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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: 407754 (history)  
Form: Version 1.0  
Age: 0.85  
Sex: Male  
Location: Michigan  
Vaccinated:2010-11-08
Onset:2010-11-08
   Days after vaccination:0
Submitted: 2010-11-10
   Days after onset:2
Entered: 2010-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3744AA / 2 RL / IM

Administered by: Other       Purchased by: Public
Symptoms: Blood glucose increased, Cardiac arrest, Death, Endotracheal intubation, Gastrointestinal tube insertion, Pulse absent, Respiration abnormal, Resuscitation, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-08
   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: None
Preexisting Conditions: Diaper rash
Allergies:
Diagnostic Lab Data: Blood sugar 137
CDC Split Type:

Write-up: Previously healthy baby taken to ER by EMS unresponsive, with no pulse, no respirations. Details of what occurred prior to EMS arrival to apartment are unknown. One report is that the baby was in the bath with an older sibling, or mom was in the bathroom with another child, heard something in another room and then went and found the baby unresponsive. Mom started CPR, it took 5 - 10 minutes before the fire department arrived and continued CPR, the EMS arrived and found the baby on the floor with vomitis in hair, continued CPR, intubated, were unsuccessful in placing an IV line and administered Epinephrine via the ET. Upon arrival to the ER the baby was asystolic, IV started, 3 rounds of Epinephrine and Atropine administered via the IV and one dose of Na Bicarb, the ET tube was removed and another one placed, NG tube placed. All attempts were unsuccessful. The baby was pronounced at 10:48 PM. Medical Examiner to handle case.


VAERS ID: 421048 (history)  
Form: Version 1.0  
Age: 1.51  
Sex: Female  
Location: California  
Vaccinated:2010-10-15
Onset:2010-11-08
   Days after vaccination:24
Submitted: 2011-04-14
   Days after onset:156
Entered: 2011-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3566BA / 1 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB444BA / 1 LL / IM

Administered by: Private       Purchased by: Private
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: 2010-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: H/O possible febrile seizure 2/2010.
Allergies:
Diagnostic Lab Data: 7 above, per medical examiner report.
CDC Split Type:

Write-up: Sudden unexplained death.


VAERS ID: 413013 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-11-05
Onset:2010-11-05
   Days after vaccination:0
Submitted: 2010-12-17
   Days after onset:42
Entered: 2010-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0689002A

Write-up: This case was reported by a regulatory authority (FI-FIMEA-20101818) and described the occurrence of fatal general physical health deterioration in a 86-year-old subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included advanced Alzheimer''s disease and wheelchair user. The subject was living in a homecare. On 5 November 2010, the subject received unspecified dose of FLUARIX (intramuscular, right deltoid). The lot number provided doesn''t match with FLUARIX lot number. On 5 November 2010, less than one day after vaccination with FLUARIX, the subject experienced general physical health deterioration, leading to death. According to the epicrisis and police investigations, after vaccination with FLUARIX, the subject was lied in the bed and was found died later. The subject died on 5 November 2010 from general physical health deterioration. It was unknown whether an autopsy was performed.


VAERS ID: 409766 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-10-21
Onset:2010-10-30
   Days after vaccination:9
Submitted: 2010-11-23
   Days after onset:24
Entered: 2010-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA610AA / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Borrelia test negative, CSF glucose increased, CSF protein normal, CSF white blood cell count negative, Death, Dysstasia, Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness, Polymerase chain reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-11
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cadue, Prilosec, Multi vit, Vit C, Aspirin, Calcium +D, Fish Oil, Arimidex, Xanax
Current Illness: no
Preexisting Conditions: HTN, Hemochromotosis, breast ca (s/p chemo & XRT) NIDDM, depression, hyperlipidemia
Allergies:
Diagnostic Lab Data: Lumbar Puncture-$gGlucose=118, protein=44, wbc 0, lyme dna pcr neg
CDC Split Type:

Write-up: Sudden onset of weakness (back and neck)progressed to lower extremities described as "gel legs", difficulty standing DX with Guillain-Barre Syndrome


VAERS ID: 405951 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: New York  
Vaccinated:2010-10-26
Onset:2010-10-27
   Days after vaccination:1
Submitted: 2010-10-29
   Days after onset:2
Entered: 2010-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3650AA / 1 UN / IM

Administered by: Other       Purchased by: Public
Symptoms: Death, Headache, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Reported
Preexisting Conditions: None noted
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: HEADACHE, Swolen painful arms


VAERS ID: 407922 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-10-26
   Days after vaccination:1
Submitted: 2010-11-05
   Days after onset:10
Entered: 2010-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLU538AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute pulmonary oedema, Death, Resuscitation, Septic shock
SMQs:, Cardiac failure (narrow), Toxic-septic shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-27
   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:
Current Illness: HEMODIALYSIS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0682882A

Write-up: This case was reported by a regulatory authority (# 126424) and described the occurrence of acute pulmonary edema in a 80-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included hemodialysis. On 25 October 2010 the subject received unspecified dose of FLUARIX (intramuscular). On 26 October 2010, 1 day after vaccination with FLUARIX, the subject experienced acute pulmonary edema and septic shock. The subject was treated with cardiopulmonary resuscitation, antibiotics, amine and cortisone. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX. The subject died on 27 October 2010, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 407287 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2010-10-22
Onset:2010-10-25
   Days after vaccination:3
Submitted: 2010-11-08
   Days after onset:14
Entered: 2010-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFUA602AB / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Back pain, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-11
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccinated on 10/22/10. Reports back pain and muscle weakness increasing through weekend. Admitted on 10/27/10.


VAERS ID: 709454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / UN

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Autopsy, Cyanosis, Death, Microscopy, Vaccination complication
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2017SA151511

Write-up: Initial unsolicited report received from the literature on 16-Aug-2017. This case was linked with 2017SA151529, 2017SA151538, 2017SA151548. (Same article). The following is the verbatim from the article: Immunization plays an important role in the prevention of infectious diseases and it is currently one of the best measures to prevent diseases. With the implementation of the Expanded Program on Immunization, the types of vaccines have increased and the immunization rate of type 2 vaccines has also increased. The constant public attention paid to suspected abnormal reactions to immunization and the increasing number of negative reports related to vaccines, caused people to be more worried about the safety of vaccines. The improper handling of this matter can easily lead to medical disputes. Past literatures reported that most cases of deaths reported following vaccination are pure coincidences, while there were also some reports that believed vaccines can induce or aggravate potential diseases. This paper determined the cause of death of four infants who died following vaccination through an autopsy of their bodies, determining the relation between the vaccines and cause of death, and providing a reference for reducing the occurrence of coincidental events and the promotion of safe vaccination services. At the same time, it can help to reduce the negative impact of vaccine events and reduce public concerns about vaccination. Materials and Methods: Data Source: The diagnostic data of four cases of deaths following vaccination between January-2010 to December-2016 from an expert group on abnormal reactions to vaccination were collected. The data were taken from the AEFI Surveillance System. Each case has complete birth information, vaccination information, death information, laboratory test results, as well as the autopsy reports. They were all cases of death following vaccination, and the possibility of death by violence and exogenous intoxication was ruled out. Analysis Method: The vaccination units reported the deaths due to suspected abnormal reactions to vaccination to the county-level disease control and prevention institution where the vaccine recipients were located. Either by the fastest methods, such as phone call, within two hours in accordance with the requirements of the "National Suspected Abnormal Reactions to Vaccination Surveillance Program". The county-level disease control and prevention institution immediately submit direct online reports of the cases through the National Immunization Information Management System after verification. Investigation of deaths due to suspected abnormal reactions to vaccination after receiving the report, the municipal center for disease control and prevention immediately organized experts on the diagnosis and investigation of abnormal reactions to vaccination to conduct an investigation and collect vaccination, clinical treatment, death and other related data. The preliminary results of the investigation were reported within seven days. The parents were persuaded to carry out an autopsy during the investigation and the results of the autopsies were recorded. Diagnosis of deaths due to suspected abnormal reactions to vaccination the investigation was carried out by the municipal or provincial expert group on the investigation and diagnosis of abnormal reactions to vaccination. Clinical manifestations, autopsy results and the results of vaccine quality test were combined for a comprehensive analysis and a conclusion was made on the investigation and diagnosis based on the laws, administrative regulations, departmental regulations and technical specifications. Epidemiological analysis a descriptive approach was used to analyze the autopsy results and the investigation and diagnostic data of the death cases. This case involves 12-months-old female patient who was vaccinated with first dose of INFLUENZA VACCINE on the deltoid region of her left upper arm, and second dose of MENINGOCOCCAL POLYSACCHARIDE on the deltoid region of her right upper arm (Batch number, expiry date, dose, and route of administration were not reported for both the vaccines) on 25 Oct 2010 at 11:20:00 A.M. The patient medical history and concomitant medications were not reported. On 25 Oct 2010, 50 minutes after the vaccinations, the patient died due to anaphylactic shock, and the patient also had a cyanosis of the lips and fingernail beds (as per autopsy report). The patient relevant lab tests and corrective treatment were not reported. The patient autopsy revealed that the patient had normal development. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. Identification of the cause of death: Death caused by anaphylactic shock. The diagnostic conclusion of the municipal expert group on the diagnosis of abnormal reactions was an abnormal reaction to vaccination. Upon internal review the company decided to consider the event as serious due to important medical event cyanosis of the lips and fingernail beds. List of documents held by sender: none. Sender''s Comments: Patient died due to anaphylactic shock 50 minutes after receiving a group A meningococcal polysaccharide and split-virus influenza vaccines. Time to onset is compatible with the role of vaccines. The autopsy revealed that the child had normal development and that here was cyanosis of the lips and fingernail beds. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. As a result the cause of death was identified as anaphylactic shock however autopsy report was not provided. Additional information including but not limited to the patient anamnesis including allergic history (food allergy and patient''s immunization history are needed to further assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately. Reported Cause(s) of Death: Anaphylactic shock; Autopsy-determined Cause(s) of Death: Anaphylactic shock.


VAERS ID: 406908 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2010-10-22
Onset:2010-10-24
   Days after vaccination:2
Submitted: 2010-11-03
   Days after onset:10
Entered: 2010-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3621GA / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0632Y / UNK UN / IM

Administered by: Other       Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Blood urea increased, Chest X-ray, Dysaesthesia, Full blood count, Hypoaesthesia, Metabolic function test, Muscular weakness, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-09
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HCTZ; Atenolol; Lisinopril; Zolpidem; Simvastatin; Nortriptyline
Current Illness: None
Preexisting Conditions: PCN -allergy; HTN; Diabetes
Allergies:
Diagnostic Lab Data: 10/31/10 CXR done CBC; WBC 14.0; CMP with CK of 263; BUN -29; Sed Rate 53; Transferred to hospital - higher level of care with dx of R/o Guillian Barre Syndrome
CDC Split Type:

Write-up: Numbness, pain bilateral lower extremities progressive weakness, tingling, dyesthesias in soles of feet - started on 10/24 seen at clinic on 10/26 - started on LYRICA d/t hx of diabetes seen in ER on 10/31 - with dyesthesias in hands and fingers - transferred to different hospital.


VAERS ID: 404258 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2010-10-11
Onset:2010-10-18
   Days after vaccination:7
Submitted: 2010-10-18
   Days after onset:0
Entered: 2010-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3566BA / UNK RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB441BA / UNK LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0647Z / UNK RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0552Z / UNK LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Death, Pulse absent, Resuscitation
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL Children''s PO; QVAR 80, 1 inhaler, 10/14/2010, take 2 puffs by inhalation twice daily while awake; DIFLUCAN 10 MG/ML susr, 14 day supply, 10/11/2010, take 5 mL by mouth daily. Take 5 mls on day 1, then take 2.5 mls on days 2-14, or
Current Illness: None
Preexisting Conditions: Multiple congenital anomalies; Developmental delay; Esophageal reflux; Pneumonia, organism unspecified; Prematurity 36 weeks EGA; Hypothyroidism; Hypothalamic dysplasia; Bicuspid aortic valve; Oral thrush; Decreased sensation larynx; Stridor; GERD; Feeding difficulty; Dysphagia, pharyngeal
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient was found pulseless and apneic in her bed by mom in the morning (0500). CPR performed and pt taken to ED. Unable to resuscitate.


VAERS ID: 404792 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Utah  
Vaccinated:2010-10-13
Onset:2010-10-14
   Days after vaccination:1
Submitted: 2010-10-19
   Days after onset:5
Entered: 2010-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U3635AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of chronic conditions including severe cardiopulmonary issues (unspecified), cataracts, and was "crippled". The reporter stated the patient had been very ill and his quality of life was poor. The patient received an influenza vaccine annually. Follow-up on 18 October 2010: Per the reporter, the patient''s medical history of cardiopulmonary issues (unspecified) was "more cardiac rather than pulmonary", but no specifics were provided.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201005967

Write-up: Initial information received from a health care professional on 15 October 2010. A 75-year-old male patient with a history of severe cardiopulmonary issues (unspecified), cataracts, and who was "crippled", received a dose of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3635AA, on 13 October 2010 at 10:00 a.m. The route and site of vaccination were not reported. Following vaccination, the patient experienced no adverse events or reactions and was reported to be "fine" at 8:30p.m. that evening. The following day, on 14 October 2010 at 11:00 a.m., he was found dead by his sister. Autopsy status is unknown and no cause of death was reported. Per the reporter, the patient had been very ill prior to vaccination and his quality of life was poor. Follow-up information received on 18 October 2010 from a health care professional. The reporter stated that it is unknown if an autopsy was planned for the patient, but that if the patient had been seen by one of their physicians during the month prior to the event it is unlikely an autopsy would be performed. In addition, the reporter stated that the patient''s past medical history of cardiopulmonary issues (unspecified) were "more cardiac rather than pulmonary", but no specifics were provided. List of documents held by sender: none


VAERS ID: 404173 (history)  
Form: Version 1.0  
Age: 0.84  
Sex: Female  
Location: Kentucky  
Vaccinated:2010-09-29
Onset:2010-10-11
   Days after vaccination:12
Submitted: 2010-10-13
   Days after onset:2
Entered: 2010-10-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B250BA / 3 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3581BA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 913967 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVACID; FLOVENT
Current Illness: Resolving pneumonia
Preexisting Conditions: Spinal muscular atrophy, Type II; Asthma; GERD
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. deceased 10/11/2010. Unknown cause at present time; per mo-pt found in crib, prone, not breathing on morning of 10/11/2010. Past history significant for spinal muscular atrophy Type II. Treated for pneumonia 9/20-9/22/2010.


VAERS ID: 407037 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Michigan  
Vaccinated:2010-10-08
Onset:2010-10-11
   Days after vaccination:3
Submitted: 2010-11-05
   Days after onset:25
Entered: 2010-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3580CA / 5 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Chest X-ray normal, Condition aggravated, Convulsion, Influenza A virus test positive
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), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
   Days after onset: 9
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: Is on: Trilepta Albuterol Pulmicort
Current Illness: No
Preexisting Conditions: Developmental Delay Obstructive Sleep Apnea Seizure Disorder Prior History of Aspiration Pneumonia Dysphasia
Allergies:
Diagnostic Lab Data: Nasal Washing showed positive for Influenza A
CDC Split Type:

Write-up: Mom states patient had 2 minute seizure and then another one a little bit later that lasted about 5 minutes. She states she hasn''t had a seizure for about 4 to 5 months. Took her into ER per ambulance at 2:30am. Left ER 5:30am. Called ambulance again when she had a 35 minute seizure around 9:30am. Had chest x-ray earlier which was clear. Her Trilepta dosage was increased and she was sent home again.


VAERS ID: 406022 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-11
Onset:2010-10-11
   Days after vaccination:0
Submitted: 2010-10-29
   Days after onset:18
Entered: 2010-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 108601 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Base excess decreased, Blood bicarbonate decreased, Blood potassium increased, Cardiac arrest, Cardiac failure acute, Death, Electrocardiogram abnormal, Heart rate irregular, Malaise, Oxygen saturation decreased, PCO2 increased, Pallor, Posture abnormal, Resuscitation, pH body fluid increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Lactic acidosis (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), Dystonia (broad), 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), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prostate cancer; Hepatic cancer metastasis, Very active pancreatic cancer with metastasis in the liver; Malaise, Ill with decreased appetite 3-4 days prior to vaccination; Decreased appetite, Ill with decreased appetite 3-4 days prior to vaccination; Heart rate irregular; Pancreatic carcinoma metastatic, Very active pancreatic cancer with metastasis in the liver
Preexisting Conditions: Vascular graft; Very active pancreatic cancer with metastasis in the liver; Ill with decreased appetite 3-4 days prior to vaccination
Allergies:
Diagnostic Lab Data: Base excess; 27.4; Low; Blood bicarbonate; 6.3; Low; Blood potassium; 83; High; Oxygen saturation; 84%; Low; PCO2; 9.24; High; pH body fluid, 6.76; High
CDC Split Type: PHHY2010DK71270

Write-up: Initial serious report received from a physician via Health Authority on 25 Oct 2010: The patient had medical history of very active pancreatic cancer with metastasis in the liver, prostate cancer and bypass surgery. The patient was ill with decreased appetite, 3-4 days prior to vaccination and came to the consultation in order to get clarification about future treatment. Due to unwell felling since 3-4 days, an electrocardiogram (ECG) was performed on an unknown date which showed an irregular heartbeat. It was agreed that the patient should be hospitalized sub acutely. Afterward the patient went home. The patient was vaccinated with AGRIPPAL (batch number 108601) on 11 Oct 2010. About half to one hour after vaccination, the patient experienced sudden cardiac arrest (acute heart failure). The patient''s head suddenly fell back, and the patient seemed very distant and suddenly became pale. An ambulance was called for. The paramedics found a shock-able heart rhythm. The patient was given shocks eight times and appropriate medication by the paramedics. On the way to the ambulance, the patient went into asystole and appropriate medical treatment was provided. The patient was taken to the hospital while given persistent artificial respiration. In total, the patient received 600 mg CORDARONE IV, 8 mg epinephrine IV and 3 mg ATROPINE, all without effect. Artificial respiration was continued at the hospital. The patient was resuscitated for a total of 55 minutes. Based on the patient''s cancer, the patient was pronounced dead. Investigations performed at the hospital included an A puncture which showed a pH of 6.78, partial pressure of carbon dioxide (pCO2) of 9.24, base excess of 27.4, bicarbonate of 6.3, SAT 84%, potassium level of 8.3, and lactate level of 13.4 (units not specified). According to the physician, the patient was under the circumstances well when he left the praxis. The physician did not believe that there was a connection between the vaccination and the patient''s death.


VAERS ID: 407943 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-09
Onset:2010-10-09
   Days after vaccination:0
Submitted: 2010-11-11
   Days after onset:33
Entered: 2010-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, 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: 2010-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diltiazem hydrochloride; Tiotropium; Allopurinol; Symbicort; Carbocisteine; Isosorbide mononitrate; Ramipril; Salbutamol sulphate; Nicotine
Current Illness: Ischemic heart disease; unwell
Preexisting Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0682334A

Write-up: This case was reported by a physician via the regulatory authority (GB-MHRA-ADR 20728958) and described the occurrence of sudden death in a 78-year-old male patient who was vaccinated with FLUARIX. The patient''s medical included myocardial infarction. Concurrent medical conditions included ischemic heart disease and unwell. Concurrent medications included diltiazem, nitroglycerine (GTN), co-codamol, aspirin, clopidogrel, simvastatin, tiotroprium, allupurinol, SYMBICORT, carbocisteine, isosorbide mononitrate, ramipril, salbutamol sulphate, and nicotine. On 09 October 2010 the patient received an unspecified dose of FLUARIX (.5ml, intramuscular). On the same day 09 October 2010, the patient was fine after receiving the FLUARIX but 4.5 hours after vaccination with the FLUARIX, the subject experienced sudden death. Health authorities reported that the patient did not experience any anaphylactic reaction immediately after receiving the FLUARIX. An autopsy was performed. The pathologist did not feel that a post-mortem would provide information that would narrow down any possible reaction to flu jab. It was reported that the ''death was not felt to be linked to FLAURIX. from the history it was felt that the patient died from the natural causes rather than a reaction to the FLUARIX. Advised to report incident, but death is not felt to be linked to flu jab. Received ''flu jab and was fine after injection, but four and a half hours later died at home lying on their bed. Had a history of ischaemic heart disease and myocardial infarction eight months previously. From history it was felt they died from natural causes rather than reaction to ''flu jab (coroner in agreement). No anaphylactic reaction immediately after the ''flu jab. Spouse reported they had not been well for some time. Pathologist did not feel a post-mortem would provide information that would narrow down any possible reaction to ''flu jab. Coroner not aware of any link between flu jab and sudden death.


VAERS ID: 404181 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2010-10-05
Onset:2010-10-06
   Days after vaccination:1
Submitted: 2010-10-19
   Days after onset:13
Entered: 2010-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3575EA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Soft tissue arm pain that radiates down arm to hand. Hand feels weak at times. no improvement over 2 weeks. No sign of infection or hematoma. No indication of nerve pain.


VAERS ID: 405327 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-05
Onset:2010-10-06
   Days after vaccination:1
Submitted: 2010-10-25
   Days after onset:19
Entered: 2010-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010DE70854

Write-up: Initial report received from the foreign Health Authority (reference number PEI2010030411) on 20 Oct 2010: This patient with an unknown medical history received influenza virus vaccine (manufacturer and batch number unknown) on 05 Oct 2010. The patient experienced vaccination reaction on 06 Oct 2010. The event was reported as serious (life threatening). After 11 days on an unspecified date the patient died. It was not known whether autopsy was performed or not. The health authority diagnosed the event as vaccination adverse reaction.


VAERS ID: 401548 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2010-09-24
Onset:2010-09-24
   Days after vaccination:0
Submitted: 2010-10-01
   Days after onset:7
Entered: 2010-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3654AA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Was released from hospital on 09/21/2010 after having "fluid drawn off lungs" as reported by wife. Had heart disease.
Preexisting Conditions: heart disease, unspecified heart valve abnormality
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Wife reports after leaving the Health Department, she and her husband completed some errands, the stopped approximately one hour later to let their dogs exercise. After getting out of the truck for a few minutes, he returned to the truck, then suddenly collapsed onto her lap. Was transported to Hopital.


VAERS ID: 401842 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: California  
Vaccinated:2010-09-21
Onset:2010-09-24
   Days after vaccination:3
Submitted: 2010-10-01
   Days after onset:7
Entered: 2010-10-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U3601AA / UNK RA / UN

Administered by: Private       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: 2010-09-27
   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: Allergy shot; EFFEXOR; FLOMAX; NEURONTIN; hydromorphone; guiafesen
Current Illness:
Preexisting Conditions: Patient had a history of asthma and allergies to weeds and molds.
Allergies:
Diagnostic Lab Data: None
CDC Split Type: 201005586

Write-up: Initial report was received 30 September 2010 from a health care professional, who received the report from the patient''s wife. A 74-year-old male patient who had a history of asthma and allergies to weeds and molds, had received a first dose of FLUZONE HIGH-DOSE (lot number, route and site of administration unknown at the time of the report) and an unspecified allergy shot on 21 September 2010. On 24 September 2010, three days post vaccination, the patient developed a slight fever which resolved the following day. According to the reporter, the patient went to bed on 26 September 2010 and the following day on 27 September 2010, six days post vaccination, the patient was found dead in bed. The patient had no concurrent illness at the time of vaccination. The patient had been taking EFFEXOR, FLOMAX, "NEURONTIN", Hydromorphone and "guiafesen"concomitantly. The patient had also received allergy shots in the past. At the time of the report, it was unknown if an autopsy had been performed. No additional information was provided at the time of the report. Documents held by sender: None.


VAERS ID: 438723 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-21
Onset:2010-09-22
   Days after vaccination:1
Submitted: 2011-10-17
   Days after onset:390
Entered: 2011-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-09-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0073016A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2011032831) and described the occurrence of septicaemia in a 45-year-old female subject who was vaccinated with seasonal Influenza vaccine 2010/2011 ((unspecified), manufacturer unspecified). Information concerning the subject''s medical history and concomitant medication was not provided. Previous vaccination with not further specified vaccines have been well tolerated. On 21 September 2010 the subject received the first dose of seasonal Influenza vaccine 2010/2011 (unspecified) (0.5 ml, unknown). Approximately one day post vaccination with seasonal Influenza vaccine 2010/2011 (unspecified), on 22 September 2010, the subject experienced septicaemia. The reporter considered that the event was life threatening. After three days, on or around 24 September 2010, the subject died from sepsis. An autopsy was performed but the autopsy report was not provided. Poisoning had been excluded. According to autopsy the possibility of a causal relationship of septicaemia and vaccination with seasonal Influenza vaccine 2010/2011 (unspecified) could not be excluded. The foreign regulatory authority has requested further information. At the moment no further information was available.


VAERS ID: 398967 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2010-09-17
Onset:2010-09-17
   Days after vaccination:0
Submitted: 2010-01-20
   Days after onset:239
Entered: 2010-09-21
   Days after submission:243
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA608BA / UNK LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Abdominal discomfort, Blood test, Death, Diarrhoea, Faeces discoloured, Feeling hot, General physical health deterioration, Nausea, Pulmonary oedema, Pulse absent, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-18
   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: 10mg LIPITOR; Levothyroxine 100 mcg; INDERAL 160 LA 1x; WELCHOL 1 PRN; NORVASC 10mg 1x; PLAVIX 75mg 1x; Potassium 10 meq 2x
Current Illness: Mycobacterium chelonae
Preexisting Conditions: BP (good at Dr. visit); High cholesterol (under control); occluded carotid artery (plav
Allergies:
Diagnostic Lab Data: None at present
CDC Split Type:

Write-up: Patient received combination Flu shot on 01-17-1- at approx. 1PM. Had shot at doctor''s office. Had blood drawn at hospital at 1:38PM. After arriving home, deceased complained of being sick to stomach and hot. Began vomiting and had black, runny diarrhea. Overnight patient condition deteriorated, lung filled with fluid and had no pulse when EMS arrived at approx, 12:40 PM 9-18-10. Patient pronounced dead at 1:07 PM on 9-18-10. On 9-18-10 AM before EMS arrived patient vomiting brown bile and had runny, black diarrhea


VAERS ID: 470610 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-09-01
Onset:2010-09-10
   Days after vaccination:9
Submitted: 2012-10-19
   Days after onset:770
Entered: 2012-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Chronic fatigue syndrome, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-23
   Days after onset: 194
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: Not sure. She had been taking pain meds, psych meds, and laxatives.
Current Illness:
Preexisting Conditions: Hypothyroidism Bipolar disorder Back pain
Allergies:
Diagnostic Lab Data: My mom died from a small bowel obstruction. I believe the vaccine may have precipitated the mechanical obstruction. As a healthcare worker being forced into the flu vaccine, I am extremely afraid of the effect on me or losing my job as a CRNA.
CDC Split Type:

Write-up: Extreme malaise lasting months. Diagnosed with chronic fatigue syndrome from the flu vaccine.


VAERS ID: 399572 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: California  
Vaccinated:2010-09-02
Onset:2010-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2010-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 11170P1 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Was informed that patient died 2 days after flu shot, no symptoms were reported by police office department.


VAERS ID: 426774 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-19
Onset:2010-08-05
   Days after vaccination:108
Submitted: 2011-07-04
   Days after onset:333
Entered: 2011-07-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH072AC / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Blood test normal, Chorea, Computerised tomogram head, Computerised tomogram normal, Convulsion, Death, Dyskinesia, General physical health deterioration, Influenza like illness, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-12
   Days after onset: 38
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: Measles in April 2010, characterized by severe generalized rash and fever. No previous history of adverse event to a vaccine or a drug.
Allergies:
Diagnostic Lab Data: CT scan of the brain, MRI of the brain, blood tests and lumbar puncture revealed no abnormalities.
CDC Split Type: 201005637

Write-up: Case received from a healthcare professional in a foreign country on 01 October 2010 under the local reference number 71/2010. A 13-year and 05-month-old male patient, with a reported medical history and no concomitant therapy, had received his dose of ROUVAX (batch number, route and anatomical site of administration not reported) in May 2010. It was administered in the context of a mass campaign. The patient had also received his dose of H1N1 (manufacturer, batch number, route and anatomical site of administration not reported) on an unspecified date. The patient had a medical history of Measles in April 2010, characterized by severe generalized rash and fever. He had no previous history of adverse event to a vaccine or a drug. On 05 August 2010, the patient experienced flu-like symptoms and unvoluntary movement of the right hand and leg. He was hospitalized the same day. The patient then developed 10 episodes of seizures and became aphasic. CT scan of the brain, MRI of the brain, blood tests and lumbar puncture revealed no abnormalities. He was transferred to another hospital on 10 August 2010 where his condition deteriorated. The patient died on 12 September 2010. His family declined the request for an autopsy to be carried out. Additional information received from the local affiliate on 01 December 2010: Chorea, i.e. unvoluntary, jerky, repetitive and rapid movements was previously reported but was illegible. Follow-up information received from the reporter through the local affiliate on 31 January 2011: The patient had received his intramuscular dose of ROUVAX (batch number E5001-1) in the right deltoid on 19 April 2010. The patient had also received his intramuscular dose of H1N1 (manufacturer not reported, batch number UH072AC) in the right deltoid on 26 July 2010. There was no information regarding the patient''s resuscitation. Follow-up information received from the reporter through the local affiliate on 22 June 2011: The reporter stated that the H1N1 vaccine was manufactured by sanofi pasteur (no further details provided).


VAERS ID: 495937 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-04-04
Onset:2010-07-05
   Days after vaccination:92
Submitted: 2013-07-01
   Days after onset:1092
Entered: 2013-07-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Chills, Cough, Death, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: 2010-07-18
   Days after onset: 13
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: Medical history included asthmatic bronchitis.
Allergies:
Diagnostic Lab Data: Examination for detection of H1N1 was performed with positive results (date not reported).
CDC Split Type: 201307405

Write-up: Initial report received from a health care professional via the local affiliate on 25 June 2013. This case is medically confirmed. A 10-year-old patient (date of birth and gender unknown) had received a dose of Influenza Vaccine (manufacturer name and lot number unknown) on 04 April 2010 and on 05 July 2010 presented with fever, cough, coryza, chills, arthralgia and myalgia and was hospitalized that day. Examination for detection of H1N1 was performed with positive results. The patient was medicated with TAMIFLU, but died on 18 July 2010 due to H1N1. The patient had medical history of asthmatic bronchitis. Family history was unknown. No additional information was provided. Documents held by sender: None.


VAERS ID: 398497 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Unknown  
Vaccinated:2009-10-01
Onset:2010-07-01
   Days after vaccination:273
Submitted: 2010-08-25
   Days after onset:55
Entered: 2010-09-16
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Confusional state, Death, Drug abuse, Endoscopy abnormal, Gastric ulcer haemorrhage, Haemoglobin decreased, Hypotension, Immunoglobulin therapy, Multi-organ failure, Platelet count decreased, Renal failure acute, Surgery, Upper gastrointestinal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Drug abuse and dependence (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-07-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin + Caffeine + paracetamol; Meloxicam
Current Illness:
Preexisting Conditions: Osteoarthritis
Allergies:
Diagnostic Lab Data: 01Jul2010, Blood Platelet count, 15L/L; 01Jul2010, Blood Hemoglobin, 6.6g/dL; 08Jul2010, Blood Platelet count, 33L/L; 08Jul2010, Blood Hemoglobin, 9.3g/dL
CDC Split Type: R0013070A

Write-up: This female subject was enrolled in the 2nd year of prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of preservative-free FLUARIX or FLU NG. The subject''s past medical history included osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine, 15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage. On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed multisystem organ failure. The subject was hospitalised and the events were life-threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not performed. The investigator considered that there was no reasonable possibility that the multisystem organ failure, upper gastrointestinal hemorrhage and acute renal failure may have been caused by investigational product and that the events were possibly due to the concomitant medication, Goody powder and meloxicam and the subject''s medical history of osteoarthritis. Investigator Comments: RE: Goodys Powders on Relevant Medication screen. This medication was not reported to the subject''s PCP as being taken so I have no start date, dosage, frequency or unit. Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted to the hospital. Subject was transfused 2 units of packed red blood cells. Initially she was doing well but became confused and agitated and hypotensive. An endoscopy was done which showed a massive bleeding from the pylorus. Subject was taken to surgery and the bleeding stopped. Subject did well until post-op day 5 when she started to deteriorate. Subject went into renal failure, then into multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD, Other respiratory system disorder, Other gastrointestinal and hepatobiliary system disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout, Other musculoskeletal system and connective tissue disorder, Other nervous system disorder. .


VAERS ID: 393893 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: California  
Vaccinated:2006-10-05
Onset:2010-06-11
   Days after vaccination:1345
Submitted: 2010-07-29
   Days after onset:48
Entered: 2010-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Death, Meningococcal bacteraemia, Neisseria test positive
SMQs:, Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-12
   Days after onset: 1
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: Trauma due to car accident. Vaccine given following splenectomy.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Neisseria meningitidis detected by hospital laboratory, confirmed and serogrouped.
CDC Split Type:

Write-up: Patient diagnosed with meningococcemia, serogroup W-135.


VAERS ID: 404810 (history)  
Form: Version 1.0  
Age: 1.78  
Sex: Female  
Location: Foreign  
Vaccinated:2010-06-09
Onset:2010-06-10
   Days after vaccination:1
Submitted: 2010-10-19
   Days after onset:131
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UP223AA / 2 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration bronchial, Death, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005310

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-676). A 21-month-old female patient, whose medical history and concomitant therapies were not reported, received a second dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UP223AA, route and anatomical site of administration not reported), on 09 June 2010. The patient had also received an unspecified polio vaccine during a polio campaign (date and details not provided). As per the patient''s father, the patient had been vaccinated on 09 June 2010 at 09:30 and she had been well throughout the day, ate normally and went to bed at 20:40. The next day, the child was found dead. The death record indicated that the cause of death was respiratory failure and bronchoaspiration. No other information was provided. The case was classified as "severe". Documents held by sender: None.


VAERS ID: 397669 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-18
Onset:2010-05-20
   Days after vaccination:2
Submitted: 2010-09-07
   Days after onset:110
Entered: 2010-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP212A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Brain oedema, CSF protein abnormal, Death, Guillain-Barre syndrome, Muscular weakness, Respiratory failure, Thymus hypoplasia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Interstitial lung disease (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), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-06-06
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History included an unspecified chronic disease. Unknown family medical history. Unknown previous history of adverse event to a vaccine or a drug. Unknown concomitant therapy.
Allergies:
Diagnostic Lab Data: CSF study: protein-cytological dissociation
CDC Split Type: 201004724

Write-up: Case received from Institute through the VIS (Vaccination Information Service) of sanofi pasteur on 25 August 2010 under the local reference number BR2010-334. A 7-year-old male patient, with an unspecified chronic disease, unknown family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received a dose of H1N1, batch number UP212A, route and anatomical site of administration unknown, on 18 May 2010. On 20 May 2010, the patient presented with ascending muscle weakness, ascending paralysis in the lower limbs and respiratory failure. The patient was hospitalized on an unknown date. A CSF study protein revealed cytological dissociation. Corrective treatment was unknown. On 06 June 2010, the patient died. As per the "Deaths Verifications Service": diffuse cerebral edema / acute respiratory syndrome in adults (aRSA) / thymic hypoplasia. According to the report the case was under investigation. No other information was provided. Documents held by sender: none.


VAERS ID: 388083 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-11
Onset:2010-05-11
   Days after vaccination:0
Submitted: 2010-05-18
   Days after onset:7
Entered: 2010-05-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 27402 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-11
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010023142

Write-up: Report received on 13-May-2010. A male patient received single dose of FLUVAX (Batch no. 27402) on 11-May-2010 at an unknown time. Medical history and concomitant medications are unknown. On 11-May-2010, the same day as receiving FLUVAX vaccination, the patient was observed in the clinic for 15 minutes. He did not show any allergic symptoms post vaccination and was well when he left the clinic. Subsequently, the patient was involved in a motor car accident on his way home. The single vehicle accident resulted in death. The reporter considered the event possibly related to the suspect drug, FLUVAX. This case was reported as serious due to death. The company considered the event possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product. Batch review results were received for 090627402 on 29-Apr-2010. On completion of this investigation, it has been determined that, all deviations related to the manufacturer of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event report. Cause (s) of death: Motor vehicle accident Death date: 11-May-2010


VAERS ID: 407053 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-05-10
Submitted: 2010-10-19
   Days after onset:162
Entered: 2010-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH003AC / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Mother received a dose of H1N1 vaccine at approximately 32 weeks of gestation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005470

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-680). This case is for a fetal death that was noted by ultrasound scan on 10 May 2010. The mother had received H1N1 vaccine (sanofi pasteur, batch number UH003AC), on 08 April 2010, at approximately 32 weeks gestation. The events for the mother are captured in case 2010-05316, which included the following description: A 23-year-old female patient, whose medical history and concomitant therapies were not reported, received a dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UH003AC, route and anatomical site of administration not reported), on 08 April 2010. The patient was pregnant at the time of vaccination. No other vaccines were administered. On 09 May 2010, 31 days after vaccination, the patient was 37 weeks pregnant and presented pain in the lower abdomen and bleeding. An ultrasound scan done the following day indicated fetal death and pronounced "oligoamnio". The outcome was a stillbirth. The patient had a hypertensive peak three months ago. No other information was provided. Documents held by sender: None.


VAERS ID: 404838 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-05-05
Submitted: 2010-10-19
   Days after onset:167
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER VM00244 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-05
   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:
Preexisting Conditions: Mother''s obstetric history included six pregnancies and one abortion.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005580

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur affiliate, from the "Ministry of Health" through foreign Institute (local case reference number BR2010-669). This case is for a fetal death which occurred on 05 May 2010 (gestational age not reported). The mother had received an H1N1 vaccine (batch number VM00244), on 01 April 2010. The events for the mother are captured in case 2010-05296, which included the following description: A 39-year-old female patient, whose medical history and concomitant therapies were not reported, received a dose of H1N1 vaccine (batch number "VM00244", route and anatomical site of administration not reported), on 01 April 2010. No other vaccines were administered. On 04 May 2010, the patient developed a headache, myalgia , and low fever. The next day, she returned to the health unit with metrorrhagia and metro systole which resulted in abortion with fetal death (referred to institute). The patient had six pregnancies and one abortion. She was also hypertensive (onset date not reported, unclear if this was medical history). On 05 August 2010, the report from the institute confirmed placenta failure and early placental separation. The patient''s outcome was unknown. No other information was provided. The case was classified as "severe". Documents held by sender: None.


VAERS ID: 404097 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-05-04
Onset:2010-05-04
   Days after vaccination:0
Submitted: 2010-10-18
   Days after onset:167
Entered: 2010-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH040AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Chest pain, Cyanosis, Hyperhidrosis, Loss of consciousness, Resuscitation, Sudden death, Syncope, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of epilepsy and hypertension. Concomitant medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005280

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-665). A 49-year-old female patient, whose medical history included epilepsy and hypertension, received a dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UH040AB, route and anatomical site of administration not reported), on 04 May 2010. Twenty-five minutes after vaccination, the patient returned to the Health Unit with a strong chest pain, BP 180/100 mmHg, sweating, cyanosis, fainting, loss of consciousness, wheezing, and subsequent apnea. Resuscitation measures were performed unsuccessfully and the patient died. No other information was provided. The case was classified as "severe". This case was assessed as serious due to the mention of unexpected sudden death. Documents held by sender: None.


VAERS ID: 414136 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2009-09-14
Onset:2010-05-01
   Days after vaccination:229
Submitted: 2011-01-01
   Days after onset:245
Entered: 2011-01-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97846P2A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Condition aggravated, Death, Herpes zoster, Living in residential institution, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-26
   Days after onset: 178
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: many
Current Illness: no
Preexisting Conditions: COPD - died from COPD but the shingles amplified her condition.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My mom received shingles vac. on 7/15/09. In May she developed a very intense case of shingles & developed severe neuropathy in her left leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted living, never fully recovered & died 10/26/10.


VAERS ID: 386690 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2010-04-29
Onset:2010-04-30
   Days after vaccination:1
Submitted: 2010-05-04
   Days after onset:4
Entered: 2010-05-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 107522P1 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bronchopneumonia, Death, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, Bronchopneumonia stated as cause of death.
CDC Split Type: PHHY2010EC27966

Write-up: Initial report received from a physician via health authority on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch number 107522P1) on 29 Apr 2010. 24 hours after vaccination, the patient presented with sudden respiratory failure on 30 Apr 2010 and two hours later, the patient died. Medical history of the patient was unknown. Autopsy was performed and cause of death was stated as bronchopneumonia.


VAERS ID: 392601 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-15
Onset:2010-04-29
   Days after vaccination:14
Submitted: 2010-07-09
   Days after onset:71
Entered: 2010-07-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090626902 / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-29
   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:
Current Illness:
Preexisting Conditions: Recalcitrant hypertension; "Cardiac history"; Chronic depression; Substance abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010024989

Write-up: Report received from the regulator on 29-JUN-2010 (case number: 269814). A 74 year old male patient received one dose of FLUVAX (batch number: 090626902) on 15-Apr-2010. The Patient also received PANVAX on 18-Mar-2010. The patient''s medical history includes recalcitrant hypertension, an unknown cardiac condition since 2000, chronic depression and substance abuse. On 29-Apr-2010, 2 weeks after vaccination with FLUVAX, the patient was found deceased in his house. The patient had passed away due to a heart attack from a long-standing cardiac condition. The reporter assessed this event as serious (death). The reporter considered events possibly related to the suspect drug, FLUVAX. The company considered events serious (death) and possibly related to FLUVAX. Information derived from this AE report does not change the current safety profile of the product. Cause(s) of death: Heart attack. Death Date: 29-Apr-2010.


VAERS ID: 386357 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Female  
Location: Virginia  
Vaccinated:2010-04-28
Onset:2010-04-28
   Days after vaccination:0
Submitted: 2010-04-30
   Days after onset:2
Entered: 2010-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP063AA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Sudden cardiac death, Syncope
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), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   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: Glyburide-Metformin 5-500mg Verapamil HCL CR 240mg Coumadin
Current Illness: Uncontrolled diabetes Protein C deficiency noncompliant Coumadin therapy
Preexisting Conditions: hypertension hyperlipidemia history of PE in 1995 & 2002
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt collapsed and sent to ER by rescue squad. Sudden cardiac death.


VAERS ID: 387029 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-28
Onset:2010-04-28
   Days after vaccination:0
Submitted: 2010-05-07
   Days after onset:9
Entered: 2010-05-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   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: ANTICOAGULANTS; ANTIHYPERTENSIVE DRUGS; CARDIOTONIC
Current Illness: Unknown
Preexisting Conditions: Cardiac failure; Device failure; Arrhythmia; Oedema peripheral; Acute pulmonary oedema; Pneumonia; Tachycardia
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010AR28991

Write-up: Initial report received from a consumer on 05 May 2010: This polymedicated patient had medical history of heart failure, pump failure, arrhythmia and lower-limb swelling. The patient had been hospitalized for three times in past due to acute pulmonary oedema. Pneumonia and tachycardia prolonged the hospitalization in intensive care unit. The patient was vaccinated with seasonal influenza vaccines (manufacturer and batch number unknown) on 28 April 2010. Less than one hour after vaccination, the patient died. The physician stated that, cause of death was cardio-respiratory arrest due to severe heart failure. The physician informed that resuscitation maneuvers were performed unsuccessfully.


VAERS ID: 397330 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-28
Onset:2010-04-28
   Days after vaccination:0
Submitted: 2010-09-02
   Days after onset:127
Entered: 2010-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH001AH / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 1003091 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Convulsion, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes, hypertension and stroke sequelae. In March 2010, he was hospitalized for 28 days due to decompensated diabetes and ARI (Acute Respiratory Insufficiency). Unknown family medical history. Unknown previous history of adverse events to a vaccine or a drug. Unknown concomitant therapy.
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: 201004651

Write-up: Case received from the VIS (Vaccination Information Service) of Sanofi Pasteur on 25 August 2010 under the local reference number BR2010-251. A 59-year-old male patient, with an unknown family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received his dose of H1N1, batch number UH001AH, route and anatomical site of administration unknown, concomitantly with his dose of seasonal flu vaccine (MFR UNK, batch number 1003091), route and anatomical site of administration unknown, on 28 April 2010. The patient had a personal medical history of diabetes, hypertension and stroke sequelae. In March 2010, he was hospitalized for 28 days due to decompensated diabetes and ARI (Acute Respiratory Insufficiency). On 28 April 2010, 45 minutes post-vaccination, the patient experienced seizure leading to hospitalization. Two hours later, he presented with cardio-respiratory arrest and died. The cause of death was not certain at the time of report. This case was also assessed as a significant medical condition. Documents held by sender: none.


VAERS ID: 404831 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-15
Onset:2010-04-28
   Days after vaccination:13
Submitted: 2010-10-19
   Days after onset:174
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cerebrovascular accident, Death, Haemorrhage intracranial, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005321

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by Sanofi Pasteur, from the "Ministry of Health" through foreign Institute (local case reference number BR2010-620). A 24-year-old female patient had received a dose of H1N1 vaccine (manufacturer and batch number unknown, route and anatomical site of administration not reported) on 15 April 2010, and 13 days later on 28 April 2010, she was found dead. Unexpected sudden death was also reported. Autopsy findings revealed extensive diffuse intracranial brain hemorrhage. According to the report, the cause of death was hemorrhagic CVA. Outcome was fatal. The case was classified as "Severe". No further information was provided. Unexpected sudden death. Documents held by sender: None.


VAERS ID: 407026 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-07-27
Onset:2010-04-27
Submitted: 2010-10-19
   Days after onset:175
Entered: 2010-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 1003091 / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute myocardial infarction, Cardio-respiratory arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Lung cancer diagnosed in January 2009 and submitted to radiotherapy and chemotherapy.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005352

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur from the Ministry of Health through foreign Institute (local case reference number BR2010-656). A 67-year-old male patient, who has medical history of lung cancer in January 2009 and submitted to radiotherapy and chemotherapy, had received a dose of H1N1 vaccine (Sanofi pasteur Inc. lot number UH001AH corresponding to lot number 1003060 which was allocated at packing by the agency, route and anatomical site of administration not reported) on 27 July 2010. On "27 April 2010" (date is noted to be prior to vaccination) it was reported the patient was admitted to the hospital emergency room with cardiopulmonary arrest and attested acute myocardial infarction. It was reported the patient was not hospitalized. The case was classified as "Severe". Outcome was reported as unexpected sudden death (cause of death not reported). No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to cardiopulmonary arrest and acute myocardial infarction with unexpected sudden death. Documents held by sender: None. Corrective version performed to clarify the vaccination date and the onset date: The vaccination date was reported as 27 July 2010 and the onset date was reported as 27 April 2010 (clarification was requested). Relevant Test/Laboratory Data: Not reported


VAERS ID: 386625 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-23
Onset:2010-04-23
   Days after vaccination:0
Submitted: 2010-05-03
   Days after onset:10
Entered: 2010-05-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Malaise, Sepsis, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-04-23
   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:
Preexisting Conditions: personal medical history of sickle cell anemia, unknown family medical history and previous history of adverse reaction to a vaccine or a drug.
Allergies:
Diagnostic Lab Data: Autopsy pointed the cause of death to be from serious sepsis
CDC Split Type: 201002538

Write-up: Case received from the a media announcement in a foreign country through the VIS of Sanofi Pasteur on 28 April 2010 under the local reference number BR2010-098. A 20-year-old female patient, with a personal medical history of sickle cell anemia, had received her dose of Influenza A/H1N1 vaccine (manufacturer, batch number, route and anatomical site of administration unknown) on 23 April 2010. The patient''s concomitant therapies were unknown. She also had an unknown family medical history and previous history of adverse reaction to a vaccine or a drug. On 23 April 2010, in the hours post-vaccination, the patient experienced "general illness" and intense vomiting. There was no local reaction. The patient needed medical care and was hospitalized. On 23 April 2010, she had sudden death. The patient was discharged on "28" April 2010. "Autopsy pointed the cause of death to be from serious sepsis". In the announcement, the Director of the health authority stated that the patient''s death was not related to the vaccine.


VAERS ID: 397332 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-19
Onset:2010-04-21
   Days after vaccination:2
Submitted: 2010-09-02
   Days after onset:134
Entered: 2010-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH040AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-21
   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:
Current Illness:
Preexisting Conditions: Unknown personal and family medical history; unknown previous history of adverse event to a vaccine or a drug; unknown concomitant therapies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201004657

Write-up: Case received from Institute through the VIS (Vaccine Information Service) of sanofi pasteur on 25 August 2010 under the local reference number BR2010-259. A 27-year-old male patient, with an unknown personal and family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received his dose of H1N1, batch number UH040AA, route and anatomical site of administration unknown, on 19 April 2010. The patient was well the day of vaccination and he worked in the subway (no further details provided). The patient worked normally until 21 October 2010. On 21 April 2010 at night, i.e. 2 days post-vaccination, the patient was found dead in his bedroom. Autopsy results were not available at the time of the report. This case was also assessed as a significant medical condition. Documents held by sender: none.


VAERS ID: 407052 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-23
Onset:2010-04-21
Submitted: 2010-10-19
   Days after onset:181
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hydrocephalus, Intracranial pressure increased, 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: 2010-04-30
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hydrocephaly
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005343

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the "Ministry of Health" through foreign institute (local case reference number BR2010-650). A 06-year-old male patient, with a medical history of hydrocephaly, no reported concomitant therapy and "no other vaccine", had received his dose of H1N1 vaccine (batch number UH001AH, route and anatomical site of administration not reported) on 23 April 2010. Sanofi pasteur Inc. lot number is UH001AH and the corresponding lot number allocated at packaging by institute is 1003060. On 21 April 2010, i.e. 2 days pre-vaccination, the patient experienced fatal intracranial hypertensive syndrome and hydrocephalus. To be noted that the date of death was also reported to be 7 days post-vaccination. Unexpected sudden death was also mentioned. The patient was hospitalized on unspecified date. This case was considered as "severe". Documents held by sender: none.


VAERS ID: 395413 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-27
Onset:2010-04-15
   Days after vaccination:19
Submitted: 2010-08-16
   Days after onset:123
Entered: 2010-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 106836P1 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-15
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010CO36664

Write-up: Initial report received from a physician on 03 Jun 2010: This pregnant patient was vaccinated with H1N1 (manufacturer unknown; batch number 106836P1) intramuscularly on 27 Mar 2010. The patient died on 15 Apr 2010 which was reported as early postpartum maternal mortality. The reporter did not suspect a causal relationship between drug and the event. Follow up report received from the quality assurance department on 11 Aug 2010: Initially reported batch number 106836P1 of given influenza vaccine was confirmed to be a Novartis pandemic vaccine S-OIV FLUVIRIN.


VAERS ID: 407056 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-10
Onset:2010-04-11
   Days after vaccination:1
Submitted: 2010-10-19
   Days after onset:191
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER VH040AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Convulsion, Death, Intensive care, Loss of consciousness, Renal failure acute, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005348

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-653). A 24-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of H1N1 vaccine (batch number "VH040AB", route and anatomical site of administration not reported) on 10 April 2010 and 31 hours after vaccination the patient presented with sudden seizures followed by loss of consciousness and cardio-respiratory arrest. She was revived by the mobile medical emergency service and subsequently referred to the hospital and transferred to ICU progressing to seizures, acute renal failure and death. Date and cause of death were not reported. Unexpected sudden death was reported. The case was classified as "Severe". Outcome was reported as death. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to severe seizures and acute renal failure, and unexpected sudden death. Documents held by sender: None.


VAERS ID: 386374 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-08
Onset:2010-04-09
   Days after vaccination:1
Submitted: 2010-04-29
   Days after onset:20
Entered: 2010-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 090627402 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Histology normal, Laparoscopy normal, Pathology test, Tryptase
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Temporary loss of function in one leg
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022572

Write-up: Report received from consumer via media on 25-APR-2010. A 2 year old female patient received seasonal flu vaccination (brand unspecified) on 08-APR-2010 at 3pm. The patient''s medical history and concomitant medications were unknown. The child was ''perfectly fine'' prior to vaccination. The patient died on 09-APR-2010, the day after vaccination with the suspect drug. She was found deceased in her cot at approximately 6:30am. A coroner report was pending. The reporter considered events possible to the suspect drug. The reporter ''could not believe the patient''s death was no linked to a flu shot''. The case was reported was serious due to fatal outcome. The reporter considered events possible to the suspect drug. Follow up information received from a physician on 28-APR-2010. The patient was 2 years and 4 months old. Medical history had nothing of note, the patient was a twin (not known if identical). The patient had a previous history of temporary loss of function in one leg on 2 occasions. This was referred to a paediatrician. Nothing was found, if episode was repeated, patient was to have an MRI. Childhood vaccinations received at 18 months. No other vaccination was provided at the time of FLUVAX. The patient had not received PANVAX as far as the reporter was aware. The patient had no concomitant medications. The patient received FLUVAX JUNIOR (batch unknown) 0.25ml at 4pm on 08-APR-2010. The patient''s twin also had the vaccination at the same time. Both were put to bed and both were fine. The other twin started to vomit around midnight (see case: 2010022576). The patient was found deceased next morning by parent on 09-APR-2010. Autopsy results as follows: no cause of death found, no aspiration in lungs, no cardiac defects found, laparoscopy normal, histology normal, large barrage of testing for pathogens - nothing found tryptase normal, urine found in bladder (making seizure unlikely), no brain haemorrhage, still waiting for some results. Follow up information received from physician on 29-APR-2010: The patient received FLUVAX JUNIOR batch number: 090627402. According to the practice records, the patient had not received PANVAX or 2009 seasonal influenza vaccine. Batch review report received on 29-APR-2010 as follows: On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality, all QC testing was satisfactory with no out of specification results reported, there are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 410055 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-07
Onset:2010-04-07
   Days after vaccination:0
Submitted: 2010-11-23
   Days after onset:230
Entered: 2010-11-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient presented diarrhea 15 days before vaccination. No corrective treatment was given to the patient for the diarrhea.
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201006585

Write-up: This case report is part of a batch of several hundred reports associated with H1N1 vaccine, that was received by sanofi pasteur affiliate under local case reference number BR2010-723 from foreign Institute who received these reports on 08 November 2010 from the "Ministry of Health". A 2-year-old male patient, with a medical history of diarrhea 15 days before vaccination, experienced unexpected sudden death the same day he had received his injection of H1N1 vaccine package (batch number UH001AH, number in series, route and site of administration not reported) on 7 April 2010. No concomitant vaccine was administered at the time of immunization. Sanofi pasteur Inc. lot number is UH001AH and the corresponding lot number allocated at packaging is 1003060. It was reported that the mother was inattentive to the patient. The days care center reported that the patient presented with diarrhea 15 days before immunization but the mother refused to treat him. The patient''s mother had some troubles with social services because of bad treatment of her child and inattentiveness. No corrective treatment was reported. The reporter stated that the status of the case was "descarted" (i.e. the event was not related to the vaccine). Documents held by sender: none.


VAERS ID: 407564 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-05
Onset:2010-04-05
   Days after vaccination:0
Submitted: 2010-10-19
   Days after onset:197
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Convulsion, Dizziness, Musculoskeletal chest pain, Nausea, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), 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:
Current Illness:
Preexisting Conditions: Epilepsy that was treated with medication; however the patient had stopped his medication on an unknown date.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005351

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the "Ministry of Health" through foreign institute (local case reference number BR2010-655). A 25-year-old male patient, who has medical history of epilepsy and who had stopped taking his medication (date not reported), had received a dose of H1N1 vaccine (Sanofi pasteur Inc. lot number UH001AH corresponding to lot number 1003060 which was allocated at packaging by institute, route and anatomical site of administration not reported) on 05 April 2010 and 4 hours after vaccination the patient presented with dizziness, nausea and vomiting. He also complained of intense pain in the intercostal left side that was radiating to the epigastrium. On 23 April 2010, the patient received medical assistance, presenting with seizures. The patient was hospitalized (dates not reported). The case was classified as "Severe". Outcome was reported as unexpected sudden death. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to the Seizures and unexpected sudden death. Documents held by sender: None.


VAERS ID: 385142 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Iowa  
Vaccinated:2010-04-01
Onset:2010-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2010-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3607AA / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3266CA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44520 / 3 LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Apnoea, Aspiration, Condition aggravated, Death, Lissencephaly
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Recent Pneumonia
Preexisting Conditions: Lissencephaly; Aspiration; Mixed Apnea
Allergies:
Diagnostic Lab Data: received 3 vaccines < 1 hour prior to apnea/ bradycardia asystole.
CDC Split Type:

Write-up: Patient had life threatening lissencephaly aspiration (G Butter Fed) & mixed apnea known risk & partial no code.


VAERS ID: 391548 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-04-01
Submitted: 2010-06-25
   Days after onset:85
Entered: 2010-06-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: autopsy included numerous laboratory tests (not provided)
CDC Split Type: 201003406

Write-up: Case report from 2 literature articles received on 15 June 2010. A 2-year-old female patient with no reported medical history died in early April 2010, the day after she had received a seasonal flu vaccination (manufacturer, batch number not reported). According to the articles, an autopsy was performed; the autopsy results were provided by a health pathologist to the coroner and the results were released: the autopsy included numerous laboratory tests, but did not determine a definitive cause of death. According to the chief health officer, the autopsy has found no evidence linking the vaccine to the death of the patient receiving the flu vaccine. Coronial investigations into the death were continuing. List of documents held by sender: 2 literature articles.


VAERS ID: 386461 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-03-25
Onset:2010-03-28
   Days after vaccination:3
Submitted: 2010-04-30
   Days after onset:33
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 1002026 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Drug exposure during pregnancy, Foetal hypokinesia, Intra-uterine death, Microbiology test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Allergies:
Diagnostic Lab Data: The necropsy revealed no fetal malformation and intracavitary pleural effusion. Placenta and microbiology testings were ongoing at the time of the report.
CDC Split Type: 201002492

Write-up: Case received via Sanofi pasteur on 23 April 2010 under the reference number BR2010-102. Case linked with case 2010-022480 (mother''s case). A 37-year-old pregnant female women in her 36-37 week of gestation with no reported medical history had received her injection of PANDEMIC INFLUENZA Vaccine batch number 1002026 on 25 March 2010 (number in series, route and anatomical site of vaccination not reported). On 26 March 2010, i.e. 1 day after the vaccination, the patient''s mother experienced general illness, myalgia and prostation. On 27 March 2010, i.e. 2 days after the vaccination, the patient''s mother presented with chest pain. On 28 March 2010, the patient''s mother noticed arrest of fetal movements. The patient''s mother was submitted to a C-section. It was not reported if the fetus was already dead when the procedure was performed or if the fetus died after it. The patient''s mother underwent a fetal ultrasound 15 days before the adverse events and it was normal. The necropsy revealed no fetal malformation and intracavitary pleural effusion. Placenta and microbiology testings were ongoing at the time of the report. According to the reporter the status of this case was under investigation at the time of the report.


VAERS ID: 404835 (history)  
Form: Version 1.0  
Age: 1.83  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-26
Onset:2010-03-26
   Days after vaccination:0
Submitted: 2010-10-19
   Days after onset:207
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER 956330 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Cardiac arrest, Coma, Death, Decreased appetite, Disseminated intravascular coagulation, Neurogenic shock, Somnolence, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005323

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur affiliate, from the "Ministry of Health" through foreign Institute (local case reference number BR2010-642). A 22-month-old male patient, with no reported medical history, no reported concomitant therapy and "no other vaccine", had received his 1st dose of H1N1 vaccine (manufacturer unknown, batch number "956330", route and anatomical site of administration not reported) on 26 March 2010. On 26 March 2010, 4 hours post-vaccination, the patient experienced drowsiness and vomiting. He was hospitalized for 14 hours. On admission, the patient''s temperature was 37.2 degrees C. He was prescribed "oral serum" and IM PLASIL. On 27 March 2010, the patient presented with hyporexia and temperature (max 37.8 degrees C). He also developed acute disseminated encephalomyelitis and died. The death records mentioned asystole, neurogenic shock, coma, acute disseminated encephalomyelitis, disseminated intravascular coagulation and thrombosis of the right upper limb. This case was considered as "severe". This case was also assessed as dealing with a significant medical condition. Documents held by sender: none.


VAERS ID: 386283 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Michigan  
Vaccinated:2010-03-22
Onset:2010-03-23
   Days after vaccination:1
Submitted: 2010-04-29
   Days after onset:37
Entered: 2010-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP112AA / 2 UN / IJ
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1397Y / 3 UN / IJ
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AHIBC245AA / 3 UN / IJ
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1232Y / UNK UN / IJ

Administered by: Private       Purchased by: Public
Symptoms: Brain death, Brain operation, Cerebral haemorrhage, Crying, Death, Dyspnoea, Loss of consciousness, Pain, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-26
   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: Tuberculosis test
Current Illness: vomiting, complaining of stomach pain, weakness
Preexisting Conditions: Born premature, signs of autism
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter was sick. She was complaining about pain in her stomach, she was vomiting for previuos 4 days. So I decided to take her to her pediatrician and check what is wrong with her. Instead she was given 5 vaccines at her pediatrician office. He said that she is fine. She was given second dose of H1N1, HIB, Hepatitis A, varicella and tuberculosis shot. Since this time she was uncontrollable crying and she was being in constant pain. She could not keep the food. She was throwing up. The next day she collapsed, she stop breathing, she was unconscious. My wife call the ambulance. In a hospital doctors said that she had bleeding on one side of her brain. They transfer her from one hospital to another. She was still unconscious but moving her limbs. The next day morning doctors decided to perform surgery on her brain because of the bleeding. She never came out from that. The brain was dead. She was dead...


VAERS ID: 386498 (history)  
Form: Version 1.0  
Age: 1.45  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-22
Onset:2010-03-23
   Days after vaccination:1
Submitted: 2010-04-30
   Days after onset:38
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-23
   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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201002505

Write-up: Case received from the Institute through the sanofi pasteur on 23 April 2010 under the local reference number BR2010-093. An 18-month-old male patient, with an unknown medical history, had received his primary dose of Influenza A/H1N1 vaccine (manufactured by sanofi pasteur, batch number, route and anatomical site of administration unknown) on 22 March 2010. The patient''s concomitant therapies were unknown. On 23 March 2010, i.e. the following day post-vaccination, the patient experienced unexpected sudden death. It was not known whether the patient was hospitalized or not. The case was still under investigation at the time of the report. List of documents held by sender: none.


VAERS ID: 386513 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-17
Onset:2010-03-20
   Days after vaccination:3
Submitted: 2010-04-30
   Days after onset:41
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 1002024 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-20
   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:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201002485

Write-up: Case received from Institute via the Sanofi Pasteur on 23 April under the reference number BR2010-084. A 2-year-old female patient with no reported medical history had received her injection of PANDEMIC INFLUENZA VACCINE vaccine batch number 1002024 on 17 March 2010 (number in series, route and anatomical site of vaccination not reported). On 20 March 2010, i.e. 3 days after the vaccination, the patient experienced unexpected sudden death. According to the reporter the status of this case was under investigation at the time of the report. List of documents held by sender: none.


VAERS ID: 383127 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Texas  
Vaccinated:2010-03-19
Onset:2010-03-19
   Days after vaccination:0
Submitted: 2010-03-21
   Days after onset:2
Entered: 2010-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP081AA / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Aortic rupture, Chest pain, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: No
Preexisting Conditions: none known
Allergies:
Diagnostic Lab Data: His aorta ruptured after being released from E.R causing his death at 12:00 am
CDC Split Type:

Write-up: He recieved the H1N1 vaccine around 9:00 am. At he at 12:00 Complaining of chest pain. No Diagnosis, then released from hospital. He Died at midnight (12:00 am) from a ruptured aorta.


VAERS ID: 382341 (history)  
Form: Version 1.0  
Age: 1.51  
Sex: Female  
Location: Washington  
Vaccinated:2010-03-09
Onset:2010-03-10
   Days after vaccination:1
Submitted: 2010-03-10
   Days after onset:0
Entered: 2010-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3191AA / 4 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3352AA / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cyanosis, Death, Pyrexia, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-10
   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: 03/02/2010:AMOXICILLIN 400 MG/5ML suspension 1 tsp by mouth twice daily x 7 days for BOM, URI
Current Illness: Child was happy and healthy at time of visit
Preexisting Conditions: febrile seizures, developmental delay, hx URI, hx otitis media.
Allergies:
Diagnostic Lab Data: none currently available at this time
CDC Split Type:

Write-up: reported child developed a fever early this am with possible febrile seizure. Child was placed down for afternoon nap mother went in room to check on child realized something wrong/ not moving/responding turned child over and discovered child was blue. Coroner did note child had had an emesis.


VAERS ID: 388188 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2010-03-09
Onset:2010-03-09
   Days after vaccination:0
Submitted: 2010-05-19
   Days after onset:70
Entered: 2010-05-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP078AA / 1 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0621Y / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Dizziness, Lethargy, Nausea, Neck pain, Pain, Pyrexia, Unresponsive to stimuli
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-12
   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: ALENDRONATE
Current Illness: None
Preexisting Conditions: Possibly Elevated cholesterol; possibly Osteoarthritis
Allergies:
Diagnostic Lab Data: Autopsy at office of the Medical Investigator
CDC Split Type:

Write-up: Received H1N1 & Pneumonia vaccine 12 March 2010. Apparently developed fever that night & the following 2 days was "achy, dizzy & had nausea all day". On 12 Mar, complained of neck pain & dizziness, developed lethargy & then became unresponsive.


VAERS ID: 407028 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-09
Onset:2010-03-09
   Days after vaccination:0
Submitted: 2010-10-19
   Days after onset:223
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypertension, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201005326

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign institute (local case reference number BR2010626). A 49-year-old female patient, with no reported medical history, no reported concomitant therapy and "no other vaccine", had received her dose of H1N1 vaccine (manufacturer and batch number unknown, route and anatomical site of administration not reported) on 09 March 2010. On 09 March 2010, 30 minutes post-vaccination, the patient experienced sweating, fatigue and hypertension (BP 15 x 11). On 11 March 2010, the patient developed headache and "maintained hypertension" (148 x 107). He was reevaluated at the medical service the same day. The patient received corrective therapies with analgesics and antihypertensive drugs. On 12 March 2010, there was a new medical assessment (rest of the information was cut on the source document). The patient was hospitalized on unspecified dates. The patient finally experienced unexpected sudden death on an unspecified date. This case was considered as "severe". Documents held by sender: none.


VAERS ID: 381128 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2010-02-22
Onset:2010-02-23
   Days after vaccination:1
Submitted: 2010-02-23
   Days after onset:0
Entered: 2010-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 104044P1A / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-23
   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: None
Preexisting Conditions: HTN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt died suddenly within 24 hrs of administration. Clinically suspect unrelated.


VAERS ID: 381972 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-20
Onset:2010-02-20
   Days after vaccination:0
Submitted: 2010-03-05
   Days after onset:13
Entered: 2010-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS AFLSA125AA / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 15801 / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. NK270501627X / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-20
   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: Asthma; cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0636089A

Write-up: This case was reported by the foreign regulatory authority (GB-MHRA-FLU 00039643) and described the occurrence of collapse unspecified in a 34-year-old female subject who was vaccinated with PANDEMIC H1N1 unspecified, (GlaxoSmithKline), (non-gsk) PNEUMOVAX II and Seasonal Influenza vaccine. Concurrent medical conditions included asthma and cardiomyopathy. On 20 February 2010 the subject received unspecified dose of PANDEMIC H1N1 unspecified, and unspecified dose of PNEUMOVAX II and an unspecified dose of Seasonal Influenza vaccine. On 20 February 2010, less than one day after vaccination with PANDEMIC vaccine H1N1 unspecified. PNEUMOVAX II and Seasonal Influenza vaccine, the subject was found early evening collapsed with dilated pupils. Paramedics were called and resuscitation attempted. The subject was pronounced dead on arrival at the hospital. The subject died on 20 February 2010 from collapse unspecified. It was unknown whether an autopsy was performed. After vaccination in the morning the patient was well. The patient''s husband found the patient in the early evening collapsed with dilated pupils. Paramedics were called and resuscitation attempted. The patient was pronounced dead on arrival at the hospital.


VAERS ID: 436320 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-20
Onset:2010-02-20
   Days after vaccination:0
Submitted: 2011-09-29
   Days after onset:585
Entered: 2011-09-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 15801 / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER AFLSA125AA / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1627X / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-20
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA02574

Write-up: This fatal case was received from the health authority on 20-SEP-2011 under the reference number GB-MHRA-FLU21073156. This case was medically confirmed. A 34 year old female patient with an unreported medical history and concomitant medication received a dose of PNEUMOVAX 23 (lot#663861/1627X, and batch number NK27050) route and site not reported on 20-FEB-2010. The patient also received a dose of H1N1 influenza vaccine (unspecified) (other manufacturer, batch number AFLSA125AA) and a dose of influenza virus vaccine (unspecified) (other manufacturer, batch number 15801) route and site not reported on 20-FEB-2010. On 20-FEB-2010, the same day as the vaccinations the patient died after she experienced collapse and dilated pupils. After the vaccination in the morning the patient was well. The patient''s husband found the patient in the early evening collapsed with dilated pupils. Paramedics were called and resuscitation attempted. The patient was pronounced dead on arrival at the hospital. It was unknown if an autopsy was done. Other business partner numbers include E201105587. No further information is available. A lot check has been initiated.


VAERS ID: 383459 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Georgia  
Vaccinated:2009-11-11
Onset:2010-02-18
   Days after vaccination:99
Submitted: 2010-03-24
   Days after onset:33
Entered: 2010-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP009AA / 1 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Cough, Dyspnoea exertional, Pyrexia, Sputum discoloured, Sputum increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-21
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 23 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Received 3 5-day courses of oseltamavir after admission on 2/23/2010
Current Illness: Not known
Preexisting Conditions: Cystic fibrosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was admitted to the hospital on 2/23/2010 with cough and increased green sputum production. Had had low grade fevers, none higher than 100 degrees. He states that he has had increased dyspnea on exertion. He states that he normally requires about 4-1/2 liters of home O2 while at rest and 6 liters while he is up with activity and he states that his saturation is normally about 94-95 percent.


VAERS ID: 381178 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2010-02-10
Onset:2010-02-11
   Days after vaccination:1
Submitted: 2010-02-18
   Days after onset:7
Entered: 2010-02-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3260AA / 2 RL / IM
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500824P / 1 NS / IN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB349AA / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Cough, Croup infectious, Death
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-11
   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: Dexamethasone one dose
Current Illness: Viral croup
Preexisting Conditions: 30 weeks gestation at birth --$g respiratory distress
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 28 month old (ex - 30 week preemie) male was seen in pediatric clinic for outpatient evaluation of croup. Examining attending physician described barking cough but no stridor at rest. Given dexamethasone 9 mg and vaccines. Child put to bed "fine". Found dead next morning. Unsuccessful resuscitation.


VAERS ID: 393060 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Unknown  
Vaccinated:2009-11-17
Onset:2010-02-09
   Days after vaccination:84
Submitted: 2010-07-10
   Days after onset:150
Entered: 2010-07-19
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102126P1A / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Autopsy, Death, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trazodone; TOPAMAX; PRILOSEC; ZOMIG PRN; dicyclomine; KLONOPIN
Current Illness: None
Preexisting Conditions: sleep apnea; migraines; obesity; insomnia; allergic rhinitis; ED; TOB use
Allergies:
Diagnostic Lab Data: Autopsy as above
CDC Split Type:

Write-up: Pt died. Autopsy revealed Giant cell myocarditis. Pt received H1N1 vaccine 2 1/2 months prior. Unsure if related.


VAERS ID: 395043 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Georgia  
Vaccinated:2009-12-11
Onset:2010-02-02
   Days after vaccination:53
Submitted: 2010-08-12
   Days after onset:190
Entered: 2010-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102129P1 / 1 RA / IM

Administered by: Military       Purchased by: Unknown
Symptoms: CSF test, Electromyogram, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-23
   Days after onset: 170
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EMG & CSF
CDC Split Type:

Write-up: Admitted with GUILLAIN-BARRE 2/2/10.


VAERS ID: 388916 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Male  
Location: Georgia  
Vaccinated:2010-01-07
Onset:2010-01-28
   Days after vaccination:21
Submitted: 2010-05-13
   Days after onset:104
Entered: 2010-05-21
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP035BA / 2 UN / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1100Y / 1 UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0764Y / 1 UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1229Y / 1 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Death, Endocardial fibroelastosis, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. received vaccines on 1/7/10 and was found unresponsive in crib on 1/28/10. Autopsy showed pt. died from Fibroelastosis of the heart.


VAERS ID: 382201 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-09
Onset:2010-01-28
   Days after vaccination:80
Submitted: 2010-03-09
   Days after onset:40
Entered: 2010-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, C-reactive protein increased, Carbon dioxide decreased, Chest X-ray abnormal, Continuous positive airway pressure, Cyanosis, Death, Feeling abnormal, Fibrosis, Intensive care, Livedo reticularis, Loss of consciousness, Oxygen saturation decreased, PCO2 decreased, Respiration abnormal, Respiratory distress, Respiratory rate decreased, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Alendronate sodium; acetylcysteine; cyclophosphamide; prednisolone; furosemide; spironolactone; CALCICHEW-D3
Current Illness: Aortic stenosis; Pulmonary fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood carbon dioxide, 6.9; Blood carbon dioxide, 5.0; C-reactive protein, 20; C-reactive protein, 186; C-reactive protein, 91; Chest X-ray, fibrosis; Pulse oximetry, 85-90%; Pulse oximetry, 29%; Pulse oximetry, 50-60%; Pulse oximetry, 50-70%; Respiratory rate, 35-40bt%min
CDC Split Type: B0637780A

Write-up: This case was reported by a regulatory authority (# 100285) and described the occurrence of death in a 71-year-old female subject who was vaccinated with PANDEMRIX H1N1, (GlaxoSmithKline), FLUARIX. Concurrent medical conditions included aortic stenosis and pulmonary fibrosis. Concurrent medications included alendronate sodium, acetylcysteine, SENDOXAN, prednisolone, LASIX, spironolactone and CALCICHEW-D3. On 9 November 2009, the subject received 1st dose of PANDEMRIX H1N1 (unknown route and injection site, batch number not provided). At an unknown moment after 1st vaccination of PANDEMRIX, the subject felt infected but it was transient. On 16 December 2009, the subject received 2nd dose of PANDEMRIX H1N1 (intramuscular, unknown injection site, batch number not provided) and unspecified dose of FLUARIX (unknown route and injection site, batch number not provided). A few days later the patient felt that the respiration gradually deteriorated. She came to hospital on 27 December 2009 with severely affected breathing. Tests were performed : pulse oximeter (POX) 50-70%, increasing to 85-90% on 4 liters of oxygen. Pulmonary X-ray showed fibrosis where consolidation could not be excluded. The patient was nursed initially at ICU, without respirator treatment. She was given treatment with cefotaxime and high-dose cortisone. CRP was measured : 91 (<5 mg / L) when admitted, two days later increased to a maximum of 186 and then decreased gradually to 20. The patient still required oxygen treatment. She was discharged to home on 18 January. At that time she presented tachypnoeic and weakness but was eager to go home. She was given oxygen treatment at home. On 26 January 2010, There was a sudden worsening of breathing. When the ambulance arrived the patient showed severe respiratory distress, had cyanotic on the lips and was discretely marbled on the underside of the thighs. Tests : POX 29%, respiratory rate 35-40. Upon arrival at the emergency room somewhat improved oxygen saturation, POX 50-60%. Abdominal respiration. Blood gas showed signs of carbon dioxide retention with pCO2 6.9 (4.4 - 6.0 kPa) and PO2 5.0 (10.6 - 13.8 kPa). Received VENTOLINE, ATROVENT, and BETAPRED. She was admitted to the ICU and was given antibiotics and cortisone. She did not tolerate CPAP-treatment (Continuous Positive Airway Pressure) so she was given high doses of oxygen via mask. There was a deterioration during the day. It was decided that further ICU treatment was not appropriate, was moved to the ward. There was further deterioration in the evening of 27 January 2010. She was Unconscious. The subject died on 28 January 2010 from unknown cause of death. It was unknown whether an autopsy was performed.


VAERS ID: 378368 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Male  
Location: Michigan  
Vaccinated:2010-01-21
Onset:2010-01-21
   Days after vaccination:0
Submitted: 2010-01-26
   Days after onset:5
Entered: 2010-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3496AA / 3 - / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3209AA / 1 RL / IJ
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1251Y / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D84740 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0318Y / 3 MO / PO

Administered by: Other       Purchased by: Public
Symptoms: Death, Intensive care, Meningitis, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Noninfectious meningitis (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: diagnosis: meningitis.
CDC Split Type:

Write-up: upper respiratory complaints - admitted to ICU.


VAERS ID: 379507 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Indiana  
Vaccinated:2010-01-21
Onset:2010-01-21
   Days after vaccination:0
Submitted: 2010-02-04
   Days after onset:14
Entered: 2010-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102135P1 / UNK - / IJ

Administered by: Other       Purchased by: Public
Symptoms: Death, Eating disorder, Hypotonia, Lethargy, Parkinson's disease
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro tab 10 mg Amitiza Caps 24mcg Nasonex Scent Free Ns Spr 17g 50mcg Omeprazole Caps 20mg Requip Tabs 0.25mg Xalatan Opth Soln 2.5ml 0.005% Carbidopa/levodopa Tabs 25/100mg Megestrol Oral Susp 40mg/ml
Current Illness: Parkinson''s Disease
Preexisting Conditions: Parkinson''s Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lethargic, stopped drinking, stopped eating on the 21st. On the 22nd his arms layed limp at his sides when previously they were rigid and locked from the Parkinson''s. He would not eat or drink on the 22nd.


VAERS ID: 441707 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: California  
Vaccinated:2009-12-22
Onset:2010-01-18
   Days after vaccination:27
Submitted: 2011-11-07
   Days after onset:658
Entered: 2011-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102136P1A / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chromaturia, Death, Dyspnoea, Haemolytic anaemia, Myocardial infarction, Renal failure, Splenectomy
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-02-01
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Full physical exam prior to vaccination with no negative report.
Preexisting Conditions: No other medical conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1/18/2010 red color in urine, 1/23/2010 out of breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-2/1/2010 kidneys failed, heart attack with death on second heart attack.


VAERS ID: 483022 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2010-01-15
Onset:2010-01-18
   Days after vaccination:3
Submitted: 2013-01-30
   Days after onset:1108
Entered: 2013-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 6 AR / SYR
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 AR / SYR

Administered by: Public       Purchased by: Public
Symptoms: Blood glucose increased, Blood test, Chills, Confusional state, Encephalitis viral, General physical health deterioration, Lumbar puncture abnormal, Mental status changes, Neck pain, Pyrexia, Urinary tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-05-17
   Days after onset: 483
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin, fluid pill, vitamin D, eye drops for Glaucoma.
Current Illness: None
Preexisting Conditions: Diabetes, Leaking heart valve
Allergies:
Diagnostic Lab Data: Blood work & lumbar puncture.
CDC Split Type:

Write-up: Extreme neck pain, increase blood sugar & confusion. Fever & chills began two days later. Took to doctor''s office on 01/25/2010 & was referred to ER where she was diagnosed with UTI & sent home with oral antibiotics. Health continued to deteriorate so had her taken by ambulance to ER where she wad admitted due to deminished mental capacity. Diagnosed with Viral Encaphlitis. A lumbar puncture done on 02/03/2010 to confirm diagnoses. IV anitibiotic was administered for 21 days. On 02/08/2010 was transferred to nursing home for completement of IV. Never regained health.


VAERS ID: 377750 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:2010-01-14
Onset:2010-01-16
   Days after vaccination:2
Submitted: 2010-01-21
   Days after onset:5
Entered: 2010-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102148P1 / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Coronary artery disease, Death
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-16
   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: ASA; Lisinopril 20mg; PLAVIX; Simvastatin 40mg; NITROQUICK; Metoprolol 25mg; albuterol
Current Illness: F/up HTN
Preexisting Conditions: HTN; Hyperlipidemia; Coronary atherosclerois
Allergies:
Diagnostic Lab Data: scheduled CMP, Lipid panel - Not done
CDC Split Type:

Write-up: Death apparent heart attack 1/16/10. Pt. w/ CAD/ angioplasty 7/09 w/ stent placement. On multiple meds, smoker, denied symptoms 1/14/10.


VAERS ID: 378772 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-24
Onset:2010-01-16
   Days after vaccination:23
Submitted: 2010-01-28
   Days after onset:12
Entered: 2010-01-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR E5925 / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Coma, Coronary artery disease, Death, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: medical history of diabetes mellitus
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201000446

Write-up: Case received from lay media and foreign Health Authority on 18 January 2010 through the company representative under the reference number HKG-2010-009. A 60-year-old female patient with a medical history of diabetes mellitus had received an injection of PANENZA (batch number not mentioned, should be E5925) on 24 December 2009, a shot of seasonal influenza vaccine (Mfr unknown) on 02 November 2009 and a shot of pneumococcal vaccine (Mfr unknown) on 02 November 2009. On 16 January 2010, i.e. 23 days after the injection of pandemic influenza vaccine and 75 days after seasonal influenza vaccine and pneumococcal vaccine, the patient had complained of chills and vomiting. She was sent to the hospital on 17 January 2010. She was found to be in a coma and was certified dead on 17 January 2010. The patient had received an unknown kind of injection several days before the death. According to the government official statement, there was no evidence showing the death is related to the vaccination. At the time of the report, further examination by forensic pathologists was pending. Additional information received on 25 January 2010: according to the local Centre for Health Protection, the patient died of coronary heart disease and the death was not related to the vaccination.


VAERS ID: 378027 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Virginia  
Vaccinated:2010-01-12
Onset:2010-01-15
   Days after vaccination:3
Submitted: 2010-01-21
   Days after onset:6
Entered: 2010-01-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP074AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-15
   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: None reported
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: No adverse reactions within first hour after vaccination administered. Notified of client''s death on 01/15/2010.


VAERS ID: 380328 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2010-01-06
Onset:2010-01-14
   Days after vaccination:8
Submitted: 2010-02-05
   Days after onset:22
Entered: 2010-02-15
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED 102123P1 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Confusional state, Death, Decreased appetite, Laboratory test normal, Lethargy, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Excess uric acid feet
Preexisting Conditions: Cardio/Artery disease; Hypertension
Allergies:
Diagnostic Lab Data: Negative
CDC Split Type:

Write-up: Loss of appetite, confusion, lethargy, excessive mucus. Patient did not want to be hospitalized. Jan 14 thru Jan 18, 4 AM.


VAERS ID: 381784 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2010-01-14
Onset:2010-01-14
   Days after vaccination:0
Submitted: 2010-02-11
   Days after onset:28
Entered: 2010-03-03
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP062AA / UNK UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal discomfort, Condition aggravated, Grip strength decreased, Pain in extremity, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-10
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications included unspecified medications for neurological problems. Concomitant medications included Ketamine and other unspecified medications
Current Illness:
Preexisting Conditions: The patient had no illness at the time of vaccination. Her medical history included an allergy to morphine and reflex sympathetic dystrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201000788

Write-up: Initial case received on 28 January 2010 from a healthcare professional and also from a non-healthcare professional. A healthcare professional reported a 64 year old female patient received an 0.5 ml intramuscular injection (site not reported) of H1N1 (lot number UP062AA) on 14 January 2010. The patient experienced an unspecified fever and hives (site not specified) on 15 January 2010 and non-specified stomach problems on 27 January 2010. Her medical history included neurological problems of hands . A non-healthcare professional reported the patient''s medical history included reflex sympathetic dystrophy and an unspecified allergy to morphine. Since 14 January 2010 (date of vaccination), the patient experienced "increased hand pain" and her grip not being as good in both hands. The reporters both stated that the patient had no illness at the time of vaccination. She had contacted, but was not seen by her physician. It was unknown if the patient recovered from the adverse events. Documents held by sender: None.


VAERS ID: 376710 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Male  
Location: New York  
Vaccinated:2010-01-08
Onset:2010-01-11
   Days after vaccination:3
Submitted: 2010-01-12
   Days after onset:1
Entered: 2010-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3431AA / UNK UN / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3167FA / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D39016 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-11
   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: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: According to mother, mom called office stated that she walked into baby room he was unresponsive, she called EMS and baby was taken to local ER where he was pronounced dead. Have not spoken to mother, she called office and spoke with nurse.


VAERS ID: 376990 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2010-01-08
Onset:2010-01-10
   Days after vaccination:2
Submitted: 2010-01-14
   Days after onset:4
Entered: 2010-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 500805P / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: unknown


VAERS ID: 376969 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Virginia  
Vaccinated:2010-01-06
Onset:2010-01-09
   Days after vaccination:3
Submitted: 2010-01-14
   Days after onset:5
Entered: 2010-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP035BA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Coagulopathy, Death, Drug interaction, International normalised ratio increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-11
   Days after onset: 2
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: COUMADIN
Current Illness: NonHodgkins Lymphoma
Preexisting Conditions: lymphoma; chronic DVT
Allergies:
Diagnostic Lab Data: Increased INR
CDC Split Type:

Write-up: Suspect H1N1 caused interaction with COUMADIN/coagulation.


VAERS ID: 376712 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-01-09
Submitted: 2010-01-12
   Days after onset:3
Entered: 2010-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Severe congenital diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IL01167

Write-up: Initial report received from a newspaper on 11 Jan 2010: This patient had a medical history of severe congenital diseases. The patient was vaccinated with H1N1 flu vaccine (Influenza virus vaccine, unknown), on an unspecified date (reported as a month before). The boy lost his consciousness after administration of the vaccine and was hospitalized and died on 09 Jan 2010. The agency claimed that there was no relation between the vaccine and the death.


VAERS ID: 379777 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-08
Onset:2010-01-08
   Days after vaccination:0
Submitted: 2010-02-08
   Days after onset:31
Entered: 2010-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0630716A

Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-FLU 00037862) via a consumer and described the occurrence of heart attack in a 72-year-old male subject who was vaccinated with PANDEMIC VACCINE H1N1 (manufacturer unspecified), influenza virus vaccine. Concurrent medical conditions included heart disorder. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On 8 January 2010 the subject received unspecified dose of PANDEMIC VACCINE H1N1 unspecified (1 injection, unknown), unspecified dose of Influenza virus vaccine (1 injection, unknown). On 8 January 2010, less than one day after vaccination with Influenza virus vaccine and PANDEMIC VACCINE H1N1 unspecified, the subject experienced heart attack. The subject died on 8 January 2010 from a heart attack. It was unknown whether an autopsy was performed. Verbatim Text: Reaction Severity: Caused death. Reaction Description: unknown.


VAERS ID: 377459 (history)  
Form: Version 1.0  
Age: 1.69  
Sex: Male  
Location: Colorado  
Vaccinated:2009-12-29
Onset:2009-12-31
   Days after vaccination:2
Submitted: 2010-01-20
   Days after onset:20
Entered: 2010-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UT030EA / 2 LL / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Autopsy, Brain death, Death, Life support, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: Seizure~Pneumo (Prevnar)~3~0.50~Patient|Seizure~Influenza (Seasonal) (Fluzone)~1~0.50~Patient|Seizure~DTaP + IPV + Hib (Pentacel
Other Medications:
Current Illness: Some preceding gastroenteritis in the couple weeks prior to immunization. O/W no known significant illnesses.
Preexisting Conditions: Very serious neurological syndrome (Dravet''s Syndrome) involving intractable poorly controlled frequent seizures and poor prognosis. (Dx had been confirmed by DNA Probe).
Allergies:
Diagnostic Lab Data: Prelim autopsy results inconclusive for cause of death. Tentative dx is SUDEp. (Sudden Unexpected Death of Epilepsy).
CDC Split Type:

Write-up: DEATH. (Toddler was napping in crib during day. Parent found child in full arrest. (Unclear if he''d be seizing prior.) CPR/EMS achieved pulse with full interventions but pt was brain dead and life-support was withdrawn within 8 hours of resuscitation.


VAERS ID: 381778 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2009-12-28
Onset:2009-12-29
   Days after vaccination:1
Submitted: 2010-03-03
   Days after onset:64
Entered: 2010-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102136P1A / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3351AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Death, Headache, Malaise, Meningitis, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-01-01
   Days after onset: 3
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: On meds from specialist
Current Illness: Autoimmune d/o NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: At hospital.
CDC Split Type:

Write-up: 15 hours after vaccinated started feeling ill, headache, nausea, vomiting. To hospital where diagnosed w/ meningitis. Died a few days later.


VAERS ID: 375144 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2009-12-23
Onset:2009-12-27
   Days after vaccination:4
Submitted: 2009-12-28
   Days after onset:1
Entered: 2009-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102131P1 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: sick sinus syndrome,coronary artery disease, type 2 diabetes, hyperlipidemia, chronic anemia, hypertension,
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Resident complained of being dizzy and not feeling well, went unresponsive and passed away at 9:30 PM. Resident was a comfort care only resident no medical attention was necessary. 01/12/2010 Death Certificate received. DOD 12/27/09. Cause of Death: Congestive Heart Failure as a consequence of CAD. Additional information abstracted: Contributing factors - Diabetes mellitus.


VAERS ID: 434287 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: California  
Vaccinated:2009-12-17
Onset:2009-12-25
   Days after vaccination:8
Submitted: 2011-09-13
   Days after onset:626
Entered: 2011-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP015AA / 1 UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Brain neoplasm, Death, Diplopia, Dysphagia, Fall, Fatigue, Feeling abnormal, Headache, Incontinence, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-02-14
   Days after onset: 51
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: Terazosin HCL 1 mg; Cyclobenzaprine HCl 10 mg
Current Illness: None
Preexisting Conditions: Diverticulitis-occasional flare ups
Allergies:
Diagnostic Lab Data: MRI
CDC Split Type:

Write-up: Shortly after the vaccine, he started feeling tired, out of sorts, disconnected. In January 2010, he started having headaches, seeing double, difficulty swallowing, eventually lost continence. Would fall and be unable to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-10.


VAERS ID: 374073 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:2009-12-16
Onset:2009-12-18
   Days after vaccination:2
Submitted: 2009-12-18
   Days after onset:0
Entered: 2009-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 102042P1 / 1 LA / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3366AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Novologmix 70/30 insulin 35 u am 15 u pm
Current Illness: Pharyngitis Rx Z pack. 12/24/09 PCP records received. Service dates 12/9/08 to 12/16/09. On day of immunization diabetic patient c/o ''sugar is up'', thrush in throat.
Preexisting Conditions: diabetes. 12/24/09 PCP records received. Service dates 12/9/08 to 12/16/09. Depressed, multiple drug overdose, traumatic stress disorder. Hysterectomy, diabetes, migraine headaches, neuropathy of lower extremities.
Allergies:
Diagnostic Lab Data: 12/23/09 ED records and Hospital Record of Death received. Service date 12/18/09. LABS and DIAGNOSTICS: EKG - Abnormal. CBC - WBC 15.4 K/mm3 (H) Neutrophils 23.7% (L) Lymphocytes 70.7% (H) Lymphocytes 10.9 k/mm3 (H). CHEM - Glucose 450 mg/dl (H) Total Protein 4.4 g/dl (L) Albumin 2.4 g/dl (L) AST 165 IU/L (H) ALT 160 IU/L (H). Brain Natriuretic 200 pg/ml (H).
CDC Split Type:

Write-up: Nausea/vomiting became unresponsive went into cardiopulmonary arrest and died - was unable to be resuscitated by emergency department staff.


VAERS ID: 374692 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: New York  
Vaccinated:2009-12-11
Onset:2009-12-18
   Days after vaccination:7
Submitted: 2009-12-22
   Days after onset:4
Entered: 2009-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP0068A / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None. ``` albuterol.
Current Illness: None
Preexisting Conditions: None.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Heart stop beating, past away.


VAERS ID: 376499 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2009-12-14
Onset:2009-12-17
   Days after vaccination:3
Submitted: 2010-01-11
   Days after onset:25
Entered: 2010-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP050AA / 1 LA / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR U3377AA / 2 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR UF457AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown.
Allergies:
Diagnostic Lab Data: unknown.
CDC Split Type: ND0938

Write-up: Unknown if symptoms occured following vaccination but patient passed away 3 days later.


VAERS ID: 374649 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Iowa  
Vaccinated:2009-12-16
Onset:2009-12-16
   Days after vaccination:0
Submitted: 2009-12-21
   Days after onset:5
Entered: 2009-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP051AA / 1 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Blood culture positive, Cardiac arrest, Death, Diarrhoea, Endotracheal intubation, Meningococcal infection, Mental status changes, Pyrexia, Rash, Streptococcus identification test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Pseudomembranous colitis (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), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-12-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Runny nose
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Rapid Strep Test - Negative; Blood Cultures - Neisseria Meningitidis. 12/31/09 ED consultation records received. Service date 12/17/09. LABS and DIAGNOSTICS: Blood Gases - Abnormal. Lactate 12.0 mmol/L (H). CHEM - Creatinine 1.4 mg/dL (H) Postassium 3.4 mmol/L (L) Anion Gap 26 mmol/L (H) Glucose 133 mg/dL (H) Calcium 7.2 mg/dL (H). CBC - WBC 4.8 x10e/uL (L) HGB 10.4 g/dL (L) HCT 31.7% (L) Platelets 12.0 x10e3/uL (L) Mono# 0.0 x10e3/uL (L) Anisocytosis slight, Microcytosis slight. Chest X-ray - Abnormal. ECG Abnormal.
CDC Split Type: IA090030

Write-up: 12/16 2130. Presented to ED 12/16 with fever 104.8. Treated with TYLENOL and discharged to home. Returned to ED on 12/17-0615 - altered Mental Status, diarrhea, Rash, T 99.8 - Cardiac arrest - Intubation, code Meds, ROCEPHIN, Vancomycin, acyclovir. Transferred. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. 12/30/09 Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional information abstracted: Cerebrospinal fluid positive for gram negative diplococci on gram stain. /ksk 12/31/09 ED consultation records received. Service date 12/17/09. Assessment: Thrombocytopenia, purpuric rash, cardiopulmonary respiratory arrest, shock with septic and hypovolemic metabolic acidosis, hematemesis, screen for meningococcemia. Child presented to the ED the previous evening with a temperature of 104.8 F was medicated for fever and discharged. This AM presents with a purpuric rash all extremities. Diarrhea, lethargic. Decreased level of consciousness. Intubated and attempted to stabilize for air transport. Abdominal distention. Blood-tinged mucus fluid from nose and mouth. Full CPR. Pulseless electrical activity.


VAERS ID: 388189 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2009-11-24
Onset:2009-12-16
   Days after vaccination:22
Submitted: 2010-05-19
   Days after onset:153
Entered: 2010-05-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 1009234P / UNK RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Diarrhoea, Influenza like illness, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), 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: 2009-12-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes; hypertension; depression; Alcohol abuse.
Allergies:
Diagnostic Lab Data: Autopsy. OFC of Med Investigator
CDC Split Type:

Write-up: Shortly after H1N1 vaccine "began having flu-like symptoms". 1 week prior to death had nausea, vomiting, fever & diarrhea.


VAERS ID: 376066 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Arizona  
Vaccinated:2009-12-12
Onset:2009-12-14
   Days after vaccination:2
Submitted: 2010-01-06
   Days after onset:23
Entered: 2010-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102133P1 / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Dyspnoea, Endotracheal intubation, Gastrostomy, Plasmapheresis, Renal failure acute
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (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 (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-09
   Days after onset: 26
Permanent Disability? Yes
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:
Current Illness:
Preexisting Conditions: NKDA, Diabetes, HTN, Hx CVA.
Allergies:
Diagnostic Lab Data: LABS and DIAGNOSTICS: Troponin - Elevated. Chest X-Ray - Abnormal. ECG - Abnormal. CT Head - Abnormal. CT Thorax - Abnormal. EEG - Abnormal. CBC - WBC 17.5 K/MM3 (H) RBC 3.76 K/MM3 (L) HGB 11.2 g/dL (L) HCT 33.4% (L) Segs 88% (H) Lymphs 5% (L) Neut# 15.4 X10^9/L (H). CHEM - Glucose 182 mg/dL (H) BUN 34 mg/dL (H) Creatinine 0.55 mg/dL (L) BUN/Creat Ratio 62 (H) Potassium 3.0 mmol/L (L) Albumin 2.5 g/dL (L) Alb/Glob Ratio 0.7 (L). Arterial Blood Gases - Abnormal. Sputum Culture (+) for Alpha Hemolytic Streptococci. Sputum Gram stain (+) for Gram Positive Cocci and Gram Negative Rods. Vancomycin-Trough 27.8 ug/mL (H).
CDC Split Type:

Write-up: Weakness, Shortness of breath, elevated troponins, acute renal failure - Diagnosis per neurology Guillane Barre 2'' vaccination? - Patient received plasmaphoresis x5 days, required intubation and subsequent trach and PEG and discharge to SNF.


VAERS ID: 378423 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Ohio  
Vaccinated:2009-12-14
Onset:2009-12-14
   Days after vaccination:0
Submitted: 2010-01-27
   Days after onset:44
Entered: 2010-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 102141P1 / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Death, Diarrhoea, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: He took Lasix each night but I am not sure if he took them during the week after having the diarrhea. I had told him on other occassions not to take them when he was having a bought of diarrhea. He took Motrin as needed for pain but not e
Current Illness: Patient was overweight but relatively in good health.
Preexisting Conditions: Patient as far as we have learned had not seen a doctor in many years. He was taking Lasix, which we found that he was ordering abroad by mail. He retained fluid and had told me he was seeing a doctor for the pills but we have learned that he was not.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He had diarrhea many times throughout the night and all day the next day. I live an hour and a half from him and he traveled home on Tuesday having to stop to go to the bathroom twice. He got home and had diarrhea all day on Tuesday 12/15/2009. He also told me all week that he was feeling very weak. He was even having trouble walking. I had told him all week to go to the emergency room and he kept telling me he would be ok. Finally on Friday 12/18/2009 he agreed to call the emergency squad after I told him I would meet him at the Hospital. The emergency squad arrived and being a big man he decided to walk to the squad. He went down the first of two steps and died. They tried to bring him back but was unsuccessful.


VAERS ID: 379514 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2009-12-11
Onset:2009-12-12
   Days after vaccination:1
Submitted: 2010-02-05
   Days after onset:55
Entered: 2010-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR - / 1 UN / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-12
   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: metformin 500 mg Tums Lantus Humalog
Current Illness: Yes; hyperglycemia; BS 300 on 12/11/09
Preexisting Conditions: IDMM newly diagnosed. Admitted on 12/7/09 in DKA coma and hyperosmolar state.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient unresponsive at home after being discharged on 12/12/09 at 9:15pm. Patient arrested, brought to hospital and pronounced dead at 11:40 PM.


VAERS ID: 375527 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Illinois  
Vaccinated:2009-12-04
Onset:2009-12-11
   Days after vaccination:7
Submitted: 2009-12-30
   Days after onset:19
Entered: 2009-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 10127803 / UNK LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Blood product transfusion, Electromyogram abnormal, Endotracheal intubation, Fatigue, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies abnormal, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-31
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unfortunately the vaccination took place at an outside facility, and information regarding the vaccine and lot number has not been available. Medications prior to admission on 12/13/09 include: alendronate carbidopa-levodopa diltiazem enta
Current Illness: Parkinson''s disease, atrial fibrillation, neurogenic bladder, Ig A deficiency
Preexisting Conditions: Penicillins - rash Blood products that contain E antigen - transfusion reaction/hemolysis since the patient has alloantibody anti-E.
Allergies:
Diagnostic Lab Data: EMG / NCV from 12/17/09: Impression: Findings are abnormal, widespread, consisting of segmental demyelination, distal and proximal conduction blocks-a pattern typically seen in Guillain Barre Syndrome
CDC Split Type:

Write-up: Patient presented to the emergency department on 12/13/09 with 2-3 days of fatigue and lower extremity weakness. The patient was admitted to the hospital and experienced progressive ascending paralysis with subsequent respiratory distress which required intubation on 12/15/09. Per the immunology physicians note on 12/17, diagnosis was Acute Inflammatory Demyelinating neuropathy consistent with Guillain-Barre Syndrome. The patient received a course of five plasmapheresis treatments, followed by one treatment of IVIG.


VAERS ID: 375507 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Maryland  
Vaccinated:2009-12-09
Onset:2009-12-10
   Days after vaccination:1
Submitted: 2009-12-30
   Days after onset:20
Entered: 2009-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP008AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; ENALAPRIL; GLYBURIDE; VIAGRA; METOPROLOL; SIMVASTATIN; VIT D
Current Illness: Congestion; Sneezing.
Preexisting Conditions: Allergies: coated aspirin; history of diabetes - type II; coronary artery disease; HASCVD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported cold-like symptoms (congestion and sneezing) and was seen for that and for blood in his semen. He was given H1N1 vaccine and was released. The next morning he was found dead of a suspected heart attack.


VAERS ID: 378001 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Missouri  
Vaccinated:2009-12-09
Onset:2009-12-10
   Days after vaccination:1
Submitted: 2010-01-24
   Days after onset:45
Entered: 2010-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP037DA / 1 LA / IM
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB167DA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Condition aggravated, Hepatic encephalopathy, Osmotic demyelination syndrome, Unresponsive to stimuli
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-02
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 45 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Liver and Kidney Disease
Preexisting Conditions: Liver and Kidney Disease
Allergies:
Diagnostic Lab Data: Numerous on medical record at hospital.
CDC Split Type:

Write-up: Increased hepatic encephalopathy and non-responsiveness followed by a coma for about eight days. Diagnosis was later rendered that patient had suffered central pontine myelinolysis.


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Glaucoma; Hypertension; Osteoporosis; Pneumonia; Respiratory problem
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: All kinds of tests (unspecified) came back negative. CT scan head and neck showed no apparent cord compression.
CDC Split Type: A0860663A

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


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