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VAERS ID: 163506 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Georgia  
Vaccinated:2000-11-21
Onset:2000-11-21
   Days after vaccination:0
Submitted: 2000-11-22
   Days after onset:1
Entered: 2000-12-11
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR 40422CA / 4 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA00123

Write-up: The pt received the flu shot on 11/21/00 without complications. The pt was found ill at home by his son and subsequently died at 5:00pm that same day.


VAERS ID: 163596 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Alabama  
Vaccinated:2000-12-04
Onset:2000-12-05
   Days after vaccination:1
Submitted: 2000-12-05
   Days after onset:0
Entered: 2000-12-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0415AA / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Cortef, DDAVP, Synthroid, Dimetapp, Ventolin
Current Illness: ROM, URI
Preexisting Conditions: Optic Glioma, Panhypopituitarism, GERD, Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt arrived at the medical center in full arrest. Grandmother had found him struggling for breath in bed. Death certificate received states cause of death: respiratory arrest due to cardiac arrest due to respiratory distress. Other significant conditions noted was a brain tumor.


VAERS ID: 163673 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2000-11-30
Onset:2000-12-01
   Days after vaccination:1
Submitted: 2000-12-12
   Days after onset:11
Entered: 2000-12-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E59090GA / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Circulatory collapse, Feeling abnormal, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-01
   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:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: CT200006

Write-up: Pt volunteer fireman, called out on evening of 12/1/00, was photographer. Wasn''t feeling well. Vomited at the scene. Refused treatment by EMT''s. Returned home, collapsed and EMT''s were unable to resuscitate.


VAERS ID: 163778 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Texas  
Vaccinated:2000-12-05
Onset:2000-12-07
   Days after vaccination:2
Submitted: 2000-12-08
   Days after onset:1
Entered: 2000-12-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0321BA / 4 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0813K / 3 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA547AA / 3 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Agitation, Coma, Cyanosis, Febrile convulsion
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: NONE
Preexisting Conditions: febrile seizure
Allergies:
Diagnostic Lab Data: autopsy - pending
CDC Split Type:

Write-up: The infant was examined on 12/5. The examination was normal and was given vaccination. The parents report that she appeared normal the evening of 12/5 and the day of 12/6. She awakened at 11 PM on 12/6 crying and was given a dose of Motrin for teething. When parents went to waken her on 12/7 AM she was found blue and unresponsive. She was pronounced dead at the scene by the paramedics. Autopsy states cause of death sudden death associated with history of febrile seizure disorder.


VAERS ID: 163810 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Maryland  
Vaccinated:2000-11-08
Onset:2000-11-19
   Days after vaccination:11
Submitted: 2000-12-12
   Days after onset:23
Entered: 2000-12-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV044 / 7+ LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling and tenderness (local)~Anthrax (no brand name)~12~48.00~In Patient
Other Medications: Synthroid; ASA
Current Illness: NONE
Preexisting Conditions: Hypothyroidism, past history of pulmonary embolism (1993)
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: 00AEFAV176

Write-up: The pt died suddenly at home. Cause of death given as acute myocardial infarction.


VAERS ID: 163884 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Male  
Location: Maryland  
Vaccinated:2000-10-26
Onset:2000-11-03
   Days after vaccination:8
Submitted: 2000-12-12
   Days after onset:39
Entered: 2000-12-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV044 / 4 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-13
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Headache~Vaccine not specified (no brand name)~1~52.00~In Patient
Other Medications: atenolol, cilostazol, Zocor, allopurinol, Ecotrin
Current Illness: NONE
Preexisting Conditions: hypertension, coronary artery disease, peripheral vascular disease, gout, hypercholesterolemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: 00AEFAV175

Write-up: The pt experienced cardiorespiratory arrest at work.


VAERS ID: 163936 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Missouri  
Vaccinated:2000-09-07
Onset:2000-09-08
   Days after vaccination:1
Submitted: 2000-12-11
   Days after onset:94
Entered: 2000-12-20
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0313CB / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0285K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R14902 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471655 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt was found deceased at 10:00 am on 9/8/00. Pt did take 6:00 AM feeding without complication. Found face down in corner of a "love seat" where she was sleeping. Autopsy states cause of death consistent with sudden infant death syndrome.


VAERS ID: 163937 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New Hampshire  
Vaccinated:2000-06-28
Onset:2000-07-12
   Days after vaccination:14
Submitted: 2000-12-12
   Days after onset:153
Entered: 2000-12-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0151K / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-07-12
   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:
Preexisting Conditions: On apnea monitor for prematurity. Hospitalized from birth until 5/22/00. Respiratory distress syndrome at birth. Secondary dx at birth: Metabolic acidosis, hypotension, hemo-dynamically insignificant heart murmur, patent foramenovalve, peripheral- pulmonary artery stenosis, apnea and bradycardia of prematurity, suck/swallow/breath incoordination, r/o sepsis (resolved), neutropenia (resolved), hyperbilirubinemia (resolved), retinopathy of prematurity stage 1, intra-retinal hemorrhage OD.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0019

Write-up: The baby died from SIDS.


VAERS ID: 163938 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: New Hampshire  
Vaccinated:2000-08-15
Onset:2000-09-19
   Days after vaccination:35
Submitted: 2000-12-12
   Days after onset:84
Entered: 2000-12-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 961A2 / 1 - / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM ENG3220A2 / 2 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA524AA / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R1345 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0020

Write-up: The pt died from SIDS.


VAERS ID: 164027 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New Hampshire  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-12-18
Entered: 2000-12-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness
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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ4854614DEC2000

Write-up: Post vax, the pt died. No further information was available at the date of this report. The reporter indicated that 9 pts experienced this event, however, they are not presently identifiable. 15 day follow-up states that the pt experienced flu-like symptoms as did a total of 9 pts.


VAERS ID: 164043 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-12-19
Entered: 2000-12-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ4993318DEC2000

Write-up: Post vax, the pt developed Guillain-Barre syndrome. No further information was available at the date of this report. FU received indicated the patient was an elderly female who received 1999-2000 formula influenza virus vaccine. See related case HQ5472103JAN2001.


VAERS ID: 164060 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2000-11-01
Onset:2000-11-02
   Days after vaccination:1
Submitted: 2000-12-19
   Days after onset:47
Entered: 2000-12-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E65620HA / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Myocardial infarction, Pneumonia, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-12
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Coumadin
Current Illness:
Preexisting Conditions: Arteriosclerotic cardiovascular disease; unknown atrial fibrillation
Allergies:
Diagnostic Lab Data: Influenza titer-neg
CDC Split Type: MPI2000049800

Write-up: Report received on 12/12/00, via telephone from a nurse regarding a possible adverse event associated with Fluvirin. On 11/1/00, an 80 year old male pt (DOB 8/1920), received vaccination with Fluvirin and 1 day later, developed a fever of unknown origin. The pt was seen in the ER and hospitalized. He was dx''d with pneumonia and died on 11/12/00 from respiratory failure secondary to the pneumonia. An influenza titer was done during the pt''s hospitalization with negative results. On follow-up, the reporter also stated that the physician felt that it was a coincidence of events that ensued following vaccination. No other information was available at the present time. Attempts are being made to obtain further information. FU shows the pt had a non Q wave myocardial infarction.


VAERS ID: 164158 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Arizona  
Vaccinated:2000-12-13
Onset:2000-12-15
   Days after vaccination:2
Submitted: 2000-12-19
   Days after onset:4
Entered: 2000-12-28
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0453AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: K-Dur, bumetanide, nitroglycerine, Zeroxin, Lipitor, Azmacort, Atrovent
Current Illness: NONE
Preexisting Conditions: CAD; Chronic CHF
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death within 48 hours, post vax; Myocardial Infarction.


VAERS ID: 164159 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Georgia  
Vaccinated:2000-11-30
Onset:0000-00-00
Submitted: 2000-12-20
Entered: 2000-12-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0435AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None reported.


VAERS ID: 164351 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2000-12-12
Onset:2000-12-15
   Days after vaccination:3
Submitted: 2000-12-21
   Days after onset:6
Entered: 2001-01-03
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5151A2 / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Coma, Crying, Dyspnoea, Hypotonia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy performed/toxicology labs are pending.
CDC Split Type: 20010000821

Write-up: This child received her 3rd Hep-B vaccine on 12/12/00 about 14:30. At 02:00, on 12/15/00, the parents were awakened by the child''s cry. They found her limp, unresponsive and gasping for breath. The parents called 911 and started CPR. The child was pronounced dead at the hospital. The parents came in on 12/19/00 and voiced their concern that the death may have been related to the Hep-B vaccine. Follow up information- Report 2001000092-1 describes the death of a 22 year old female who received an injection of hepatitis B vaccine (Engerix-B). The vaccinee was reported to be ab active, healthy child with no known acute or chronic medical conditions. She had no known allergies. There was no history of substance abuse and no family history of stroke, heart diesease, or sudden death. Her height and weight were not known, but she was described as "small for her age". There were no concurrent medications. the vaccinee received her first injection of Engerix B (lot ENG2205A2) on June 01, 2000 and her second injection of Engerix B (lot # ENG3141A2) on July 6, 2000. She had no adverse experiences following receipt of these two injections. She received her third injections of Engerix B on Dec 12, 2000. After receiving the third injection, she reportedly took one tablet of acetaminophen (Tylenol) to prevent local soreness. She was well until approximately 02:00 on Dec 15, 2000, when her parents were awakened by the child''s cry. They found her lying in bed limp, unresponsive to verbal stimuli, and gasping for breath. Her eyes were half open. The vaccinee then stopped breathing. Her parents began cardiopulmonary resuscitation and summoned emergency medical personnel. The vacinee was transported by ambulance to the local hospital, where she was pronounced dead on arrival. An autopsy reportedly did not reveal a cause of death, although toxicology results were pending as of Feb 26, 2001. The vaccine provider considers the death to be unrelated to Engerix B administation. The most recent information, received on March 2, 2001, indicated that the childs parents voiced their concern that the death may have been related to the hepatitis B vaccine. The reportr stated that the vaccinee''s 13 year old brother received three injections of Engerix B on the same dates, and from the same lots, as his sister. The brother had no adverse experience following receipt or any of the injections. He continued to be well as of Jan 04, 2001.


VAERS ID: 164355 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-12-21
Entered: 2001-01-03
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Hypoxia, Infection, Pneumonitis, Rash vesicular, Respiratory distress, Viral infection
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Congenital cytomegalovirus infection
Allergies:
Diagnostic Lab Data: Respiratory aspirate specimen; BAL fluid specimen; PCR analysis present; sweat analysis positive
CDC Split Type: WAES00120881

Write-up: Information has been received from a physician concerning an 11 year old female pt who was vaccinated with varicella virus vaccine live and approx. 5 weeks, post vax, presented with a diffuse vesicular rash and respiratory distress requiring hospitalization and intubation. The pt was dx''d with "post vaccine varicella pneumonitis". A respiratory aspirate, as well as BAL fluid specimens were both found to be positive for VZV through the hospital laboratory, however, the physician stated that a number of cultures had been "contaminated with bacteria". The pt is currently improving on acyclovir and is undergoing an "immune work-up". The physician indicated as of 12/12/00, the pt had been extubated. The physician is interested in submitting specimens to a university for PCR analysis. No further information is available. 15-Day follow-up received on 2/7/01 provided no additional data. The follow up received on 7/23/03 indicated that both the bronchioalveolar lavage and the endotracheal secretions specimen were VZV (+). Both specimens were contaminated with bacteria. The presence of Oka/Vaccine VZV was identified by PCR analysis. Further follow-up info from a physician indicated suspicion that the pt has cystic fibrosis with a positive sweat test. "The other reason this was suspected was that the bronchial secretions had an incrreased bacteria load which lead the lab to pursue PCR since they were not able to grow VZV." The physician indicated that "the pt is undergoing an extensive immunologic evaluation." Follow-up info from a physician for the case of hte 11 year old female which indicated that he believes he has discovered a "novel" immune deficiency. Subsequently, the patient''s experience was reported in a published article. The patient had recurrent and presumably virus respiratory infections and mental retardation and presented with a 5 day history of an erythematous rash over her trunk and scalp and with diminished activity. Three days before presentation she developed labored breathing, cough and increased respiratory secretions. on the day of admission, she was lethargic, hypothermic, hypoxemic, and had several erythematous papulovesicular lesions over her turnk. Results of the lab studies performed when she was admitted were notable for providing evidence of leukopenia, thrombocytopenia, and elevated serum alanine aminotransferase. Radiography of the patient''s chest revealed bilateral symmetric alveolar infiltrates. The patient was admitted to the ICU, and mechanical ventilation was administered. IV acyclovir and methylprednisolone were also admitted. The patient was extubated on hospital day 6 and was discharged on hospital day 17, to complete a 21 day course of acyclovir with follow up at an immunology clinic. It was noted that he patient died 10 months after the reported illness, presumably because of the embolic complications related to a closed fracture of the femur. Results of the analysis of skin lesion smears were positive for VZV, by indirect immunofluorescent assay. An endotracheal tube-aspirate sample was subjected to RFLP analysis and was identified as the Oka vaccine strain. Assessment of the patient''s immune system revealed a normal phagocytic and complement function as well as IgG, IgA, and IgM levels that were normal to high, both during her acute illness and recovery. It was noteworthy that the patient had markedly elevated titers of antibodies against several Herpes viridae: CMV specific IgG was $g 14 IU/mL but IgM was absent; Epstein Barr virus specific IgG was $g19 IU/mL and herpes simplex virus-specific IgG was 1.08 IU/mL. During the patient''s acute infection, VZV specific IgG was elevated to 7.51 IU/mL, indicating VZV specific immunity. It was noted that VZV specific lymphocyte proliferation measured 5 months after the patient''s disseminated VZV infection revealed appropriate virus specific proliferation. The patient was negative for HIV-1 and -2, by antibody testing, RT PCR for HIV RNA, and culture. Lymphocyte analysis revealed a low to normal absolute lymphocute count during our patient''s illness, with an inverted CD4-CD8 ratio that normalized 1 month later. It was noted that the levels of the patient''s NKT cells, as measured on the basis of either CD16/CD56/CD3 or CD161/CD3, were abnormally low. Multiple analyses of the patient''s PBMC''s by flow cytometry revealed a deficiency of CD16/CD56/CD161/CD3 NKT cells in general and a profound deficiency of Valpha24 iNKT cells in particular. It was noted that her immunodeficiency had presented only as a recurrent upper respiratory tract infections; no mention was made of past measles immunization, and she may not have had difficulties with the vaccine. No further info is available.


VAERS ID: 164361 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:2000-12-05
Onset:2000-12-08
   Days after vaccination:3
Submitted: 2000-12-28
   Days after onset:20
Entered: 2001-01-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0428AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Cough, Diarrhoea, Headache, Influenza like illness, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type: U200000993

Write-up: It was reported that a male pt received Fluzone SV ''00-''01 vaccination on 12/5/00. Approx. 3 days, post vax, pt developed "flu-like" symptoms. Pt was admitted to the hospital on 12/10/00. Pt expired on 12/18/00 and an autopsy was done, results not provided. Further information requested. Autopsy also states patient had headaches, muscle aches, diarrha, nausea, vomiting, fever, cough, sore throat, abdominal pain.


VAERS ID: 164442 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: California  
Vaccinated:1999-04-27
Onset:1999-08-12
   Days after vaccination:107
Submitted: 2000-12-21
   Days after onset:497
Entered: 2001-01-04
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (CERTIVA) / NORTH AMERICAN VACCINES C002 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 2930A2 / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 412353A / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. P01275 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-08-12
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This pt expired probably due to SIDS per pt''s doctor. No record in pt''s chart but pt''s doctor said that the death was reported in the newspaper and that the baby was found lying face down in crib. No record at county coroner''s office.


VAERS ID: 164478 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-01-03
Entered: 2001-01-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5472103JAN2001

Write-up: A nurse reported that a pt received an injection of 2000-2001 formula influenza virus vaccine in 2000 and subsequently, developed Guillain-Barre syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA. See cancelled report, HQ4993318DEC2000. Follow-up received on 1/2/01, indicated that the pt was an elderly female who received 1999-2000 formula influenza virus vaccine. Five to 6 months, post vax, she developed Guillain-Barre syndrome. She died.


VAERS ID: 164642 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Arizona  
Vaccinated:2000-10-18
Onset:2000-10-20
   Days after vaccination:2
Submitted: 2001-01-04
   Days after onset:76
Entered: 2001-01-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0317AB / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 471871 / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0161 / 2 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471226 / 2 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Anorexia, Apnoea, Cardiac arrest, Fatigue, Pneumonia
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 (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Milicon drops
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy report-haven''t received yet
CDC Split Type:

Write-up: Within 48 hours post vax, the pt was found not breathing and had no heart rate. Following the vaccination she had been very tired and missed some feedings. When she was found not breathing, she was rushed to the hospital and within an hour of being found they were able to get a heart rate with resuscitation efforts. She remained intubated in the hospital but was brain dead and died on 10/21/00. Autopsy states cause of death as pneumonia.


VAERS ID: 164712 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Montana  
Vaccinated:2000-11-10
Onset:2000-11-11
   Days after vaccination:1
Submitted: 2000-12-15
   Days after onset:34
Entered: 2001-01-16
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 968A2 / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0787K / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0118 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473338 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: MT0102

Write-up: None reported to this office. Autopsy states cause of death as sudden infant death syndrome.


VAERS ID: 164713 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Massachusetts  
Vaccinated:2001-01-05
Onset:2001-01-06
   Days after vaccination:1
Submitted: 2001-01-08
   Days after onset:2
Entered: 2001-01-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0313AA / UNK RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 471876 / UNK RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1327J / UNK LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473341 / UNK RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1869J / UNK LL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-06
   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: Poliovax by Connaught, Lot #R0692 given SC
Current Illness: Constipation
Preexisting Conditions: Cerebral dysgenesis, congenital CMV, developmental delay
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 1/8/01, the physician received a phone call stating that the pt died on 1/6/01 in the A.M.


VAERS ID: 164715 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Arizona  
Vaccinated:2000-10-19
Onset:2000-10-23
   Days after vaccination:4
Submitted: 2000-10-24
   Days after onset:1
Entered: 2001-01-16
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0328B4 / UNK LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0788K / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0160 / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471226 / UNK RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Coma, Cyanosis, Pneumonitis, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-23
   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: NONE
Current Illness:
Preexisting Conditions: Baby was a twin.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 10/23/00 at 17:15, doctor received a phone call from ER stating baby brought in. Found in bed, already had some rigor/cyanosis; coded but pronounced dead. Autopsy states the cause of death as interstitial pneumonitis. Also states baby girl was found unresponsive in her play pen, lung congestion


VAERS ID: 164757 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Massachusetts  
Vaccinated:2000-12-19
Onset:2000-12-19
   Days after vaccination:0
Submitted: 2001-01-08
   Days after onset:20
Entered: 2001-01-17
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0712K / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Post mortem exam revealed no specific cause of death.
CDC Split Type:

Write-up: The pt died from SIDS less than 12 hours post vax.


VAERS ID: 164758 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2000-12-19
Onset:2000-12-20
   Days after vaccination:1
Submitted: 2000-12-21
   Days after onset:1
Entered: 2001-01-17
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008175 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of heart problems in the past.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: LA010101

Write-up: The pt experienced a heart attach and died. The pt had a hx of heart problems in the past.


VAERS ID: 164914 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Connecticut  
Vaccinated:2001-01-10
Onset:2001-01-12
   Days after vaccination:2
Submitted: 2001-01-17
   Days after onset:5
Entered: 2001-01-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0278AB / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 613803A / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R1472 / 1 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Lung disorder, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-12
   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: Synagis
Current Illness: BPD
Preexisting Conditions: History of BPD, on nasal O2 and home monitor. Premature at 31 weeks gestation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: CT200101

Write-up: A call was received from a medical examiner stating the child had died of SIDS on 1/12/01. Autopsy states pulmonary congestion and edema. Final cause of death given as sudden death associated with bronchopulmonary dysplasia.


VAERS ID: 164955 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:1990-02-01
Submitted: 2001-01-15
   Days after onset:4001
Entered: 2001-01-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Convulsion, Drug ineffective, Dysarthria, Electroencephalogram abnormal, Encephalitis, HIV infection, Haemoglobin decreased, Leukopenia, Lymphopenia, Muscle twitching, Necrosis, Nervous system disorder, Respiratory distress, Tachypnoea, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: hemophilia A, HIV
Current Illness:
Preexisting Conditions: Hemophilia A; human immunodeficiency virus infection
Allergies:
Diagnostic Lab Data: CSF and CT of head-were nml; EEG-showed right frontal slowing with spike discharges centrally; CBC-nml; CXR-nml; lab-showed evidence of the syndrome of inappropriate secretion of adrenocorticotropic hormone was found; Titers of measles antibody at this time were undetectable; autopsy-the brain weighed 1.540 g (expected weight, 1.350 g) and its gross characteristics were nml; Focal acute neuronal necrosis was evident in the dentate nucleus
CDC Split Type: WAES01010267

Write-up: In 4/90, 11 days post vax, the pt experienced recurrent focal seizures. At the time his HIV infection was diagnosed in 10/85, blood analysis consistently revealed leukopenia, mild thrombocytopenia and hemoglobin concentrations of 11.2 to 13.6, lymphocyte counts were around 200-300, CD4 to CD8 ratios of 0.2-0.47. In 10/89, therapy with zidovudine was initiated. The pt had no symptoms related to HIV infection or zidovudine therapy. Although he had received the measles vaccine in 1973 at the age of 3 and a dose of MMR in 1976 at the age of 7, the pt was admitted to the hospital for three days in 2/90 with uncomplicated measles. Tachypnea and respiratory distress responded promptly to therapy with oxygen and aerosolized ribavirin. The pt responded well until two months later, when he presented after two days of recurrent right arm twitches without fever. Physical exam revealed only continuous fine twitches of th right arm. CSF analysis and computed tomography of the head gave normal results, electroencephalography, however, showed right frontal slowing with spike discharges centrally, persisted despite therapeutic anticonvulsant concentrations in serum. the pt was admitted 11 days after the onset of seizures for further diagnostic evaluation. At the time of admission, he was conscious and afebrile. He had right-arm and right-leg twitching but was able to walk. His mental status and the results of motor and sensory examination were normal. Although the latter condition responded to the fluid restriction, the pt developed slurred speech and gradually became unresponsive requiring endotracheal intubation. A 10 day course of IV therapy was given. The pt remained comatose, experiencing continuous focal seizures that could not be controlled with anticonvulsant agents. Neurological and electroencepahlographic exam on day 24 of hospitalization indicated brain death. Mechanical ventilation was discontinued on day 30. The cause of death was subacute measles encephalitis.


VAERS ID: 165145 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2000-12-29
Onset:2001-01-03
   Days after vaccination:5
Submitted: 2001-01-09
   Days after onset:6
Entered: 2001-01-24
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0313AB / UNK RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3318B9 / 2 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA483AB / UNK LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R14902 / UNK RL / -

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Coma, Cyanosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), 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: 2001-01-03
   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: congestion
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Medical examiner''s report-pending 6-8 weeks
CDC Split Type: TX0101

Write-up: Pt found in crib unresponsive and cyanotic baby. CPR started by EMS and transported to local hospital. Pt stayed in asystole even after 3 epi doses and 2 atropine CPR. Pronounced DOA at ER and medical examiners office notified and body transferred.


VAERS ID: 165708 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: New York  
Vaccinated:2001-01-26
Onset:2001-01-26
   Days after vaccination:0
Submitted: 2001-01-29
   Days after onset:3
Entered: 2001-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1475K / 3 - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Myocarditis, Pyrexia, Upper respiratory tract infection, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: URI, ? Viral.
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CBC; BMP MG PHOS were to be done that day
CDC Split Type:

Write-up: Autopsy pending = Final cause of death. Most likely acute myocarditis. Questionable viral awaiting final culture results. Child has mild temperature 100., and URI. Autopsy states cause of death as myocarditis.


VAERS ID: 165308 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Florida  
Vaccinated:2000-12-13
Onset:0000-00-00
Submitted: 2001-01-25
Entered: 2001-01-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0448AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Guillain-Barre 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), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tiazac, Vioxx, Cozaar, Lipitor
Current Illness: unspecified shortness of breath
Preexisting Conditions: allergy to Motrin, HPTN, OA, gastritis, diverticulosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001002100

Write-up: Sometime following vaccination, the pt developed [[name]] Barre Syndrome. The pt was hospitalized on 1/22/01. Further information is requested. F/U correspondence rec''d on 2/27/01 additional pt and the vaccine administrator info were provided. From faxed f/u correspondence rec''d on 6/18/01 for the doctor,stated that the pt was transferred from one hospital to another hospital on 2/8/01. Teh following info was sent to the doctor on 6/26/01. Date of admission to hospital 2/9/01, date of expiration 3/28/01 at 12:28pm. Dx at time of death Guillian-Barre'' syndrome immediate cause of death due to respiratory failure due to problems associated with [[name]] -Barre'' syndrome. Follow up 07/26/2001: "final diagnosis was GBS. Diagnosis was not made by a neurologist. it is not known if the patient experienced any other illnesses previous to GBS."


VAERS ID: 165497 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Texas  
Vaccinated:2000-11-21
Onset:2000-11-26
   Days after vaccination:5
Submitted: 2001-01-23
   Days after onset:58
Entered: 2001-02-01
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR 40428AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cerebral haemorrhage, Cerebrovascular disorder, Delirium, Headache, Vein disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa
Current Illness: depression, stress reaction
Preexisting Conditions: seasonal allergies, stress reaction, depression
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: The mother states patient had a headache and had been vomiting and collapsed.Mom found her unrepsonsive. Went to ER found blood in head. Went by care flight and 2nd hospital for surgery attempted; didn''t wake, worse bleeding from "abnormal plexus of veins" in cerebellum patient expired. Death certificate states cause of death to be cerebral herniation due to rupture of cerebellar arteriovenous malformation.


VAERS ID: 165525 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Alabama  
Vaccinated:2000-12-08
Onset:2000-12-09
   Days after vaccination:1
Submitted: 2000-12-09
   Days after onset:0
Entered: 2001-02-02
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008187 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Mydriasis, Pulmonary congestion, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-09
   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: insulin in AM and PM
Current Illness:
Preexisting Conditions: type I diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt was found in bed at home without a pulse of respirations at 8:00 am on 12/9/00. She was given a glucogon injection and CPR was started and continued until EMS arrived. The pt was intubated and 2 doses of epinephrine and 1 dose of atropine were given during transport to the ER. The pupils were fixed and dilated. At the ER, the pt received epinephrine and atropine in the ER. The pt expired at 9:30 AM on 12/9/00 with cause of death being cardiopulmonary arrest. The pt had taken the normal dose of insulin on 12/8/00 with an accucheck of 147 at 10:20PM on 12/8/00. She had received the flu vaccine at 3:00PM on 12/8/00 in the physicians office. Death certificate states cause of death to be cardiopulmonary arrest. Autopsy report states: pulmonary vascular congestion and edema.


VAERS ID: 165569 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: California  
Vaccinated:2000-11-08
Onset:2000-11-09
   Days after vaccination:1
Submitted: 2001-01-18
   Days after onset:70
Entered: 2001-02-06
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E67330KA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Headache, Injection site haemorrhage, Injection site pain, Neck pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol #3, Atrovent Inhaler, Valium, Altace, Pravachol/Azmacort
Current Illness:
Preexisting Conditions: Bronchitis, asthma, back and heart surgery history with back surgery 2 months previously and hayfever. Myeloid leukemia, ASHD.
Allergies:
Diagnostic Lab Data: Blood work, Urine test, Bone Marrow
CDC Split Type: CA000163

Write-up: One day post vax the pt had a sore arm and some slight bruising. The aching increased up into his neck with a bad headache, and eventually to both shoulders and down the other arm. By the next day his pain was so severe, his wife drove him to the ER. FU: pt passed away at home. Cause of death: myeloid leukemia and ASHD.


VAERS ID: 165630 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Tennessee  
Vaccinated:2000-12-12
Onset:2000-12-23
   Days after vaccination:11
Submitted: 2001-01-08
   Days after onset:16
Entered: 2001-02-07
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 960A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0297K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T01862 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473338 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN00052

Write-up: Immunization was given on 12/12/2000; weight 11lbs 10ozs, temperature 97.0. The infant died of SIDS on 12//23/2000.


VAERS ID: 165631 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Wisconsin  
Vaccinated:1999-04-05
Onset:0000-00-00
Submitted: 2001-02-05
Entered: 2001-02-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 888A2 / 1 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Brain oedema, Influenza like illness, Myocarditis, Viral infection
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-04-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type: 20010027841

Write-up: Report 20010027841 describes acute viral myocarditis and diffuse brain swelling in an 11 month old male. This report was received from an attorney, and the attorney''s "medical expert", and has not been verified by a physician or other health professional. The vaccinee and his family had no history of drug allergies or vaccine reactions. The vaccinee was healthy with no prior or current illness. He was taking no medications except for the vaccines listed below. On 04/05/1999, the vaccinee received vaccinations of IPV OPV, and Hib (reportedly non-Smithkline Beecham products) in addition to Infanrix. On 04/05/1999, the vaccinee received the unspecified dose of Infanrix. At an unspecified time thereafter, the vaccinee developed flu-like symptoms (nos). His symptoms worsened, and he was transported to the hospital on 04/11/1999. During transport, the vaccine "coded" and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute myocarditis and diffuse brain swelling. Reportedly, post-mortem viral titers were "uninformative" (nos). The reporter indicated that he believed that the events were most likely related to the OPV / IPV vaccinations, and not to Infanrix. Cause of death given as acute viral myocarditis. Also, there was brain swelling.


VAERS ID: 165790 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: South Carolina  
Vaccinated:2001-01-11
Onset:2001-01-11
   Days after vaccination:0
Submitted: 2001-02-05
   Days after onset:25
Entered: 2001-02-13
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cyanosis, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: prematurity (29 weeks), ROP
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This patient presented to ED in shock. The patient was then transported to PICU. The patient in shock requiring cardiopulmonary resuscitation. The patient expired approximately 72 hours after admission. The patient had received Prevnar the day prior to admission. Autopsy shows baby was cyanotic, not breathing


VAERS ID: 165791 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Alabama  
Vaccinated:2001-01-05
Onset:2001-01-06
   Days after vaccination:1
Submitted: 2001-01-19
   Days after onset:13
Entered: 2001-02-13
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0341BA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3233C9 / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 473379 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472045 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-06
   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:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt died from sudden infant death syndrome on 1/6/01 within 18 hours of vaccine administration.


VAERS ID: 165921 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Idaho  
Vaccinated:2000-12-18
Onset:0000-00-00
Submitted: 2000-12-30
Entered: 2001-02-16
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 159345A / 1 - / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 518A2 / 2 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 593453A / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. 21437 / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Colic-resolving
Preexisting Conditions: Colic-resolving
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID01004

Write-up: Infants cause of death SIDS


VAERS ID: 165922 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Florida  
Vaccinated:2000-12-12
Onset:0000-00-00
Submitted: 2001-02-13
Entered: 2001-02-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBTITER) / PFIZER/WYETH 581253 / 3 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0580K / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 475382 / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1249K / 1 LL / SC

Administered by: Private       Purchased by: Public
Symptoms: Cardio-respiratory arrest, Encephalopathy
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent, albuterol
Current Illness: Gastroenteritis
Preexisting Conditions: Chronic lung disease; prematurity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This infant died of cardiopulmonary arrest of unknown etiology; at this time autopsy is pending. Autopsy stated cause of death as acute encephalopathy.


VAERS ID: 165924 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Idaho  
Vaccinated:2000-12-01
Onset:2000-12-15
   Days after vaccination:14
Submitted: 2001-01-02
   Days after onset:18
Entered: 2001-02-16
   Days after submission:45
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / PFIZER/WYETH 4008181 / UNK - / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lescol, Verapamil, Zestril, Zantac, Coumadin, ASA, Vitamins
Current Illness: NONE
Preexisting Conditions: No known allergies, CAD, PVD, HTN, PUD, Oral CA, Hyperlipidemia
Allergies:
Diagnostic Lab Data: CT Scan head, CBC Chem panel - All Wnl
CDC Split Type: ID01003

Write-up: This patient has Guillain Barre'' Syndrome, He was hospitalized. Follow up 07/06/2001: "Final diagnosis was GBS. Patient experienced other previous illnesses or medical conditions before the onset of GBS, however, it was not stated. Patient was previously vaccinated with INfluenza prior."


VAERS ID: 165969 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Maryland  
Vaccinated:2000-12-13
Onset:2000-12-20
   Days after vaccination:7
Submitted: 2000-12-29
   Days after onset:9
Entered: 2001-02-20
   Days after submission:53
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 7330BA / 2 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0610J / 2 LA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. P0998 / 2 RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-20
   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: heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt died one week after receiving immunizations.


VAERS ID: 165970 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Florida  
Vaccinated:2000-11-15
Onset:2000-11-15
   Days after vaccination:0
Submitted: 2001-02-13
   Days after onset:90
Entered: 2001-02-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E71290LA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Aneurysm, Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received phone from from daughter of pt requesting manufacturer and lot number. Stated that her father died at 8:30 PM the day he received the flu vaccine from a heart aneurysm.


VAERS ID: 165974 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Florida  
Vaccinated:2001-01-16
Onset:2001-01-23
   Days after vaccination:7
Submitted: 2001-02-14
   Days after onset:22
Entered: 2001-02-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Encephalitis, Immune system disorder
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: failure to thrive, immunodeficiency
Allergies:
Diagnostic Lab Data: spinal tap - pending
CDC Split Type: WAES01020506

Write-up: Information has been received from a physician concerning a 14 month old female with failure to thrive and possible immunodeficiency who on approx. 1/16/01, was vaccinated with MMR II. On approx. 1/23/01, the pt experienced encephalitis, seizures and immune deficiency (that could have possibly been present prior to vaccination). The encephalitis, seizures and immune deficiency required hospitalization. At the time of the report (2/6/01), a spinal tap was pending. The pt''s hospitalization continued and the pt was noted to be in poor condition. Additional information has been requested. Follow-up states the pt has died.


VAERS ID: 165976 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-08
Entered: 2001-02-20
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Difficulty in walking, Guillain-Barre syndrome, Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: myelodysplastic syndrome
Allergies:
Diagnostic Lab Data: Guillain Barre Syndrome
CDC Split Type:

Write-up: On 01/28, this patient had progressive weakness of the lower extremities, aching and pain of lower extremities, numbness, and difficulty walking. The symptoms have been ongoing for 3 months.


VAERS ID: 165979 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Minnesota  
Vaccinated:1998-10-21
Onset:1999-01-01
   Days after vaccination:72
Submitted: 2001-02-15
   Days after onset:776
Entered: 2001-02-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0975770 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amnesia, Confusional state, Mental impairment, Neoplasm
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001004120

Write-up: Following vaccination the pt''s family noticed a sudden onset of confusion and mental deterioration in 1/99. A rapid progression from short-term memory loss to death in March 2000. A diagnosis of paraneoplastic disorder was given. Further information is requested.


VAERS ID: 166139 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Unknown  
Vaccinated:2000-07-19
Onset:2000-08-27
   Days after vaccination:39
Submitted: 2001-02-21
   Days after onset:178
Entered: 2001-02-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 961A2 / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0427K / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 470140 / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R06684 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472542 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-08-27
   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: UNK
Current Illness:
Preexisting Conditions: Gastroesophageal reflux disease (The child experienced a life-threatening event due to GERD at 12 days of age.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ7326116FEB2001

Write-up: Information has been received from an investigator concerning a 3 month old female who received her 1st injection of Prevnar, Hib-Titer, Infanrix and IPV vaccines and her 2nd injection of Recombivax-HB vaccine on 7/19/00, as part of a study trial. On 8/27/00, the child died due to sudden infant death syndrome. Both the investigator and the medical monitor agree that this event was not related to vaccine administration.


VAERS ID: 166140 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2000-04-25
Onset:2000-06-14
   Days after vaccination:50
Submitted: 2001-02-20
   Days after onset:251
Entered: 2001-02-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 921A2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 469398 / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. P03013 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471213 / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dermatitis, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type: HQ7326316FEB2001

Write-up: Information was received from an investigator regarding a 2 month old male who received his vaccinations on 04/25/2000. On 06/14/00, at age of 4 months, the patient died. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. Both the investigator and medical monitor consider this event not related to vaccine administration. This report of a serious, labeled event is being submitted to the FDA in a 15-day time frame, as requested by FDA. Autopsy also stated the infant had dermatitis, pulmonary edema and congestion.


VAERS ID: 166169 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Illinois  
Vaccinated:2000-11-13
Onset:0000-00-00
Submitted: 2000-11-15
Entered: 2001-02-27
   Days after submission:104
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0313BA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0789K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R1433 / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cyanosis, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-14
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: NONE
CDC Split Type:

Write-up: This patient died 11/14/00, from possible SIDS. He was taken to the ER 11/14/00, after being found in his crib cyanotic at 8:30 AM. Autopsy also states pulmonary congestion and edema. Final opinion of autopsy is the infant died because of sudden infant death syndrome.


VAERS ID: 166170 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Unknown  
Vaccinated:2000-08-07
Onset:2001-01-09
   Days after vaccination:155
Submitted: 2001-02-22
   Days after onset:44
Entered: 2001-02-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 961A2 / 3 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1736J / 2 RL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 470140 / 3 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472542 / 1 LL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardio-respiratory arrest, Coma, Hypoxia, Sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (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 (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-11
   Days after onset: 2
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: UNK
Current Illness:
Preexisting Conditions: 2/20-bronchiolitis and given Albuterol; 1/4/01-croup; 1/7/01-inner ear infection and given Vantin
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ7324416FEB2001

Write-up: Information has been received from an investigator concerning a 15 month old male who received his first injection of Prevnar, his second injection of Recombivax-HB, and his third injection of Hib-Titer and Infanrix vaccines on 08/07/00. The child was found in his crib one morning not breathing and in cardiac arrest. The child was taken to a local emergency room where a heartbeat was re-established following a long code. The child was placed on a ventilator, but was unresponsive to light and painful stimuli. The patient was removed from the ventilator and died due to "SIDS-LIKE SYNDROME" on 01/11/01. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. NOTE: This report is being submitted in a 15-day time frame as requested by FDA. F/U received on 4/25/02 from the study investigator contained autopsy results. The reported cause of death has been changed from "Sids-like syndrome" to "cardiorespiratory failure (cardio-respiratory arrest) secondary to possible sepsis, etiology unknown" as found upon autopsy. The investigator considered the event not related to vaccine administration.


VAERS ID: 166211 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Washington  
Vaccinated:2001-01-25
Onset:2001-01-29
   Days after vaccination:4
Submitted: 2001-02-01
   Days after onset:3
Entered: 2001-02-28
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 956A2 / 2 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 522AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R02352 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472046 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-29
   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: NONE
Allergies:
Diagnostic Lab Data: Autopsy - SIDS
CDC Split Type:

Write-up: Pt died of SIDS on 1/29/01, in the afternoon. She had no preceding symptoms was breast fed about 1 1/2 hour before the event where she was found dead in a crib. Pathologist''s autopsy findings consistent with SIDS.


VAERS ID: 166212 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Florida  
Vaccinated:2001-02-20
Onset:2001-02-21
   Days after vaccination:1
Submitted: 2001-02-21
   Days after onset:0
Entered: 2001-02-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM 684B6 / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Atherosclerosis, Cardiovascular disorder, Diabetes mellitus, Hypertension, Obesity, Unevaluable event
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: CHF; CHD; IDDM
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type:

Write-up: Pt was given Hep-A vaccine at 18:00-18:15. He was a chaplain with the Police Dept and was riding with a Police Officer. The Police Officer took the pt home at 23:30. States that the pt had no complaints at that time. At 02:15, the Police Dept was informed by the pt''s wife that he had been sent to the hospital and died. Autopsy states cause of death as atherosclerotic cardiovascular disease. Other significant conditions: diabetes, hypertension, obesity.


VAERS ID: 166213 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: New Mexico  
Vaccinated:2001-02-09
Onset:0000-00-00
Submitted: 2001-02-16
Entered: 2001-02-28
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0317BB / UNK LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1827K / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0484 / UNK LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474734 / UNK LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-15
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: Resolved bronchiolitis; 35 week preemie
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No data received. Autopsy states cause of death as probale asphyxia.


VAERS ID: 166214 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Washington  
Vaccinated:2001-02-07
Onset:2001-02-09
   Days after vaccination:2
Submitted: 2001-02-14
   Days after onset:5
Entered: 2001-02-28
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 975A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA528AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R03972 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474724 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Bronchiolitis January, 2001
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Parents found infant in crib upon arising; infant had expired.


VAERS ID: 166215 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Maryland  
Vaccinated:2001-02-05
Onset:2001-02-06
   Days after vaccination:1
Submitted: 2001-02-08
   Days after onset:2
Entered: 2001-02-28
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0356BA / 3 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 474709 / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472552 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Irritability, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-06
   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: Tylenol prn
Current Illness: NONE
Preexisting Conditions: Prematurity (35 weeks); Twin gestation
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: Pt received vaccines on 2/5/01 in the PM. Did experience fussiness and low-grade fever. Was treated with Tylenol. In the AM of 2/6/01, was found unresponsive.


VAERS ID: 166230 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Utah  
Vaccinated:1999-07-21
Onset:1999-07-22
   Days after vaccination:1
Submitted: 2000-10-26
   Days after onset:462
Entered: 2001-03-01
   Days after submission:126
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 46235J / UNK - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0601J / 3 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. N7272 / UNK - / IM

Administered by: Public       Purchased by: Public
Symptoms: Anoxia, Brain oedema, Convulsion, Lethargy, Opisthotonus, Retinal detachment, Retinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Retinal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-09-14
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seizures, lethargy, arching back. Autopsy gives cause of death as cerebral edema and anoxia. Other significant conditios: retinal hemorrhages and right retinal detachment.


VAERS ID: 166370 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-23
Entered: 2001-03-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Spenectomy
Allergies:
Diagnostic Lab Data: CSF culture was performed 1 month after vaccination which isolated pneumococci type 15B.
CDC Split Type: WAES01021803

Write-up: Information received concerning a 72 year old female pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.


VAERS ID: 166371 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-23
Entered: 2001-03-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Spenectomy; hemolytic anemia
Allergies:
Diagnostic Lab Data: CSF culture was performed 6 months after vaccination which isolated pneumococci type 18C.
CDC Split Type: WAES01021804

Write-up: Information concerning a 9 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.


VAERS ID: 166372 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-23
Entered: 2001-03-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Splenectomy; idiopathic thrombocytopenic purpura
Allergies:
Diagnostic Lab Data: Blood culture-positive isolated pneumococci type 22F; CSF-positive isolated pneumococci type 22F
CDC Split Type: WAES01021805

Write-up: Information concerning a 62 year old female who previously underwent a splenectomy was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.


VAERS ID: 166373 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-23
Entered: 2001-03-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Post trauma spenectomy
Allergies:
Diagnostic Lab Data: Blood culture was performed 12 month after vaccination which isolated pneumococci type 22F.
CDC Split Type: WAES01021806

Write-up: Information concerning an 11 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed sepsis and subsequently died. The case of death was sepsis.


VAERS ID: 166724 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: New Mexico  
Vaccinated:2001-02-09
Onset:2001-02-10
   Days after vaccination:1
Submitted: 2001-02-26
   Days after onset:16
Entered: 2001-03-08
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 970A2 / 3 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1287K / 2 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER QA1082A / 4 - / IM

Administered by: Military       Purchased by: Military
Symptoms: Apnoea, Coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-10
   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: oral Decadron, inhaled albuterol
Current Illness: BPD - chronic
Preexisting Conditions: bronchopulmonary dysplasia, 28 week premature infant
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt was found unresponsive/apneic by parents around 4:00pm on 2/10/01. The pt was transported to the ER. The pt died in the ER.


VAERS ID: 166725 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Washington  
Vaccinated:2001-01-08
Onset:2001-01-22
   Days after vaccination:14
Submitted: 2001-02-05
   Days after onset:14
Entered: 2001-03-08
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473825 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Endocrine disorder
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine, Fluoride, Prednisone, Reglan, multivitamins
Current Illness: NONE
Preexisting Conditions: microcephaly, undiagnosed endocrine abnormality, GE reflux, G-tube fed
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WA011712

Write-up: The child had an undiagnosed metabolic/endocrine problem had gradual deterioration in the last few months of life. A week before death the pt had a "strange" breathing pattern, like gasping. Died 15 days post vax. PMD does not think it is causally related. Sudden death, no fever.


VAERS ID: 166796 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Colorado  
Vaccinated:2001-01-25
Onset:2001-01-25
   Days after vaccination:0
Submitted: 2001-01-31
   Days after onset:6
Entered: 2001-03-08
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 473440 / 2 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1475K / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 474703 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472046 / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Cardiac failure congestive
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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: 2001-01-25
   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: Sulfatrim, vitamin D & E
Current Illness: VSD, ASD, PDA with a bicuspid valve, severe bilirubinemia, paralyzed below the waist, extension deformities of knees, clubfeet.
Preexisting Conditions: Meningomyelocele and clubfeet were dx''d prenatally. Baby born by C-section after 36 hours of labor and stayed in the hospital 3 weeks. She has a feeding tube in her nose which the parents use for gastric lavage. The hips are high and dislocated and the knees are dislocated. She has spina bifida of the lumbosacral region, horseshoe kidney, VSD, ASD, PDA with a bicuspid aortic valve, pulmonary hypertension, jaundice, fracture femur, direct hyperbilirubinemia. Trisomy 18, Cholestasis, omphalocele, CHF
Allergies:
Diagnostic Lab Data: MANY
CDC Split Type:

Write-up: The patient was seen for well check 24 hour after seeing cardiology everything appeared well for this patient, had vaccines, no fever, became congested and heart stopped.


VAERS ID: 167098 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Florida  
Vaccinated:2001-03-07
Onset:2001-03-08
   Days after vaccination:1
Submitted: 2001-03-15
   Days after onset:7
Entered: 2001-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 981A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1851K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R1472 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473332 / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-08
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt died within 24 hours post vax. Time is unknown. Grandmother advised office staff of possible SIDS. Cause of death given as sudden infant death syndrome. Infant found unresponsive.


VAERS ID: 167376 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Virginia  
Vaccinated:2001-02-20
Onset:2001-02-23
   Days after vaccination:3
Submitted: 2001-03-15
   Days after onset:20
Entered: 2001-03-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1308K / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472355 / 2 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1466K / 1 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis acute, Cardio-respiratory arrest, Contusion, Nasal congestion, Pulmonary oedema, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol, Zithromax.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was seen for a well 15 month checkup on 2/20/01. She had mild wheezing and was afebrile. She was given MMR, Varivax and Prevnar #2. She was treated with albuterol syrup and Zithromax. She had a cardiopulmonary arrest on 2/23/01. Is there a correlation between mild wheezing, any of the vaccines, the medications used and sudden death? Pt had unexplained cardiopulmonary arrest and expired. Autopsy also states bruise right side of forehead, congestion, pulmonary edema. Cause of death given as acute bronchitis.


VAERS ID: 167681 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2001-02-19
Onset:2001-02-20
   Days after vaccination:1
Submitted: 2001-02-20
   Days after onset:0
Entered: 2001-03-22
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0320AB / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1040K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0187 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474722 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2001020

Write-up: No data provided.


VAERS ID: 167703 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-03-20
Entered: 2001-03-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: gastroesophageal reflux
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ7750127FEB2001

Write-up: Information has been received from an investigator regarding a 3 month old female who received her first dose of Prevnar as part of a post-marketing safety surveillance trial. At 39 days, post vax, the infant died due to Sudden Infant Death Syndrome. Both the medical monitor and the investigator agree that this event was not related to the vaccine. A follow up report received 4/13/2001 adds: Upon further review, this case is being forwarded to as a 15 day alert report per agreement with the FDA. MANUFACTURER''S NOTE: Upon case review on 04/11/2001, this report was found to be a duplication of report with case ID #HQ7326116FEB2001. Therefore, this case has been canceled and informational contents merged with HQ7326116FEB2001.


VAERS ID: 167704 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2000-11-01
Onset:2000-11-01
   Days after vaccination:0
Submitted: 2001-03-19
   Days after onset:138
Entered: 2001-03-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E6562CHA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Apnoea, Asthenia, Blood glucose increased, Cardiac failure congestive, Disorientation, Dyspnoea, Hypoxia, Infection, Movement disorder, Myocardial infarction, Nausea, Osteoporosis, Pain, Pharyngolaryngeal pain, Pneumonia, Psychotic disorder, Pyrexia, Speech disorder, Tremor
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-12
   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:
Current Illness:
Preexisting Conditions: Cancer, heart attack 1999, Cataract surgery 2000, pneumonia 2x.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This patient was admitted to the hospital on 11/01/00 and died on 11/12/00. The patient was examined and given a flu shot on 11/01/00, he had shortness of breath and sore legs, so the doctor wanted to do a CXR, R-Tibia X-ray, and a EKG. His diagnosis was osteoporosis. The patient was taken to the ER on 11/01/00 at 10 PM because he had terrible tremors, fever, weakness, and nausea. The patient was immediately admitted to the hospital and he told the doctor of his flu shot the doctor said he had a mild heart attack, had a high fever, and there appeared to be an infection in his lungs. The patient had two previous bouts with pneumonia treated with antibiotics an no lung problems since then. The patient was put in the ICU on a respirator. Saw an infectious disease doctor who focused on his right leg because she thought there might be an infection but there was no sign of infection. The patient was eventually put in telemetry on the 8th floor. He had a monitor that would show signs of a heart attack at the nurses station. His fever was still high and the wife was told they would watch her husband to make sure the fever goes down but there were no cold blankets, no ice packs. He was on a nose device for oxygen. The wife and friends observed a lack of activity in looking in on the patient. By Sat. there was no news as to the infection or the fever. On Sat. night the patient spent time with his wife had two visitors who thought he was bloated, he was weak, when he went to the bathroom. Prior to his trip to the bathroom the wife noticed that he did not have his oxygen nose piece in. It was carefully wrapped and hanging in the back of the patient''s bed. The patient said they took it off. That evening when the wife left she asked for the nurses to help and look in on her husband because he was weak and could fall and hurt himself. That evening about 8:30 PM the wife received a phone call her husband took a turn for the worse and was being put back on a respirator and back into ICU. When she arrived she was not able to see her husband until 10:30 PM, three nurses assured her that he had been in the bathroom and had an attack, while they were with him. A female resident told the wife she had to put a tube down his throat because he could not breathe. The next three days were critical (the doctor said the next 24 hours). The patient was very weak, his kidney were slowing. By Thursday he improved and the respirator was removed. They were going to test him, he was put in a chair and strapped; he swallowed soft items; he was at first disoriented (ICU psychosis) as the nurses and doctors put it. He then wanted water and said his throat hurt. He was moved back to Telemetry on Friday afternoon was alert and talking. The doctors were told again of the patient''s recent flu shot before his attack and the doctors could not believe it. They were more concerned with the patient lungs than his heart. The doctor told the wife that the patient had congestive heart failure and sometimes a bigger attack occurs after a small one. The family never knew of his congestive heart failure. To the family''s knowledge he was not ordered to curtail some heavy activities. The patient was put on an ice blanket because the fever was up. The wife requested for his move back up to the 8th floor that her husband be put across from the nurses station and not at the end of the hall, the doctor noted that. The wife asked why he was being taken off from the monitor so fast. The patient was still weak, he could not move his arms, his speech was weak. About 9 PM on Saturday the patient''s sugar was high 300+. He needed insulin, and his wife requested that they make sure he sipped some ensure or he would bottom out. The wife was worried about her husband at this point a nurse had said he was "very sick" so she requested to speak with the doctor in the morning (Sunday) and reminded the nurses he had a living will on file. The patient told his wife she''d better go it was getting late and that was the last time she saw her husband alive. She received a call at approximately 3 AM that he had taken a turn for the worse, same night, same staff, same floor as the previous week. The wife reminded the nurse of the living will. When she arrived at the door of her husbands room she found 25 people in the room with paddles, pumps, respirators, electronic shocks. She screamed at the same resident from the previous week that she should have know better, that they had talked. She asked why they had put her husband through that when she talked about this very thing with the nurses around 10 PM that night. The resident said oh you didn''t want us to do it, she then turned around went back into the room and told everyone to stop. The resident told the wife that her husband was not breathing and they did everything to revive him. The wife stated that this is not what her husband wanted and asked everyone in the room how would they feel if it was their son or husband. The husband was dead and the wife had several questions.


VAERS ID: 167705 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2001-01-29
Onset:2001-01-31
   Days after vaccination:2
Submitted: 2001-03-16
   Days after onset:44
Entered: 2001-03-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0173CA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0056K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R1345 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473338 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 48 hours post vax, the baby died from SIDS in the ER department.


VAERS ID: 167835 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Kentucky  
Vaccinated:2000-11-28
Onset:2000-11-29
   Days after vaccination:1
Submitted: 2001-03-19
   Days after onset:110
Entered: 2001-03-27
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 3228A2 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardio-respiratory arrest, Nasal congestion, Pulmonary congestion, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (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), Neonatal disorders (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy - SIDS
CDC Split Type:

Write-up: The pt was taken to a local ER for cardiopulmonary arrest less than 24 hours post vax. Autopsy gave final diagnosis of SIDS. Autopsy also shows pulmonary congestion, visceral congestion.


VAERS ID: 167990 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Connecticut  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-12-14
Entered: 2001-03-30
   Days after submission:106
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 3 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ4792613DEC2000

Write-up: A physician reported that a patient received 3 doses of Hib-Titer and died from "H. Influenza meningitis". The physician declined to provide additional information.


VAERS ID: 168012 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New Hampshire  
Vaccinated:2000-12-04
Onset:2000-12-07
   Days after vaccination:3
Submitted: 2001-03-10
   Days after onset:93
Entered: 2001-04-02
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 972A2 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5153C9 / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA549AB / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0395 / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 476724 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood gases abnormal, Pulse absent, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: PH-6.29
CDC Split Type:

Write-up: This patient died on 12/07/01. He went to the ER pulseless, no respiratory effort, no response to resuscitative efforts. The coroner unofficial report- SIDS. Autopsy states cause of death as SIDS.


VAERS ID: 168013 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Illinois  
Vaccinated:2001-02-21
Onset:2001-02-21
   Days after vaccination:0
Submitted: 2001-03-22
   Days after onset:29
Entered: 2001-04-02
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 466925 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0875J / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0025 / 2 LL / -

Administered by: Public       Purchased by: Public
Symptoms: Cough, Crying, Diarrhoea, Sudden infant death syndrome, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-06
   Days after onset: 13
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: Cough started 2/21/01. Vomiting phlegm the weekend before 3/3/01 and 3/04/01 crying with no tears. She was eating and had no fever. Stool very runny. Saw doctor on 3/1/01. She lost 5 oz from 2/13/01 to 3/01/01. Doctor found nothing wrong. Autopsy states cause of death as sudden infant death syndrome.


VAERS ID: 168014 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Indiana  
Vaccinated:2001-01-05
Onset:2001-01-06
   Days after vaccination:1
Submitted: 2001-03-18
   Days after onset:71
Entered: 2001-04-02
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 469395 / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 468487 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R0691 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473346 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-06
   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: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS


VAERS ID: 168361 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: New York  
Vaccinated:2001-03-24
Onset:2001-03-26
   Days after vaccination:2
Submitted: 2001-03-30
   Days after onset:4
Entered: 2001-04-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0356CA / 3 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5166A2 / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA578AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474729 / 3 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Cardiac arrest, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: The mother found the baby in the crib in cardiac arrest and not breathing suddenly and unexpectedly. He had a tem of 101 in the AM. He was acting fine with good feeding.


VAERS ID: 168648 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: New Jersey  
Vaccinated:2001-04-04
Onset:2001-04-05
   Days after vaccination:1
Submitted: 2001-04-05
   Days after onset:0
Entered: 2001-04-13
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1527K / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0484 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474728 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood creatinine increased, Blood sodium decreased, Blood urea increased, Coma, Hydrocephalus, Hypertonia, Hypotonia, Staring
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-16
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness:
Preexisting Conditions: Increased tone; developmental delay; bilateral dilated frontal horns
Allergies:
Diagnostic Lab Data: CT scan of head in ER on 4/5/01-hydrocephalus; labs-Na-128; K-5.2; CR-99; C02-21; Bun-40; CR-1.1; Gluc-90; Ca-8.8 Left kidney-dystrophic calcification; right kidney-focal acute inflammation; right adrenal-dystrophic calcificaton; right lung-congestion and focal aspiration; left lung-congestion; thymus-dystrophic calcification
CDC Split Type:

Write-up: About 20 hours after receiving immunizations, at about 8:30 AM; at home the baby started tonic / clonic movements lasting about 25 minutes according to family. the eyes staring and unresponsive. At the ER 3 hours later the events reappear. Follow-up received on 4/26/01 states that the baby has died.


VAERS ID: 168643 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Indiana  
Vaccinated:2001-04-04
Onset:2001-04-06
   Days after vaccination:2
Submitted: 2001-04-09
   Days after onset:3
Entered: 2001-04-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 473441 / UNK - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0718H / UNK - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 476676 / UNK - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0187 / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-06
   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: Amoxil
Current Illness: None-- hd just recovered from BOM
Preexisting Conditions: hospitalization 3/10/01 to 3/11/01 for RSV
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001006110

Write-up: It was reported that a male patient received an IPOL, a Hibtiter, a Hepatitis B, and an Acel-Imune vaccination on 04/04/01. Reportedly two days after vaccinations the patient expired. The patient was put down for a nap, The patient''s mother went to check on him, the patient wasn''t breathing; she called 911. Cause of death SIDS.


VAERS ID: 168749 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Missouri  
Vaccinated:2001-03-19
Onset:2001-03-21
   Days after vaccination:2
Submitted: 2001-04-04
   Days after onset:13
Entered: 2001-04-17
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0356CA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0506 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Cough-lung CTA
Preexisting Conditions: Otitis Media 2 1/2 weeks prior to immunizations
Allergies:
Diagnostic Lab Data:
CDC Split Type: MO2001021

Write-up: No data obtained. Parents are awaiting final autopsy report and the death certificate. These will not be produced until a final toxicology report is obtained. All of this is per the coroner. Autopsy states cause of death as undetermined. Death certificate states cause of death due to cerebral laceration w/open skull fracture due to an automobile accident.


VAERS ID: 168909 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2001-01-01
Submitted: 2001-04-12
   Days after onset:100
Entered: 2001-04-20
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Lymphoma, Spleen disorder
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (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: UNK
Current Illness:
Preexisting Conditions: Hodgkin''s lymphoma, splenectomy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01040902

Write-up: Information has been received from a male consumer concerning his wife who had a history of Hodgkin''s Disease and a splenectomy. On an unspecified date, the patient was vaccinated with pneumococcal vaccine polyvalent. Subsequently, she developed pneumococcal disease. The patient died in approximately January 2001 due to pneumococcal disease. The consumer reported that his wife had not received the five year follow up vaccination with pneumococcal vaccine 23 polyvalent. No further info is available.


VAERS ID: 169020 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Illinois  
Vaccinated:2001-04-17
Onset:2001-04-18
   Days after vaccination:1
Submitted: 2001-06-06
   Days after onset:49
Entered: 2001-04-25
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 470527 / UNK RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 582953A / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0266 / UNK LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac failure congestive, Congenital megacolon, Oesophagitis, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Congenital, familial and genetic disorders (narrow), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient had uneventful birth 02/05/01. Sister had strep infection 3 WEEKS AGO BUT THE BABY DID NOT GET SICK.
Allergies:
Diagnostic Lab Data: Autopsy findings: Hirschprung''s disease, acute congestive heart failure, chronic esophagitis
CDC Split Type: U2001006400

Write-up: It was reported that a 2 month old healthy male infant was vaccinated on 4/17/01 with IPOL, DPT and Hib-Titer. Reportedly, the parents found the baby dead in the morning of 4/18/2001. An autopsy is being performed. Sudden Infant Death reported. Autopsy report findings: Hirschsprung''s disease.


VAERS ID: 169022 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: New Mexico  
Vaccinated:2001-02-21
Onset:2001-02-26
   Days after vaccination:5
Submitted: 2001-02-27
   Days after onset:1
Entered: 2001-04-25
   Days after submission:56
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 983A2 / 3 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1291K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0160 / 3 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Asphyxia, Coma, Cyanosis
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Reglan, Zantac, Bactrim
Current Illness: Chronic laryngotracheomalacia
Preexisting Conditions: Laryngotracheomalacia; GERD; left ureteral vesical junction obstruction
Allergies:
Diagnostic Lab Data: Autopsy ordered
CDC Split Type: NM030001

Write-up: A patient received DTaP #3, IPV #3, Comvax #1, on 02/21/01 during her well baby visit. The patient was found blue and unresponsive at home midday on 02/26/01. She was transferred to the ER unable to resuscitate. The ER Dr states the patient was secured in infant seat device to maintain upright position. The patient was found in infant seat turned on side , the foster mother had been out of the room approximately 10 minutes. ER doctor states "probable positional asphyxia"). The patient had been well prior to death.


VAERS ID: 169023 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Colorado  
Vaccinated:1998-11-09
Onset:0000-00-00
Submitted: 2001-04-18
Entered: 2001-04-25
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 7+ - / -

Administered by: Military       Purchased by: Military
Symptoms: Amnesia, Arthralgia, Blood pressure increased, Completed suicide, Disturbance in attention, Dizziness, Haemorrhage, Heart rate decreased, Lymphadenopathy, Mood swings, Night sweats, Paraesthesia, Rash, Staring, Syncope, Tinnitus, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-02
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: Per death certificate: clinical history of post traumatic stress syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Loss of concentration, dizzy, memory loss, mood swings, night sweats, tinnitus, joint pains, increased BP, low pulse, syncope, staring spells for 5-10 minutes duration, numbness and tingling of left upper and lower extremities, splinter hemorrhages, 75 lb weight loss, rash and swollen glands. Also, had Anthrax vaccines on 10/31/98, 11/9/98, 4/4/99, 11/99 and 6/3/00. Committed suicide. Autopsy report received states pt cause of death as gun shot wound to the head. Death certificate confirms cause of death.


VAERS ID: 169360 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2000-09-08
Onset:2000-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2001-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES - / 4 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R12901 / 4 RL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0406K / 2 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Seizures~Measles + Mumps + Rubella (MMR II)~1~0.00~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: Condition caused by prior vaccine (seizures and developmentally delayed).
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seizures and developmentally delayed with 1st set of vaccines. Had a high temperature and death with 2nd set.


VAERS ID: 169361 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Unknown  
Location: Alabama  
Vaccinated:2000-12-08
Onset:2000-12-09
   Days after vaccination:1
Submitted: 2001-01-16
   Days after onset:38
Entered: 2001-05-02
   Days after submission:105
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4008174 / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-09
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5878312JAN2001

Write-up: A healthcare professional reported that a 4 year old child received an injection of the Flu Shield 2000-2001 formula on 12/8/00. The following day, the child died. No further information was available at the date of this report.


VAERS ID: 169375 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Arkansas  
Vaccinated:2001-02-22
Onset:2001-02-23
   Days after vaccination:1
Submitted: 2001-04-23
   Days after onset:58
Entered: 2001-05-04
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 965A2 / UNK RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1657K / 2 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA490AA / UNK LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0395 / UNK RL / SC

Administered by: Public       Purchased by: Other
Symptoms: Brain oedema, Murder, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-02-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: breathing different~Hep B (no brand name)~1~0.00~In Patient
Other Medications: Carbinoxam
Current Illness: Sepsis, Pneumothorax, congested.
Preexisting Conditions: Head trauma at birth.
Allergies:
Diagnostic Lab Data: Blood, x-ray, EEG, CT Scan.
CDC Split Type:

Write-up: The infant''s brain swelled. She died the next day. All the doctors did was run tests. They didn''t do anything to try and save her. Autopsy report received states child died from bilateral subdural hematoma - homicide.


VAERS ID: 169527 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-05-04
Entered: 2001-05-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01050372

Write-up: Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female (WAES 01042680) who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant''s father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast). No further details were provided. Additional information has been requested.


VAERS ID: 169616 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Mississippi  
Vaccinated:2001-04-25
Onset:2001-04-26
   Days after vaccination:1
Submitted: 2001-05-02
   Days after onset:6
Entered: 2001-05-09
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0357CA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1522K / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0505 / 2 RL / -

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Coma, Epistaxis, Pulse absent
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-26
   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: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: MS01015

Write-up: The pt was taken to health services on 4/26/01 at 8:00 am. The pt was unresponsive, not breathing, blood at nose. ACL protocol started immediately. No rhythm or pulse. Code stopped. Autopsy report states cause of death: changes suggestive of vaccine related death, however, rollover cannot be excluded and would have to be excluded by scene investigation; findings are not consistent with SIDS.


VAERS ID: 169643 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Female  
Location: Michigan  
Vaccinated:2001-04-25
Onset:2001-04-27
   Days after vaccination:2
Submitted: 2001-04-30
   Days after onset:3
Entered: 2001-05-10
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 975A2 / 4 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1590K / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477449 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Cerebral haemorrhage, Cough, Dehydration, Dyspnoea, Ear disorder, Gastrointestinal haemorrhage, Gastrooesophageal reflux disease, Haematocrit decreased, Haemoglobin decreased, Hypoxia, Laboratory test abnormal, Necrosis, Nervous system disorder, Pulmonary oedema, Pyrexia, Respiratory disorder, Supraventricular tachycardia, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-27
   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: Pulmicort, Serevent, Aldectozide, Lasix, Zantac, NaCl, KCl, Prednisone taper; Albuterol; Aldactone, Prelone; home oxygen
Current Illness: Chronic illness only, no acute.
Preexisting Conditions: Bronchopulmonary dysplasia, severe prematurity, gastroesophageal reflux disease, reactive airway disease, retinopathy due to prematurity and possible right-sided heart failure, pulmonary stenosis; numerouse hospitalizations due to respiratory disease (last visit 4/25/01) 3 days prior to death
Allergies:
Diagnostic Lab Data: T- 40.2 on admit to ED, HR - 190, Pulse Ox 94%, EKG with SVT. Hemoglobin-7; Hematocrit-22 and thought to have a GI bleed
CDC Split Type:

Write-up: Heavy breathing and pulling at ears the night before carrying her to the ER, some cough. In the ED, T to 40.2 on the evening of 04/27/01. Normally uses 0.5 L prn O2 at home, in ED pulse ox 94% on R.A. coffee ground material from G-tube. Initially hemoccult neg, but later when rechecked was hemoccult positive. Initially tachycardia, became SVT after albuterol, developed diminished respiratory effort, cardiac arrest and death at 9:10 PM. Autopsy report states cause of death as medical complications of prematurity: dehydration, bronchopulmonary dysplasia and edema, s/p Nissen fundoplasty for esophageal reflux, gliosis and extensive neuronal necrosis of the brain (brain atrophy) , small subdural hemorrhage (manner of death - natural). Cause of death-medical complications of prematurity.


VAERS ID: 169644 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Oklahoma  
Vaccinated:2001-03-22
Onset:2001-03-26
   Days after vaccination:4
Submitted: 2001-04-26
   Days after onset:30
Entered: 2001-05-10
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0371A8 / 1 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA559AA / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0485 / 1 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Eye disorder, Injection site mass, Irritability, Loss of consciousness, Malaise, Oral intake reduced, Pain, Pyrexia, Restlessness, Screaming, Somnolence, Staring
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Corneal disorders (broad), Retinal disorders (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: 2001-03-31
   Days after onset: 5
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: Fever and crankiness.~Hep B (no brand name)~2~0.00~In Patient|~Vaccine not specified (no brand name)~~5.00~In Sibling
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 03/22/01, Thursday, this child was given his two month vaccines at around 3:45 PM, he immediately started screaming and had a small lump at the sites, (3 needles). He had a slight fever the next couple of days, below 101, went away with Motrin or Tylenol, alternated. By Monday he was unusually fussy and restless, even when held, on Tuesday his eyes were matted, but after washing them two times with warm cloth it never came back, that night around 4 PM he just started screaming like he was in horrible pain, for about 3 - 4 hours. Once he was finally asleep, he slept for 12 hours. On Wednesday morning, he seemed like he still didn''t feel very good, so his I bathed and fed him. He didn''t want to eat as much as usual that day, again around 4 or 5 PM he started screaming again just like the day before, on both days after he would finally stop screaming, his eyes looked glassy and he would get quiet, with a blank look on his face, for a few minutes and then he would pass out asleep. I thought he was exhausted from the screaming fits so we didn''t think much about it, his eyes got matted again on Wednesday night, and he refused his 9 PM feeding, screaming until around 10 or 11. He finally took his cereal and bottle, and passed out in my lap. Again I thought from exhaustion. On Thursday morning, on my way out to go to work, at 4:40 AM, I told the baby''s dad that if he was cranky still and his eyes were matted when he woke up to call the doctor for an appointment. At 10:35 AM, I came home from work and found him dead in his crib.


VAERS ID: 169647 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: Unknown  
Vaccinated:2000-05-09
Onset:2000-07-01
   Days after vaccination:53
Submitted: 2001-05-08
   Days after onset:311
Entered: 2001-05-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV047 / 6 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Aphasia, Asphyxia, Cerebral haemorrhage, Cognitive disorder, Demyelination, Diplopia, Fatigue, Hypokinesia, Influenza like illness, Laboratory test abnormal, Lymphoma, Multi-organ failure, Multiple sclerosis, Myalgia, Nuclear magnetic resonance imaging brain abnormal, Ophthalmoplegia, Paraesthesia, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Optic nerve disorders (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Malignant lymphomas (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-04
   Days after onset: 338
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: He had been receiving high doses of immune-modulating drugs
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: July 2000- MRI of the brain: characteristic multiple periventricular hyperintense lesions on T2 - weighted images. Dec 2000 - Lumbar Puncture (3rd): positive for myelin basic protein and oligoclonal bands. Jan 2001 - Visual Evoked Potentials: poor quality study; no conduction delay noted. Jan 15, 2001 - MR Spect: increased choline peak concerning for acute MS vs Neoplasia. Jan 15, 2001 - MR Thallium: markedly increased frontal parietal uptake worrisome for aggressive malignancy. Jan 23, 2001 - Brain Biopsy: consistent with demyelinating process; special stains rule out secondary etiologies; cancer and infection ruled out. Follow-up info received 8/14/01: pathologic dx from autopsy report indicated a diffuse large B-cell lymphoma involving both cerebral hemispheres, both cerebellum and multiple levels of the brain stem. The autopsy also reveals hemorrhagic lesions in the brain. Sections from the left cerebral hemisphere reveal a necrotic mass composed predominantly of large, atypical lymphoid cells. Similar appearing perivascular lymphoid cells are also noted in the right basal frontal lobe and the cerebral hemispheric sections also confirm the presence of extravasated red blood cells within the subarachnoid space overlying the left middle frontal gyrus the associated hemorrhagic necrosis of the adjacent cortex and an intraparenohymal hemorrage within the right occipital lobe. Autopsy reveals diagnosis of diffuse large B-cell lymphoma, recent subarachnoid and intraparenchymal hemorrhage, and acute neuronal necrosis
CDC Split Type: BIT010001

Write-up: This patient is reported to have multiple sclerosis, diplopia, bilateral internuclear ophthalmoplegia, right-sided paraesthesias, expressive aphasia, cognitive deficit, sensory deficit, spastic paraparesis, fatigue, and myalgia. Subject BIT010001, a 33 year old male, with no previous medical conditions, received the 6th dose of Anthrax vaccine (lot # FAV047) on 05/09/00. The patient was taking no concomitant medications at the time of the event. The patient had no previous reactions to the Anthrax vaccines. Approximately two weeks after the 6th Anthrax vaccine, the patient experienced flu-like symptoms with fatigue, and myalgia without fever, which completely resolved within 24 hours. In July 2000, the patient reported a 3 week history of intermittent diplopia. In early October 2000, he experienced right-sided paraesthesias. In early December 2000, he began having difficulty with finding his words. From 12/21/00 to 02/05/01, he had persistent sensory deficits with deteriorating motor function. As of March 2001, deficits have slightly improved, though the patient remains completely bedridden. The patient was treated with multiple courses of high doses of steroids, intravenous immunoglobulin, interferon beta 1-6, and mitoxantrone. The patient was hospitalized at WRAMC on 12/21/00 and remains hospitalized. Follow up received on 6/20/01 states the pt has died from multiple organ failure. He had been receiving high doses of immune-modulating drugs which suppressed his immune system. An autopsy will be performed and the results will be provided in a follow-up report when the information is available.


VAERS ID: 169932 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2000-11-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2001-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 296A12 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0285K / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R1433 / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473342 / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: To give Tylenol after shots for fever.
Current Illness: Nasal congestion
Preexisting Conditions: Bilateral Inguinal hernias 11/1/00
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2001034

Write-up: Death within 24 hours. (According to death certificate, undetermined cause and manner of death). Autopsy states cause of death as undetermined. Infant was found in bassinet in prone position.


VAERS ID: 169933 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: North Carolina  
Vaccinated:2001-05-15
Onset:2001-05-16
   Days after vaccination:1
Submitted: 2001-05-16
   Days after onset:0
Entered: 2001-05-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 992A2 / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1474K / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 477381 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0562 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472547 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Haemorrhage, Pulmonary congestion
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-16
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: This patient was seen for a well child check on 05/15/01. First office visit since birth. No previous immunizations. Received DTaP, IPV, HIB, Prevnar, and Hep B. The patient was found dead in the crib 05/16/01 in the AM. Autopsy shows congestion in lungs. A cause of death could not be determined. Petechial hemorrhages were found on several serosal surfaces raising the possibility of SIDS but suffocation by overlying cannot be excluded.


VAERS ID: 169943 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: California  
Vaccinated:2001-04-24
Onset:2001-04-25
   Days after vaccination:1
Submitted: 2001-04-25
   Days after onset:0
Entered: 2001-05-18
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473343 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Coma, Pneumonitis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-25
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA010049

Write-up: Infant died in his sleep. Infant found unresponsive. Autopsy states cause of death as undetermined. Interstitial pneumonitis was a contributing factor in the death. Also noted were subdural neomembranes.


VAERS ID: 172279 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Delaware  
Vaccinated:2001-05-02
Onset:2001-05-04
   Days after vaccination:2
Submitted: 2001-05-21
   Days after onset:17
Entered: 2001-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U034113A / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 582953A / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0471 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474723 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cough, Nasal congestion, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-21
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Reglan, Zantac, Xopenex
Current Illness: NONE
Preexisting Conditions: laryngotracheomalacia, bronchomalacia, gastroesophageal reflux, atrioseptal defect, vascular ring
Allergies:
Diagnostic Lab Data: Autopsy - pending
CDC Split Type:

Write-up: The pt was seen on 5/7 with 3 day hx of a loose productive cough and marked nasal congestion. This was thought to be a URI. Cough persisted in spite of inhalation therapy and steroids. Pt was seen on 5/16 and started on Biaxin with improvement.


VAERS ID: 170058 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: New York  
Vaccinated:2001-04-13
Onset:2001-04-22
   Days after vaccination:9
Submitted: 2001-05-13
   Days after onset:21
Entered: 2001-05-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0394K / UNK - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1155K / UNK - / SC

Administered by: Private       Purchased by: Other
Symptoms: Albumin globulin ratio abnormal, Blood calcium increased, Blood lactate dehydrogenase increased, Cardiac arrest, Dehydration, Erythema multiforme, Haemoglobinaemia, Meningitis, Pyrexia, Red blood cell sedimentation rate increased, Respiratory arrest, Sepsis, Shock, Skin necrosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Haemolytic disorders (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-28
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Chinese herbs (unspecified)
Current Illness:
Preexisting Conditions: History of allergies and eczema; on 6/12/00, the pt had a hematoma on the forehead (CT Scan was nml)
Allergies:
Diagnostic Lab Data: Full blood work-up and blood cultures were negative; temperature 101F; CBC-nml except for a few extra bands. PCR and VZV analysis-neg; WBC-8.4 and 8.1; serum calcium-10.8 (high); albumin-4.4 (high); mean corpuscular hemoglobin concentration of 33.9 (high); LDH-541 (high); neutrophil ct-19%; hematology-14%; ESR-34; antistreptolysis O antigen test-5.0; skin biopsy-clusters of necrotic keratinocytes in the superficial epidermis and a small amt with also exocytosis of mononuclear cells and some extravascated erythrocytes and these features are difficult to interpret and is being tested for viran DNA
CDC Split Type: WAES01050031

Write-up: Information has been received from a physician concerning a 12 month old female who was vaccinated with MMRII and varicella virus vaccine live. Ten days later, the pt developed a fever and rash. The physician noted that under the microscope he can not determine what caused the rash. Follow-up from the physician indicated that he was the pathologist who had received the skin biopsy specimen of the rash from the pt''s dermatologist. He received the specimen, 3 days prior to the pt''s death. Additional information from the pt''s pediatrician, indicated that the child received MMRII, varicella and Prevnar on 4/13/01 and on 4/25/01, the pt was brought into the office with a fever of 101F associated vomiting, lethargy, dehydration and a generalized rash that looked like erythema multiforme. Another physician was working with the physician that day and they both agreed that it looked like erythema multiforme. The parents were told to bring the pt back on 4/26/01 for a follow-up visit. On 4/26/01, the rash still appeared as erythema multiforme, however, it was not as generalized and was more discrete. The parents reported that the child was also on a Chinese herbal medicine and the baby sitter reported that the child had eaten a new kind of fish that night. The pediatrician referred the pt to a dermatologist and when he saw the pt, he reported that he had never seen anything like the rash that the pt presented with and he did a skin biopsy. The next day, the pediatrician called the pt''s home to check her condition. The child''s baby sitter reported that the child was doing fine, eating, drinking and the rash was getting better. On 4/27/01, the pediatrician called the pt''s home again and wanted the child to come in to be seen, however, the family was reluctant because they reported the child was doing fine, the rash had faded and the child''s fever was gone. On the night of 4/28/01, the family took the child to the ER. The ER physician called the pt''s pediatrician and told her that the pt presented to the ER with fever, crying with no tears and dehydration and vomiting. The ER physicians were unable to get an IV line into the child, the child went into shock and arrested, with failure to revive. The family refused to autopsy. The cause of death on the death certificate was meningococcal meningitis. The pediatrician reported that the cause of death could not possibly be meningococcal meningitis because the blood cultures that she had done on the pt at the height of the rash on 4/25/01 were negative and the fever and rash had gone away without any prophylaxis treatment. The pt''s father could not tell the pediatrician the name of the Chinese medication, only that it was herbal Chinese medication. The pediatrician reported that a piece of the skin biopsy was sent for PCR analysis and the pediatrician was unsure if this would be conclusive or not. The pediatrician also reported that there was no blood obtained for IgG or IgM titers. The pediatrician noted that she did not know the cause of death. The child''s body was being taken to another country to be buried. Follow-up from another physician indicated that the pt had negative blood cultures taken in the PCP''s office and he was not sure where the dx of meningococcal meningitis came from without further lab support. He was questioned as to whether the community where the child lived may need prophylaxis and from the description of the child''s symptoms, he did not feel the symptoms were consistent with a meningococcal bacteria. The physician noted that the child looked septic on admission to the hospital and he wondered if the child was actually dehydrated. The physician was unsure if the child 1st respiratory or cardiac arrested, however, he did feel that it would be unusual for a child this age to 1st cardiac arrest. The physician confirmed that the child did eat a different type of fish and wondered if the child may have contracted a Vibrio infection from ingesting infected raw fish. Conflicting information from this physician indicated that the child was seen on 4/22/01 by the PCP and a maculopapular rash was dx''d as an atypical measles type rash. The child''s rash then reportedly improved however on admission to the ER, the child reportedly had a florrid, "violatious" rash. The physician wondered about the child''s immune status, since the child lived on a commune where group marriages occurred. The commune consisted of approx. 300-400 people. The physician noted that this was all just philosophical discussion since an autopsy was not performed and the cause of death will probably not be known. No further details were provided. Additional information received on 05/23/2001 indicated that PCR results from the parafin block extraction were negative for V2V. Additionally the specimen was concentrated down, in hopes of going further and making it more sensitive; however, it was still negative for V2V. The patient''s physician was planning to have a PCR done for measles, as "atypical measles" was one of the clinical diagnoses for the pt. The physician reaffirmed that she did not believe the child''s rash was varicella. The physician plans to have additional specimens sent for measles PCR. Additional info has been requested. Follow-up info has been received from a physician who stated that, according to the CDC, the skin tissue tested neg. for MMR. He also reported that the VZV was neg. Additional information has been requested.This is an amended report. The pt''s age was changed from 12 months to 13 months. This is a corrected report as amended.


VAERS ID: 170122 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Arizona  
Vaccinated:2001-04-04
Onset:2001-04-05
   Days after vaccination:1
Submitted: 2001-05-16
   Days after onset:41
Entered: 2001-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 988A2 / UNK LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 473372 / UNK - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0505 / UNK LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471225 / UNK - / IM

Administered by: Private       Purchased by: Public
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-05
   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: Augmentin
Current Illness: Otitis Media
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy - pending
CDC Split Type:

Write-up: The pt died 24 hours post vax. Autopsy pending. COD as per autopsy report was sepsis.


VAERS ID: 170129 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Unknown  
Vaccinated:2000-10-27
Onset:2000-11-04
   Days after vaccination:8
Submitted: 2001-05-08
   Days after onset:184
Entered: 2001-05-23
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Cough, Dyspnoea, Hyperventilation, Hypoxia, Oedema, Pneumonia, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Morbid obesity (411 lbs, 5''5"), seizure disorder (long standing history), history of GERD, mild to moderate mental retardation, NKDA, history of medication noncompliance, and type II diabetes mellitus.
Allergies:
Diagnostic Lab Data: RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative.
CDC Split Type:

Write-up: This patient was admitted thru the ER on 11/04/01 with progressive SOB, chest pain in the mid-chest associated only with cough, and deep breath. According to the family the patient there were no new problems until one day after the patient received the influenza vaccine when he ran a fever and became progressively following that injection. The influenza vaccine was given about 1 week PTA. On the day of admission, he developed severe, SOB, and developed pleuritic chest pain. RR 28, o2 Sat 50%, O2 by mask was 90% on admit. Also 1-2 + pitting pedal edema present the day of admission. Chest x-ray revealed pneumonia. Initial cardiac enzymes were negative. On admit the patient had scattered rhonchi.


VAERS ID: 170249 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2001-04-13
Onset:2001-04-14
   Days after vaccination:1
Submitted: 2001-05-03
   Days after onset:19
Entered: 2001-05-24
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 968A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1033K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0505 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 4741953 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Child was at Disneyland with family; paramedics were called. The child died. This is a coroner case. No other details are available to us at this time.


VAERS ID: 170303 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2001-05-04
Onset:0000-00-00
Submitted: 2001-05-11
Entered: 2001-05-29
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5168A2 / 1 - / IM

Administered by: Public       Purchased by: Public
Symptoms: Bacterial infection, Sepsis, Sudden infant death syndrome, Unevaluable event
SMQs:, Neonatal disorders (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: On 4/19/01 had Medimmune/Synagis/QA7181A/IM/LL/0 previously
Current Illness: NONE
Preexisting Conditions: Prematurity - gestational age at 36 weeks.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This patient was seen on 05/04/2001 for a well physical exam. The patient was given Hep B vaccine # 1 on 05/04/01. The Health Bureau was notified on 05/07/01 at 8 AM that the involved child had expired over the weekend. Autopsy states cause of death as sudden death in infancy. Autopsy also showed E. Coli septicemia.


VAERS ID: 170356 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:2000-03-06
Onset:2000-04-14
   Days after vaccination:39
Submitted: 2001-05-23
   Days after onset:404
Entered: 2001-05-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / CONNAUGHT LABORATORIES UA160AA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Chronic back pain, atherosclerosis Hx of nasal allergy, periodic HTN, rectal polyps, Hepatitis B, and ETOH abuse
Allergies:
Diagnostic Lab Data: Autopsy-lobes have yellow green opacified material present, consistent with purulent meningitis process.
CDC Split Type: U2001007430

Write-up: It was reported that an adult male pt received a Menomune A/C/Y/W-135 vaccination on 3/6/00. Reportedly, the pt died on 4/14/00. dx''d with purulent meningitis. Autopsy done at medical examiner''s office. Further medical follow-up is requested and ongoing. On 05/22/2001, the autopsy and medical examiners reports were received. Autopsy report revealed the following findings from the head and central nervous system. "The leptomeninges overlying the frontal lobes have yellow-green opacified material present, consistent with purulent meningitis process." From the correspondence received from a physician it was stated "This case was associated with large numbers of gram positive diplococci having the morphology consistent with S. pneumonia. A silver stain and a PAS did not support the presence of any other organism."


VAERS ID: 170392 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Virginia  
Vaccinated:2001-04-23
Onset:2001-04-25
   Days after vaccination:2
Submitted: 2001-05-25
   Days after onset:30
Entered: 2001-05-31
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0321BA / UNK - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 00502 / UNK - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Intussusception, Leukocytosis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-04-26
   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:
Allergies:
Diagnostic Lab Data: Leukocytosis on WBC and non-specific radiological findings
CDC Split Type:

Write-up: Vomiting and weakness occurred on 4/25/01. Visited ER on 4/26/01 at 03:00 and transferred to ER of another hospital at 10:30 on 4/26/01, Pt died at hospital.


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