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VAERS ID: 281033 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-12-21
Onset:2006-12-21
   Days after vaccination:0
Submitted: 2007-06-07
   Days after onset:167
Entered: 2007-06-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Abnormal behaviour, Convulsion, Death, Dyskinesia, Irritability, Lethargy, Muscle tightness
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-24
   Days after onset: 3
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: Unknown
Current Illness: Influenza like illness; Pyrexia; Tremor; Viral infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Reported Cause of Death unknown
CDC Split Type: HQWYE488805JUN07

Write-up: Information regarding Prevnar vaccine was received from a consumer, the mother of a 16-month-old female patient who on 21-Dec-2006, received a dose of Prevnar along with a dose of Hib (manufacturer unknown), a dose of Varivax (manufacturer unknown), and a dose of M-M-R II (Merck Sharp & Dome). On the same day, the patient experienced lethargy, possible seizure, irritability, was not acting normally, had jerky movements and clenched hands. On 22-Dec-2006, the child would not respond and on 24-Dec-2006, the child died. On 21-Dec-2006, the patient with a history of influenza like illness, pyrexia, virus (unspecified) and tremor of hands, was evaluated at the physician''s office for those symptoms and was also administered Prevnar along with Hib, Varivax, and M-M-R II. Later that day, the child was lethargic and experienced a possible seizure, irritability, was not acting normally, had jerky movements and clenched hands. On 22-Dec-2006, child would not respond and was taken to the hospital and placed on life-support for two days. On 24-Dec-2006, the child died. The cause of death was not reported. The reporter stated she "feels that her daughter had an adverse reaction to Prevnar." No additional information was available at the time of this report.


VAERS ID: 282747 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-06-22
Entered: 2007-06-25
   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: WAES0706USA02351

Write-up: Information has been received from a physician who attended a conference that mentioned two patients who were vaccinated with Gardasil. Subsequently the patients died. The cause of death not reported. 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. Additional information has been requested.


VAERS ID: 282860 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Illinois  
Vaccinated:2007-06-25
Onset:2007-06-25
   Days after vaccination:0
Submitted: 2007-06-26
   Days after onset:1
Entered: 2007-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B097AB / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0066U / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B26510A / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0028U / 1 MO / PO

Administered by: Public       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: 2007-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby was found in crib unresponsive by a babysitter. She moved the baby to a couch until EMS arrived. Was placed in the crib at 2pm and found 1 1/2 hrs later. No fever or prodromal symptoms per the ER doctor. Unknown if Tylenol had been given. Was seen by private MD at 10am. 2/26/08 Reviewed autopsy report which states COD as undetermined. Pathologic findings: tox results neg; pulmonary vascular congestion, mild, combined weight of lungs 132 grams; petechiae of lung pleura, mild; no evidence of significant natural disease, injury, active infection, congenital anomaly, malformation metabolic disorders or malignancy.


VAERS ID: 282926 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2007-06-25
Onset:2007-06-26
   Days after vaccination:1
Submitted: 2007-06-27
   Days after onset:1
Entered: 2007-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B115AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 006511 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH BO8679B / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1237F / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-26
   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:
Current Illness: recovered after a viral syndrome
Preexisting Conditions: there is a hystory of cardiac problem;no documentation available.The parent states that baby was followed up by cardiology and the echo exam was normal.
Allergies:
Diagnostic Lab Data: baby was recovering after a viral syndrome;T-98.8;full clinical exam normal the day of immunization.
CDC Split Type:

Write-up: baby was administered the Pediarix,Hib,pcv and Rotavirus;before and after the vaccine administration baby appeared in good health,stable;no adverse effect observed in clinic or home;the next morning,after being fed and put to sleep on his tummy, baby was found unconscious, face down in crib and expired in E.R. 7/3/07 Received vax records which confirm RO lot & dose # as reported. 11/27/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined. Diagnoses included: sudden death of 2 mo old baby boy sleeping prone in bassinet on blanket found face down with anterior fixed lividity on abdomen & surrounding nose & mouth; atrial septal defect, secundum type; 6 fingers on each hand.


VAERS ID: 283066 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-06-18
Onset:2007-06-20
   Days after vaccination:2
Submitted: 2007-06-21
   Days after onset:1
Entered: 2007-06-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B090AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1013F / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08689K / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0940F / 1 MO / PO

Administered by: Public       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: 2007-06-20
   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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Grandmother found baby not breathing after nap around 3:55 pm. EMS notified and CPR began 10 minutes after discovery. Baby transported with CPR in progress. Baby pronounced dead at 4:31 pm. 7/10/07 Received vax records from HD which confirms RO dose & lot # as reported. 10/2/07 Autopsy Report reviewed which states COD as SIDS.


VAERS ID: 283502 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-06-29
Entered: 2007-07-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: [therapy unspecified]
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA03813

Write-up: Information has been received from a physician concerning a 2-month-old patient who was vaccinated with a dose of Rotateq (lot number not provided). Concomitant therapy on that same day included "several other shots" (not further specified). The physician reported that, within 24 hours of vaccination, the patient had bloody stools and within 48 hours died. Upon internal review, bloody stools was determined to be an other important medical event. No further information is available.


VAERS ID: 284014 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Indiana  
Vaccinated:2007-06-19
Onset:2007-06-29
   Days after vaccination:10
Submitted: 2007-07-06
   Days after onset:7
Entered: 2007-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B090BA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0205U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08690A / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0022U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mother answered NO to all screening questions.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Screening questionnaire from Immunizations all answered by mother as no. 8/7/07 Received Death Certificate from HD which reveals COD as positional asphyxia. Received Autopsy Report from Coroner which reveals COD as same w/anatomic findings of pulmonary congestion, edema & petechial hemorrhage; petechial hemorrhages of thymus & heart; mild bilateral facial cheek abrasions; facial plethora; & pericardial effusion. Report indicates patient found face down in bumper of the bed. Manner of death is accidental.


VAERS ID: 284759 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2007-06-21
Onset:2007-06-26
   Days after vaccination:5
Submitted: 2007-07-16
   Days after onset:20
Entered: 2007-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U2059AA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1242F / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0326 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B58845C / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0506U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-26
   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: None reported by mother
Current Illness: None reported by mother
Preexisting Conditions: None reported by mother
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 6/28/07, received report of infant death from Coroner''s Office. 7/17/07 T/C to coroner to request prelim COD: stated as Undetermined. Patient was sleeping in bassinet using pillows & blankets as mattress & was found face down. 8/24/07 Received vax record which confirms RO dose & lot # as reported. 11/6/07 Received death certificate & autopsy report which state COD as undetermined in setting of non-standard (home made mattress) bedding in which patient was placed face down.


VAERS ID: 284994 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Colorado  
Vaccinated:2007-07-12
Onset:2007-07-16
   Days after vaccination:4
Submitted: 2007-07-18
   Days after onset:2
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0757F / 3 LL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0246U / 1 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0431U / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 808681E / 4 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant death. Infant discovered in crib by parents on 7/16/07 expired. No conclusive findings on post. 8/24/07 Received autopsy report which reveals COD as undetermined & manner of death as undetermined.


VAERS ID: 286402 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Arizona  
Vaccinated:2007-07-26
Onset:2007-07-28
   Days after vaccination:2
Submitted: 2007-07-31
   Days after onset:3
Entered: 2007-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1952DA / UNK LA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0618U / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Death, Feeling cold, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: hyperlipidemia, mild bronchiectasis, Chronic Kidney Disease III PMH: osteopenia/ostoporosis; hyperlipidemia; minimal change disease nephrotic syndrome w/acute renal dysfunction, resolved (2005); DJD; chronic loose stools; quit smoking 2004; muscle cramps (using quinine & magnesium); mild bronchiectasis; chronic airway obstruction; pulmonary insufficienty; diastolic heart dysfunction via echocardiogram; bilateral hearing loss & wears hearing aids; IBS & lactose intolerance; mild HTN; anxiety secondary to complicated bereavement of spouse (died 2005); anemia.
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 7/26/07 routine exam, TD & Zostavax immun given, 7/28/2007 reported to family members aches, chills, "can''t get warm", did not contact medical personnel nor feel need to seek emergent care. retrospective report from family member. 7/29/2007found by family member in AM within a few hours after death. 8/3/07 Received pcp medical records which reveal patient seen 7/5 & 7/26 in office for right foot pain, RUQ abdominal pain. X-ray of right foot revealed arthritic changes. US of gallbladder revealed sludge. Labs revealed decreased kidney function c/w chronic kidney disease III. Urine c/s neg. Lipids significantly increased as patient had stopped on her own the statin drug presribed. CXR was WNL w/streaking due to scarring. EKG unchanged from prior tracings revealed right axis deviation & borderline R-wave progression. Last seen by nephrologist 4/06 & was d/c from service due to resolution of condition. Records include vax records which confirm dose & lot #s as reported. 9/11/07 Received Autopsy Report which states COD as hemopericardium w/cardiac tamponade due to acute MI w/cardiac rupture due to arteriosclerotic heart disease. Pathological diagnoses included: I. Arteriosclerotic heart disesae A. Atherosclerosis of coronary arteries w/acute thrombus. B. Acute MI w/cardiac rupture. C. Hemopericardium w/cardiac tamponade. II. Systemic atherosclerosis A. Atherosclerosis of cerebral arteries. B. Atherosclerosis of aorta. III. Nephrosclerosis. IV. Fibroma of ovary. V. Hyperlipidemia by clinical history. VI. IBS by clinical history. VII. Osteoporosis by clinical history.


VAERS ID: 286834 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-07-23
Onset:2007-07-23
   Days after vaccination:0
Submitted: 2007-08-03
   Days after onset:11
Entered: 2007-08-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Aortic rupture, Death, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-23
   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: Oxygen; COUMADIN
Current Illness: Cardiac disorder; Oxygen supplementation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA04690

Write-up: Information has been received from a consumer concerning his friend, a 73 year old male with a "deteriorating heart" and no known allergies who on 23-JUL-2007 at "about 07:30" was vaccinated once SC with a 0.65 mL dose of Zostavax. Concomitant therapy included COUMADIN and oxygen (started "a few days before this happened"). Two hours after vaccination the patient "died from a heart attack when his aorta ruptured." It was reported that the patient was revived with CPR but when the patient got to the hospital the doctor stated that he had "died instantly." There was no product quality complaint involved. No further information was provided. Additional information has been requested. The reporter considered the patient''s to be serious as other important medical events. The patient''s events were also considered serious for death.


VAERS ID: 287884 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: New York  
Vaccinated:2007-06-22
Onset:2007-06-30
   Days after vaccination:8
Submitted: 2007-08-10
   Days after onset:41
Entered: 2007-08-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA00914

Write-up: Information has been received from a physician concerning a 2-month-old male who on 22-JUN-2007 was vaccinated with a 2mL PO dose of Rotateq (Lot # "2028U"). Suspect therapy that day included a dose of HIB conj-hepatitis B vaccine, a dose of PREVNAR, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and a dose of "ITV". On 30-JUN-2007 the patient passed away. CPR was noted. The autopsy medical examiner gave verbal to the mother stating that no cause has been determined. At the time of the report, the physician still did not have the autopsy report. No further information was provided. There was no product quality complaint. The event was considered to be an other important medical event by the reporter. Additional information has been requested.


VAERS ID: 287888 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-05-21
Onset:2007-05-23
   Days after vaccination:2
Submitted: 2007-08-10
   Days after onset:79
Entered: 2007-08-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-23
   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: hormonal contraceptives
Current Illness:
Preexisting Conditions: None 7/2/08-records received-HX of heroin and prescription drug abuse.
Allergies:
Diagnostic Lab Data: autopsy - no findings
CDC Split Type: WAES0708USA00407

Write-up: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified) ("MERCET"). On 23-MAY-2007, the patient died suddenly. The cause of death was unknown. Unspecified medical attention was sought. Laboratory diagnostic studies included an autopsy which showed no findings. No product quality complaint was involved. The reporter stated that Gardasil did not cause the patient''s death. Additional information is not expected. 7/2/08-records received-Adverse effect of drugs.Toxicology survey findings:urine positive for methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine, diphenhydramine and naproxen.


VAERS ID: 287915 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Iowa  
Vaccinated:2007-08-02
Onset:2007-08-06
   Days after vaccination:4
Submitted: 2007-08-13
   Days after onset:7
Entered: 2007-08-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B079BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF117AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B20510B / 1 RL / IM

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: 2007-08-06
   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: None
Current Illness: None
Preexisting Conditions: Preterm Birth HX: mother required 1 mo hospitalization prior to birth & had uterine rupture during delivery. Seen on weekly basis by pcp & HH nurse. Had no signs of illness prior to death.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died 8/6/07 presumed SIDS, autopsy pending. 8/23/07 Received prelim autopsy report from coroner. COD is pending. Patient was 34 wk preemie twin. Mother had been hospitalized x 1 mo prior to delivery for uterine rupture. Patient was on home monitor. Found lying on side co-sleeping w/twin in crib. 10/5/07 Reviewed autopsy report which states COD as SIDS with prone sleeping position; twin gestation & manner of death as natural. Pathologic dx include: premature birth (34 wk), mild right ventricular dilatation and pulmonary edema.


VAERS ID: 288180 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2007-07-17
Onset:2007-07-18
   Days after vaccination:1
Submitted: 2007-08-15
   Days after onset:28
Entered: 2007-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B127AA / 1 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0078U / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08679C / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0578F / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Acidosis, Brain damage, Cardio-respiratory arrest, Culture negative, Intensive care, Pulse absent, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow)

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: TYENOL prescribed
Current Illness: none
Preexisting Conditions: prematurity 31 weeks 12/28/07-records received-31 week premature
Allergies:
Diagnostic Lab Data: Intitial pH=6.8 7/18 8am. All cultures negative 12/28/07-records received- EEG revealed bilateral cerebral dysfunction with right temporal epileptiform activity and no reactivity to stimulation. MRI diffuse cystic change with volume loss.
CDC Split Type:

Write-up: Patient received vaccinations on 7/17 pm. Mother reported no illness or fever. Mother reported normal feeding that evening and in the morning. On 7/18 am, mother reported feeding the baby and then putting in crib after feeding finished. Baby did not move when put in crib and found to be not breathing by mom. 911 called and child was found to be in pulseless arrest. CPR performed for 25 minutes or more before pulse restored in ER. Child has been in PICU with evidence of brain damage since then.


VAERS ID: 288181 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:2007-08-03
Onset:2007-08-09
   Days after vaccination:6
Submitted: 2007-08-14
   Days after onset:5
Entered: 2007-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B114BB / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF018AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B58845E / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-09
   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: Infant Tylenol
Current Illness: NONE
Preexisting Conditions: UMBILICAL HERNIA UNDERWEIGHT
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found August 9,2007 in between both parents unresponsive. 8/17/07 Received call from provider, will not send vax record but read lot #s to check against report. RO dose & lot # correct as reported; however, 2 other lot #s corrected in VAERS database. 9/25/07 Reviewed Autopsy Report which reveals COD as traumatic asphyxia due to entrapment of head between mattress & headboard. Manner of Death: accident.


VAERS ID: 288471 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2007-08-16
Onset:2007-08-17
   Days after vaccination:1
Submitted: 2007-08-20
   Days after onset:3
Entered: 2007-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B114BB / 1 - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0077U / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08700H / 1 - / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0971U / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-17
   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: Infant Tylenol
Current Illness: None
Preexisting Conditions: None Umbilical hernia
Allergies:
Diagnostic Lab Data: Unavailable Autopsy Findings: Acetaminophen level 13 mg/L & CAH 17-OHP level abnormal.
CDC Split Type:

Write-up: Prelim reported that pt''s vomited and gone to respiratory arrest. 8/21/07 Spoke w/MD who states patient was in good health on day of vax. Looked tired but exam was WNL. Family concerned only about umbilical hernia. 8/21/07 Received pcp medical records & vax records which confirm RO dose & lot # as reported. Records indicate patient was in good health on day of vax w/only medical concern umbilical hernia. 3/11/08 Autopsy report states COD as undetermined.


VAERS ID: 288631 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-08-02
Onset:2007-08-06
   Days after vaccination:4
Submitted: 2007-08-21
   Days after onset:15
Entered: 2007-08-22
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-06
   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: Unknown
Current Illness: Cardiac disorder
Preexisting Conditions: Stroke PMH: mitral valve replacement; atrial fibrillation; pacemaker 8/2006; CVA; TIA; well controlled HTN; right cerebellar stroke; dental prophylaxis antibiotics; endometrial cancer; dyslipidemia; osteopenia; hysterectomy; seasonal allergies. Allergic to sulfa & quinidine.
Allergies:
Diagnostic Lab Data: Unknown LABS: last done 7/26/07, CBC & chemistry WNL. Glucose elevated 142. Digoxin WNL. PT/INR therapeutic.
CDC Split Type: WAES0708USA01838

Write-up: Information has been received from a pharmacy technician concerning a 75 year old (previously reported as "about 75 year old") female "in poor health" with heart problems and a history of stroke and other unspecified medical conditions who on 02-AUG-2007 was vaccinated with a dose of Zostavax. For an unspecified amount of time after vaccination the patient was observed for any reaction. The patient then left the pharmacy without any signs of an untoward reaction. Several days later the pharmacy technician read in the paper obituaries that the patient passed away on 06-AUG-2007. The cause of death was not reported. There was no product quality complaint involved. No further information was available. Additional information has been requested. 08/23/2007 Per email from FDA: A 75 y/o female in poor health with heart problem and a hx of stroke died 3 days after receiving Zostavax. Her name was in newspaper obituaries. She did not experience any immediate AEs after vaccination. Called Meck for follow up information including cause of death. 8/27/07 FDA obtained patient name & DOB from Merck. No autopsy was done. COD was intracranial hemorrhage. Merck will provide additional medical records. 9/7/07 Reviewed pcp medical records which reveal patient on chronic anticoagulant therapy for mitral valve replacement & was seen approx every 2 weeks for labs & eval. Weight & vital signs stable. 10/29/07 Reviewed Death Certificate which states COD as subdural hematoma with anticoagulation for valvular heart disease as contributing factor.


VAERS ID: 288632 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-08-21
Entered: 2007-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apraxia, Autopsy, Blood creatinine normal, Blood immunoglobulin G normal, Blood iron increased, Blood pressure, Body temperature, Body temperature decreased, CSF cell count increased, CSF cell count normal, CSF glucose normal, CSF immunoglobulin increased, CSF lymphocyte count, CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Cerebellar syndrome, Ceruloplasmin increased, Chlamydia serology positive, Computerised tomogram abnormal, Computerised tomogram normal, Confusional state, Coordination abnormal, Crying, Cytomegalovirus antibody negative, Death, Dizziness, Electroencephalogram abnormal, Enterovirus serology test negative, Epstein-Barr virus antibody negative, Fall, Feeding disorder, Fungus serology test negative, Gait disturbance, Gliosis, Globulins increased, Headache, Hemiparesis, Herpes simplex serology positive, Hyperreflexia, Hypertonia, Immunoglobulins increased, Incontinence, Iron binding capacity total increased, Lipase increased, Lymphocyte count decreased, Measles, Memory impairment, Meningitis aseptic, Moaning, Monocyte count increased, Movement disorder, Nausea, Neutrophil count increased, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abnormal, Oxygen saturation, Pleocytosis, Polymerase chain reaction, Pregnancy, Pregnancy test positive, Protein albumin ratio, Rubella antibody positive, Serum ferritin decreased, Streptococcus identification test positive, Subacute sclerosing panencephalitis, Transferrin increased, Urine analysis abnormal, Varicella zoster virus serology positive, Venogram normal, Virus serology test, Vomiting
SMQs:, Acute pancreatitis (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown) Pregnancy
Preexisting Conditions: Pregnancy; Termination of pregnancy - elective; Measles; Fall; Head injury, Varicella
Allergies:
Diagnostic Lab Data: head computed axial - slight, diffuse prominence of ventricular system, no intracranial mass or other focal brain lesion, blood pressure - 107/81, magnetic resonance - hyperintense signal in left hippocampus and parhippocampal gyrus, electroencephalography - diffuse theta slowing and frontal intermittent rhythmic delta activity R $gL, venography - head-normal, magnetic resonance - new hyperintense signal in pons and middle cerebellar peduncles with assoc. restricted diffuse, electroencephalography - increase attenuation of background activity and less abundant frontal intermittent delta activity, neutrophil count 72% 40-62, lymphocyte count 21% 27-40, serum creatinine 0.5 mg/d 0.5 - 1.5, serum globulin test 4.2 g/dL 2.6 - 4.1, serum lipase test 7.5U/dL 1.3 - 6.0, total iron-binding 464 ug/d 228 - 428, urine ceruloplasmin 84 mg/d 27- 50, serum ferritin assay 9 ng/d 10-200, serum transferrin test 361 mg/d 188 - 341, serum antistreptolysin 208 IU/m <200, serum protein 1490 mg/d 614 - 1295 IgG, serum herpes simplex - positive, CSF red blood cell 2250/mm3, CSF red blood cell 2438/mm3, CSF white cell count 100/mm3, CSF white cell count 46/mm3, CSF neutrophil count 6%, body temp 36.3 C, CSF lymphocyte count 80%, CSF lymphocyte count 82%, CSF monocyte count 7%, CSF monocyte count 4%, cerebrospinal fluid 100 mg/d 5 - 55, CSF gamma-globulin 38.9 mg/d, cerebrospinal fluid - no organisms, pulse oximetry 100%, CSF VZV IgG Ab - non detected, enterovirus PCR - CSR-non detected, Cytomegalovirus culture - CSR-non detected, Epstein-Barr virus - CSR-non detected, CSR HSV Ab - non detected, serum West Nile virus - CSR-non detected, cerebrospinal fluid - no growth, fungal culture - CSR- no growth, adenovirus PCR - CSR-no growth, enterovirus PCR - CSR- no growth
CDC Split Type: WAES0708USA02565

Write-up: It was report in a published article, title as stated above, that "A 20-year-old pregnant woman was admitted to this hospital at 26 weeks of gestation because of dizziness, confusion, and difficulty walking. Ten weeks before admission, the patient had a positive result on a home pregnancy test and presented to a neighborhood health center for prenatal screening. Tests for sickle cell trait, syphilis, and human immunodeficiency virus (HIV) and hepatitis B and C virus antibodies were negative. Serologic tests for varicella-zoster virus and rubella IgG were positive. Two weeks later, an endocerival specimen was positive for Chlamydia trachomatis infection and negative for gonorrhea. The patient missed follow-up appointments and treatment with azithromycin was initiated 4 weeks later. (She) was happy, with a childlike affect, a poor memory, confusion, and odd movements of her head. During the next 2 weeks, nausea and vomiting occurred daily and were controlled with metoclopramide. Four days before admission, dizziness and weakness on the left side developed; she began to fall to her left and vomited several times. The next day, she went to the ED of another hospital. On evaluation, the patient was oriented to location but not to date, day, or month, and she provided inconsistent information about her medical history. The uterus was gravid, and he remainder of the physical examination was normal. An EKG revealed sinus tachycardia and counterclockwise rotation with T waves in the right precordial leads. Urinalysis showed a protein level of 30 mg per deciliter and a glucose level of 100 mg per deciliter (5.6 mmol per liter). Tricyclic metabolites were present on toxicology screening of a urine specimen. CT scanning of the head revealed a slight, diffuse prominence of the ventricular system. There was no intracranial mass or other focal brain lesion. On the second hospital day, the patient was alert, calm, cooperative, and oriented to person, location, and current events but was not aware of details of her life. There were no tremors or extrapyramidal signs. Ultrasonographic examination revealed normal fetal anatomy and growth, corresponding to a gestation of 25 weeks 6 days. On the third day, the weakness, nausea and vomiting had resolved, and the patient was thought to have returned to her baseline mental status. She was discharged to the shelter with a recommendation to schedule a follow-up neurologic evaluation. At the shelter, she was dizzy, had difficulty walking, and fell into a chair. That evening, she was brought to the emergency department of this hospital. In the emergency department, the patient reported feeling "woozy" and nauseated. She noted a mild headache of gradual onset, extending bandlike across the brow. The history as given by the patient was inconsistent; the history was then provided by staff members of the shelter, and many details were lacking. She had had measles at 4 months of age and varicella infection in childhood. at 7 years of age, she injured her head in a fall but was said to have recovered fully. Immunizations included polio vaccine and diphtheria, pertussis, and tetanus vaccine series; measles vaccine felt (at 11 months of age); measles, mumps and rubella vaccine combination; and hepatitis B vaccine (between 2 and 3 years before admission, on enrollment in high school). She had no known allergies and did not use alcohol, illicit drugs, or tobacco. On examination in the ED, the patient was alert but somewhat uncooperative, with involuntary head movements. Her mental status was not formally assessed, but her level of cognitive function was said by a friend to be at baseline. The abdomen was soft, gravid, and not tender; the fetus appeared to be healthy. The 1st cranial nerve was not tested, and the 2nd through 12th nerves were intact. Strength was intact, and the gait was unsteady. The remainder of the examination was normal. After premedication with lorazepam at a dose of 1 mg to control involuntary movements, MRI of the brain was performed without administration of contrast material. On T2-weighted, FLAIR images, hyperintense signal was seen in the left hippocampus and parahippocampal gyrus as well as in the posterior limb of the left internal capsule. There was no evidence of restricted diffusion. Examination by a neurology consultant showed that the patient was oriented to person and place, with a childlike affect. Her speech was fluent, and naming was intact. She could read a short sentence and do simple addition. She was left-handed, could write her name but not a sentence, and followed simple and complex commands. Her attention was variable, and testing of her memory showed recollection of zero of three items at 5 minutes on repeated examination. Smell and taste were not tested. The function of the other cranial never was intact. There were choreiform movements of the head and neck, poor performance of rapid alternating movements, and apraxia. Hypertonia and hyperreflexia with clonus were noted in the right leg. The gait was wide-based, with postural instability and leaning toward the left. She was unable to stand on one foot. She was admitted to the neurology service. On the second hospital day, a lumbar puncture was performed. An enzyme-linked immunosorbent assay for serum antibodies against HIV was negative. An EEG showed diffuse theta slowing and frontal intermittent rhythmic delta activity, which was more prominent in the right hemisphere than in the left. There was no epileptiform activity. Repeated MRI of the brain after the administration of gadolinium showed no changes and no evidence of abnormal enhancement. Acyclovir was administered IV. The next day, a serum Lyme antibody test, a test of a throat swab for Mycoplasma pneumoniae nucleic acid, and cultures of blood and urine were negative. On the fifth day, the patient''s condition appeared to be improved. She was oriented and remembered details of her past; dysmetria and truncal ataxia were reduced. Results on a repeated EEG were unchanged. The next day, a repeated lumbar puncture was performed. Between the 7th and 18th hospital days, the patient''s motor function gradually worsened, right-sided neglect developed, she became unable to feed herself, her responsiveness and ability to follow commands decreased, and she became incontinent. She began lying in a fetal position, moaning and crying out unintelligible sounds. A skin test for tuberculosis, a test of a nasopharyngeal specimen for respiratory viral antigens, and a viral culture of a stool specimen were negative. Nucleic acid testing for HIV RNA and tests for antinuclear antibodies were negative. Levels of free and total thyroxine were normal, and the thyroglobulin level was elevated (54.7 ng per milliliter). On the 12th day, the acyclovir was discontinued, and ceftriaxone, at a dose of 2 g, was administered IV. A repeated EEG study showed increased attenuation of background activity and less abundant frontal intermittent rhythmic delta activity. MRI on the 13th day showed new hyperintense signal in the pons and middle cerebellar peduncles with associated restricted diffusion of water on T2-weighted FLAIR images. Restricted diffusion was also noted in the posterior limb of the left internal capsule. There was atrophy in the left medical temporal lobe, with resolution of the abnormal hyperintense signal on FLAIR images. On the 14th day, a third lumbar puncture was performed. On the 18th hospital day, a test result was received. The patient lived semi-independently until she became pregnant 27 weeks before admission. Her level of function at that time was unknown, and because of the lack of information, it was not possible to determine either her level of function before her illness or the tempo of her disease. This patient''s neurological examination showed abnormal cognitive function indicating dysfunction of the cortical and subcortical gray matter, abnormal motor function indicating dysfunction of the pyramidal motor system, and choreiform movements indicating dysfunction of the extrapyramidal motor systems. This examination also showed a clumsy gait and difficulty performing rapid alternating movements, indicating dysfunction of the cerebellum or its connections. The results of the cerebrospinal fluid analysis in this patient showed a lymphocytic pleocytosis with few red cells, a mildly elevated protein level, and a normal glucose level. These findings are characteristic of aseptic meningitis. Although they were nonspecific, the cerebrospinal fluid findings provide support for the possibility of acute or subacute infection or inflammatory illness. The presence of an inflammatory response made chronic degenerative disease such as Huntington''s disease, Wilson''s disease and systems abiotrophies such as multisystem atrophy unlikely. The initial EEG was markedly abnormal, but the findings were nonspecific. The slow and attenuated posterior dominant rhythm suggests cortical gray-matter disease, whereas the intermittent frontal rhythmic delta activity suggests subcortical gray-matter disease. The monomorphic slow waves also suggest that initially the subcortical white matter was relatively spared. Axial T2-weighted FLAIR images from the MRI studies of the brain on the day of admission, performed without the administration of gadolinium, revealed a region of hyperintense signal in the left medical temporal lobe and subtle increased signal in the posterior limb of the left internal capsule corresponding to the location of the cortispinal tract. These foci did not show restricted diffusion or abnormal enhancement on a gadolinium-enhanced study performed the next day. The appearance of the pons was unremarkable, and no other clinically significant findings were noted. Magnetic resonance venography of the head was normal. By day 13, there had been marked changes. There was a region of abnormal signal in the pons, with areas of restricted diffusion on the diffusion-weighted image and apparent-diffusion-coefficent maps. The hyperintensity of the left medial temporal lobe had resolved, and there was volume loss in the region of the hippocampal formation. There was restricted diffusion in the left corticospinal tract; no abnormal enhancement was detected. These findings were interpreted as resulting from a subacute encephalitis caused by an infection or an autoimmune disorder. In summary, this patient has a disturbance of cognitive function, pyramidal tract and cerebellar dysfunction, and a choreiform-movement disorder, and both laboratory tests and EEG and imaging studies suggest an infectious or autoimmune encephalitis. This patient had only a minimally elevated antistreptolysin-antibody titer, with no other evidence of recent streptococcal infection or cardiac disease. The antiphospholipid-antibody syndrome2 may be primary or secondary to systemic lupus erythematosus, and it may become manifest during pregnancy. This patient had no symptoms or signs of systemic lupus. antiphospholipid-antibody testing and all laboratory studies for lupus were negative. Herpes simplex encephalitis was initially considered as one of the acute infectious encephalitis because of the abnormality detected in the left hippocampus on MRI. The negative results on cerebrospinal fluid testing for herpes simplex virus nucleic acid and the lack of response to acyclovir made this diagnosis unlikely. This patient''s clinical and cerebrospinal fluid findings were not consistent with paraneoplastic encephalitis. This patient did not have a recent history of immunizations or a viral infection or evidence of optic neuritis, and the imaging findings were not typical of acute disseminated encephalomyelitis. The cerebrospinal fluid findings were an important clue to the diagnosis in the case. Although the protein level in the initial cerebrospinal fluid specimen was modestly elevated, the IgG component was markedly elevated. Cerebrospinal fluid levels of total protein, albumin, and IgG obtained on the second hospital day are shown. Agarose-gel electrophoresis of cerebrospinal fluid revealed oligoclonal bands in the gamma region. The cerebrospinal fluid to serum mass concentration quotients for albumin and IgG concentrations were QA1b=4.7x10-3 and QIgG=26.1x10-3, corresponding to an IgG index of 5.6. On the basis of an analysis developed by Reiber, this patient''s results indicated markedly increased intrathecal IgG synthesis (intrathecal production fraction, 87.7%) without evidence of clinically significant blood-brain barrier dysfunction. The mass concentration ratio of IgG to total protein in the cerebrospinal fluid was 58.9%. This patient did not have syphilis, as shown by negative results on serologic testing and a symptom complex that was inconsistent with the disease. Examination of the cerebrospinal fluid shows pleocytosis and a moderately elevated protein level, with up to 50% of the cerebrospinal fluid protein composed of immunoglobulins. The diagnosis is confirmed by a high antirubella-antibody titer in the cerebrospinal fluid. In summary, this patient presented with a subacute progressive neurologic disease characterized by widespread dysfunction of the central nervous system, inflammatory features in the cerebrospinal fluid, and an extremely high level of cerebrospinal fluid IgG. My colleagues and I favored the diagnosis of subacute sclerosing panencephalitis, a delayed consequence of her infection with measles at 4 months of age. This condition may have been exacerbated by her pregnancy. Specimens of serum and cerebrospinal fluid from the 14th hospital day were sent for testing for levels of antibodies against measles. The measles-specific cerebrospinal fluid to serum IgG antibody index was elevated at 31.8. Measles-specific IgM antibodies were not detected in the serum. This profile indicates a chronic immune response to measles infection in the cerebrospinal fluid compartment. The results confirm the diagnosis of subacute sclerosing panencephalitis in the patient. The disease was a late consequence of persistent infection with measles virus. When we made the diagnosis in this patient, she was 28 weeks of gestation, and her condition was deteriorating rapidly. We believed that an attempt at treatment was in the best interest of the patient and her fetus. We treated her with interferon and inosine pranobex for 8 weeks, without any clear clinical benefit. After the delivery of a healthy baby by elective cesarean section at 34 weeks gestation, a decision was made to discontinue treatment with the consent of the patient''s mother. The patient died 6 weeks later. The autopsy revealed inflammatory infiltrates containing macrophages, plasma cells, and lymphocytes around vessels, with neuronal destruction and reactive gliosis that were most prominent in the brain stem. No viral inclusions of the type usually seen in acute measles encephalitis were seen in the nuclei or cytoplasm of any cell types (neurons, glia, or vascular endothelial cells). In the cerebral cortex, neuronal populations were perserved, but there was marked gliosis with reactive astrocytes. The brain stem was softened by the pathologic process, but the hemispheric white matter was firmer than normal; this was most evident when the brain was cut in the fresh state. This firmness corresponds to the sclerosis in the name, subacute sclerosing panencephalitis. The subcortical white matter also showed reactive gliosis and extensive microglial activation. These findings are nonspecific, but together with the serologic studies, they are consistent with a diagnosis of subacute sclerosing panencephalitis. Immunohistochemical analysis for measles virus nucleoprotein antigen was negative. Molecular diagnostic studies performed to detect portions of the measles genome were negative in repeated attempts at amplification of regions of the measles nucleoprotein gene. Weak signals were detected in a real-time reverse-transcriptase-polymerase-chain-reaction assay, but there were insufficient amounts of amplified DNA product to perform a sequence analysis. As a result, it was not possible to definitively establish the presence of measles virus in this case. Two years before admission, the patient was seen in the emergency department of another hospital because of an episode of loss of consciousness that was associated with rolling of the eyes and arching of the back. On examination, there were intermittent involuntary movements of the head and neck and jerking movements of the arms. Deep-tendon reflexes were brisk and symmetric. CT scanning of the head and an electroencephalogram were normal. Further testing showed an early pregnancy, which was electively terminated. During the next 20 months, the patient was lost to medical follow-up, and it is not known whether the abnormal movements stopped. Anatomical Diagnosis: Subacute sclerosing panencephalitis secondary to measles virus infection. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 288921 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Iowa  
Vaccinated:2007-08-21
Onset:2007-08-23
   Days after vaccination:2
Submitted: 2007-08-24
   Days after onset:1
Entered: 2007-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B127AA / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF117AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B26510B / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none - had been in ER 8/1 + 8/2 for pharyngitis + upper resp infection
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: See ER notes attached
CDC Split Type:

Write-up: See ER notes attached. 11/27/07 Reviewed autopsy report which states COD as encephalomyelitis due to enterovirus (EV 71) & manner of death as natural. States history as: found supine in crib, unresponsive; no recent illness; no previous medical history;brain swelling; SDH, minimal; SAH, bilateral; microglial clusters, neuronal loss, neuronophagia & mild perivascular lymphocytic infiltrate w/gliosis in keeping with a viral poliomyelitis.


VAERS ID: 289100 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Illinois  
Vaccinated:2007-08-23
Onset:2007-08-24
   Days after vaccination:1
Submitted: 2007-08-27
   Days after onset:3
Entered: 2007-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B115AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0077U / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B53981A / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0508U / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Developmental delay, Failure to thrive
SMQs:, Neonatal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-25
   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:
Current Illness: none
Preexisting Conditions: Microcephalus, underweight BIRTH HX: 38-wk emergency c-section due to deceleration, nuchal cord & decreased amniotic fluid. 6 days in NICU. Parents are 1st cousins (+ consanguinity). Had 5yo sibling deceased w/similar s/s & seizure disorder, apnea & flat head.
Allergies:
Diagnostic Lab Data: LABS: MRI at birth showed areas of hypoplasia of corpus callosum. Echocardiogram done during resuscitation revealed very wide QRS & bradycardia which progressed to EMD w/o any mechanical cardiac funation. Abdomen KUB revealed nonspecific nonobstructive bowel gas patter w/paucity of small bowel gas. CXR WNL. Blood c/s (+) for bacillus species but may have been contaminant.
CDC Split Type:

Write-up: Patient died two days after receiving vaccines. Infant had multiple problems including failure to thrive, and developmental delays. Was admitted with complete heart block. 8/28/07 Spoke w/the reporter on this case who will provide medical records from clinic & hospital as well as a copy of the Death Certificate. No autopsy was done. Reporter stated this child had multiple medical problems & was being followed by several clinic specialists including geneticist. Sibling of this child also had multiple problems & expired at unknown time. 9/7/07 Reviewed medical records & Death Certifiate from reporter. COD stated as complete heart block w/microcephaly & failure to thrive as contributing factors. Vax record confirms dose & Lot # of all vax as reported. Had microcephaly, hypertonia & contractures of UEs noted on d/c from birth hospital. Referred by birth hospital to Easter Seals for developmental therapy eval 7/07. Medical records show that on day of vax had cough & sneeze along w/very slow feeding & poor growth noted. Referred for feeding eval. PCP records indicate patient on home monitor. Neuro, Genetic & Cardio consults. Very slowly gained weight & remained significantly underweight. Genetics eval done 7/07. Developmental delay. Cardiac consult on day of death reveals patient admitted 8/24 for diarrhea & poor feeding then developed slow heart rate & complete heart block. FINAL DX: complete heart block, microcephaly & failure to thrive.


VAERS ID: 289148 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Alabama  
Vaccinated:2007-08-01
Onset:2007-08-02
   Days after vaccination:1
Submitted: 2007-08-28
   Days after onset:26
Entered: 2007-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B129AA / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF117AA / 1 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08690K / 1 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 12 hr after receiving the vaccine-baby found dead in hotel bed next to his mother Autopsy Dx: SIDS. 8/31/07 Received vax record from pcp which confirm dose & lot as reported. 1/15/08 Reviewed autopsy report which states COD as Undetermined. Found dead in bed. Findings at autopsy included: SIDS; petechial hemorrhages of thymus & pleura; pulmonary edema & congestion; cerebral edema; & patent ductus arteriosus.


VAERS ID: 289543 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2007-08-09
Onset:2007-08-10
   Days after vaccination:1
Submitted: 2007-08-13
   Days after onset:3
Entered: 2007-08-31
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B124AA / 1 RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0077U / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B540138 / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1238F / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Diet refusal, Gaze palsy, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-10
   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: Nystatin suspension
Current Illness: thrush, oral umbilical hernia
Preexisting Conditions: sickle-cell trait
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per ER call to on call physician 8/11. Last night he stopped feeding and then his eyes rolled back and he stopped breathing. 911 called and CPR initiated. Coded for 1-1/2 hours (paramedics and ER) without success. 9/4/07 Received pcp medical records which included vax record which confirmed RO dose & lot #s as reported. Office note of 8/9 indicates well child visit on day of vax excep for thrush & umbilical hernia. 1/8/08 Reviewed autopsy report which states COD as sudden unexplained infant death syndrome due to dilated cardiomyopathy & primary endocardial fibroelastosis, dilated form.


VAERS ID: 289874 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: California  
Vaccinated:2007-07-18
Onset:2007-08-15
   Days after vaccination:28
Submitted: 2007-09-05
   Days after onset:21
Entered: 2007-09-05
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: 2007-08-15
   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:
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject in pneumococcal vaccine trial died approximately one month after vaccination alone in his home. Cause unknown. No autopsy. 1/18/08 Received death certificate which states COD as hypertensive cardiovascular disease & COPD as contributing factor.


VAERS ID: 290566 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: California  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-09-12
   Days after onset:7
Entered: 2007-09-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2650AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR A0122 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0872 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B97283B / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Reporter denied the patient had any illnesses, pre-existing medical conditions, use of other medications, or any adverse events following prior vaccinations at the time of the vaccinations on 05 September 2007. It was reported the patient had no known allergies. No vaccines were administered within four weeks prior to the vaccinations on 05 September 2007.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200703071

Write-up: Initial report received on 10 September 2007 from a health care professional. A four-month-old infant with no concurrent illnesses, no known allergies, and who had no pre-existing medical history, had received a second intramuscular dose of ActHib, lot number UF160AA (Sanofi Pasteur SA lot number A0122-2) in the left thigh; a second intramuscular dose of Daptacel, lot number C2650AA in the right thigh; a second intramuscular dose of IPOL, lot number Z0872-2 (reported as Z0872), in the right thigh; and a second intramuscular dose of Prevnar (manufacturer Wyeth), lot number B97283B, in the left thigh. The patient had not experienced any adverse events following prior vaccinations. Later that evening the patient was "found expired." Reportedly, an autopsy will be completed. 3/19/08 Reviewed autopsy report which states COD as complications of congenital pulmonary malformation. 3/19/08 Autopsy states pathologic diagnoses as: I. Congenital Pulmonary malformation with A. Microscopic characteristics most c/w congenital cystic adenomatoid malformation, Type I B. lymphocytic & macrophage peri-bronchial inflammation, mod to marked C. Intraalveolar hemorrhage, marked D. pulmonary edema, marked III. Abnormal 17 hydroxyprogesterone study w/o microscopic abnormality of adrenal glands.


VAERS ID: 290655 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2007-08-30
Onset:2007-09-11
   Days after vaccination:12
Submitted: 2007-09-14
   Days after onset:3
Entered: 2007-09-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Musculoskeletal stiffness, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC Split Type: HQWYE111312SEP07

Write-up: This is a 7-day report. This case was unblinded, the patient received Prevnar. Information regarding Prevnar was received from an investigator regarding a 2-month-old male participant in a study who experienced death. The participant received the first dose on 30-AUG-2007. On 11-Sep-2007, the patient was found in the crib at Day Care on his back, unresponsive, blue and not breathing. Day Care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response. Upon emergency medical response arrival , the child was noted to be apneic and pulseless. The patient was intubated without difficulty and cardiopulmonary resuscitation was continued. An intraosseous line was placed in the left lower extremity that was infusing well. A total of 4 doses of epinephrine were given without any response. The child remained apneic and pulseless. Upon arrival to the emergency room the child had blood pooling on the posterior back and neck area. On physical examination pupils were fixed at approximately 2-3 mm. bilaterally and no pulse was noted. The physician also noted hypothermia and stiffness. The patient was pronounced dead at 12:42 in the afternoon at the hospital. The cause of death was reported as unknown. The parents reported the child had been completely healthy up to this point. No additional information was available at the time of this report. The investigator(s) considered death possibly related to the study product. The medical monitor(s) considered death not related to the study product because temporal relationship 12 days after vaccination does not suggest causal relationship.


VAERS ID: 290672 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Arkansas  
Vaccinated:2007-03-22
Onset:2007-03-23
   Days after vaccination:1
Submitted: 2007-04-05
   Days after onset:13
Entered: 2007-09-17
   Days after submission:165
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B090AA / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF084AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08691E / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Choking, Cough, Death, Pneumonia viral
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-23
   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: Unknown
Current Illness: No fever/playful/happy
Preexisting Conditions: None Had been seen hospitalized 3/15-3/19/2007 w/RSV pneumonia. Worsened 3/22/07 & taken back to ER where she arrested.
Allergies:
Diagnostic Lab Data: Infant had been hosp 3-17-07/3-19-07 with dx of viral pneumonia according to mother.
CDC Split Type: AR0730

Write-up: Mother stated "gave breathing medicine to my baby at 5 PM Friday and baby began to choke and cough. Took baby to the ER and she died at midnight." 9/25/07 Reviewed medical records provided by reporter which reveal patient in good health on day of vax. Admitted to ER on 3/22/07 w/difficulty breathing & vomiting. Family noted hospitalization x 5-6 days for RSV bronchiolitis & d/c 3 days prior to ER visit. Tx w/nebs & supplemental O2 w/initial improvement but then worsened again. Mottled cool skin w/sluggish cap refill, tachycardic, prolonged expiratory phase respiration, tracheal tugging, intercostal & subcostal retractions, fever 105. Multiple attempts to establish IV access & to obtain ABG were unsuccessful. Intubated emergently. Had to start chest compressions secondary to EMD. Epi administered via interosseos access as well as endotracheal w/o initiation of perfusing rhythm or spontaneous breathing. Reporter notes indicate patient expired w/dx respiratory arrest secondary to RUL pneumonia. 12/4/07 Received autopsy report which states COD as acute bronchopneumonia due to viral respiratory infection. Manner of death: natural. Findings at autopsy: chronic inflammation, upper & lower airways; acute & chronic otitis media; and acute bronchopneumonia. Had been seen hospitalized 3/15-3/19/2007 w/RSV pneumonia. Worsened 3/22/07 & taken back to ER where she arrested.


VAERS ID: 290673 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Missouri  
Vaccinated:2007-08-28
Onset:0000-00-00
Submitted: 2007-09-07
Entered: 2007-09-17
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2657AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF169AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z1009 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B26510K / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0972U / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Sudden infant death syndrome, 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), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-02
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 PMH: Nasal congestion. Birth Hx: c-section. Mother smoker & diabetic.
Allergies:
Diagnostic Lab Data: Autopsy report pending
CDC Split Type:

Write-up: Sudden infant death. Family visiting relatives found baby unresponsive in crib. 6/13/08 Autopsy report states COD as SIDS. Report states patient traveled with family out of state over holiday w/e. Placed in portable crib for nap. Found unresponsive & cool approx 3 hrs later. CPR started & EMS called but no pulse or respirations.


VAERS ID: 290781 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Idaho  
Vaccinated:2007-08-21
Onset:2007-09-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2007-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B133AA / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVA066AA / 3 UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0079U / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR KO772 / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B540076 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0941U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-04
   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: None
Current Illness: No
Preexisting Conditions: (L) finger hemangioma PMH: umiblical hernia, GERD, hemangioma on finger, vomiting & pyloric stenosis ruled out by abd sonogram WNL, thrush Birth Hx: 39 wk c-section. 7 lbs 6 oz. Family Hx: eczema, migraines, asthma.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None stated. 9/18/07 T/C to reporter/provider to clarify reported death. Box 7 blank on form. Message left for return call. 9/20/07 T/C to reporter. Message left. 9/25/07 T/C to reporter. Stated patient did expire. Autopsy requested. Preliminary COD is pending but coroner indicated to MD that is probably SIDS. Reporter stated patient had no health problems or birth complications. Letter faxed to request vax record./ss 9/28/07 Linked w/291475. 10/9/07 Reviewed pcp medical records which reveal patient experienced good health on day of vax. Vax records indicate RO dose & lot # correct as reported but other vax corrections made in VAERS database. 11/6/07 Reviewed Autopsy report which states COD as sudden unexplained death in infancy. Had been placed in crib face up & then found unresponsive when later checked.


VAERS ID: 290869 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: New York  
Vaccinated:2007-07-06
Onset:2007-07-07
   Days after vaccination:1
Submitted: 2007-09-05
   Days after onset:60
Entered: 2007-09-19
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Blood culture negative, Blood test normal, Computerised tomogram normal, Confusional state, Death, Dysphagia, Electroencephalogram normal, Facial palsy, Full blood count normal, Gait disturbance, Incontinence, Somnolence, Staring
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hearing impairment (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-28
   Days after onset: 21
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: Synthroid, Metoprolol, Lisinopril, Digitek, Zoloft, Warfarin, B-12 supplement
Current Illness: None
Preexisting Conditions: Hypothyroid, Atrial Fib, CHF, high blood pressure PMH: depression, osteoporosis, mitral regurgitation, dysuria, hyponatremia, anemia, B12 deficiency.
Allergies:
Diagnostic Lab Data: Complete Blood Work, Blood Cultures, on heart monitor, CT scan of Brain (3x), EEG - all normal LABS: EKG revealed a-fib & bradycardia.
CDC Split Type:

Write-up: Shot (vaccine) given 7/6/07. 7/7/07 Somewhat not responding to conversation. 7/8/07 - Very sleepy, hard time answering questions, difficulty getting out of chair - as the next 20 days progressed, she experienced feeling of weakness, some facial droop, swallowing difficulties, unable to answer questions (stare, then a shrug [I don''t know]), confusion, incontinence, walk very slowly, occasional dragging of foot. Just before she died (approx 17 hours earlier), she described some things that she did at rehab. Her descriptions were rather odd - after she said them, she realized they sounded odd and stated she thought she must be going crazy - she knew something wasn''t right. She went from being able bodied, alert, communicative, capable person to unable to do simple personal tasks. An otherwise healthy person does not have a rapid change as this one without a reason. All tests run came back perfectly normal - 3 Cat scans showed nothing wrong. Blood work - that of a 50 year old. No evidence of stroke. Drs - both primary MD and Hospital staff said vaccine couldn''t have done it. Symptoms occurred w/in 24 hours of getting vaccine. 9/25/07 Received medical records & death certificate from pcp which reveals COD as cardio-respiratory arrest with atrial fibrillation, mitral regurgitation, HTN, hypothyroid, anemia as contributing factors. Medical records reveal patient in usual state of health & on Coumadin for a. fib when received zostavax on 7/6/07 but no lot # provided. Returned to pcp on 7/9/07 after a fall 7/8/07 & now w/trouble ambulating & speech & memory were slow. No hx of neuro problems & no current head injury, but w/bruising of right arm. Dx at that time: syncope. Admitted directly to hospital. Returned to pcp on 7/18 for hospital f/u. Receiving home health RN, PT/OT & was doing poorly w/dysphagia, lethargy/sleepiness & incontinence. Readmitted to hospital directly. 10/9/07 Reviewed hospital medical records which reveal patient experienced fall at AL facility, seen in pcp office & direct admitted to hospital for mental status changes & inability to transfer or ambulate. Admitted 7/9-7/11/2007. Symptoms resolved w/med changes. FINAL DX: syncope, atrial fibrillation, bradycardia, HTN, deconditioning.


VAERS ID: 290946 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2007-09-19
Onset:2007-09-20
   Days after vaccination:1
Submitted: 2007-09-20
   Days after onset:0
Entered: 2007-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B110A / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0076U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08679E / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0669U / 1 MO / PO

Administered by: Other       Purchased by: Public
Symptoms: Cyanosis, Death, Irritability
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-20
   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: 2 month complete physical exam - WNL
CDC Split Type:

Write-up: On 9/19/07 between 11:30-12N child received 4 vaccinations (see below). Dr saw infant 3 hrs later and he appeared well. Parents state between 6p-8p infant fussy. In AM of 9/20/07 child found "blue" 911 called but infant died.


VAERS ID: 290970 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Female  
Location: Indiana  
Vaccinated:2007-07-24
Onset:2007-08-08
   Days after vaccination:15
Submitted: 2007-09-20
   Days after onset:43
Entered: 2007-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2290BA / 4 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB141AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF058AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1026F / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B588456 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0362U / 1 RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, 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: 2007-08-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no meds
Current Illness: none reported
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Currently autopsy reveals no confirmed cause of death
CDC Split Type:

Write-up: Mother reported that child ran a fever following the immunizations.


VAERS ID: 291337 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Alabama  
Vaccinated:2006-10-19
Onset:0000-00-00
Submitted: 2007-09-25
Entered: 2007-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Possible Sepsis, underlying medical conditions
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reported to immunization staff by a physician. A mother refused vaccine due to a death the mother heard about. All the information on this case at this time. 11/27/07 Reviewed autopsy report which states COD as Sepsis, blood culture positive for Klebsiella pneumoniae.


VAERS ID: 291338 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Alabama  
Vaccinated:2007-08-09
Onset:0000-00-00
Submitted: 2007-09-25
Entered: 2007-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B070AA / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0065U / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08679D / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cause of death undetermined at this time. Reported from a doctor with a mother who refused vaccine due to 2 deaths she heard about after children received vaccines. Only information available at this time. 2/21/08 Reviewed autopsy report which states COD as sudden unexplained & unexpected death in infancy. Manner of death as undetermined (co-sleeping). 2/29/08 Reviewed vax record & database updated w/same.


VAERS ID: 291391 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-09-26
Entered: 2007-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza like illness, Intensive care, 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: 2006-12-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: PMH: mood disorder & depression.
Allergies:
Diagnostic Lab Data: UNK MD office LABS: EKG sinus tachycardia. pulse ox unable to register. Hospital LABS: Blood cultures (+) for fungemia.
CDC Split Type: A0683361A

Write-up: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of Stevens Johnson syndrome in a female subject aged between 20 and 29 years old who was vaccinated with Flu vaccine, manufacturer unspecified) for prophylaxis. Co-suspect medication included Lamotrigine (Lamictal). On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). In 2006, at an unspecified time after vaccination with Flu vaccine, the subject experienced Stevens Johnson syndrome, organ failure, flu-like symptoms, and fever. The subject was hospitalized. The subject died from Stevens Johnson syndrome. An autopsy was performed. The patient developed flu-like symptoms but had just been given the flu vaccine. She then spiked a fever of 106 degrees and was hospitalized. Lamictal was not discontinued because the providers were originally associating the events with the flu vaccine. The patient went into organ failure and was placed in the intensive care unit and then died. The autopsy results indicated that the patient died of Stevens Johnson syndrome which might have been caused by Lamictal use. 10/2/07 Received patient demographics from FDA. 10/5/07 Reviewed MD medical records which reveal patient made emergency visit on 11/30/2006 3 days s/p flu shot at unknown facility. Day after flu shot, developed severely high fever, shaking & chills follwed by SOB, chest discomfort & decreased urine output over past couple of days. Had started Lamictal 14 days prior. Temp in office 107 via ear by MD. Face & chest were red & patient considered extremely toxic w/shaking chills, cracked dry lips, dry mucous membranes. MD called ambulance & sent to ER. Also called pts psychiatrist. MD FINAL DX: malignant hyperthermia, unclear etiology. possible reaction to flu vaccine, possible drug reaction to Lamictal or possible Stevens Johnson syndrome. possible reaction to psychiatric medication. 10/19/07 Received autopsy report which states COD as complication of probable drug hypersensitivity syndrome due to Lamictal therapy for treatment of bipolar disorder & manner of death as therapeutic complication. Final Dx: I. Probable drug hypersensitivity syndrome. A. recent initiation (approx 7-10 days prior to clinical presentation) of Lamictal therapy for treatment of bipolar disorder. B. hospital admission 11/30/06 in acute distress, febrile w/generalized rash & facial & lip swelling. C. progressive deterioration w/multi-organ system failure. D. S/P attempted resuscitation. E. scattered petechiae of head, torso & extremities F. diffuse alveolar damage of lungs G. centrizonal hepatic nectosis H. multifocal infarcts of spleen. I. autolysis of stomach & pancreas. J. focal ischemic changes of small & large intestine. II. Cardiac enlargement. 12/14/07 Reviewed hospital medical records which reveal patient experienced fever, chills & facial rash. Tx empirically for UTI w/IV antibiotics. DX: anticonvulsant hypersensitivity syndrome, renal failure & progressive ARDS. To ICU on vent. Continued fever spikes, DIC & generalized body rash. Tx w/antihistamine & steroids w/some rash improvement. Pulmonary failure progressed & developed bilat pleural effusions. Emergent bronchoscopy done & bilat chest tubes placed. Continued to deteriorate w/progressive acidosis, cardiomyopathy & ischemic bowel. Coded & expired. FINAL HOSPITAL DX: anticonvulsant hypersensitivity reaciton; DIC; ischemic bowel; cardiomyopathy; renal failure; ARDS; fungemia; pulmonary failure; hx of bipolar disease.


VAERS ID: 291476 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Idaho  
Vaccinated:2007-09-12
Onset:2007-09-15
   Days after vaccination:3
Submitted: 2007-09-26
   Days after onset:11
Entered: 2007-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B124B / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54007C / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0968U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Peripheral coldness, Sudden infant death syndrome, 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), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-09-15
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown PMH: circumcised but buried penis in adhesions. right parietal cephalohematoma, 2 cm in diameter. Birth Hx: 41 wk emergent c-section for failure to dilate, 7 lbs 14 oz. jaundice.
Allergies:
Diagnostic Lab Data: autopsy - pending
CDC Split Type: WAES0709USA03810

Write-up: Information has been received from a physician concerning a 17-week-old male who on 12-Sep-2007 was vaccinated with a dose of Rotateq (lot# 656838/0968U). Suspect vaccination included PedvaxHib (manufacturer unknown). Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II and Varivax). On 14-Sep-2007, the parents put the infant to sleep on his back. The infant had a pacifier and no blankets in the crib. At midnight, when the parents checked on him, he was fine. When the parents checked on him at 6am on 15-Sep-2007, he was unresponsive and cold. 911 was called and the baby was coded. The infant was dead on arrival to the hospital. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will provided when they become available. Additional information has been requested. 10/9/07 Reviewed pcp medical records which reveal patient was in good health on day of vax. Vax records reveal RO lot # correct as reported & was Dose #2. Other vax updated in VAERS database. 11/16/07 Received autopsy report which states COD as sudden unexplained death during infancy.


VAERS ID: 291677 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-09-11
Onset:2007-09-12
   Days after vaccination:1
Submitted: 2007-09-18
   Days after onset:6
Entered: 2007-10-01
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B110AB / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0255U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08690D / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: NC07097

Write-up: Pt died within 24 hrs of receiving vaccine. 1/4/08 Reviewed autopsy report which states COD as SIDS. Findings at autopsy included severe congestion in lungs, petechial hemorrhages of thymus gland & probe patent foramen ovale.


VAERS ID: 291678 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Connecticut  
Vaccinated:2007-09-24
Onset:2007-09-25
   Days after vaccination:1
Submitted: 2007-10-01
   Days after onset:6
Entered: 2007-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B056CA / 4 LA / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2456BA / 1 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0700F / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0823U / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: mild febrile rxn~Vaccine not specified (no brand name)~UN~0.00~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: Febrile seizure 3/07 - nl EEG 5/07
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Healthy 18 mo male with history of febrile seizure in 3/07 given MMR II, VZV, DTaP & Flu vaccine on 9/24/07. Child discovered by mother deceased in bed approx 9/25/07. 11/30/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined. Anatomic diagnoses: pulmonary congestion & edema, sudden of unknown etiology. Patient was found unresponsive face down on mattress in crib.


VAERS ID: 291803 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2007-09-21
Onset:2007-09-22
   Days after vaccination:1
Submitted: 2007-09-27
   Days after onset:5
Entered: 2007-10-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS SKBAC21B129AC / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. MSD0072U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH WAL608700A / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. MSD0876U / 1 MO / PO

Administered by: Unknown       Purchased by: Public
Symptoms: Chest X-ray abnormal
SMQs:, Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Seborrhea
Preexisting Conditions: Prematurity - 33 weeks BW 4 lbs 0 oz. PMH: 33 wk preemie. 14 days in NICU.
Allergies:
Diagnostic Lab Data: CXR from 9/20/07 with enlarged ht/ enlarged left ventricular prominent/ distended abdomen
CDC Split Type:

Write-up: Child received vaccines on 9/21/07 child brought to ER in full arrest 9/22 late /9/23 early am ---$g died report of autopsy pending. 12/18/07 Reviewed autopsy report which reveals COD as SIDS. Patient co-sleeping w/parent in twin size bed. Found unresponsive w/blood in nose when parent awoke.


VAERS ID: 291804 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-07-13
Onset:2007-09-01
   Days after vaccination:50
Submitted: 2007-10-01
   Days after onset:30
Entered: 2007-10-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-19
   Days after onset: 18
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: IDDM, uncontrolled. Smoker. anemia.
Preexisting Conditions: Unknown PMH: IDDM, uncontrolled. Smoker. Right buttock abscess 8/31/07. Anemia. Father w/diabetes. ALLERGIES: PCN, cipro, ultram (hives).
Allergies:
Diagnostic Lab Data: Unknown Vitreous glucose 667 (H).
CDC Split Type: WAES0709USA04400

Write-up: Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of Gardasil (yeast, unknown lot number) and in July 2007, was vaccinated with the second dose of Gardasil. In September 2007, the patient died. No further details or symptoms were known regarding the patient''s death. The physician mentioned that an autopsy would be done however, had not received the results yet. The reporting physician felt that the patient''s death was not related to therapy with Gardasil. Additional information has been requested. 10/11/2007 Patient demographics provided by CDC. 10/15/07 Received vax record from pcp. VAERS database updated w/same. 10/15/07 Received pcp & hospital medical records from CDC which reveal patient experienced vomiting with elevated blood sugars who became unresponsive & pulseless. CPR started & taken to ER on 9/19/07. Resuscitation was unsuccessful & patient pronounced 9/19/07. 10/26/07 Reviewed autopsy report which reveals COD as diabetic ketoacidosis & manner of death as natural. Patient had been found by parent unresponsive at home. History of severe diabetes mellitus. Vitreous glucose 667 (H).


VAERS ID: 292125 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-03
Entered: 2007-10-04
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: antimicrobial (unspecified)
Current Illness: Pneumonia
Preexisting Conditions: Unknown PMH: chronic dementia, Alzheimer''s, hypothyroidism, hyperlipidemia, recurrent UTI, DJD
Allergies:
Diagnostic Lab Data: Unknown LABS: WBC 21.21, neutros 93.6 (H), lymphs 3.7 (L), monos 2.3 (L), segs 91 (H). UA (+) for UTI. Blood c/s neg.
CDC Split Type: WAES0709USA04329

Write-up: Information has been received from a nurse practitioner (N.P.) concerning a 93-year-old immunocompromised female who was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included an unspecified antibiotic. It was reported that the patient was just out of the hospital for pneumonia, received Zostavax. Subsequently, the patient died. The cause of death was unknown. No further information was available at the time of this report. No product quality complaint was involved. Additional information has been requested. 10/16/07 Reviewed ER medical records of 8/19/07 which reveal patient seen for UTI. Exam revealed bilateral basilar rales & cool purple feet. Tx w/IV antibiotics & IVF. Foley catheter inserted. D/C to nursing home to continue IV antibiotics x 5 more days. 4/1/08 Reviewed death certificate which states COD as urosepsis.


VAERS ID: 292236 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-06-27
Onset:2007-06-27
   Days after vaccination:0
Submitted: 2007-10-04
   Days after onset:99
Entered: 2007-10-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea, Fatigue, Incorrect dose administered, Overdose, Pain
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-07-08
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cardiac failure congestive
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04727

Write-up: Initial and follow up information has been received from a Registered Nurse concerning a 96 year old female patient with a congestive heart failure. On 01-OCT-2007 the nurse reported that patient''s son reported that on 27-JUN-2007, the patient who lived at a long term care facility received five times the recommended dose of Pneumovax 23. Prior to the vaccination, the patient was walking independently and doing her own care. After vaccination, the patient developed multiple aches, pain, fatigue and labored breathing. It had been reported that her vital signs would be monitored on 27-JUN-2007 through 29-JUN-2007. On 08-JUL-2007, the patient died. The cause of death was unknown. No further information, including lot number, was available. Additional information has been requested.


VAERS ID: 292395 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Utah  
Vaccinated:2007-09-27
Onset:2007-09-29
   Days after vaccination:2
Submitted: 2007-10-03
   Days after onset:4
Entered: 2007-10-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0740U / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: vaccine given 9/27/07 died in sleep 9/29/07 presumed cardiac arrest by autopsy. 1/15/08 Reviewed autopsy report which states COD as occlusive coronary artery disease with HTN & sleep apnea as contributing factors. Findings at autopsy included: RCA 70% occluded; LAD 80-90% occluded; LCA 70% occluded; microscopic evidence of ischemic heart disease w/increased fibrosis in tissue; fatty infiltration into RV wall of heart; and chronic HTN. Patient died in his sleep after recently c/o being tired.


VAERS ID: 292566 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-09-19
Onset:2007-09-03
   Days after vaccination:349
Submitted: 2007-10-02
   Days after onset:29
Entered: 2007-10-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB301AA / UNK - / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2154CA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2572AA / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Culture, Death, Serology test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-09
   Days after onset: 6
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: disease/death~Meningococcal (no brand name)~1~19.00~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: None PMH: pyelonephritis, distant past.
Allergies:
Diagnostic Lab Data: culture, serogrouping LABS: CSF 9/6/07 protein 44, glucose 52, WBC 0, RBC 21. LABS: 9/8/07 WBC 14.5. LP repeated & CSF showed WBC 310 w/100% segmented neutrophils, RBC 160, protein 415 & glucose 29. CT of head showed cerebral edema. Blood & urine c/s neg.
CDC Split Type:

Write-up: fatal meningococcal disease serogroup C confirmed by BOL. 10/19/07 Reviewed hospital medical records 9/6-9/9/2007. FINAL DX: Neisseria bacterial meningitis, serogroup C Records reveal patient experienced URI, sore throat, HA, stiff neck & high fever. Seen in ER on 9/6/07 where LP done. D/c to home w/dx viral infection. Smptoms worsened & became lethargic. Returned to ER. Admitted 9/8-9/9/2007. Tx w/IV antibiotics, antivirals & steroids. Cerebral edema increased after 2nd LP. Neurology & neurosurgery consults done (reports not available). Pupils were fixed & dilated. Declared brain dead then experienced ventricular fibrillation & resuscitation unsuccessful. Family refused autopsy. 11/09/2007 Received death certificate which states COD as cerebral edema +/- herniation: Bacterial Meningitis; cerebral edema; brain herniation.


VAERS ID: 292942 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2007-10-05
Onset:0000-00-00
Submitted: 2007-10-12
Entered: 2007-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA302BA / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Cyanosis neonatal, Death, Dehydration, Infantile apnoeic attack, Jaundice neonatal, Lethargy, Sepsis, Wrong drug administered
SMQs:, Congenital, familial, neonatal and genetic disorders of the liver (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (narrow), Congenital biliary disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: As in narrative.
Current Illness: newborn, rule out sepsis.
Preexisting Conditions: Birth Hx: 35 wk, c-section due to maternal pain. Nuchal cord at birth & vacuum extraction. Apgar scores were 3/6/8 at 1/5/10 minutes. Patient cyanotic & lethargic at birth.
Allergies:
Diagnostic Lab Data: 10/8 CXR negative LABS: echocardiogram. EKG revealed SVT. Troponin 36.8.Liver enzymes (H). Bilirubin 12.2. H/H 9.7/27.8. D-dimer (+). Transfused w/PRBCs & FFP.
CDC Split Type:

Write-up: This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children''s Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown. 10/16/07 T/C to reporter who provided patient demographics. 10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported. D/C to home 10/6 with f/u scheduled for 10/8. 11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home. Lethargic w/multiple apneic events at pcp office on 10/8/07. WBC 16.8, platelets 20,000 in pcp poffice. Pcp placed on O2 & called EMS. Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007. Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated. Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.


VAERS ID: 293120 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-15
Onset:2007-10-15
   Days after vaccination:0
Submitted: 2007-10-15
   Days after onset:0
Entered: 2007-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA300BA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown; code team contacted his supervisor who reports that he was well the morning of 10/15/2007.
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient received influenza vaccine at 1105 AM 10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM. Resuscitative efforts were unsuccessful.


VAERS ID: 293387 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-10-16
Entered: 2007-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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: WAES0710USA02394

Write-up: Information has been received from a consumer concerning a 60 or 70 year old female who was vaccinated SC once with a 0.65 ml dose of Zostavax (Oka/Merck). The reporter stated that "her friend told her that she had heard of another person who died after receiving Zostavax (Oka/Merck)." The reporter stated that it was unknown whether the death was related to vaccination, and the reporter noted that she did not have complete adverse information. Additional information is not expected.


VAERS ID: 293388 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2007-06-13
Onset:2007-10-06
   Days after vaccination:115
Submitted: 2007-10-12
   Days after onset:6
Entered: 2007-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Computerised tomogram abnormal, Death, Headache, Malaise, 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: 2007-10-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications not reported; it was unknown if the patient was ill at time of vaccination.
Allergies:
Diagnostic Lab Data: 07/Oct/2007: Brain CT showed meningococcal disease ER LABS: CT scan & CXR WNL. WBC 14.9 (H), Neutros 87.2 (H), lymphs 6.4 (L). Creatinine 1.2 (H), ALT 27 (L). CSF WBC 4455 (H), RBC 171 (H), neutros 100% (H), glucose 29 (L), protein 371 (H). Blood & urine cultures neg. CSF (+) neisseria meningitidis. Hospital LABS: bronchoscopy & echocardiogram done prior to organ donation were WNL. CSF gram stain revealed neisseria species. WBC 19.1, neutros 86 (H), lymphs 5 (L). CRP 19.3 (H).
CDC Split Type: 200703414

Write-up: This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon ''appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination. 10/18/07 Patient name received from FDA. 10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis. 10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007. VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm. 11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day. Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus. Intubated & IV antibiotics started & transferred to higher level of care. Neurosurgery & ID consults done. Pupils dilated & nonreactive. Diffuse cerebral edema leading to brain herniation & death. 12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007. Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia. Temp in ER max 104.7 Became nonresponsive w/posturing in ER. Intubated. Started on IV antibiotics & transferred to higher level of care.


VAERS ID: 293421 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Florida  
Vaccinated:2007-10-01
Onset:2007-10-04
   Days after vaccination:3
Submitted: 2007-10-13
   Days after onset:9
Entered: 2007-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B133BA / 2 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0073U / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B5007H / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0240U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death 11/27/07 Reviewed vax record which confirms dose & lot #s as reported. 4/15/08 Autopsy report states COD as anoxic/hypoxic encephalopathy & bronchopneumonia due to infantile reflux & aspiration while sleeping.


VAERS ID: 293594 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2007-10-18
Onset:2007-10-18
   Days after vaccination:0
Submitted: 2007-10-18
   Days after onset:0
Entered: 2007-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 78995 / 7+ RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-18
   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: unknown
Current Illness:
Preexisting Conditions: PMH: COPD on home O2. ASCVD, s/p CABG. Recent hx of hemoptysis & URI
Allergies:
Diagnostic Lab Data: CXR right pneumothorax.
CDC Split Type:

Write-up: Client presented to drive through flu exercise for influenza vaccination. Gave history of having had flu shots in past without incident. No contraindications to vaccinations identified. Client was vaccinated and returned home. At some time after returning home client went to Hospital emergency room where he coded and expired. 10/23/07 Reviewed hospital medical records which reveal patient experienced weakness & decreased respirations upon arriving home s/p flu shot. Collapsed in seat of pickup truck. EMS intubated, started CPR & transported to hospital. CXR revealed right pneumothorax & chest tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with atherosclerotic cardiovascular disease & CHF as contributing factors.


VAERS ID: 294105 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Iowa  
Vaccinated:2007-10-05
Onset:0000-00-00
Submitted: 2007-10-16
Entered: 2007-10-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1347U / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Breath sounds abnormal, Cyanosis, Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-09
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: Clotrimazole, Diltiazem HCL, Fosamax tablet, Spriva Handhaler, therapeutic tablet, Warfarin sodium, Docusate Sodium, GNP calcium, Lorazepam, Genebs Apap, Prednisone
Current Illness:
Preexisting Conditions: Demerol PMH: pulmonary fibrosis. Recently hospitalized for pneumocystis pneumonia, pulmonary embolism & generalized frailty.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IA07013

Write-up: 10/7/07 Slight temp, nausea, course Lung sounds @ 2:30pm 10/7/07 3:30p elevated temp, labored breathing, cyanotic lips and finger tips. 10/7/07 4:00 resident transferred to hospital. 10/26/07 Hospital medical records reviewed which reveal patient experienced progressively worsening SOB. Admitted 10/7-10/9/2007. Exam revealed air hunger, rales, rhonchi. Initially improved w/pulmonary toilet & IV antibiotics & IV steroids. Deteriorated & expired. No autopsy done. FINAL Dx: bilateral pneumonia, presumably bacterial, unknown organism; and pulmonary fibrosis. 11/27/07 Reviewed death certificate which states COD as pneumonia due to chronic interstitial lung disease.


VAERS ID: 294274 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2007-10-20
Onset:2007-10-20
   Days after vaccination:0
Submitted: 2007-10-24
   Days after onset:4
Entered: 2007-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 78476 / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Death, Syncope, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: This was a Public Health Mass Immunization clinic. This patient does not come here for routine care. We know that he had had flu vaccine in the past, has a GI upset reaction to eaten eggs, but still eats them, and reported no febrile illness in the 48 hours prior to vaccination and was not allergic to thimerisol
Preexisting Conditions: Discussion with cardiologist listed above revealed that the patient was under his care for "a significant heart condition" and that the doctor does not believe that the immunization contributed to the patient''s demise. He stated that if the patient had been in his office, his risk factors would have warranted vaccination with influenza vaccine. PMH: ischemic cardiomyopathy, ejection fraction 20%; CHF class 2-3; ventricular tachycardia; chronic renal insufficiency; multiple CVAs; COPD; PVD; chronic pain. PMH: MI, HTN, CABG x 5, cardiac stents, pacemaker. Abdominal aneurysm.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s daughter called after the event and reported that patientexperienced wheezing, cough and syncope "later that day" after he returned home from flu clinic. She did not indicate which, if any, hospital he was taken to, but that she had called his physician. Cardiologist. She reported that her father died on Sunday 10-21-2007 11/6/07 Received hospital clinic & cardiology medical records which reveal patient experienced CAD, s/p CABG (1982 & 1990) & severe LVD s/p ICD biventricular deployment; chronic back problems; hyperlipidemia; diabetes type 2; & controlled HTN. Cardiac cath of 4/2006 revealed patent left internal mammary arter to LAD bypass graft w/other grafts being occluded. Had been hospitalized 7/07 for pacemaker device discharge. Had DOE at that time. Pacer rate was increased due to myocardial ischemia. Developed chest pain, nausea & additional DOE. Dx w/unstable angina 7/11/07 & admitted to hospital. 1/18/08 Reviewed ER records of 10/22/07 which reveal patient fell & had witnessed cardiac arrest at home 50 min prior to arrival in ER. Had been intubated & IV access placed in field. ECG revealed V-fib & then asystole & patient expired 10/22/07. 1/29/08 Cardiac arrest per death certificate.


VAERS ID: 294509 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-10-08
Onset:2007-10-09
   Days after vaccination:1
Submitted: 2007-10-26
   Days after onset:17
Entered: 2007-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B130AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF205AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702C / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0941U / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Body temperature increased, Death, Pulse absent, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen 40mg given immediately after vaccinations. By report the family gave the same amount again at about 07:00pm on 10/08/2007.
Current Illness: None.
Preexisting Conditions: None.
Allergies:
Diagnostic Lab Data: Autopsy results pending.
CDC Split Type:

Write-up: Mother awakened in early morning and noticed that patient was not breathing or moving. Resuscitation attempted by father and by EMS and hospital personnel. By report, first recorded temperature during resuscitation was 102 F. Pulse was never reported to have been attained. 4/1/08 Autopsy report states COD as sudden unexplained infant death & manner of death not determined. Report states patient had recent URI. Found unresponsive on soft pillow on couch w/parent.


VAERS ID: 294659 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2007-05-25
Onset:2007-05-25
   Days after vaccination:0
Submitted: 2007-10-29
   Days after onset:157
Entered: 2007-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Irritability, Respiratory arrest, Rhinorrhoea, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-30
   Days after onset: 5
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: carnitine
Current Illness: She had been diagnosed with C.H.A.R.G.E
Preexisting Conditions: She had a heart defect(DORV), C.H.A.R.G.E BIRTH HX: Patient born 4/3/07 & was hospitalized until 4/24/07. D/C dx: complex congenital heart disease, CHARGE association, choanal atresia, feeding difficulties, s/p gastrostomy tube placement, failed audiology screening, bilateral chorioretinal colobomas involving bilateral optic nervs & left renal peviectasis. Mom had gastric bypass surgery 2001. Pregnancy uncomplicated. Apgars 5/6 at 1/5 minutes. No evidence of inborn error of metabolism. Low carnitine level (+).
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My child was very fussy with a runny nose for two days then she was very unresponsive on the third. On the fourth day she stopped breathing. The on call physicians only advice for treatment was baby tylenol. 11/18 Death certificate states COD as severe hypoxic ischemic injury w/cardiac arrest & complex cyanotic heart disease as contributing factors. 11/13/07 Reviewed hospital medical records which also included birth records. Admitted 5/29-5/30/2007 s/p cardiopulmonary arrest at home. Seen initially in outlying ER & transferred for higher level of care s/p resuscitation, intubation & interosseus dopamine drip. IV & a-line established & placed on ventilator. Transfused PRBCs & FFP. Acidotic, hypoglycemic & hypocalcemic on admit. Tx w/antibiotics. EEG showed very low voltage activity. Extubated & patient expired quickly w/parents in attendance.


VAERS ID: 294789 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Wisconsin  
Vaccinated:2007-07-23
Onset:0000-00-00
Submitted: 2007-10-28
Entered: 2007-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B113AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1275F / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B36258D / 1 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-01
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: Meningitis pneumococcal
CDC Split Type: USWYEH00731507

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 3-month-old patient who experienced pneumococcal meningitis. The patient received a dose in 2007. The patient developed pneumococcal meningitis on an unspecified date in 2007. It was reported that the child expired close to the date of 01-Sep-2007. The cause of death was reported as meningitis pneumococcal. 12/18/07 Received vax records. 1/18/07 Reviewed autopsy report which states COD as bacterial meningitis (days).


VAERS ID: 294842 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Michigan  
Vaccinated:2007-10-18
Onset:2007-10-24
   Days after vaccination:6
Submitted: 2007-10-30
   Days after onset:6
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA294CA / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-24
   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: restoril 30 mg q HS, avadart 1 qD, ASA 81 mg q day, remeron 45 mg q HS, oxycodone ER 20 mg bid, magic cup 1-2 q day (nutritional supp given by oncology)deptestosterone 200 mcg IM biweekly, augmentin 875 mg bid
Current Illness: lung ca rul, chronic pneumonia rul due to partial obstruction
Preexisting Conditions: HTN, COPD, CAD, RUL lung CA, depression PMH: HTN, CAD, RUL SCCA of lung.
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 1 week after administration found dead at home. History of COPD and squamous cell lung cancer RUL with obstruction of airway and s/p palliative treatment. Daughter felt he became more lethargic 24 hours after vaccination and requested we report this. No autopsy performed by medical examiner and death certificate pending. 11/27/07 Reviewed death certificate which states COD as right lung pancoast tumor due to chronic obstructive pulmonary disease. 1/4/08 Reviewed medical records which reveal patient experienced cough, recurrent RUL infections which responded to antibiotic tx, RUE pain s/p brachial plexus involvement, poor appetite on 10/18/07. Dx w/RUL lung Pancoast squamous cell carcinoma, stage B & tx w/chemo & radiation tx.


VAERS ID: 294848 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-10-28
Onset:2007-10-29
   Days after vaccination:1
Submitted: 2007-10-30
   Days after onset:1
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA062AA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: omeprazol 20 mg daily, Zyprexa 2.5mg evening, ativan 0.25mg po twice daily, remeron 15mg po qhs
Current Illness: See # 19.
Preexisting Conditions: chronic ischemic heart disease. HTN, depression, A-fib. no known allergies. 11/2/07 Received medical records from reporter which reveal patient experienced a PMH: anxiety, depression, dementia, recurrent UTIs, CAD, atrial fib, MI, cataracts.
Allergies:
Diagnostic Lab Data: lot # aflla062aa
CDC Split Type:

Write-up: patient was not acutely ill but was found dead in her chair within 24 hours of flu vaccine. 1/15/08 Death certificate states COD as acute myocardial infarction w/chronic ischemic heart disease as contributing factor.


VAERS ID: 294850 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2007-10-26
Onset:2007-10-28
   Days after vaccination:2
Submitted: 2007-10-30
   Days after onset:2
Entered: 2007-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA062AA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-28
   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: atenolol 12.5mg po daily, HCTZ 12.5mg po daily, omeprazole 20mg daily, glyberide 5mg twice daily, aggrenox sa 1 cap twice daily, hydralizine 10mg four times daily, lipator 20mg every pm, lasix 40mg daily. remeron 15mg po in pm, namenda 10 m
Current Illness: see # 19.
Preexisting Conditions: diabetes, HTN, SDAT, collitis PMH: Alzheimer''s, lipid disorder, BPH, TURP, prostate cancer, polypectomy, HTN, DM, bowel neoplasm, CVA 2004 requiring craniotomy & evacuation, CHF, ejection fraction 60% in 2003, first degree AV blockdiverticulosis, side branch IPMN, prostate cancer.
Allergies:
Diagnostic Lab Data: LABS: Sodium 131, BUN 45, creatinine 2.9. CXR pulmonary edema. KUB distended bowel loops. Amylase 108, lipase 31
CDC Split Type:

Write-up: Patient found dead in his chair 36 hours after vaccine. Had not been acutely ill prior to vaccination. 11/02/07 Received medical records from reporter which reveal patient w/extensive medical hx. H&P of 5/07 indicates had recent diarrhea, apple core lesion in mid to distal sigmoid colon, severe dementia, SOB & extremely poor appetite who had been admitted to hospital then transferred to LTC due to lethargy, fatigue & falls. Had cellulitis & inflammation of lower leg but afebrile on day of vax. Next day had congested productive cough w/green phlegm & vomiting. 10/28 had increased congestion, unresponsive w/dusky color. BP 89/66 & placed on O2 due to sats of 50-60%. Taken to hospital. 11/16/07 Received hospital ER medical records of 10/28/2007. FINAL ER DX: respiratory failure, sepsis Records reveal patient experienced fever, lethargy altered mental status & abdominal guarding. Exam revealed bilateral diffuse rhonchi, increased respiratory rate, diffuse abdominal tenderness & guarding, decreased bowel sounds, pitting edema of LE''s & tachycardia, temp 101.3. Patient was DNR & comfort measures provided until expiration. ME declined case.


VAERS ID: 295031 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Washington  
Vaccinated:2005-11-12
Onset:2005-11-19
   Days after vaccination:7
Submitted: 2007-10-24
   Days after onset:703
Entered: 2007-10-31
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Death, Eye disorder, Herpes simplex serology positive, Herpes virus infection, Stomach discomfort, Streptococcal infection
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Retinal disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-12-04
   Days after onset: 15
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: Nursing mother given MMR at same time
Current Illness: No - newborn
Preexisting Conditions: No - newborn baby Family hx: parent w/hx of cold sores but none recent.
Allergies:
Diagnostic Lab Data: 11-26-05 Positive for herpes LABS: viral culture (+) for herpes.
CDC Split Type:

Write-up: A small sore appeared on baby''s left eye. When he was in for circumcision 11-21-05 doctor mentioned it looked like herpes but did nothing. On 11-25 he began to get upset tummy and on 11-26 Mom took him to emergency for test. On Tuesday 11-29-05 doctor called parents and told them to take him to hospital for treatment with IV Acyclovir. Contracted strep in hospital and died. 5/29 Autopsy states COD as ischemic hemorrhagic colitis of small bowel; peritoneal surfaces demonstrate focal adhesions; neonatal herpes (c/s +). 12/14/07 Reviewed hospital medical records which reveal patient seen in ER on 11/26/2005 after experienced small spot on lateral edge of left eye x 3 days. Area had opened up & then crusted over, eyes reddened & became slightly swollen. Viral c/s obtained & tx w/Bactroban & was to be seen by pcp next day. Both hospital records for admission of 11/29/2005 included. Eye lesion had cleared but then developed blistering lesions on outside of left eye & base of penis. PCP wanted patient transferred to higher level of care but family declined. After culture (+) for herpes, returned to hospital & agreed to transfer to higher level of care. Admitted 11/29-12/4/2007. Tx w/IV antivirals & peds optho consult done. Optho dx: herpetic keratitis & herpetic dermatitis of eyelid. Condition deteriorated, intubated & admitted to PICU. Taken to OR 12/4/05 secondary to abdominal distention due to sepsis. Penrose drain inserted & drained approx 200 cc of clear straw colored fluid. Cultures sent. Continued to deteriorate & developed bloody drainage from abdominal drain. Taken back to OR for exp lap & found total intestinal ischemia from ligament of Treitz to descending left colon. Suspected a vascular insult due to underlying disease process.


VAERS ID: 295043 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2007-10-22
Onset:2007-10-22
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:9
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2489MA / UNK RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cyanosis, Death, Irritability
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol (2.5mg/3ml-Bullets) 3 ml BID or TID & PRN; Robinul (0.2mg/ml) 2 ml TID Prevacid SoluTab (15mg/tab) 1 tab BID(am & hs) Glycolax 2 tsp QD Children''s Tylenol 4ml Q4 hours PRN increased Temperature
Current Illness:
Preexisting Conditions: This child was in a program. He had a multitude of diagnoses and problems including interrupted development of white matter of the brain, seizures, arthryogryposis of CNS origin, cyanotic spells, apneic events, problems with thermoregulation, reflux, aspiration. He had a pacemaker implanted about a year ago and had been doing much better since then. Parents report he has not have a respiratory or cardiac arrest since then. He did still have seizures monthly. He had posturing and tics on a daily basis. He had an uncoordinated swallow and was at high risk for aspiration. I am the child''s nurse case manager and I have only been working with the family for about 4 months (the family was transferred to me due to internal staff reassign-ments). I reported his death to the State as required. I don''t know who administered the immunization. I don''t know if nurse filed a VAERS. Dr. was not in the office due to his father being in intensive care. The family reports patient had flu shots in the past without difficulty. I spoke with Dr. because I felt a VAERS was warranted. She gave me information and the website info and I am submitting this form today. I will be out of my office for about 3 weeks starting Sunday, November 4. In my absence, you may speak with my program''s director. She is aware that I have filed this report. PMH: early ROM w/decreased amniotic fluid & subsequent joint contractures. Medically fragile w/multiple conditions including severe GERD. Multiple malformations of brain with developmental delay. Recurrent episodes of apnea & structural compromise of airway.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child had flu shot @ about 10 am. Waited in office for 20 minutes. Went home w/mother and private duty nurse. Nurse reported he was fussy after the immunization. She held him until he went to sleep. They put child to bed in parental bedroom upstairs. Nurse went to kitchen to get g-tube feeds ready. Apnea alarm went off shortly thereafter. When RN got to the child, he was face down in the bed and blue. They administered CPR, called 911. He was airlifted to hospital, where he was pronounced dead approximately two hours after receiving the flu shot. 11/13/07 Received autopsy report which reveals COD as complications of cerebral dysgenesis of indeterminate etiology; arthrogryposis multiplex congenita was a significant contributing factor. Had been placed on side for nap but was found prone. Disabilities rendered unable to lift head/body to protect airway. 11/16/07 Received vax records from pcp. VAERS database updated w/same.


VAERS ID: 295076 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Georgia  
Vaccinated:2007-10-29
Onset:2007-10-29
   Days after vaccination:0
Submitted: 2007-10-30
   Days after onset:1
Entered: 2007-10-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB163AB / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal behaviour, Cardiac arrest, Convulsion, Death, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-10-30
   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: None
Current Illness: None
Preexisting Conditions: None PMH: small child, picky eater, eczema, URI at 3 mos,
Allergies:
Diagnostic Lab Data: ER LABS: CXR revealed fine ground glass opacity throughout & numerous air bronchograms bilaterally. Hospital LABS: Head CT showed diffuse loss of gray-white differentiation, bilateral cerebral infarction w/herniation, indicating global hypoxic/ischemic event. Echocardiogram revealed severe LV dysfunction, septal posterior & anterior wall hypokinesis. Ejection fraction of 26%. CXR showed perihilar edema. PT/PTT very prolonged. PCP LABS: lead <3 10/05, Hgb 13.3 (N) 10/05, RSV (+) 12/04.
CDC Split Type:

Write-up: Approx. 45 min after injection, mother noted child was not acting correctly and returned to the office with him. He was noted to be having a seizure and was transported to the hospital where he suffered resp. failure and cardiac arrest. He is currently on life support. Died 10-30-07. 5/16/08 Autopsy report states COD as sudden unexplained child death associated w/acute pneumonia. Autopsy findings include: hypoxic-ischemic encephalopathy; wide spread acute pneumonia; phenytoin & lorazepam; no trauma. Patient had witnessed seizure followed by respiratory distress, intubation & subsequent cardiac arrest. Short hospitalization & expired despite therapeutic intervention. 11/1/07 Received medical records from CDC which reveal patient experienced shaking & unresponsive behavior after being seen in pcp office for vax. Returned to pcp & exam revealed patient having right sided seizure w/eyes deviated to right & right extremity twitching. Taken to ER after seizing for approx 15-20 min. Received 2 doses of ativan, intubated, received versed, paralytics, Pb, epi, bicarb, mannitol, lasix, solumedrol & atropine along w/IVF. Transferred by flight to higher level of care. 11/2/07 Received hospital medical records from CDC which contain PICU Death Summary. Reveals patient admitted s/p seizure & cardiac arrest. Multiple episodes of ventricular fibrillation, lidocaine & defibrillation during transport from outlying ER. Arrived at hospital hypotensive w/weak femoral pulses & quickly coded again for approx 5 min & pulse returned. BP maintained on epi drip until brain death pronounced. 11/6/07 Reveiwed pcp medical records from CDC which confirm dose & lot # as reported. Patient reported to be in usual state of health on day of vax but a little sleepy & cranky. Returned to office approx 45 min s/p vax with patient having right sided seizure w/eyes deviated to right. Office unable to obtain ativan, taken to ER, given O2 & IM ativan, then IV ativan when IV access obtained. Seizure stopped w/n 4 min & patient became apneic & was intubated. Stable for aprox 30-40 min then O2 sat dropped, bradycardia & then asystole. CPR started. Remained asystolic for approx 1 hour & then regained pulse. Developed ventricular fibrillation on the way to the helicopter & was converted back in ER. Then transported to higher level of care.


VAERS ID: 295195 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Michigan  
Vaccinated:2007-10-31
Onset:2007-11-01
   Days after vaccination:1
Submitted: 2007-11-01
   Days after onset:0
Entered: 2007-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2459LB / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-01
   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:
Current Illness:
Preexisting Conditions: Fetal Omphalocele
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client passed away today. Cause of death unknown at this time. An autopsy is to be performed down state. 8/18/09 Autopsy report 11/02/06. Additional information abstracted: Medical complications of omphalocele. History of repair of congenital omphalocele. Severe abdominal adhesions with extensive dilation of loops of small and large intestine. Status post gastrostomy tube placement. Acute proximal and distal convoluted tubular necrosis of kidneys. Extensive intersitial calcification of kidneys.


VAERS ID: 295485 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-02
Entered: 2007-11-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Back pain, Blood bilirubin increased, Blood culture positive, Body temperature increased, Chest X-ray normal, Death, Erythema, Haematocrit decreased, Haemoglobin decreased, Headache, Hepatic enzyme abnormal, Hepatic function abnormal, Hepatomegaly, Laboratory test abnormal, Lethargy, Oxygen saturation normal, Pain in extremity, Pallor, Platelet count normal, Pneumococcal sepsis, Pyrexia, Tachycardia, Tachypnoea, Thrombocytopenia, Ultrasound abdomen, Ultrasound liver normal, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: folic acid
Current Illness: Sickle-cell beta thalassaemia
Preexisting Conditions: Fever; Sickle cell crisis; Hospitalisation
Allergies:
Diagnostic Lab Data: physical examination - See narrative; chest X-ray - Normal; diagnostic laboratory - profound anemia; hepatic ultrasound - Inferior vena cava maintained a good flow; hepatic ultrasound - No detectable hepatic vein, portal vein, or hepatic arterial blood flows; abdominal ultrasound - See narrative; autopsy - See narrative; diagnostic laboratory - Ceftriaxone-induced acute hemolysis ruled out; temperature measurement - febrile to 39 degrees C; hemoglobin 7.1 g/dl; hemoglobin 3.2 g/dL - profound anemia; platelet count 17,00 uL - thrombocytopenia; hemoglobin - hemoglobin levels dropped rapidly after each transfusion; total serum bilirubin 4 mg/d - mostly conjugated; hemoglobin 7.5 g/dL - baseline; hemoglobin - S $g82%, F 12-16%, A2 3.9-7.8%, no detectable A1; hemoglobin - Plateau above 12 g/dL; blood culture - After 14 hours grew gram-positive diplococci (later identified as S. Pneumoniae serotype 13); hepatic function tests - 12-fold increased; WBC count 4600 uL; hemoglobin 2.1 g/dL - profound anemia; WBC count 16,70 uL; platelet count 115, 0 uL; hematocrit 21.6%; pulse oximetry - 98 percent
CDC Split Type: WAES0710USA04997

Write-up: Information has been received from the author of a published article. It was reported that, "a 5-year-old black male with sickle B - thalassemia born to a mother with sickle cell trait and a father with B-thalassemia trait was admitted to the hospital for fever and pain of the left arm and back. He had a history of 2 prior admissions: one for moderately severe vaso-occlusive crisis of the legs and another for fever of unknown origin. He received Pneumovax 23 at the age of 2 years and was on folic acid oral supplementation. There was no history of acute chest syndrome or splenic sequestration and no history of blood transfusions. Review of his medical records showed a baseline hemoglobin level of 7.5 (+/- 0.6) g/dL and a pretransfusion hemoglobin electrophoresis showed hemoglobin S $g82 percent; F 12 percent to 16 percent; A2 3.9 percent to 7,8 percent; and no detectable A1. At presentation, the child was febrile to 39 degrees C with an oxygen saturation of 98 percent on room air by pulse oximetry. The physical examination showed erythema of the oropharynx, and notably no hepatomegaly was appreciable by either the admitting or the inpatient physician. Pain was assessed as 6 on a scale of 1 to 10, thus morphine sulfate was given intravenously and acetaminophen orally. Hemoglobin level was 7.1 g/dL, hematocrit was 21.6 percent, total white blood cell count was 16,700/ uL, and platelet count was 115,000/uL. A chest x-ray was normal. Ceftriaxone 50 mg/kg was given intravenously after blood cultures were collected. Four hours after admission, he complained of a severe headache, was found to be more lethargic, toxic looking, and had a persistent tachycardia and tachypnea. His lips were pale. The abdomen was slightly distended in comparison with his initial assessment but soft and firm liver edge was palpable 4 cm below the costal margin in the mid-clavicular line. A blood sample showed profound anemia (hemoglobin 3.2 g/dl, repeat in 30 min was 2.1 g/dL) and thrombocytopenia (17,000/uL) with a drop in the initial white count to 4600/uL. Ceftriaxone-induced acute hemolysis was considered and ruled out with the appropriate testing. Packed red blood cell (PRBC) transfusion was started promptly. The hemoglobin levels dropped rapidly after each transfusion. The liver enlarged progressively, and within 2 hours is spanned 8 cm in the right mid-clavicular line. Liver enzymes were 12-fold increased whereas bilirubin measured 4 mg/dL (mostly conjugated). An abdominal ultrasound showed massive hepatomegaly (14 cm vertical span), thickened gallbladder wall, and edema of the bowel loops. Doppler study of the liver showed no detectable hepatic vein, portal vein, or hepatic arterial blood flows. The inferior vena cava maintained a good flow. The patient subsequently became hemodynamically unstable and needed cardiorespiratory support in addition to repeated transfusion of PRBC, platelets, and fresh frozen plasma. This picture was consistent with sepsis. After 14 hours of incubation, the blood culture grew gram-positive diplococci, later identified as S. pneumoniae serotype 13. Although the hemoglobin level seem to plateau above 12 g/dL, the patient''s condition worsened progressively with maximal cardiorespiratory support, massive hepatomegaly (12 cm below the costal margin in the mid-clavicular line), and a very tense abdominal wall. He died 18 hours after admission. Postmortem examination was performed. The liver was significantly enlarged weighing 1089 g. almost twice the normal weight for age (normal weight for age = 596 g), with a red smooth homogenous surface and focal areas of necrosis. Microscopic examination showed markedly dilated sinusoids packed with red blood cells the majority of which were sickle-shaped. However, a fair number of normal erythrocytes were also present, probably donor RBCs form blood transfusions. The spleen weighted only 20.5 g (normal weight for age = 47 g). All other organs examined were congested and hemorrhagic, consistent with terminal disseminated-intravascular-thrombosis. The authors reported that, "hepatic sequestration was preceded by pneumococcal sepsis. The role of the pneumococcal bacteremia as a possible triggering factor for the sequestration process and as a major contributor to the irreversible hemodynamic decompensation should be taken into consideration." No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 295504 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Maine  
Vaccinated:2007-11-02
Onset:2007-11-02
   Days after vaccination:0
Submitted: 2007-11-05
   Days after onset:3
Entered: 2007-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2502AA / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arthritis; HTN
Preexisting Conditions: Arthritis; HTN
Allergies:
Diagnostic Lab Data: ? Possible adverse reaction vs. M.I. LABS: EKG revealed acute inferior STEMI
CDC Split Type: ME01207

Write-up: On 11-02-2007 during routine office visit for arthritis and HTN, Flu vaccine given. Pt left the office with no c/o any. She went to shop and few hours later she was brought back in lethargic condition. O2 - 4 Epipen - applied, 911 - called, and she was transported by ambulance to Emergency Room. 12/11/07 Reviewed hospital ER records & death summary which reveal patient experienced severe substernal chest pain & collapsed while shopping 11/2/2007. EMS took to ER where she developed complete heart block & bradycardia. Tx w/meds, pacemaker & intubation. Resuscitated & taken for cardiac cath. In cath lab, arrested & CPR started. Developed ventricular fibrillation non responsive to defibrillation & meds & pronounced. 1/11/08 Received death certificate which states COD as ventricular fibrillation, acute MI & ateriosclerotic heart disease.


VAERS ID: 296073 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-10-23
Onset:2007-10-23
   Days after vaccination:0
Submitted: 2007-11-09
   Days after onset:17
Entered: 2007-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 78478 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20071247

Write-up: We received from a health care professional via the agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL 1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The patient died shortly after the vaccination after he left the facility and walked down the hall. Caller felt that individual was properly screened, reported no allergies to any component, and filled out the waiver for the vaccine prior to administration, and had prior flu vaccinations. The reporter felt the death was coincidental based on the age and history of the patient. Company assessment: Seriousness criterion: death. Causality: insufficient data. Expectedness assessment according to manufacturer label: Death after Fluvirin is not expected. No change in benefit-risk-ratio. No measure necessary. Addendum We received from a health care professional via the medical agencies additional information on 29 OCT 2007: The batch-no. was 78478 (and not 78428 as previously reported). No change in assessment. NA07-005622


VAERS ID: 296075 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Kentucky  
Vaccinated:2007-10-29
Onset:2007-10-30
   Days after vaccination:1
Submitted: 2007-10-30
   Days after onset:0
Entered: 2007-11-08
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2607AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1158F / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 21009 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 853981 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 05084 / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-30
   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: Nystatin
Current Illness: constipation, thrush
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: death. 12/17/07 Reviewed autopsy report which states COD as SIDS. Patient found in crib lying on back & unresponsive. 12/17/07 Received vax record & medical records which confirm vax dose & lot #s as reported. Patient had thrush & was constipated during office visit 10/29/07, otherwise, healthy.


VAERS ID: 296120 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2007-10-09
Onset:2007-10-21
   Days after vaccination:12
Submitted: 2007-11-08
   Days after onset:18
Entered: 2007-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2464AA / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Blood pressure increased, Body temperature increased, Electromyogram abnormal, Guillain-Barre syndrome, Intubation, Lumbar puncture, Muscular weakness, Plasmapheresis, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (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 (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-25
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 32 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Nexium, Ambien, Lisinopril, Hydrochlorothiazide, Taztia XT, Aspirin, Doxazosin, Alprazolam, Tylenol #3.
Current Illness: none 12/17/07-records received-Headache which lasted over the last few weeks.
Preexisting Conditions: Hypertension, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis, Atrial Fibrilation. 12/17/07-records received-PMH: coronary artery disease. Hypertension. Atrial fibrillation. Gastroesophageal reflux disease. Osteoarthritis. Insomnia.
Allergies:
Diagnostic Lab Data: Contrast MRI, Spinal tap, prolonged F wave response 12/17/07-records received- Lumbar puncture showed cyto-albuminic disassociation, elevated protein and enhancement of lumbar roots on MRI. D-dimer elevated at 766. Increased segmented neutrophils 72%. Abdominal and pelvic CT normal. CT head showed small possible meningioma in left occipital parietal area not causing any of his problems. EMG F waves consistent with Guillain-Barre syndrome.
CDC Split Type:

Write-up: Patient is suffering from Guillain Barre Syndrome. The patient presented about 9 days after flu vaccine administration with symptoms of weakness in his lower extremities and lower back pain. The patient is currently intubated due to respiratory failure and has had 5 days of high dose IV immunoglobulin with no improvement. The patient is finishing his last round of plasmapharesis in the next day. During his time at the hospital he experienced elevated blood pressure which was hard to treat, he also had an increased core temperature for a couple of days. 12/17/07-records received for DOS 10/22-11/25/07-DC DX: Guillain-Barre syndrome. Persistent encephalopathy seconary to Guillain-Barre syndrome. Respiratory failure requiring mechanical ventilation. Death. Presented to ED with severe back pain with increasing weakness. Back pain started on 10/21/07-Low back pain with some numbness and tingling in legs. Today unable to get up. PE: mild quadriparesis along with mild sensory changes at distal extremities.Treated with IVIG. 5/15/09 Death certificate states COD as respiratory failure due to Guillain Barre syndrome.


VAERS ID: 296231 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: California  
Vaccinated:2007-10-17
Onset:2007-11-01
   Days after vaccination:15
Submitted: 2007-11-06
   Days after onset:5
Entered: 2007-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500486P / UNK NS / IN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2758AA / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-01
   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:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200703735

Write-up: A 25-year-old patient, with no reported concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a left deltoid (route not provided) dose of Adacel (lot number C2758AA), and a dose (route not provided) of FluMist (manufacturer MedImmune) (lot number 500486P) on 17 October 2007. Fifteen days post-vaccinations, on 01 November 2007, the patient expired in his sleep. At the time of the report, the autopsy was not complete. No cause of death has been determined at this time. 12/14/07 Received vax record from provider which confirms lot #s as reported. 1/18/08 Reviewed autopsy report which states COD as idiopathic mitral prolapse. Findings at autopsy included: enlarged dilated heart w/LVH & clean coronaries; parachute deformity w/hooding of anterior mitral cusp & lengthening of the chordae tendineae w/mild white thickening of the septal endocardim behind mitral valve; hyperinflated lungs; pneumomediastinum; enlarged liver/spleen/hepatic portal lymph nodes.


VAERS ID: 296240 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Michigan  
Vaccinated:2007-10-03
Onset:2007-10-06
   Days after vaccination:3
Submitted: 2007-11-06
   Days after onset:31
Entered: 2007-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 79489 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Unknown 11/16/07 Reviewed death certificate which reveals COD as liver cancer.


VAERS ID: 296690 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-10-10
Onset:2007-10-15
   Days after vaccination:5
Submitted: 2007-10-27
   Days after onset:12
Entered: 2007-11-14
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / PFIZER/WYETH AFLLA037AA / UNK LA / -

Administered by: Private       Purchased by: Other
Symptoms: Cardiac failure, Death, Vaccination complication, Viral infection
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-27
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UPPER RESPRITORY VIRAL INFECTION
Preexisting Conditions: PMH: mitral valve replacement 1996 w/recent coumadin change, rheumatic fever, CVA x 2-3, HTN, Type 2 DM, CHF, mitral valve stenosis allergy to phenobarbital.
Allergies:
Diagnostic Lab Data: LABS: WBC 18.3 (H), segs 81%(H), monos 3% (L), lymphs 16% (L), platelets 482 (H). CK 24, CKMB 17.8, troponin neg. AST 37, LDH 234. PT/PTT 17.6/26l6, INR 2.0. Dig level 1.0. Blood glucose 451(H), K 5.4 (H), BUN 28 (H), creat 1.3, Cl 93 (L), CO2 16.7 (L), NA 130 (L). CXR revealed cardiomegaly, mild failure w/minimal bilateral perihilar infiltrates. Repeat CXR revealed increased failure w/diffuse pulmonary edema & bilateral infiltrates suggesting aspiration pneumonia.
CDC Split Type:

Write-up: oct.28.2007 treated for upper respritory viral infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral infection complecated by influensa vaccine.oct.27 2007died heart failer complecated by virial infection 11/16/07 Reviewed vaccine record from pcp & VAERS database updated w/same. 11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital medical records which reveal patient experienced chest & left arm pain, cold & clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived. EMS rhythm strip revealed BBB w/ST segment depression. In ER, vomited & had diarrhea. EKG revealed atrial fib w/rapid ventricular response. DX w/acute bronchitis & atrial fib w/RVR. Became unresponsive & developed cardiac arrest. Resuscitated & intubated. While being tansferred to higher level of care via helicopter, coded again. Returned to ER & unable to resuscitate. 3/7/2008 Judge states he signed death certificate as directed by state law when patient is not in hospital & only seen in ER but paper copy no longer available. States COD as undetermined & manner of death natural. 3/11 Death certificate reviewed & states COD as undetermined & manner of death as natural.


VAERS ID: 296797 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Ohio  
Vaccinated:2007-05-07
Onset:2007-05-13
   Days after vaccination:6
Submitted: 2007-11-14
   Days after onset:185
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B090BA / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF051AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08666A / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infantile spitting up, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-05-13
   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
Current Illness: Left eye drainage
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son went in on May 7th 2007 for his 4 month shots and a check-up. Was found to be a healthy baby boy. He was fussy and spit up but nothing out of the normal. 6 days later on May 13, 2007 died at 12:59pm. 11/16/07 Received autopsy report which reveals COD is sudden infant death syndrome. 11/27/07 Received vax record which confirms report.


VAERS ID: 297079 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2007-11-08
Onset:2007-11-12
   Days after vaccination:4
Submitted: 2007-11-13
   Days after onset:1
Entered: 2007-11-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B046AA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0500U / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0872 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702H / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: 34 weeks gestation
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: received phone call that infant had expired. 2/5/08 Reviewed Autopsy Report & death certificate which accompanied autopsy report which states COD consistent w/Sudden Infant Death Syndrome (Group B) in co-sleeping infant. Findings included: sudden death in 2 mo old co-sleeping infant; hx of parental drug abuse (opiates per parents); post mortem tox exam neg for drugs or alcohol; hx of preemie, 36 wk, 5 lbs, 4 oz.


VAERS ID: 297178 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-11-07
Onset:2007-11-10
   Days after vaccination:3
Submitted: 2007-11-16
   Days after onset:6
Entered: 2007-11-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U2156AA / 4 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF205AA / 4 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0873 / 4 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0706F / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702H / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 06084 / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchopneumonia, Death, Electrolyte imbalance, Gastroenteritis, Histology, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-12
   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: NONE
Current Illness: NONE
Preexisting Conditions: PRE-MATURE BIRTH....NO COMPLICATIONS
Allergies:
Diagnostic Lab Data: Electrolytes with mild dehydrate. Histology shows acute gastroenteritis and broncho-pneumonia
CDC Split Type:

Write-up: Child started with high fever, 48 C, post vaccination and died on 11/12/2007. 12/11/2007 Reviewed autopsy report which states COD as acute bronchopneumonia complicated by acute gastroenteritis. Blood c/s neg.


VAERS ID: 297225 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-11-16
Entered: 2007-11-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antimicrobial susceptibility test resistant, Blood pressure, Culture negative, Death, Developmental delay, Failure to thrive, Heart rate increased, Hypertension, Pyrexia, Rash papular, Rash pustular, Respiratory distress, Respiratory failure, Respiratory rate increased, Skin lesion, Skin ulcer, Staphylococcal bacteraemia, Systemic candida, Tachycardia, Tachypnoea, Varicella, Varicella zoster virus serology positive, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (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) (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), Hypertension (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Premature birth; Choanal atresia; Patent ductus arteriosus; Congenital choroid plexus cyst; Calculus renal; Tracheostomy; Gastrostomy tube insertion; Lymphopenia; Humoral immune defect; Hospitalisation; Antibody test negative; Reactive airways disease; Respiratory syncytial virus infection; Dermatitis ichthyosiform; Failure to thrive; Developmental delay
Allergies:
Diagnostic Lab Data: blood pressure 120/8 mm, diagnostic laboratory Tzanck smear negative, total heartbeat count 150 beat, respiratory rate 45/min, VZV strain positive for vaccine-strain (Oka) varicella, arterial blood O2 28%, viral culture negative, fungal culture negative
CDC Split Type: WAES0711USA01429

Write-up: It was reported in a published article, title as stated above, that an 18 month old female with medical history significant for preterm delivery at 32 weeks'' gestation via cesarean section, secondary to maternal prolactinoma and polyhydramios. At birth she was noted to have choanal atresia and a patent ductus arteriosus; a choroid plexus cyst was also noted on computed tomography of the head, and bilateral renal calculi were seen on ultrasound. The result of prenatal testing of the patient''s mother for HIV antibody was negative, and the result of testing of the patient for HIV antibody as part of the state''s newborn screening program was also negative. In the early postnatal period she required both a traceheostomy and gastrostomy-tube placement. Although her anomalies suggested a congenital syndrome, a specific diagnosis was not established at birth or through subsequent investigation. The finding of persistent lymphopenia on serial lymphocyte count and the absence of a thymic shadow on chest radiograph raised the suspicion of DiGeorge anomaly, but results of a fluorescent in situ hybrization study to detect the 22q11.2 deletion were negative. However, initial determination of lymphocyte subsets revealed severe depletion of both CD4 and, particularly, CD8 subsets, with normal or increased B cells (CD19) and natural killer cells (CD56). Lymphocyte-proliferation assays also revealed absent proliferation to standard mitogens. That trend would persist, albeit with some normalization of CD4 percentage, until the admission. In additional to her deficits in cellular immunity, the patient also had severe humoral dysregulation. Although her immunoglobuin (Ig)G, IgM, and IgA concentrations were within normal limits for her age, she failed to produce protective antibody titers to tetanus toxoid and Haemophilus influenza type B after immunization. Further workup of her immunodeficiency included testing for genotypes of severe combined immunodeficiency, such as ZAP-70 deficiency and associated promoter mutations, all of which were unremarkable. Because of the nursing care her tracheostomy required, she was placed in a chronic care facility. The patient had been hospitalized multiple times. During several admissions for exacerbations of chronic reactive airway disease, test results of nasopharyngeal aspirates were positive for respiratory syncytial virus. On 1 of those admissions, at 9 months of age, the patient suffered an exacerbation of her chronic ichthyosiform rash that was manifested by diffuse erythroderma, alopecia, and electrolyte disturbances. Quantitative Igs at that time revealed markedly elevated serum IgE (36000 IU); however her clinical course was not felt to be compatible with Job syndrome because of absent history of deep organ abscess. A diagnosis of Netherton syndrome was considered but not supported by the results of skin biopsy and hair-shaft examination. Furthermore, molecular testing results were negative for mutation on SPINKS. The diagnosis of Omenn syndrome was also considered, but testing for RAG1 and RAG2 was not performed. Despite the gastrostomy tube, she continued to suffer from failure to thrive and weighed only 8.6 kg at 18 months of age, with profound developmental delay. No cause for her immunodeficiency was ever elucidated, but because of this condition, her physician advised that she receive no live vaccines. Nevertheless, 5 weeks before her admission she was vaccinated with Varivax (Oka/Merck). The patient was admitted with a 4-day history of fever and increasing numbers of papulovesicular/pustular skin lesions. The rash was first noted on the patient''s trunk 6 days before admission when she began having intermittent fevers. At that time, she was seen by her primary physician as an outpatient and evaluated by a pediatric dermatologist. Since that time, the lesions had become generalized, and on admission they covered her entire body including her scalp, palms, and soles. A culture from blood drawn 4 days before admission did not grow any bacteria, but a culture from 1 of the pustules revealed infection with methicillin-resistant Staphylococcus aureus. Three days before admission, she was started on benzathine penicillin and erythromycin, but the rash continued to progress. On the evening before the admission she was brought to the emergency department because of a fever of 103F. On admission the patient was awake, alert, responsive, and moving all extremities. She was afebrile but hypertensive, tachycardic, and tachypneic and had a blood pressure of 120/80 mm Hg, a heart rate of 150 beats per minute, and respiratory rate of 45/minute on 28% O2 via a tracheostomy collar. There were generalized erythematous-based vesicles and pustules, including on her palms, soles, scalp, and trunk, with the highest concentration being in the genital area. Her breath sounds were coarse, with occasional wheezes; her liver was palpable 3 cm below the costal margin, but laboratory testing on admission revealed a normal complete blood count, chemistry, and liver function. The patient was admitted with a preliminary diagnosis of staphylococcal pustulosis, but because of the mixed nature of the lesions and the history of varicella immunization, treatment was begun with intravenous vancomycin, intravenous ceftriaxone, and intravenous acyclovir. A 3-mm punch biopsy was performed by the pediatric dermatology service, 2 vesicles on the dorsum of the left foot were unroofed for bacterial, fungal, and viral cultures, and a Tzanck smear was obtain; the results of these tests were negative. On hospital day 4, fluid obtained from 1 of the vesicles was sent for diagnostic polymerase chain reaction and viral strain determination. New lesions continued to appear for $g1 week, for a total of $g14 days after initial appearance of the rash, and the patient continued to have low-grade fevers and mild respiratory distress. A chest radiograph on hospital day 4 revealed bilateral patchy consolidation. Two punched-out ulcers appeared on her left flank and another on her left frontal scalp; all 3 were $g1 cm in diameter and surrounded by 3 to 4 cm of erythema and induration. On hospital day 4, the pathology report on the biopsy reported results consistent with a herpesvirus infection, although differentiation between herpes simplex virus and varicella zoster virus (VZV) was not possible. On the 4th day hospital day, the PCR was reported positive for vaccine-strain (Oka) varicella. After the 9th hospital day, new lesions gradually diminished, and by the 17th hospital day, the punched-out ulcers began to fill with granulation tissue. Although the patient''s hospital course was complicated by S. aureus bacteremia and candidemia, as well as methicillin-resistant S. aureus superinfection of the primary lesions, her varicella continued to improve after this point. After a lengthy and difficult hospital course, she was discharged back to her chronic care facility on the 55th hospital day. The patient was subsequently readmitted on several occasions for ulcerated skin lesions and respiratory illness. VZV was never isolated from any specimen. Her lymphocyte-proliferation responses remained severely depressed, and she eventually died at 2 years, 2 months of age from respiratory failure. Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 297526 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2007-10-17
Onset:0000-00-00
Submitted: 2007-11-21
Entered: 2007-11-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B124DB / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF220AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54007D / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0239U / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Cyanosis, Fatigue, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-19
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/Small macular VSD
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 2day hx of extra tired after shots. No other symptoms (D) 2 after shots/found non responsive/cyanotic/face down. 11/30/07 Reviewed vax record from pcp which confirms dose/lot as reported & provided vax date of 10/17/2007. 1/8/07 Reviewed autopsy report which states COD as SIDS. Other finding at autopsy was probe patent foramen ovale.


VAERS ID: 297528 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-09-15
Onset:2007-10-06
   Days after vaccination:21
Submitted: 2007-11-20
   Days after onset:45
Entered: 2007-11-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-10-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA02619

Write-up: Information has been received from a physician''s assistant concerning a 12 year old female with no reported medical history who on approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was not where the vaccine was administered, rather they were the patient''s family physician. On 06-OCT-2007 the patient died in her sleep. No further information was provided. No lot number was given. Additional information has been requested.


VAERS ID: 297565 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Texas  
Vaccinated:2007-10-31
Onset:2007-11-13
   Days after vaccination:13
Submitted: 2007-11-22
   Days after onset:9
Entered: 2007-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLLA043AA / UNK UN / SC
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0964U / UNK UN / SC

Administered by: Private       Purchased by: Private
Symptoms: CSF culture negative, CSF protein increased, Miller Fisher syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-29
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Pemphigus Vulgaris. PE (+) for Pemphigus lesions, and thrush. Of note, CBC on date of vax with WBCs of 16.4 (low Eos 0.10%, lymph 4.0%, monos 4.40% and high neu 90.9%).
Preexisting Conditions: PMH: Pemphigus vulgaris on long-term steroids.
Allergies:
Diagnostic Lab Data: CSF; Protein/negative cxs. Labs and Diagnostics: CBC with WBCs of 16.1. PT/INR WNL. Head CT with no acute pathology on 11/18/07. MRI brain 11/19/07 with no evidence of acute pathology. CT brain scan 11/26/07 shows subarachnoid hemorrhage with diffuse cerebral edema, possible cerebellar tonsil herniation. Dopplar studies of the lower extremities WNL. Initial Chemistry with low Na+, Cl-, and Albumin 3.1 and glucose of 183. LFTs WNL on admission elevated by 11/25/07 (AST 67, ALT 120, Alk Phos 137, Total Protein 9.0 and Albumin 2.2). Sed rate 38. CSF protein 75.4. CSF Bacterial antigens (-). Initial Blood cultures (-). Later blood cultures (+) for Enterococcus fecalis.CSF cultures (-). UC (-). Cardiac enzymes unremarkable. ANA (-). Lyme and VDRL (-). CXR initially WNL later showed a L pleural reaction. EEG showed no cerebral activity.
CDC Split Type:

Write-up: Miller - Fisher Syndrome. Respiratory failure. 12/07/2007 MR received for DOS 11/18-29/2007 with DX: Miller-Fisher Syndrome. Pt expired on 11/29/2007. Progress note 11/28/07 states " diagnosis of brain death due to massive intracranial hemorrhage". Pt presented to ER on 11/18/07 with fever and progressive lower extremity weakness and swelling of the R side of face associated with weakness and numbness. Admission PE (+) for multiple superficial skin ulcers, bilateral conjunctival hemorrhage R$gL, L eyelid ptosis, R-sided facial weakness motor function 2/5 in lower extremities and nystagmus. Neuro consult 11/19/07 reports that pt developed double vision, trouble walking, and weakness 2 weeks s/p vaccination. PE (+) for 3rd and 6th cranial nerve palsy, ataxic gait, and absent DTRs. No respiratory problems at that time. Later that day pt developed agonal respirations and respiratory distress and mental status changes. Dx: Acute Respiratory Failure. Intubation was attempted and pt placed on ventilator. On 11/22/07 pt developed fever and started on abx. By 11/23/07 pt was unresponsive and developed myoclonic activity. On 11/29/07 pt was removed from life-support with dx of brain death due to massive intracranial hemorrhage. 12/07/2007 Death summary received as above. Final DX: Massive cerebrovascular accident with subarachnoid hemorrhage. Brain dead with flat EEG and (+) apnea test. Bactermia with enterococcus faecalis and coagulase-negative staphylococcus. S/P comatose state. Miller Fisher Syndrome on admission. pemphigus vulgaris. S/P respiratory failure. 01/11/2008 Death Cert received. Immediate COD: Cerebrovascular Accident-Approximate interval:onset to death-hours. Ascending Polyneuropathy-onset to death: days. Pemphigus-onset to death: years.


VAERS ID: 298067 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2007-11-20
Onset:2007-11-25
   Days after vaccination:5
Submitted: 2007-11-26
   Days after onset:1
Entered: 2007-11-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B125BB / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0260U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B972838 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1461U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unable to breathe through nose
Preexisting Conditions: Cerebropalsy (L) arm; (L) cephalhematoma PMH: jaundice & left brachial plexus birth trauma both of which had resolved by 10/8. SVD w/vacuum assist at 35wks. Perinatal period complicated w/hypoglycemia which resolved before d/c to home.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Death 10/21/08 Autopsy states COD as pneumonia, other undetermined factors, sudden unexpected infant death. Manner of death is undetermined. Autopsy report also states patient found unresponsive in crib in lateral position on a pillow. X-rays revealed healing rib & clavicular fractures. Micro revealed evidence of bronchopneumonia. Investigation revealed patient had cough & nasal congestion x approx 10 days prior to death & had been seen in ER & by PCP for same. Ears had been pierced day before death. 11/30/07 Reviewed pcp medical records which confirm dose & lot as reported. Office note of 11/20 reveals patient had nasal congestion x 1 week. Dx w/formula allergy & formula changed to soy. Had been seen in ER 11/17 for cough with chest/nasal congestion. Exam revealed a sore in left nostril.


VAERS ID: 298149 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Unknown  
Vaccinated:2007-11-16
Onset:2007-11-23
   Days after vaccination:7
Submitted: 2007-11-29
   Days after onset:6
Entered: 2007-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 0880U / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ear pain, Herpes zoster, Oral disorder, Otorrhoea, Rash, Rash vesicular, Swelling face, Tympanic membrane perforation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-05
   Days after onset: 12
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: Correg, Prilosec, ASA, Synthroid, Lasix, Cordarone, Sennekot, Lortab, Aricept, Naprosyn, Citracal, had received steroid injection in spine for pain control
Current Illness: none
Preexisting Conditions: atrial fibrillation, congestive heart failure, arthritis, hyperlipidemia, back pain PMH: atrial flutter, DJD, GERD, colonic polyps, hyperlipidemia, allergic rhinitis
Allergies:
Diagnostic Lab Data: LABS: initial CT scan WNL. MRI revealed midbrain CVA in pons.
CDC Split Type:

Write-up: Patient received Zoster vaccination on 11/16/07. Onset of left ear pain on 11-23-07. Mild rash reported on left side of face and ear (vesicular). Left ear drainage. Pain and rash increased and was seen in Emergency Dept. on 11/25/07. Diagnosis of shingles secondary to vaccination was made. Follow up to personal physician on 11/26/07 reports leisons inside mouth, rash and pain on left side only and a ruptured ear drum. Mild facial swelling, on left noted. Was treated with Famvir 500 mg tid, Medrol dose pack and Zithromax 5 day course. Follow up on 11/28/07 reports improvement in symtoms. 12/21/07 Reviewed death certificate which reveals COD as respiratory failure, cardiac arrest & CVA. 1/4/08 Reviewed hospital medical records which reveal patient experienced blisters & cold sores on the left mouth & left ear pain on 11/17 & went to ER. Tx w/steroids, antivirals & antibiotics & d/c to home. Improved initially then patient began to experience balance difficulty & multiple falls. Returned to hospital & was admitted 11/30-12/5/2007. Patient developed respiratory distress which progressed to cardiopulmonary arrest. Resuscitated, intubated & transferred to ICU. Was able to be extubated but had trouble swallowing. Otherwise progressed well until 12/5 when developed sudden onset of bradycardia leading to asystole & expiration. FINAL DX: herpes zoster, CVA, respiratory failure, cardiopulmonary arrest.


VAERS ID: 298153 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Unknown  
Vaccinated:2004-03-09
Onset:2007-07-25
   Days after vaccination:1233
Submitted: 2007-11-29
   Days after onset:127
Entered: 2007-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV082 / 1 - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4030013 / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: 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: 2007-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: mother denied son had any problems PMH: tonsillitis & enlarged cervical lymph nodes w/neg strp 3/9/2007; gastritis 1/2006 w/neg H. pylori. NKA. Occasional smoking & ETOH use, no illicit drugs. New job after discharge in office building. Overseas deployment x 4. One episode 8/2006 of passing out while playing soccer & admitted to hospital overnight; dx w/possible pinched nerve & concussion. Gingivitis & cavities 2004-2007
Allergies:
Diagnostic Lab Data: medical records pending
CDC Split Type:

Write-up: Patient died from unknown causes 7/25/2007 following syncopal episode playing soccer. Similar episode of syncopal like events in 5/2006 playing soccer however he received typhoid vac in 5/2006 not AVA. Someone asked if AVA vaccine may be an underlying cause. 3 AVA vac received 3/9/2004, 5/13/04, 7/7/04. Typh received 5/1/06 4/18/08 Reviewed medical records from HC which included vax records & autopsy report. FINAL COD: cardiac arrhythmia. Summary diagnoses: pulmonary congestion & edema; mild cerebral edema; passive visceral congestion. Tox screen neg. Manner of death natural. Vax records indicate patient received Typhoid VI lot # Z0042, Aventis on 5/1/2006. Narrative reports patient received influenza vaccine 1/10/2007 but is not recorded on vax record. Received Anthrax #1 FAV082 on 3/9/2004; #2 FAV084 on 5/13/2004; & #3 FAV 084 on 7/7/2004 & was medically exempted from remainder of anthrax series. Records reveal patient had been ill w/flu-like symptoms for approx 1 week prior to death. Same type symptoms had recurred several times since 12/2006. Work-up s/p vaso-vagal syncopal episode in 8/2006 playing soccer while deployed reported as: x-rays, EKG, labs all WNL. No seizure activity or postictal state at that time. Records reveal patient experienced feeling ill, collapsed, had seizure & died on 7/25/2007 while playing soccer. Patient had been d/c from military 05/05/2007 in good health.


VAERS ID: 298905 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Virginia  
Vaccinated:2007-11-26
Onset:2007-11-27
   Days after vaccination:1
Submitted: 2007-11-30
   Days after onset:3
Entered: 2007-12-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2474CA / 1 LL / IM

Administered by: Private       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: 2007-11-27
   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: Also received Synagis at the same time
Current Illness: URI
Preexisting Conditions: Pulmonary atresia s/p VP shunt/HIV exposure PMH: chronic hypoxia. Had cardiac cath done 11/20/07.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient collapsed while eating breakfast at home. He was taken to the ER and pronounced dead. 12/18/07 Reviewed hospital ER records which reveal patient in usual state of health on 11/27 when coughed & then collapsed at home. Was unresponsive in ER & resuscitation unsuccessful. ER COD stated as sudden cardiac death. 1/21/08 Reviewed autopsy report which states COD as complication from congenital cardiac disease (probable arrhythmia.


VAERS ID: 299062 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2007-11-19
Onset:2007-11-21
   Days after vaccination:2
Submitted: 2007-12-07
   Days after onset:16
Entered: 2007-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. 1085U / 1 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Balance disorder, Blood sodium decreased, Chromaturia, Diet refusal, Differential white blood cell count, Ejection fraction decreased, Fall, Feeling abnormal, Insomnia, Musculoskeletal pain, Myalgia, Myoglobin blood increased, Nausea, Pharyngolaryngeal pain, Platelet count normal, Protein urine present, Red blood cells urine positive, Renal failure acute, Rhabdomyolysis, Urine analysis abnormal, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-11-25
   Days after onset: 4
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: 1) Albuterol 90/Ipratrop 18mcg 200d Po Inhl Inhale 2 Puffs By Mouth Four Times A Day 2) Aloh/Mgoh/Simeth/Diphen/Lidocaine Visc Rinse 2 Teaspoonfuls By Mouth Every 4 Hours (2x16oz Bottles (Equal Parts Of Each Ingredient) 3) As
Current Illness: 1. COPD, not on oxygen, never had PFTs acc to patient 2. HyperLipidemia 3. HTN 4. osteoarthritis of knees 5. Depression 6. Carcinoma of tonsil - completed treatment 1 year ago
Preexisting Conditions: NKDA PMH: throat cancer w/radiation treatment 1 year ago. HTN, hyperlipidemia, COPD, OA, depression, tonsillar carcinoma. Obese. Ex-smoker, (+) ETOH use. Ex-drug user.
Allergies:
Diagnostic Lab Data: Labs include: WBC 6.29 Hgb14.9 Platelets 156 band neut 77% segs 17% lymph 2%. Na 125 K 4.1 Cl 89 Co2 19 BUN 51 Creat 3.8 Glu 103 Ca 8.9. May 2.3 ESR 17. CK 5225, CKMB 109.4, RI 2.1. Myoglobin $g4000 Trop .67. ---- ABG ---- ARTERIA 11/25 11/25 Reference 2007 2007 19:06 18:00 Units Ranges ------------------------------------------------------------------------------- pH 7.22 L* 7.05 L* 7.35 to 7.45 PCO2 34 L 38 mmHg 35 to 45 pO2 194 H 253 H mmHg 80 to 95 BASE EX -13 L -21 L mmol/L -2 to 2 HCO3 13 L 10 L mmol/L 22 to 26 TCO2CAL 23 to 27 O2SAT-C 99 100 % 95 to 100 ER LABS: CT of head WNL. CXR WNL. WBC 6000, bands 77% (H), segs 12% (L), lymphs 2% (L). Electrolytes multiple abnormalities: Na 125 (L), Cl 89 (L), Bicarb 19 (L), BUN 51 (H), creat 3.8 (H). Rapid flu test neg. UA showed trace blood & protein 30 (H). CK enzymes 5,200 (H), CK-MB 109.4 (H), troponin I 0.67 (H). Myoglobin 4,000 (H). EKG showed sinus rhythm. Blood c/s (+) group G beta streptococcus. Hospital LABS: WBC 2.8 (L), Na 122 (L), BUN/creat 54/3.7 (H), AST 408 (H), ALT 73 (H)CK 15,404 (H), Troponin I 1.36 (H). Blood c/s neg. Adenosine cardiolite in 2/06 revealed EF 58% & small fixed perfusion w/no reversible defect.
CDC Split Type:

Write-up: Copied from Admission note: Patient is a 67 year old white gentleman with a past med hx sig for HL, HTN, COPD, OA, Dep, and carcinoma of tonsil who was trassferred to Hospital for ARF and rhabdomyolysis. Patient states that he received the Zostavax immunization on Monday 11-19-07. On Wednesday 11-21-07, he began to feel bad. He states that he lost his balance and fell. This went away. On Thursday 11-22-07 he developed a severe sore throat. He took some mouthwash that he had left over from when he was receiving treatment for tonsillar cancer and this helped. He also felt some nausea on Thursday. On Friday 11-23-07, he developed right knee pain and could not get up out of bed. He wanted to "wait it out over the weekend" but felt horrible this am. He developed joint and muscle aches in his forearms, shoulders, ankles, and right knee so he went to the hospital today Sunday, 11-25-0. He has not slept in 4 days. He has not eaten since Wednesday. He denies any visual changes or headches. He denies any vomiting or diarrhea/constipation. Denies fevers or chills. Denies abd or back pain, sob, change in cough. States that he went to the hospital and they gave his IVF. He did urinate 200cc of brown urine there. Before that, he had not urinated since Friday. Currently he c/o joint aches and pains. Says that he does not feel up to walking around because he does not trust himself. Labs that were done in Lincoln includ: WBC 6.29 Hgb14.9 Platelets 156 band neut 77% segs 17% lymph 2%. Na 125 K 4.1 Cl 89 Co2 19 BUN 51 Creat 3.8 Glu 103 Ca 8.9. May 2.3 ESR 17. CK 5225, CKMB 109.4, RI 2.1. Myoglobin $g4000 Trop .67. CT of head done which was neg for acute problem - did show mild atrophy. Blood cultures drawn. UA performed and was yellow, slightly cloudy, sp grav $g1.030, ph 5, prot 30, trace blood. Patient states that he does not use oxygen at home for COPD and occ uses inhalers. Has not had PFTs done. Did have an adenosine cardiolyte 2/06 which showed EF of 58% and small fixed perfusion defect and no reversible defect. 12/11/07 Reviewed ER medical records of 11/25/07 which reveal patient experienced weakness. States patient had received pneumonia, flu & shingles vaccinations on 11/20/07. Developed sore throat, decreased appetite, dry cough, nausea & loss of balance w/multiple falls starting 11/22/07. Developed generalized body aches, weakness & difficulty walking. Had to lift right leg w/hands due to weakness. Transferred to higher level of care. FINAL ER DX: rhabdomyolysis w/renal failure & weakness. 1/29/08 Reviewed hospital medical records of 11/25/07 which reveal patient transfered from outlying ER for acute renal failure & rhabdomyolyis. Records state zoster vax 7 days prior to admit & flu shot 2 weeks prior to admit. Pst developed balance difficulty, falls, sore throat, nausea, joint pains, muscle aches, sleep disturbance, decreased appetite. Admitted & shortly after admission found w/dusky face, stiff jaw, swollen neck, decreased air intake. Intubated & CPR started. Resuscitated & ABG revealed severe acidosis. Transferred to ICU. Developed v tach, resuscitated several times & eventually failed to respond. FINAL DX: Cardiopulmonary arrest; acute renal failure; rhabdomyolysis; HTN; hyperlipidemia; anxiety; COPD. 2/12/08 Reviewed autopsy report which states COD as septic shock w/acute rhabdomyolysis & renal failure.


VAERS ID: 299262 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: California  
Vaccinated:2003-12-03
Onset:2003-12-06
   Days after vaccination:3
Submitted: 2007-12-11
   Days after onset:1466
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Asthenia, Chest X-ray abnormal, Death, Haemorrhage, Lethargy, Pain, Pulmonary congestion, Stomach discomfort, Surgery, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-12
   Days after onset: 6
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:
Current Illness: Diabetes, Arthritis, TIA,Hypertension records received 12/26/07-Reportedly fell two days ago and struck her head.
Preexisting Conditions: Diabetes Mellitus, Arthritis. TIA, Hypertension records received 12/26/07-HX of diabetes, cerebrovascular accident, atrial fibrillation.
Allergies:
Diagnostic Lab Data: The emergency room doctors took x-rays of her lungs and found bleeding areason one side of the lung. It was uncontrollable and they attempted to suction it off first, then called a surgeon in to operate. The surgery was unsuccessfull and she never regained consciousness. records received 12/26/07-INR of 9. CT of head no acute intracranial hemorrhage detected. Pumonary hemorrahge noted on CT.
CDC Split Type:

Write-up: On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises. They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician. She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm. On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed. On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but very weak and her family made attempts to drive her quickly to Emegency Room for treatment. She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin. Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus


VAERS ID: 299540 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-11-30
Onset:0000-00-00
Submitted: 2007-12-12
Entered: 2007-12-13
   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, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: general symptom
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01742

Write-up: Information has been received from a physician concerning a female with "some health troubles" who on 30-NOV-2007 was vaccinated with Zostavax single dose of the series. The patient had a heart attack and died. The physician mention that she does not think it was due to Zostavax as the patient had "some health trouble before." Additional information is not expected.


VAERS ID: 299556 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Illinois  
Vaccinated:2007-11-29
Onset:2007-11-30
   Days after vaccination:1
Submitted: 2007-12-13
   Days after onset:13
Entered: 2007-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B218AB / 1 RL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0819U / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54015E / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1192U / 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: 2007-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: born 36 wks gest., 5lb 6oz at birth PMH: 1st born. 36 wk preemie. NVD induced due to low amniotic fluid. Birth wt 5 lbs 6 oz. Home in 2 days. Grandmother had lost baby to SIDS in 1994.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt found expired no breathing - non responsive next AM after getting shots. 12/18/07 Reviewed provider medical records including vax records which confirm vax dose & lot #s as reported. Family found patient not breathing in crib. 07/04/2008 Reviewed the pathology report received via fax from CDC: FINAL DX: mild focal tracheitis & vascular congestion of multiple organs. No immunohistochemical or PCR based evidence of influenza A or B, mycoplasma pneumoniae or bacillus cereus. No infectious etiology identified. 9/11/09 Autopsy report received. DOD 11/30/07 - Sudden Infant Death Syndrome.


VAERS ID: 299871 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New York  
Vaccinated:2007-11-30
Onset:2007-12-03
   Days after vaccination:3
Submitted: 2007-12-14
   Days after onset:11
Entered: 2007-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA282DA / 2 LA / IM

Administered by: Public       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: 2007-12-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: celiac disease
Preexisting Conditions: Aortic stenosis; Hyprtension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died suddenly while snowblowing. 12/18/07 Reporter states no autopsy done. Received vax record which confirms lot # as reported. 2/29/08 Received death certificate which states COD as cardiac arrest w/CAD as contributing factor.


VAERS ID: 299918 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Oklahoma  
Vaccinated:2007-12-05
Onset:2007-12-08
   Days after vaccination:3
Submitted: 2007-12-14
   Days after onset:6
Entered: 2007-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B128AB / 1 RA / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0995U / 1 LA / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54013H / 1 LA / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1393U / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Possible Reflux/Second Hand Smoke Exposure PMH: necrotizing enterocolitis at 1 wk of age. 2 1/2 wks premature. Birth HX: 6 lbs 12 oz, apgars 8/8 at 1/5 min. C-section due to fetal tachycardia & maternal temp of 100.6. Blood c/s neg.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. expired 3 days after ck-up. Parents reportedly found child dead in bed. 6/20/08 Autopsy states COD as SIDS. Report states pathological diagnosis as patent foramen ovale; lungs w/congestion & atelectasis; small bowel IS; GERD. Found unresponsive in bassinet after being placed prone approx 5 hrs earlier. CPR initiated 1/4/08 Reviewed pcp medical records & vax records which confirms vax as reported. Records indicate patient in good health on day of vax, only concern was constipation & formula changed.


VAERS ID: 300018 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:2007-11-26
Onset:2007-11-28
   Days after vaccination:2
Submitted: 2007-12-14
   Days after onset:16
Entered: 2007-12-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B09AA / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0498L / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54013H / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0902U / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Relevant medical history was not provided. PMH: mother 16yo; 39 wk vaginal w/vacuum assist birth. Maternal temp & kept in hospital x 3 days w/mom.
Allergies:
Diagnostic Lab Data: death, unknown
CDC Split Type: USWYEH01681507

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a female infant (between 0 and 6 months) who on 26-NOV-2007, received a first dose of Prevnar along with a dose of Haemophilus Influenzae B (manufacturer unknown), a dose of Pediarix and a dose of Rotarix. On 26-Nov-2007, the patient received a dose of Prevnar along with other childhood vaccines. On 28-Nov-2007, approximately 48 hours post-vaccination, the child died. The cause of death was unknown. An autopsy was performed, but results were not provided. No additional information was available at the time of this report. 1/22/08 Reviewed ER medical records of 11/28/07 which reveal patient found in crib by family. Transported to ER via EMS & pronounced DOA. 1/24/08 Reviewed pcp medical records which reveal patient in good health on 11/26/07 except for slight weakness of left arm & suspected brachial plexus birth injury. Note indicates patient received Pediarix, Prevnar, Hib & Rotavirus vaccines but no vax record included w/notes. 2/12/08 Received vax records. 5/6/08 Autopsy report states COD as SIDS. Manner of death: natural.


VAERS ID: 300036 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: South Carolina  
Vaccinated:2007-09-19
Onset:2007-09-20
   Days after vaccination:1
Submitted: 2007-12-17
   Days after onset:88
Entered: 2007-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B115CB / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0256U / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0553U / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-20
   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: TYLENOL OTC
Current Illness: COLD LIKE SYMPTOMS
Preexisting Conditions: NONE. PMH: Former 34-36 week premie with IUGR. Birth weight 4-14. Developed respiratory distress syndrome requiring CPAP and O2. Resolved in 2-3 days. Infant on abx while r/o sepsis-sepsis screen (-). (+) neonatal jaundice. (+) diaper rash. Initial newborn thyroid screen-abnormal. F/U WNL (TSH 5.161, T4 1.43). URI 6/20/07. II/IV Systolic murmer noted 7/24/07 and 9/19/07. Otherwise normal exams.
Allergies:
Diagnostic Lab Data: INVESTIGATION, AUTOPSY AND TOXICOLOGY COMPLETED
CDC Split Type:

Write-up: INFANT DECEASED 16 HRS. POST IMMUNIZATION ADMINISTRATION. NO ADVERSE SIGNS OR SYMPTOMS DESCRIBED BY MOTHER. AUTOPSY DID NOT IDENTIFY ANY SIGNS OF ADVERSE REACTION. 12/26/2007 Vax record and MR received from PCP. Vax record as reported on VAERS report. 1/11/2008 Autopsy Report received with Child Fatality Investigation Report. COD: Sudden Unexpected Death in Infancy. Infant had been sleeping on sofa with mother. Mother felt child was warm and gave Tylenol. Respiratory Distress was noted by mom. EMS notified and CPR initiated however child was pronounced dead upon arrival at medical center. Unsafe sleeping conditions documented. Distinction between SIDS and subtle forms of asphyxia could not be made by autopsy alone.


VAERS ID: 300066 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-11-12
Onset:0000-00-00
Submitted: 2007-12-14
Entered: 2007-12-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0106U / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-11-25
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: Obesity
Preexisting Conditions: Asthma, morbid obesity, smoker, occasional ETOH. OCP unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02658

Write-up: Information has been received from a physician concerning a large female who received one dose of Gardasil. Subsequently, the patient was found dead in her truck from a blood clot that traveled from her legs to her lungs. The cause of death was reported to be a blood clot. Additional information has been requested. 3/5/08 Autopsy states COD as pulmonary thromboembolus w/deep vein thrombosis of right leg & obesity as contributing factor.


VAERS ID: 300259 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: North Carolina  
Vaccinated:2007-12-05
Onset:2007-12-07
   Days after vaccination:2
Submitted: 2007-12-10
   Days after onset:3
Entered: 2007-12-18
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2289CA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08700B / 2 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-07
   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: Syragis manufactured by MedImmune, lot #055607 0.92ml R&L thigh, 1st dose; Immune-globin manufactured by Gamastan-Tafecris, lot #26N8782, IM L thigh, 1st dose
Current Illness: Hypoplastic (L) Heart Syndrome
Preexisting Conditions: Mitralatresia - Aortic Atresia; Supraventricular tachycardia; GER reflux; (L) Vocal cord paresis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Complex congenital heart (hypoplastic (L)) repair with a modified normal/sano content. Vaccination 12/5 county on K/G expired en route to hospital 12/7. No post done at hospital. Vaccines were all #2 except Synagis #1.12/26/07-ER notes from facility for DOS 12/7/07-12/26/07-DX: cardiac arrest. Congenital heart anomaly. No autopsy performed. 12/27/07-COD hypoplastic left ventricle. CHF.


VAERS ID: 300400 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Arizona  
Vaccinated:2007-12-11
Onset:2007-12-11
   Days after vaccination:0
Submitted: 2007-12-19
   Days after onset:8
Entered: 2007-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B133AA / 2 RL / IM
HBPV: HIB POLYSACCHARIDE (HIBIMUNE) / PFIZER/WYETH 0500U / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54015D / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Nervous system disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Received Synagis at same visit
Current Illness: None, did have chronic problems
Preexisting Conditions: Holoproencephaly, hydrocephalus, blindness, G-tube dependent
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient died the night he was given immunizations; he had a chronic neurological condition of unknown etiology. 5/2/08 Reviewed ER medical records which consisted of EKG strip showing asystole & a copy of death certificate which states DOD as 12/12/2007 & COD stated as cardiopulmonary arrest; aspiration; congenital brain malformation. No autopsy was done.


VAERS ID: 300760 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2007-12-06
Onset:2007-12-08
   Days after vaccination:2
Submitted: 2007-12-12
   Days after onset:4
Entered: 2007-12-21
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B097AB / 1 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF201AB / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08690D / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1129U / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-08
   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: Thrush
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired on 12/8/07 after an accidental suffocation at home.


VAERS ID: 300774 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: California  
Vaccinated:2007-12-11
Onset:2007-12-13
   Days after vaccination:2
Submitted: 2007-12-21
   Days after onset:8
Entered: 2007-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B115AA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0436U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B97283B / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-13
   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: URI symptoms
Preexisting Conditions: 37 Week Twin
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Found Dead in Crib 2/27/2008 Autopsy Summary received with COD: Sudden Infant Death Syndrome (SIDS). Contributing: Acute Bilateral Otitis Media.


VAERS ID: 300901 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Unknown  
Vaccinated:2007-12-04
Onset:2007-12-07
   Days after vaccination:3
Submitted: 2007-12-21
   Days after onset:14
Entered: 2007-12-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ACZ1B101AA / UNK RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF054AA / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B47300A / UNK LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none.
Allergies:
Diagnostic Lab Data: Unknown. Labs and Diagnostics: WBCs on 12/7 9.0 and UA (-). LP revealed purulent CSF with glucose 1, protein 232, WBCs 145,600 (82 polys) 149,000 RBCs with GPC (unidentified) and GNR (E.coli) on Gram stain. Many intra and extracellular bacteria. CBC showed WBCs 22, BMP and UA WNL. Blood cx (+) for E. coli. Head CT with mildly dilated ventricles and evidence of meningitis. F/U head CT showed large areas of infarction bilat with hydrocephalus.
CDC Split Type: WAES0712USA08252

Write-up: Information has been received from a nurse practitioner, concerning an infant (gender and specific age not reported) who on an unknown date was vaccinated with a dose of PedvaxHIB (lot # not reported) and the day after vaccination died in the hospital, from meningitis (no details available). The NP stated there were "rumors in the community" that the death was related to PedvaxHIB. She felt it was possibly related to the vaccine recall, and had received "no definitive information." No further details were provided. Additional information has been requested. 12/28/07 No autopsy done per Decedant Affairs rep at hospital./pc 12/31/2007 Vax record and WCC of 12/04/2007 received from CDC. No concerns at this time. Temp 99.1''F. PE WNL. 01/04/2008 Death Cert received. COD: meningitis. 01/22/2008 MR received from hospital for DOS 12/11-12/2008. Child presented to ER after transfer from local hospital with DX: Meningitis and altered mental status. Initially seen by PCP on 12/7/07 for fever/vomiting. Pt has several 2-3 min seizure-like episodes: eyes rolling back and spacing out x 1 minute. No T-C activity. (+) irritability. Presented again to local hospital 12/9/07 with increasing irritability, emesis with nuchal rigidity. Pt admitted to ICU with (+) eye rolling, responsive only to painful stimuli. Pt had further seizures. Transferred following head CT showing large bi-hemispheric strokes. Intubated and sedated. Externalized ventricular shunt placed for CSF drainage. Neuro condition deteriorated progressively (posturing, not responsive to any stimuli) to brain death. Pt was extubated and care withdrawn per parent request. Pt expired at 1712. Assessment: Polybacterial meningitis, Hydrocephalus. 01/29/2008 D/C summary received for above hospitalization. Principal Final DX: Escherichia coli meningitis. Additional DX: Bilateral cerbral infarcts and hydrocephalus with increased intracranial pressure and seizures.


VAERS ID: 300933 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: New York  
Vaccinated:2007-12-03
Onset:2007-12-03
   Days after vaccination:0
Submitted: 2007-12-10
   Days after onset:7
Entered: 2007-12-26
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2509AA / UNK - / IM

Administered by: Public       Purchased by: Private
Symptoms: Death, Pulse absent, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-12-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: No acute - cleared for vaccine
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: At 10:30, patient assessed for contraindications for vaccine. No contraindications, consent signed, vaccine given. No s/d of reaction. 13:50, patient found by staff, unresponsive, no pulse, no respiration''s. MD notified. Stated patient expired due to disease and secondary diagnosis. 6/3/08 Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial fibrillation, CHF & cerebrovascular disease.


VAERS ID: 300934 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2007-12-17
Onset:2007-12-18
   Days after vaccination:1
Submitted: 2007-12-24
   Days after onset:6
Entered: 2007-12-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B125BB / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0260U / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54016D / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1393N / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Death, Diarrhoea, Melaena, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-12-23
   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: Synthroid; Amoxicillin
Current Illness:
Preexisting Conditions: Down''s Syndrome; Grade 5 Reflux; Hypothyroidism; Duodenal Atresia 1/7/08-records received- HX of duodenal atresia status post repair and Trisomy 21. 3/28/08- Status post surgical anastomosis for duodenal atresia on Day 2 of life.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: vomiting started after vaccine no fever for 2 days-soft stools tarry oral hydration done at hosp with Pedialyte 1/7/08-records received for DOS 12/23/07-Presented to ED with cardiac arrest. The patient was found by family in cardiac arrest, unresponsive, abdomen distended. Vomiting day before. 3/28/08-COD:Complications of a small bowel obstruction. Extensive small bowel adhesions involving the spleen, pancreas, stomach, liver and large bowel. Exucdate in patchy distribution over the surface of the small bowel, liver and retroperitoneal fat. Small bowel luminal narrowing and serosal congestion and hemorrhage. Bilateral cystic dilation of kidneys and ureters.


VAERS ID: 301159 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Idaho  
Vaccinated:2007-09-26
Onset:0000-00-00
Submitted: 2007-12-19
Entered: 2007-12-28
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B049AA / 2 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0155U / 1 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR AO1092 / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54007C / 2 RL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0968U / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Physical examination normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Vitals taken 09/26/2007 01:45; Body Length 25.5 in 25.591-29.134; Weight 14.8125 lbs 29-56; Head Circumference 43cm 42-47; Body Mass Index 16.0; Body Surface Area 0.33. Remainder of physical exam on 9/26/07 WNL.
CDC Split Type:

Write-up: Patient is a 4 month 12 day old male. Source of information on MD office visit of 9/26/07 was mother. Past medical history reviewed and found to be negative. Physical exam on 9/26/07 office visit was WNL. 12/28/07 Reviewed autopsy report which states COD SIDS. Sleeping in adult bed, supine position & found unresponsive w/vomitus on face. Findings at autopsy included: bilateral otitis media (culture neg), slight hepatomegaly & resolved SDH (probable birth trauma).


VAERS ID: 301744 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2000-08-30
Onset:2001-07-08
   Days after vaccination:312
Submitted: 2008-01-04
   Days after onset:2371
Entered: 2008-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS LY145A9 / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Anaemia, Antinuclear antibody negative, Arthralgia, Asthenia, Autoimmune disorder, Back pain, Blood calcium normal, Blood immunoglobulin G, Blood immunoglobulin M, Bone scan, Brachial plexopathy, Bursitis, Cancer pain, Chemotherapy, Chronic obstructive pulmonary disease, Coagulopathy, Cognitive disorder, Computerised tomogram abnormal, Convulsion, Death, Dehydration, Delirium, Dyspnoea exertional, Full blood count normal, Immunology test, Irritability, Joint swelling, Lethargy, Liver function test abnormal, Metastasis, Musculoskeletal pain, Neck pain, Neuropathy, Non-small cell lung cancer, Pain, Personality change, Pneumonia, Radiotherapy, Red blood cell sedimentation rate decreased, Restlessness, Spinal osteoarthritis, Synovial fluid analysis abnormal, Tonic clonic movements, Unresponsive to stimuli, Urinary incontinence, White blood cell count increased, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Dehydration (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-30
   Days after onset: 1180
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: Multivitamin
Current Illness: Unknown
Preexisting Conditions: Acute renal failure, alcohol consumption, blurred vision, brain metastasis, chronic obstructive pulmonary disease, corneal abrasion, death NOS, elevated liver function test, fatty liver, low back pain, muscular strain, non small cell lung carcinoma, orthostatic dizziness, osteoarthritic changes, pleurisy, pneumonia, progression of pre-existing cancer, pulmonary mass, renal cyst, smoking, vertebral bone spur, wears glasses. On 24 October 1995, the subject presented to the emergency room with lower back pain after "moving boulders"; on that date, degenerative osteoarthritic spurring of the lumbar spine was identified by X-ray. History of smoking one pack per day. Evaluation for cough and right chest pain in August 2002, at which time a left upper lung mass was identified.
Allergies:
Diagnostic Lab Data: Antinuclear antibody, 28Aug2001, negative; erythrocyte, sedimentation rate, 29Jul1998, 10 mm/hr; erythrocyte sedimentation rate, 01Sep1998, 7 mm/hr; erythrocyte sedimentation rate, 17Dec1998, 16 mm/hr; erythrocyte sedimentation rate, 16Jun1999, 20 mm/hr; erythrocyte sedimentation rate, 28Aug2001, 9 mm/hr. Diagnostic results: August 2002: A subsequent X-ray revealed mass in the apex of the left lung, and a bone scan was recommended in light of shoulder pain. 27 September 2004: His white blood cell count increased despite antibiotic therapy. 28 August 1998: Lyme Ab IgG and IgM by Western blot, "A diagnosis of Lyme disease is not confirmed; if early Lyme disease is suspected, recommend retesting in 2 to 4 weeks". 09 July 2001: Synovial fluid analysis revealed 1390 white blood cells/uL and "moderate" red blood cells, 20 percent mononuclear leukocytes, and 80 percent polymorphonuclear leukocytes. X-rays of right elbow showed normal results. 08 July 2004: Computed tomography scan of the head without intravenous contrast was of poor quality but was suggestive of cerebral metastasis; three or potentially four lesions in the brain strongly suspicious of metastatic disease, two with hyper-dense elements which may relate to small hemorrhagic foci. Complete blood count, calcium, and comprehensive metabolic panel results were "benign".
CDC Split Type: A0600399A

Write-up: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). An unspecified time after vaccination with LYMErix, the subject experienced arthralgia, body aches and pains, swollen joints, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune-mediated or other mechanism. At the time of reporting the outcome of the events was unspecified. The information in this case was received via a Statement of Injuries. Follow up information was received on 27 December 2007 via medical records. The subject''s history included non-small cell lung carcinoma, chronically elevated liver function tests, chronic obstructive pulmonary disease, osteoarthritic spurring of the lumbar vertebrae, and back pain. The subject received his first, second, and third doses of LYMErix (all administered intramuscularly in the left deltoid , 0.5 cc) on 16 June 1999, 05 July 1999, and 30 August 2000. Approximately 10 months after the third LYMErix injection on 08 July 2001, the subject presented to the emergency room due to pain in elbow. Right elbow radiology results were normal. On 23 July 2001, he was seen for follow up of right elbow swelling and was diagnosed with bursitis. Treatment included Celebrex. In early August 2002, the subject developed pain in the upper back over the right shoulder area. A subsequent x-ray revealed a mass in the apex of the left lung, and a bone scan was recommended in light of shoulder pain. He was diagnosed with non small cell lung cancer. The subject was hospitalized on 08 July 2004 with a chief complaint of generalized seizure (according to the subject''s wife) after experiencing tonic clonic activity and urinary incontinence. He had reportedly experienced irritability and personality changes in the preceding few months. In the emergency department, he exhibited agitation and delirium. He was "striking out" and required four-point restraint. Treatment included Dilantin and Valium. His oncologist was consulted due to end-stage non small cell lung cancer, and reported that the subject had undergone radiation therapy and chemotherapy following his diagnosis of small cell lung cancer, and his disease was reportedly "at a standstill". At the time of admission medications included Neurontin for arm neuropathy in addition to potassium chloride, Endocet, Ambien, oxandrine, Bextra, Ritalin, Prilosec, and "a variety of herbs and supplements". His pain medications were reported for treatment of neck pain. The indications for these medications, with the exception of Neuronton and pain medications, were not provided. A computed tomography scan was of poor quality but was suggestive of cerebral metastasis. It was noted that "metastases may certainly explain the seizure". Impression was of 1) non small cell carcinoma of lung, metastatic to brain with new onset seizures status post radiation and chemotherapy and 2) chronic neck and shoulder pain from metastatic lung cancer. He was discharged on 11 July 2004 with a final diagnosis of grand mal seizure and secondary diagnoses of multiple cerebral metastases, one and a half year history of non small cell lung cancer, and brachial plexopathy status post chemotherapy and radiation therapy. He returned to the emergency department on 27 September 2004 with increasing weakness and lethargy and bilateral plexopathies secondary to metastatic disease. He reported "several seizures" over the past several weeks, and increased dyspnea on exertion. At that time he was diagnosed with pneumonia "most likely post-obstructive from tumor". He was admitted with diagnoses including seizure disorder "secondary to his metastatic lung cancer", acute renal failure secondary to dehydration, coagulopathy with strong suspicion of liver metastases, anemia, and cancer pain. Renal function improved, but pulmonary status did not. His white blood cell count increased despite antibiotic therapy, and he experienced decreased responsiveness and restlessness. He died on 30 September 2004. Due to the original claim of arthralgia, body aches and pains, swollen joints, and rheumatologic, neurologic and or cognitive impairment associated with LYMErix vaccinations, the events of seizures and associated symptoms, arm neuropathy, personality change, irritability, delirium, and agitation were reported as adverse events. The events of seizures and urinary incontinence were assessed to be medically significant. However, due to the subject''s diagnosis of metastatic non small cell lung cancer with brain and possibly liver metastases and the lack of identification of an association with LYMErix vaccination, the remaining events and the subject''s hospitalization and death in September 2004 were considered to be incidental findings.


VAERS ID: 302022 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Unknown  
Vaccinated:2007-10-02
Onset:2007-10-08
   Days after vaccination:6
Submitted: 2008-01-08
   Days after onset:92
Entered: 2008-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0436U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Multi-organ failure
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-10-13
   Days after onset: 5
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: therapy unspecified
Current Illness: Mental retardation severity unspecified; Pulmonary hypertension; Ventricular septal defect; Cardiac failure congestive; Patent ductus arteriosus
Preexisting Conditions: PMH: profound mental retardation, dysmorphic facies, congenital heart disease, Bixler''s syndrome, pulmonary HTN, hypochloremic alklosis, HH, cleft lip/palate, multiple bony abnormalities & rib anomalies, s/p heart valve repair, subtotal hemicolectomy & partial ilectomy, tracheostomy, PEG feeding tube.
Allergies:
Diagnostic Lab Data: Unknown LABS: WBC 16.8 (H), H/H 7.7/25.6 (L), lymphs 55.3 (H), segs 38 (L). CXR showed cardiomegaly.
CDC Split Type: WAES0801USA00406

Write-up: Information has been received from a nurse practitioner concerning an 18 month old female with mental retardation, pulmonary hypertension, ventricular septal defect, congestive heart failure, patent ductus arteriosus and no known allergies who on 02-OCT-2007 was vaccinated intramuscularly in the right arm with the 1st 0.5ml dose of PEDVAXHIB (lot#656521/0436U). The nurse practitioner was calling from a long term care facility for mental retardation. The reporter stated that the patient was on numerous medications but did not specify them. On 08-OCT-2007, the patient went into cardiac arrest and was rushed to a local hospital 10 miles away. On the same day the child was transported via helicopter to another hospital. on 13-OCT-2007 at 7:30 pm, the patient died at the hospital. The cause of death was cardiac arrest and multiple symptom organ failure. Cardiac arrest and multiple symptom organ failure were considered to be immediately life-threatening, disabling, other important medical events and congenital anomalies by the nurse practitioner. Additional information has been requested. 1/11/08 Reviewed hospital medical records from initial hospital which reveals patient arrived in cardiac arrest w/cpr in progress on 10/8/2007. Reportedly playing in state school home when suddenly became unresponsive & apneic/pulseless. Resuscitated & transferred to higher level of care. FINAL ER Dx: cardio-pulmonary arrest. 1/11/08 Reviewed hospital medical records from transfer hospital which reveal patient admitted to PICU on pressors, antibiotics & ventilator. Developed multi-system organ failure includeing renal failure, liver failure, cardiac failure, respiratory failure & refractory shock. Admitted 10/9-10/13/2007 when expired. 5/15/09 Death certificate states COD as brain death; hypoxic ischemic injury; multiple congenital anomalies.


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