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VAERS ID: 381218 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Male  
Location: Arkansas  
Vaccinated:2010-02-17
Onset:2010-02-19
   Days after vaccination:2
Submitted: 2010-02-22
   Days after onset:3
Entered: 2010-02-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3554AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D94433 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA817 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR1004

Write-up: 2-19-2010 Notified by coroner that child had died today requesting copy of immunization record. No other information available.


VAERS ID: 381305 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2007-08-26
Onset:2010-02-13
   Days after vaccination:902
Submitted: 2010-02-22
   Days after onset:9
Entered: 2010-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2324AA / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Bacterial infection, Death, Joint sprain, Lumbar puncture abnormal, Meningitis meningococcal, Meningococcal infection, Polymerase chain reaction
SMQs:, Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No illness at the time of vaccination. Medical history was unknown.
Allergies:
Diagnostic Lab Data: Autopsy spinal tap revealed gram negative rods, meningococcal type C. 14/Feb/2010: Neisseria Meningitidis PCR and Meningitidis Serogroup PCR of the brain : Neisseria Meningitidis serogroup C DNA detected.
CDC Split Type: 201001159

Write-up: Initial report received on 19 February 2010 from health care professional. A 16 year old female patient with an unknown medical history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963 days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June 2007 (route and site were unknown). The patient was seen by a physician on 12 February 2010 after an emergency room visit for a sprained ankle after playing in the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home. On 14 February 2010 the patient had a real-time PCR assay of the brain for detection of neisseria meningitidis performed which detected Neisseria Meningitidis serogroup C DNA. A spinal tap was done during an autopsy which revealed gram negative rods Meningitis Type C DNA. The physician stated that the patient did not have any symptoms of meningitis. No further information was provided. List of Documents held by Sender: lab results.


VAERS ID: 381726 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Florida  
Vaccinated:2010-03-02
Onset:2010-03-02
   Days after vaccination:0
Submitted: 2010-03-03
   Days after onset:1
Entered: 2010-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3565AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1022Y / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D93211 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1212Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Cleft Palate; Maternal substance abuse (methadone/benzo)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found dead at home per dad in phone call. No ER note available yet.


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: 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: 381986 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Florida  
Vaccinated:2009-09-08
Onset:2009-09-10
   Days after vaccination:2
Submitted: 2010-03-05
   Days after onset:176
Entered: 2010-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 89881 / 2 UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Computerised tomogram, Convulsion, Lumbar puncture normal, Nuclear magnetic resonance imaging, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-20
   Days after onset: 283
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: sinus infection
Preexisting Conditions: tingling in face, began having seizures.
Allergies:
Diagnostic Lab Data: patient has had two lumbar punctures with negative results, numerous MRI''s and CT''s.
CDC Split Type:

Write-up: tin.


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

Administered by: Other       Purchased by: Other
Symptoms: Body temperature normal, Cardio-respiratory arrest, Condition aggravated, Glycosylated haemoglobin increased, Low density lipoprotein normal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus; Hypertension; Hyperlipidaemia; Coronary artery disease; Chronic back pain
Preexisting Conditions: Myocardial infarction; Obesity; Oedema peripheral; Angina pectoris; Herniotomy
Allergies:
Diagnostic Lab Data: blood pressure, 10/29/07, 94/50 mmHg; diagnostic laboratory, 10/29/07, 7.8%, Hga1c; total heartbeat count, 10/29/07, 71; temperature measurement, 10/29/07, 97.6 degrees F; serum LDL-C, 10/29/07, 159
CDC Split Type: WAES1003USA00551

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


VAERS ID: 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: 382444 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Utah  
Vaccinated:2010-02-09
Onset:2010-02-17
   Days after vaccination:8
Submitted: 2010-03-11
   Days after onset:22
Entered: 2010-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3191AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1274Y / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF816AB / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR D0480 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E20366 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1473Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: He was put to bed but did not awaken at the usual time (about 2 AM) for feeding. It was then that mother found him in his bed,child was transported to the hospital.


VAERS ID: 382602 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Female  
Location: Oklahoma  
Vaccinated:2010-01-05
Onset:2010-01-06
   Days after vaccination:1
Submitted: 2010-03-14
   Days after onset:67
Entered: 2010-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0950Y / 1 LG / IJ
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0824Y / 1 LG / IJ
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1006Y / 1 LG / IJ

Administered by: Private       Purchased by: Other
Symptoms: Abasia, Abdominal distension, Aphasia, Condition aggravated, Decreased appetite, Dehydration, Lethargy, Somnolence, Staring, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-04-04
   Days after onset: 87
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: Severe Vomiting and spasm of body~Hep B (no brand name)~1~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Had previously been to the hospital for dehydration and vomiting about 2 weeks earlier...allergies suspected, but doctors could not find any other problem.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vomiting (up to 8 days later), lethargic, no appetite, dehydration, had to go back to the hospital for hydration. Stopped walking and talking and interacting with us. Stared into space, very droggy, wanted to sleep all the time; started losing weight and got a very distended abdomen, and loss of appetite. This has lasted for almost 3 full months, now.


VAERS ID: 382746 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Michigan  
Vaccinated:2009-10-20
Onset:2009-11-04
   Days after vaccination:15
Submitted: 2009-11-06
   Days after onset:2
Entered: 2010-03-16
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB707AA / 2 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR D0052 / 1 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0153Y / 2 RA / SC
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3027AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3250AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1046Y / 1 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Drug exposure during pregnancy, Foetal heart rate decreased, Unevaluable event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Developmental delay (severe); strabismus
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Unknown.


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: 383169 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2010-01-22
Onset:2010-01-31
   Days after vaccination:9
Submitted: 2010-03-19
   Days after onset:46
Entered: 2010-03-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1003USA02619

Write-up: Information has been received from an administrator concerning her nephew who on 22-JAN-2010 was vaccinated with a dose of RECOMBIVAX HB (lot# not reported). On 31-JAN-2010 the patient died. At the time of death, in approximately 31-JAN-2010 the patient had a bloody nose. The cause of death was unknown. Additional information has been requested.


VAERS ID: 383175 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-19
Entered: 2010-03-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1003USA02519

Write-up: Information has been received from a consumer via an internet newspaper concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that a parent can be guilty because if he had known about the side effects, then he might not have allowed the pediatrician to vaccinate the child, which resulted in death (cause of death unspecified). It was unknown if the patient sought medical attention. It was also reported that polysorbato 80 or tween 80 that is a chemical that causes infertility in mice and aluminum which is neurological toxin are in GARDASIL. This is one of several reports from the same source. Additional information is not expected.


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: 383479 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Kansas  
Vaccinated:2010-03-22
Onset:2010-03-23
   Days after vaccination:1
Submitted: 2010-03-24
   Days after onset:1
Entered: 2010-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0837Y / 1 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Nervousness, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Therapeutic coumadin use.
Current Illness: Patient reported she was "unable to fill out paperwork" because she''s too shaky ("normal" behavior for patient, by pharmacist''s observations)
Preexisting Conditions: Allergies: Penicillin, quinolones, ticlopidine
Allergies:
Diagnostic Lab Data: When pt contacted pharmacist to report problems, pt was asked to contact physician to report reaction, and was told VAERS would be reported.
CDC Split Type:

Write-up: Pt reported no problems Monday. Upon awakening Tues, had spots on left (vaccinated) arm, left neck, and front of chest. Pt reports rash is painful, not itchy. Wed AM, more "spots", and much more painful. Pt reported feeling "shaky". 88 y/o female received ZOSTAVAX 3-22-10 9AM; pt awoke 3-23 10 with painful rash on left arm, neck & chest. Rash was reported to pharmacist on Wed 3-24 afternoon ---$g pt. instructed to call dr. Pt saw dr. 3-24-10 in afternood - dr. confirmed pt had shingles, Pt. was prescribed VALTREX & LORTAB prescriptions for gen. VALTREX (1 gram BID x 7 days) and gen LORTAB 7.5-500 (1-2 QID prn pain) were picked up by family members 3-26-10 early afternoon. Pt''s obituary was inlocal paper Tues 3-30-10 (DOD 3-28-10). Dr''s office was contacted and nurse said pt did have shingles - like rash 3-25-10. Dr-on-call was contacted by pt Sat 3-27-10.. Pt refused to go to ER, but instead went to stay at daughter''s house Pt was found unresponsive ~ 2AM 3-28-10. According to nurse no evidence of stroke, but pt had subdermal hematoma - a fall at some time is expected, but unknown.


VAERS ID: 383548 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Arkansas  
Vaccinated:2010-03-08
Onset:2010-03-10
   Days after vaccination:2
Submitted: 2010-03-25
   Days after onset:14
Entered: 2010-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3533AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 08904 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D84740 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0535Y / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: 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: 2010-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child found unresponsive by parents and taken to local ED


VAERS ID: 383746 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Arizona  
Vaccinated:2009-11-20
Onset:2009-11-20
   Days after vaccination:0
Submitted: 2010-03-21
   Days after onset:120
Entered: 2010-03-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 10P012 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Death, Dizziness, Dyspnoea, Fatigue, Heart rate increased, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-20
   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: None
Preexisting Conditions: HALDO, any psych except PAXIL x 1 a day
Allergies:
Diagnostic Lab Data: Taken that AM 11/20/09 Blood Test office. Also Hosp 11-18-09 11-19-09
CDC Split Type:

Write-up: Patient received H1N1virus shot late AM 11-20-2009. On the way home she was tired, near lunch I gave her peaches & a little soup. Heart rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up & went to bathroom & died.


VAERS ID: 384071 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Indiana  
Vaccinated:2010-02-17
Onset:2010-02-17
   Days after vaccination:0
Submitted: 2010-04-02
   Days after onset:43
Entered: 2010-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR 3542AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 88183 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036A / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-17
   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: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: No symptons,or signs prior to child not breathing. Child taken to ER and CPR was implemented.


VAERS ID: 384648 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-03-10
Onset:2010-03-16
   Days after vaccination:6
Submitted: 2010-04-08
   Days after onset:23
Entered: 2010-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1190Y / UNK LA / IJ

Administered by: Military       Purchased by: Military
Symptoms: Angiogram, Biopsy lung, Diabetes mellitus, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-26
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 31 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: dry cough
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: angiogram, catscans, lung biopsies, nebulizing treatment, IV antibiotics, Steriods, blood tests, diabetes caused by steriods, insulin shots
CDC Split Type:

Write-up: shortness of breathe and wheezing


VAERS ID: 384848 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: South Carolina  
Vaccinated:2010-04-07
Onset:2010-04-08
   Days after vaccination:1
Submitted: 2010-04-09
   Days after onset:1
Entered: 2010-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B242AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF876AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44433 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-08
   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: No
Preexisting Conditions: GERD diagnosed at visit
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found dead in crib.


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: 385210 (history)  
Form: Version 1.0  
Age: 0.52  
Sex: Male  
Location: Massachusetts  
Vaccinated:2010-04-13
Onset:2010-04-14
   Days after vaccination:1
Submitted: 2010-04-15
   Days after onset:1
Entered: 2010-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3307AA / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D66586 / 3 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Increased bronchial secretion, Skeletal survey
SMQs:, Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-14
   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: None
Current Illness: None
Preexisting Conditions: Atopic dermatitis
Allergies:
Diagnostic Lab Data: Skeletal survey at medical center Emergency Room
CDC Split Type:

Write-up: Patient asymptomatic on day of immunization. Afebrile before and after immunization. Patient found dead next day with face down on bed with lots of secretions.


VAERS ID: 385303 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2010-03-01
Submitted: 2010-04-15
   Days after onset:44
Entered: 2010-04-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA01848

Write-up: Information has been received from a Nurse at the physician''s office who heard from another Nurse that a patient came in to the office to receive the third dose of GARDASIL and the friend of the patient told her not to get the third dose because she knew of another girl that received the third dose of GARDASIL and died "within the last month" (cause of death not reported). It was unknown if the patient sought medical attention. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.


VAERS ID: 385430 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Illinois  
Vaccinated:2010-04-14
Onset:2010-04-17
   Days after vaccination:3
Submitted: 2010-04-19
   Days after onset:2
Entered: 2010-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3162BA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1379Y / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44520 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1523Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-17
   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: ZANTAC 15mg/mL 0.6 mL BID
Current Illness:
Preexisting Conditions: GERD.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 385948 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Indiana  
Vaccinated:2010-04-22
Onset:2010-04-24
   Days after vaccination:2
Submitted: 2010-04-26
   Days after onset:2
Entered: 2010-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3606AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44520 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0768Y / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-25
   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: LASIX .4 ml TID; spironolactone .4 BID; ZANTAC 1 ml BID
Current Illness: None
Preexisting Conditions: Trisomy 21; VSD; ASD sacral dimple; respiratory depression; laryngomalacia; cardiomegaly
Allergies:
Diagnostic Lab Data: Chest x-ray 4/23/10 & 4/25/10 No significant change from previous x-rays
CDC Split Type:

Write-up: Diarrhea 4/24/10. Fever 4/25/10.


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: 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: 386360 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: California  
Vaccinated:2009-10-16
Onset:2009-10-17
   Days after vaccination:1
Submitted: 2010-04-25
   Days after onset:190
Entered: 2010-04-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 07249111A / UNK RA / UN

Administered by: Military       Purchased by: Military
Symptoms: Death, Pyrexia, Toxicologic test abnormal
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: 2009-10-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPAMID; ZENEXTRA; ibuprofen; aspirin
Current Illness: Possible H1N1 in incubation stage
Preexisting Conditions: Obesity; severe insomnia; observed sleep apnea; possible undiagnosed fibromyalgia; arthritis.
Allergies:
Diagnostic Lab Data: Toxicology report showed high ethanol content (0.43%) except she didn''t drink. 8hrs forensic investigation did not turn up any alcohol/containers/ glasses etc.
CDC Split Type:

Write-up: Death - 13 hours after Influenza A administration. Spouse had evidence of febrile event when found. spouse had been exposed to son with H1N1 (swine) continuously for 5 days in preceding 8 days before death. It was unknown at time that son had H1N1 and only became known to us 6 weeks after patient''s death.


VAERS ID: 386490 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Iowa  
Vaccinated:2006-08-09
Onset:2010-04-13
   Days after vaccination:1343
Submitted: 2010-04-23
   Days after onset:10
Entered: 2010-05-03
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Test results (not specified) were pending.
CDC Split Type: 201002362

Write-up: Initial report was received 22 April 2010 from a press article. A 22-year-old male college student had received a meningococcal vaccination before entering college (manufacturer, lot number, route, site and date of administration not reported), and an unspecified amount of time later on 13 April 2010, the patient reported feeling ill. He was taken to the emergency room by his friends at approximately 5:30pm and within hours (also reported as before 11:30pm), he died from meningococcal disease/bacterial meningitis. According to the report, test results (not specified) were pending. No additional information was provided at the time of the report. Documents held by sender: None.


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: 386796 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Texas  
Vaccinated:2009-02-18
Onset:2009-02-23
   Days after vaccination:5
Submitted: 2010-05-02
   Days after onset:432
Entered: 2010-05-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B192DA / UNK LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF617AA / UNK RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D01075 / UNK RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1359X / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-02-23
   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: Concentrated TYLENOL infants drops contains acetaminophen (grape flavor)
Current Illness: 3 weeks prior to shots my son suffered from gastrointestinal diarrhea.
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: At birth at Hospital patient began with Infamil formula and when perinatal insurance cut me off I was forced to use Similac Advanced, my son took ill with gastrointestinal diarrhea immediately. Health professional & Doctor were fully aware of this. Health professional threatened me she was fully aware of my C.P.S. history & would report me if patient wasn''t brought in by 2-18-09 for his shots.


VAERS ID: 386863 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2009-10-06
Onset:2009-10-09
   Days after vaccination:3
Submitted: 2010-05-06
   Days after onset:209
Entered: 2010-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR AFLLA285AA / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Culture positive, Death, Influenza, Influenza like illness, Laboratory test, Polymerase chain reaction, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-09
   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: Not known; Apparently used home oxygen
Current Illness: Flu like symptoms
Preexisting Conditions: High cholesterol; Diabetes; Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Autopsy - Office of Med Invest - H1N1 by RT-PCR confirmed
CDC Split Type:

Write-up: Apparently had flu-like symptoms starting about 2 OCT 09. He had lab work & flu shot at the Health Clinic, on 6 OCT 09. He had a respiratory arrest at home on 9 OCT 09. H1N1 influenza from lung cultures & Nl Swab at autopsy.


VAERS ID: 386946 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Louisiana  
Vaccinated:2010-04-26
Onset:2010-04-28
   Days after vaccination:2
Submitted: 2010-04-29
   Days after onset:1
Entered: 2010-05-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3494CC / 1 LL / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1275Y / UNK RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E01563 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0768Y / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Bradycardia, Death, Endotracheal intubation, Presyncope, Respiratory distress, Resuscitation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications: ASA - 1/4 Baby ASA daily; Synagis for RSV prophylaxis
Current Illness:
Preexisting Conditions: Hypoplastic left heart syndrome; S/P Norwood Sano procedure.
Allergies:
Diagnostic Lab Data: Unknown.
CDC Split Type:

Write-up: Child had been in distress at cardiology office - was transported to hospital. When intubated for transport child had vagal response with bradycardia - unable to resuscitate and child expired at ER.


VAERS ID: 387104 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Unknown  
Location: Minnesota  
Vaccinated:2007-11-07
Onset:2009-10-14
   Days after vaccination:707
Submitted: 2010-04-30
   Days after onset:198
Entered: 2010-05-10
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-14
   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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD died of unknown cause on 10/14/09. Vaccination took place 10/07/07. According to physician the relationship is ''unlikely''.


VAERS ID: 387119 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: California  
Vaccinated:2008-05-14
Onset:2009-08-29
   Days after vaccination:472
Submitted: 2010-04-30
   Days after onset:244
Entered: 2010-05-10
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autoimmune hepatitis, Death
SMQs:, Hepatitis, non-infectious (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: 2009-09-17
   Days after onset: 19
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:
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial, with severe COPD died of autoimmune hepatitis on 9/17/09. Vaccination took place 5/14/2008. According to physician the relationship is ''unlikely''.


VAERS ID: 387143 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Tennessee  
Vaccinated:2010-05-07
Onset:2010-05-07
   Days after vaccination:0
Submitted: 2010-05-10
   Days after onset:3
Entered: 2010-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3450AA / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E44433 / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 387160 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Hawaii  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-10
Entered: 2010-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-10-24
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: WAES1005USA00536

Write-up: Information has been received from a physician who found out from another treating physician who was also the father of the patient, concerning a 16 year old female patient who on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient developed a severe headache. Then the patient went to sleep that night and passed away. The autopsy was performed which revealed no cause of death. It is unknown if the patient sought medical attention. Severe headache was considered to be immediately life-threatening. Additional information has been requested.


VAERS ID: 387614 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Male  
Location: Illinois  
Vaccinated:2010-05-06
Onset:2010-05-06
   Days after vaccination:0
Submitted: 2010-05-17
   Days after onset:11
Entered: 2010-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3334AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB818AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E45350 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-13
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen 80 mg given before the shots.
Current Illness: CONSTIPATION
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Taken to ER. Coroner aware. Details unknown.
CDC Split Type:

Write-up: According to parents the baby was found not breathing in bed. Taken to ER. Died before reaching the ER.


VAERS ID: 387625 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Female  
Location: New Hampshire  
Vaccinated:2010-04-30
Onset:2010-05-06
   Days after vaccination:6
Submitted: 2010-05-17
   Days after onset:11
Entered: 2010-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3157AA / 4 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB362AA / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin w/ Fluoride
Current Illness: No
Preexisting Conditions: Amoxicillin; Zithromax - rash
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH05072010

Write-up: Child found dead one morning.


VAERS ID: 387760 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Minnesota  
Vaccinated:1996-07-30
Onset:2008-12-16
   Days after vaccination:4522
Submitted: 2010-05-18
   Days after onset:517
Entered: 2010-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 432774 / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Culture stool positive, Death, Exposure to vaccinated person, Muscle spasms, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-03-23
   Days after onset: 96
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 92 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Mother had combined variable immunodeficiency.
Allergies:
Diagnostic Lab Data: Stool culture on 3/3/09 positive for sabin poliovirus type 2
CDC Split Type:

Write-up: Pt with combined immune deficiency was exposed to OPV through daughter''s vaccination in 1996. In December 2008 developed (L) calf cramping which progressed to bilateral lower extremity weakness. (see attached sheet)


VAERS ID: 387830 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Hawaii  
Vaccinated:2010-05-13
Onset:2010-05-17
   Days after vaccination:4
Submitted: 2010-05-17
   Days after onset:0
Entered: 2010-05-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3563AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E45349 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1586Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-17
   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: None
Current Illness:
Preexisting Conditions: Infantile Acropustulosis
Allergies:
Diagnostic Lab Data: Autopsy/death scene investigation pending
CDC Split Type:

Write-up: Sudden unexplained death on 5/17/10.


VAERS ID: 388096 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Female  
Location: Rhode Island  
Vaccinated:2010-01-25
Onset:2010-02-25
   Days after vaccination:31
Submitted: 2010-05-18
   Days after onset:81
Entered: 2010-05-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B210BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR OF740AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D84741 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB036A / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Autopsy, Culture urine negative, Death, Meningitis pneumococcal, Pneumococcal sepsis, Pyuria
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes premature baby (born at 29 weeks gestation).
Preexisting Conditions: The patient has a past history of staphylococcal infection (possible while in the nursery).
Allergies:
Diagnostic Lab Data: Culture (results: Streptococcus pneumoniae) and culture urine (results: negative) were done in Feb-2010.
CDC Split Type: USWYEH15078510

Write-up: Information regarding PREVNAR was received from an emergency room physician regarding a 3-month-old (114 day-old) female patient who experienced pyuria, Streptococcus pneumoniae meningitis and Streptococcus pneumoniae sepsis and died. The patient received a dose on 25-Jan-2010. On an unknown date in Feb-2010, the patient experienced pyuria and was empirically placed on an unknown antibiotic thought to be either KEFLEX or OMNICEF. On an unknown date in Feb-2010 the urine culture was negative. On 25-Feb-2010 the child was transported to the emergency room where she died due to Streptococcus pneumoniae meningitis and Streptococcus pneumoniae sepsis. The patient was not hospitalized. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis and the autopsy cause of death was meningitis pneumococcal and pneumococcal sepsis. The serotype of the pneumococcal bacteria was not identified. No additional information was available at the time of this report.


VAERS ID: 388098 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Male  
Location: Indiana  
Vaccinated:2010-04-19
Onset:2010-04-28
   Days after vaccination:9
Submitted: 2010-05-19
   Days after onset:21
Entered: 2010-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1259Y / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1222Y / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH D94433 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1405Y / 1 LL / SC

Administered by: Private       Purchased by: Public
Symptoms: Blood culture negative, Brain herniation, CSF culture negative, Chest X-ray abnormal, Chronic sinusitis, Computerised tomogram abnormal, Death, Electroencephalogram abnormal, End-tidal CO2 abnormal, Endotracheal intubation, Exposure to communicable disease, Herpes simplex serology negative, Hypocalcaemia, Intensive care, Lethargy, Listless, Livedo reticularis, Lumbar puncture, Meningitis, Mental status changes, Nystagmus, Peripheral coldness, Polymerase chain reaction, Poor peripheral circulation, Pupillary reflex impaired, Sepsis syndrome, Tonic clonic movements, Use of accessory respiratory muscles
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-05-04
   Days after onset: 6
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: none
Current Illness: no
Preexisting Conditions: hypospadius repair 1-22-2010
Allergies:
Diagnostic Lab Data: Note: All result statuses are Final unless otherwise noted. Tests: (1) BLOOD CULTURE (BLC) Order Note: ! SPECIMEN DESCRIPTION "Result Below..." *1 RESULT: BLOOD(A) PERIPHERAL STICK ! SPECIAL REQUESTS "Result Below..." *2 RESULT: Peds bottle only received. ! CULTURE NO GROWTH 6 DAYS *3 ! REPORT STATUS FINAL *4 05042010 Note: An exclamation mark (!) indicates a result that was not dispersed into the flowsheet. Document Creation Date: 05/04/2010 8:21 AM CT HEAD WITHOUT CONTRAST Indication: Mental status changes, cyanotic, unresponsive Comparison: None Findings: The ventricles and CSF spaces are within normal limits. There is no acute hemorrhage, abnormal fluid collection or midline shift seen. No acute infarction or mass is seen. MRI may be helpful if symptoms persist. There are mild chronic sinusitis changes in the maxillary sinuses. Impression: 1. Mild chronic maxillary sinusitis changes. 2. Otherwise unremarkable for age. Note: All result statuses are Final unless otherwise noted. Tests: (1) HSV 1 AND 2 PCR QL (HSVPC) Order Note: ! HSV 1 NOT DETECTED NTD *1 ! HSV 2 NOT DETECTED NTD *2 This test was developed and its performance characteristics determined by Lab. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.Testing performed using real-time polymerase chain reaction (PCR) technology ! SOURCE "Result Below..." *3 RESULT: CEREBROSPINAL FLUID Note: An exclamation mark (!) indicates a result that was not dispersed into the flowsheet. Document Creation Date: 04/29/2010 1:22 AM Note: All result statuses are Final unless otherwise noted. Tests: (1) CSF CULTURE (CSFC) Order Note: ! SPECIMEN DESCRIPTION "Result Below..." *1 RESULT: CEREBROSPINAL FLUID ! SPECIAL REQUESTS "Result Below..." *2 RESULT: CEREBROSPINAL FLUID ! CULTURE NO GROWTH 5 DAYS *3 ! REPORT STATUS FINAL *4 05/03/2010 Note: An exclamation mark (!) indicates a result that was not dispersed into the flowsheet. Document Creation Date: 05/03/2010 7:40 AM Portable chest 4/28/2010 COMPARISON: None HISTORY: Shortness of breath COMMENT: The endotracheal tube is in satisfactory position on this single view. The patient is rotated. No effusion or pneumothorax is seen. The right lung appears grossly clear. There may be airspace disease in the left lung. IMPRESSION: Question left airspace disease. The right lung is grossly clear. The patient is rotated. Endotracheal tube appears satisfactory in this single view. CHEST XRAY BEDSIDE, Apr 28, 2010 02:52:39 PM INDICATION: Dyspnea There continue to be extensive areas of infiltrate predominately in the left upper lobe. The endotracheal tube is again noted. There has been apparent placement of an orogastric tube. The tip is located in the proximal portion of the thoracic esophagus. The right lung remains clear. IMPRESSION: 1. Presumed placement of an orogastric tube as discussed. 2. The study is otherwise unchanged from a study done earlier in the day. Reason For Initial Request: Pt Evidently, pt brought into ER on 4/28/10 for "Prolonged Seizure." Was intubated and transferred to another hospital. Currently, still intubated and determined significant hypoxia. Actions Taken Patient/Significant Other notified, MD notified Further Dialogue Received a call from resident Dr. Pt transferred from ER with Dx of meningitis. Per Dr, they think, pt had some sort of encephalopathy. Yesterday he had herniation of the cerebellar tonsils and pupils were not responding. Neurology consult was called in and an EEG done did not show any activity. After consultation with the relatives of the child it decided to withdraw life support and baby passed away last night. I appreciate Dr calling us and personally making us aware of this unfortunate incident. To Nurse PCC: kindly connect with parent/s to offer our condolence and to enquire if they need any help from us. 2 Failed attempts to reach mother at home. Reached Grma who will inform mother that we are aware and offering sympathy and assistance as needed. She does believe the list of support grief groups would be helpful and told we will mail in card to her. The Obituary will be listed tomorrow Friday, and services -12-2p 2pm Eulogy. Mother lives with son, and her father, also caregiver for pt.
CDC Split Type:

Write-up: CHIEF COMPLAINT: He presents here as a 12 month old that was brought in by mother, carried in from triage to shock room 2, lethargic and listless. HISTORY OF PRESENT ILLNESS: The patient, according to mother''s history, was exposed to several family members who have had URI symptoms over the last 24 hours and this morning he slept more than usual, walking up around 10:30 this morning, and was found to be lethargic. The patient was carried into shock room 2. Further history was not available. PAST MEDICAL HISTORY AND SURGICAL HISTORY: Negative. ALLERGIES: Negative. MEDICATIONS: Currently negative. REVIEW OF SYSTEMS: As per HPI; otherwise, all negative. PHYSICAL EXAMINATION: General: The patient was lethargic, listless, and unremarkable. HEENT: His oropharynx was clear. He did not have any tongue lacerations or abrasions. He had moist mucous membranes. Neck: Supple. I did not appreciate any obvious lymphadenopathy or meningeal signs. Lungs: Clear on auscultation. He had moderate accessory muscle use with intercostal retractions. Abdomen: Soft. I did not appreciate any distention or signs of trauma. Extremities: The lower extremity exam was cold to touch. He had poor perfusion. He was mottled. Neurologic: The patient had positive nystagmus and almost exhibited tonic-clonic-like activity. EMERGENCY DEPARTMENT COURSE: Immediately, we decided to intubate this patient to maintain a definitive airway. Using a 4.5 endotracheal tube that was uncuffed, I proceeded with intubation. A peripheral IV was inserted immediately by our nurse. I used 15 mg of IV succinylcholine with a dosing determined using a weight based scale. We believed the patient was anywhere from 10 to 12 kg. Once the patient was adequately paralyzed, I was able to successfully intubate this patient. He had positive end-tidal CO2 and condensation in the tube. He had blood work including a CBC, a blood culture, and a BMET. I had the patient transferred immediately to head CT which showed evidence of chronic maxillary sinusitis with no evidence of mass effect. When the patient returned back to the emergency room into shock room 2, I proceeded with spinal tap. Given the emergency situation, we did not have a chance to consent mother who was not immediately available. We went ahead and proceeded with the procedure. I was able to successfully perform a spinal tap using his pelvic crests as my landmarks. The entire procedure was performed under sterile conditions. The back was cleaned using iodine applied in circular fashion x3. Using the pediatric LP tray, and the spinal needle that was within the tray, I used the L3-L4 interspace to access the subarachnoid space. I was able to collect 3 tubes of CSF, at least 2 mL each, and these were sent for studies including HSV, PCR. We went ahead and ordered antibiotics including Rocephin 100 mg per kg IV. Laboratories returned with a white count 30.7, hemoglobin 14.0, platelet count 344. Sodium 153, potassium 6.9, chloride 113, CO2 of 10, BUN 88, creatinine 1.15, calcium 7.2. We are getting a BMET. I have ordered IV glucose, D25 2 mL/kg. A urine culture, and urinalysis, and a blood culture were ordered and pending. Postintubation chest x-ray showed left-air space disease. Right lung was clear. Endotracheal tube appeared to be in satisfactory position. Head CT did show evidence of chronic maxillary sinusitis. I spoke to Dr. from ICU and the patient will be transferred there in critical but stable condition. He asked that we go ahead and give him vancomycin 20 mg/kg IV as well as Acyclovir 20 mg per/kg IV, and I will also order maintenance IV fluids after receiving initial 200-mL normal saline bolus. We also gave him an ampule of calcium gluconate for his hypocalcemia. IMPRESSION: 1. Mental status changes. 2. Acute meningitis. 3. Sepsis syndrome. DISPOSITION: To ICU in critical but stable condition. CRITICAL CARE TIME: Exclusive of all procedures which included endotracheal intubation as well as spinal tape, greater than 60 minutes.


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: 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: 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: 389121 (history)  
Form: Version 1.0  
Age: 1.49  
Sex: Male  
Location: Oregon  
Vaccinated:2010-04-19
Onset:2010-04-24
   Days after vaccination:5
Submitted: 2010-04-26
   Days after onset:2
Entered: 2010-05-24
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B086AB / 4 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1292Y / 3 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Atrial rupture, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-24
   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: no
Preexisting Conditions: Anemia
Allergies:
Diagnostic Lab Data: Per Death Certif. - death caused by chest injury from accident of T.V. falling on top of toddler
CDC Split Type: OR201015

Write-up: Patient came in for well child check on 4/19/10 received DTAP and HIB at the same visit. Clinic contacted by Medical Examiner that patient died on 4/24/2010 of ruptured R atrium after T.V. fell on him. D. Cert attached.


VAERS ID: 389842 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Male  
Location: Virginia  
Vaccinated:2010-04-26
Onset:2010-05-19
   Days after vaccination:23
Submitted: 2010-05-27
   Days after onset:8
Entered: 2010-06-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR 8511AA / 2 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 47472 / 1 LG / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 15234 / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Bacterial test positive, Blood culture positive, CSF culture, Death, Pyrexia, Streptococcal sepsis, Streptococcus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: Therapy regimen changed.
Preexisting Conditions: The patient previously (04-Feb-2010), received a dose of PREVNAR 7, ROTATEQ and PENTACEL and did not experience an adverse event. The patient was reported as a "healthy child".
Allergies:
Diagnostic Lab Data: In May-2010 test results were: culture (results: (site unknown) growth of Streptococcal pneumoniae); CSF culture (results: pending); and autopsy (results: pending). Blood culture (results: Group A Streptococcus pyogenes) was done on 18-May-2010.
CDC Split Type: USWYEH15278510

Write-up: This case involves a fatal event was considered medically important for the events of vomiting and fever. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting and died due to an overwhelming sepsis from Group A Streptococcus pyogenes. The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and the second dose of ROTATEQ (Merck & Co Inc). On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room. On an unspecified date in May-2010, a culture (reported as "a very early culture of unspecified origin) was performed that revealed Streptococcus pneumoniae, however a blood culture on 18-May-2010 revealed Group A Streptococcus pyogenes. On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes. The cause of death was reported as streptococcal sepsis. The autopsy cause of death was undetermined. No additional information was available at the time of this report.


VAERS ID: 390042 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2010-03-19
Onset:2010-03-22
   Days after vaccination:3
Submitted: 2010-06-04
   Days after onset:74
Entered: 2010-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1670Y / 1 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E28211 / 4 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Death, Febrile convulsion, Pyrexia, Toxicologic test normal, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-02
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xopenex, Prevacid
Current Illness: URI, h/o wheezing on nebulized Xopenex
Preexisting Conditions: Asthma bronchiolitis
Allergies:
Diagnostic Lab Data: negative autopsy and toxicology
CDC Split Type:

Write-up: Febrile seizure 3/22/10. Patient found dead on morning of 4/2/10, per parents febrile to 102 t bedtime with URI but no other sx. Autopsy and toxicology were negative.


VAERS ID: 390137 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Florida  
Vaccinated:2010-03-11
Onset:2010-03-17
   Days after vaccination:6
Submitted: 2010-06-07
   Days after onset:82
Entered: 2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Known
Preexisting Conditions: None Known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS


VAERS ID: 390402 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Indiana  
Vaccinated:1973-11-29
Onset:1973-12-04
   Days after vaccination:5
Submitted: 2010-06-08
   Days after onset:13334
Entered: 2010-06-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal tenderness, Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Albumin urine present, Autopsy, Band neutrophil percentage, Bilirubin conjugated increased, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium normal, Blood creatinine increased, Blood glucose normal, Blood phosphorus normal, Blood pressure decreased, Blood urea increased, Body temperature increased, Chest X-ray abnormal, Chills, Cholestasis, Coma, Confusional state, Death, Dehydration, Delirium, Depressed level of consciousness, Diet refusal, Disseminated intravascular coagulation, Electrocardiogram T wave peaked, Electrocardiogram abnormal, Electrocardiogram low voltage, Fibrin degradation products, Gastritis atrophic, General physical health deterioration, Haematocrit normal, Heart rate increased, Hepatic function abnormal, Hepatic lesion, Hepatic necrosis, Hepatic steatosis, Hypertrophy, Hypotension, Influenza like illness, Intensive care, Lethargy, Lipids abnormal, Lymphocyte percentage, Malaise, Mental impairment, Microscopy, Mucous membrane disorder, Myalgia, Nausea, Neutrophil percentage, Obesity, Oropharyngeal pain, Platelet count decreased, Pleural effusion, Prothrombin time prolonged, Pyrexia, Red blood cell count increased, Red blood cells urine positive, Renal failure acute, Respiratory tract congestion, Swelling face, Thrombocytopenia, Urinary casts, Urine output decreased, Viral test negative, Vomiting, White blood cell count increased, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Angioedema (narrow), Dyslipidaemia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was admitted to the hospital 6 weeks ago with lassitude pallor, peripheral edema, anemia (hemoglobin 6.6 g/dL), low serum iron, folate, and B12, diagnosed as pernicious enemia. During that admission, he had mild hepatosplenomegaly and slightly elevated bilirubin of 1.4 mg/dL
Allergies:
Diagnostic Lab Data: Day of admission: temperature 98.6 deg F, pulse 120, blood pressure (BP) 84/48, BUN 140 mg/dL, glucose 116 mg/dL, total bilirubin 4.4 mg/dL, albumin 2.6 g/dL; alkaline phosphatase, calcium and phosphorus normal. Day after admission: BP 60/40, temp 102 deg F, urine output minimal, BUN 190 mg/dL, creatinine 7.8 mg/dL, bilirubin 5.5 mg/dL (4.2 direct), SGPT 102 U/L, alkaline phosphatase 93 U/L, hematocrit 46.7%, platelets 46,000, white blood cell (WBC) count 13,800/mm3 with 66% polymorphonuclear cells, 3 % bands, 31%lymphocytes. Urinalysis showed 12-15 WBC, 50-60 red blood cells, 3-4 renal epithelial cells, 2+ albumin. Bilirubin increased to 11.2 mg/dL (9.4 direct), developed thrombocytopenia (40000/mm3), prolonged prothrombin time (15.4 seconds, 11.4 seconds control), partial thrombocytopenia (66.0 seconds, 31.9 control) and positive fibrin split products. EKG showed low voltage and peaked T waves in V1-V6. Chest x-ray showed fluid in the right pleural space congestion. Fluorescent stain of the frozen liver tissue was negative for yellow fever antigen. Fixed liver tissue was examined by electron microscopy and found negative.
CDC Split Type: 201003079

Write-up: Initial case was retrieved from the scientific literature on 31 May 2010. A 75-year-old male patient, with a medical history of a recent hospital admission 6 weeks prior for lassitude, pallor, peripheral edema, anemia (hemoglobin 6.6 g/dL), low serum iron, folate, and B12, diagnosed as pernicious anemia, mild hepatosplenomegaly and slightly elevated bilirubin of 1.4 mg/dL, received an injection (route and site not provided) on 29 November 1973 of Yellow Fever Vaccine (lot number and manufacturer unknown). "Six days later he developed flu-like symptoms, with fever, chills, myalgia, nausea, vomiting, mild sore throat, and abdominal pain. He was seen by a physician who noted a temperature of 100 degrees Fahrenheit and prescribed penicillin and an analgesic. The next day, the patient became confused and did not take food or fluids. He was admitted the following day (8 days after vaccination) to the hospital. On the day of the current admission, the patient was found to be moderately obese, lethargic, acutely ill, and complaining of abdominal pain. The temperature was 98.6 degrees Fahrenheit, pulse 120 and blood pressure 84/48. The face appeared swollen, mucus membranes were dry, the abdomen protuberant and generally tender, with liver and spleen palpable on deep inspiration. Serum urea nitrogen (BUN) was 140 mg/dL, glucose 116 mg/dL, total bilirubin 4.4 mg/dL, albumin 2.6 g/dL; alkaline phosphatase, calcium, and phosphorus normal. On the day after admission, he was admitted to the intensive care unit because of hypotension and deteriorating mental status. The blood pressure was 60/40, temperature 102 degrees Fahrenheit, urine output minimal, and sensorium obtunded. The BUN was 190 mg/dL, creatinine 7.8 mg/dL, bilirubin 5.5mg/dL (4.2 direct), SGPT 102 U/L, alkaline phosphatase 93 U/L, hematocrit 46.7%, platelets 46,000, white blood cell (WBC) count 13,800/mm3 with 66% polymorphonuclear cells, 3 % bands, 31%lymphocytes. Urinalysis showed 12-15 WBC, 50-60 red blood cells, 3-4 renal epithelial cells, 2+ albumin. The patient was thought to be in acute renal failure, dehydrated, and to have significant hepatic dysfunction. His condition deteriorated, with progression from delirium to coma. His temperature, BUN, creatinine, and WBC remained elevated. Bilirubin increased to 11.2 mg/dL (9.4 direct). He developed a consumption coagulopathy with thrombocytopenia (40,000/mm3), prolonged prothrombin time (15.4 seconds, 11.4 seconds control) and partial thromboplastin (66.0 seconds, 31.9 control), and positive fibrin split products, but did not develop overt bleeding. He was treated with corticosteroids, mannitol, heparin, furosemide, and vasopressors. The electrocardiogram (EKG) showed low voltage and peaked T waves in V1-V6. Chest x-ray showed fluid in the right pleural space and congestion. The patient died 3 days after admission (11 days after vaccination). On autopsy, gross anatomical findings included diffuse, focal necrosis of the liver, atrophic gastritis of the stomach, lipid depletion of the adrenal glands, and congestion of both lower lobes of the lung. A number of experts evaluated the liver histopathology. The findings included focal single cell necrosis, scattered acidophilic degeneration, marked areas of hepatocellular unrest, marked Kupffer cell hypertrophy, cholestasis, and fatty degeneration. The distribution of lesions was not mid-zonal, and for that reason the changes were not considered caused by yellow fever. A fluorescent stain of the frozen liver was negative for yellow fever antigen and fixed liver tissue was examined by electron microscopy and found negative. Documents held by sender: None.


VAERS ID: 390561 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: South Carolina  
Vaccinated:2010-06-07
Onset:2010-06-10
   Days after vaccination:3
Submitted: 2010-06-14
   Days after onset:4
Entered: 2010-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B242DA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1420Y / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E44521 / 2 LL / IM

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

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

Write-up: Infant found unresponsive by parents on the afternoon of 6/10/10.


VAERS ID: 390648 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Georgia  
Vaccinated:2010-03-09
Onset:2010-03-13
   Days after vaccination:4
Submitted: 2010-06-15
   Days after onset:93
Entered: 2010-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B207AA / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1212Y / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: 06/15/2010 - per patient''s mother, the autopsy report just came back and indicated SIDS.
CDC Split Type:

Write-up: Parents of patient found him dead the morning of 03/12/2010. Per ER physician, rigor mortis had set in. Per the ER physician, mother mentioned questionable abdominal pain and questionable cold symptoms, but says that child seemed okay.


VAERS ID: 390676 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-14
Entered: 2010-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1006USA00766

Write-up: Information has been received from an anonymous nurse concerning a male patient who on an unspecified date, was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (lot no. not reported) because it was a required vaccine for citizenship. The vaccine was not given by a physician but someone else. On an unspecified date, the patient passed away. An autopsy was being done at that time. The patient passed away was considered to be immediately life-threatening and disabling by the reporter. Additional information has been requested.


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: 391439 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-24
Entered: 2010-06-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Convulsion
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA02143

Write-up: Information has been received from a Registered Nurse concerning an 18 year old female patient with a history of seizures prior to GARDASIL, who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse advised that the patient experienced seizure and subsequent death after receiving GARDASIL. It was not advised which injection in the series caused the adverse experience or how the injection was administered. The health care professional was contacted by telephone and call would not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number and date of event. Seizure was considered to be disabling and immediately life-threatening. Additional information has been requested.


VAERS ID: 391910 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Illinois  
Vaccinated:2010-06-09
Onset:2010-06-26
   Days after vaccination:17
Submitted: 2010-06-29
   Days after onset:3
Entered: 2010-07-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 01527 / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALPHAGAN; LIPITOR; ELAVIL; FOSAMAX; LUMIGAN; COSOPT; Calcium
Current Illness: None
Preexisting Conditions: Benadryl (allergy); hypercholesterolemia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None reported - pt. left office without incident - Found 6/26/10 AM-died while sleeping.


VAERS ID: 392434 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Iowa  
Vaccinated:2010-06-24
Onset:2010-06-26
   Days after vaccination:2
Submitted: 2010-07-07
   Days after onset:11
Entered: 2010-07-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Diarrhoea, Malaise, Pain in extremity
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1007USA00139

Write-up: Information has been received from a physician concerning a 90 year old female who on 24-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). The physician reported that on Saturday (26-JUN-2010), the patient complained to a neighbor that she was not feeling well, had diarrhea and arm pain. The physician stated that the patient was found deceased at home on Monday 28-JUN-2010. The cause of death was unknown. The patient did not seek medical attention. Additional information has been requested.


VAERS ID: 392516 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-07-08
Entered: 2010-07-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalopathy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-01
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: WAES1007USA00132

Write-up: Information has been received from a published article, regarding a case in litigation concerning a female patient who in 2004 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Secondary suspect therapy included PNEUMOVAX 23 (Manufacturer unknown) and PEDVAXHIB (Manufacturer unknown), IPV (Manufacturer unknown) and DTAP (Manufacturer unknown). The next day the patient died of a table encephalopathy. The cause of death was encephalopathy. No further information is available.


VAERS ID: 392671 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2009-10-23
Onset:2009-10-23
   Days after vaccination:0
Submitted: 2010-07-13
   Days after onset:263
Entered: 2010-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 978471P1 / UNK UN / IM
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac valve disease, Congestive cardiomyopathy, Death, Dizziness, Feeling abnormal, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (narrow), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-10
   Days after onset: 48
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: Lupus
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On day of vaccination throat was closing up for about 40 minutes after vaccine, then was dizzy for several days after. Stated she didn''t feel good. On 12/4/09 was diagnosed with heart valve damage both mitral and tricuspid and dilated cardiomyopathy. Was admitted to CCU on 12/10/09 and died. Had H1N1 vaccine on 10/23/09.


VAERS ID: 393036 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Illinois  
Vaccinated:2010-07-13
Onset:2010-07-15
   Days after vaccination:2
Submitted: 2010-07-16
   Days after onset:1
Entered: 2010-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3535AB / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E46124 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1612Y / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-15
   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: None
Current Illness:
Preexisting Conditions: Congestion - was referred to ENT
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated


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: 393137 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Georgia  
Vaccinated:2010-06-23
Onset:2010-06-24
   Days after vaccination:1
Submitted: 2010-07-09
   Days after onset:15
Entered: 2010-07-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3682AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E60221 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 03012 / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-24
   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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient with SIDS event after shots. Unsure if shots related or if coincidence. Autopsy reportedly (-).


VAERS ID: 393479 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: Indiana  
Vaccinated:2010-02-24
Onset:2010-03-01
   Days after vaccination:5
Submitted: 2010-07-22
   Days after onset:142
Entered: 2010-07-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 06324 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-17
   Days after onset: 107
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: Haemodialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1007USA01293

Write-up: Information has been received from a registered nurse concerning a haemodialysis male patient who in approximately July 2005 was vaccinated with the first dose of PNEUMOVAX 23. In March 2010 the patient received the second dose of PNEUMOVAX 23 but may have possibly be given 1 ml dose instead of 0.5 ml intramuscularly. The nurse also reported that the patient was helping his son move and was lifting heavy objects when he died at the end of June 2010 (Date unknown). The registered nurse thought that the cause of death on the certificate stated cardiac problems, but was unsure since she did not have the medical records at the time of the report. Additional information has been requested.


VAERS ID: 393575 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2008-08-08
Onset:0000-00-00
Submitted: 2010-07-23
Entered: 2010-07-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02499B1

Write-up: Information has been received from a consumer concerning her daughter, who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular while she was 2 months pregnant. The consumer stated her daughter was almost five and a half to six months pregnant when she started having pains in her side, went to the doctor and was told everything was ok and went home. The next week her pains started again and then felt like contractions, and when she went to the doctor she was already dilated around four or more centimeters and they couldn''t stop her contractions. The consumer reported that the baby was born and then died (No further details provided). The mother''s experience is reported in WAES 0810USA02499. Upon internal review, preterm labor was determined to be an other important medical event. Additional information has been requested.


VAERS ID: 393620 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Male  
Location: Virginia  
Vaccinated:2009-07-21
Onset:0000-00-00
Submitted: 2010-07-26
Entered: 2010-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3506AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C6543 / 1 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1487X / 1 MO / PO

Administered by: Unknown       Purchased by: Other
Symptoms: Crying, Death, Diarrhoea, Eating disorder, Infantile spitting up
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-08-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: High pitch crying, frequently spitting up, direahea, and eating pattern wasn''t regular.


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: 393972 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Female  
Location: Massachusetts  
Vaccinated:2010-07-26
Onset:2010-07-28
   Days after vaccination:2
Submitted: 2010-07-29
   Days after onset:1
Entered: 2010-07-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1456Y / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-28
   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: Small for gestational age; 6# 10oz @ time of vaccination
Allergies:
Diagnostic Lab Data: unavailable/ME report pending
CDC Split Type:

Write-up: Unexpected death after sudden cardiorespiratory arrest.


VAERS ID: 394031 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Female  
Location: New Jersey  
Vaccinated:2009-12-08
Onset:2010-05-04
   Days after vaccination:147
Submitted: 2010-07-29
   Days after onset:86
Entered: 2010-07-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D75886 / 4 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Drug ineffective, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-07
   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: Concomitant medications were not reported.
Current Illness: Unknown
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USWYEH16388910

Write-up: Information regarding PREVNAR was received from a healthcare professional regarding a 17-month-old female patient who experienced pneumococcal meningitis/drug ineffective. At 12 months of age, the patient received the fourth dose on 08-Dec-2009. On 04-May-2010, the patient developed pneumococcal meningitis. Treatment included (unspecified) intravenous antibiotics. On 07-May-2010, the patient died. The cause of death was reported as meningitis pneumococcal. No additional information was available at the time of this report.


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: 395175 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Maryland  
Vaccinated:2010-08-09
Onset:2010-08-10
   Days after vaccination:1
Submitted: 2010-08-13
   Days after onset:3
Entered: 2010-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B054BA / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood cholesterol increased, Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood phosphorus increased, Blood thyroid stimulating hormone normal, Blood triglycerides increased, Convulsion, Cyanosis, Death, Haematocrit normal, Haemoglobin normal, High density lipoprotein decreased, Low density lipoprotein increased, Platelet count increased, Respiratory arrest, Resuscitation, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-10
   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: Furosemide, spironolactone, folic acid, lansozaprole, metoprolol, lactulose, pancrease, thiamine, multivitamins
Current Illness: no acute illnesses at time of vaccination
Preexisting Conditions: Alcoholic cirrhosis, stable and relatively asymptomatic (ascites resolved, normal albumin, no edema, elevated alk phos) Hyperlipidemia, Smoker BMI 17
Allergies:
Diagnostic Lab Data: June 2010: WBC 13 H/H 12.5/37, plat 436,000 creat 0.6, glu 83, magn 1.7, phosph 4.7 Alk phos 252, bili 0.8, AST 23 ALT 14, TSH 2.1, Albumin 3.7 March 2010: Chol 409 LDL 342, HDL 33, TG 168
CDC Split Type:

Write-up: Pt had been on an outing to the city with family, returned home, sat on couch, had a seizure, then respiratory arrest, pt turned blue, husband administered cpr, but she died.


VAERS ID: 395200 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Idaho  
Vaccinated:2010-08-09
Onset:2010-08-13
   Days after vaccination:4
Submitted: 2010-08-13
   Days after onset:0
Entered: 2010-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3578AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E49136 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none at time of vaccine
Current Illness: none noted
Preexisting Conditions: possible left ear hearing loss. ABR on 7-20-10 interpreted as normal for age with re-evaluation in 6 months recommended
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found dead in crib by mother.


VAERS ID: 396820 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Wyoming  
Vaccinated:2010-08-25
Onset:2010-08-26
   Days after vaccination:1
Submitted: 2010-08-30
   Days after onset:4
Entered: 2010-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B193AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF747AB / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E46123 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0772Y / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient received 1st Hep-B at birth, with no known adverse events.
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None


VAERS ID: 396858 (history)  
Form: Version 1.0  
Age: 1.02  
Sex: Female  
Location: Texas  
Vaccinated:2008-08-27
Onset:2008-09-09
   Days after vaccination:13
Submitted: 2010-08-30
   Days after onset:720
Entered: 2010-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0492 / 1 LL / SC

Administered by: Unknown       Purchased by: Other
Symptoms: Brain oedema, Computerised tomogram abnormal, Death, Diarrhoea, Lethargy, Nasopharyngitis, Nuclear magnetic resonance imaging abnormal, Plasminogen activator inhibitor increased, Pyrexia, Thrombosis, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-09-23
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: bronchiolitis~DTaP (no brand name)~3~0.33~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Plasminogen Activator Inhibitor was over 1000 (should be less than 25). This was not a genetic blood clotting problem.
CDC Split Type:

Write-up: Minor cold for about a week and a half. Then a fever started on 9-19-08. Doctor visit/urgent care the next day on 9-20-08, doctor found nothing wrong. Urgent care and ER on 9-21-09 after an episode of shaking and a higher fever. Vomiting at urgent care. IV was inserted at urgent care. Diarrhea started after IV. Ambulance to the ER. Extreme lethargy. Spinal tap. Doctors weren''t sure what was wrong. A CT scan around midnight (Sunday night) didn''t find anything wrong. Second CT scan on 9-22-08 found swelling on the brain. MRI later on 9-22-08 found a blood clot. Our daughter died on 9-23-08. We were told by two specialists that it was vaccine-related, but they wouldn''t tell us more.


VAERS ID: 397045 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2010-06-14
Onset:2010-06-15
   Days after vaccination:1
Submitted: 2010-08-30
   Days after onset:76
Entered: 2010-08-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0152Z / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Balance disorder, Confusional state, Death, Dyspnoea, Fall, Heart rate increased, Intensive care, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-07-06
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: SEE ATTACHED
Current Illness:
Preexisting Conditions: DIABETES; A-FIB; RENAL PROBLEMS; PACEMAKER
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: June 15 and 16 weakness, unsteadiness - June 17 weakness, falling, fever, fast heartbeat, confusion - June 18 same as above and difficulty breathing (on June 18 20:00 AM put in ICU in critical condition).


VAERS ID: 397123 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2007-07-31
Onset:2010-06-06
   Days after vaccination:1041
Submitted: 2010-09-01
   Days after onset:87
Entered: 2010-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB179AA / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2388AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacteraemia, Cardiac failure, Culture positive, Neisseria test positive, Renal disorder
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: 2010-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisone 60 mg every other day at time of illness (unknown if taking at time of vaccination)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neisseria meningitidis serogroup Y isolated from blood, confirmed by culture (collection date: 6/8/2010)
CDC Split Type:

Write-up: Primary bacteremia, complications resulted in heart failure. (Note: Patient was on 60 mg prednisone every other day for kidney problems.)


VAERS ID: 397437 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-02
Entered: 2010-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: WAES1008USA04132

Write-up: Information has been received from a physician that he heard from a parent of one of his patients who also heard from elsewhere concerning a female who was vaccinated with a 0.5ml dose of GARDASIL, IM. "Some time passed, then she died". The cause of death was not reported. The patient received unspecified medical attention. Died was considered to be disabling and immediately life-threatening. No further information is available.


VAERS ID: 397525 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-02
Entered: 2010-09-07
   Days after submission:5
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: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201004682

Write-up: Initial report was retrieved from scientific literature on 31 August 2010; with additional information received on 02 September 2010 from online news report. According to the two literature citations previously noted the objective was to report the occurrence and characteristics of Guillain-Barre syndrome (GBS) after administration of H1N1 vaccine in 2009. The method used the data from the Vaccine Adverse Event Reporting System supplemented by additional data from the center for biologics and research under the Freedom of Information Act. All data was reviewed by a neurologist certified in neuromuscular diseases to confirm the diagnosis of GBS. The data excluded GBS cases that occurred within two days after vaccination. The results were as follows: Thirty five cases (mean age 36.6 +/- 22.5 years; 14 were men) of GBS were reported after administration of H1N1 influenza vaccination, with an estimated occurrence of 3.5 per 10 million vaccinations. All cases of GBS except one were reported within six weeks of vaccination, with 23 cases reported within the first two weeks after vaccine administration. Twenty three of the GBS cases (65.7%) were reported in the first two weeks after vaccination with maximum occurrence in the second week. One report of death and one of disability were reported in the 33 patients who were hospitalized. In 2009, 57 patients were diagnosed with GBS after vaccination with the seasonal influenza vaccine with an estimated occurrence of 7.3 per 10 million vaccinations. The time period of occurrence was similar to that reported for GBS cases after H1N1 influenza vaccination. Documents held by sender: None.


VAERS ID: 397858 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Unknown  
Vaccinated:2010-01-11
Onset:2010-05-18
   Days after vaccination:127
Submitted: 2010-09-09
   Days after onset:114
Entered: 2010-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2932AA / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Death, Eosinophilic myocarditis, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-18
   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
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: not known
CDC Split Type:

Write-up: Acute Necrotizing Eosinophilic Myocarditis. Patient died at home.


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: 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: 399078 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: New Hampshire  
Vaccinated:2010-02-26
Onset:0000-00-00
Submitted: 2010-09-21
Entered: 2010-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB8183A / 1 UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Death neonatal, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH10003

Write-up: SIDS baby: unexpected death at 6 weeks.


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: 401356 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: North Carolina  
Vaccinated:2010-09-27
Onset:2010-09-28
   Days after vaccination:1
Submitted: 2010-09-30
   Days after onset:2
Entered: 2010-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B249AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1486Y / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 913964 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0767Z / 1 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Blood test, Cardio-respiratory arrest, Chest X-ray, Computerised tomogram head, Electroencephalogram, Endotracheal intubation, Resuscitation, Skeletal survey, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (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), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: nasal congestion for 1 week
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: Head CT, Bone survey, blood work, EEG, Chest x-ray. Patient remains hospitalized and undergoing tests.
CDC Split Type:

Write-up: Patient was found unresponsive, EMS brought to ER in full cardiopulmonary arrest. CPR was given and patient intubated and sent to hospital.


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: 402154 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2005-09-08
Onset:2010-04-21
   Days after vaccination:1686
Submitted: 2010-10-06
   Days after onset:168
Entered: 2010-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1589AA / 1 RA / UN

Administered by: Other       Purchased by: Public
Symptoms: Blood test abnormal, CSF test abnormal, Death, Diarrhoea, Endotracheal intubation, Hypotension, Nausea, Neck pain, Neisseria test positive, Pyrexia, Sepsis, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-04-22
   Days after onset: 1
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:
Current Illness:
Preexisting Conditions: Lupus
Allergies:
Diagnostic Lab Data: Blood & CSF collected 4/21 were positive for N. meningitidis. Blood isolate was identified as serogroup Y.
CDC Split Type:

Write-up: 4/21 daytime - nausea, vomiting, diarrhea, fever & neck pain. 4/21 10:29PM At hospital ED - febrile, appearing septic & hypotensive & had tachycardia. 4/21 11:34 PM Intubated. 4/22 12:36AM Pronounced dead.


VAERS ID: 402744 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Washington  
Vaccinated:2010-09-16
Onset:2010-09-20
   Days after vaccination:4
Submitted: 2010-10-04
   Days after onset:14
Entered: 2010-10-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3715AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBNB803AB / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E55894 / 1 RL / IJ
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0595Z / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per police report, pt was found deceased in parents bed, in prone position. Vaccines were given 4 days prior to death. No complications occurred in Dr office on that day.


VAERS ID: 403696 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2010-06-28
Onset:2010-06-29
   Days after vaccination:1
Submitted: 2010-10-17
   Days after onset:110
Entered: 2010-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Public       Purchased by: Other
Symptoms: Asthenia, Brain death, Cerebrovascular accident, Colitis, Death, Extubation, Incontinence, Intracranial pressure increased, Pyrexia, Sepsis, Transfusion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-08-14
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: My father had lung disease at the time of vaccination. His lungs were filled with mucus and he could not breathe properly.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My father developed high fevers a day after the forced Pneumonia vaccine was given to him. This was given to him without asking our authorization or making us sign any kind of paper. He begun to go on himself constantly and we were told he developed Colitis, which he did not have. He also was given blood transfusions constantly because they told us he was weak and he would have benefited from the transfusions. A week after receiving the Pneumonia Vaccine he had a massive stroke. Nothing was done to diagnose and prevent it. The doctors who kept on coming in said that he was very very sick and everyone was shaking their heads. When we saw how badly he was doing we even asked what they did to him? His personal physician said he was given a Pneumonia Vaccine which was very, very good! This is what he told us and he quickly walked out of the room. On July 27th he was moved to Meadowlands Hospital in Secaucus. After they moved him to Meadowlands Hospital a doctor asked me, why they did not operate on his brain to relieve the pressure and stop the stroke. We were told he did not have colitis, but Sepsis. His blood stream had become completely poisoned. He died on August 14th, two days after we pulled the breathing tube away from him because they told us he was brain dead and there was no hope that he would ever come out of it.


VAERS ID: 403759 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2010-09-09
Onset:2010-09-17
   Days after vaccination:8
Submitted: 2010-10-15
   Days after onset:28
Entered: 2010-10-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0568Z / UNK RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1778Y / UNK RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR UA3058AA / UNK LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3476AA / UNK LA / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Death, Malaise
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-09-20
   Days after onset: 3
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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Mother called me on 9-17-10 afternoon that her son is sick and feeling very weak. I recommended the mother to take him to nearest ER as the patient was about 50 miles away and mother took him to ER where he was transferred to another hospital.


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: 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: 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: 404478 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Utah  
Vaccinated:2009-10-19
Onset:0000-00-00
Submitted: 2010-10-20
Entered: 2010-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500779P / 1 NS / IN

Administered by: Public       Purchased by: Private
Symptoms: Death, Fatigue, 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: 2009-11-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Medical examiner said client died of myocarditis. Attributed to a recent viral infection. Patient had not had any known infections prior.
CDC Split Type:

Write-up: A couple weeks after receiving the H1N1 Flumist, client complained of being tired and felt tired "all the time".


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: 405388 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-10-25
Entered: 2010-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 3 UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Dyspnoea, Endotracheal intubation, Hypotension, Immunisation reaction, Injection site erythema, Injection site pain, Injection site swelling, Mechanical ventilation, Pyrexia, Resuscitation
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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1010USA02230

Write-up: Information has been received from a physician and a consumer''s family concerning an 88 year old "healthy" female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (MSD) and a third dose of PNEUMOVAX 23 (MSD). The consumer received ZOSTAVAX (MSD) and PNEUMOVAX 23 together and "almost immediately" experienced swelling, pain and redness at the injection site (unspecified site). The consumer then had difficulty breathing and was hospitalized. The consumer developed a low grade fever. The consumer was then sent home. About 9 hours later the consumer returned to the hospital and had low blood pressure. The consumer arrested but was resuscitated and placed on a ventilator and stabilized. about 6-8 hours later the consumer arrested again but could not be resuscitated. The consumer died and the cause of death as reported by the physician was "probably a reaction from the vaccines". It was reported that the consumer died 2 days after receiving the vaccines. The consumer previously received PNEUMOVAX 23 in 2008 and 2009. Please reference WAES # 1010USA02427 for the patient''s experiences on PNEUMOVAX 23. Additional information has been requested.


VAERS ID: 405821 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2010-08-30
Onset:2010-09-27
   Days after vaccination:28
Submitted: 2010-10-27
   Days after onset:30
Entered: 2010-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1333Y / 1 UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-09-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness: Cardiac disorder; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA02704

Write-up: Information has been received from a physician concerning a 15 year old male with asthma and "cardiac history" (unspecified) who on 30-AUG-2010 was vaccinated with GARDASIL (Lot number 665607/1333Y). Concomitant therapy included LIPITOR. On 27-SEP-2010 the patient died while playing hockey. The physician reported "awaiting autopsy results". At the time of report no further information was available. The reporter considered death to be life-threatening. A lot check has been initiated. Additional information has been requested.


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: 405998 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-10-28
Entered: 2010-10-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA02400

Write-up: Information has been received from a physician who reported in a magazine article regarding Cervical Cancer and in the article physician stated that "GARDASIL has caused 70 young healthy girls to die right after receiving the vaccine due to neurological problems. CERVARIX is covering three other HPV strains and it has been proven." No further AE information filed. There was no specific patient information, physician information, or date of death for the 70 patients in the article. Neurological problems considered to be immediately life-threatening. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.


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