National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Found 8,467 cases where Patient Died

Case Details

This is page 24 out of 85

Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85   next


VAERS ID: 223310 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Female  
Location: California  
Vaccinated:2004-06-15
Onset:2004-06-16
   Days after vaccination:1
Submitted: 2004-06-21
   Days after onset:5
Entered: 2004-06-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1680AA / 1 LA / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1113N / 1 RA / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0313 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495881 / 1 RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Meningitis, Pyrexia, Rash, Sepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-06-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Patient has been investigated or is being investigated for possible meningitis.
CDC Split Type:

Write-up: Death within 48 hours of vaccine. Patient presented with high grade fever to 105 within 24 hours of vaccine. Seen at hospital on 6/17/04 (informant states); worked up, released from hospital ED 6/18/04. Fever and spots and pronounced dead. Nurse follow up on 08/10/04 states: "Septicemia."


VAERS ID: 223530 (history)  
Form: Version 1.0  
Age: 0.04  
Sex: Female  
Location: New Jersey  
Vaccinated:2004-02-12
Onset:2004-03-19
   Days after vaccination:36
Submitted: 2004-06-22
   Days after onset:94
Entered: 2004-06-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5511B9 / 1 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Abscess, Bacterial infection, Crying, Pyelonephritis, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: No congenital defects. On autopsy, external but non-functional PDA; patent ductus arteriosus.
Allergies:
Diagnostic Lab Data: On autopsy, finding of E.coli in the blood, pyelonephritis and some urinary bladder inflammation.
CDC Split Type:

Write-up: On March 19, baby threw up (only time in her life, and the nights of March 19 and 20, cried a lot more than usual and cries weaker than usual. Measured temperature under arm pit on March 20: 100 degrees F. She seemed better by night of March 21, but still had temp of 100F, measured daily by forehead strip, until day she died. Nurse follow up on 07/13/04 states: pyelonephritis w/abcesses, E. coli sepsis.


VAERS ID: 223572 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Tennessee  
Vaccinated:2004-06-28
Onset:2004-06-29
   Days after vaccination:1
Submitted: 2004-06-30
   Days after onset:1
Entered: 2004-07-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1696AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1154N / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0711 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494779 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient seen for 2 month check up 6/28/04. Exam WNL. Received 2 month shots; DTaP #1, HIB and Hep B #1, IPV #1, and Prevnar #1. Tolerated well. Office notified 6/30/04 of patient''s death on 6/29/04 while asleep at babysitters. Nurse follow up on 06/30/04 states: "None."


VAERS ID: 223740 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Texas  
Vaccinated:2001-08-10
Onset:2001-08-12
   Days after vaccination:2
Submitted: 2004-07-07
   Days after onset:1060
Entered: 2004-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 508A2 / UNK LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0448L / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1676K / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0561 / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481543 / UNK LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-08-12
   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: Caffeine, Reglan, Zantac
Current Illness: none
Preexisting Conditions: born at 28 weeks gestation
Allergies:
Diagnostic Lab Data: Autopsy indicated SIDS
CDC Split Type:

Write-up: My son died on Sunday evening after getting shots on friday afternoon. He was in perfect health prior to his shots and death. Nurse follow up on 07/26/04 states: "Complete."


VAERS ID: 223780 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Oregon  
Vaccinated:2004-07-07
Onset:2004-07-08
   Days after vaccination:1
Submitted: 2004-07-08
   Days after onset:0
Entered: 2004-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21928B2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE204AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493507 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Respiratory arrest, Sudden infant death syndrome
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), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Born prematurely at 32 weeks gestation.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby cosleeping with mom found in cardiorespiratory arrest by mom. Nurse follow up on 07/12/04 states: "None." Nurse follow up on 08/30/04 states: "SIDS."


VAERS ID: 223808 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Unknown  
Vaccinated:1998-11-03
Onset:1998-11-17
   Days after vaccination:14
Submitted: 2004-07-09
   Days after onset:2060
Entered: 2004-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 0980530 / 4 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Atrial fibrillation, Guillain-Barre syndrome, Hypotension, Laboratory test abnormal, Leukocytosis, Multi-organ failure, Pneumonia, Renal failure, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-01-22
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 60 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: decadron,mannitol
Current Illness: Vaccine given at pre-op physical for meningioma resection. Afebrile and well at time of exam except for headache and irritibility/personality changed referable to right frontal meningioma.
Preexisting Conditions: none except meningioma
Allergies:
Diagnostic Lab Data: EMG consistent with G-B syndrome. Two neurologists agreed with diagnosis. Sputum culture from admission positive beta-hemolytic strep, not group A. WBCs at presentation 48,000 with a left shift.
CDC Split Type:

Write-up: Adverse event: Guillain-Barre syndrome presenting on 11/18/2004 in conjunction with Beta-hemolytic streptococcal pneumonia. Individual was also post-op from craniotomy for meningioma on 11/09/1998 and had been continuously treated with IV Decadron and Mannitol since that procedure for ongoing cerebral edema. Yeast was also present in tracheal aspirates at presentation; not cultured for campylobacter yersenia nor tested for CMV. He developed ARDS and sepsis and despite treatment with plasmapheresis and IVIG died 66 days after presentation with multiple organ failure. Manufacturer of vaccine was Connaught, lot 0980530 or possibly 0986530. Influenza vaccine givne IM left deltoid. Exp 06/99. He had had influenza vaccine for at least the preceeding 3 years. Nurse follow up on 07/26/04 states: "atrial fib, renal failure, hypotension."


VAERS ID: 224262 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2004-06-10
Onset:2004-07-06
   Days after vaccination:26
Submitted: 2004-07-22
   Days after onset:16
Entered: 2004-07-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / 5 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0707 / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0610N / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Brain oedema, Convulsion, Eye irritation, Eye swelling, Lymphadenopathy, Pyrexia, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sachronic meds
Current Illness: NONE
Preexisting Conditions: No chronic disease.
Allergies:
Diagnostic Lab Data: Serum/CSF/Autopsy specimens pending.
CDC Split Type:

Write-up: 7/4/04: Puffy eyes/itchy eyes, diagnosed with OM. Prescribed but did not take amoxicillin (because of possible allergy). 7/6/04: Clinic. Temp 102.7. B posterior lymphadenopathy; alert, well appearing. 7/7/04 Seizure at home. ED; repeat seizure, apneic episodes 3 times. Flumazanil, Dilantin and transferred. Never regained consciousness. LP positive, WBC. Died 7/9/04. Labs. Nurse follow up on 08/02/04 states: "Complete." Autopsy report received stated patient experienced Epstein Barr infection and cerebral edema.


VAERS ID: 224362 (history)  
Form: Version 1.0  
Age: 0.14  
Sex: Female  
Location: Oregon  
Vaccinated:2004-06-21
Onset:2004-07-01
   Days after vaccination:10
Submitted: 2004-07-13
   Days after onset:12
Entered: 2004-07-27
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1663AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1289N / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0772 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495170 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Encephalitis, Sudden infant death syndrome
SMQs:, Noninfectious encephalitis (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-01
   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: Parents reported respiratory congestion, but lungs clear.
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: OR200418

Write-up: SIDS death 7/1/04. Nurse follow up on 10/05/04 states: "Focal chronic encephalitis."


VAERS ID: 224363 (history)  
Form: Version 1.0  
Age: 0.59  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2004-05-03
Onset:2004-05-04
   Days after vaccination:1
Submitted: 2004-07-13
   Days after onset:70
Entered: 2004-07-27
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21899B9 / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE201AA / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cefzil
Current Illness: NOEN
Preexisting Conditions: Mild familial macrocephaly; Seborrheic dermatitis; Candiadol
Allergies:
Diagnostic Lab Data: Autopsy: consistent with SIDS; can not rule out asphyxiation.An autopsy was performed on 5MAY2004. 5MAY2004: blood alcohol not detected, drug screen negative. It was noted in the autopsy report that the infant was rebuct, well nourished, and had no anomalies or distinguishing features. There were no petechiae of the conjuncive eyelids, or finefacial skin. Bloody mucoid fluid purging from the nostrils was observed. It was also noted that there was osme blood mucoid staining in the infant''s bassinet. Both lungs were "congested and slightly edematous with a few pleural petechiae and some scattered subpleural hemorrhagic blotchy patches but no focal lesions are noted about the pleural surfaces or cut sections." Histological examinaiton of the lungs revealed "intense vascular congestion and scattered foci of fank intra-alveiolar and interstitial hemorrhage especially in the lowe lobes". "Minimal" focal atelectasis was observed. Petechiae were observed over the inferior surace of the thymus. Other autopsy findings included generalized visceral congestion, a moderately "dusky" and congested brain, and chronic viscid mucus otitis of both middle ears. Blood analyses for ethanol and a drug screen were both negative. The forensic pathologist wrote, "the death may be attributed to the phenomenon of sudden unexplained death with asphyxia not able to be excluded." The causeof death was recorded as "Sudden Infant Death."
CDC Split Type:

Write-up: Patient presented to ER in cardiac arrest. Was coded, pronounced dead that evening less than 28 hours following immunizations. Nurse follow up on 07/27/04 states: "SIDS." Follow up report: this report was received from the CDC in response to a Freedom of Information request by GSK. It described the occurrence of sudden infant death syndrome in a month old male patient who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. The patient''s medical history included "mild" familial macroencephaly, candidiasis, seborrheic dermatiti, otitis media (4FEB2004), and wheezing bronchitis. Concurrent medications included Cefzil for an unspecifed indication. On 3MAY2004, the patient received the third dose of Pediarix. On the same day, the patient also received an injection of Haemophilus influenzae type b conjugate vaccine. Approximately one day following receipt of the immunizations, on 4MAY2004, the patient "was found unresponsive and without vital signs in the rather small crib where he had been laiddown to sleep a few hours before and had last been seen apparentl alive and well less than one hour before." Emergency medical personnel were summoned; they began cardiopulmonary resuscitaiton and transported the patient to the ER. Resuscitation attempts were unsuccessful, and the patient was pronounced dead less than 28 hours after receipt of the immunizations. An autopsy was performed on 5MAY2004. It was noted in the autopsy report that the infant was rebuct, well nourished, and had no anomalies or distinguishing features. There were no petechiae of the conjuncive eyelids, or finefacial skin. Bloody mucoid fluid purging from the nostrils was observed. It was also noted that there was osme blood mucoid staining in the infant''s bassinet. Both lungs were "congested and slightly edematous with a few pleural petechiae and some scattered subpleural hemorrhagic blotchy patches but no focal lesions are noted about the pleural surfaces or cut sections." Histological examinaiton of the lungs revealed "intense vascular congestion and scattered foci of fank intra-alveiolar and interstitial hemorrhage especially in the lowe lobes". "Minimal" focal atelectasis was observed. Petechiae were observed over the inferior surace of the thymus. Other autopsy findings included generalized visceral congestion, a moderately "dusky" and congested brain, and chronic viscid mucus otitis of both middle ears. Blood analyses for ethanol and a drug screen were both negative. The forensic pathologist wrote, "the death may be attributed to the phenomenon of sudden unexplained death with asphyxia not able to be excluded." The causeof death was recorded as "Sudden Infant Death."


VAERS ID: 224633 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Connecticut  
Vaccinated:2004-07-20
Onset:2004-07-30
   Days after vaccination:10
Submitted: 2004-08-02
   Days after onset:3
Entered: 2004-08-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21931A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE143AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495767 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Injury
SMQs:, Acute central respiratory depression (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: CT200405

Write-up: Per case analysis, mother rolled over on child and the child suffocated. Follow Up: This report was received from the Centers for Disease Control and Prevention in response to a Freedom of Information request by a manufacturer. It described the possible occurrene of sudden infant death syndrome in a 2 month old male patient who received diptheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated polioviurs vaccine combined. There were reportedly no pre-existing medical conditions or current illnesses. On 20JULY2004, the patient received the first dose of Pediarix. On the same day, the patient also received injections of Haemophilus influenzae type b conjugte vaccine. The health department nurse wrote, "a bottle of Tylenol given after shots administered, it is assumed that the paracetamol was dispensed for subsequent administration, since paracetamol overdose was not reported. The nurse also wrote, "no adverse reaction reported after vaccination." Approximately 10 dyas after the receipt of the immunizaitons, at 12:00 PM on 30JULY2004, the patient was found dead in bed. Initially, it was reported that the patient''s mother, accidentally rolled over onto the infant and the infant died from suffocation. On followup , a newspaper article written a few days afte the death was forwarded to the manufacturer. The article quoted a police officer as stating indicated that the infant died from sudden infant death syndrome. An autopsy was performed. On 11AUG2004, the medical examiner stated that the autopsy report was not complete and would be forwarded as soon as it became available. It was not available as of 8NOV2004.


VAERS ID: 225216 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Unknown  
Vaccinated:2004-06-23
Onset:2004-06-27
   Days after vaccination:4
Submitted: 2004-08-03
   Days after onset:37
Entered: 2004-08-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Delirium, Paralysis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-07-09
   Days after onset: 12
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: NONE
Current Illness: UNK
Preexisting Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20040384

Write-up: A 12 year old male boy was bitten by a stray dog on 6/9/04. Wound toilet was done and vaccination with 4 doses of Rabipur started on 6/9/04. The other three doses he received on 12th, 16th, and on 23rd of June 2004. No information on RIG application available. The patient complained about fever on 22 and on 6/25/04. Delirium started on 6/26/04, lasting for one day. Patient was admitted with paralysis of left lower limb on 6/27/04. Suspecting typhoid, patient was given Monocef and Decandran. Delirium subsided. The patient died on 7/9/04. We are awaiting further information. Preliminary assessment. Seriousness criteria: hospitalization, life-threatening, death. Causality: not related. Addendum 8/13/04: We received information that the patient was not administered any immunoglobulins. Assessment: unchanged.


VAERS ID: 225432 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Florida  
Vaccinated:2004-08-09
Onset:2004-08-09
   Days after vaccination:0
Submitted: 2004-08-13
   Days after onset:4
Entered: 2004-08-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 610B4 / 1 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER U8238AA / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 496267 / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Cardiac arrest, Cardiovascular disorder, Crying, Hypoxia, Pallor, Respiratory arrest, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cefixime
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: On 8/9/04, patient had received Pediarix, HIB, and Prevnar at doctor''s visit. Baby turned pale and was told to wait before leaving. Child got worse and CPR started and fire/rescue called. They continued CPR and were unsuccessfully intubating. Transferred to hospital where baby expired. Nurse follow up on 09/02/04 states: "Pulseless, apnea." Autopsy report stated patient unresponsive and crying.


VAERS ID: 225540 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-04-11
Onset:2003-05-17
   Days after vaccination:36
Submitted: 2004-08-17
   Days after onset:458
Entered: 2004-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Chest pain, Coronary artery atherosclerosis, Coronary artery occlusion, Hypertrophy, Myocardial infarction, Pulse absent, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Treated for cholesterol and blood pressure.
Current Illness:
Preexisting Conditions: Hypercholesterolemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: While exercising, suddenly collapsed and found without pulse. CPR initiated. Resuscitation attempts unsuccessful. "Long history of hypercholesterolemia and hypertension for which taking medication." Had prior episodes of chest pain related to exercise. Autopsy revealed severe 3-vessel coronary occlusion, remote healed myocardial infarct, left ventricular hypertrophy. No myocarditis noted. "Died of arteriosclerotic coronary vascular disease." Will fax autopsy report.


VAERS ID: 225671 (history)  
Form: Version 1.0  
Age: 0.95  
Sex: Male  
Location: Alabama  
Vaccinated:2004-08-02
Onset:2004-08-04
   Days after vaccination:2
Submitted: 2004-08-13
   Days after onset:9
Entered: 2004-08-23
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 622A2 / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1215M / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0799 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495926 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Infection, Pneumonia, Respiratory distress, Tachycardia, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-08
   Days after onset: 4
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: Phenobarbital; Klonopin; Zantac
Current Illness: Miller-Dieker Syndrome; Asthma; Seizures; GE Reflux
Preexisting Conditions: Miller-Dieker syndrome; Asthma; Seizures; GE reflux;
Allergies:
Diagnostic Lab Data: Blood cultures negative; Chest x-ray: possible pneumonia
CDC Split Type:

Write-up: Developed respiratory distress with tachypnea and tachycardia. Evaluated in ER for respiratory status at about 03:00; received two neb treatments with albuterol. Admitted. On antibiotics clindamycin and Omnicef for possible pneumonia/infection. Respiratory status deteriorated and patient died. Discharge/Death Summary received on 11/23/2004 states pt experienced respiratory failure.


VAERS ID: 225903 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-08-25
Entered: 2004-08-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 989A2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0523164A

Write-up: This case was reported by a representative of the Division of Vaccine Injury Compensation and described the death of a child (age and gender not specified who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed that may have been Infanrix. Concurrent medications and medical history were not reported. On an unspecified date in 2001, the child received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine. In the immunization record, the manufacturer was recorded; however, the handwritten lot number looks like Q or the number 2 then 989AZ or 989A2. A lot number DTPA989A2 would correspond to Infanrix. At an unspecified time post-immunization, the child died. A claim was filed that asserts that the death was caused by thimerosal. Thimerosal was not used as a preservative in Infanrix lot DTPA989A2.


VAERS ID: 226156 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Georgia  
Vaccinated:2004-07-13
Onset:2004-07-21
   Days after vaccination:8
Submitted: 2004-07-22
   Days after onset:1
Entered: 2004-09-01
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21918D2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0718N / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495031 / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Sudden infant death syndrome, Unevaluable event
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA04029

Write-up: Infant found deceased in crib. Follow up: this report was received from the Centers for Disease Control and Prevention in response ot Freedom of Information by GSK. This case was reported by the CDC and Prevention and described the occurrence of death in a 2month old male patient who received diphtheria and tetanus toxois and acellular pertussis adsorbed , hepatitis B recombinant and inactivated poliovirus vaccine combined. On 13JULY2004, the patiet received the first dose of Pediarix. On the same day, the paitent also received injectons of Haemophilu influenzae type b conjugate vaccine and 7 valent pneumococcal conjugate vaccine. Approximately eight days following the receiipt of the immunizations, on 21JULY2004, the patient was found dead in his crib. It is unknown whether an autopsy was performed. Autopsy report received which reveals COD as unexpected death of infant while cosleeping.


VAERS ID: 226283 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Female  
Location: Arkansas  
Vaccinated:2003-09-08
Onset:2004-04-27
   Days after vaccination:232
Submitted: 2004-09-03
   Days after onset:129
Entered: 2004-09-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492819 / 3 LL / IM

Administered by: Public       Purchased by: Other
Symptoms: Bacterial infection, Cough, Drug ineffective, Pyrexia, Rhinorrhoea, Upper respiratory tract infection, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic 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: 2004-05-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Viral upper respiratory tract infection; Jaundice
Allergies:
Diagnostic Lab Data: Streptococcus pneumoniae antibody titers are similar to those found in similarly aged children who have not received a full series for age of pneumo conjugate vaccine. Pneumococcal titers are lower than expected for a fully immunized child. A culture from brain tissue revealed Streptococcus pneumoniae serotype 19-F. WBC 13K.
CDC Split Type: HQWYE610423JUN04

Write-up: Follow up information from the attending physician provided the patient''s date of birth, dates of Prevnar immunization, event onset date and date of death. Information regarding Prevnar was received from a physician regarding a 13 month old female patient who received the third dose at 6 months of age, and died of invasive S. pneumo on 5/2/04. The patient''s concurrent illness included a viral upper respiratory tract infection with a past history of jaundice (at 4 days old) and upper respiratory tract infection (at 1 year and 3 weeks of age). Family history included antitrypsin deficiency. Indication for Prevnar was immunization. Product was administered on 9/8/03. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. On 4/27/04, the patient presented with a fever of 102-104 degrees F, cough with post-tussive vomiting, and sinus drainage. A white blood cell count was 13K. The child was diagnosed with a viral upper respiratory tract infection. No antibiotics were received. On 5/2/04, the child was found dead by the parents. A culture of brain tissue revealed Streptococcus pneumoniae serotype 19-F. A pneumococcal antibody test revealed: Streptococcus pneumoniae antibody titers are similar to those found in similarly aged children who have not received a full series for age of pneumo. conjugate vaccine. Titers are lower than expected for a fully immunized child. The reported cause of death was Streptococcus pneumoniae meningitis. The child had received Prevnar vaccine at 2, 4, and 6 months of age. The fourth dose was not given. Nurse follow up on 09/07/04 states: "Complete." Follow up on 09/10/04 states: "The cause of the death of pt, was an infection around the brain with Streptococcus pneumoniae, a bacteria commonly found in the nose and air passages and a frequent cause of meningitis in this age group. There is no evidence of significant trauma. Toxicology showed nothing abnormal."


VAERS ID: 226613 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Female  
Location: New York  
Vaccinated:2004-08-24
Onset:2004-08-31
   Days after vaccination:7
Submitted: 2004-09-10
   Days after onset:10
Entered: 2004-09-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21932B2 / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE384AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57753D / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Brain oedema, Cerebral ischaemia, Convulsion, Diabetes insipidus, Grand mal convulsion, Haemorrhage intracranial, Mental impairment, Pyrexia, Retinal haemorrhage, Upper respiratory tract infection, Viral infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Retinal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol; Mylicon; Colace
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had fever and URI 7 days after vaccine. A day later, she had multiple seizures, rapid deterioration of mental status and died within 4 days of illness. Nurse follow up on 10/15/04 states: "Family reported infant "not breathing" prior to arrival at ER, and that PCP diagnosed a viral syndrome the day prior to arrival at ER." Medical Record received on 12/15/2004 states pt experienced status epilepticus, global anoxic brain injury, edema brain, brain hemorrhage, retinal hemorrhage, and diabetes insipidus. Nurse follow up on 10/19/04 states: No new information. 1/6/05 Received autopsy report which states COD as complications of seizures of undetermined etiology & manner of death as natural. Neuropathology report provides diagnoiss of global hypoxic/ischemic encephalopathy (respirator brain).


VAERS ID: 226651 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Male  
Location: Massachusetts  
Vaccinated:2004-09-02
Onset:2004-09-03
   Days after vaccination:1
Submitted: 2004-09-10
   Days after onset:7
Entered: 2004-09-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1219N / 2 LL / -

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Unevaluable event
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), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-03
   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: NONE
Current Illness: NONE
Preexisting Conditions: jaundice in newborn resolved;
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: NONE. Nurse follow up on 09/23/04 states: "cardiac arrest, pulmonary arrest." Nurse follow up on 10/05/04 states: "none, awaiting autopsy report."


VAERS ID: 226696 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2002-09-01
Submitted: 2004-09-14
   Days after onset:744
Entered: 2004-09-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Lung neoplasm malignant, Neoplasm malignant
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-15
   Days after onset: 287
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: UNK
Preexisting Conditions: Relevant medical history was not provided
Allergies:
Diagnostic Lab Data: Reported cause of death: mesothelioma.
CDC Split Type: HQWYE973910SEP04

Write-up: Information regarding ORIMUNE vaccine was received from an attorney regarding a male patient who developed mesothelioma and subsequently expired. The decedent received a dose of ORIMUNE vaccine on an unspecified date. Relevant medical history was not provided. Indication for ORIMUNE vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. It is alleged that the decedent''s exposure to asbestos and asbestos-containing products and the Simian virus 40 contained within the polio vaccine, caused severe and permanent injury to the decedent, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. It is further alleged that on or about 9/02, the decedent was diagnosed with mesothelioma and subsequently expired on 6/15/03. The cause of death was reported as mesothelioma. No additional informatin was available at the time of this report.


VAERS ID: 226823 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Arkansas  
Vaccinated:2004-08-04
Onset:2004-08-05
   Days after vaccination:1
Submitted: 2004-09-14
   Days after onset:40
Entered: 2004-09-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21918A9 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE168AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57559A / 1 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Cyanosis, Heart disease congenital, Hypoxia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-05
   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: Lasix; Reglan; Zantac
Current Illness:
Preexisting Conditions: Hypoplastic left heart syndrome S/P repair.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pertinent history of hypoplastic left heart. Patient died; ER resuscitation attempted with intubation. 5 doses epinephrine after acute episode collapse. Nurse follow up on 10/07/04 states: "Cyanosis." Autopsy Report received on 1/07/2005 states congenital heart disease.


VAERS ID: 226876 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: New York  
Vaccinated:2004-09-14
Onset:2004-09-14
   Days after vaccination:0
Submitted: 2004-09-15
   Days after onset:1
Entered: 2004-09-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1697AA / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0027P / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 0799 / 2 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495159 / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Coma, Cyanosis, Hypoxia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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 (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-15
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CT Scan; CPR; Blood work; Intubation/respirator at ER.
CDC Split Type:

Write-up: Patient well at visit; received vaccines. Was fine when leaving office and at home. Was put in for a nap in early afternoon. Found 30 minutes later, was blue and nonresponsive. Received CPR and taken to ER. Nurse follow up on 09/28/04 states: "No new information." Medical records reviewed state patient COD was cardia arrest.


VAERS ID: 227004 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Florida  
Vaccinated:2004-08-27
Onset:2004-08-29
   Days after vaccination:2
Submitted: 2004-09-24
   Days after onset:26
Entered: 2004-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 01698A / 1 - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5506A / 1 - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M23AA / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X14C2A / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Cyanosis, Epistaxis, Lung disorder, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), 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 (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown.
Current Illness: Mild facial rash typical of young infants
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Death within 24-48 hours of vaccinations. Mother found infant not breathing and with bleeding from his nose. He was in his crib. Mother called 911. EMT''s transported infant to ER. Infant probably died prior to EMT''s arrival per reporter. Autopsy report received on 11/29/2004 cause of death is SIDS. Pt also experienced bilateral pulmonary congestion and edema perimortem. Nurse follow up on 10/13/04 states: "Blue in color, cardiac arrest."


VAERS ID: 227197 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Georgia  
Vaccinated:2004-07-30
Onset:2004-08-06
   Days after vaccination:7
Submitted: 2004-09-27
   Days after onset:52
Entered: 2004-09-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21881C9 / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA865AA / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493262 / 2 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Bacterial infection, Cardiac arrest, Cyanosis, High-pitched crying, Pyrexia, Stupor, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Waiting for final autopsy report to be complete.
CDC Split Type:

Write-up: Patient felt like he may have had a slight fever the night before his passing. He laughed and played that night. 10 PM he ate oatmeal and banana. 12:00, he had a bottle and fell asleep. He awoke at 3:41 AM and had another bottle; played a little while, fell asleep. He began to scream so I picked him up and laid him on my chest. He slept there until 7:00 AM. I laid him on the bed while I got ready for work. He was asleep when I left for work at 8:10 AM. He was fine. His father checked on him and he was not breathing. Nurse follow up on 10/21/04 states: "unresponsive, bacterial infection, cyanosis, asystole." Autopsy Report received on 1/25/2005 states SIDS.


VAERS ID: 227278 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Maryland  
Vaccinated:2004-06-21
Onset:2004-07-07
   Days after vaccination:16
Submitted: 2004-09-29
   Days after onset:84
Entered: 2004-10-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 805A6 / 1 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0799 / 1 RA / SC
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD. 3000421 / 1 MO / PO
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE172AA / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Cardiomegaly, Cardiovascular disorder, Fall, Neoplasm
SMQs:, Cardiac failure (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-07
   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: Mitral plasty 1995
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Patient fell down stairs on 7/7/04. Autopsy revealed enlarged heart. Echo in 01/04; heart normal size. No symptoms, no meds. Followup: cause of death: cardiomegaly with atherosclerotic cardiovascular disease. Natural death. Carcinoid tumor of Ileon


VAERS ID: 227290 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: California  
Vaccinated:2004-09-13
Onset:2004-09-16
   Days after vaccination:3
Submitted: 2004-10-01
   Days after onset:15
Entered: 2004-10-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1300DA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0089P / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1006 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495253 / 2 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Agitation, Anorexia, Cardiac arrest, Cough, Insomnia, Nasal congestion, Otitis media, Pneumonia, Pyrexia, Respiratory arrest, Somnolence, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol; Amoxicillin
Current Illness: Nasal congestion; Otitis;
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Preliminary negative autopsy. Negative RSV; Rest of histology/toxicology pending.
CDC Split Type:

Write-up: Received 4 month immunizations on 04/13/04. Developed cold symptoms 09/14 and fever to 101.3. Pt was seen in office 16:00 on 09/16/04. Diagnosed with upper respiratory infection and otitis and treated with Tylenol and Amoxicillin. Parents reported increased nasal congestion not latching to breast feed. Called advice nurse 5:00am 09/17/04 with questions regarding cold and fever (100.8). Then at 8:00am mom was holding baby; noticed no heartbeat. 911 called pt in asystole from initial paramedic contact until pronounced at hospital. PCP states patient''s mother mentioned the baby was sleepy and quieter than usual after her immunizations. Nurse follow up on 10/05/04 states: "Sleeping poorly, coughing, and fussy, gagging." - 10/05/2004 Review of well-baby progress note from 9/13/04 indicates child essentially normal. The ill-baby progress note indicates fever, runny nose/worsening congestion, fussiness, difficulty eating, gagging, cough, and not sleeping well. There was no diarrhea or vomiting. Exam indicated erythematous and bulging right TM with normal left TM, clear rhinorrhea, and clear lungs. - 10/28/2004 ER report indicates discharge impression was cardiopulmonary arrest. Baby arrived to ER with CPR and ventilatory assistance in progress. At no time was there a spontaneous pulse or respiration. Several doses of epinephrine were administered. Baby''s body was released to the morgue as a coroner''s case. - 03/15/2005 autopsy report states COD was acute bronchopneumonia.


VAERS ID: 227394 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-10-24
Onset:2004-09-23
   Days after vaccination:335
Submitted: 0000-00-00
Entered: 2004-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Deep vein thrombosis, Gastrointestinal necrosis, Gastrointestinal neoplasm, Intestinal obstruction, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal obstruction (narrow), Thrombophlebitis (broad), Ischaemic colitis (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin C, E, B complex; Testosterone injections; Slo K; Maxide; Lasix; Acupril; Zyloprim; ASA;
Current Illness:
Preexisting Conditions: Received a dose of RSV vaccine or Placebo and Influenza vaccine. Administration date not reported. Blood pressure high; Hypertension; Congestive Heart Failure; Osteoarthritis; wac degenerative; Left orchiectomy in 2002;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403234

Write-up: This subject is a 67 year old male who was admitted to the hospital and died while enrolled in a study. The subject received two doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/23/03. The subject was hospitalized for a stomach mass, date of hospitalization not reported. While in the hospital subject developed a blood clot and died 334 days post immunization on 9/21/04. The subject''s death due to a blood clot was reported by the investigator as unknown in relationship to the study vaccine. Follow up on 10/08/04 states: "There was no autopsy done for this decedent." Nurse follow up on 10/14/04 states: "pulmonary embolism; deep vein thrombosis." Nurse follow up on 10/19/04 states: "small bowel mass." Nurse follow up on 11/11/04 states: "fat necrosis of the mesentery with partial small bowel obstruction."


VAERS ID: 227395 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Wisconsin  
Vaccinated:2004-07-28
Onset:0000-00-00
Submitted: 2004-09-15
Entered: 2004-10-06
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21923A2 / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0223P / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495305 / UNK LL / 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: 2004-08-28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Denied
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: WI0412

Write-up: Mother reported no adverse reaction after immunization. Being investigated as a SIDS death. Nurse follow up on 11/03/04 states: "No new information." 10/21/04 ER records received which revealed patient was in cardiac arrest on arrival & was unable to be resuscitated. ER called coroner.


VAERS ID: 227515 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: California  
Vaccinated:2004-08-20
Onset:2004-08-24
   Days after vaccination:4
Submitted: 2004-10-07
   Days after onset:44
Entered: 2004-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21936A2 / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 0036P / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 429-399 / 2 LL / IM

Administered by: Military       Purchased by: Military
Symptoms: Coma, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Medical Record received on 11/22/2004 states pt had a history PPS murmur and prematurity.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant was found unresponsive in crib at home. Parents brought child to emergency room. Follow up: COD is SIDS per ME''s office. Copy of final autopsy report is awaiting the ME''s signature. ER Report received on 11/22/2004 states pt experienced respiratory arrest. Autopsy Report received on 12/01/2004 states SIDS.


VAERS ID: 227616 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Texas  
Vaccinated:2004-10-05
Onset:0000-00-00
Submitted: 2004-10-11
Entered: 2004-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21932B2 / 1 LL / IM
HIBV: HIB (PROHIBIT) / SANOFI PASTEUR UE205AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57539A / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Retinal haemorrhage, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Cardiomyopathy (broad), Retinal disorders (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol nebulizer solution
Current Illness: URI, bronchiolitis resolved
Preexisting Conditions: bronchiolitis diagnosed on 9/9/2004
Allergies:
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Unknown after vaccine administered on 10/5/2004. Medical Records received on 12/07/2004 states asystole and bilateral retinal hemorrhages. Autopsy Report received on 1/12/2005 states SIDS.


VAERS ID: 227619 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:2004-05-28
Onset:2004-06-24
   Days after vaccination:27
Submitted: 2004-07-19
   Days after onset:25
Entered: 2004-10-12
   Days after submission:85
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR - / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain upper, Anorexia, Ascites, Asthenia, Calculus ureteric, Cardiac arrest, Cholelithiasis, Diarrhoea, Gallbladder disorder, Hepatic cirrhosis, Hepatic neoplasm malignant, Hepatitis C virus, Hydronephrosis, Laboratory test abnormal, Liver disorder, Nausea, Neoplasm malignant, Pleural effusion, Renal disorder, Renal impairment, Skin ulcer, Vomiting, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Liver malignant tumours (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-02
   Days after onset: 8
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: Tylenol; Ibuprofen
Current Illness:
Preexisting Conditions: History of Hepatitis C and Nephrolithiasis. Past surgical history: Lithotripsy. No know drug allergies.
Allergies:
Diagnostic Lab Data: Vital signs: temp 98, blood pressure 136/87, heart rate 85, respiratory rate 22, O2 saturation 100 on room air. Shows temporal wasting and cachexia. Lungs: decreased breath sounds bilaterally. Cardiovascular: 81/82, regular rate and rhythm, 2+ pulses bilaterally. Abdomen: distended, normoactive bowel sounds but tender to palpation in the right upper quadrant. Rectal: exam in negative per surgery note. Extremities: showed no clubbing, no cyanosis, and no edema. Neurologic: grossly non focal. X-ray findings: chest x-ray shows an elevated right hemidiaphragm, bilateral pleural effusion. Laboratory data: initial labs showed an abnormal ALT of 102, bilirubin of 1.8, alkaline phosphatase 168. EKG shows normal sinus rhythm at the rate of 82. The initial CT scan dose showed ascites and multiple lesions consistent with carcinomatosis. A cirrhotic liver was also noted, a thickened gallbladder, no diluted ducts and right hydronephrosis. The etiology of the cirrhosis was likely due to the hepatitis C. The question remains of the cause of the hepatic metastases. A CEA, PSA, and AFP will be checked. A phone call was made to the IR department for paracentesis for both diagnostic and therapeutic procedure. If this pt has symptoms, spironolactone 12.5 mg daily should be started. From additional information received on 07Jul04 the following laboratory results were provided 16June04 at 8:45am, glucose random high 179 mg/dl (normal range 60-159) RLW high 14.4% (normal range 11.9-14.3), Plt x 10-3 low 101 K/uL (normal range 140-400) Lymphocytes low 19% (normal range 20-50), Monocyte high 13% (normal range 0-11) 16June04 at 8:48AM Urinalysis showed a trace of blood. 27Jun04 at 12:15PM Chloride high 108 mBg/L (normal range 98-107), Glucose random high 200mg/dL (normal range 60-159), Alkaline phos high 177 U/L (normal range 38-126), Bili Tot adult high 2.1 mg/dL (normal range 0.2-1.3), ALT (SGPT) high 98 U/L (normal range 11-66), RDW High 15.4% (normal range 11.9-14.3), Plt x10-3 low 114 K/uL (normal range 140-400), Lymphocyte low 17% (normal range 20-50) Monocyte high 13% (normal range 0-11), 27June04 at 1:56PM Abdominal ultrasound abnormal examination. There is a large volume of ascites, free liquid is seen around the liver and spleen as well into the pelvis. The liver is course and somewhat increased in echogenicity in a diffuse inhomogeneous pattern. It also appears somewhat shrunken and irregular. The gallbladder wall is markedly thickened, but while this may represent a cholecystitis, it may also be a reflection of the overall ascites. There are gallstones present. There is no obvious dilatation of the biliary tree. There is adronephrosis in the right kidney. There is a marked dilatation of the right renal collecting system. There are calculi present within the dilated right renal collecting system. There probably are right ureteral calculi present as well. There is an increased echogenicity in the left renal pelvis, but this may reflect interface artifacts. There is overall mildly increased echogenicity to the renal cortical parenchyma bilaterally, but substantial cortex is still present. The right kidney is about 11.6cm long, the left is greater than 10cm in length. The spleen is enlarged, measuring nearly 17cm, no masses are seen. 27June04 at 3:06PM Chest: no prior examination. Heart and pulmonary vascularity are normal. There is elevation of both hemidiaphragms with bilateral subsegmental atelectasis. There is blunting of both costophrenic angles. 27Jun04 at 7:30PM BUN high 21mg/dL (normal range 9-20), Chloride high 110 mg/L (normal range 98-107) Alkaline phos high 168 u/l (normal range 38-126), Tot Adult high 1.8mg/dl (normal range 0.2-1.3) SGPT high 102 u/l (normal range 11-66), RDW high 15.5% (normal range 11.9-14.3) Plt x10-3 low-111 K/ul (normal range 140-400), Monocyte high 13% (normal range 0-11) PT pt high 13.0 Sec (normal range 9.2-11.9), Pt INR high 1.3 ratio (normal range 0.9-1.1), 27Jun04 at 8:14PM CT Scan of the abdomen and pelvis, findings on the sonogram are largely corroborated. There is marked inhomogenecity and irregularity of architecture of the liver. The liver is shrunken and in a patter that is entirely consistent with cirrohisis. Although distinct masses are not seen, there is sufficient inhomogenecity and indistinctness of portions of the liver that a mass or masses could be easily be obscured. There is a very large volume of ascites. Additionally, there is inhomogeneous and mixed density present within the ascetic fluid with what appears to be mesenteric, peritoneal, and mental caking or infiltration. Concern therefore is for a diffuse peritoneal carcinomatosis. There is a right moderately severe right hydronephrosis. Right renal calculi are present and the proximal ureter is dilated. A ureteral calculus is not immediately obvious. No left renal abnormality on the examination. Gallstones are present. There is thickening of the gallbladder wall. No distinct biliary ductal dilatation although, once again it is emphasized that the liver is sufficiently inhomogeneous to obscure some bile duct dilatation. The pancreas is grossly intact. Bowel loops are unremarkable, ingested barium has traveled well into the small intestine and feces and air are present in colon in a nondescript pattern. No bladder masses, renal activity is seen by contrast in the left ureter into the bladder. Right ureter opacification is not seen and it is possible that there is dilatation of the right ureter distally. The lung bases are clear. 28Jun04 7:55AM Bili, Tot Adult high 2.2mg/dl (normal range 0.2-1.3) CEA EIA high 44.4 ng/mL (normal range 0.0-5.0) AFP, NonMaterna high 8489.9 mg/mL (normal range 0.0-15.0), ALT high 98 U/L (normal range 11-66), RIW high 15.7% (normal range 11.5-14.3), Plt x10-3low-115 K/uL (normal range 11.9-14.3), Lymphocytes low 19% (normal range 20-50) 28June04 at 11:51AM Abdominal fluid cytology-negative cytology; no malignant cells identified. Predominately blood. Gross description-abdominal fluid 120 ml bloody fluid. Diagnostic paracentesis-Ultrasound guidance, a multi side hole catheter was inserted. this allowed free aspiration of blood. The CT scan was then reviewed. This exhibits a hepatoma of the right lobe of the liver with associated free peritoneal fluid. This is all consistent with rupture of a hepatoma with hemoperitoneum. The catheter was removed. The referring physicians were informed. The pt was sent back to the ward in stable condition. June2004 at 2:28PM MRI scan of the abdomen multiple axial T1 and T2 weighted images, coronal T2 weighted images and axial T1 weighted images were acquired. Dynamic axial T1 weighted images were acquired after the intravenous administration of contrast. Comparison is made with previous CT scan dated 27Jun04. Again noted is made of ascites. Inhomogeneity of the liver is noted, specifically in the dome of the liver, right lobe with bright T1 signal which appears to be right on T2 suggesting blood products. There is a diffuse signal abnormality to the dome of the liver and right lobe of areas of satellite signal abnormality and there is abnormal enhancement suggestive of neoplastic process. Cirrhosis is also noted within the liver. There is right hydronephrosis and cholelithiasis. Spleen is upper limits of normal in size. Lung bases suggest that there is an exophytic component to the mass in the dome of the liver that extends to the subpulmonic region and inferior pleural surface. The pancreas appears unremarkable. Left kidney appears unremarkable.
CDC Split Type: 200402265

Write-up: This subject is a 70 year old male, who was admitted to the hospital due to abdominal pain while enrolled in a study. The last dose prior to the event was given on 5/28/04. The patient received either a foreign Td vaccine or Td vaccine (control product) (lot number not reported). The subject developed abdominal pain 30 days post-immunization and was admitted to the hospital the same day. He had a seven day history of epigastric and right upper quadrant pain and a two week history of weakness, nausea, vomiting, weight loss, diarrhea and anorexia. The initial CT scan done showed ascites and multiple lesions consistent with carcinomatosis. A cirrhotic liver was also noted, a thickened gall bladder, no diluted ducts and right hydronephrosis. Reportedly, the etiology of the cirrhosis was likely due to the hepatitis C. A chest x-rays showed an elevated right hemi-diaphragm and bilateral pleural effusion. Initial labs showed an abnormal ALT of 102, bilirubin of 1.8, alkaline phosphatase 168. Treatment given was not reported. He was discharged from the hospital three days later. The subject''s recovery status was unknown at the time of this report. The abdominal pain was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: Fax covers, initial reporting form, history and physical, physical examination, lab reports, IND SAE fax reports and fax confirmation (12 pages). From additional information received on 7/7/04 it was reported that the patient died on 7/2/04. Patient developed abdominal pain on 6/24/04 changing the latency to 27 days post immunization. He was diagnosed with ruptured hepatoma/hepatocellular carcinoma, ascites, carcinomatosis, Hepatitis C with cirrhosis of the liver and hydronephrosis. An ultrasound guided paracentesis which showed frank blood in the ascetic fluid compatible with a possible hematoma with probable rupture associated with a hemo-peritoneum. The subject underwent an MRI of the abdomen which did confirm ruptured hepatoma/hepatocellular carcinoma. The subject was discharged home with hospice care to follow up as an outpatient. The following medications were prescribed on discharge: Vicodin 2 tables orally every four hours for a pain scale less than 5.10. Use morphine sulfate liquid for breakthrough pain. A stool softener of Colace to be taken twice a day was prescribed for constipation. The ruptured hepatoma/hepatocellular carcinoma, ascites, carcinomatosis, Hepatitis C with cirrhosis of the liver, hydronephrosis and death was reported by the investigator as unrelated to the study vaccine. The etiology of the cirrhosis was likely due to the hepatitis C. The question remains of the cause of the hepatic metastases. A CEA, PSA, and AFP will be checked. A phone call was made to the IR department for paracentesis for both diagnostic and therapeutic procedure. If this patient has symptoms, spironolactone 12.5mg daily should be started. No autopsy was done. Pt died at home. Nurse follow up on 10/13/04 states: "Liver cancer, Hepatitis C, Cardiovascular arrest, ruptured hepatoma."


VAERS ID: 227712 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2004-10-07
Onset:2004-10-07
   Days after vaccination:0
Submitted: 2004-10-11
   Days after onset:4
Entered: 2004-10-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1380AA / UNK RA / 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: 2004-10-07
   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: Lupron; Atenolol; Imdur; Actos; Digoxin; Aspirin; Norvasc; Furosemide; Lisinopril; Zocor
Current Illness:
Preexisting Conditions: The patient had a history of unspecified cardiac problems and prostate cancer. He had previously received influenza vaccines in 2002 and 2003, and a Pneumovax vaccine in 2003. Nurse follow up on 10/14/04 states: "Diabetes Type II; Myocardial Infarct 2000; aortic stenosis; ischemic cardiomyopathy." From additional information received on 10/21/04, it was reported that the patient had no illnesses at the time of vaccination. He had previously received at least three or more influenza vaccines in the past without experiencing any adverse events. His previous medications had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril, and metformin. His current medication list was not available at the time of this report, so it is unknown if the patient was taking any of these medications at the time he received the influenza vaccine on 10/7/04. From additional information received on 11/8/04, it was reported the patient''s medical history included coronary artery disease with myocardial infarction in 10/00, triple coronary arter bypass, ischemic cardiomyopathy, aortic stenosis, prostate cancer, cataract extraction with intraocular pressure, total hip arthroplasty in 1993 and adult onset diabetes mellitus. Patient''s previous medications included Imdur, Actos, Atenolol, Digoxin, Aspirin, Norvasc, and Furosemide all taken every morning. Evening medications included Atenolol, Lisinopril and Zocor.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403324

Write-up: From initial information received from a health care professional on 10/7/04 regarding an adverse event occurring in the USA, it was reported that an 80 year old male patient with a history of cardiac problems and prostate cancer received a FLUZONE vaccination, lot number U1380AA, administered in the right deltoid on 10/7/04. One hour after receiving the vaccine, the patient died in his car in the hospital parking lot. Per the reporter, the coroner''s initial impression was that it may have been a coronary heart attack and he stated that he would check for this. No other information was provided at this time. There was no autopsy done. Nurse follow up on 10/19/04 states: "No new information." Follow up on 10/28/04 states: "From additional information received on 10/21/04, it was reported that the pt had no illnesses at the time of vaccination. He received the FLUZONE SV ''2004-2005 vaccination IM. He had previously received at least 3 or more influenza vaccines in the past without experiencing any adverse events. His previous medicaitons had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril and metformin. His current medication list was not available at the time of this report, so it is unknown if the pt was taking any of these medications at the time he received the influenza vaccine on 10/07/04."


VAERS ID: 227846 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Wisconsin  
Vaccinated:2004-08-13
Onset:2004-09-23
   Days after vaccination:41
Submitted: 2004-10-13
   Days after onset:20
Entered: 2004-10-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21920C9 / 2 LL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0036P / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57556F / 2 LL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Diarrhoea, Pyrexia, Rash, Sudden infant death syndrome, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Tachypnea at birth and probable pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None known. FU: Per telephone f/u with nurse reporter, the preliminary COD is SIDS. This was confirmed by telephone f/u with the coroner. He related that the baby was found by in home caregiver swaddled in a blanket in the center of an adult bed and not breathing. She called 911 and EMTs transported infant to hospital where he was pronounced dead. An autopsy was done. Per telephone f/u with PCP vaccine provider he related the following: it was thought likely that the baby had arrested quite soem time before the caregiver found him. There were no apparent signs of trauma reported. The infant had appeared well at the time of his well baby check on 8/13/04. He had some previous problems with diarrhea and gad probably due to cow''s milk, but this was apparently resolved or at least decreased with formula change On 8/23/04, the baby was brought in with what was later determined to be a viral illness. He''d reportedly had a recent truncal rash that had resolved prior to the actual appointment and also had fever up to 102 degrees. Blood cultures were negative after 5 days and more immediate blood work was such that antibiotics were not indicated. The child appeared alert and in no acute distress. Nurse follow up on 11/16/04 states: "baby was more tired, had fever, and had decreased appetite on 8/23/04. Diagnosed with viral illness." - 11/16/04 Medical records reviewed. Pt had history of neonatal pneumonia and cellulitis at circumcision site. Later c/o mild regurgitation and gagging without vomiting, abdominal gas and loose stools. At time of AE the baby seemed more tired than usual and had decreased appetite. Blood culture was found to be negative for growth 5 days later. Diagnosis was viral illness. 12/1/04 Autopsy report confirms COD as SIDS.


VAERS ID: 228035 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Unknown  
Vaccinated:2004-08-12
Onset:2004-08-14
   Days after vaccination:2
Submitted: 2004-09-28
   Days after onset:45
Entered: 2004-10-21
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21936A2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0016P / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495702 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-14
   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; Healthy Infant
Preexisting Conditions: NONE; Healthy Infant.
Allergies:
Diagnostic Lab Data: Likely SIDS or smothered infant. Patient autopsy: No abnormalities suggesting abuse.
CDC Split Type:

Write-up: There were no signs of adverse events at the clinic. Infant was found dead in the morning on or around 8/14. Infant was well evening before. Mother had slept in same bed with her infant daughter.


VAERS ID: 228168 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2004-10-05
Onset:2004-10-07
   Days after vaccination:2
Submitted: 2004-10-22
   Days after onset:15
Entered: 2004-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1394CA / 7+ RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cerebral ischaemia, Chills, Hypertension, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Diabetes; previous strokes; cerebellar atrophy and bilateral prostatic hypertrophy - BPH.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SC0439

Write-up: Client''s wife called health department and reported that client received his flu shot on Tuesday, October 5, 2004 and was feeling fine. On Thursday, October 7th, client told his wife he didn''t feel well, was having body aches. Wife reported client continued to feel worse and that by Saturday he reported he hurt all over and wanted to stay in bed. Sunday AM, October 10th, client ate a bowl of cereal then returned to bed where he watched a ball game. After the game his wife went to read the paper and came back into the client''s room about 5:15 PM to see what he wanted for supper. He told his wife he still didn''t feel good, was feeling cold and shivering, but would eat a little of whatever she was having. A little later the wife sent their adult daughter to the client''s room to get him for supper and found him dead, still sitting up in bed. Due to client''s work in a local funeral home he had requested no autopsy be done so client was taken directly to the funeral home and buried on Wednesday, October 13th. According to his wife he had suffered several previous strokes and was a diabetic. The wife also reported that a friend who is also a physician stated it sounded like the client had a heart attack. The client has received flu vaccinations through the health department since 1998 with no adverse events. Nurse follow up on 11/01/04 states: "cardiovascular arrest; cerebrovascular ischemic disease; hypertension." -- 10/29/04 Copy of Death Certificate is received and lists COD as: cardiovascular arrest; cerebrovascular ischemic disease and hypertension.


VAERS ID: 228231 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Maryland  
Vaccinated:2004-10-08
Onset:0000-00-00
Submitted: 2004-10-25
Entered: 2004-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1489AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Cerebral infarction, Circulatory collapse, Gait disturbance, Hyperlipidaemia, Hypertension, Lung disorder, Myasthenic syndrome, Myelitis transverse, Pain, Paraesthesia, Pulmonary oedema, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Dyslipidaemia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Lipodystrophy (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: Sciatica, HTN
Allergies:
Diagnostic Lab Data: unknown to me at this time
CDC Split Type:

Write-up: unknown to me at this time. Nurse follow up on 10/29/04 states: "multiple lacunar infarcts in the thalami, (L) caudate head & periventricular white matter; transverse myelitis; hypertension; hyperlipidemia; pain & numbness; weakness of lower extrem; difficulty walking." Autopsy Report received on 12/07/2004 states severe acute CHF, bilateral acute ischemic renal infarcts, severe pulmonary congestion and edema, severe congestion, liver and spleen, and circulatory collapse. 11/18/04 Lab reports received. No new evidence found.


VAERS ID: 228204 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-10-25
   Days after onset:6
Entered: 2004-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1503AA / UNK LA / -

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: 2004-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: TN04052

Write-up: Local hospital reported that pt had no prior cardiac history. 10/26/04 Spoke the reporter/provider for this death. The only information their clinic has on the decedent''s prior medical hx is that she did not check off any of the items listed under medical history on the vax permission sheet including those asking about cardiac problems. She did not list any current meds. This woman was the aunt of one of the other health dept. nurses and this nurse has apparently stated that she is unaware of any health problems for her aunt. They are not aware of the name of her PMD. The reporter states that an autopsy was not done. We have requested the hospital records. 10/27/04 Copies of the ER report and the code blue record and death summary are received and sent for scanning. She arrived at the ER at 8:50 AM and expired at 10:48 AM in the CATH lab. The attending physician''s summary notes COD most likely an inferior posterior acute myocardial infarction based on ECHO and presenting sxs. Family was apparently advised that she was in cardiogenic shock w/ a small chance for survival without therapy. A temp pacemeaker, intra-aortic balloon pump and possibly salvage angioplasty were planned. In between insertion of the pacemaker and beginning of the angioplasty, she was found to have no pulse by palpation and confirmed on EKG and prolonged code was unsuccessful. Please refer to the scanned records for details. 10/27/04 Call to funeral director to request copy of Death Certificate. This record is received and notes Myocardial Infarction as the COD. Neither the hospital record, the original VAERS reporter nor the hospital attending who signed the Death Certificate know who the PMD was for this woman. I placed a call to the son today. There was no answer and no VM. Died of a massive MI on Tuesday morning 10/19/04 while in store.


VAERS ID: 228205 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-10-25
   Days after onset:6
Entered: 2004-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1419AA / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Cerebrovascular accident, Haemorrhage, Haemorrhage intracranial
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: TN04053

Write-up: Local hospital reported patient had no prior cardiac history. Patient was found in her bed around noon on Tuesday, 10/19. They believed she had died from a hemorrhagic stroke early Tuesday morning. Nurse follow up on 10/27/04 states: "intracranial hemorrhage."


VAERS ID: 228334 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Michigan  
Vaccinated:2004-10-25
Onset:2004-10-26
   Days after vaccination:1
Submitted: 2004-10-27
   Days after onset:1
Entered: 2004-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0514P / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-26
   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: Evista, Coumadin, Calan, Prevacid, Esgic-plus, Duo Neb, Advair Inhalant
Current Illness: None
Preexisting Conditions: History of: Hodgkin''s disease, severe migraines, severe asthma, radiation induced pulmonary scarring, hypertension, respiratory failure with intubation X3 prior to present incident.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe Bronchial asthma with respiratory failure.


VAERS ID: 228345 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:0000-00-00
Submitted: 2004-10-27
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, Blood pressure decreased, Cerebrovascular accident, Chromaturia, Coma, Hypertension, Medication error, Pallor, Pulse absent, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bumetanide; Celebrex; Docusate sodium; Flomax; Potassium CL; Meclizine; Prevacid
Current Illness:
Preexisting Conditions: History of colon cancer; arthritis; vertigo; hypertension; benign prostatic; hypokalemia; diverticular disease; obesity.
Allergies:
Diagnostic Lab Data: 10/20/04: Urine analysis and culture positive for Proteus mirabilis.
CDC Split Type:

Write-up: 80 year old nursing home resident, no acute illness. 10/18/04, dark, cloudy urine noted; UA ordered (10/24 lab report: numerous proteus mirabilis). On 10/22/04 at13:10 patient observed unresponsive and pale; no pulses, no respiration, no BP. CPR initiated, but unsuccessful. Note: Order written for 1cc flu vaccine; documented administration same, though facility says patient actually received 0.5cc. Nurse follow up on 11/01/04 states: "UTI." Death Certificate received on 11/16/2004 states causes of death are hypertension and CVA.


VAERS ID: 228346 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-16
   Days after vaccination:2
Submitted: 2004-10-27
   Days after onset:11
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK - / -

Administered by: Other       Purchased by: Private
Symptoms: Body temperature decreased, Cardiac failure, Cellulitis, Coronary artery disease, Dry skin, Fatigue, Laboratory test abnormal, Oral intake reduced, Pallor, Skin warm, Stomach discomfort
SMQs:, Cardiac failure (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-16
   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: Humulin; Zomig; Ferrous sulfate; Lopressor; Lopid; Senokot; Microk; Metamucil; Lexapro; Cardizem; Bumex; Aranes; Protonix; Allopurinol; Nitro patch; Coumadin; Clindamycin; ASA; Glucophage; Oscal.
Current Illness: Resolving of cellulitis.
Preexisting Conditions: Diabetes Mellitus; Hypercholesterolemia; Hyperlipidemia; Anemia; Depression; Coronary artery disease; Atrial Fib; CHF; Lymph edema; Renal insufficiency; hematuria. Allergies to PCN and Ether.
Allergies:
Diagnostic Lab Data: 10/12: CBC: WBC 17.4, RBC 2.85, Hgb 8.2, HCT 25.4, MCV 89, MCH 28.8, MCHC 32.3, Platelet count 310, Lymphocyte 8; Pro time 25.0, INR 2.1.
CDC Split Type:

Write-up: Flu vaccine given 10/14/04; unknown time (none charted). Flu vaccine 1cc with route not documented. 10/15/04 VS: 126/70, temp 97.7, 72, 20. No noted problems. 10/16/04 03:20, VS 140/50, 96.6, 64, 24; with time 97.3, 64, 24, 140/50. Complaints of feeling tired. 10/16/04 13:00 refused lunch (upset stomach); ate liquid diet. Skin W/D and pale. 14:25 while being assisted to bathroom, resident slumped. Nurse follow up on 11/01/04 states: "bilateral cellulitis of legs." Death Certificate received on 11/16/2004 states cause of death is CHF and coronary artery disease.


VAERS ID: 228347 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-18
   Days after vaccination:4
Submitted: 2004-10-27
   Days after onset:9
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dementia, Hypoxia, Pyrexia, Respiratory distress, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-10-25
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Docusate Na; Miacalcin; Celebrex; Ostcal; Act Fears; Tylenol; O2 by nasal cannula.
Current Illness:
Preexisting Conditions: Dementia; Agitation; Depression; Cancer. dysphagia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Last physical 9/17/04. Nasal O2, alert. Last PRRS, S2, no murmur. 10/15 temporary episode of respiratory distress. 10/18 Fever 100.5; no coughing. 10/23 Fever 100.5, responsive, given O2; fever broke late morning. 10/24 Fever 102.2. 10/23 fever 102.4, rapid breathing; on O2, no respiratory distress. Died at 21:00. Death Certificate received on 11/16/2004 states cause of death is end-stage dementia. 11/2/04 Received medical records from PCP which revealed patient with multiple complex medical problems including late stage Alzheimers.


VAERS ID: 228348 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-23
   Days after vaccination:9
Submitted: 2004-10-27
   Days after onset:4
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK - / -

Administered by: Other       Purchased by: Private
Symptoms: Choking, Coma, Convulsion, Cough, Dementia, Emphysema, Hypoxia, Laboratory test abnormal, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-23
   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: Depakote; Dilantin; Aspirin; Colace; Lexapro; Multivitamin; Zantac; Vitamin B1; Megace; Oystcal; Nicotrol cartride inhaler; Tylenol; Morphine sulfate; Roxanol
Current Illness:
Preexisting Conditions: Dementia; Nicotine addiction; Emphysema; Seizure disorder; Anxiety; Acute delirium; Bipolar disorder; No known allergies.
Allergies:
Diagnostic Lab Data: 10/14/04 WBC 12.2, MCV 101, MCH 33.4, Neutrophils 26 (decreased), Lymphocytes 60 (increased); Mono 14 (increased). Smear suggestive of viral infection. (labs ordered 10/11/04).
CDC Split Type:

Write-up: *Note: resident exhibiting cough 9/20/04. 10/7/04 choking and cough with food. 10/14/04 flu vaccine given. 10/20/04 worst cough and lung congestion. Blood oxygen 80-85% O2 at 26. 10/21/04 97.4, 60, 20, 150/80. Blood oxygen 92% with O2. 10/21/04 Hospice ordered. 10/22/04 99, 80, 28, 130/70; O2 saturation 90% with 3LO2. Unresponsive (1100). 10/23/04 0535 expired. Death Certificate received on 11/16/2004 states cause of death is COPD and end-stage dementia. 11/2/04 Nurses notes & med list from nursing home received. Patient also had history of nicotine addition, dementia, emphysema and seizure disorder.


VAERS ID: 228361 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-19
   Days after vaccination:5
Submitted: 2004-10-27
   Days after onset:8
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK RA / -

Administered by: Other       Purchased by: Private
Symptoms: Anorexia, Cardiac failure congestive, Cough, Dehydration, Hyperventilation, Hypoventilation, Hypoxia, Oral intake reduced, Pyrexia, Rales, Somnolence
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B12; Prevacid; Lasix; Bumex; Zithromax; Lumigan; Plavix; Synthroid; Terazosin
Current Illness: Hypothyroid; Incontinence; Depression
Preexisting Conditions: Hypothyroid; Chronic Pain; Depression; Partial Gastrectomy; Stroke
Allergies:
Diagnostic Lab Data: Medical Record received on 11/23/2004 states O2 stats depressed.
CDC Split Type:

Write-up: 10/19 Raled left lung; temp 97.4. 10/20 Mild congestive heart failure seen on x-ray, noisy breathing; started antibiotics. 10/21 Temp 99.5. 10/24 Temp 98.8. 10/25 Pale, rochi/crackles, decreased appetite, decreased voiding, slept all day. 10/26 Refused food, dehydration, water given, shallow breathing, O2 saturation 79%. Care refused by prior request. Medical Record received on 11/23/2004 states pt experienced rales and cough. Follow up 01/19/05, Recovery status unknown, patient expired in October.


VAERS ID: 228414 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Ohio  
Vaccinated:2004-08-26
Onset:2004-10-11
   Days after vaccination:46
Submitted: 2004-10-27
   Days after onset:16
Entered: 2004-10-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES C1699AA / 2 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1156M / 2 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 2 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A575600 / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Laboratory test abnormal, Meningitis, Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Noninfectious meningitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac
Current Illness: UNK
Preexisting Conditions: Gastroesophageal reflux disease; Coxsackie viral infection.
Allergies:
Diagnostic Lab Data: On 10/11/04, test results were: blood culture (results: positive for Streptococcus pneumoniae); white blood cell count (results: 1.9; range: 5.0-14.5); blood pH (results: 7.09); PO2 (results: 43); and PCO2 (results 49). The cause of death was reported as Pneumococcal meningitis. Autopsy and serology results were pending.Follow up: Serotypes for cultrues of ear and blood are 15A
CDC Split Type: HQWYE922920OCT04

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 5 month old male patient who experienced pneumococcal meningitis and pneumococcal bacteremia. At 4 months of age the patient received the second dose on 8/26/04. The patient''s concurrent illness includes gastroesophageal reflux disease with a past history of coxsackie viral infection. Indication for Prevnar was immunization. Product was administered on 8/26/04. Dose regimen was 1 dose 1 time per day (IM). Concomitant therapy included Zantac. The patient experienced pneumococcal meningitis and pneumococcal bacteremia on 10/11/04. He was treated with Motrin for fever on 10/11/04. The infant expired that same day. No additional information was available at the time of this report. 11/7/04 Received PCP progress notes. Autopsy Report received on 11/22/2004 states COD is Sepsis due to streptococcus pneumoniae w/associated injury in multiple organs.


VAERS ID: 228478 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Arizona  
Vaccinated:2004-10-19
Onset:2004-10-21
   Days after vaccination:2
Submitted: 2004-10-25
   Days after onset:4
Entered: 2004-11-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2044AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0145P / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0799 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A79659D / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardio-respiratory arrest, Sudden infant death syndrome
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), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-21
   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: NONE -Per review of medical records on 11/10/04, there was some congestion present at time of vaccination.
Preexisting Conditions: Stridor (intermittent); - Per review of medical records on 11/10/04 pt was recently diagnosed with colic.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient expired 48 hours after immunization (Cardiopulmonary arrest). Autopsy Report received on 1/20/2005 states SIDS. - Review of medical records on 11/10/04 indicate the office visit of 9/30/04 was for nasal congestion and fussiness. TMs were clear and there was no fever or cough. Given NS drops and suggested use of vaporizer. Visit of 10/7/04 was for continued congestion, gassiness and fussiness. Temp was 100 rectally and 98.9 on repeat. Diagnosed with colic.


VAERS ID: 228504 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: New York  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-10-26
   Days after onset:7
Entered: 2004-11-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 622A2 / 3 LL / -
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1407AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 3 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74404 / 3 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Irritability, Liver disorder, Nasal congestion, Nervous system disorder, Pulmonary congestion, Sudden infant death syndrome, Unevaluable event
SMQs:, Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-19
   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: NONE
CDC Split Type:

Write-up: Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death. - Review of well-baby progress note on 11/8/04 indicates baby was apparently healthy at time of immunizations. No additional symptoms. - - 03/23/2005 autopsy report rec''d. COD was SIDS.


VAERS ID: 228585 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Arizona  
Vaccinated:2004-10-20
Onset:2004-10-23
   Days after vaccination:3
Submitted: 2004-11-01
   Days after onset:9
Entered: 2004-11-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A0010BA / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE258AA / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57560H / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Cyanosis, Lymphadenopathy, Pneumonia, Unevaluable event, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (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: 2004-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.Nurse follow up on 11/02/04 states: "cyanosis; v-fib; cardiopulmonary arrest." Autopsy report received which revealed COD as interstitial pneumonia (compatible w/viral pneumonia), petecchial hemorrhage of the lungs & thymus and Cervical lymphadenopathy.


VAERS ID: 228586 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: New Hampshire  
Vaccinated:2004-01-09
Onset:2004-02-06
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2004-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5514A2 / 1 RL / -

Administered by: Public       Purchased by: Public
Symptoms: Lacrimal disorder, Pyrexia, Rhinitis, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Lacrimal disorders (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-06
   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: Feeding problems
Preexisting Conditions: Feeding problems; feeding disorder neonatal; perioral cyanosis;
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0415

Write-up: SIDS. Nurse follow up on 11/04/04 states: "fever 1/22/04; nasal congestion 2/2/04; blocked tear duct 2/2/04."


VAERS ID: 228587 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Nebraska  
Vaccinated:2004-10-21
Onset:2004-10-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2004-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 63982 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0410P / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0772 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74398A / 1 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: 2004-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy consistent with SIDS.
CDC Split Type:

Write-up: Patient received vaccine 10/21/04 about 2:00 PM. On 10/22/04 at 04:00, patient was found dead in bed. Autopsy report received on 11/22/2004 states pt had SIDS.


VAERS ID: 228788 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Michigan  
Vaccinated:2004-09-24
Onset:2004-09-28
   Days after vaccination:4
Submitted: 2004-10-24
   Days after onset:26
Entered: 2004-11-04
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1699AA / 2 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0092P / 2 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0706 / 2 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495941 / 2 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Faeces discoloured, Insomnia, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Common cold
Preexisting Conditions: Tested positive on Biotinidase Deficiency. Then tested negative on second test.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sleeplessness, blue/green/black stools. 4 days later he past away. Nurse follow up on 11/05/04 states: "No new information." Autopsy report gives COD as SIDS (03/02/2005).


VAERS ID: 228819 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Unknown  
Vaccinated:2004-09-30
Onset:2004-10-01
   Days after vaccination:1
Submitted: 2004-11-04
   Days after onset:34
Entered: 2004-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole, Bendroflumethiazide, Enalapril, Salbutamol, Paracetamol.
Current Illness:
Preexisting Conditions: The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200403742

Write-up: This case concerns an 87 year old female pt. The pt received a 0.5ml dose of influenza vaccine, manufacturer unknown, batch # not reported, given IM on 09/30/04. On 10/1/04 the pt died at home during sleep. A post mortem was carried out, the cause of death was established as acute myocardial infarction. The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97. No further information is expected, case is closed.


VAERS ID: 228893 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2004-08-28
Onset:2004-08-28
   Days after vaccination:0
Submitted: 2004-11-08
   Days after onset:72
Entered: 2004-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UE296AA / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Headache, Injury, Loss of consciousness, Nasal congestion, Nausea, Pyrexia, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: Patient had caught a cold on Friday and was feeling a little tried and she had alot of drainage.
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: high fever, dizziness, nausea, congestion and diffculty breathing, wheezing, extremely bad headache, like a bad migraine. Patient passed out while driving her car and crossed over the highway into oncoming traffic and was killed instantly. Four different individuals have given us details of her being so sick that she couldn''t even hold her head up. 11/11/04 Medical records received from PCP. Autopsy Report received on 11/22/2004 states pt expereinced blunt force injuries.


VAERS ID: 228894 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Michigan  
Vaccinated:2004-10-27
Onset:2004-10-28
   Days after vaccination:1
Submitted: 2004-11-02
   Days after onset:5
Entered: 2004-11-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Anaemia, Cardiac arrest, Dysuria, Lung disorder, Multiple myeloma, Myocardial ischaemia, Renal failure, Respiratory arrest, Respiratory failure, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI
Preexisting Conditions: COPD; Respiratory Failure; Multiple Myeloma; Anemia; pneumonia, chronic renal failure, encephalopathy, HBP, arrhythmias, hypercholesterolemia, seizure disorder, degenerative joint disease, osteoporosis, quadriparesis, and ischemic heart disease; renal insufficiency
Allergies:
Diagnostic Lab Data: UTI; COPD; Respiratory failure; Multiple Myeloma
CDC Split Type:

Write-up: UTI. Nurse follow up on 11/15/04 states: "dysuria; acute cardiopulmonary arrest; Death Certificate received which revealed COD as acute cardiopulmonary arrest, ischemic heart disease & COPD, all with chronic anemia and renal insufficiency as contributing factors.


VAERS ID: 228895 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-13
Onset:0000-00-00
Submitted: 2004-11-02
Entered: 2004-11-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK LA / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0062P / UNK RA / -

Administered by: Private       Purchased by: Private
Symptoms: Arteriosclerosis, Cardiac disorder, Chest pain, Malaise
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chest pain; Malaise
Preexisting Conditions: myocardial infarction, HBP, and nocturia.
Allergies:
Diagnostic Lab Data: Chest pain; Malaise
CDC Split Type:

Write-up: First visit to physician. Normal EKG. Received ER medical records. Death Certificate received on 12/01/2004 states pt experienced arteriosclerotic heart disease.


VAERS ID: 228986 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2004-10-28
Onset:2004-11-05
   Days after vaccination:8
Submitted: 2004-11-05
   Days after onset:0
Entered: 2004-11-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A008AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE234AC / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57561A / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Nasal congestion, 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: 2004-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Medical record received on 11/22/2004 states pt had a history of hip laxity.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found in crib unresponsive. Medical record received on 11/22/2004 states pt expereinced congestion. Autopsy Report received on 1/12/2005 states SIDS.


VAERS ID: 228987 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: Ohio  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-11-01
   Days after onset:13
Entered: 2004-11-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1489AA / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Convulsion, Diarrhoea, Dwarfism, Dyspnoea, Gastroenteritis, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-10-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zithromax suspension
Current Illness: Otitis Media.
Preexisting Conditions: Micro-cephalic osteodyplastic primoidal dwarfism Type I (lethal genetic disease).
Allergies:
Diagnostic Lab Data: Stool for C diff toxin sent 10/22 (negative).
CDC Split Type:

Write-up: Patient had micro-cephalic osteodysplastic primoidal dwarfism type I, a lethal genetic disorder with DNR/DNI status. Per parent request, vaccine given 10/18. Fever developed 10/19 PM. Other symptoms began 10/22, including vomiting, diarrhea, rash and continued fever. Seizure one time in afternoon. Dyspnea developed about 12 AM. 10/23 Patient transported to hospital; patient died about 0830 on 10/23. Medical record received on 11/22/2004 states pt experienced gastroenteritis and respiratory failure. Death Summary & ER Record received on 12/01/2004 states pt experienced Beach Disease and respiratory failure. Death Certificate received on 12/02/2004 states pt experienced respiratory failure, Majewski''s micro-Cephalic osteodysplastic Dwarfism Type 1.


VAERS ID: 229134 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: California  
Vaccinated:2004-11-08
Onset:2004-11-09
   Days after vaccination:1
Submitted: 2004-11-11
   Days after onset:2
Entered: 2004-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2044AA / 3 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0493P / 3 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A76399E / 3 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Cardiac arrest, Cyanosis, Hypothermia, Sudden infant death syndrome
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), Accidents and injuries (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-09
   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: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Child received DTaP #2, IPV #2, Comvax #2, and Prevnar #2 one day prior to sudden death. Cause of death not yet established. Autopsy Report received on 11/22/2004 states pt experienced apnea, asystole, cyanosis, and hypothermia. ER Record & Death SUmmary recceived on 12/01/2004 states pt experienced acute cardiopulmonary arrest. 4/29/05 Autopsy report received reveals COD as SIDS.


VAERS ID: 229192 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Maryland  
Vaccinated:2004-05-21
Onset:0000-00-00
Submitted: 2004-11-14
Entered: 2004-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Eye disorder, Injury, Oral intake reduced, Sleep disorder
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-06-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: had a slight cold
Preexisting Conditions: problems with bowels
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Bleeding in the eyes, change in cry, feeding habits changed drastically, couldn''t keep head up. Cry when you moved her head, sleep patterns changed. Autopsy report received on 12/01/2004 states pt experienced multiple injuries. COD is multiple injuries, homicide.


VAERS ID: 229286 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Illinois  
Vaccinated:2004-09-16
Onset:2004-09-18
   Days after vaccination:2
Submitted: 2004-11-16
   Days after onset:59
Entered: 2004-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1698AA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0069N / 1 LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / PFIZER/WYETH X0799 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495221 / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Injection site oedema, Irritability, Oedema peripheral, Viral infection
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-18
   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: Xopenex .63mg Pulmicort .25 mg Zithromax 1.5 ml Augmentin 3 cc
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient experienced swelling in both of her legs and irritibility since the date the shots were admistered. Swelling at injection site, edema inject site, irratibility after immunizations, agitation. Autopsy Report received on 2/14/2005 states viral illness.


VAERS ID: 229288 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2004-10-18
Onset:2004-10-20
   Days after vaccination:2
Submitted: 2004-11-15
   Days after onset:26
Entered: 2004-11-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1427AA / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Cyst, Nausea, Pain, Pyrexia, Sudden death, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA; Trazodone; Niacin; Zantac
Current Illness: NONE
Preexisting Conditions: Obesity; Kidney stones; Depression; High Cholesterol; Sleep apnea; Hernia repair; Chronic pain.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received a influenza shot 10/18/04, Fluzone U1427AA, .05ml, IM. Patient nausea, low grade fever and chills and seen 10/25/04. She had sudden death 10/27/04. Medical Record received on 11/22/2004 states pt experienced viral syndrome, Baker''s Cyst, and calf pain.


VAERS ID: 229289 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: California  
Vaccinated:2004-11-12
Onset:2004-11-13
   Days after vaccination:1
Submitted: 2004-11-16
   Days after onset:3
Entered: 2004-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1300AA / 1 RA / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1289N / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495701 / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Hyperglycaemia, Pneumonitis, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (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), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Nasal congestion
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: None stated. Medical Records received on 12/07/2004 states cardiopulmonary arrest and hyperglycemia. 12/14/04 Autopsy report received states COD as cardiorespiratory failure & acute bilateral pneumonitis.


VAERS ID: 229393 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2004-06-21
Onset:2004-11-08
   Days after vaccination:140
Submitted: 2004-11-16
   Days after onset:8
Entered: 2004-11-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR - / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adrenal disorder, Cardiac arrest, Coronary artery disease, Coronary artery occlusion, Diabetes mellitus, Hyperlipidaemia, Hypertension, Liver function test abnormal, Neuropathy
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Lipodystrophy (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: 2004-11-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403644

Write-up: This subject is a 70 year old female, who died while enrolled in a study. The subject received the study vaccine on 6/21/04. The study is blinded in the age group for this subject. The subject died at home 140 days post immunization. The cause of death is unknown at this time. There is no report of hospitalization. The death certificate will be provided up receipt from the subject''s family. Additional information to be provided when available. The death was reported by the investigator as unrelated to the study vaccine. List of additional information received and available in source file: ISAEF, Telephone Contact; SAE Reports, SAE Fax Transmittal and Confirmation. Death Certificate states COD is acute coronary occlusion, coronary artery disease, diabetes mellitus and cardiopulmonary arrest. Medical Records received on 11/23/2004 states the pt experienced diabetes mellitus, diabetic neuropathy, hyperlipidemia, elevated liver enzymes, adrenal mass, and hypertension.


VAERS ID: 229524 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Male  
Location: Washington  
Vaccinated:2003-01-31
Onset:2003-01-31
   Days after vaccination:0
Submitted: 2004-11-22
   Days after onset:661
Entered: 2004-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 3 RA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH - / 2 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Anxiety, Blindness, Cardiac failure, Chills, Depression, Disturbance in attention, Dyspnoea, Fatigue, Gastrointestinal necrosis, Headache, Hepatic necrosis, Influenza like illness, Injury, Insomnia, Laboratory test abnormal, Myocarditis, Nasal congestion, Neck pain, Necrosis, Osteoarthritis, Pain, Paranoia, Pulmonary embolism, Pyrexia, Sepsis, Skin candida, Skin odour abnormal, Thermal burn, Tremor, Wheezing
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-08-26
   Days after onset: 572
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 358 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: Had a skin rash on arms, back, and stomach for about one year it was a systemic yeast later found out by the civilian hospital.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy Information received from medical records states abnormal lab values. msv 3/5/05 Medical reports received from MC.
CDC Split Type:

Write-up: Headaches, bodyaches, chest congestion and flu like symptoms. Insomnia, paranoia, uncontrolable shaking of hands, wheezing out of breath, Loss of vision, anxiety attacks, fatigue, not able to concentrate or read, depression and an odor that came from his skin. Information from medical records state costocondritis, body ache, chills, fever, headache, neck pain, myopericarditis. Autopsy report received & states COD as 80% total body burn, septicemia and multiorgan failure.


VAERS ID: 229621 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Arizona  
Vaccinated:2004-09-30
Onset:2004-10-30
   Days after vaccination:30
Submitted: 2004-11-23
   Days after onset:24
Entered: 2004-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A001AA / 1 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0230P / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57560H / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No adverse reactions reported to us. Patient expired 30 days after vaccinations given. Death Certificate received on 12/01/2004 states pt expereinced asphyxiation and aspiration. Autopsy Report received on 2/16/2005 states asphyxia.


VAERS ID: 229919 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Ohio  
Vaccinated:2004-11-12
Onset:2004-11-21
   Days after vaccination:9
Submitted: 2004-11-24
   Days after onset:3
Entered: 2004-12-02
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1314CA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0356P / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1212 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A79659B / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Cardiac disorder, Cardiac failure, Cardiomyopathy, Diarrhoea, Pulmonary oedema, Respiratory distress, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-21
   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:
Current Illness: Left hypoplastic heart
Preexisting Conditions: Hypoplastic left heart; S/P Norwood Procedure. Discharge Summary received on 12/15/2004 states pt had congenital heart disease.
Allergies:
Diagnostic Lab Data: Was admitted on 11/01 for dehydration; S/P Norwood Procedure; UTI.
CDC Split Type:

Write-up: Patient died 11/21/04. Child has respiratory distress and died in route to ER. Cause of death currently unknown. Suspected heart failure. Discharge Summary received on 12/15/2004 states pt experienced cardiopulmonary arrest. Medical Record received on 12/15 states pt expereinced vomiting and diarrhea. Follow up: COD, ischemic and congestive cardiomyopathy due to congenital heart dx. Autopsy Report received which stated patient experienced cardia fibroma, hemorrhagic pulmonary edema and congenital heart disease.


VAERS ID: 229978 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Alabama  
Vaccinated:2004-11-16
Onset:2004-11-18
   Days after vaccination:2
Submitted: 2004-11-29
   Days after onset:11
Entered: 2004-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1439AA / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Bronchitis, Cardiac failure congestive, Condition aggravated
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-18
   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: UNK
Current Illness: Chest Congestion
Preexisting Conditions: History of CHF. Discharge Summary received on 12/15/2004 states pt has a history of HTN, TIA, Cartoid Stenosis, Hyperlipidemia, Leukemia and Hyponatremia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: AL0427

Write-up: Patient died within 48 hours of being given flu vaccine. Cause of death CHF and bronchitis. Patient sick with chest congestion prior to vaccine per niece. Hospitalized 11/18/04. Previous history of CHF.


VAERS ID: 230198 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2004-11-30
Onset:2004-11-30
   Days after vaccination:0
Submitted: 2004-12-07
   Days after onset:7
Entered: 2004-12-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0181P / 3 LA / -

Administered by: Private       Purchased by: Public
Symptoms: Brain oedema, Cardio-respiratory arrest, Cerebral haemorrhage, Convulsion, Fall, Injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Discharge Summary received on 12/15/2004 states pt has an allergy to PCN, ADHD
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient fainted and fell to the floor several minutes after receiving the Hep B vaccine (#3) and sustained a head injury. The patient went into a seizure and cardiopulmonary arrest and CPR was not successful. Follow Up: frontal lobe contusion, cerebral hemorrhage, cerebral edema Autopsy report received which revealed COD as blunt head trauma, occipital scalp contusion, contre-coup contusions, 10-ml subarachnoid hemorrhage of right frontal region, cerebral edema and transtentorial herniation.


VAERS ID: 230199 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-08
Entered: 2004-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The patient''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0535927A

Write-up: This case was reported by a consumer and described the occurrence of death in a 2-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The reporter is the sister of the patient. A physician or other health care professional has not verified this report. On an unspecified date, the patient received a dose of Infanrix (dose number not specified). At an unspecified time following the administration of Infanrix, on an unspecified date, the patient died. The cause of death was not provided. It is unknown whether an autopsy was performed.


VAERS ID: 230831 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Illinois  
Vaccinated:2004-12-06
Onset:2004-12-09
   Days after vaccination:3
Submitted: 2004-12-01
   Days after onset:8
Entered: 2004-12-10
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2104AA / 2 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0807P / UNK - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1212 / UNK RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A6718C / 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: 2004-12-09
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient in office for routine well child check and immunizations on 12/6/04. Sudden infant death 12/9/04.


VAERS ID: 230832 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Male  
Location: California  
Vaccinated:2004-12-03
Onset:2004-12-05
   Days after vaccination:2
Submitted: 2004-12-06
   Days after onset:1
Entered: 2004-12-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A007AA / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-05
   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: Ferinsol
Current Illness: NONE
Preexisting Conditions: Former SGA; 31 week premie. Some formula intolerance. No neurologic problems. Intrauterine methaphetamine exposure.
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA040078

Write-up: Death during night; unknown cause. Autopsy pending.


VAERS ID: 230877 (history)  
Form: Version 1.0  
Age: 1.13  
Sex: Female  
Location: Arkansas  
Vaccinated:2004-04-22
Onset:2004-04-24
   Days after vaccination:2
Submitted: 2004-05-17
   Days after onset:23
Entered: 2004-12-13
   Days after submission:210
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U172AA / 3 RA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE094AA / 3 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0313 / 3 RA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0958N / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0885N / 1 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Abnormal sleep-related event, Apnoea, Pharyngitis, Rhinitis, Rhinorrhoea, Sudden infant death syndrome
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: mini case of chicken pox~Varicella (no brand name)~1~1.00~In Sibling|~Varicella (no brand name)~~0.00~In Sibling
Other Medications: Tylenol Elixir with Hydrocodone
Current Illness: NONE
Preexisting Conditions: Ear infection 1 month prior to immunizations.
Allergies:
Diagnostic Lab Data: Autopsy results pending.
CDC Split Type: AR0464

Write-up: Infant seemed fine except for cold (clear drainage) and was teething (2 teeth trying to come in). 4/23/04 PM, infant became more upset. Mother gave infant Tylenol Elixir with hydrocodone and infant spit it out on clothes. Infant was alive at 2 AM on 4/24/04 and was not breathing at 8 AM. Mother took her to ER. Autopsy report received which revealed COD to be SIDS & cosleeping.


VAERS ID: 230878 (history)  
Form: Version 1.0  
Age: 0.52  
Sex: Female  
Location: Arkansas  
Vaccinated:2004-05-18
Onset:2004-05-20
   Days after vaccination:2
Submitted: 2004-05-20
   Days after onset:0
Entered: 2004-12-13
   Days after submission:207
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21918A9 / 5 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493376 / 1 LL / -

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: 2004-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy being performed.
CDC Split Type: AR0463

Write-up: Presented DOA at hospital 5/20/04. Received immunization records from health dept. 6/8/04 Received Autopsy Report which revealed COD as SIDS.


VAERS ID: 231268 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: Massachusetts  
Vaccinated:2004-12-07
Onset:2004-12-11
   Days after vaccination:4
Submitted: 2004-12-14
   Days after onset:3
Entered: 2004-12-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57556D / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0651P / 1 LA / 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: 2004-12-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy negative so far.
CDC Split Type:

Write-up: Found by family in morning in crib deceased. Received ER medical records which revealed patient arrived in ER lifeless. COD thought to be cardiac arrest likely caused by SIDS.


VAERS ID: 231269 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Oregon  
Vaccinated:2004-12-09
Onset:2004-12-10
   Days after vaccination:1
Submitted: 2004-12-10
   Days after onset:0
Entered: 2004-12-20
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1556AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Arteriosclerosis, Bradycardia, Coma, Pulse absent, Respiratory rate decreased
SMQs:, 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), 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: 2004-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc; Lisinopril; Impur; Cipro; Aspirin;
Current Illness: NONE
Preexisting Conditions: Anemic; CVA
Allergies:
Diagnostic Lab Data:
CDC Split Type: OR200442

Write-up: Resident with toileting. Observed by staff to become nonresponsive, slumped off toilet two times. Body lift and then to bed. Respirations shallow and significant decreased with decreased ausultated lungs followed by pulse drop to 30-40 BPM. Then no BP. Then no pulse and no respiration. Resident deceased. Attempted CPR and oxygen. Death Certificate received on 12/29/2004 states COD is ASHD.


VAERS ID: 231270 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Ohio  
Vaccinated:2004-07-28
Onset:2004-07-29
   Days after vaccination:1
Submitted: 2004-11-23
   Days after onset:117
Entered: 2004-12-20
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0179P / 2 - / SC

Administered by: Private       Purchased by: Other
Symptoms: Apnoea, Cardiac arrest, Coma, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-29
   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: Nystatin
Current Illness: Thrush
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found unresponsive in her crib at 6:45 AM when her motion sensitive baby monitor sounded on alarm. CRP was performed; EMT arrived. Patient was transported to hospital where she was DOA. Autopsy Report received on 12/22/2004 states SIDS. Discharge Summary received on 1/7/2005 states apnea and asystole.


VAERS ID: 231321 (history)  
Form: Version 1.0  
Age: 0.85  
Sex: Female  
Location: Florida  
Vaccinated:2004-08-23
Onset:2004-08-27
   Days after vaccination:4
Submitted: 2004-11-03
   Days after onset:68
Entered: 2004-12-21
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494313 / 3 LL / IM

Administered by: Military       Purchased by: Military
Symptoms: Abdominal distension, Apnoea, Bronchiolitis, Bronchitis, Hypoxia, Respiratory failure, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-27
   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: NONE
Current Illness: NONE
Preexisting Conditions: Syndactyly
Allergies:
Diagnostic Lab Data: Autopsy with diffuse eosins throughout all tissues. Death due to bronchiolitis/abdominal distention.
CDC Split Type:

Write-up: Pt presented to clinic 5 days after immunization with abdominal distention, tachypnea, decreased sats, developed repiratory failure in ER and subsequently intubated. Pt died. Autopsy report received on 12/22/2004 states pt experienced bronchitis, hypoxia, and apnea.


VAERS ID: 231322 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Florida  
Vaccinated:2004-12-01
Onset:2004-12-03
   Days after vaccination:2
Submitted: 2004-12-21
   Days after onset:18
Entered: 2004-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2103AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE396AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0800 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399H / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death 2 days post shots. 2/28/05 Autopsy report received which revealed that patient was large for gestational age & was not rolling over yet. Hx of recent URI. Found in crib w/heavy pillow over face. Bystander CPR unsuccessful. Also found hyperostosis w/expanded bone marrow at right parieto-occipital calvaria. COD: no anatomic COD. Manner of death: undetermined.


VAERS ID: 231398 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Texas  
Vaccinated:2004-12-06
Onset:2004-12-22
   Days after vaccination:16
Submitted: 2004-12-22
   Days after onset:0
Entered: 2004-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A007AA / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE273AA / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74400C / 1 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nasal congestion
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy being done
CDC Split Type:

Write-up: Mom called reporting fever 102.7 during night after receiving vaccines via triage. On 12/7/04, mom was told to give Tylenol every 4 hours and to call for worsening symptoms. Did not hear from mom again. Baby was brought into ER via EMS on 12/22/04 with unknown cause of death. Autopsy Report received on 2/02/2005 states SIDS.


VAERS ID: 231409 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-28
Onset:2002-12-27
   Days after vaccination:60
Submitted: 2004-12-20
   Days after onset:724
Entered: 2004-12-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, 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), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lanoxin; Prinovil; Atenolol; Lasix; Lopid; Coumadin; Aspirin; Flovent; Combivent; Axid; Dynbac
Current Illness:
Preexisting Conditions: COPD, Pacemaker 1995, Atrial fibrillation, angina, MI in 1991, hypertension, edema, gastric reflux, bronchitis, elevated cholesterol.
Allergies:
Diagnostic Lab Data:
CDC Split Type: F20030552

Write-up: 77 year old male was vaccinated with RSV vaccine or placebo and Influenza vaccine on 10/28/02 and 60 days later collapsed and died at home while showering. It was stated that the patient apparently died of cardiac arrhythmia. Relevant medical history includes a pacemaker in 1995, atrial fibrillation, angina, MI in 1991 and COPD. The subject was unblinded at the request of the investigator for documentation in view of organ donation. The participant received the RSV vaccine. The investigator assessed the event as unrelated to the study products. Additional information received on 12/17/04: The subject collapsed and died at home while showering. Apparently, the cause of death was cardiac arrhythmia. No death certificate is available. Additional information received on 12/20/04 from the investigator: The lot number for the study product was verified to be the same as the subject number and it was confirmed that this subject was unblinded.


VAERS ID: 231627 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: California  
Vaccinated:2004-12-16
Onset:2004-12-19
   Days after vaccination:3
Submitted: 2004-12-21
   Days after onset:2
Entered: 2004-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1501AA / 4 LA / IM

Administered by: Private       Purchased by: Unknown
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: 2004-12-19
   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: Albuterol; Pulmicort; Reglan; Zantac
Current Illness: NONE
Preexisting Conditions: Tay Sachs disease; Mental Retardation; GE Reflux; Lung Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient brought to ED on 12/19/04 in full arrest and could not be resuscitated. That ED notified our hospital that patient had died. Our hospital does not have further details at this time.


VAERS ID: 231628 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: California  
Vaccinated:2004-10-15
Onset:2004-10-18
   Days after vaccination:3
Submitted: 2004-12-01
   Days after onset:44
Entered: 2004-12-28
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1394BA / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Caromra, ASA, Pedol, Pravadoe, Parcept, Flexout, Lisinopril, Lasix, Tablol
Current Illness: CAD; DSD; HTN; DMI; CHF
Preexisting Conditions: CAD; DSD; HTN; DMI; CHF
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: S/P Flu vaccine 3 days earlier. Found expired in morning.


VAERS ID: 231664 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Maryland  
Vaccinated:2004-12-15
Onset:2004-12-23
   Days after vaccination:8
Submitted: 2004-12-28
   Days after onset:5
Entered: 2004-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1527AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Laboratory test abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-23
   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:
Current Illness: None reported
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Urinary antigen positive for Legionella
CDC Split Type:

Write-up: Patient hospitalized with diagnosis on Legionellosis on 12/21/2004. Onset of symptoms 12/16/2004 - patient and family attributed illness to vaccination.


VAERS ID: 231755 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Male  
Location: California  
Vaccinated:2004-11-17
Onset:2004-11-18
   Days after vaccination:1
Submitted: 2004-11-30
   Days after onset:12
Entered: 2004-12-30
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1519AB / 1 LA / -

Administered by: Other       Purchased by: Public
Symptoms: Apnoea, Coma, Confusional state, Dyspepsia, Encephalopathy, Hypersensitivity, Malaise, Rash, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Respiratory failure (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: 2004-11-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA040096

Write-up: Client complained of "heartburn" like sensation and was sent to medical center. They diagnosed him with "allergic reaction " to flu vaccine. This was on 11/18. Client became unresponsive on Sunday 11/21 and had begun to show "red bumps" on face. He was alert in the morning, ate breakfast then fell ill. He was transferred to another hospital when he fell into a coma and passed away 11/23/04. Discharge Summary revealed patient had confusion and respiratory failure.


VAERS ID: 231829 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: D.C.  
Vaccinated:2000-05-24
Onset:2000-06-08
   Days after vaccination:15
Submitted: 2004-12-28
   Days after onset:1664
Entered: 2005-01-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 3 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Coagulopathy, Fungal infection, Hepatomegaly, Multi-organ failure, Nephrosclerosis, Proteinuria, Pulmonary embolism, Renal failure, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-12
   Days after onset: 1495
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: BP 102/60 7May00, 120/72 May99, 116/86 Apr97, 120/80 Feb96. No records of UAs after Jul91. At that time UA negative for all components including protein.
CDC Split Type:

Write-up: Developed proteinuria which progressed to nephrosclerosis then eventually to multi-organ system failure and death in 2004. Received medical records from WRAMC VHC which revealed COD as glomerulosclerosis leading to multi-organ failure. CT scan revealed fungal abscess of lungs. Developed significant coagulation problems & was unable to be intubated due to excessive amounts of blood in his throat.


VAERS ID: 231830 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2004-10-11
Onset:2004-10-11
   Days after vaccination:0
Submitted: 2004-12-22
   Days after onset:72
Entered: 2005-01-03
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 7+ - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Pneumonia, Renal failure, Respiratory failure, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-13
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 63 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lipitor; Pindol; Synthyroid; Koracon; Prednisone; Hydrochlorazide
Current Illness:
Preexisting Conditions: The patient''s past medical history is significant for hypertension, high cholesterol and arthritis. She did not have any illnesses at the time of vaccination. Her vaccination history includes 10 doses of influenza vaccine on unspecified dates. At the time of vaccination, the patient was also taking the following medications: Lipitor, Pindol, Hydrochlorazide; Synthyroid, Kloracon, and Prednisone.
Allergies:
Diagnostic Lab Data: EKG; CT scan of the head; X-ray of the head; Chest X-ray, an EEG and blood work were performed, however the results were not provided. An autopsy was not performed.
CDC Split Type: 200404004

Write-up: From initial information received on 12/21/04 from the patient''s niece regarding an adverse event occurring in the USA, it was reported that an 89 year old female patient received a dose of FLUZONE at 11:00 AM on 10/11/2004. The lot number, site and route of administration were not provided. Eight hours later, on 10/11/04 at 7:00 PM, the patient complained of dizziness and her hands were shaking. She was seen in an emergency room, was diagnosed with kidney failure and was admitted to the hospital on 10/11/04. The patient was seen by renal specialists, critical care physicians, neurologists and infectious disease. The patient was hospitalized until she died on 12/13/04. No autopsy was performed. Medical Records received on 1/07/2005 states pneumonia and respiratory failure.


VAERS ID: 231879 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: Ohio  
Vaccinated:2004-11-30
Onset:2004-12-02
   Days after vaccination:2
Submitted: 2004-12-21
   Days after onset:19
Entered: 2005-01-04
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5514A2 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiovascular disorder, Cyanosis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Was in NICU because hypovolemia, metabolic acidosis, transient tachypnea of newborn and physiologic jaundice.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 12/2/04 morning, parents noticed baby not breathing. Taken to ER and pronounced DOA. Had autopsy done. Report pending. Discharge Summary received on 1/25/2005 states pt was pulseless and cyanotic.


VAERS ID: 231965 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Virginia  
Vaccinated:2004-08-26
Onset:2004-08-26
   Days after vaccination:0
Submitted: 2005-01-04
   Days after onset:131
Entered: 2005-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 2191C2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0362P / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495724 / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Somnolence, Sudden death, Sudden infant death syndrome, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Autism~Measles + Mumps + Rubella (MMR II)~1~1.50~In Sibling|~Measles + Mumps + Rubella (MMR II)~~0.00~In Sibling
Other Medications: Tylenol I know he was not allergic to this he had taken this before on numerous occassions and it is also documented in his medical records
Current Illness: He had a Viral Upper Respiratory Infection on 7-8-04 and was diagnosis with a Upper Respiratory Infection on 7-27-04 I am not sure these were fully resolved. We may sure have waited before we vaccinated but again no one done any teaching or asked me if I thought my child could be sick so I was not fully aware that sick babies should not be vaccinated.
Preexisting Conditions: Viral Upper Respiratory Tract Infection on 7-8-04 and Upper respiratory Tract Infection on 7-27-04 Lots of congestion and drainage.
Allergies:
Diagnostic Lab Data: Autopsy cause of death undetermined Sudden Unexpected Death in Infancy
CDC Split Type:

Write-up: I was not educated about the side effects, risks and benefits and was not given the vaccine information sheets nor did I sign a consent form. I did not even know that my son recieved a combination vaccine and I have the documentation to prove it. Vital signs were not obtained. This facility expected me to remember all of the information that I had received on 6-18-03 when my other son received his vaccines. My son received his vaccines on 8-26-04 around 2:30pm. My son received his 2 month old vaccinations Pediarix, Hib, and Prevnar only one nurse administered these shots. He did not cry after receiving these painful IM injections. I questioned the nurse about why he was not crying because I thought it was very unusual she was not concerned she just smiled and said "he whimpered a little bit". I gave him some Tylenol because I did not want him to have any pain at the injection site before we left the doctor''s office this was one of the things I remembered from past vaccinations. The only thing I was aware concerning vaccines was that children may be cranky, may run a fever or have pain at the injection site. I was so unaware of the dangers of vaccinations. No one educated me. He went into a deep sleep before we left the doctor''s office parking lot. He slept for prolonged periods and would not wake to sound or touch. He woke up a few times ate very little and went right back to sleep. He was found dead on his back less than 20 hours from vaccinations. I know he was not allergic to Tylenol because he had taken it many times before it had to be the vaccines. No one told us that an unusual behavior could indicate a possible reaction. 1/5/05 Autopsy report received which revealed COD as SIDS. Patient found supine on couch w/blanket. Autopsy also revealed recent URI and glomerulosclerosis.


VAERS ID: 232015 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: California  
Vaccinated:2004-12-27
Onset:2004-12-27
   Days after vaccination:0
Submitted: 2004-12-29
   Days after onset:2
Entered: 2005-01-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21928A2 / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE246AB / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495929 / 1 LL / -

Administered by: Other       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Stupor, Sudden infant death syndrome
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nystatin; Tylenol; Cream
Current Illness: NONE
Preexisting Conditions: Premature birth
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA040119

Write-up: Patient stopped breathing about 5:50. Paramedics were called. Baby pronounces dead at medical center. Autopsy confirmed natural causes (SIDS). Discharge summary rec''d on 03/02/2005 states additional codes of heart arrest and stupor.


VAERS ID: 232068 (history)  
Form: Version 1.0  
Age: 0.49  
Sex: Male  
Location: Washington  
Vaccinated:2004-12-16
Onset:2004-12-17
   Days after vaccination:1
Submitted: 2004-12-28
   Days after onset:11
Entered: 2005-01-10
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1996AA / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE227AA / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A83578F / 2 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Bronchitis, Pneumonia, Pneumonitis, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Interstitial lung disease (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild URI
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Medical examiner COD- interstitial pneumonitis, not SIDS
CDC Split Type:

Write-up: 5 month old male afebrile (97.8), mild URI, immunized with DTaP, IPV, HIB, and PCV about 14-20 hours prior to sudden death. Found lifeless in crib. Autopsy Report received on 1/25/2005 states bronchial pneumonia, tracheitis, and pulmonary edema.


VAERS ID: 232070 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-01-06
Entered: 2005-01-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Hypoglycaemia, Myocardial fibrosis, Myocardial ischaemia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Respiratory failure (broad), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s pre-existing medical conditions include Type I Diabetes. Reportedly, the patient is non-compliant.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200500058

Write-up: From initial information received on 1/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male patient in his 50''s received a dose of FLUZONE administered on an unspecified date. The lot number, route and site of administration were not reported. Four hours later, the patient experienced a severe hypoglycemic attack. Per the reporter, he refused to be transferred to the hospital. Twelve hours later, the patient had a cardiac arrest and was found dead. Reportedly, the patient had Type I Diabetes, but was non-compliant. Discharge Summary received on 1/20/2005 states past ischemic injury and myocardial fibrosis.


VAERS ID: 232179 (history)  
Form: Version 1.0  
Age: 1.68  
Sex: Male  
Location: New York  
Vaccinated:2005-01-08
Onset:2005-01-09
   Days after vaccination:1
Submitted: 2005-01-12
   Days after onset:3
Entered: 2005-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1411AA / UNK LL / 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: 2005-01-09
   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: Bronchitis treated with Zithromax on 12/28/04.
Allergies:
Diagnostic Lab Data: Autopsy by coroner.
CDC Split Type:

Write-up: Child was found dead early AM about 16-20 hours after the flu vaccine second dose 0.25ml. Child was fine when went to bed. Happy playful and no respiratory difficulty. Autopsy report received on 2/16/2005 states SIDS.


VAERS ID: 232210 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Oregon  
Vaccinated:2004-12-30
Onset:2004-12-30
   Days after vaccination:0
Submitted: 2005-01-07
   Days after onset:8
Entered: 2005-01-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Apnoea, Cardiac arrest, Coma, Hyperglycaemia, Hypokalaemia, Leukocytosis, Liver function test abnormal, Myocardial infarction, Oedema peripheral, Pneumonia, Stupor, Tongue oedema, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril; HCTZ
Current Illness: NONE
Preexisting Conditions: Hypertension; Allergy to penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.


VAERS ID: 232259 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2001-11-05
Onset:2001-11-06
   Days after vaccination:1
Submitted: 2002-10-10
   Days after onset:337
Entered: 2005-01-14
   Days after submission:827
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-06
   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: Aspirin, Cardora, Cardizem, Vasotec, Effexor, Imdur, Lopressor, Plavix, Prevacid, Trazadone, Nitroglycerin, Tylenol, Zantac
Current Illness:
Preexisting Conditions: Acute but ill-defined cerebrovascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100387

Write-up: A report received from a health care professional on 08Nov01 regarding a 61 year old male pt who died on 06Nov01 after receiving Fluvirin vaccine on 05November2001. Relevant medical history included right CVA(hemiparesis), hypertension and coronary bypass surgery. The pt was taking acetylsalicylic acid, doxazosin mesilate, diltiazem hydrochloride, enalapril maleate, venlafaxine hydrochloride, isosorbide mononitrate, metoprolol tartrate, clopidogrel sulfate, lanscprazole, trazodone, glyceryl trinitrate, parecetamol and ranitidine hydrochloride. The pt was institutionalized in a nursing home and received a Fluvirin injection on 05Nov01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 06Nov01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unk.


VAERS ID: 232360 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2001-11-12
Onset:2001-11-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2005-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, Sepsis, Urinary tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-06
   Days after onset: 22
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: brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, ceti
Current Illness:
Preexisting Conditions: Diabetes Mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100473

Write-up: A report was received from a health professional on 11Dec01 regarding a 78 year old female pt who experienced urinary tract infection (14Nov01), pneumonia (23Nov01), sepsis (unk date) and subsequently died on 06Dec01 after receiving Fluvirin vaccine on 12Nov01. The pt''s medical history included Non insulin diabetes mellitus, hypertension, chronic obstructive pulmonary disease, bipolar disorder, glaucoma, anxiety and right hip replacement. The pt was also receiving brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, cetirizine hydrochloride, paracetamol and insulin. On 12Nov01, the pt received Fluvirin vaccine. Two days later, the pt was hospitalized for urinary tract infection, which resolved on 19Nov01. Then the pt was admitted to hospital for pneumonia on 23Nov01 and discharged on 28Nov01. On 06Dec01, the pt was re-admitted to hospital for an unk reason and died secondary to sepsis on the same day. No death certificate was available. The pt had received a flu vaccine last year without any problem. The reporter has assessed the relationship of study medication to the events as unrelated.


VAERS ID: 232381 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Female  
Location: Nevada  
Vaccinated:2005-01-07
Onset:2005-01-09
   Days after vaccination:2
Submitted: 2005-01-13
   Days after onset:4
Entered: 2005-01-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 066AA / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Dysphagia, Dyspnoea, Hypotension, Respiratory arrest, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-09
   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: Nystatin Suspension
Current Illness: 1/6/05 Hematemesis x1, URI, Positional Dyspnea
Preexisting Conditions: Jaundice
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received Hep B #2 on 1/7/05 at well check and presented 1/9/05 to ER, Respiratory Arrest. Unable to resuscitate. Discharge Summary received on 2/14/2005 states unresponsive, choking, breathing stopped, difficulty breathing, loss of blood pressure and cardiac arrest. 3/4/05 Autopsy report received which revealed COD as undetermined and manner of death as undetermined.


VAERS ID: 232507 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: California  
Vaccinated:2005-01-05
Onset:2005-01-09
   Days after vaccination:4
Submitted: 2005-01-11
   Days after onset:2
Entered: 2005-01-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A008AA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0805P / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A6718A / 2 LL / 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: 2005-01-09
   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: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: SIDS death. 3/4/05 Received autopsy report which revealed COD as SIDS.


VAERS ID: 232509 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Minnesota  
Vaccinated:2003-12-10
Onset:2003-12-17
   Days after vaccination:7
Submitted: 2005-01-04
   Days after onset:384
Entered: 2005-01-19
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 622B2 / 3 LL / -
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1128AA / 1 RL / -

Administered by: Public       Purchased by: Private
Symptoms: Blindness, Convulsion, Delirium, Developmental delay, Gene mutation identification test positive, Growth retardation, Hypokinesia, Hypotonia, Irritability, Neutropenia, Oral intake reduced, Pyrexia
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-10-12
   Days after onset: 664
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 40 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Cefzil for possible left ear infection.
Current Illness: Left ear slightly pink, possible ear infection Information from medical records state otitis media.
Preexisting Conditions: NONE PMH: leukodystrophy, seizures, leukoencephalopathy, neutropenia.
Allergies:
Diagnostic Lab Data: She has had genetic testing for all known Leukodystrophies multiple times - results negative. Has been tested for any/all diseases and disorders that can cause damage to white matter of the brain - all negative. Information from medical records state neutropeni. 2/5/07 Received labs from ME office which reveal: 8/15/04 unremarkable RBCs; vacuolated monocytes; unremarkable plts. 3/23/05 absolute neutropenia, marked; absolute monocytosis, mild; & apparently normal RBC & plts.
CDC Split Type:

Write-up: Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.


VAERS ID: 232753 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: New York  
Vaccinated:2004-10-12
Onset:2004-10-14
   Days after vaccination:2
Submitted: 2005-01-24
   Days after onset:102
Entered: 2005-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1442AA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Lung disorder, Malaise, Pneumonia, Pyrexia, Respiratory distress, Sepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-12-24
   Days after onset: 71
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 66 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Levaquin
Current Illness: Bronchitis Allergies
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT Received Vaccination on Tues October 12th, On Saturday Oct 16 PT complained of feeling sick, Pt was admitted on Monday. PT was diagnosed with Pneumonia, and Septic Shock. Pt was in ARDS and never recovered. Pt was under other doctors care for bronchitis. PT deceased on 12/24/2004. Discharge summary from hospital received which revealed pt had multiple respiratory allergies, heavy smoker had SOB, fever, back & chest pain. CXR consistent w/multilobar pneumonia & COPD.


VAERS ID: 232760 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Unknown  
Vaccinated:2001-12-04
Onset:2002-01-15
   Days after vaccination:42
Submitted: 2005-01-21
   Days after onset:1102
Entered: 2005-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 522A2 / 1 RL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5226A9 / 1 RL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 479268 / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0986 / 1 RA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481549 / 1 LL / -

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: 2002-01-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE671618JAN05

Write-up: Information regarding Prevnar was received from an investigator regarding a 5 month old male participant in a study who experienced SIDS. The participant received the first dose on 12/4/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 12/4/01. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix, Engerix B, and IPV. The patient died on 1/15/02. The coroner''s office reported the cause of death as SIDS. An autopsy was performed and material has been requested. The investigator and medical monitor considered sudden infant death syndrome not related to the study product. This report of a serious, labeled, not related event is being submitted in a 15-day time frame as requested by FDA. Autopsy report received which revealed COD as SIDS in 7-week preemie.


Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=24&PERPAGE=100&DIED=Yes


Copyright © 2020 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166