered to be medically significant. Additional information has been requested.


VAERS ID: 605086 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Maryland  
Vaccinated:2015-10-08
Onset:2015-10-10
   Days after vaccination:2
Submitted: 2015-10-22
   Days after onset:12
Entered: 2015-10-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 173538 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure congestive, Death, General physical health deterioration, Hospice care
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX; MSIR; HALDOL; ZOFRAN; TYLENOL; Allopurinol; Amlodipine; COREG; Glipizide
Current Illness: Multiple chronic illnesses
Preexisting Conditions: Allergy: sulfa - see #7 for PMH
Allergies:
Diagnostic Lab Data: Family requested reporting of event.
CDC Split Type:

Write-up: Pt. was a home care hospice patient w/ a terminal diagnosis of CHF. Was in usual state of health on 10/08/2015. Son reports that patient began to rapidly decline over the next few days, ultimately dying on 10/15/15. RN reports no local reaction to vaccine. PMH significant for: DM II; cardiomyopathy; glaucoma; hypothyroidism; osteoporosis; renal insufficiency.


VAERS ID: 607797 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Virginia  
Vaccinated:2015-10-01
Onset:2015-10-10
   Days after vaccination:9
Submitted: 2015-11-05
   Days after onset:26
Entered: 2015-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI437AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood sodium increased, Hypernatraemia, Mental status changes
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-11-09
   Days after onset: 30
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: Flomax, Seroquel
Current Illness: None
Preexisting Conditions: Debility
Allergies:
Diagnostic Lab Data: Persistently elevated serum sodium, unresponsive to treatment.
CDC Split Type:

Write-up: Progressive hypernatremia to 180, with severe mental status changes.


VAERS ID: 601733 (history)  
Form: Version 1.0  
Age: 0.76  
Sex: Female  
Location: Virginia  
Vaccinated:2015-10-08
Onset:2015-10-08
   Days after vaccination:0
Submitted: 2015-10-09
   Days after onset:1
Entered: 2015-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5304FA / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Autopsy, Death, Life support, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-08
   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: None
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Afebrile, no acute illness noted.
CDC Split Type:

Write-up: Pt at well-baby office visit 10/08/15. Received Fluzone quadrivalent, preservative-free, 0.25 mL IM dose appropriately. About ~6 hours later, found unresponsive at home. Parents called 911. EMS arrived at ~22:15 and began CPR. Brought to the ED where CPR and ACLS continued. Death pronounced at ~22:50. Unclear by hospital summary whether sudden infant death or vaccine-related. Autopsy being conducted to provide further details.


VAERS ID: 608707 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Florida  
Vaccinated:2015-10-06
Onset:2015-10-07
   Days after vaccination:1
Submitted: 2015-11-03
   Days after onset:27
Entered: 2015-11-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR UI438AA / 2 UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Computerised tomogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-21
   Days after onset: 14
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: Hypertension; Prostate Ca
Allergies:
Diagnostic Lab Data: CT scan
CDC Split Type:

Write-up: Brain Hemorrhage.


VAERS ID: 638978 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2015-09-18
Onset:2015-09-21
   Days after vaccination:3
Submitted: 2016-06-13
   Days after onset:266
Entered: 2016-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI4228AB / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Feeling hot, Hyperhidrosis, Impaired work ability, Malaise, 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: 2015-09-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: The only other medications we were aware of that patient was taking was high blood pressure medications. Patient was also on a CPAP machine nightly for his Sleep Apnea. Patient and his brother both have taken the flu shot every year their
Current Illness: No.
Preexisting Conditions: High blood pressure and sleep apnea.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient started feeling ill after his night shift started. He worked as an overnight stocker at the location where he received the vaccination. As the night went on, patient started feeling sick and after his lunch break around 2 am he got hot, feverish and was sweating profusely. He went and sat down in the meat cooler to try and cool down for a few minutes. After awhile he told his supervisor and a co-worker that he was leaving to go home sick. He asked his co-worker to get the chair for him he left in the cooler and left his jacket there overnight. It is not like patient to leave work early, much less ask someone to get a chair for him that he left behind. The next night he called in sick again from work which was Sunday, Sept. 20, 2015. He died later that evening according to paramedics whom did not find him until a good friend and next door neighbor found him laying on the floor in his home dead on Monday, Sept. 21 around 6:39 PM. The paramedics and sheriff said he had been gone for possibly 18-24 hours.


VAERS ID: 584978 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-05
Onset:2015-05-21
   Days after vaccination:197
Submitted: 2015-07-07
   Days after onset:47
Entered: 2015-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 149202 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Atrial fibrillation, Cognitive disorder, Condition aggravated, Confabulation, Confusional state, Death, Diarrhoea, Dizziness, Dysphagia, Electroencephalogram abnormal, Electromyogram abnormal, Encephalitis post immunisation, Erythema, Gastrointestinal haemorrhage, Hiccups, Lumbar puncture abnormal, Lymphadenopathy, Lymphocytosis, Memory impairment, Meningioma, Nausea, Peripheral sensory neuropathy, Pleural disorder, Pneumonia, Polyneuropathy, Rectal haemorrhage, Retroperitoneal lymphadenopathy, Scan abnormal, Scan brain, Somnolence, Ureteral disorder, Urosepsis, Vertigo, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-21
   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: bisoprolol; metformin; ramipril; furosemide; LANOXIN
Current Illness: Paraesthesia; Asthenia; Hypertension; Bedridden; Claustrophobia; Diuretic therapy; Cardiac failure; Type 2 diabetes mellitus; Cardiac valve disease; Drug hypersensitivity; Dysphagia
Preexisting Conditions: Prostatectomy; Neoplasm; Carpal tunnel syndrome
Allergies:
Diagnostic Lab Data: Electroencephalogram, abnormal, significant, slow theta activity delta on the fronto temporal regions bilaterally that sometimes is organized in bilateral and synchronous bouffees. Intercurrent urosepsis have been reported; 04/02/2015, Electromyogram, abnormal, significant axonal sensory polyneuropathy of the lower limbs; Lumbar puncture, abnormal, significant detection of protein and CSF lymphocytosis; 03/26/2015, Scan brain, abnormal, significant, finding of meningioma; 04/04/2015, Scan brain, abnormal, significant finding of meningioma; 04/16/2015, Scan brain, abnormal, significant finding of meningioma
CDC Split Type: PHHY2015IT076594

Write-up: Case number PHHY2015IT076594, is an initial spontaneous report from a health care professional via Agency (reference number: 314800) received on 23 Jun 2015, with a follow up received from health care professional via Agency on 25 Jun 2015 with a follow up received from the quality assurance department (QA, reference number: 1002411) on 02 Jul 2015. This report refers to an 84-year-old male patient. The patient''s current conditions included diabetes mellitus maturity onset, systemic arterial hypertension, dysphagia to liquids, paresthesia in the upper limbs and strength deficit, decompensation cardiac and cardiac valve disease (mitral valvulopathy). The patient was allergic to penicillin and was on diuretic therapy. Past medical history included epithelioma and bilateral carpal tunnel syndrome. In the past the patient underwent prostatectomy. Concomitant medications included bisoprolol, metformin, ramipril, furosemide and LANOXIN. The patient was vaccinated with AGRIPPAL S1 (batch number: 149202) intramuscularly in to the left deltoid at a dose of 0.5 ml on 05 Nov 2014. On 12 Nov 2014, the patient experienced memory deficit, dizziness, postural instability, vertiginous syndrome, nausea, vomiting, diarrhea, worsening of existing paresthesia in the upper limbs and strength deficit. Further the patient had skin redness infiltrated of about seven cm in the deltoid region. The patient was hospitalized and the diagnosis was encephalitis after vaccination. The patient was hospitalized in department of neurosciences from 26 Mar 2015 to 12 May 2015. During hospitalization, the patient underwent radiological investigations. Among them computerized tomogram (CT) scan of the head, nuclear magnetic resonance imaging of the head were withdrawn due to claustrophobia. On 05 May 2015, the patient underwent lumbar tap, CT scan of the abdomen and of the chest, thoracentesis and lymph nodal inguinal biopsy on the right side anesthesiological class of the patient ASA3 without evidence of neuro-axial infections. However there was an evidence of suspected localization of lymphoproliferative disease at the pleural level, presence of lymphadenopathies at several levels, liver formation art the left liver lobe of 48 into 46 mm of not clear significance, presence of retroperitoneal lymphonodal tissue and/or fibrotic tissue that involve the ureter on the left side and the retroperitoneal region upstream of the bifurcation of the iliac in para-aortic on the left side. The patient underwent brain scan on 26 MAR 2015, 04 Apr 2015 and 16 Apr 2015 and it showed findings of meningioma. On 02 Apr 2015, electromyography revealed axonal sensory polyneuropathy of the lower limbs. In lumbar puncture there was a detection of protein and CSF lymphocytosis. On 14 Apr 2015, the patient underwent echo Doppler carotid arteries but the results were not reported. Electroencephalogram (EEG) showed slow theta activity delta on the fronto temporal regions bilaterally that sometimes was organized in bilateral and synchronous bouffees and inter-current urosepsis were reported. Later the patient was transferred on 12 May 2015 with the diagnosis of sub-acute cognitive deterioration, postural instability, suspected encephalitis and suspected lymphoproliferative disease associated with hemorrhage of the lower digestive ways under mild improvement. At the time of the transferring the patient was soporous, with a cognitive deterioration and was dysphagic as far as the liquids were concerned. Paroxystic atrial fibrillation was not treated prophylactically due to rectal bleeding of not determined nature and abdominal lesions under investigations in suspected lymphoproliferative disease. Further, patient presented with episodes of soporous state alternated with moments of greater alertness, mental confusion, confabulation, hiccups, and arrhythmias due to probable atrial fibrillation. Histological examination performed on the lymph node inguinal had no evidence of any localization of the lymphoproliferative disease in that area. The patient was initially mobilized to the armchair and was soon forced on to the bed. The outcome of the events was not reported. The patient at last presented with bilateral bronchopneumonia. On 21 May 2015, the patient died due to bilateral bronchopneumonia complicating hypokinetic adynamic syndrome secondary to possible encephalitis. It was reported that autopsy was not performed. The reporter considered causality to be suspected to the administration of AGRIPPAL S1 (vaccination may have contributed to the events). Follow up received from a health care professional via Agency on 25 Jun 2015: updated current condition (decompensation cardiac), concomitant medications (bisoprolol, metformin, ramipril, furosemide and LANOXIN), lab data (lumbar puncture, scan brain and electromyogram), new events (cognitive deterioration, rectal bleeding, sopor, mental confusion, confabulation, hiccups, atrial fibrillation, meningioma, lymphoproliferative disorder, generalised lymphadenopathy, retroperitoneal lymphadenopathy, sensory polyneuropathy axonal, urosepsis and bronchopneumonia) and other clinically relevant information in the narrative. Non significant follow-up received from Quality Assurance Department (QA, reference number: 1002411) on 02 Jul 2015: Updated QA reference number.


VAERS ID: 581908 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-23
Onset:2015-05-02
   Days after vaccination:9
Submitted: 2015-06-09
   Days after onset:38
Entered: 2015-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Death, Pneumonia, Squamous cell carcinoma of lung
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-09
   Days after onset: 7
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: ATROVENT; Azithromycin; Escitalopram; Heparin sodium; Hydrocortisone; TAMIFLU; TAZOCIN; Vancomycin hydrochloride
Current Illness:
Preexisting Conditions: Severe COPD; Lung cancer; Type 2 diabetes; Cholesterol
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015051497

Write-up: This medically confirmed health authority report (initial receipt 26-May-2015) concerns a 73 year old male patient who suffered from severe COPD (Chronic Obstructive Pulmonary Disease) and lung cancer and had a medical history of type II diabetes and cholesterol. On the 23-Apr-2015, the patient received the influenza vaccine (batch number ''4460'') from his GP (General Practitioner). On the 02-May-2015, the patient was tested positive for influenza A. Medications whilst in hospital included antibiotics, antivirals and heparin. They were piperacillin/tazobactam, azithromycin, ipratropium, vancomycin, heparin, hydrocortisone, oseltamivir, esomeprazole. On the 09-May-2015, the patient died. The cause of death was pneumonia, severe COPD, squamous cell carcinoma of the lung. Outcome was fatal. Reporter comments: The regulator reported the case as possible in relation to the influenza vaccine. There was no autopsy/Coroners court report. The regulator reported the Preferred Term of concomitant disease progression.


VAERS ID: 621718 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Male  
Location: North Carolina  
Vaccinated:2013-11-06
Onset:2015-03-12
   Days after vaccination:491
Submitted: 2016-02-03
   Days after onset:328
Entered: 2016-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS J5LP9 / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4694EA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS NY79F / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH850AB / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G75064 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J005237 / 3 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Blood chloride decreased, Blood sodium decreased, Blood urea increased, Death, Dehydration, Gastroenteritis, Hyponatraemia, Rotavirus infection, Rotavirus test positive
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Rotavirus A detected by stool culture. Eye vitreous electrolytes detected low sodium of 116, low chloride and high urea nitrogen level supporting diagnosis of hyponatremic dehydration.
CDC Split Type:

Write-up: Child received three vaccines with Rotateq at age 2, 4, and 6 months, however, he contracted gastroenteritis on 3/12/15 and died from dehydration and Rota Virus A infection on 3/13/15 which was detected on autopsy.


VAERS ID: 565640 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Massachusetts  
Vaccinated:2015-02-13
Onset:2015-02-14
   Days after vaccination:1
Submitted: 2015-02-18
   Days after onset:4
Entered: 2015-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS F4327 / 1 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U5064AB / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Peripheral coldness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine; POLY-VI-SOL; Mupirocin Ointment
Current Illness: None
Preexisting Conditions: Cerebral palsy; Dystonia; Ischemic Encephalopathy; Central Vision Improvement; Microcephaly
Allergies:
Diagnostic Lab Data: Hospitalization for bronchiolitis - improved
CDC Split Type:

Write-up: Received first vaccines 2/13/15, no apparent problems that afternoon or evening, found dead in crib following AM - cold, likely died hours before. Complex PMH following anoxic/ischemic brain injury at birth. Hx seizures, weaned off anticonvulsants - 2m ago after EEG normal.


VAERS ID: 575349 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-11
Onset:2015-02-13
   Days after vaccination:94
Submitted: 2015-02-25
   Days after onset:12
Entered: 2015-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 148201A / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Multi-organ failure, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-17
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Endocarditis; Myocarditis; Cardiac failure chronic; Chronic obstructive pulmonary disease; Sleep apnoea syndrome; Obesity; Cardiac assistance device user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015DE022198

Write-up: Case number PHHY2015DE022198 is a combined initial and follow up spontaneous report from a physician via Novartis Medical Information Center (MIC: 1-411909385) received on 24 Feb 2015. This report refers to a 47-year-old male patient. His current conditions included an endocarditis and myocarditis due to which the patient suffered since several year from chronic heart failure. He had a pacemaker, chronic obstructive pulmonary disease (COPD grade III to IV), sleeping apnea and was obese. On 11 Nov 2014, the patient was vaccinated with BEGRIPAL (batch number: 148201A). On 13 Feb 2015, the patient suffered from multi organ failure and influenza. The physician reported a vaccination failure. The patient was hospitalized due to the events. The patient died on 17 Feb 2015 at 01:30 due to multi organ failure and influenza. No autopsy scheduled. At the time of reporting, no additional information was available and medical reports as well as testing results for detection of influenza were requested. The causality of the events was not reported.


VAERS ID: 658368 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Florida  
Vaccinated:2015-01-19
Onset:2015-02-01
   Days after vaccination:13
Submitted: 2016-10-10
   Days after onset:616
Entered: 2016-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Death, Dyspnoea, Fatigue, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Paralysis, Respiratory distress, Tracheostomy, Walking aid user
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-06-02
   Days after onset: 486
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hip surgery - osteoarthritis
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: January 2015 - patient received vaccine during hip surgery. February 2015 - experienced tingling and numbness in hand/arms and impaired breathing continued and extreme fatigue. May - difficulty walking, used a walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory distress and had tracheostomy; treatment during period included immunosuppressants. Died on 6/2/16.


VAERS ID: 630787 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: New York  
Vaccinated:2015-01-14
Onset:2015-01-14
   Days after vaccination:0
Submitted: 2016-04-09
   Days after onset:450
Entered: 2016-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI245AA / 7+ LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4812AA / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin, Levothyroxine, Albuterol
Current Illness: Within a couple of days, flu like symptoms developed. Death followed, early on January 19th. Coroner only mentioned pneumonia, which was not present prior to vaccination.
Preexisting Conditions: Diabetes, Asthma, more
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu like symptoms, followed by death on Jan 19. Coroner mentioned pneumonia.


VAERS ID: 560533 (history)  
Form: Version 1.0  
Age: 1.19  
Sex: Male  
Location: California  
Vaccinated:2014-12-22
Onset:2014-12-30
   Days after vaccination:8
Submitted: 2015-01-05
   Days after onset:6
Entered: 2015-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5036CA / 2 LA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI067AA / 4 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J23867 / 4 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-30
   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: None
Current Illness: No
Preexisting Conditions: Erb''s Palsy at birth; fully resolved.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was found deceased in his crib on the morning of 12/30/2014. He did have a fever of 102 the night before.


VAERS ID: 568987 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Indiana  
Vaccinated:2014-10-13
Onset:2014-12-27
   Days after vaccination:75
Submitted: 2015-03-05
   Days after onset:68
Entered: 2015-03-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI205AC / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Laboratory test abnormal, Pneumonia
SMQs:, 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: 2014-12-28
   Days after onset: 1
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: None
Current Illness: UNK
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Lab tests reported as - "ER + flu + pneumonia"
CDC Split Type: 2015SA023893

Write-up: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924, 2015SA023928. A 74 year-old patient, gender unknown had received on 13 October 2014 in the morning, an intramuscular left arm injection of FLUZONE QUADRIVALENT, lot number UI205AC with expiration date of June 2015 and at an unspecified time after vaccination was diagnosed with flu and pneumonia; the patient died on 28 December 2014, approximately 3 months after vaccination. Relevant diagnostic tests were reported as "ER + flu + pneumonia". Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.


VAERS ID: 753156 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-17
Onset:2014-12-17
   Days after vaccination:0
Submitted: 2018-05-31
   Days after onset:1260
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143401 / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Death, Hypotension, Incorrect route of product administration, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-29
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOX; TRITTICO; NORVASC; CARDIOASPIRIN; TAVOR
Current Illness:
Preexisting Conditions: Steroid therapy; Mastitis bacterial, in 2006 hospitalization; Vascular encephalopathy; Cognitive impairment; Feeding disorder; COPD; Percutaneous endoscopic gastrostomy, about 1 year
Allergies:
Diagnostic Lab Data: 17-DEC-2014, Blood pressure measurement, 140/80, normal; 17-DEC-2014, Blood pressure measurement, 85/50, depressed; 17-DEC-2014, Blood pressure measurement, 110/70, depressed
CDC Split Type: PHHY2014IT167250

Write-up: Case number PHHY2014IT67250 is a combined initial spontaneous report received from a Health Authority (HA, reference number: 285972) on 22 Dec 2014, with follow up information received on the same date, with a combined follow up received from Health Authority on 09 Jan 2015 and 12 Jan 2015 respectively, with the follow-up information received from Quality Assurance Department (reference number: 344592) on 15 Jan 2015 and a follow up received from Health Authority on 21 Jan 2015. This report refers to a 95 years old female patient. The patient''s past medical history included tuberculous mastitis (hospitalized in 2006), chronic obstructive pulmonary disease (COPD), chronic vascular encephalopathy, severe cognitive impairment with refusal to feed. For about one year the patient was a carrier of percutaneous endoscopic gastrostomy. Concomitant medications included LANSOX, TRITTICO, NORVASC, CARDIOASPIRIN and TAVOR. Vaccination history included administration of influenza vaccine (manufacturer unknown, batch number: not reported). She was vaccinated with FLUAD (batch number: 143401) subcutaneously (characterised as inappropriate route of vaccination) in the left deltoid at a dose of 0.5 ml on 17 Dec 2014 approximately at 16:00. Subsequent to the vaccination, the patient blood pressure was 140/80 mmHg, was in good health and answering to the questions. On the same day three hours after the vaccination, the patient experienced vomiting, tachycardia and hypotension (blood pressure: around 85/50 and saturation 94%). The patient was administered regular fluid infusion at drip slowly (saline, vial 500 cc plus URBASON 20 mg) and administered liquids. The patient was stabilized. The blood pressure of the patient recovered to 110/70 mmHg. Therapy with concomitant medications TRITTICO, TAVOR and NORVASC was interrupted after the adverse events. In the following days, the patient had high and low pressure and the patient was put on corticosteroid therapy (URBASON 20 mg) by infusion in saline once daily. On 24 Dec 2014, emergency service was called and the physician confirmed to administer the current treatment of the patient. On 29 Dec 2014, the patient died due to drowsiness in senile cachexia. The outcome of the events was fatal. It was reported that autopsy was not performed. The Health Authority assessed the case as serious and causality as unassessable (reported as undetermined) to the administration of FLUAD. Based on the performed review on FLUAD batch number: 143401, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Combined follow up received from Health Authority on 09 Jan 2015 and 12 Jan 2015 respectively: updated medical history, vaccination history, lab data, outcome of the events and other clinically relevant information in the narrative. Follow-up Information received from the Quality Assurance Department (reference number: 3445492) on 15 Jan 2015: Updated FLUAD batch review report. Follow up received from Health Authority on 21 Jan 2015: updated concomitant medications and HA comment (autopsy was not performed). Follow-up information received on 07-Jun-2017, from physician via Health Authority (RNF: IT-MINISAL02-285972): Added patient initials, medical history (percutaneous endoscopic carrier for a year), cause of death, added event (inappropriate route of vaccination), updated events details. Case Comment: MAC: This 95 year old patient with severe cognitive impairment, cachexia and a PEG feeding tube, developed hypotension, tachycardia, vomiting, and oxygen desaturation approximately 3 hours following vaccination. Although the close temporal relationship of the events to the vaccine raise the possibility of a hypersensitivity reaction, it was reported that she was treated with IV fluids and liquids with recovery on the same day, suggests her hypotension may also have been related to dehydration, a frequent complication of chronic cachexia and tube feedings. Over the subsequently days, exact onset was not reported, her blood pressure fluctuated and she was started on corticosteroids for unspecified reasons. Twelve days after the vaccination and an unspecified number of days following fluctuation of her blood pressure, it was reported that she died due to "senile cachexia". Based on the reported date, the most likely cause of death appears to be advanced age, senile cognitive impairment and chronic cachexia: a causal relationship to FLUAD vaccination appears unlikely.


VAERS ID: 562088 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-12-11
Onset:2014-12-11
   Days after vaccination:0
Submitted: 2014-12-22
   Days after onset:11
Entered: 2014-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR L8304 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J81984 / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014347925

Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 285002. A general practitioner (contactable through Regulatory Authority only) referred that a 67-year-old male patient received on 11Dec2014 a dose of PREVENAR 13 (Lot n. J81984 expiration date 31May2017) subcutaneous and INTANZA (Lot n. L8304-1, expiration date 30Jun2015) subcutaneous. The patient medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 11Dec2014 after 90 minutes from vaccination. The emergency medical service was contacted. The patient died on 11Dec2014.


VAERS ID: 567040 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2014-12-02
Onset:2014-12-02
   Days after vaccination:0
Submitted: 2015-02-25
   Days after onset:85
Entered: 2015-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5008BA / UNK UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody positive, Asthenia, Biopsy kidney normal, Biopsy lung normal, Chest pain, Chills, Cough, Culture negative, Death, Dyspnoea, Influenza like illness, Intensive care, Nausea, Pneumonia, Renal failure acute, Respiratory failure, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-02-23
   Days after onset: 83
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Psyllium 1.7g PO BID; chloecalciferol 50,000 IU PO monthly; amlodipine 2.5 mg daily; dicyclomine 10mg PO QID; clopidogrel 75mg PO daily; pravastatin 40 mg PO at bedtime; citalopram 20mg PO daily; metoprolol 50mg PO BID
Current Illness:
Preexisting Conditions: Hypertension, fibromyalgia, atrial fibrillation, CVA
Allergies:
Diagnostic Lab Data: Anti-myeloperoxidase Ab = 5.7 AI on 1/27 Anti-myeloperoxidase Ab = 5.2 AI on 2/6 Anti-proteinase 3 Ab = < 1.0 AI on 1/27 Anti-proteinase 3 Ab = < 1.0 AI on 2/6 Renal and lung biopsies both negative for vasculitis
CDC Split Type:

Write-up: Patient started out with flu-like symptoms starting on the night after the vaccine was administered. Per family, patient never fully returned to baseline state of health. Patient went on to develop chest pain and presented to hospital on 12/27 complaining of chest pain. ACS was ruled out and patient was discharged home the next day with a course of Ceftin for suspected pneumonia. Patient presented to the ED again on 1/22 with complaints of weakness, chills, nausea, dry cough, and increased shortness of breath. Patient was quickly transferred to the MICU with respiratory failure and acute renal failure. Patient was treated for pneumonia but did not respond to antibiotics and all cultures were negative. Patient was subsequently treated for suspected vasculitis based on ANCA studies with cyclophosphamide and methylprednisolone but subsequently expired on 2/23.


VAERS ID: 573517 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-11
Onset:2014-12-01
   Days after vaccination:20
Submitted: 2014-12-26
   Days after onset:25
Entered: 2015-01-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT168563

Write-up: Case number PHHY2014IT168563, is an initial spontaneous report from a consumer (journalist) via company representative received on 23 Dec 2014. This report refers to an 84-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was in good clinical condition before the vaccination. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 11 Nov 2014. On an unknown date, a few days after vaccination, the patient experienced malaise and the patient hospitalized. The patient''s malaise seemed to be transitory. In Dec 2014, about a month after the vaccination, the patient''s general malaise worsened quickly and the patient had respiratory complications. The outcome of the events was fatal. The cause of death seemed to be respiratory complications. The medical staff had ordered an autopsy and investigational examination but the results were not available. The medical staff excluded the relationship between vaccination and the events. The patient''s family stated that the patient was in good condition before the vaccination. The patient condition had worsened after the vaccination followed by a sudden aggravation which required hospitalization. Seriousness of the events was reported as death and hospitalization and causality to be suspected to the administration of the vaccine.


VAERS ID: 874858 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-11
Onset:2014-12-01
Submitted: 0000-00-00
Entered: 2020-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 379C / UNK - / OT
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER V2125 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Ammonia increased, Aspartate aminotransferase increased, Base excess decreased, Blood bicarbonate normal, Blood chromium, Blood creatine phosphokinase increased, Blood culture negative, Blood pH decreased, Blood urea increased, Brain oedema, C-reactive protein increased, CSF cell count normal, CSF glucose increased, CSF protein normal, CSF test, Chills, Coagulation time shortened, Coagulopathy, Coma scale, Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal, Computerised tomogram neck, Computerised tomogram thorax abnormal, Death, Dehydration, Diarrhoea, Electroencephalogram abnormal, Encephalopathy, Endotracheal intubation, Epistaxis, Fibrin D dimer increased, Fibrin degradation products increased, Gastric haemorrhage, Gastroenteritis, Haemoglobin decreased, Hepatic function abnormal, Hepatitis, Influenza virus test negative, International normalised ratio increased, Low density lipoprotein increased, Mechanical ventilation, Metabolic acidosis, Mouth haemorrhage, Multi-organ disorder, Oliguria, PCO2 increased, Pancreatic enlargement, Platelet count, Pneumonia, Prothrombin time prolonged, Pyrexia, Renal failure, Seizure, Shock haemorrhagic, Status epilepticus, Streptococcus test negative, Tonsillitis, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-01
   Days after onset: 31
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: ONON; BUDESONIDE; ALERCON [OLOPATADINE HYDROCHLORIDE]; CROMOGLICATE SODIUM; MEPTIN; TULOBUTEROL; IMOVAX POLIO subcutaneous
Current Illness: Asthma bronchial; Nasal congestion
Preexisting Conditions: Comments: Febrile convulsion (elder brother) Historical condition: None Allergy history: None Adverse drug reaction history: None
Allergies:
Diagnostic Lab Data: Test Date: 20141230; Test Name: APTT; Result Unstructured Data: ABOVE 150; Test Date: 20141229; Test Name: Ammonia; Test Result: 138 {DF}; Test Date: 20141230; Test Name: aspartate aminotransferase; Result Unstructured Data: ABOVE 7000; Test Date: 20141229; Test Name: BE; Test Result: -12.6 {DF}; Test Date: 20141229; Test Name: bicarbonate; Test Result: 24.7 {DF}; Test Date: 20141229; Test Name: chromium; Test Result: 0.7 {DF}; Test Date: 20141230; Test Name: chromium; Test Result: 2.9 {DF}; Test Date: 20141230; Test Name: Creatine Kinase; Result Unstructured Data: ABOVE 16000 iU/L; Test Date: 20141230; Test Name: blood culture; Test Result: Negative ; Test Date: 20141230; Test Name: BUN; Test Result: 38 {DF}; Test Date: 20141229; Test Name: body temperature; Result Unstructured Data: Before vaccination: 36.5 degrees C; around 05:00: 38-40 degrees C; Test Date: 20141230; Test Name: Coagulation time; Result Unstructured Data: BELOW 10; Test Date: 20141229; Test Name: coma scale; Result Unstructured Data: 200-300; Test Date: 20141229; Test Name: Neck CT; Result Unstructured Data: Normal; Test Date: 20141229; Test Name: c-Reactive protein; Test Result: 3.5 {DF}; Test Date: 20141229; Test Name: CSF cell count; Test Result: 1 {DF}; Test Date: 20141229; Test Name: CSF cell count NOS; Test Result: 1 {DF}; Test Date: 20141229; Test Name: CSF glucose; Test Result: 114 {DF}; Test Date: 20141229; Test Name: CSF protein; Test Result: 29 {DF}; Test Date: 20141229; Test Name: CSF test; Test Result: 25 {DF}; Test Date: 20141230; Test Name: Fragment D dimer; Result Unstructured Data: ABOVE 600; Test Date: 20141230; Test Name: Fibrin degradation products; Result Unstructured Data: ABOVE 1200; Test Date: 20141230; Test Name: haemoglobin; Test Result: 4.0 {DF}; Test Date: 20141229; Test Name: inr; Test Result: 1.42 {DF}; Test Date: 20141230; Test Name: LDL; Result Unstructured Data: ABOVE 8000 IU/L; Test Date: 20141229; Test Name: PCO2; Test Result: 140 {DF}; Test Name: pH; Test Result: 6.07 {DF}; Test Date: 20141229; Test Name: pH; Test Result: 6.87 {DF}; Test Date: 20141230; Test Name: Platelet count; Test Result: 1.6 {DF}; Test Date: 20141230; Test Name: prothrombin time; Result Unstructured Data: ABOVE THE MEASURING UPPER LIMIT; Test Date: 20141229; Test Name: Prothrombin time; Test Result: 1.42 {DF}; Test Date: 20141229; Test Name: WBC; Test Result: 14500 {DF}
CDC Split Type: JPSA2015SA031780

Write-up: Brain oedema; pneumonia; Chills; vomiting; body temperature of 38-40 degrees C; Metabolic acidosis; Diarrhoea; dehydration; Gastroenteritis; Tonsillitis; Shock haemorrhagic; haemorrhage from the nasal cavity; Mouth haemorrhage; Gastric haemorrhage; Encephalopathy acute; status epilepticus; Convulsive seizure; Multi-organ disorder; renal failure; oliguria; Hepatic function disorder; coagulation disorder; Initial information received on 12-Mar-2015 regarding an unsolicited valid serious case received from Health Authorities under reference JP-SA-2015SA031780. This case involves a 35 months old female patient (3.644 kg) who experienced encephalopathy acute and shock haemorrhagic, while she received vaccine IPV (VERO) [IMOVAX POLIO subcutaneous] and while treated with INFLUENZA VACCINE and VARICELLA ZOSTER VACCINE LIVE [VARICELLA VACCINE LIVE ATTENUATED]. The patient''s past vaccination(s) included VARICELLA ZOSTER VACCINE LIVE, IPV (1st dose), IPV (2nd dose), IPV (3rd dose), MEASLES VACCINE LIVE;RUBELLA VACCINE LIVE (Vaccine only, Lot#: UNKNOWN, Manufacturer: OTHER), ACT-HIB (Vaccine only, Lot#: UNKNOWN, Manufacturer: OTHER), PREVENAR (Vaccine only, Lot#: UNKNOWN, Manufacturer: OTHER) and DRIED BCG VACCINE (Vaccine only, Lot#: UNKNOWN, Manufacturer: OTHER). The patient''s past medical history and medical treatment(s) were not provided. At the time of the event, the patient had ongoing Asthma since 01-JUL-2014 and Nasal congestion. Notes: Family history: Febrile convulsion (elder brother) Historical condition: None Allergy history: None Adverse drug reaction history: None Birth weight: 3644 g Concomitant medications included PRANLUKAST (ONON) for Asthma; BUDESONIDE (BUDESONIDE) for Asthma; OLOPATADINE HYDROCHLORIDE (ALERCON [OLOPATADINE HYDROCHLORIDE]) for Asthma; CROMOGLICATE SODIUM (CROMOGLICATE SODIUM) for Asthma; PROCATEROL HYDROCHLORIDE (MEPTIN) for Asthma; and TULOBUTEROL (TULOBUTEROL) for Asthma. On 01-Jul-2014, the patient was diagnosed as having bronchial asthma, for which pranlukast hydrate, budesonide, olopatadine hydrochloride, sodium cromoglicate and procaterol hydrochloride hydrate were prescribed. On 11-Dec-2014, the patient received simultaneous vaccinations with INFLUENZA VACCINE (Lot No. 379C), IPV (booster immunization, Lot No. J0235) at 0.5 mL and VARICELLA ZOSTER VACCINE LIVE (Lot No. V2125) at hospital A. Body temperature before the vaccinations was 36.5 degrees C. Before and after the vaccination, the patient had nasal congestion but did not have pyrexia or cough, and the symptoms of bronchial asthma had been controlled. On 26-Dec-2014, TULOBUTEROL was additionally prescribed for bronchial asthma. On 29-Dec-2014, around 05:00, the patient had vomiting and was seen at hospital A. Body temperature was 38-40 degrees C. Gastroenteritis, tonsillitis, and dehydration were observed. A test for infection was negative for influenza virus and hemolytic streptococcus. At 13:15, DOMPERIDONE was administered. At 14:00, the patient received 3/4 of one ACETAMINOPHEN suppository. The patient went home after being prescribed an antibacterial drug. After the patient went home, she was active and took a bath after eating meal. She did not take the antibacterial drug. Around 23:00, the patient began to have chills, and an ambulance was called. During the transportation, she had convulsion, and ventilation using a bag valve mask was performed. At 23:40, the patient arrived hospital B. On arrival, the level of conscious was 200-300 on the Coma Scale, and diarrhoea, haemorrhage from the nasal cavity, mouth haemorrhage, and a small amount of gastric haemorrhage were observed. She suffered from status epilepticus, and received an anticonvulsant drug. However, convulsion persisted. Then, convulsion disappeared with diazepam, midazolam, and thiopental. However, the respiratory condition was unstable, and the patient was intubated and placed on mechanical ventilation. Head CT was normal. Cerebrospinal fluid cell count was 1/mcL; cerebrospinal fluid protein, 29 mg/dL; cerebrospinal fluid glucose, 114 mg/dL; cerebrospinal fluid lactose, 25 mg/dL. Hematology and biochemistry tests and blood gas analysis: WBC (white blood cells), 14500/mcL, PT-INR (prothrombin time and International Normalized Ratio), 1.42; pH, 6.87; PCO2, 140 mmHg; HCO3-, 24.7 nmol/L; BE, -12.6 nmol/L; C-Reactive Protein, 3.5 mg/dL; NH3-138 mcg/dL; Chromium, 0.7 mg/dL. The results suggested metabolic acidosis. The patient was diagnosed as having acute encephalopathy, which was treated with steroid pulse therapy, ACICLOVIR, antibacterial drug, and etc. On 30-Dec-2014, head CT showed diffuse cerebral oedema, and chest and abdominal CT showed pneumonia, mild inflammation around the intrahepatic portal vein, and mild swelling of the pancreas. Subsequently, on an unknown day in Dec-2014, electroencephalogram showed a low voltage pattern, and shock state, coagulation disorder, renal failure, hepatic function disorder, and multi-organ disorder occurred. Oliguria was also observed. Hematology and biochemistry tests during hospitalization: Hb (hemoglobin), 4.0 g/dL; BUN (Blood urea nitrogen)-38 mg/dL; Cr, 2.9 mg/dL; AST, above 7000 IU/L; ALT, 9400 IU/L; LDL, above 8000 IU/L; CK (creatine kinase) above 16000 IU/L; PLT, 1.6x10^4/mcL; PT, above the measuring upper limit; coagulation activity below 10; APTT above 150 sec; serum FDP, above 1200 mcg/mL; D-dimer, above 600 mcg/mL; blood culture was negative. On 01-Jan-2015, at 20:38, the patient was confirmed dead. The cause of death was hemorrhagic shock and encephalopathy syndrome. At that time, no diagnostic imaging or autopsy was performed. The patient developed a serious encephalopathy acute (encephalopathy) 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious shock haemorrhagic 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious status epilepticus 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious convulsive seizure (seizure) 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious multi-organ disorder. This event was assessed as medically significant and was leading to death. The patient was hospitalized for this event. The patient developed a serious brain oedema 19 days following the administration of IPV (VERO), 19 days following the first dose intake and 18 days following the last dose intake of INFLUENZA VACCINE and 19 days following the first dose intake and 18 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was already hospitalized when the event occurred. The patient developed a serious renal failure. This event was assessed as medically significant and was leading to death. The patient was hospitalized for this event. The patient developed a serious oliguria. This event was assessed as medically significant and was leading to death. The patient was hospitalized for this event. The patient developed a serious hepatic function disorder (hepatic function abnormal). This event was assessed as medically significant and was leading to death. The patient was hospitalized for this event. The patient developed a serious pneumonia 19 days following the administration of IPV (VERO), 19 days following the first dose intake and 18 days following the last dose intake of INFLUENZA VACCINE and 19 days following the first dose intake and 18 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was already hospitalized when the event occurred. The patient developed a serious metabolic acidosis 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious diarrhoea 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious dehydration 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious vomiting 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was already hospitalized when the event occurred. The patient developed a serious body temperature of 38-40 degrees c (pyrexia) 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious chills 19 days following the administration of IPV (VERO), 19 days following the first dose intake and 18 days following the last dose intake of INFLUENZA VACCINE and 19 days following the first dose intake and 18 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was already hospitalized when the event occurred. The patient developed a serious gastroenteritis 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious tonsillitis 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious haemorrhage from the nasal cavity (epistaxis) 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious mouth haemorrhage 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious gastric haemorrhage 18 days following the administration of IPV (VERO), 18 days following the first dose intake and 17 days following the last dose intake of INFLUENZA VACCINE and 18 days following the first dose intake and 17 days following the last dose intake of VARICELLA ZOSTER VACCINE LIVE. This event was assessed as medically significant and was leading to death. The patient was hospitalized on the same day this event occurred. The patient developed a serious coagulation disorder (coagulopathy). This event was assessed as medically significant and was leading to death. The patient was hospitalized for this event. Relevant laboratory test results included: Activated partial thromboplastin time - On 30-Dec-2014: [ABOVE 150] Ammonia - On 29-Dec-2014: 138 UNK Aspartate aminotransferase - On 30-Dec-2014: [ABOVE 7000 iU/L]; on an unknown date: Base excess - On 29-Dec-2014: -12.6 mmol/L Blood bicarbonate - On 29-Dec-2014: 24.7 mmol/L Blood chromium - On 29-Dec-2014: 0.7 mg/dL; on 30-Dec-2014: 2.9 mg/dL Blood creatine phosphokinase - On 30-Dec-2014: [ABOVE 16000 iU/L] Blood culture - On 30-Dec-2014: Negative Blood urea - On 30-Dec-2014: 38 mg/dL Body temperature - On 29-Dec-2014: [Before vaccination: 36.5 degrees C; around 05:00: 38-40 degrees C] C-reactive protein - On 29-Dec-2014: 3.5 mg/dL CSF cell count - On 29-Dec-2014: 1 UNK then 1 /uL CSF glucose - On 29-Dec-2014: 114 mg/dL CSF protein - On 29-Dec-2014: 29 mg/dL CSF test - On 29-Dec-2014: 25 mg/dL Coagulation time - On 30-Dec-2014: [BELOW 10] Coma scale - On 29-Dec-2014: [200-300] Computerised tomogram neck - On 29-Dec-2014: [Normal] Fibrin D dimer - On 30-Dec-2014: [ABOVE 600] Fibrin degradation products - On 30-Dec-2014: [ABOVE 1200] Haemoglobin - On 30-Dec-2014: 4.0 g/dL International normalised ratio - On 29-Dec-2014: 1.42 UNK Low density lipoprotein - On 30-Dec-2014: [ABOVE 8000 IU/L] PCO2 - On 29-Dec-2014: 140 mmHg Platelet count - On 30-Dec-2014: 1.6 10*4 Prothrombin time - On 29-Dec-2014: 1.42 UNK; on 30-Dec-2014: [ABOVE THE MEASURING UPPER LIMIT] White blood cell count - On 29-Dec-2014: 14500 UNK pH body fluid - On 29-Dec-2014: 6.87 UNK; on an unknown date: 6.07 UNK Final diagnosis was (fatal) shock haemorrhagic and (fatal) encephalopathy acute. The patient was treated with DIAZEPAM (DIAZEPAM) for Encephalopathy, MIDAZOLAM (MIDAZOLAM) for Encephalopathy, THIOPENTAL SODIUM (THIOPENTAL SODIUM) for Encephalopathy, DOMPERIDONE (DOMPERIDONE) for Encephalopathy, ACETAMINOPHEN (ACETAMINOPHEN) for Encephalopathy and ACICLOVIR (ACICLOVIR) for Encephalopathy. The patient outcome is reported as Fatal on 01-Jan-2015 for encephalopathy acute, status epilepticus, convulsive seizure, shock haemorrhagic, multi-organ disorder, brain oedema, renal failure, oliguria, hepatic function disorder, coagulation disorder, haemorrhage from the nasal cavity, mouth haemorrhage, gastric haemorrhage, pneumonia, metabolic acidosis, diarrhoea, dehydration, vomiting, body temperature of 38-40 degrees c, chills, gastroenteritis, and tonsillitis. No autopsy was done. The cause of death was reported as Encephalopathy and Shock haemorrhagic. Reporter comment: The treating physician of hospital B commented the following: the possibility of the events having been induced by some kind of infection was considered; however, the pathogen was not identified and infection was unproved; in addition, the causalities of the events to the vaccines were unknown. The physician of hospital A who had administered the vaccines commented the following: Although the event was considered to have been due to some kind of infection, no virus antibody titer tests had been performed, and the cause of the events was unknown. The causalities of the events to the vaccines seemed unlikely. Additional information was received on 27-Nov-2015 from health authority: The patient''s underlying condition or concurrent condition reported as bronchial asthma. It was reported that on 29 December 2015 the patient also had chills (18 days after the vaccinations). No autopsy was performed. Additional information was received on 08-Dec-2015 from the authority: Updated clinical course and medical history. Internal review on 26-Jun-2020: Updated event death details, other relevant history, laboratory data, product information, adverse event information, and clinical course.; Sender''s Cojmments: This case concerns a 35 month old baby who died due to acute encephalopathy and haemorrhagic shock after vaccination. The time to onset is compatible. Clinical features are suggestive of an underlying infection but reportedly no pathogen was identified, however the infectious work-up was very limited and the patient may have received antibiotics and antivirals before the conduction of the tests. Based on data available, the role of the vaccine appears unlikely.; Reported Cause(s) of Death: encephalopathy acute; Shock haemorrhagic


VAERS ID: 560982 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2014-05-12
Onset:2014-11-30
   Days after vaccination:202
Submitted: 2015-01-12
   Days after onset:43
Entered: 2015-01-12
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, Oesophageal carcinoma
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Human immunodeficiency virus.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015047726

Write-up: This medically confirmed spontaneous report (initial receipt-29-Dec-2014) concerns a patient of unknown demography. The patient had a concurrent condition of human immunodeficiency virus which was contributing to death but not resulting in the underlying cause of death. On 12-May-2014, the patient received influenza virus vaccine (manufacturer and batch number not reported). On 30-Nov-2014, the patient died due to metastatic esophageal carcinoma. The Medical Examiner or Coroner was contacted. The outcome was reported as fatal. Reporter comments: It was unknown if tobacco contributed to death. The manner of death was natural.


VAERS ID: 700097 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-30
Submitted: 2017-06-11
   Days after onset:923
Entered: 2017-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700834

Write-up: This initial spontaneous case received on 05-Jun-2017, was reported by other non-health professional via health authority (RNF: IT-MINISAL02-282899) and concerns a female patient of an unspecified age. On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, trade name manufacturer, batch number and expiration date: not reported). On 30-Nov-2014, the patient experienced diarrhoea and fever. As a result, the patient was died on an unspecified date and it was unknown if an autopsy was performed or not. The Health Authority stated that, the outcome was not due to the INN Flu Vaccine Seasonal and assessed the causality between events and INN Flu Vaccine Seasonal as related. This report was serious (death).


VAERS ID: 753293 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-25
Onset:2014-11-29
   Days after vaccination:4
Submitted: 2018-05-31
   Days after onset:1278
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test normal, Cachexia, Cardiac disorder, Death, Interstitial lung disease, Ischaemic cardiomyopathy, Large cell lung cancer, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tiklid; TRIATEC; LOBIVON; LAROXYL; LASIX; SINVACOR; ZYLORIC; Minias
Current Illness: Hemiparesis (left); Post procedural stroke; Bedridden; Malnutrition; Dehydration; Pressure sore; Urinary incontinence; Living in care; Postictal state
Preexisting Conditions: Stroke
Allergies:
Diagnostic Lab Data: Blood test, Normal, In the past
CDC Split Type: PHHY2014IT158328

Write-up: Case number PHHY2014IT158328 is an initial spontaneous report received from a health care professional via health authority (HA reference number: 282518) on 03 Dec 2014 with a follow-up information received from Quality Assurance Department (QA reference number: 340731) on 09 Dec 2014 and a follow up information received from the health authority on 06 Apr 2015. This case refers to an 88 years old male patient. His current conditions included left hemiparesis and post stroke state. He was under integrated home care and was bedridden with malnutrition and dehydration complicated by pressure ulcer at the third stage with left hemiparesis from previous stroke and urinary incontinence. His blood test was normal in the past. Concomitant medication included Tiklid 250 mg coated tablet 1 dosage form daily, TRIATEC 5 mg tablet 1 dosage form daily, LOBIVON 5 mg tablet 1 dosage form daily, LAROXYL 40 mg/ml oral drops at a dose of 5 drops daily, LASIX 25 mg tablet, SINVACOR 40 mg film coated tablet, ZYLORIC 300 mg tablet 1 dosage form daily and Minias 2.5 mg/ml oral drops at a dose of 20 drops daily. He was vaccinated with FLUAD (batch number: 143301, expiry date: 31 Jul 2015) at dose of 0.5 ml intramuscularly on 25 Nov 2014. On 29 Nov 2014, the patient died. Autopsy was done and the results revealed that the cause of death was "senile cachexia in patient with chronic ischemic cardiomyopathy, large cell lung cancer, interstitial pneumonia, left hemiparesis as a result of stroke and syndrome of bedridden patient with urinary incontinence and malnutrition and dehydration. Lungs showed a macroscopic picture of interstitial pneumonia with cancer of the upper lobe of right lung unknown to the doctor until the autopsy. Hence severe respiratory failure was represented as the cause of death of patient in association with compromised cardiac conditions. In conclusion, the autopsy did not show a causal like between FLUAD and death, it was just a co-incidence. The reporter stated that the relation between the vaccination and the adverse drug reaction was possible. Based on the performed review on FLUAD batch number 143301, there was no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that might be potentially related to the reported events. QA department confirmed that the involved batches were complaint with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340731) on 09 Dec 2014: Updated FLUAD batch review reported. Follow up information received from the health authority on 06 Apr 2015: Updated current conditions, indication for suspect vaccine, concomitant medications dosage details, causality and autopsy results.


VAERS ID: 560289 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-27
Onset:2014-11-28
   Days after vaccination:1
Submitted: 2014-12-02
   Days after onset:4
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 148801A / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, 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), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-28
   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: Enalapril; LOBIDIUR; ZANEDIP
Current Illness: Aortic stenosis; Hypertensive heart disease; Nasal turbinate hypertrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157200

Write-up: Case number PHHY2014IT157200 is an initial combined spontaneous report received from a physician via Novartis employee on 29 Nov 2014 with a follow up information received from health care professional via health authority (HA reference number: 282036) on 01 Dec 2014 and a follow up information received from quality assurance department (QA reference number: 340231) on 02 Dec 2014. This report refers to a 68 years old male patient. His current conditions included aortic stenosis, hypertensive heart disease and nasal turbinate hypertrophy. His concomitant medications were enalapril 20 mg, LOBIDIUR 5mg/12.5 mg film coated tablet and ZANEDIP 10 mg coated tablet. He was vaccinated with first booster dose of AGRIPPAL S1 (batch number: 148801A) at a dose of 1 posologic unit intramuscularly on 27 Nov 2014. On 28 Nov 2014, he experienced arrhythmia. It was reported that on the same day he died due to cardio-circulatory arrest. The emergency service arrived and remarked the death. It was reported that autopsy was required (not reported whether it was performed or not). The reporter assessed the event as serious. The general practitioner stated that there was no relationship between death and administration of AGRIPPAL S1. The health authority reported that the event was suspected to be related with vaccination with AGRIPPAL S1.


VAERS ID: 699915 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-28
Submitted: 2017-06-09
   Days after onset:923
Entered: 2017-06-16
   Days after submission:7
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, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 201700821

Write-up: This initial spontaneous case was received on 01-Jun-2017, from the other non-health care professional via Health Authority (RPN: IT-MINISAL02-282428) and concerns a male patient of an unspecified age. On an unspecified date, the patient received the INN flu vaccine seasonal (dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported). On 28-Nov-2014, the patient had distress respiratory and he was died on an unspecified date. It was unknown if an autopsy was performed. The Health Authority stated that, the drug might have contributed for the event and assessed the causality between event and INN flu vaccine seasonal as related. This report was serious (death).


VAERS ID: 753254 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-27
Onset:2014-11-28
   Days after vaccination:1
Submitted: 2018-05-31
   Days after onset:1279
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Cardiopulmonary failure, Clonus, Death, Dehydration, Depressed level of consciousness, Diarrhoea, Hyperpyrexia, Influenza, Nuclear magnetic resonance imaging brain abnormal, Pleural effusion, Seizure, Sopor, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-04
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchopneumonia; COPD; Confusional state; Pleural effusion; Chronic obstructive bronchopneumopathy; Cor pulmonale; Kidney failure chronic; Postictal confusion
Preexisting Conditions: Stroke, hospitalized two months ago
Allergies:
Diagnostic Lab Data: 15-NOV-2014, Nuclear magnetic resonance Imaging abnormal, Area of hyperintensity in the sequences Flair involved the temporo-insular region and thalamic region on the right side anomalies slow-irritative on the hemispheric derivations on the right side in the context of a recording diffusely slowened
CDC Split Type: PHHY2014IT161309

Write-up: Case number PHHY2014IT161309, is an initial spontaneous report received from a healthcare professional via health authority (HA, reference number: 283341) on 09 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 341670) on 16 Dec 2014 with a follow up received from a healthcare professional via health authority on 09 Jan 2015. With a follow, up information received on 11-Apr-2017. This report refers to an 86-year-old female patient. The patient medical history was ictus cerbri (admission at the department two months ago). Concurrent conditions included, COPD, bronchopneumonia, pleural effusion, post-stroke confusion, postictal confusion, kidney failure chronic cor pulmonale and chronic obstructive bronchopneumopathy (BPCO). No concomitant medication was reported. The patient was vaccinated with FLUAD (0.5 ml, intramuscular, batch number: 143301 and expiry date: Jul 2015) on an unknown date (about one week before hospitalisation) by her general practitioner. On an unknown date, the patient had hyperpyrexia, vomiting, diarrhea NOS and flue-status after the administration of the vaccine. Hyperpyrexia lasted until 15-Nov-2014. The patient had not travelled or has not been exposed to ticks. On an unknown date, the patient had aphasia, convulsions, reduction of the conscience status/responsivity and soporous with clonus at the left hemiside. No signs of endocranial hypertension had been observed. On 15-Nov-2014 encephalous magnetic nuclear resonance (RMN) with contrast material performed and the area of hyper intensity the sequences Flair involved the temporo-insular region and thalmic region on the right side. The report was doubtful nature (encephalitis) anomalies slow-irritative on the hemispheric derivation son the right side in the context of a recording diffusely slowed. On 28 Nov 2014, she developed cardio-respiratory failure, unspecified pleural effusion, diarrhea NOS and dehydration and was hospitalized. The patient died on 04 Dec 2014 and the cause was unknown. Outcome of the events was fatal except for hyperpyrexia which resolved. Autopsy performed was unknown. The patient''s relatives believed the clinical condition of the patient had worsened and this led to the hospitalization of the patient. The Health Authority considered the causality as unassessable (reported as unclassifiable) for the events dehydration, diarrhea NOS, unspecified pleural effusion, cardio-respiratory failure and as not related for the other events. Based on the performed review on FLUAD batch number: 143301, there was no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with CGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 341670) on 10 Dec 2014: Updated QA reference number only. Follow-up Information received from the Quality Assurance Department (reference number: 341670) on 16 Dec 2014: Updated FLUAD batch review report. Follow-up received from healthcare professional via health authority on 09 Jan 2015: updated current conditions (chronic pulmonary heart disease, previous stroke, bronchopneumonia and pleural effusion) and reporter comments. Follow up received from the reporter on 11-APR-2017: Added current condition (BPCO, updated historical condition (recent ictus cerebri), added lab data (RMN, events (hyperpyrexia, vomiting, aphasia, convulsions, reduction of the conscience status/responsivity and flue status), updated reporter''s causality (not related) and reporter''s comment. Updated narrative accordingly. Follow-up report was received from the physician via Health Authority (IT-MINISAL02-283341) on 05-Jun-2017: Physician was added as a reporter. Concurrent conditions (from chronic pulmonary heart disease to cor pulmonale and chronic renal failure to kidney failure chronic) were updated and postictal confusion was added. The indication of the suspect vaccine (flu prevention) and route of administration (intramuscular) was updated. Description as reported and to be coded for the events was updated. The reporter causality was changed from not related to unassessable for the events dehydration, diarrhea NOS, unspecified pleural effusion and cardio-respiratory failure.


VAERS ID: 560453 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2014-10-02
Onset:2014-11-27
   Days after vaccination:56
Submitted: 2015-01-05
   Days after onset:39
Entered: 2015-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5016AA / UNK LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H86652 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Fall, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture abnormal, Sensory loss, Urinary incontinence
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Accidents and injuries (narrow), Demyelination (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-30
   Days after onset: 64
Permanent Disability? Yes
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: Heat Condition medications.
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Spinal Tap resulted in diagnosis of Guillain Barre disease
CDC Split Type:

Write-up: Unsteady on feet, loss of balance, loss of bladder control by weekend; loss of feeling in hands and arms by end of following week and constant falling.


VAERS ID: 691857 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-26
Onset:2014-11-26
   Days after vaccination:0
Submitted: 2017-04-25
   Days after onset:880
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 129301 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Cardiac arrest, Cardiac ventriculogram normal, Death, Electrocardiogram, Hypophonesis, Lethargy, Loss of consciousness, Nausea, Pallor, Rales, Somnolence, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORAL; CARDURA; NORVASC; ZYLORIC; ATENOL; LASIX; gabapentin molteni; BUSCOPAN; FLUIFORT; acetylcysteine; TAULIZ; RATAC; EUBRON
Current Illness: Type 2 diabetes mellitus; Hypertensive cardiomyopathy; Obesity; Lymphoedema, Improved; Hemiparesis; Hypokinesia; Walking aid user; Hypertension
Preexisting Conditions: Haemorrhagic stroke, 15 years ago; FLUIBRON; Cerebrovascular accident, about 5 years ago; Respiratory disorder, at the visit (29-Oct-2014)
Allergies:
Diagnostic Lab Data: 23-10-2014: heart rate (64 beats per minute); 24-11-2014: heart rate (68 beats per minute); 10/23/2014, Blood pressure measurement, 120/76; 10/29/2014, Blood pressure measurement, 120/75, normal; 11/24/2014, Blood pressure measurement, 125/70; 10/29/2014, Electrocardiogram, Unknown, Ventriculogram at limits of normality, cardiac tones were rhythmic with IV tone. Rales at left pulmonary base were not many and modificable with cough. Hypophonesis at right pulmonary base; Oxygen saturation, 93%, normal, Done by spirometry; Oxygen saturation, 90%; Oxygen saturation, 90%; Sinus rhythm, 11; 10/29/2014, Sinus rhythm, 79 beats per minute; Spirometry, 93%; 10/29/2014, Spirometry, 93%, oxygen saturation of 93%
CDC Split Type: PHHY2014IT157148

Write-up: Case number PHHY2014IT157148 is a combined initial and follow up spontaneous report from a health care professional on 28 Nov 2014 and from the health care professional via health authority (reference number: 281956) received on 01 Dec 2014 with a follow up information received from the health authority via fax on 01 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 340123) on 02 Dec 2014. This report refers to a 70-year-old female patient. Her medical history included hemorrhagic stroke 15 years ago, multifocal brain stroke and respiratory abnormality, unspecified. Her historical drug included FLUIBRON which was replaced with EUBRON. Her current conditions included right hemiparesis due to the previous stroke, Diabetes non insulin-dependent, hypertensive cardiopathy, obesity and lymphedema at lower limbs since few months and resolving at the time of report. She had scarce deambulation and she moved with walker. Her concomitant medications were METFORALMILLE, CARDURA, NORVASC, ZYLORIC, ATENOL, LASIX, Gabapentin Molteni, BUSCOPAN, EUBRON and TALUIZ. She had a cardiological examination on 29 Oct 2014 with electrocardiogram (ECG) at home and it was found that her arterial pressure was 120/75. On 23-Oct-2014 her arterial pressure was observed as 120/76 and on 24-Nov-2014 it was 125/70. Sinus rhythm was 79 beats per minute, ventriculogram at limits of normality and her cardiac tones were rhythmic with IV tone. There were rales at left pulmonary base, not many and modificable with cough. There was hypophonesis at right pulmonary base. It was reported that recent pneumological examination with spirometry at home was done and was found that her oxygen saturation was 93%. She was vaccinated with FLUAD (batch number: 142901, Expiry date: Feb-2015) on 26-Nov-2014 at 12:45. On the same date at 16:30, she developed somnolence, lethargy, skin pallor, arthralgia at arms and legs, nausea, stomach ache and back pain. At 20.00, she took PANTORC and under suggestion of her general practitioner took one posologic unit of BUSCOPAN. On 27-Nov-2014, patient experienced loss consciousness and torpor. She died on 27 Nov 2014 at 06:30. It was reported that paramedics diagnosed her with cardiocirculatory arrest. The health authority reported the events as serious. The causality of the events reported as suspected to be related to the administration of FLUAD. Based on the performed review on FLUAD batch number: 142901, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Reporters assessment: The other health professional considered the influenza vaccine and events as related. Follow up information received from the health authority via fax on 01 Dec 2014: Updated current conditions, historical drug, concomitant medications, laboratory tests, nausea added as event, narrative updated. Follow-up information received from the Quality Assurance Department (reference number: 340123) on 02 Dec 2014: Updated FLUAD batch review report. Regulatory follow-up received on 10-Apr-2017: No any new medically significant information received. Follow-up report received on 12-Apr-2017: Patients initials were updated. Multifocal brain stroke and respiratory abnormality, unspecified were updated as historical condition. Spirometric examination was done which showed the result of oxygen saturation of 93 percent. On 23-Oct-2014, arterial pressure was 120/76 and on 24-Nov-2014 it was 125/70. Frequency of concomitant medication METFORALMILLE updated as daily. Dose of PANTROC and FLUIFORT were updated. Action taken for FLUIFORT was updated from unknown to drug withdrawn as it was reported that it has been replaced by EUBRON. Start date of BUSCOPAN was updated. Lot no, of suspect product influenza vaccine was updated to 129301 from 142901. Expiry date was updated to Feb-2015. Gastric pain, Loss consciousness and torpor were added as an event. Start date, outcome, and seriousness were updated for the events Loss consciousness and torpor. The other health professional considered the events are related to influenza vaccine.


VAERS ID: 697788 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-26
Onset:2014-11-26
   Days after vaccination:0
Submitted: 2017-05-22
   Days after onset:907
Entered: 2017-05-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 142602 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Retching
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENITRIN; KANRENOL; NICETILE; STILNOX; CARDIOASPIRIN; lorazepam; losartan
Current Illness: Senile dementia, since 8 years; Activities of daily living impaired; 22-May-2017 10:05, Coronary artery sclerosis; Angiosclerosis; Kidney stone; Hypertensive; Cerebral damage
Preexisting Conditions: Flu vaccination
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157147

Write-up: Case number PHHY2014IT157147 is an initial spontaneous report from a health care professional (physician) via health authority (reference number: 281950) received on 28 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 340222) on 02 Dec 2014, and with a follow up report received from health authority on 12 Dec 2014. This report refers to a 94-year-old male patient. Medical history included senile dementia since 8 years, with total inability to perform common daily activities; myocardial coronarosclerosis with atherosclerotic and supra-aortic trunks angiosclerosis basis; hypertension since about 20 years and presence of small kidney stone at urinary tract without complication, cerebral decay. Historical drug included flu vaccines. His concomitant medications included losartan 100 mg; NICETILE 500mg oral for 15 days cyclically. Never took specific drugs to treat cerebral impairment as antipsychotic. Since 15 years on treatment with VENITRIN 5mg for coronary sclerosis; CARDIOASPIRIN for anti-aggregation/fluidzing; KANRENOL 100mg/die as antihypertensive; STILNOX 10 mg as needed to sleep and lorazepam 10 drops upon needed when agitated. Intake of losartan and CARDIOASPIRIN interrupted in September due to low blood pressure and frequent epistaxis. In the last 20 years, annually the patient received seasonal flu vaccination (manufacturer and batch number unknown) without any adverse reaction. He was vaccinated with first booster dose of FLUAD (batch number: 142602) intramuscularly on 26 Nov 2014 at 09:30 am. The patient daughter referred that in the afternoon the patient developed retch and breathing difficult so in the evening he was taken to emergency room. On the same date at night, the patient was hospitalized due to breathing difficulty. It was reported that lab exams (unspecified) were preformed in emergency room during the hospitalization. On 27 Nov 2014, the patient died. The cause of death was reported as breathing difficult. The causality of the event reported as suspected with the administration of FLUAD. Based on the performed review on FLUAD batch number: 142602, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events, QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340222) on 02 Dec 2014: Updated FLUAD batch review report. Follow up report received from health authority on 12 Dec 2014. Updated medical history and concomitant drug information. Following an internal review of the data received on 28 Nov 2014. The manufacturer receipt date 28 Nov 2014 of the previously reported information was corrected from 01 Dec 2014 to 28 Nov 2014. Follow up received on 15 May 2017 from Health Authority (RNF: IT-MINISAL02-281950): Added reporter physician, patient details (initials), added medical history (hypertension, cerebral decay and historical drug vaccines (for flu)), updated indication of suspect drug, updated event verbatim (breathing difficult) with cause of death. Case Comment: Medical assessment: Though reported time-to-event (same day), indicates positive temporal relationship and causal association cannot be excluded. Patient''s advanced age, current medical conditions and concomitant medications are confounders to causality assessment. Lack of information on notes from in-hospital clinical examination, and details of lab examinations makes the comprehensive causality not assessable. Case will be reassessed after more details are available.


VAERS ID: 699914 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-25
Submitted: 2017-06-09
   Days after onset:926
Entered: 2017-06-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cardio-respiratory arrest, Death, Erythema, Metabolic acidosis, Multiple organ dysfunction syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (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), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700824

Write-up: This initial spontaneous case received on 01-Jun-2017, was reported by other non-health professional via health authority (IT-MINISAL02-282197) and concerns a Female patient of unspecified age. On an unspecified date, the patient received INN flu vaccine seasonal, (dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported). On 25-Nov-2014, the patient had asthenia, cardio-respiratory arrest, erythema diffuse, metabolic acidosis and multi organ failure. As a result the patient was died on an unspecified date and it was unknown if an autopsy was performed. The Health Authority stated that, the drug might have contributed for the events and assessed the causality between events and INN flu vaccine seasonal as related. This report was serious (death and medically significant).


VAERS ID: 753134 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-24
Onset:2014-11-25
   Days after vaccination:1
Submitted: 2018-05-31
   Days after onset:1282
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure immeasurable, Cardiac arrest, Coma, Pupil fixed, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157258

Write-up: Case number PHHY2014IT157258, is a combined initial and follow up spontaneous report received from a consumer (son) on 28 Nov 2014 and from health authority (reference number: 282214) on 02 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 340227) on 08 Dec 2014 and a follow up received from a lay press newspaper article (journalist) on 08 May 2015. This report refers to an 89 year old female patient. Her medical history was not reported. On 12 Nov 2014, 14 Nov 2014 and on 18 Nov 2014 the patient took unspecified medication (right and left heel). The patient was never vaccinated with FLUAD in the past. She was vaccinated with FLUAD (batch number: 143301) 0.5 ml intramuscular on 24 Nov 2014. The patient presented with deep comatose state, pupillary reflex was absent; blood pressure was not detectable and cardiac arrest on 25 Nov 2014, Paramedical Intervention was called. She had a sudden death at 11:10 AM on the same day before the arrival of the ambulance. The death occurred after about 22 hours from the vaccination. The article reported that the result of the autopsy performed on 02 Dec 2014 had the following result: there was no causal relationship between the death and the vaccination with FLUAD. The article also ruled out any type of allergic reaction. The elderly patient would have died of a clinical picture compromised of different pathologies. Health authority assessed the event as serious and causality as unassessable (reported as unclassified). Based on the performed review on FLUAD 2014/2015 batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340227) on 08 Dec 2014: Updated FLUAD 2014/2015 batch review report. Follow up received from a lay press newspaper article (journalist) on 08 May 2015: updated reporter comment. Follow up received from health professional via Health Authority (RNF: IT-MINISAL02-282214): Start date of suspect vaccine was changed from 25-Nov-2014 to 24-Nov-2014. Onset of the event was changed from 26-Nov-2014 to 25-Nov-2014. The suspect product indication was updated as flu vaccination. The reporter assessed the causality between the events and vaccine as unassessable (reported as unclassifiable). Cardiac arrest was added as cause of death. Case Comment: This case concerns an 89-year-old female patient, who developed, coma state, absent pupillary reflex and cardiac arrest leading to death 22 hours after receiving a dose of FLUAD vaccine. It was reported that autopsy performed ruled out any allergic reaction to vaccine and stated that there was no causal relationship between the death and suspect vaccine. Based on the available information, nature of the events and considering the age of the subject, the causal role of suspect vaccine seems unlikely, hence assessed as not related.


VAERS ID: 700056 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-24
Submitted: 2017-06-11
   Days after onset:929
Entered: 2017-06-19
   Days after submission:8
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, Multiple organ dysfunction syndrome
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700825

Write-up: This is initial spontaneous case from other non-health professional via Health Authority (RNF: IT-MINISAL02-283251) on 05-Jun-2017 and concerns a male patient of unknown age. On an unspecified date, the patient was administered with Influenza vaccine "trade name, manufacturer, batch no. not reported" (dose, expiry date, anatomical location, route of administration and indication were not reported). On 24-Nov-2014, the patient had multi-organ failure. It was unknown whether autopsy was done. The outcome of the event was fatal. The reporter assessed the causality between the events and vaccine as related. Health Authority assessed the event as serious (death, life-threatening and medically significant).


VAERS ID: 715173 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-24
Submitted: 2017-09-26
   Days after onset:1036
Entered: 2017-09-27
   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: Cardiac failure, Cystitis escherichia, Death, Dyspnoea, Polymyalgia rheumatica
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vasculitis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700826

Write-up: This serious spontaneous case reported by other non-health professional via health authority (IT-MINISAL02-282601) on 05-Jun-2017 and concerns 83-year-old, elderly, male patient. On an unspecified date, the patient received influenza vaccine (dose, route of administration, expiry date, anatomical location, trade name, manufacturer, batch no: not reported). On 24-Nov-2014, the patient experienced Escherichia coli cystitis, cardiac failure and dyspnoea. On unspecified date, the patient also experienced polymyalgia rheumatica. Outcome of the event polymyalgia rheumatica was not reported. The patient died on an unspecified date. It was unknown whether the autopsy performed at the time of this report. The Health Authority assessed this case as serious (death) and considered the events cardiac failure, Escherichia coli cystitis and dyspnea as related to the influenza vaccine. Follow-up information was received via health authority (IT-MINISAL02-384968) on 19-Sep-2017: Gender of the patient was updated to male from female and age was updated to 83 years. Polymyalgia rheumatica was added as an event and narrative was amended accordingly. Case Comment: This case concerns an 83 year old male patient who had died due to Cardiac failure, Escherichia coli cystitis and dyspnoea, after receiving a dose of Influenza vaccine seasonal. The information regarding the vaccination details, previous vaccination history, medical history, concomitant medications and diagnosis work-up were not reported. The causality of the events was assessed as not related with respect to the suspect vaccine due to biological implausibility. However, the case will be reassessed when more information becomes available. Due to missing information regarding the time to onset for the event polymyalgia rheumatica and complementary investigations, the causal role of suspect vaccine cannot be assessed. The event polymyalgia rheumatica was considered medically significant.


VAERS ID: 753136 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-21
Onset:2014-11-24
   Days after vaccination:3
Submitted: 2018-05-31
   Days after onset:1283
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiomyopathy NOS; Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157155

Write-up: Case number PHHY2014IT157155 is an initial spontaneous report received from a health care professional via Health Authorities (reference number: 282033) on 30 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 340230) on 08 Dec 2014. This case refers to an 85 years old male patient. He was in good health condition despite important cardiopathy NOS. Current condition included heart disease, unspecified. Concomitant medication was not reported. He was vaccinated with first booster dose of FLUAD (batch number: 143301 and expiry date: Jul 2015), intramuscularly on 21 Nov 2014 at 16:00 PM. On 24 Nov 2014, he died in a very short time for probable acute cardiac crisis. Health authority reported the case as serious and assessed the causality as unassessable (reported as unclassifiable). Based on the performed review on FLUAD batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340230) on 08 Dec 2014: Updated FLUAD batch review report. Following an internal review of the data received on 30 Nov 2014. The manufacturer receipt date 30 Nov 2014 of the previously reported information was corrected from 01 Dec 2014 to 30 Nov 2014. Follow-up information received on 01-Jun-2017, from physician via Health Authority (IT-MINISAL02-282033): Added medical history (heart disease), updated reported causality.


VAERS ID: 699916 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-22
Submitted: 2017-06-09
   Days after onset:929
Entered: 2017-06-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700820

Write-up: This initial spontaneous case received from other non-health professional via health authority (RNF: IT-MINISAL02-282102) on 01-Jun-2017, was and concerns a male patient of an unspecified age. On an unspecified date, the patient received Influenza vaccine, (batch number, expiry date, dose, anatomical location and route of administration: not reported) for an unknown indication. On 22-Nov-2014, the patient was suddenly died (as reported: sudden death). The cause of death was not reported. It was unknown whether the autopsy performed at the time of this report. The reporter assessed the causality between the event (death) and the suspect vaccine as related. Health Authority considered this case was serious (death).


VAERS ID: 555192 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Washington  
Vaccinated:2014-11-19
Onset:2014-11-21
   Days after vaccination:2
Submitted: 2014-11-21
   Days after onset:0
Entered: 2014-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI207AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Death, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Over the counter pain relievers, type is unknown.
Current Illness: No
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown if attributed to vaccine. Patient had vaccination on 11/19/2014 symptoms of fever, dizziness, headache began next day. Patient demise time unclear may not be related however per process noting that vaccination had occurred in the previous 36 hours.


VAERS ID: 562407 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-19
Submitted: 2014-12-05
   Days after onset:16
Entered: 2014-12-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 149502A / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Bronchopneumonia, Catarrh, Cough, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX
Current Illness: Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT158290

Write-up: Case number PHHY2014IT158290 is an initial spontaneous report received from a healthcare professional via Health Authority (HA reference number: 282543) on 03 Dec 2014. This report refers to a 95 year old female patient. Her current conditions included a heart disease and concomitant medications included LASIX (25 mg tablets) at a dose of 50 mg orally. On an unspecified date, she was vaccinated with AGRIPPAL (batch number: 149502A). On 19 Nov 2014, the patient had mild fever. On 20 Nov 2014, she had fever, catarrh and cough. On 24 Nov 2014, she had suspected outbreak of bronchopneumonic on the left characterised by fever, cough, catarrh, dyspnea, gasps and reduced vesicular murmur on the left. It was reported that the fever was of unknown origin. The patient died on 24 Nov 2014. The health authority assessed the causality of the events as suspected to be related to the administration of AGRIPPAL.


VAERS ID: 556292 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: New York  
Vaccinated:2014-10-15
Onset:2014-11-16
   Days after vaccination:32
Submitted: 2014-12-02
   Days after onset:16
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3RE4F / 7+ LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cardiac failure, Chest X-ray abnormal, Death, Extracorporeal membrane oxygenation, Feeling cold, Hyperhidrosis, Intensive care, Pneumonia, Viral test negative
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amiodarone 5mg PO once a day Aspirin 81mg PO once a day Carvedilol 2.4mg PO twice a day Enalapril 4mg PO twice a day Polyethylene Glycol 17grams PO once a day Xopenex 0.63mg/3ml inhaled as needed for wheezing
Current Illness: Patient had had a viral illness 1 week prior with desat to 85% at school. On day of vaccine said he felt better.
Preexisting Conditions: Cardiomyopathy, atypical muscular dystrophy (not Becker or Duchenne)
Allergies:
Diagnostic Lab Data: Respiratory virus panel negative x2; CXR with L retrocardiac opacity on admission
CDC Split Type:

Write-up: Mother called mid morning that patient was cool and diaphoretic. Went to ED found to have worsening heart failure. Admitted to PICU 10/17/14, CXR with pneumonia, respiratory virus panel neg x 2, placed on ECMO 10/19/14. Patient died 11/16/14 of heart failure while on ECMO.


VAERS ID: 557253 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Georgia  
Vaccinated:2014-11-07
Onset:2014-11-16
   Days after vaccination:9
Submitted: 2014-12-08
   Days after onset:22
Entered: 2014-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS XZ3SP / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: On Hospice care at long term care facilty
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died from ??UTI/Sepsis.


VAERS ID: 701272 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-14
Onset:2014-11-16
   Days after vaccination:2
Submitted: 2017-06-28
   Days after onset:954
Entered: 2017-06-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal X-ray, Acute kidney injury, Agitation, Asthenia, Atrial fibrillation, Bacterial test negative, Blood gases, CSF culture negative, CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF test abnormal, CSF white blood cell count increased, Coma scale abnormal, Confusional state, Electrocardiogram, Fibrin D dimer increased, Lumbar puncture, Malaise, Multiple organ dysfunction syndrome, N-terminal prohormone brain natriuretic peptide increased, Pain, Platelet count decreased, Procalcitonin increased, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LACIREX; CARDIOASPIRIN
Current Illness: Benign essential hypertension; Acute renal failure, unspecified; Unspecified transient cerebral ischemia (Transient ischaemic attack); 28-Jun-2017 10:47; Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, unknown; 22-NOV-2014, Bacterial test, Negative; CSF was negative for development of bacterial flora in presence of antibiotic therapy, no colonies; Blood gases, Unknown; CSF glucose depressed, 1; CSF protein elevated, 690; CSF red blood cell count positive elevated, 1200 ml; CSF white blood cell count elevated per mcl (mainly neutrophils) 600/microl; Coma scale significant, 5; 16-NOV-2014, Coma scale significant, 12; Electrocardiogram, Unknown; Fibrin D dimer elevated, 14245; Lumbar puncture Significant CSF collected appeared cloudy with yellow colour, slightly haematic, Abnormal; Microscopy, Unknown; N-terminal prohormone brain natriuretic peptide, 33990 pg/ml; Platelet count depressed, 14000 (units and normal values were not reported); Procalcitonin, 159
CDC Split Type: PHHY2014IT155910

Write-up: Case Description: Case number PHHY2014IT155910 is an initial spontaneous report received from a health care professional via health authority (HA reference number: 281215) on 27 Nov 2014, with a combined follow up received from Health Authority on 28 Nov 2014 and 01 Dec 2014 respectively, with a follow-up information received from Quality Assurance Department (reference number: 339779) on 02 Dec 2014. This report refers to a 79 years old female patient. Her current conditions included benign essential hypertension, acute renal failure, unspecified, unspecified transient cerebral ischemia and atrial fibrillation and concomitant medications were LACIRIX 4 mg film coated tablet and CARDIOASPIRIN 100 mg gastro-resistant tablet. She was vaccinated with FLUAD (batch number: 143301, and expiry date: Jul 2015) via intramuscular route as a dose of 0.5 ml on 14 Nov 2014. On 16 Nov 2014, two days after vaccination, she experienced meningoencephalitis. She went to emergency room with paramedical intervention because she presented with diffuse pain, asthenia and general malaise. She was less cooperative during the visit with apparent confusion, GSC 12 and atrial fibrillation with high ventricular response. She was admitted in the emergency medicine department and the events rapidly worsened and she entered in coma status (GSC 5) with associated multi-organ failure. Nephrology and reanimation advice were performed. Spinal tap was done and CSF collected appeared cloudy with yellow colour and slightly haematic with protein in liquor): 690 mg/dl, glucose in liquor: 1 mg/dl, leukocytes in liquor: 600/mcl (mainly neutrophils) and erythrocytes: 1200 x ml. Her procalcitonin was 159 ng/ml, ProBNP was 33990 pg/ml and D-dimer was 14245 ng/ml. CBC was done and her platelet count was 14000 (units and normal values were not reported). She also underwent ECG, microscopic examination of blood sample, systemic arterial blood gas and abdominal X-ray (results were not reported). She was hospitalized on 17 Nov 2014 due to agitation status with suspected stroke (ICTUS). Complications were acute renal failure, transient cerebral ischaemia and atrial fibrillation. She was treated with steroids and unspecified antibiotics. She was discharged on 19 Nov 2014 with principal diagnosis of comatose state from likely bacterial meningitis. She died on 18 Nov 2014, within 48 hours of vaccination. The cause of death was reported as meningoencephalitis. On 22 Nov 2014, the result of bacterial culture of CSF was negative for development of bacterial flora in presence of antibiotic therapy. The health authority reported the event as serious and causality of the event as not related to vaccination due to strong evidences resulting from liquor analysis. The HA stated that autopsy was not performed. The health care professional considered the events as serious (Death) and did not provided the causality between the events and suspect vaccine. Based on the performed review on FLUAD batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with Internal procedures and with CGMP requirements. On 1 December of unknown year, the Agency announced the first test results; there was no presence of endotoxins and the content and characteristics of the vaccine virus antigen were compliant with quality standards.9 On 3 December of unknown year Committee concluded that there was no evidence of a causal relationship between the reported fatal events and the administration of FLUAD and reassured other countries about the safety of the flu vaccine. Combined follow up received from Health Authority on 28 Nov 2014 and 01 Dec 2014 respectively: updated date of vaccination (14 Nov 2014) and HA comment (autopsy was not performed). Follow-up information received from the Quality Assurance Department (reference number: 339779) on 02 Dec 2014: Updated FLUAD batch review report. Follow-up information was received from the physician via Health Authority (Agency: IT-MINISAL02-281215) on 01-Jun-2017: Physician was added as a reporter. Patient initials and date of birth were updated, suspect vaccine''s route of administration was updated, event verbatim was updated and reporter causality was updated. Follow up received on 14-Jun-2017: This is a serious follow-up literature case received. Event updated from meningitis NEC to meningoencephalitis, cause of death updated and accordingly changes were made and hence, narrative was amended.


VAERS ID: 753155 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-14
Onset:2014-11-16
   Days after vaccination:2
Submitted: 2018-05-31
   Days after onset:1291
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143002 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute pulmonary oedema, Death, Electrocardiogram abnormal
SMQs:, Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension; Dyslipidemia; Arthrosis multiple; Polyneuritis; COPD (Chronic obstructive pulmonary disease); Hypertensive cardiomyopathy; Cardiac arrhythmia; Venous insufficiency; Anxious depression; Fatty liver
Preexisting Conditions: Diabetic gangrene, wet diabetic gangrene of the right foot the patient was amputated at the middle third of the right leg
Allergies:
Diagnostic Lab Data: 16-NOV-2014, Electrocardiogram, abnormal
CDC Split Type: PHHY2014IT161316

Write-up: Case number PHHY2014IT161316, is a combined initial and follow up spontaneous report received from a healthcare professional via health authority (HA, reference number: 283413) and from Quality Assurance department (reference number: 341716) both on 09 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 341716) on 19 Dec 2014. This report refers to a 78-year-old female patient. The patient''s historical condition included web diabetic gangrene of the right foot of the patient was amputated at the middle third of the right leg in 2011. The patient''s concurrent condition included diabetes mellitus (since an unspecified date), hypertension (since an unspecified date), dyslipidemia (since an unspecified date), diffuse polyarthrosis (since an unspecified date), diabetic polyneuritis (since an unspecified date), COPD (chronic obstructive pulmonary disease, since an unspecified date), venous insufficiency lower limbs (since an unspecified date), anxious-depressive syndrome (since an unspecified date), chronic fatty liver disease (since an unspecified date), hypertensive cardiomyopathy (since an unspecified date), cardiac arrhythmia (since an unspecified date). The patient''s concomitant medications were not reported. The patient was vaccinated with FLUAD (dose: 0.5 ml, frequency: total, batch number: 143002 and expiry date: Jul 2015) intramuscularly at a dose of 0.5 ml on 14-Nov-2014 at 10 am in good clinical condition. On 16-Nov-2014, she developed acute pulmonary oedema into diabetes mellitus. When paramedical intervention arrived, ECG (electrocardiogram) was performed and resulted flat. It was reported that the patient died on 16-Nov-2014 at 16:10 hours. The outcome of acute pulmonary edema was fatal. The cause of death was reported as acute pulmonary edema due to severe cardiomyopathy. It was unknown whether autopsy was done or not. Health authority assessed the event was unassessable. This report was considered as serious (death). Based on the performed review on FLUAD batch number: 143002, there was no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that might be potentially related to the reported events. QA department confirmed that, the involved batches were compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 341716) on 19 Dec 2014: Updated FLUAD batch review report. Follow up received on 6-Apr-2017 from a health care professional: Added historical condition (wet diabetic gangrene of the right foot the patient was amputated at the middle third of the right leg in 2011), current condition (hypertension, dyslipidemia, diffuse polyarthrosis, diabetic polyneuritis, COPD, venous insufficiency lower limbs, anxious-depressive syndrome, chronic fatty liver disease, hypertensive cardiomyopathy, cardiac arrhythmia), lab data (ECG) updated indication of the vaccine (anti flu vaccination), added event (cardiomyopathy) with details (outcome, seriousness and causality). Accordingly, update narrative. Follow-up information received on 05-Jun-2017, from other non-healthcare professional (commander) via Health Authority (IT-MINISAL02-283413): The suspect product indication was updated as influenza immunization. The reporter causality was changed from related to unassessable. Significant case correction received on 05-Sep-2017: Changed verbatim of the event from acute pulmonary edema to acute pulmonary edema into diabetes mellitus. The event cardiomyopathy was deleted due to cardiomyopathy was not reported as an event via health authority and cardiomyopathy was the pre-existing condition of the patient. Case Comment: This case concerns a 78-year-old female patient who developed acute pulmonary edema 2 days after receiving a dose of FLUAD VACCINE and died of severe acute pulmonary edema due to severe cardiomyopathy. Even though the temporal relationship is plausible, based on the patient''s medical history and current medical condition of diabetes mellitus, hypertension, dyslipidemia, diffuse polyarthrosis, diabetic polyneuritis, COPD, venous insufficiency lower limbs, anxious-depressive syndrome, chronic fatty liver disease, hypertensive cardiomyopathy and cardiac arrhythmias, the causal role of the suspect vaccine is unlikely. Hence, the causality was assessed as not related. Since the cause of death is severe pulmonary edema due to severe cardiomyopathy, fatal outcome of the pulmonary edema is better explained by underlying medical conditions of the patient such as hypertensive cardiomyopathy and cardiac arrhythmia.


VAERS ID: 557251 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Georgia  
Vaccinated:2014-11-07
Onset:2014-11-15
   Days after vaccination:8
Submitted: 2014-12-08
   Days after onset:23
Entered: 2014-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS XZ3SP / UNK UN / SYR

Administered by: Public       Purchased by: Other
Symptoms: Cardiac disorder, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: On Hospice Care and resident of long term care facility at time of vaccination
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Died from cardiac disease.


VAERS ID: 699913 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-15
Submitted: 2017-06-09
   Days after onset:936
Entered: 2017-06-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute myocardial infarction, Death
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700822

Write-up: This initial spontaneous case received on 01-Jun-2017, was reported by other non-health professional via health authority (ITMINISAL02-282261) and concerns a male patient of an unspecified age. On an unspecified date, the patient received INN Flu Vaccine Seasonal (batch number, expiry date, dose, anatomical location and route of administration: not reported). On 15-Nov-2014, the patient experienced acute myocardial infraction. On an unknown date, the patient died. It was unknown whether the autopsy performed at the time of this report. The reporter assessed the causality between the event (myocardial infarction) and the suspect vaccine as related. Health Authority assessed the case as serious (death).


VAERS ID: 557492 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Unknown  
Vaccinated:2014-11-04
Onset:2014-11-13
   Days after vaccination:9
Submitted: 2014-12-05
   Days after onset:22
Entered: 2014-12-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1413301 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Influenza, Malaise, Pulmonary oedema, Pyrexia, Resuscitation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (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: 2014-11-13
   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: No other medications
Current Illness: Type 2 diabetes mellitus, Values within normal limits and was being managed; Blood cholesterol increased, Values within normal limits and was being managed.
Preexisting Conditions: 11/13/2014, Resuscitation; Pyrexia
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2014US024100

Write-up: Case number PHEH2014US024100 is a combined initial and follow up spontaneous report from a nurse received on 02 Dec 2014 and from quality assurance department (QA reference number: 340811) received on 03 Dec 2014. This report refers to a 66-year-old female patient. Her current conditions included type 2 diabetes and elevated cholesterol with values at normal limits and were being managed. She went for cardiac work up, 1-2 weeks prior to vaccination and everything was normal. She did not have any blockages, no complaints of chest pains, but had fever. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On the same date, since vaccination she was feeling ill and had flu. On an unknown date, she had fever. On 13 Nov 2014, she was burning up with fever, had taken off her night gown (Not typical behaviour), drank water, went to sofa, threw up en route and had cardiac arrest. Her husband performed CPR (cardiopulmonary resuscitation) and called the ambulance. In the emergency room, she was being resuscitated, but she died on the same day. No autopsy was performed. It was reported that something caused pulmonary edema. She had no congestive heart failure and not on any diuretics. The outcome of the events fever, feeling ill, flu and threw up was not reported. The outcome of the events pulmonary edema and cardiac arrest reported as death. The seriousness of the events fever, feeling ill, flu and threw up was not reported. The causality of the events was not reported.


VAERS ID: 700057 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-12
Submitted: 2017-06-11
   Days after onset:941
Entered: 2017-06-19
   Days after submission:8
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, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 201700831

Write-up: This is initial spontaneous case reported by other non-health professional via Health Authority (RNF reference number: IT-MINISAL02-294397) on 05-Jun-2017 and concerns a male patient of an unspecified age. On an unspecified date, the patient received the viral haemagglutinin "trade name, manufacturer, batch no. not reported" (INN flu vaccine, dose, route of administration, anatomical location, expiration date were not reported). On 12-Nov-2014, the patient had petechiae. On an unspecified date, the patient died. It was unknown whether an autopsy done. The reporter assessed the causality between the event and INN flu vaccine as related. Health Authority considered the event as serious (death).


VAERS ID: 753153 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-11
Onset:2014-11-12
   Days after vaccination:1
Submitted: 2018-05-31
   Days after onset:1295
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 142901 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Acute kidney injury, Arthralgia, Blood gases abnormal, Bronchoscopy abnormal, Cardiac arrest, Cardiogenic shock, Computerised tomogram abnormal, Death, Dyspnoea, Ejection fraction decreased, Electrocardiogram abnormal, Endotracheal intubation, Headache, Hyperglycaemia, Hyperhidrosis, Hyponatraemia, Hypoxia, Intensive care, Lactic acidosis, Mechanical ventilation, Oxygen saturation decreased, Pallor, Pleural effusion, Respiratory failure, Tachycardia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-29
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Allopurinol; insulin; PANTORC; CARDIOASPIRIN; CARDICOR; LUVION; COVERLAM; UDCA; DEURSIL; SINVACOR
Current Illness: Unknown to Ongoing, COPD; Unknown to Ongoing, Hypertension, Hypertension in heart failure; Unknown to Ongoing, Insulin dependent diabetic; Unknown to Ongoing, Chronic renal failure; Unknown date, Metabolic syndrome; Unknown date, Diabetic retinopathy;
Preexisting Conditions: Unknown date, Hemiparesis (left), Left hemiparesis due to stroke; Unknown to 31-May-2018, 20:37, Stroke, Left hemiparesis due to stroke; Unknown date, Cardiomyopathy; Unknown date, Heart failure; Unknown date, Aortic ectasis; Unknown date, Antibiotics; Unknown date, Hyperuricemia; Unknown date, Glaucoma; Unknown date, Polyarthritis
Allergies:
Diagnostic Lab Data: 26-NOV-2014: Blood pressure (PA): 98/70 mmHg; 26-NOV-2014: Heart beat: 84 beat/min.; 26-NOV-2014: Oxygen saturation: 70%; 26-NOV-2014: Body temperature (TC): 36 degrees C, GSC 15; 26-NOV-2014: Hemogas-analysis (EGA): Metabolic acidosis with marked increase in the lactates, hypoxia with P/F reduced hyponatremia and hyperglycaemia; 27-NOV-2014: Fibro-bronchoscopy and CT scan: Presence of pleural effusion bilaterally that requested the positioning of a thoracic drainage on the right side; 27-NOV-2014: ECG: Akinesia of the apical segments of the left ventricle with reduced ejection fraction (EF) (30%).
CDC Split Type: PHHY2014IT157743

Write-up: Case number PHHY2014IT157743, is an initial spontaneous report received from a health care professional via Health Authorities (HA report no: 282247) on 01 Dec 2014 with a follow up report received from the Health Authorities on 03 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 340351) on 09 Dec 2014. This report refers to a 73-year-old female patient. Medical history included left hemiparesis due to stroke, chronic obstructive pulmonary disease (COPD), cardiopathy, aortic ectasia, insulin dependent diabetes, chronic renal failure, diabetic retinopathy, glaucoma, ipovisus, and polyarthritis and hypertension in heart failure. Concomitant medications included PANTORC gastroresistant tablet at a dose of 20 mg orally, CARDIOASPIRIN gastroresistent tablets at a dose of 100 mg orally, CARDICOR tablets at a dose of 1.25 mg orally, LUVION tablets at a dose of 25 mg orally, COVERLAM tablets at a dose of 20 mg orally, DEURSIL hard capsules at a dose of 300 mg, SINVACOR coated tablets at a dose of 20 mg orally, Allopurinol tablets at a dose of 300 mg orally, UDCA capsules at a dose of 300 mg, and insulin. On 11 Nov 2014, she was administered with FLUAD (batch number: 142901) at a dose: 0.5 ml intramuscularly. On 12 Nov 2014, the patient experienced cephalgia and stomach pain. On 13 Nov 2014, the patient experienced dyspnea, gastralgia and arthralgia. Medical therapy for treating events included LASIX 250 mg infusion, noradrenaline, dobutamine, antibiotics NOS and pleural drainage. The patient was hospitalized on 26 Nov 2014, at 06:40 AM in intensive care for worsening respiratory failure, severe lactic acidosis, hyponatremia, acute renal failure, and cardiogenic shock. On objective examination of the patient was conscious, pale, sweated, tachycardic, with vesicular murmur reduced, anuric. The relevant lab details were blood pressure (PA) was 98/70 mmHg, heart beat was 84 beat/min, oxygen saturation was 70 percent. Body temperature (TC) was 36 degrees C, GSC 15, hemogas-analysis (EGA) was metabolic acidosis with marked increase in the lactate, hypoxia with P/F reduced hyponatremia and hyperglycaemia. In anamnesis left hemiplegia due to previous stroke, diabetes, ischaemic-hypertensive cardiopathy, chronic renal insufficiency, and as reported by the relatives, recent anti-flu vaccination. At the emergency department (PS) medical therapy under emergency has been performed, mask for CPAP has been positioned, chest X-ray, ECG, and cardiological and resuscitation consultants have been requested. The physician resuscitator, after having evaluated the hematobiochemical examinations, and instrumental examinations performed, and considering the worsening of the clinical conditions, proceeded with the tracheal intubation of the patient with ventilator assistance, and programmed the admission of the patient at the General Resuscitation Department. At the department PICCO catheter has been positioned for the hemodynamic monitoring that evidenced a low cardiac output with reduced contractility indexes, (not legible) within the normal limits, and peripheral vascular resistances increased. Based on the hemodynamic parameters the therapy with vasoactive amines had been modulated, and diuretic had been administered with the addition to the correction of the acidosis and of the hyperglycaemia. On the day 27, due to the worsening of the respiratory exchanges firstly a fibro-bronchoscopy had been performed, afterwards a CT scan of the chest, which evidenced the presence of pleural effusion bilaterally that requested the positioning of a thoracic drainage on the right side; antibiotic therapy had been started. In the following hours (not legible) episodes of polymorphous ventricular tachycardia, treated with cardiac massage, defibrillator, and medical therapy. The echocardiography 2d for evaluation follow-up evidenced akinesia of the apical segments of the left ventricle with reduced ejection fraction (ER) (30 percent). At the hour 08:25 AM of the day 29 onset of ventricular fibrillation that, despite of the repeated defibrillations, evolved to cardiac arrest leading to the patient''s death. On 29 Nov 2014, the patient died. Outcome of stomach pain, dyspnea, arthralgia and cephalgia was reported as fatal. The reporter assessed the causality of the events as not related. Health authority assessed the events as serious (fatal). Based on the performed review on FLUAD 2014/2015 batch number: 142901, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow up report was received from the Health Authorities (HA reference number: 282247) on 03 Dec 2014: Updated formulation, concentration and dose of concomitant medications. Follow-up information received from the Quality Assurance Department (reference number: 340351) on 09 Dec 2014: Updated FLUAD 2014/2015 batch review report. Following an internal review of the data received on 01 Dec 2014, The manufacturer receipt date 01 Dec 2014 of the previously reported information was corrected from 02 Dec 2014 to 01 Dec 2014. Follow up received on 11-Apr-17: Added current conditions diabetic retinopathy, glaucoma, ipovisus, and polyarthritis lab data (Blood pressure, Heart rate, Oxygen Saturation, Body temperature, hemogas-analysis (EGA), CT scan, fibro-bronchoscopy, ECG), concomitant drugs (PANTORC and UDCA, added treatment drugs (diuretic and antibiotic). Cause of death (as cardiac arrest) and deleted other causes (stomach pain, arthralgia, cephalgia, dyspnoea), added event details and reporter''s comment. Accordingly, updated narrative. Follow-up information received on 01-Jun 2017, from health professional via Health Authority (RNF: IT-MINISAL02-282247): The suspect product indication was updated as flu vaccination. Events respiratory failure aggravated, serious lactic acidosis, renal failure acute, cardiogenic shock were added with details. Updated narrative accordingly. Case Comment: This case concerns a 73-year-old female patient who developed Dyspnea, stomach pain, arthralgia and cephalgia 3 days after receiving a dose of FLUAD vaccine and Respiratory failure aggravation, cardiogenic shock, acute renal failure and lactic acidosis 16 days after vaccination. The patient died 18 days after vaccination due to cardiac arrest. It was reported that patient is suffering from Insulin-dependent diabetes mellitus, metabolic syndrome, hyperuricemia, arterial hypertension, and hypertensive cardiopathy in decompensation phase, aortic Ectasia, sequels of hemorrhagic ictus cerebri with sequels of left hemiparesis, and sensitive syndrome, chronic cerebral vasculopathy, sequels of acute pericarditis, diabetic retinopathy, glaucoma, ipovisus and polyarthritis. It was reported that the CT scan of the chest, showed the presence of pleural effusion bilaterally and 2D Echocardiography showed Akinesia of apical segments of the left ventricle with reduced ejection fraction (30%). Even thought the temporal relations is plausible: the events and fatal outcome of the events are better explained by underlying medical condition of the patient. Hence the causal role of vaccine FLUAD is assessed as not related.


VAERS ID: 701271 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-01
Onset:2014-11-11
   Days after vaccination:10
Submitted: 2017-06-28
   Days after onset:959
Entered: 2017-06-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Confusional state, Diarrhoea, Encephalitis, Pyrexia, Retching
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), 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: 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: PHHY2014IT158294

Write-up: Case number PHHY2014IT158294, is an initial spontaneous report from a health care professional via Health Authority (HA, reference number: 282093) received on 02 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 341917) on 16 Dec 2014. This report refers to an 87-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUAD (batch number: 143301, expiration date: 31 Jul 2015) on an unknown date in Nov-2014. On 11 Nov 2014, after 48 hours of vaccination, the patient experienced meningoencephalitis with associated symptoms confusional state, fever, diarrhea, retching, abdominal pain. At the time of this report, the outcome of the event was fatal. The cause of death was meningoencephalitis. It was unknown whether autopsy was done. The reporter assessed the events to be serious (life threatening and death) and causality to be suspected to the administration of FLUAD. The reporter stated that, on 01-Dec-2014, the agency announced the first tests results that, there was no presence of andotoxins and the content and characteristics of the vaccine virus antigen were compliant with quality standards, on 03-Dec-2014, committee concluded that there was no evidence of a causal relationship between the reported fatal event and the administration of FLUAD and on 23 Dec-2014, agency released the final test results (abnormal toxicity test, or ATT, and sterility test) and confirmed that, the vaccine was safe. Based on the performed review on FLUAD batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used the could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are complaint with internal procedures and with cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 341917) on 10 Dec 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 341917) on 16 Dec 2014: Updated FLUAD batch review report. Follow up received on 14-Jun-2017: This is a serious follow-up literature case. Reporter information was added, event meningoencephalitis was updated and previously reported events confusional state, retching abdominal pain, diarrhea and fever were subsumed. The outcome from unknown to fatal was updated. It was reported that, the agency announced the first tests results that, there was no presence of endotoxins and the content and characteristics of the vaccine virus antigen were complaint with quality standards, agency concluded that there was no evidence of a causal relationship between the reported fatal events and the administration of FLUAD and reassured other countries about the safety of the flu vaccine and agency released the final test results (abnormal toxicity test, or ATT, and sterility test) and confirmed the vaccine was safe.


VAERS ID: 562420 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-10
Onset:2014-11-10
   Days after vaccination:0
Submitted: 2014-12-10
   Days after onset:30
Entered: 2014-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR L8287 / 1 UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K009023 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral thrombosis, Death, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-20
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; CORLENTOR; TAPAZOLE; PEPTAZOL; CLENIL; BREVA
Current Illness: Prophylaxis against gastrointestinal ulcer; Immunisation; Bronchial disorder; Goitre; Hypertensive heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412ITA003923

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number IT-1577272925-E2014-12205) on 08-DEC-2014. Case received from Health Authority (case n. 283387) on 05-DEC-2014. Case initially reported by a physician. Case medically confirmed. A 90 year old patient was vaccinated on 10-NOV-14 with the first dose of INTANZA (batch n. L8287-2, Exp. date 30/06/2015) I.M. and with one dose of PNEUMOVAX (batch number K009023, Exp. date 30/04/2015). On the same day he presented with ischemic stroke and cerebral thrombosis. The patient was hospitalized. He was treated with parenteral nutrition, hydration and diuretic. On 20-NOV-14 the patient died. The outcome is fatal. The patient''s medical history included hypertensive heart disease, goiter and bronchopathy. Concomitant medications included CARDIOASPIRIN, CORLENTOR, TAPAZOLE, PEPTAZOL, CLENIL and BREVA. The case is closed.


VAERS ID: 560984 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-10
Submitted: 2015-01-12
   Days after onset:63
Entered: 2015-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Autopsy, Death, Hepatomegaly, Toxicologic test
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT002281

Write-up: Case number PHHY2015IT002281, is an initial spontaneous report from a consumer (journalist) via company representative received on 09 Jan 2015. This report refers to a 90-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. Despite the advanced age, the patient was very active and completely self-sufficient. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. Prior to the bedtime, the patient had not experienced any particular disorder. On 10 Nov 2014, 12 hours after vaccination, the patient died while he was sleeping during the night. After the patient died, the relatives of the patient''s observed an excessive swelling of the abdominal area and liver. The liver tissues were taken to perform toxicological examinations. It was reported that autopsy was performed; however the results were not reported. The outcome and seriousness of the events excessive swelling of the abdominal area and liver were not reported. Causality was not reported.


VAERS ID: 553902 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2014-11-07
Submitted: 2014-11-17
   Days after onset:10
Entered: 2014-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, Death, Dyspnoea, Leukaemia, Splenectomy, Splenomegaly
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1411USA006508

Write-up: This spontaneous report was received from a pharmacist via company representative. The pharmacist reported on her 72 year old father. Information regarding patient''s medical history was not reported. On an unknown date the patient was vaccinated with PCV (manufacturer unknown) (lot#, expiration date, route of administration, anatomical location were not reported). Other suspect therapies administered the same day included influenza virus vaccine (manufacturer unknown). The pharmacist reported that her father died after receiving a combination of PCV (manufacturer unknown) and influenza virus vaccine (manufacturer unknown) at the same visit. On an unknown date the patient experienced pain and tightness similar to gallbladder symptoms. Then the patient was seen in the office of his unspecified physician again and determined to have an enlarged spleen. The patient was sent to an unspecified oncologist and was diagnosed as having leukemia on an unspecified date. The patient was hospitalized on an unknown date. The patient''s spleen was surgically removed, as it was continuing to enlarge. The patient never fully recovered from the surgery and experienced breathing problems and died before leaving the hospital on 07-NOV-2014. The cause of death was not reported. The outcome of pain and tightness similar to gallbladder symptoms, leukemia and enlarged spleen was not reported. The events of pain and tightness similar to gallbladder symptoms, leukemia, enlarged spleen which was surgically removed and breathing problems were determined to be life-threatening by the reporter. Upon internal review the events of leukemia and enlarged spleen which required surgical removal were determined to be medically significant. The relatedness between the events and the therapy with PCV (manufacturer unknown) was not reported. Additional information is not expected since the reporter did not want to be contacted in any way regarding this report.


VAERS ID: 554258 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2014-11-06
Onset:2014-11-07
   Days after vaccination:1
Submitted: 2014-11-18
   Days after onset:11
Entered: 2014-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED T57806 / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Autopsy, Death, Respiration abnormal, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: To our knowledge alprazolam 2mg and hydrocodone/apap 7.5/325
Current Illness: No visible illnesses or complaints. No injection site reactions
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unresponsive at his home the next day by his mother. She called 911 and reported very light breathing. She and the paramedics tried to perform CPR but were unsuccessful and reported him dead at 2pm. Paramedics stated that it was similar to what they see in heart attack victims. No autopsy reports have been received as of 11-18-14.


VAERS ID: 556731 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2014-11-07
Onset:2014-11-07
   Days after vaccination:0
Submitted: 2014-12-01
   Days after onset:24
Entered: 2014-12-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Immediate post-injection reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unk
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA163456

Write-up: Initial unsolicited case received from a consumer on 24 November 2014, during routine media monitoring. Five patients, whose ages and genders were not reported, received Influenza vaccine (manufacturer and lot numbers not reported) on 07 November 2014. It was reported that the patients immediately developed a fever, and all died within one week of vaccination. No additional information pertaining to the patients was reported. Documents held by sender: None.


VAERS ID: 562269 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-03
Onset:2014-11-05
   Days after vaccination:2
Submitted: 2014-12-08
   Days after onset:33
Entered: 2014-12-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 149201 / UNK AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Malaise, Sepsis, Septic shock
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), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-11
   Days after onset: 6
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: Renal failure chronic, since 10 years; Ischaemic cardiomyopathy, since 09 years; Chronic obstructive pulmonary disease, since 10 years; Coronary artery disease; 2013, Ischaemic stroke
Preexisting Conditions: Aortic aneurysm rupture
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT158295

Write-up: Case number PHHY2014IT158295, is an initial spontaneous report from a health care professional via Health Authority (HA, reference number: 282680) received on 03 Dec 2014. This report refers to an 85-year-old male patient. The patient current conditions included chronic renal failure (since 10 years), ischemic cardiomyopathy (since 9 years), COPD (since 10 years) and coronary artery disease. Historical condition included previous rupture of aortic aneurysm and ischemic stroke (in 2013). He was vaccinated with AGRIPPAL (batch number: 149201) into the deltoid on 03 Nov 2014. On 05 Nov 2014, the patient experienced malaise (patient relative referred as malaise). Based on the necroscopic record and sequence of condition that conducted directly to death were reported as: on 06 Nov 2014 (5 days before the date of death), the patient had an infection of unknown origin and the patient was taken to hospital. On 07 Nov 2014, the patient was hospitalized. On 09 Nov 2014 (2 days before the date of death), the patient had septicemia. On 10 Nov 2014 (1 day before the date of death), the patient had septic shock. On 11 Nov 2014, the patient had cardio-respiratory arrest and the patient died. The reporter assessed the event to be serious (death) and causality to be suspected to the administration of AGRIPPAL.


VAERS ID: 562266 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-27
Onset:2014-10-27
   Days after vaccination:0
Submitted: 2014-12-10
   Days after onset:44
Entered: 2014-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 27649411A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Circulatory collapse, Death, General physical health deterioration
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allopurinol; Lisinopril; Atorvastatin; Clopidogrel
Current Illness:
Preexisting Conditions: COPD; Aortic valve insufficiency; Coronary sclerosis; Aneurysm of renal artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014046911

Write-up: This medically confirmed health authority report (initial receipt 26-Nov-2014) concerns a 73-year-old male patient. The patient''s medical history included chronic obstructive pulmonary disease, aortic valve insufficiency, coronary sclerosis and aneurysm of renal artery. His concomitant medications included allopurinol, lisinopril, atorvastatin and clopidogrel. On 27-Oct-2014, the patient received intramuscular AFLURIA (batch number: 27649411A) at 1 DF. On 27-Oct-2014, six hours after vaccination, the patient developed cardiac failure, circulatory failure and reduced general condition (lasting for unknown). The patient died. An autopsy was not performed. It was reported that the patient had a fatal outcome. Reporter''s comments: Unexpected adverse drug reaction, 6 to 8 hours after vaccination and from complete well-being, sudden deterioration of physical health and cardiac failure/circulatory arrest. The patient received reanimation by emergency service which was aborted without successful outcome. The health authority assessed the case as serious (patient died). Cause(s) of death: Unknown cause of death. Death Date: 27-Oct-2014.


VAERS ID: 553974 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-10-24
Onset:2014-10-25
   Days after vaccination:1
Submitted: 2014-10-31
   Days after onset:6
Entered: 2014-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autopsy, Death, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-25
   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: No other medications
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 25-OCT-2014 (12:59): vascular access portfolio was performed.
CDC Split Type: WAES1410JPN015556

Write-up: Initial information has been received from a pharmacist concerning a 79 years old female patient with a history of hypertension who on 24-OCT-2014 was vaccinated with PNEUMOVAX NP (dose, lot number, indication not reported) (route reported as parenteral). Other concomitant medication was Influenza HA vaccine (manufacturer unknown) (daily dosage, indication unknown). On 24-OCT-2014, the patient was vaccinated with PNEUMOVAX NP and Influenza HA vaccine (manufacturer unknown) at same time at hospital A. The patient felt physical deconditioning at night fall. On 25-OCT-2014, the patient developed vomiting and general malaise. The patient was transported to the reporter''s hospital by an ambulance. At 12:59, the vascular access portfolio was performed. The patient died at 14:00. The cause of death and the information of autopsy were not reported. At the time of this report, the outcome of physical deconditioning, vomiting and general malaise was unknown. The reporting pharmacist did not assess the seriousness of the physical deconditioning, vomiting and general malaise. The reporting pharmacist did not assess the relationship between death, physical deconditioning, vomiting, general malaise and PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 564470 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2014-10-24
Onset:2014-10-24
   Days after vaccination:0
Submitted: 2015-02-05
   Days after onset:104
Entered: 2015-02-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5062AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Blister, Bone pain, Death, Impaired driving ability, Mobility decreased, Musculoskeletal stiffness, Oxygen supplementation, Peripheral swelling, Pneumonia, Pruritus, Pyrexia, Rash pruritic
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-12
   Days after onset: 80
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness: Latex allergy; Drug allergy
Preexisting Conditions: Nasal polyps
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA152664

Write-up: Initial report received from a healthcare professional on 03 November 2014. A 78-year-old female patient had received first dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly in left deltoid on 24 October 2014. The patient''s medical history includes AVELOX and latex allergy and concomitant medication was not reported. The patient had not received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the patient had experienced itchy rash. After the rash patient experienced stiffness in the legs. Laboratory investigations and corrective treatment was not reported. It was reported that itchy rash was for 2 days but the outcome of the event was not reported. Follow-up information was received for this unsolicited case on 30 January 2015 from a consumer who is the patient''s daughter. Additional information was received the same day from the pharmacist who was the original reporter. According to the patient''s daughter, the patient was described as being in good shape at 78 years of age when she received the vaccine on 24 October 2014. The patient told her daughter that she had a fever and her bones were sore. The patient was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters on the back of her legs about the size of a dime and a nickel. The patient showed it to her doctor as she could not walk. She was hesitant to go back to the doctor. The patient experienced pneumonia like symptoms within the week and was put on oxygen. She could not drive because she could not move. She was treated with antibiotics two weeks later. She had swelling in her left leg. The patient was found dead in her chair on 12 January 2015. A pharmacist also reported the event on 30 January 2015 after the daughter had reported it to him. The patient had died on 12 January 2015. The patient had seen a healthcare provider for the first time after vaccination on 25 November 2014 and was treated with an antibiotic. Around this time the patient had developed pneumonia. The daughter reported that the patient had stopped taking the antibiotic because it made her itch. She returned to the healthcare practice on 8 December 2014 and was treated with another antibiotic and was placed on oxygen. The patient outcome is fatal. Documents held by sender: none.


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.


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