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VAERS ID: 211260 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:1999-06-23
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3557 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pneumonia, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302577

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Pt admitted to hospital at 3 months of age with a diagnosis of pneumonia 1 day after receiving study vaccine. On admission, had a resp rate of 78, a temp of 37, chest retractions, cough, krakles, bronchial sound, and an oxygen saturation of 95%. Chest x-ray was read as abnormal. Hemoglobulin was 10.7, WBC count was 13,800 with 32% segs. Treated with ampicillin and chloramphenicol but died 1 day after admission. Comments from study physician: Child appears to have died of pneumonia, which is not associated with the received vaccines. No evidence of relationship with vaccination. Unblinding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211261 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:1999-11-04
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3557 / 2 RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302629

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrates based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Pt admitted at 3 months of age with a diagnosis of pneumonia 6 days after receiving study vaccine. On admission, had a resp rate of 64, a temperature of 39.2 chest retractions, cough, krakles and an oxygen sat of 87%. Treated with ampicillin and chloraphenicol but died one day after admission. Comments from study physician: Death due to pneumonia. No evidence of relation to vaccination. Unblinding of the clinical trial: the pt has been exposed to study vaccine: DTP-Hib (liquid). The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211262 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:1999-04-14
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pneumonia, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He received the previous study vaccine on 3/10/99.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302628

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Patient admitted at 3 months of age with a diagnosis of pneumonia 3 days after receiving study vaccine. On admission, had a respiratory rate of 65, a temperature of 38.1, chest retractions, cough, krackles, bronchial sound and an oxygen saturation of 78%. Treated with ampicillin and chloramphenicol but died 1 day after admission. Comments from study physician: Death due to pneumonia. No evidence of relation to vaccination. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP-HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211263 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2002-06-05
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Cough, Gaze palsy, Lethargy, Oral intake reduced, Pyrexia, Respiratory rate increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302619

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: 6/1/02, 4 days before immunization, the baby was brought with main complaints of fever, and vomiting. The baby also had cough (mild), respiratory rate 55/minute. The baby was treated with amoxicillin, paracetamol, glyceril guaiacolate and oral pyridoxin. The mother was advised to return if there was no improvement. 6/5/02, the baby was brought from immunization. According to the mother, her baby was completely recovered. On physical examination, the nurse found no fever, then she immunized the baby. The mother had been advised to give her baby paracetamol and a cold compress if she had fever. 6/8/02, at 6:35am the grandmother reported that the baby had convulsions and vomiting since 1:30 AM. Physician examination at the house was as follows: the baby was lethargic, was not unable to suck the breast and her eyes always looking upward, and she had only slight fever on palpation. The reaction occurred two days after immunization. Based on the symptoms and signs above the baby is likely suffered from a CNS process (encephalitis, ormeningitis). The only treatment gave by the nurse was rub the baby with eucalyptus oil + onion and the parents were asked to bring the baby to puskesmas. On the way to the puskesmas the baby died. Comments from study physician: There is insufficient information to determine a cause of death, particularly since the infant died before seeing a physician. As noted by the local physician, CNS infection may be the most likely possiblity. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211264 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-07
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pyrexia, Respiratory rate increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He received the previous study vaccine on 10/4/00.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302615

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Cough and chest indrawing for 2 days, fast breathing for 4 days, high temperature for 3 days, vomiting after breast feeding. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient information to determine causality. However, there are no facts in the history - other than a temporal association - to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Symptom history suggestive of pneumonia death. No evidence of relation to vaccination. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211265 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-03
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Cyanosis, Feeling cold, Oral intake reduced, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: She received the previous study vaccine on 7/6/00.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302614

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Cough, fast breathing, and chest indrawing (all for 4 days). Didn''t want to breastfeed, baby felt cold, when died her back looked blue. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient information to determine causality. However, there are no facts in the history - other than a temporal association - to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Symptom history suggests death due to pneumonia. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211266 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2000-12-11
Onset:0000-00-00
Submitted: 2003-10-28
Entered: 2003-10-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Crying, Cyanosis, Feeling cold, Oral intake reduced, Pyrexia, Respiratory rate increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He received the previous study vaccine on 11/13/00.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302611

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children < 2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Cough for 2 days, high temperature for 1 day, fast breathing for 1 day, lips turned blue, vomiting after breastfeeding, cold, crying. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient information to determine causality. However, there are no facts in the history - other than a temporal association - to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211327 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2001-01-10
Onset:2001-01-17
   Days after vaccination:7
Submitted: 2003-10-29
   Days after onset:1015
Entered: 2003-10-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-17
   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:
Preexisting Conditions: She received the previous study vaccine on 11/08/2000.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302641

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. it was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55.073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Baby died at home without being examined by a physician. Cough fast breathing, indrawing, fever beginning 7 days before death. Comments from study physician: Death due to unknown cause 4 days post vaccination with multiple vaccines. Symptoms began before vaccination and verbal autopsy implicated pneumonia. No evidence of relation to vaccination. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211328 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2000-08-18
Onset:2003-08-24
   Days after vaccination:1101
Submitted: 2003-10-29
   Days after onset:66
Entered: 2003-10-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He received the previous study vaccine on 7/21/00.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302636

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. it was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55.073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: No information. Baby died at home without being examined by a physician. No verbal autopsy available. Comments from the study physician: Death due to unknown cause 6 days post vaccination with multiple vaccines. No evidence of relation to vaccine. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211329 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-09-25
Onset:2000-09-30
   Days after vaccination:5
Submitted: 2003-10-29
   Days after onset:1124
Entered: 2003-10-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-09-30
   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: He received the previous study vaccine on 8/26/00.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302634

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. it was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55.073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: No information. Baby died at home without being examined by a physician. No verbal autopsy available. No evidence of relation to vaccination. Comments from study physician: Death due to unknown cause 5 days post vaccination with multiple vaccines. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211330 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2001-03-19
Onset:0000-00-00
Submitted: 2003-10-29
Entered: 2003-10-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Oral intake reduced, Pharyngitis, Pyrexia, Respiratory rate increased, Rhinitis
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: She received the previous study vaccine on 2/17/01.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302633

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. it was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55.073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Cold, cough for 3 days, didn''t want breast feeding, high temperature for 4 days, fast breathing for 1 day. Baby died at home without being examined by a physician. Comments from study physician: Death due to unknown cause 3 days post vaccination with multiple vaccines. Symptoms began before vaccination and suggest pneumonia. Unblinding of the clinical trial: the patient has been exposed to study vaccine: DTP HIB. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211456 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-09
Onset:0000-00-00
Submitted: 2003-10-30
Entered: 2003-11-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR - / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302738

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccien on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization (WHO) schedule with DTP or DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: vomiting after breastfeeding, cough for a week. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient info to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccine the child received. Of note is that symptoms began before vaccine receipt. Unblinding of the clinical trial: the pt has not been exposed to study vaccine but he has received D30 P T60 adsorbed. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211536 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2001-04-18
Onset:0000-00-00
Submitted: 2003-10-31
Entered: 2003-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR S3741 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302761

Write-up: This case has been reported after completion of the clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Baby died at home without being examined by a physician. On verbal autopsy had chest indrawing, fever, fast breathing beginning 2 days before death. Comments from study physician: Death due to unknown cause 4 days post vaccination with multiple vaccines. Verbal autopsy implicates pneumonia. No evidence of relation to vaccination. Unblinding of the clinical trial: the patient has not been exposed to study vaccine but he ahs received D30 F T60 absorbed. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211537 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2000-04-10
Onset:0000-00-00
Submitted: 2003-10-31
Entered: 2003-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR P0607 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Eye disorder, Pneumonia, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302759

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization (WHO) schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Baby died at home without being examined by a physician. Verbal autopsy had cough, fast breathing, yellow eyes, chest indrawing and fever beginning 7 days before death. Comments from study physician: Death due to unknown cause 7 days post vaccination with multiple vaccines. Verbal autopsy implicates pneumonia. No evidence of relation to vaccination. Unblinding of the cinical trial: the pt has not been exposed to study vaccine but he has received D30 P T60 adsorbed. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was100/1000.


VAERS ID: 211538 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2001-01-22
Onset:0000-00-00
Submitted: 2003-10-31
Entered: 2003-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pharyngitis, Pyrexia, Respiratory rate increased, Rhinitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He received the previous study vaccine on 12/15/00.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302746

Write-up: This case has been reported after completion of the clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Cough, fast breathing and chest indrawing (all for a week), cold, high temperature for 3 days, vomiting. Child died at home without being examined by a physician. Comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient information to determine causality. However, there are no facts in the history - other than a temporal association - to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. No evidence of relation to vaccination. Unblinding of the clinical trial: the patient has not been exposed to study vaccine but he has received D30 P T60 absorbed. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211539 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:1999-08-26
Onset:0000-00-00
Submitted: 2003-10-31
Entered: 2003-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR P0607 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302745

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Helath Organization (WHO) radiologically confirmed alveolar infiltrate based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: Fast breathing and chest indrawing for 1 day, blue lips, still wanted to breastfeed. Child died at home without being examined by a physician. comments from study physician: As the child died at home and without a subsequent autopsy, there is insufficient information to determine causality. However, there are no facts in the history-other than a temporal association-to suggest a reasonable causal relationship between death and vaccination given what is currently known about the multiple vaccines the child received. Symptoms history suggests pneumonia mortality. Unblinding of the clinical trial: the pt has not been exposed to study vaccine but he has received D30 P T60 adsorbed. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 211540 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2000-06-19
Onset:2000-06-24
   Days after vaccination:5
Submitted: 2003-10-31
   Days after onset:1224
Entered: 2003-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR S3647 / UNK RL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Cough, Eye disorder, Loss of consciousness, Meningitis, Pneumonia, Pyrexia, Respiratory rate increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Corneal disorders (broad), Eosinophilic pneumonia (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), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302730

Write-up: This case has been reported after completion of the clinical study: "A randomized, controlled clinical trial of the effect of Haemophilus influenzae type B vaccine on pneumonia and meningitis in children." This study was conducted between 1998 and 2002. It was a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization (WHO) schedule with DTP or DTP-PRP-T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard WHO criteria. Preliminary results: 55,073 children were enrolled. DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Case history: high temperature, cough, fast breathing, yellow eyes, and chest indrawing for a week. Baby had five convulsions. Pt admitted at 2 months of age with diagnosis of pneumonia and meningitis 5 days after receiving study vaccine. On admission, had a resp rate of 67, a temp of 38.5, chest retractions, cough, krackles, convulsion, unconsciousness and an oxygen saturation of 86%. Treated with ceftriaxon but died on the day of admission. No CSF collected. Comments from study physician: Child appears to have died of pneumonia, possibly complicated by meningitis. No evidence of relationship with vaccination. Unblinding of the clinical trial: the pt has not been exposed to study vaccine but he has received D30 P T 60 adsorbed. The principal investigator stated that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000.


VAERS ID: 212435 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2003-10-25
Submitted: 2003-11-17
   Days after onset:23
Entered: 2003-11-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 - / -

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-10-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: Bite grade 3
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20030688

Write-up: We received the following information from a foreign country. A male patient received a post-exposure treatment with four doses of Rabipur after a grade 3 bite. Wound toilet was not done and RIG was not given. On 10/25/03 he developed fever, malaise and restlessness. The patient was hospitalized and died on 10/28/03. Seriousness criteria: life-threatening, hospitalization, death. Causality: unrelated.


VAERS ID: 212545 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2002-03-05
Onset:2002-03-09
   Days after vaccination:4
Submitted: 2003-11-17
   Days after onset:618
Entered: 2003-11-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR - / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cough, Encephalitis, Feeling cold, Hypothermia, Pneumonia, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (narrow), Accidents and injuries (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of convulsions before immunization. She received the previous study vaccineo n 5/02/02 (1st dose).
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301970

Write-up: This case has been reported after completion of a clinical study. This study was conducted between 1998 and 2002. It was a randomized, controlled, double blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to schedule with DTP or DTP PRP T vaccine. The primary outcome was radiologically confirmed alveolar infiltrate based on standard criteria. Preliminary results: 55,073 children were enrolled. DTP PRP T had a large effect on meningitis outcomes but prevented a small portion, if any, of measured pneumonia outcomes. More data on mortality rates are awaited. Patient history: A female baby was admitted to hospital at 3 months of age with a diagnosis of pneumonia 4 days after receiving study vaccine. On admission, she had a respiratory rate of 52, a temperature of 38.5, chest retractions, cough, krakles, and an oxygen saturation of 81%. Blood tests were not conducted. She was treated with ampicillin. X-ray was not taken. She died within 24 hours of admission. Comments from study physician: Pneumonia death. Unblinding of the clinical trial: the patient has not been exposed to study vaccine but she has received D30 P T60 absorbed. Additional information on 9/25, from principal investigator stating that the deaths were not related to vaccination and that infant mortality rate before the study was 100/1000. From information received on 11/7/03, the diagnosis was suspected encephalitis. The baby was admitted to hospital on 3/9 at 13:00 hours, 4 days after immunization. Baby was alert4, temperature 39.0, pulse 180/minute. No neck stiffness or dyspnea observed. Treated with dextrose in saline, ampicillin and diazepam. By 14:00 hours, baby condition had deteriorated and O2 saturation was at 81%. Oxygen therapy was provided. No x-ray, blood or CSF were taken. At 18:00 hours, she felt cold and stopped breathing. She died at 18:30 hours after being resuscitated. Comments from study physician: encephalitis is not a documented side effect of DTP vaccine. Moreover, this child had a history of seizures before receipt of vaccination. Thus this event is highly unlikely to be related to vaccination.


VAERS ID: 212888 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-11-17
Entered: 2003-11-25
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0311USA01281

Write-up: Information has been received from a newspaper article. A male pt, with no reported relevant history, was vaccinated on an unspecified date with a dose of MMR II. The article reported that over the eighteen months following vaccination the p developed subacute sclerosing panencephaltiis and lost the ability to do everything. It was reported that the pt died at 18 years of age from subacute sclerosing panencephalitis. The exact date of death was not specified. No further info is available. Case is closed.


VAERS ID: 213453 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:1996-06-03
Onset:2001-04-15
   Days after vaccination:1777
Submitted: 2003-12-03
   Days after onset:962
Entered: 2003-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Muscle atrophy, Muscle contractions involuntary, Muscle spasms
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-23
   Days after onset: 587
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:
CDC Split Type: B0316379A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of amyotrophic lateral sclerosis in a 71 year old male subject who received unspecified hepatitis B vaccine for prophylaxis. The family history included his mother with amyotrophic lateral sclerosis. On 11/18/95, 12/17/95, and 6/3/96, the subject received three injections of an unspecified hepatitis B vaccine. In April 2001, 5 years after the last injection, he experienced muscle cramps and fasciculation. A diagnosis of amyotrophic lateral sclerosis was made (probably a familial form). On 11/23/02, the subject died of amyotrophic lateral sclerosis. This case was not medically confirmed. According to the regulatory authority, the events were unlikely related to Engerix B.


VAERS ID: 213824 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-10-13
Onset:2003-10-18
   Days after vaccination:5
Submitted: 2003-12-04
   Days after onset:47
Entered: 2003-12-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cyanocobalamin; Folic acid
Current Illness:
Preexisting Conditions: Folate deficiency; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0311USA02895

Write-up: Information has been received from a health authority concerning a 97 year old male with a folate and Vitamin B12 deficiency who on 10/13/03 was vaccinated IM with a dose of pneumococcal 23v polysacchardie vaccine. On 10/13/03 the patient was also vaccinated IM with a dose of influenza virus sAg 3v vaccine inactivated. Concomitant therapy included IV cyanocobalamin for his Vitamin B12 deficiency and oral folic acid for his folate deficiency. On 10/16/03 the patient was seen by his physician with proximal progressive muscle weakness. The patient was hospitalized and diagnosed with GBS. On 10/18/03 the patient died. The probable cause of death was reported as GBS. A post-mortem had not been performed. Additional information is not expected. The case is considered to be closed.


VAERS ID: 213941 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-11-13
Onset:2003-12-03
   Days after vaccination:20
Submitted: 2003-12-12
   Days after onset:9
Entered: 2003-12-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS HAB251A6 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Suicide attempt, Unevaluable event
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0316764A

Write-up: This male subject was enrolled in the prophylactic open study. On 11/13/2003, he received a dose of combined hepatitis A and B vaccine. On 12/3/03, 20 days after vaccination, at 32 years of age, the subject ingested rat poison and was hospitalized. On 12/4/03, he died. Further information have been requested, vaccination date is not known up to now and we don''t know if an autopsy was performed. The investigator considered there was no reasonable possibility that the SAE may have been caused by the vaccines. A 15-day follow up report received 12/19/2003 adds: The investigator considered there was no reasonable possibility that the SAE may have been caused by the vaccines.


VAERS ID: 214003 (history)  
Form: Version 1.0  
Age: 2.7  
Sex: Female  
Location: Foreign  
Vaccinated:2003-02-28
Onset:2003-02-28
   Days after vaccination:0
Submitted: 2003-12-10
   Days after onset:285
Entered: 2003-12-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. C2831 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Neoplasm, Pyrexia, Sarcoma
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-27
   Days after onset: 272
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:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Ultrasound: there is a low echo area where an artery passes through. Diagnostic pathological examination: parvicellular malignant tumor probably originated from granulocytic sarcoma. Bone biopsy: eosinophilic granulocyte increased, neutrophil alkaline phosphatase increased. Body temp 38.5 C. WBC normal. Hemoglobin decreased. Lymphocyte count normal. Neutrophil count normal; Platelet count decreased.
CDC Split Type: WAES0312CHN00004

Write-up: Information has been received from a physician concerning a 34 month old girl who at 1:00 PM, 2/28/03 was vaccinated with MMR, 0.5 ml, IM. In the evening of 2/28/03, the girl experienced fever with 38.5 of body temperature. At 7:00 PM, 2/28/03, the girl developed a 0.5x0.5cm square of mass around her right ear. On 5/1/03, she was placed on fomentation therapy (detail unknown) for the treatment of the mass under doctor''s suggestion. On 3/25/03, the girl recovered from fever. On 4/29/03, the girl was hospitalized because the mass increased to 4x2cm square. The physical examination showed the mass was middle texture with clear borderline, coarse surface and limited mobility. At the time, the result of her blood examination revealed 7.7 of white blood cell count, 35.1 of blood lymphocyte count, 59.4 of blood neutrophil count, 2.7 of blood platelet count and 100 of blood hemoglobin. On the same day, her right ear ultrasound result showed there was a low echo area where an artery passes through. On 4/30/03, the girl was diagnosed with parvicellular malignant tumor in right parotid gland via diagnostic pathological examination. The physician estimated the parvicellular malignant tumor probably originated from granulocytic sarcoma in lymphatic and hematopoietic system. On 5/9/03, the result of her bone biopsy revealed her eosinophilic granulocyte and neutrophil alkaline phosphatase were increased. On 11/27/03, the girl died because of parvicellular malignant tumor in right parotid gland. The reporting physician felt the girl''s parvicellular malignant tumor in right glad region was definitely not related to the vaccination with MMR. Additional information is not expected.


VAERS ID: 214010 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-11-07
Onset:2003-12-01
   Days after vaccination:24
Submitted: 2003-12-15
   Days after onset:14
Entered: 2003-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Chills, Endocarditis, Musculoskeletal stiffness, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phenprocoumon, Accuzide
Current Illness: Heart Disease
Preexisting Conditions: Heart Disease
Allergies:
Diagnostic Lab Data: Body temperature 38.8 degrees C. November 25, 2003: C reactive protein 134.2, Erythrocyte sedimentation rate 29mm/h, 56mm/2h, Fibrinogen 737. November 26, 2003: Fibrinogen 592. November 25, 2003: Lactate dehydrogenase 418, Quick test 66. November 26, 2003: Quick''s test 61.
CDC Split Type: D0042459A

Write-up: This case was reported by a pharmacist and described the occurrence of fever in a male subject of approximately 60 years who was vaccinated with hepatitis A vaccine for prophylaxis. The suspected vaccine was imported from a foreign country. For a not further specified period, the subject suffered from heart disease and was treated with phenprocoumon. In January 2003, the subject received the first dose of hepatitis A vaccine. On 11/07/03 the subject received the second dose of hepatitis A vaccine, lot number unknown, and experienced fever (39.8 degrees C), shivering, upper arm pain, and a stiff neck later the same day. An unknown time later the patient died. The cause of death was unknown. A 15-day follow up report received 12/19/2003 adds: On 11/07/2003 the pt received the 2nd dose of hepatitis A vaccine, lot # unknown, subcutaneously into unknown deltoid. 20 minutes post vaccination, the pt experienced fever (39.8 degC) and shivering. There was no injection site reaction. The fever lasted for 2 days. The pt was treated with cephalosporin tablets for a few days. The events improved. Approx 1 week later, the pt developed shivering again and shoulder pain. The reporting physician referred him to the cardiologist excluded the suspected endocarditis. Because of suspected bacterial infection the pt was admitted to cardiological hospital. An aortic dissection was found via endoscopic echocardiography. A surgery was performed where an abscess was found nearby the aortic valve. The pt died during the operation. An autopsy was not performed at the time of reporting. A follow-up soon is expected. A 15-day follow up report received 12/23/2003 adds: This case was reported by a pharmacist, verified by a physician, and described the occurrence of death in a male pt of 68 years who was vaccinated with hepatitis A vaccine (Havrix 1440) for prophylaxis. The suspected vaccine was imported by MTK Pharma. Info has been partially been verbally received. For an unspecified period, the pt suffered from heart disease which led to aortic valve prosthesis. Hence he was treated with phenprocoumon (Marcumar). Concurrent medication included quinalapril + hydrochlorothiazide (Accuzide). A 15-day follow up report received 12/23/2003 adds: 11/07/2003 2nd dose of hepatitis A vaccine, injected into right deltoid. 20 minutes post vaccination, the pt experienced fever 39.8 degC) and shivering. There never was an injection site reaction. The fever lasted for approx 3 days. The pt was treated with cefuroxim-sodium (Cefuroxim 250) tablets for a few days. The events improved. 12 days later, on 11/19/2003, the pt developed shivering again and shoulder pain. The reporting physician referred him to the cardiologist who could not confirm the suspected endocarditis. Because of a suspected bacterial infection the pt was admitted to a cardiological hospital. There an aortic dissection was found via endoscopic echocardiography. Surgery was performed and how endocarditis was seen. Additionally an abscess was found near the aortic valve. On 12/01/2003 the pt died during the operation. The pathogen was unknown to the reporting physician. An autopsy has not been performed. The reporting physician considered that the event was unlikely related to vaccination with hepatitis A vaccine.


VAERS ID: 214911 (history)  
Form: Version 1.0  
Age: 1.8  
Sex: Female  
Location: Foreign  
Vaccinated:2003-11-30
Onset:2003-12-30
   Days after vaccination:30
Submitted: 2004-01-13
   Days after onset:14
Entered: 2004-01-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Convulsion, Encephalitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-30
   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: 200400038

Write-up: It was reported from a news article on 1/6/04 that a 22 month old female child died after receiving a dose of Influenza vaccine on an unspecified date in late November, 2003. The pt developed a high fever, suffered multiple seizures and subsequently experienced severe brain swelling consistent with the condition acute disseminated enceplahomyelitis on 12/30/04, approximately one month post immunization. The child was placed on life support and died on Sunday night after her parents consented to unhook life support. No other info was provided at this time. Additional information received January 19, 2004: stated that subject''s death was unrelated to the flu vaccine. This child developed fever 30days after flu vaccination and died 36 days after her flu vaccination. No further information was provided.


VAERS ID: 214912 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2003-01-22
Onset:2003-01-27
   Days after vaccination:5
Submitted: 2004-01-12
   Days after onset:350
Entered: 2004-01-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (HEXAVAC) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480289 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Asthenia, Blood creatine phosphokinase increased, Blood creatinine increased, Blood lactate dehydrogenase increased, Dyspnoea, Haemoglobin decreased, Haemolysis, Haemolytic uraemic syndrome, Hypertension, Hypoxia, Laboratory test abnormal, Nervous system disorder, Pallor, Platelet count decreased, Renal failure, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-08
   Days after onset: 161
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: In Jan 2003 test results were: hemoglobin (results: 5.6 g/dL); blood creatinine increased (results: 1.1 mg/dL); and blood lactate dehydrogenase (results: 3390 IU/L). Haemoglobin (results 6.7 g/dL) was done on 1/27/03. Blood creatinine increased (results: 1.3 mg/dL (before peritoneal dialysis)) was done in Feb 2003. Ophthalmological examination (results: constricted arterioles, fundus of hypertension) was done on 2/24/03. Chest x-ray (results: no pneumonia, normal findings heart and lung) was done on 2/28/03. blood lactate dehydrogenase (results:1500/mL) was done on 3/4/03. Echocardiogram done on 3/1/03. Platelet count (results:51000/ml) was done on 3/4/03. Echocardiogram (results: heart structure normal, competent heart valve, global ventricular hypertrophy) was done on 3/13/03. X-ray limb (results: left hand: normal calcium content, bone age 3 months) was done on 4/4/03. Additionally, the following tests were done on an unspecified date: blood creatinine increased (results: 2.8mg/dL (after start of peritoneal dialysis)); ultrasound scan (results: of abdomen: nephromegaly bilateral with increased echogenity, splenic enlargement); and bacteria blood test (results: no infection with Escherichia coli). Cytogenic analysis (results: analysis of FH1 gene showed normal findings for exons 1-9 and 11-23) was done after patient died.
CDC Split Type: DEWYE494307JAN04

Write-up: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 6 month old female pt who experienced haemolytic uraemic syndrome, renal failure, haemolysis, anaemia, LDH increased, platelet count decreased, hypertension arterial, serum creatinine increased, hemoglobin decreased, asthenia and pale. The pt received a dose on 1/22/03. The pt experienced asthenia and pale five days after administration of medication. anaemia was diagnosed and she was hospitalized. On 1/27/03 haemolytic uraemic syndrome and renal failure were diagnosed. The pt also experienced haemolysis, LDH increased, serum creatinine increased and hemoglobin decreased. After being dismissed from hospital, she again was hospitalized from 2/20/03 until 2/24/03 and from 2/27/03 until 5/14/03. She experienced platelet count decreased starting on 3/4/03. Furthermore, hypertension arterial was diagnosed. Due to increasing serum creatinine, peritoneal dialysis was started on 3/2/03 after a Tenckhoff catheter had been implanted. Due to anaemia she was given Erythropoietin. The hypertension arterial was difficult to treat. On 5/7/03 a gastrostomy was performed for alimentation. She was dismissed from hospital on 5/14/03 and was treated on an out-patient basis. On 5/31/03 pt experienced gasping for breath and a emergency physician performed cardiopulmonary resuscitation. She was admitted to an ICU. Due to worsening of condition and hypertension a bilateral nephrectomy was performed on 6/5/03. She was transferred to a nephrological unit on 6/23/03. Hypertension did not improve and signs of severe hypoxic brain damage showed. Therapy was minimized, pt was treated symptomatically with analgesic medication. She died on 7/8/03.


VAERS ID: 216187 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-02-03
Entered: 2004-02-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Heart rate increased, Hypotension, Hypoxia, Infection, Laboratory test abnormal, Pneumonia, Pyrexia, Rash papular, Respiratory disorder, Tachypnoea
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Antineoplastic (unspecified)
Current Illness:
Preexisting Conditions: Acute lymphobalstic leukaemia; T-cell count decreased; chemotherapy
Allergies:
Diagnostic Lab Data: Chest x-ray: day 5: diffuse bilateral infiltrate; blood pressure measurement; chest x-ray: prominent interstitial pattern bilaterally, particularly mid and lower lung fields; immunofluorescence antigen testing both lungs: parainfluenza virus type 3 detected; bronchial irrigation: pending: fungal, mycobacterial, legionella, mycoplasma pneumoniae cultures; bronchial irritation: negative direct staining for bacteria, fungi, P carinii, acid-fact bacilli, Legionella pneumophila; renal function study: normal; endotracheal tube culture: coagulase-negative staphylococci; blood pressure measurement: hypotension; autopsy; chest x-ray: bilateral, diffuse mixed interstitial and airspace, SC emphysema most evident in left axilla; WBC count 11.2 x 10 9/L; absolute neutrophil count 8.6, 11,400/mm3; arterial blood O2 sat 94%; body temp 39.1 C, 40 C; hemoglobin 106 g/L; platelet count 44 x 10 9/L; vital sing 30 breaths/min; blood culture: negative; nasal culture: positive for parainfluenza virus type 3; wound culture: lip: herpes simplex type 1; serum L-lactate test: lactic acidosis; cytomegalovirus antibody screen: negative: urine and buffy coat; bronchial culture: bacterial culture negative; total heartbeat count 148 beats/min; hepatic function tests: normal; urine culture: negative.
CDC Split Type: WAES0401CAN00086

Write-up: Information has been received from a physicians publishing article, January 2004 titled "Fever and Respiratory Distress in an 8 year old boy Receiving Therapy for Acute Lymphoblastic Leukemia," "Measles Vaccination" concerning an 8 year old male with acute lymphoblastic leukaemia, T-cell count decreased and chemotherapy was in remission by day 28 and had received his last dose IV chemotherapy therapy 2 weeks prior hospitalization, who in approximately 1988 was vaccinated with MMR II. The boy was previously a healthy boy. In 1995, the pt was hospitalized in a local hospital with a history of fever for a week and tachypnea and respiratory distress for 24 hrs. Therapy with ceftazidime and topical therapy was initiated on his upper lip for a cold sore. Blood culture and urine culture were negative. At day 5 of hospitalization, the pt experienced persistent high fever, hypoxemia and a deteriorating mental status. A chest x-ray demonstrated diffuse bilateral infiltrates. The pt was transferred to a hospital. On admission to the hospital, the pt had the following vital signs: body temp: 39.1 C, heart rate: 148 beats/min; oxygen sat 94% on room air, blood pressure: 90/50mmHg. The pt''s ears were red, with fluids. Examination demonstrated dry, slightly red and crusty conjunctivae and few scattered petechiea, several slightly raised, slightly red papules on skin on hand and back. No lymphadenopathy or hepatosplenomegaly were noted. Liver and renal function were normal. The pt also had the following test results: Hemoglobin: 106g/l, white blood cell count: 11.2 x 10 9/L, absolute neutrophil count: 8.6, platelets: 44 x 10 9/L, chest x-ray: prominent interstitial pattern bilaterally, particularly in the mid and lower lung fields. Therapy with piperacillin, gentamicin and high dose of trimethoprim/ sulfamethoxazole was initiated followed by IV acyclovir the next day. The following day a nasopharyngeal swab demonstrated a positive result for Parainfluenza virus type 3. The pt was still febrile (40 C) 2 days later. The pt need in oxygen increased. The pt had an absolute neutrophil count of 11,400/mm3. The pt was admitted to the ICU and received bilevel-positive airway pressure. A bronchoalveolar lavage demonstrated negative staining for bacteria, fungi, Pneumocystis carinii, acid-test bacilli and Legionella pneumophila. Result were pending on fungal, mycobacterial and legionella and Mycoplasma pneumonia cultures. Immunofluorescence antigen testing on both lungs was positive Parainfluenza virus type 3. Herpes simplex type 1 was present in a scraping of the lip, coagulase-negative staphylococci grew on an endotracheal tube culture and urine and buffy coat were negative for cytomegalovirus. The pt was intubated 2 days later because of increasing hypoxia. Therapy with amphotericin-B was initiated empirically because of persistent fever and furosemide for positive fluid balance, decreased urinary output and ''wet-looking" lungs. Diffuse air space and interstitial disease with pneumomediastinum and SC emphysema, most evident in the left axilla were noted on chest x-ray the next day. Therapy with dopamine was initiated to maintain good perfusion, therapy with acyclovir was discontinued and therapy with ganciclovir was initiated. A second bronchoalveolar lavage confirmed the findings of the first one. The pt stayed febrile and was difficult to ventilate over the course of the next several days. The pt became more and more hypotensive and developed lactic acidosis despite liquid ventilation with a perfluorocarbon emulsion containing oxygen. Decision was made to not pursue further aggressive treatment and therapy with dopamine was discontinued. The pt died 18 days after hospitalization. An autopsy was performed. "The cause of death was clearly the recent measles infection causing the giant cell pneumonia with diffuse damage to the lining epithelium of the respiratory tract from trracheal to alveolar levels." The authors also stated that the "believed that the single dose of vaccine failed to protect our pt and possibly the sibling (see WAES0401CAN00087). We believed that the child with leukemia likely had depression of T-cell function as a result of chemotherapy" and further believe that he developed measles in part because he received only a single dose of vaccine, but that the infection proved fatal because of immunosupression." No further info is available.


VAERS ID: 216652 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2004-01-02
Onset:2004-01-03
   Days after vaccination:1
Submitted: 2004-03-15
   Days after onset:72
Entered: 2004-02-20
   Days after submission:24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR X0101W1431 / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 534192 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Brain oedema, Dehydration, Hepatic steatosis, Hepatomegaly, Pneumonia, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Respiratory tract infection,Systolic Murmur
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0323239A

Write-up: This case was reported by a physician and described the occurrence of a sudden death in a 5 month old boy who had received hepatitis B for prophylaxis. Past medical history included a respiratory infection in December 2003. Concurrent medication included a dose of diphtheria tetanus pertussis and haemophilus influenzae vaccine. On 1/2/04, a dose of Engerix B and a dose of Tetract-Hib were given. On 1/3/04 in the morning, one day after vaccination, this boy was found dead. An autopsy was performed which retrieved focal interstitial pneumonia, symptoms of slight dehydration, minor vomitus aspiration, mild steatosis of the liver and haemorrhagic diathesis. The reporting physician did not assess a causal relationship. Additional information has been requested. The complete autopsy report was received on 10 May 2004 with the following findings: External post mortem examination: cadaver of a 5-month-old boy, weighing 4540 g, 60 cm, head circumference 40.5 cm, thoracic circumference 37 cm, skelton and musculature corresponding to age and relative malnutrition. Cadaveric rigor marked on out on masseters and extremities, cadaveric markes were deep purple, quite larte on right side of face and right side of head as well as on the back. Skin pale, in abdominal area left greenish. Skin turgor lowered, back skin not imparied. Head and face symmetric, eyebulbs in central positin, dried cornea and congested conjunction margin of left bulb, isocoria, 4mm, otherwise conjunctions pale. Facila foramina without secretion, lips light purple, tongue between toothless gums. Ears without secretion. Slim neck without marks of impariment, thorax flat, near right nipple skin light yellowish. Upper and lower extremities symmetric. Nails deep purple, cared. On the left side of scrotum and apex penis, marks of intertrigo. Anus without secretions. Internal examination: cranial cavity: Soft skull covering grey and dry, sunken big fontanelle (4 X 3 cm), cranial vault (13 X 11 X 0.2 cm), not impaired, dura mater stretched, light grey, without marks of haemorrhage. Brain 639 g, brain meninges slightly congested with flattened gyri, considerable brain oedma. Brain hemispheres symmetric. Section of brain tissue showed pasty consistency, congested, narrowed ventricles, purple plexuses. Basal ganglia, cerbellum, pons and medulla oblongata without focal changes. Brain tissue was generally considerably softened. Delicate arteries on the base, in brain sinuses liquid dark purple blood; skull base not impaired. Middle ear sinuses empty. Chest cavity: subcutaneous fat 2-3 mm, in the abdomen 3-4 mm, intercostal musculature pale. Lungs partially fill chest cavities, pericardium free, covered by clear liquid. Diaphragm not impaired, bilaterally reaching 6th rib. Tongue grey furred, palatal tonsils purple, congested. Pharynx congested as well as laryngeal entry and its folds congested, epiglottis delicate, pale retracted. Oesophegus folded, coated by mucus. Larygeal mucosa and trachea rose red, main bronchi mucosa considerably congested, deep red. In lumen slightly yellowish, mucoid, slightly foamed liquid. Thymus 22 g, under its covering considerably punctiform haematoma, tissue grey red, congested, solid consistency. hear 30 g, 5 X5 X 3.5 cm, pericardium delicated, punctiform haematoma on backwall, muscle right 3 mm, left 8-9 mm, outflow part slightly domed and congested, foramen oval and arterial duct closed. Coronary divisions, aorta and pulmonary artery adecuately wide, delcate. Right lung 62 g, 11 X 8 X 3 cm, under delicate pleura presence of punctiform haematomas. Section: purple congested tissue, in dorsal areas irregular defined darker focuses. In bronchi as well as in main bronchi, slight yellowish mucoid liquid. Left lung 46 g, 10 X 5 X 2.5 cm, with rare subpleural haematomas and irregularly defined atelectatic deep purple focuses situated along spine. Other findings similar as right. Thyroid gland light brown, typical. Laryngeal cartilages, neck bones and chest bones not impaired. Abdominal cavity: Abdominal organs normally situated, liver enlarged, almost filling upper and middle part of abdominal cavity. Intestinal loops sunken, stomach slightly infalted, appendix retained retrocaecally. Mesenteric nodes enlarged, grey violet. Spleen 24 g, 6 X 4 X 1.5 cm, capsule stetched, grey section: brown, red, congested tissue of typical structure. Few drops of dark yellow green liquid in gall bladder, grey, delicate mucosa. Stomach contains few ml of dark green loose chyme, dark green folded mucosa. Adrenal glands with relatively thin grey yellow cortex and brown red pulp. Right kidney 2626 g, 6 X 3 X 1.5 cm, left kidney 23 g, 5.5 X 3 X 1.5 cm, capsule peelable off, surface smooth, cortical tissue dark purple, papilas rose. Efferent urinary pathways regular, left ureter slightly dilated, grey floded mucosa. Urinary bladder contained few drops of turbid urine. Rectal mucosa not impaired. Abdominal aorta delicate, adequately wide. In small intestine mucoid, light grey content, mucosa congested, with enhanced vacularity. In large intestine soft to well-formed yellow green stools. Mucosa with falt haematomas (size 30-30 mm). Mucosa of large intestine plain. Pelvic bones and lumbar spine not impaired. Microscopic findings: Nasal mucosa: congestion, rare round cellular cells and typical epithelium. Larynx and trachea: rare round cellular cels, congestion, haematomas in larynfeal muscles and considerable eosinophila of some muscle fibres. Lungs: prevailing alveolar exsudation of macrophagic elements and rare granulocyres, in alveoli focally aspired fibrous mass of little quantity, congested interalveolar septa. Liver: acinar structure, seatosis of hepatocytes in periphery of lobules, congestion. Spleen: tissue activation, rarefaction and congestion. Heart: examined from both betricles and septum: oedema, cels of adequate size, oedema, low extent of round cellular elements presents, fat staining: only slightly positive. Brain: considerable oedma of cortex and brainstem. Lymphatic node: lymphatic tissue activation, dim structure. Adrenal gland: Cortical autlolysis, pulp congestion. Kidney: congestion, glomeruli typical, efferent canaliculi without calcifications, only peeled off epithelia. Stomach: autolysis, small inflammatory cellulization. Intestines; catarrh of small intestine, local haemorrhage of mucosa of large intestine. Bacterial findings: Lung: primoculture: 1 Streptococcus virud. Fungi cultivation: negative. Liver: primoculture: sterile. Propagation: 1. Staphylococcus epidermidis. Primoculture: sterile. Spleen: Primoculture: 1. Escheichia coli serotype EPEC: negative (including 0157). Small intestine: Primoculture: sterile. Propagation: 1. Enterococcus fascalis. Large intestine: Primoculture: 1. Enterococcus faecalis. Intestinal pathogens cultivation negative- fat staining. Liver: portobilial fat droplets. Heart muscle: negative. Skeletal muscle: negative. The reporting physician did not assess a causal relationship.


VAERS ID: 217134 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2002-07-29
Onset:2002-10-07
   Days after vaccination:70
Submitted: 2004-03-11
   Days after onset:521
Entered: 2004-03-03
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Muscle atrophy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-01
   Days after onset: 482
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: D0043215A

Write-up: A physician reported via a representative the occurrence of amyotrophic lateral sclerosis in a subject who was vaccinated with diphtheria tetanus vaccine for prophylaxis. On 29Jul02, the subject received diphtheria tetanus vaccine. Approximately two months post vaccination, on 07Oct02 the subject developed neurological symptoms. Several examinations were performed. On 14Nov02 the subject was diagnosed with amyotrophic lateral sclerosis in a neurological hospital. The pt died on 18Feb04. The reporter stated that the subject possibly did not take his treatment drugs anymore. The reporting physician ordered that the event was not related to vaccination with diphtheria tetanus vaccine. No further information will be available as the physician did not want to report the case.


VAERS ID: 217668 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2004-02-01
Submitted: 2004-03-08
   Days after onset:36
Entered: 2004-03-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1536H / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Infection, Meningitis, Unevaluable event
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-01
   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: Methotrexate; Corticosteroids
Current Illness:
Preexisting Conditions: Diabetes mellitus; Polyarthritis
Allergies:
Diagnostic Lab Data: Magnetic resonance imaging 16? Feb 04 ruled out cerebral ischema. Vascular imaging 16?Feb 04 MRA: Ruled out cerebral ischemia. Ultrasound 16?Feb04 ruled out cerebral ischemia. Electroencephalography 16?Feb04 ruled out cerebral ischemia. Chest X-ray 16? Feb 04 left lower lobe infiltration. Diagnostic laboratory test 16?Feb 04 other routine parameters normal. Diagnostic laboratory test 16?Feb 04 CSF: Increased lactate pneumococcae. WBC count 16?Feb04 23000/ ul. Blood glucose 16?Feb 237 mg/dl. Hematocrit 16?Feb 04 50%. Serum C-reactive protein 16?Feb 04 35.8 mg/dl 0.6-. Serum blood urea 16? Feb04 7.2 mg/dl. Serum direct bilirubin 16?Feb 20.8 umol/l. Total serum bilirubin 16?Feb04 45.6 umol/l. White blood hemoglobin Alc 16?Feb04 8.3%. Mean corpuscular volumen 16?Feb04 35 pg. Serum gamma-globulin test 16?Feb04 90 u/l.
CDC Split Type: WAES0403USA00182

Write-up: Information has been received from a health professional concerning an adult female patient with diabetes mellitus and chronic polyarthritis who in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy used to treat underlying diseases included methotrexate sodium, corticosteroids and oral anti-diabetics. In February 2004, the patient died from pneumococcal meningitis within two days. Additional information has been requested. On 16-Feb-2004, the patient was found by her relatives lying on the floor, unresponsive. The patient was admitted to the hosptial with suspicion of a stoke. Cerebral ischaemia was rulled out by MRI, MRA (magnetic resonance angiography). Doppler sonography (A. vertebralis/basilaris) and EEG. Chest X-ray showed and infiltration in the left lower lobe, assumed to be viral penumonia. Serum leucocytes and CRP were increased. A lumbar puncture was performed. CSF showed increased lactate and gram-positive germs, later identified as pneumococcae (no subtyping was carried). See laboratory section for additional test results. Treatment with ceftriaxone sodium (Rocephin) was started, but symptoms worsened. On 19-Feb-2004, the patient died. The reporter noted that in his opinion, the treatment with corticosteroids and methotrexate sodium (Methotrexate) could have led to a lower antibody response after vaccination and the case is not to be seen as an AER or vaccine failure. The case is closed. Other business partner numbers include E2004-00626. Additional information is not expected.


VAERS ID: 217757 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2004-01-27
Onset:2004-02-13
   Days after vaccination:17
Submitted: 2004-04-01
   Days after onset:48
Entered: 2004-03-15
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5436B9 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test abnormal, Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methadone hydrochloride; Zidovudine Lamivudine
Current Illness: HIV test positive.
Preexisting Conditions: Mother: HIV positive and drug addict, treated during her pregnancy with low doses of methadone (as substitute). Treated with lamivudine (Edivir) from 30 amenorrhea weeks. Sister of 2.5 year old, HIV negative. Treated as birth with ridvudine during 6 weeks. Subject : Apgar score was at 10/10 after caesarian delivery.
Allergies:
Diagnostic Lab Data: Apgar score 10/10; Blood HIV RNA < 50 copies; CD4 lymphocytes 739/mm3; CD8 lymphocytes 359/mm3; HIV antibodies positive; Lymphocyte count 1600/mm3; Autopsy: Macroscopic exam normal; Biological test no particular abnormality; Lactate dosage uninterpretable; AZT dosage non detectable; Viral serologies negative; No element in favor of a concomitant infection; Histological exam pending.
CDC Split Type: B0325219B

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 25 day old female baby who was vaccinated with Engerix B pediatric for hepatitis B prophylaxis. The subject''s mother was HIV positive and drug addict, treated during her pregnancy with low doses of Methadone as substitute. The subject''s sister (2.5 year old), HIV negative, has been treated with AZT at birth during six weeks. The subject''s medical history, included apgar score at 10/10 and HIV seropositivity. Co-suspect treatment included methadone transplacentary and zidovudine transplacentary and then per os. On 1/19/04, at birth, the subject received AZT transplacentary and then orally at a dose of 6mg four times per day for prophylaxis of HIV vertical transmission. On 1/23/04, lab test showed positive HIV serology with HIV RNA at less than 50 copies and normal blood lymphocyte count. On 1/27/04, she received a first injection of Engerix B 10mcg. On 2/13/04, 17 days after vaccination, the subject was found dead in the morning. The last dose of AZT given was at midnight on 2/12/04. Around twelve to one hour PM, the baby was transferred to a post mortem unit in order to perform an autopsy. First results of autopsy showed normal macroscropic exam and biological tests. Histological exam were pending. AZT dosage was undectectable and lactate dosage was uninterpretable. There was no element in favor of a concomitant infection and viral serologies (other than HIV) were negative. At the time of reporting, the cause of death was unknown. The reporting physician considered the event was possibly related to Engerix B, Methadone and AZT. Follow up on 04/29/04 states: "no new information."


VAERS ID: 217997 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2004-03-11
Onset:2004-03-12
   Days after vaccination:1
Submitted: 2004-03-19
   Days after onset:7
Entered: 2004-03-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 200123VH / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 200123VH / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 200123VH / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Brain oedema, Conjunctivitis, Joint stiffness, Nasal congestion, Pallor, Sudden infant death syndrome
SMQs:, Severe cutaneous adverse reactions (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-12
   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: Ofloxacin; Kanamycin
Current Illness: Conjunctivitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Crusty punctuation mark of the vaccination (right lateral thight). No hints on violence, no distinct signs of suffocation.
CDC Split Type: D0043403A

Write-up: A physician reported the occurrence of suspected sudden infant death syndrome in a 3 month old girl who was vaccinated with diphtheria tetanus pertussis (a) poliomyelitis/haemophilus influenzae b vaccine for prophylaxis. The subject was the first child of her parents. There was no information about the time prior to and after birth. In the child''s anamnesis there were no hints of cardiac diseases, congential heart defects, cerebral seizure disease, diabetes mellitus. Since 3/4/04, the subject suffered from conjunctivitis which was treated with some eye drops, probably kanamycin, prescribed by another physician. On 3/11 the reporter examined the child (U4). He found a mild purulent secretion of the conjuctiva and prescribed Ofloxacin at 4-5 drops daily per eye. Also, on 3/11/04 the subject received the first dose of diphtheria-tetanus-pertussis (a)-poliomyelitis/haemophilus influenzae b vaccine, lot number 200123VH, IM into one thigh (lateral). An unknown time later the police called the reporting physician and told him that the little girl was found dead in her bed on 3/12/04 at 21:00, approximately 30 hours post vaccination. SIDS was suspected. Apparently there were not any signs (e.g. syncope, seizure) before. In the evening of that day the subject was fed and was then laid in her bed. An autopsy was performed on 3/15/04. According to the reporter, temporary results were apparently not typical for SIDS, but exact findings were outstanding. The autopsy report has been requested. The autopsy report reads as follow: March 2004 at about 17:00 the subject ws fed with 180-200 ml baby food. Subsequently mother and baby got sleep. It was not quite clear if mother and baby slept in the same room or not. Allegedly at 20:05 the little was found dead in her bed by her mother. The mother stated that she found the baby lying on the right side. Sleeping position. She called an emergency physician. The physician noted the subject lying on her side with foam at her nose. There wre no signs of an infection. A police officer noticed stiffness of the jaw at about 21:00. The death certificate deat of undetermined origen was given. The time of post mortem examination the subject ws 64 cm tall, weighed 7340g and her head size was 44 cm. Areas of her face were pale, the others violet. The back of the head was not blue. The subject had foam at her nose. Signs of acute death such as congestion and oedma of the brain, patchy circulation disturbances of muscle and liver, widened stomach and fluid cadaver blood wre noticed. There was a mild diffuse increase consitency of the pulmonary tissue and foamy oaedam-liquid in the airways. An questionable crusty punctuation of the vaccination was found on the right lateral thigh. The child showed no anomalies. Hints on violence were not found. Also, no distinct signs of suffocation were seen. However, the examiner stated that suffocation soft covering could not be excluded in a baby. During section the cause of death could not be finally determined. For clarification detailled tissue examination was necessary and corresponding samples were taken of these examinations have not been provided so far.


VAERS ID: 218168 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-01-31
Onset:2004-02-05
   Days after vaccination:5
Submitted: 2004-03-25
   Days after onset:49
Entered: 2004-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER BRAZIL MANUFACT / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: sinus allergies
Preexisting Conditions: thymus gland removed in 2002 due to enlargement
Allergies:
Diagnostic Lab Data: Liver biopsy done. Results unavailable.
CDC Split Type:

Write-up: Developed high fever and chills on 2/5/04, 5 days after YF vaccine. Hospitalized, was put on respirator, and died from multiple organ system failure on 2/10/94


VAERS ID: 218632 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Female  
Location: Foreign  
Vaccinated:1997-11-01
Onset:0000-00-00
Submitted: 2004-02-11
Entered: 2004-04-07
   Days after submission:55
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / SANOFI PASTEUR - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301343

Write-up: It was reported through a nurse, that a healthy 19 month old toddler died within 24 hrs of receipt of her 4th dose of Penta which was administered in November 1997. No other vaccines were given that day and no history of any A/E''s with previous vaccination. Apparently this child was vaccinated in the afternoon and was fine throughout the day. Child was febrile in the night, was given Tylenol and fluids and was found dead in her bed in the morning (asphyxiated by vomiting). No further info is available.


VAERS ID: 218849 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-04-09
Entered: 2004-04-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 20H240 / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 20H240 / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 20H240 / 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: B0329120A

Write-up: This case was reported by investigation police and described the occurrence of death in a four month old male subject who received Infanrix-polio-HIB for tetanus, diphtheria, poliomyelitis, acellular pertussis and haemophilus influenzae prophylaxis. At an unspecified date, the subject received an injection of Infanrix Quinta (batch number 20H240). Within an unspecified delay, the subject died. At the time of reporting, the cause of death was unknown and it was unknown whether an autopsy was performed.


VAERS ID: 218851 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Female  
Location: Foreign  
Vaccinated:2004-04-02
Onset:2004-04-03
   Days after vaccination:1
Submitted: 2004-07-23
   Days after onset:110
Entered: 2004-04-12
   Days after submission:102
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 492868 / 2 GM / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-03
   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: UNK
Current Illness:
Preexisting Conditions: Premature baby, Bradycardia; Apnea
Allergies:
Diagnostic Lab Data: Autopsy, toxicologic test, microbiology test; neurological examination; histology; and interleukin mitogenic factor, TNF alpha and interleukin-10; acute inflammatory reaction, no underlying inflammatory disease; normal concentrations for c reactive protein and procalcitonic.
CDC Split Type: DEWYE689506APR04

Write-up: Additional information was received from the regulatory authority including the lot number and the patient''s initials and birth date. Information regarding Prevnar was received from a pediatrician regarding a 3 month old female patient who experienced sudden infant death syndrome. The patient received the second dose on 4/2/04. The patient''s concurrent illness includes premature baby with a past history of bradycardia and apnoea. The mother suffers from diabetes mellitus. During pregnancy she had severe attacks of hypoglycemia. One sibling died from SIDS. Indication for Prevnar was immunization. Product was administered on 4/2/04. Dose regimen was 1 dose. (IM). Concomitant therapy included Infanrix Hexa. In the morning of 4/3/04 the baby was found dead in the arms of her mother. The doctor on emergency call diagnosed sudden infant death syndrome. An autopsy revealed no comprehensible morphologic cause of death. The child was well groomed, in good nutritional condition with healthy organs. Autopsy showed no typical findings associated with SIDS in a narrower sense. Remarkable was a slight prominence of white splenic pulp an dparatracheal lymph nodes. The reporter performed further histological, neuropathological, chemical-toxicological, virological and serological examinations and provided a final assessment of the findings which might point to a immunological event that quickly led to death.


VAERS ID: 219141 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Female  
Location: Foreign  
Vaccinated:2002-04-16
Onset:2002-04-17
   Days after vaccination:1
Submitted: 2004-04-16
   Days after onset:730
Entered: 2004-04-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS 21H0027 / UNK GM / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Hypoxia, Laboratory test abnormal, Oedema, Pulmonary congestion, Pyrexia, Respiratory arrest, Sudden infant death syndrome
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Neonatal Disorder; Possible cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature 38.7 degrees C; Autopsy on 4/18/02: No indication for mechanic force or infection of the airways; brain very compact with severe congestion, possibly due to hypoxia; right side of the heart dilated; arteria lusoria; several local bleeding in the region of the thymus; arterial vessels dilated and thin with changes of the wall structure. Virological testing (PCR): Cerebrospinal fluid negative for Enterovirus, Adenovirus and Herpes Simplex virus, low value for human herpes virus 6, indicating an old but not acute infection. Lung: negative for Enterovirus, Adenovirus, Influenza A and Parainfluenza. Heart: negative for Enterovirus, Adenovirus, Influenza A, Parainfluenza and Parvovirus B19.
CDC Split Type: D0038393A

Write-up: A physician reported the occurrence of death possibly due to anaphylaxis in a 4 month old female who was vaccinated with DTPa-HBV-Polio/HIB vaccine for prophylaxis. The pregnancy was normal, but after birth the subject had mild respiratory problems and was hospitalized for three days. There were no severe illnesses since birth. No hereditary diseases were known within the subject''s family. The subject''s brother, born on 1/1/99, had epilepsy of unknown cause since the age of two years. The reporting physician also stated, that the grandparents of the subject had several deaths among their children, but no detailed information about this was available. On 4/16/02 at 11:00 the subject received the first dose of DTPa-HBV-Polio/Hib vaccine, lot number 21H0027, IM right gluteal. There was no injection site reaction. In the evening of the same day, the subject developed mild fever up to 38.7 degrees C, which was treated by a paracetamol suppository at 20:30. The subject was fed normally and brought to bed in lateral position. On 4/17/02 at 8:30 the mother found the subject dead in bed, in prone position. An emergency physician was called but could only testify the subject''s death. The cause of death was unknown, but a respiratory arrest was suspected. An autopsy was performed. According to verbal information from forensic medicine via the regulatory authority, the subject died from possible anaphylaxis. According to information received on 6/3/02 the reporting physician considered that the possible respiratory arrest was not related to vaccination with Infanrix Hexa, while the forensic physician did not specify the causality of possible anaphylaxis. The autopsy was performed on 4/18/02 and received on 3/3/03 via the regulatory authority. The possible anaphylaxis was not mentioned in the autopsy report. There was no indication for mechanic force or infection of the airways. The brain was very compact with severe congestion. The physician doing the autopsy suggested that this could possibly be due to hypoxia. The right side of the heart was dilated and the subject had arteria lusoria. There were several local bleedings in the region of the thymus, which was considered to be an indication for sudden infant death syndrome. But the arterial vessels were dilated and thin with changes of the wall structure, which the physician could not assign to a concrete syndrome. For this reason he was not able to do a final evaluation. No signs were found for a relationship of the death to vaccination, but the physician also stated that it would probably need special examinations to clarify this. In the cover letter the physician stated that it was not possible to quantify the probability of a causal relationship between the death and the vaccination. An expert report received on 4/2/03 stated the following: The autopsy findings and the general causes of cerebral oedema were reviewed with a foreign opinion leader in neuropathology. He concluded that the large thymus, with multiple bleedings under the capsule and on the surface of the cut were suggestive for SIDS. He actually identified that the signs for an oedema were very limited in this autopsy report. The presence of cerebral edema could only be suspected based on the decreased volume of the ventricles. The weight of the brain was within normal ranges. It would only be possible to conclude for the presence of oedema when additional histological analyses will be performed. If confirmed, the oedema present would most probably be of the cytotoxic type due to hypoxia, which may have many different causes at this age. Another expert report concluded that the reports did not produce any argument suggesting that the death was due to the vaccine and that the death was not a coincidental event. After an expert meeting in March 2003, virological PCR test results were received by the regulatory authority. The test showed negative values for enterovirus, Adenovirus, Influenza A and Parainfluenza in the lung, for Enterovirus, Adenovirus, INfluenza A, Parainfluenza and Parvovirus B19 in the heart and for Enterovirus, Adenovirus, and Herpes simplex virus in cerebrospinal fluid. A low value for human herpes virus 6 was found in cerebrospinal fluid, indicating an old but not acute infection. According to the information received on 3/29/04, the subject was a premature baby with very low birth weight and possibly cardiac problems. The agency stated that it is not possible to conclude a causal relationship between the death and the immunization with Infanrix hexa.


VAERS ID: 219458 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Female  
Location: Foreign  
Vaccinated:2000-08-04
Onset:2000-12-30
   Days after vaccination:148
Submitted: 2004-04-23
   Days after onset:1209
Entered: 2004-04-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Brain oedema, Coma, Convulsion, Cyanosis, Drug ineffective, Laboratory test abnormal, Petechiae, Purpura fulminans, Pyrexia, Sepsis, Skin ulcer, Somnolence, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Activated partial thromboplast 57 sec and 87 sec; Body temperature 39C; C-reactive protein 6.8mg/dl; Fibrin D dimer 2587 mcg/l; Lumbar puncture 300 cellamcl and haemophilus influenzae; Prothrombin time 1.81 INR and 3.26 INR; White blood cells 2300mm3.
CDC Split Type: B0330467A

Write-up: This case was reported in a literature article and described the occurrence of haemophilus influenzae type b sepsis in a 10 month old female subject who had received diphtheria tetanus acellular pertussis, inactivated polio and haemophilus influenzae b injection for prophylaxis. This subject was a full term baby, previously healthy and with an unremarkable medical history. She was on no concomitant medication. On 6/9/00, 7/7/00, and 8/4/00, this girl received the 1st, 2nd and 3rd dose of Infanrix hexa. Approximately on 12/25/00, 4 months after receiving the 3rd dose of Infanrix Polio HIB, this girl developed a respiratory tract infection. On 12/30/00, she was admitted to the pediatric intensive care unit because of cyanotic spells and subsequent somnolence. She had also developed fever 12 hours prior to admission. Physical examination showed a somnolent girl with minimal petechiae on the face. Initial laboratory data revealed marked leukopenia, a serum C-reactive protein concentration of 6.9mg/dl, prothombin time was an INR of 1.81 and a partial prothromboplastin time of 57s. Four hours later INR was 3.26, PTT 87s and D-dimers of 2587 mcg/l. A lumbar puncture revealed 300 nucleated cells/mcl and growth of Haemophilus influenzae which was later identified by a foreign reference center as serotype B, biotype I. Whilst empirical antibiotic therapy with cefotaxime was started immediately upon admission, the child rapidly developed severe respiratory and circulatory failure, and extensive skin lesions characteristic of purpura fulminans. On 1/4/01, despite maximum intensive care, progressive coma with brain edema and generalized seizures resulted in brain death 48 hours after admission. Autopsy was denied by the parents. Immunoglobulin deficiency and asplenia which are the most relevant immunological disorders of HIB infections could be excluded in this patient. A normal sized-spleen was documented by sonography and there were no Howell-Jolly bodies in the blood smear. The serum sample obtained on admission showed no immunoglobin deficiency (IgA 400, IgM 680, IgG 3100, IgGl 2200, IgG2 1040, IgG3 217, IgG4 less than 30 mg.dl). Hib specific antibodies titers obtained in two separate blood samples prior to the administration of plasma products, were 0.49 mcg/ml and 0.52 mcg/ml, exceeding by far the concentration of 0.15 mcg/ml assumed to be protective. Completely deficiency, another significant risk factor, was not ruled out in this patient. The patient died and the cause of death was haemophilus influenzae type B sepsis. An autopsy was not performed.


VAERS ID: 219541 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Foreign  
Vaccinated:2004-04-21
Onset:2004-04-22
   Days after vaccination:1
Submitted: 2004-04-27
   Days after onset:5
Entered: 2004-04-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS 21H015 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-22
   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: Stuffed nose;
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: D0043631A

Write-up: A physician reported the occurrence of sudden infant death syndrome (SIDS) in an 8 week old female subject who was vaccinated with diphtheria-tetanus-pertussis (a)-poliomyelitis-hepatitis B/haemophilus influenzae b vaccine (Infanrix hexa) for prophylaxis. Initial information was received by a pharmacist. The subject was the second child of a 23 year old Turkish female. Pregnancy and birth had apparently been uneventful. Birth was in time, the subject''s APGAR score was 9/10/10 and her birth weight was 3400g. The subject had been completely healthy and developed well after birth. In general the subject was breast-fed. Examination on 04/21 showed nothing unusual in the child, just her nose was a bit stuffed. She had already gained weight of 500g. The other sibling is one and a half years old and had been vaccinated with Infanrix hexa three times without any complications occurring. On 04/21/04 the subject received the first dose of diphtheria-tetanus-pertussis(a)-poliomyelitis-hepatitis B/haemophilus influenzae b vaccine, Lot # 21H0154 at 9:00 in the morning. According verbal information of the emergency physician given to the reporting physician the subject coughed a little bit an unknown time after vaccination. In the morning of 04/22 the subject was quite chirpy. At noon the subject was fed by bottle and then laid in bed. On 04/22/04 at 13:00, approximately 28 hours post vaccination, the subject was found dead in her bed. The emergency physician suspected sudden infant death syndrome. The subject was not admitted to hospital. It is unclear whether an autopsy will take place. According to verbal information received by the pharmacist the physician had never noticed any complications with Infanrix hexa. The pharmacist herself and allegedly the physician did not believe that there might be a causal relationship between the event and vaccination with diphtheria-tetanus-pertussis(a)-poliomyelitis-hepatitis B/haemophilus influenzae b vaccine.


VAERS ID: 222434 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-06-04
Entered: 2004-06-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood disorder, Multiple sclerosis
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI (07/11/95); Spinal tap (07/11/95);
CDC Split Type: WAES0406USA00143

Write-up: Information has been received from a retired physician concerning a male with no reported history who in 1996 was vaccinated with a second dose of hepatitis B virus vaccine (batch number not reported). Subsequently, the patient presented with multiple sclerosis. In 2003, he presented with complications of a blood disease. It was noted that the patient died in 2004. The cause of death was not provided. The file is to be completed. Upon internal review, multiple sclerosis and blood disease were considered to be other important medical events. Follow up on 07/19/04 states: "Follow up information received on 07/01/04 reported that the pt has no past history and was administered three doses of hepatitis B virus vaccine rHBpreS2/sAg (mammalian)(batch number not reported) on 12/06/94 and 01/05/95. The pt also received a first dose of typhoid Vi polysaccharide vaccine (batch number not reported) on 12/06/94. It was noted the pt was hospitalized on 06/26/95 for positional vertigo during his military service. On 07/11/95 the pt had a new hospitalization as he suffered from persistent vertigo and diplopia. A neurologic examination was performed (MRI, and lumbar puncture) and the diagnosis of multiple sclerosis was established. He was treated with Solumedrol and azathioprine. On 09/28/95, the pt was administered the third dose of hepatitis B virus vaccine rHBpress2/sAg (mammalian) (batch number not reported). On an unspecified date in November and December 2003 the pt was hospitalized for febrile pancytopenia. The examination revealed a Tgamma Delta lymphoma with an unfavorable fast evolution. The pt died on 03/27/04 at the age of 29 years. The case is closed. The followup information indicated the pt was administered hepatitis B virus vaccine. Therefore, WAES # 0406USA00143 is being deleted from our files on hepatitis B virus vaccine rHBsAg (yeast)."


VAERS ID: 222636 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-04-22
Onset:2004-05-04
   Days after vaccination:12
Submitted: 2004-06-11
   Days after onset:38
Entered: 2004-06-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. D2499 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute leukaemia, Dizziness, Epistaxis, Gingival bleeding, Haematocrit decreased, Lymphadenopathy, Parotid gland enlargement, Platelet count decreased, Pyrexia, Red blood cell count decreased, Thrombocytopenia, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-05-12
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Platelet count decreased; Bone marrow biopsy: marrow hyperplasia: I, Granulocyte count decreased to 4.5%, red blood cell count decreased to 3.5% and lymphocyte count increased to 92%; Blood pressure measurement 110/70; WBC increased; Hematocrit decreased; Hemoglobin normal; Lymphocyte count increased; Neutrophil count decreased; Basophil count 3.04; Eosinophil count 0.17; Monocyte count increased; HR: 96, sinus rhythm
CDC Split Type: WAES0406CHN00008

Write-up: Information has been received from an agency official concerning a 13 year old male who on approximately 4/22/04 was vaccinated with MMR, 0.5 ml, IM. On approximately 5/4/04, the boy experienced vomiting, dizziness, fever, lymph nodes swelling, teeth bleeding, nasal bleeding, parotid swelling and platelet count decreased (detail unknown). On 5/4/04, the boy was diagnosed with possible acute leukemia and was hospitalized. Subsequently (date unknown), the boy died. Follow up information was received from the reporting official on 6/4/04. It was on 4/21/04 that the boy was vaccinated with MMR, 0.5ml, IM. On approximately 4/25/04, the boy developed dizziness, weakness and vomiting without coffee-like contents and projective. On 5/2/04, the boy developed fever, rhinorrhoea and epistaxis and he was plaaced on therapies with fosfomycin and ibuprofen. Subsequently, he developed sternal pain, lymph nodes swelling and teeth bleeding when brushing. On 5/4/04, the boy was hospitalized. On the same day, the physical examination showed swelling of retruauricular lymph nodes, cervical lymph nodes, submaxillary lymph nodes, subaxillary lymph nodes and inguinal lymph nodes. The biggest lymph node was soybean-like, middle texture, movable and no tenderness. On 5/5/04, the bone marrow biopsy revealed level I of marrow hyperplasia, 4.5 of granulocute count, 3.5 of red blood cell count and 92 of lymphocyte count. The lymphoblast and prolymphocyte count was 80.5 and they were similar size, round or round-like, less volume of cytoplasm, bice color and opaque. Their nucleus was round and chromatin was crude. Pitting and fold could be observed and there were 2 to 4 nucleoli in some cells. On 5/8/04, the blood examination revealed 109.1 of white blood cells count, 0.246 of neutrophil count, 0.558 of blood lymphocyte count, 142 of blood hemoglobin, 29.4 of blood hematocrit and 70 of blood platelet count. On 5/9/04, he was placed on therapy with prednisone, 20mg three times a day. On 5/10/04, his blood examination showed 440.1 of white blood cell count, 3.93 of blood monocyte count, 0.17 of blood eosinophil leukocyte count, 3.04 of blood basophilic leukocyte count, 93.1 of lymphocyte count, 72.6 of blood hemoglobin, 25.0 of blood hematocrit, and 61 of blood platelet count. On 5/11/04, the boy developed pale face, restlessness, chest distress, and dyspnea. At that time, his BP was 110/70 and HR was 96 with sinus rhythm. On the same day, therapies with prednisone increased to 30mg three times a day and the boy was placed on therapy with dexamethasone, furosemide, and dopamine. At 4:33 PM, 5/12/04, the boy died of acute lymphocytic leukemia and respiratory failure. The physician considered respiratory failure was caused by acute lymphocyte leukemia and acute lymphocytic leukemia was definitely not related to the vaccination. This is an amended report. The US lot equivalent is 646344/0520N. Additional information is not expected. This is a corrected report, as amended.


VAERS ID: 223743 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:1995-01-05
Onset:2003-11-01
   Days after vaccination:3222
Submitted: 2004-07-06
   Days after onset:247
Entered: 2004-07-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (GENHEVAC B) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood disorder, Diplopia, Lymphoma, Multiple sclerosis, Pancytopenia, Vertigo
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (narrow), Ocular motility disorders (broad), Malignant lymphomas (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200401701

Write-up: Case reported by a retired physician on 5/28/04. It was reported that man (exact age not reported) was administered an Hepatitis B vaccine in 1996. After the second injection (date not specified) he presented with a multiple sclerosis. In 2003, he presented with complications as blood disease. He died in 2004. File to be completed. Follow up on 6/1/04: According to the PV form, the patient''s initials is ABE. He is born on 7/10/74 and was 21 years old. He was administered three doses of Hepatitis B vaccine (Genhevac, batch # not reported) on 12/6/94, 1/5/95, and 9/28/95. He received also a first dose of typhoid vaccine (Typhim Vi, batch not reported) on 12/6/94. He was hospitalized on 6/26/95 for positional paroxystic vertigo during his military service. On 7/11/95, new hospitalization as he suffered from persistent vertigo and diplopia. Neurologic check up was performed (MRI, lumbar puncture) and the diagnosis of multiple sclerosis was established. He was treated with solumedrol then azathioprine. On November and December 2003, he was hospitalized for febrile pancytopenia. The check up revealed a Tgamma Delta lymphoma, unfavorable fast evolution. The patient died on 3/27/04 at the age of 29 years. Case is closed. Follow up on 07/12/04 states: "Upon internal review the reaction onset date is 06/26/95 and the manufacturer assessment has been modified. Case is closed." Follow up 02/07/05: Company remarks: T-cell lymphoid malignancies can present either as acut lymhoid leukemia or as aggressive lymphoma. These malignancies are more common in children and young adults, with males more frequently affected than females as in this case. Malignancies of lymphoid cells are assicated with recurring genetic abnormalities, it is presumed that they exist. HTLV-1 infected T-Cells and leds directly to the development of audult T cell lymphoma in a small percentage of infected patients. In this case, no information was provided on genetics, search for HTLV-1. Moreover, the first symptoms (febril pancytopenia) occurred 8 years after the las hepatitis B vaccination. Regarding multiple sclerosis ccurred five months after vaccination, this disease had two components with not only demyelination but also ___ lesions, and its evolution is marked by inflammatory phase followed by a degenerative one. Epidemiological studies have not shown a link between MS-like syndrome and hepatitis B vaccination.


VAERS ID: 224018 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2004-06-29
Onset:2004-07-04
   Days after vaccination:5
Submitted: 2004-07-23
   Days after onset:19
Entered: 2004-07-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site haemorrhage, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Cerebrohepatorenal syndrome
Allergies:
Diagnostic Lab Data: Cytogenic analysis (results: Zellweger syndrome was confirmed) was done on an unspecified date. The cause of death was reported as Zellweger syndrome.
CDC Split Type: DEWYE893309JUL04

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 4 month old patient who experienced liver function disorder and muscle hemorrhage at injection site and died from concomitant disease progression of Zellweger syndrome. The patient received the second dose on an unspecified date. The patient''s concurrent illness includes cerebrohepatorenal syndrome (underlying disease). Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient experienced liver function disorder and muscle hemorrhage at injection site. The patient died one week after the second dose from disease progression of Zellweger syndrome. No additional information was available at the time of this report.


VAERS ID: 224411 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2004-03-02
Onset:2004-03-23
   Days after vaccination:21
Submitted: 2004-07-27
   Days after onset:125
Entered: 2004-07-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pentacoq
Current Illness: UNK
Preexisting Conditions: Vomiting
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0339951A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of sudden death in a 4 month old male subject who received a vaccination with Infanrix Quinta for diphtheria, tetanus, poliomyelitis, acellular pertussis and haemophilus influenzae type B prophylaxis. On 1/26/04, the subject received a first injection of Pentacoq without any problem. At an unspecified date, he experienced vomiting. On 3/2/04, he received the first dose of Infanrix Quinta and an injection of Prevnar. Approximately three weeks later, on 3/23/04, a sudden death was reported (no more precision). The reporter didn''t know if an autopsy was performed. The reporter causality was unknown.


VAERS ID: 225217 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Foreign  
Vaccinated:2002-05-15
Onset:2003-06-20
   Days after vaccination:401
Submitted: 2004-08-05
   Days after onset:412
Entered: 2004-08-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477702 / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amaurosis, Apnoea, Bradycardia, Brain stem syndrome, Cardiac arrest, Cerebral palsy, Hearing impaired, Hypoxia, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Hydrocephalus; Bradycardia
Preexisting Conditions: Premature baby; Meningitis pneumococcal; Gastritis erosive; Pneumonia; Convulsion; Encephalitis
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DEWYE927726JUL04

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 15 month old male patient who experienced fever, vomiting, bradycardia, asystole and apnea and died. The patient received the first dose on 5/15/02. The patient''s concurrent illnesses include hydrocephalus and bradycardia with a past history of premature baby, meningitis pneumococcal, encephalitis, convulsion, pneumonia and gastritis erosive. Indication for Prevnar was immunization. Product was administered on 5/15/02. Dose regimen was 1 dose (IM). Concomitant medication included an unspecified 6-fold vaccine. During the night of 6/20/03 the patient developed fever. The next morning (6/21/03) he vomited twice clear fluid out of mouth and nose. The oxygen requirement increased and the patient became bradycardic. The mother called an ambulance. Upon arrival the child was apneic and asystolic. The patient was intubated and ventilated. He was given Suprarenin but the heart showed no activity. The patient was resuscitated unsuccessfully for 1 1/2 hours and was brought to hospital. There he was declared dead. Furthermore, it was stated in the hospital report (written after the patient''s death) that as diagnosis the child suffered from cerebral palsy, amaurosis, severe hearing loss and severe dysfunction of brain stem. It is unclear at what time these events occurred. No quality issues were identified in review of batch records or release test records. This case is treated as a possible damage due to vaccination.


VAERS ID: 225290 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2004-07-21
Onset:2004-07-21
   Days after vaccination:0
Submitted: 2004-08-06
   Days after onset:16
Entered: 2004-08-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0857N / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

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: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0407KOR00011

Write-up: Information has been received from an agency concerning a 4 month old patient who on 7/21/04 was vaccinated with HIB conjugate vaccine in hospital. Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine. Concomitant therapy may perhaps include hepatitis B virus vaccine unknown. 5 hours later of vaccination, the patient died. Concern has been expressed regarding the lot number. Additional information is not expected. Follow up: The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. This lot complies with the standards of the center for biologics evaluation and research and was released. Additional information is not expected.


VAERS ID: 225609 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2003-02-19
Onset:2003-03-11
   Days after vaccination:20
Submitted: 2004-08-13
   Days after onset:520
Entered: 2004-08-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0446L / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Bacterial infection, Cardiomegaly, Chest pain, Endocarditis, Headache, Laboratory test abnormal, Leukocytosis, Pericarditis, Pharyngitis, Pyrexia, Sepsis, Shock
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-27
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Neuro-myopathy; Scoliosis; Congenital multiplex arthrogryposis; Motor activity retarded; breathing difficult; recurrent respiratory tract infections; Hepatosis
Allergies:
Diagnostic Lab Data: Leucocytosis; Chest x-ray; Echocardiography; Body temp 39C; Blood culture negative; Clinical serology test negative; Blood culture: staph warneri.
CDC Split Type: WAES0408USA00802

Write-up: Information has been received from a health professional concerning a 12 year old female with a history of neuromyopathy (unknown origin), scoliosis, congential multiplex arthrogryposis, motor activity retarded, breathing difficult, recurrent respiratory tract infections and hepatosis (unknown origin) who on 2/19/03 was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (lot # HR46990) (lot # 639404/0446L) IM in the upper arm. On 3/11/03, she presented with a headache. The child''s pharynx was slightly reddened and a pulmonary examination was normal. On 3/18/03, she presented again with asthenia. She was treated with antibiotics. On 3/20/03, a chest x-ray revealed no pneumonia but an enlarged heart. An echocardiography showed normal results. Since 3/24/03, symptoms improved a bit but relapsed on 4/21/03. Additionally she showed fever up to 39 C and cardialgia. A blood sample was taken and showed leucocytosis. Another antibiotic was administered and on 4/2/03 she was admitted to the hospital. Fever relapsed immediately when antibiotic treatment was stopped. Blood cultures (17) and virus serology were all negative. A diagnosis of endocarditis of the mitral valve and pericarditis was established. On 4/22/03 condition worsened (start of sepsis) and she was referred to the cardiology department of another hospital. On 4/25/03 blood culture showed Staphylococcus warneri. Antibiotics were changed again but therapy did not lead to improvement. On 4/27/03 the patient died. The cause of death was septic shock. An autopsy was refused by the parents. The reporter felt that septic shock, endocarditis and headache were not related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information is not expected. File closed.


VAERS ID: 226284 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2004-07-12
Submitted: 2004-09-03
   Days after onset:53
Entered: 2004-09-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Laboratory test abnormal, Medication error, Meningitis
SMQs:, Noninfectious meningitis (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Culture: serotype isolated 7F.
CDC Split Type: HQWYE592126AUG04

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 39 month old male patient who experienced pneumococcal meningitis, SC route of administration and drug ineffective. The patient received a dose on a unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose (SC). Concomitant medications were not reported. On an unspecified date in 2004, the patient developed pneumococcal meningitis. It was reported that the patient received the vaccine via a SC route of administration. A culture done on 7/12/04 revealed serotype 7F. The patient died on 7/12/04. No additional information was available at the time of this report. Follow up on 09/29/04 states: "Follow up information provided clarification of pt''s initials."


VAERS ID: 226764 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:1999-11-28
Onset:1999-12-01
   Days after vaccination:3
Submitted: 2004-09-16
   Days after onset:1750
Entered: 2004-09-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Joint swelling, Laboratory test abnormal, Musculoskeletal stiffness, Myalgia, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Sleep disorder, Tenosynovitis, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Follow up data received from HA on 09/06/04. The pt was reported to have been chronically immunosuppressed for a steroid-responsive optic neuropathy.
Allergies:
Diagnostic Lab Data: Results of blood testing on 1/13/00: White cell count 12000/mircoL [4-11], Neutrophil 10100/microL [2-7.5]. All other full blood count test within the normal range. Glandular fever screen negative. Endocrinology: Thyroid function test (T3, T4, TSH) within the normal range. Biochemistry: Sodium, Potassium, Urea within the normal range. Serum Creatinine 51 umol/L [55-100]. Liver and Bone profile: Total protein 59 g/L [60-79]. Albumin 36g/L [40-50]. CRP 80 mg/L [0-10]. Globulin, ALT, AST, Alkaline phosphatase, Gamma GT, Bilirubin, Calcium, Corrected Calcium, Creatine kinase, Inorganic Phosphate - within the normal range. Results on 1/26/00: Hematology: Platelet count 634000/microL [150-400]. ESR 86 mm/hr [1-20]. All other full blood count test within the normal range. Biochemistry: RA Latex 0 IU/ml [0-20]. Follow up on 2/7/01: Results of further investigations performed on the 1/13/00: Immunoglobulins: IgA 1g/L [0.8-4], IgG 9.3 g/L [6-16], IgM 1.7 g/L [0.5-2]. Protein Electrophoresis: Serum protein electrophoresis showed a normal pattern. Complement studies: C3 Complement 1.18 g/L [0.75-1.65], C4 Complement 0.43 g/L [0.14-0.54]. ME/Post viral screen: Parvovirus screen negative. Comment: No evidence of recent infection.
CDC Split Type: F200100269

Write-up: It was reported that a 41 year old woman was vaccinated on 11/28/99 with an Influenza vaccine. 3 weeks later, she developed redness at the site of the injection over her right upper arm associated with soreness and pain in most of her peripheral joints and muscles. She was stiff for about 3 hours in the morning as well as in the evening and a short course of oral prednisolone 15mg daily for 5 days provided some benefit. Her sleep pattern was disturbed and she found it difficult to roll over in bed. Her general health was otherwise good. As her condition was not progressing significantly, she was admitted at hospital on 1/12/00. At admission, she had mild pyrexia 37.2 C and looked unwell. She had mild soft tissue swelling of the MCP joint and both wrists and a degree of flexor tenosynovitis. There was marked tenderness over the muscles of the upper arm and thighs but no overt weakness. The reflexes were normal. Her blood investigation showed mild neutrophilia with normal hemoglobin, thyroid function tests, liver and bone profile and creatine kinase. C-reactive protein was markedly elevated at 80. Viral titers are not provided. See lab data. The rheumatologist though her symptoms were the likely result of a viral illness and in view of her discomfort and functional disability, she was treated with an intramuscular injection of Depomedrone 120mg and enteric coated Naproxen. She responded well to the injection and was allowed home on 1/15/00. She was seen by the rheumatologist again on 1/18/00, and had continue to improve. She was still presenting some stiffness in the morning but is fully mobile. She had minimal synovitis in her wrists and IP joints of the thumbs. She was remaining under treatment with enteric coated Naproxen 500mg twice daily, Tramadol 50mg four times a day and Temazepam 20mg at night. According to the last data received from the rheumatologist, she was fully recovered in February 2000. Further data have been requested. Follow up on 2/7/01: Results of further investigations performed on the 1/13/00 were received from the rheumatologist (see lab data). Further data on the origin of the suspected influenza vaccine are awaited from the vaccinating physician. Follow up on 4/10/02: Data not received. Case to be considered as closed. Follow up information reported on 9/6/04. It is reported that the patient has now died. The reporter states that the cause of death is unrelated to the event presented following the injection. No further details as to date of death reported. It was reported that the death was sudden but that no post-mortem was carried out. The cause of death is reported to be unknown. Additional information on previous medical history is also supplied. The patient was reported to have been chronically immuno-suppressed for a steroid-responsive optic neuropathy.


VAERS ID: 226877 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Foreign  
Vaccinated:2004-08-19
Onset:2004-08-20
   Days after vaccination:1
Submitted: 2004-10-05
   Days after onset:46
Entered: 2004-09-22
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495954 / 2 RL / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data: Blood test (08/04): normal; chest x-ray 8/20/04; lumbar puncture normal, skeletal survey normal, virus serology test, negative for SRV and positive for pertussis, probably related to vaccination with Pentavac.
CDC Split Type: FRWYE048217SEP04

Write-up: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 4 month old male pt who experienced sudden infant unexplained death. The pt received the first dose in Aug 2004. The pt has a past history of premature baby, with a birth at less than 33 weeks of amenorrhea. Indication for Prevnar was immunization. Product was administered in Aug 2004. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Infanrix-quinta (diphtheria/tetanus/acellular pertussis/poliomyelitis/haemophilus influenza vaccine). Concomitant medications were not reported. The pt experienced sudden infant unexplained death (sudden infant death syndrome) at the end of Aug 2004, twelve hours after vaccination. Blood tests (results: Normal) was done in Aug 2004. The cause of the death was reported as sudden infant death syndrome. No additional information was available at the time of this report.


VAERS ID: 226878 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2004-06-28
Onset:2004-07-01
   Days after vaccination:3
Submitted: 2004-09-20
   Days after onset:81
Entered: 2004-09-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 15760B9 / 1 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 15760B9 / UNK UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. D1640 / 1 UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER S3378453 / 1 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495885 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Upper respiratory tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-02
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE987813SEP04

Write-up: Information regarding Prevnar was received from a regulatory authority regarding a 2 month old male patient who expired after developing an upper respiratory tract infection. At 8 weeks of age, the patient received a dose on 6/28/04. The patient also received a dose of Infanrix DTPa Hep B, a dose of Sabin vaccine and a dose of Pedvax-HIB vaccine on 6/28/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 6/28/04. Dose regimen was 1 dose. Concomitant medications were not reported. On 7/1/04, a 2 month old male patient developed an upper respiratory tract infection. On 7/2/04, he was found dead. The reporter stated that the patient did not wake up. The reporter indicated possible causality between Prevnar administration and death and upper respiratory tract infection. No additional information was available at the time of this report.. Follow up on 09/24/04 states: "Follow up information provided correct lot #''s for vaccine and Infanrix DTPa Hep B vaccine. Sabin: S3376453, Infanrix: 16760B9."


VAERS ID: 227059 (history)  
Form: Version 1.0  
Age: 0.45  
Sex: Male  
Location: Foreign  
Vaccinated:2003-06-05
Onset:2003-08-16
   Days after vaccination:72
Submitted: 2004-09-24
   Days after onset:405
Entered: 2004-09-28
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug ineffective, Hepatic failure, Sepsis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Lack of efficacy/effect (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: 2003-08-16
   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: UNK
Current Illness:
Preexisting Conditions: Cholestasis
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DEWYE049820SEP04

Write-up: New version was created to add two additional events with outcome. Informatin regarding Prevnar was received from a healthcare professional regarding an 8 month old male patient who experienced pneumococcal sepsis, hepatic failure and drug ineffective. The patietn received the third dose on 6/5/03. The child is a high risk patient. The patient''s concurrent illness includes intrahepatic cholestasis. Indication for Prevnar was immunizatin. Product was administered on 6/5/03. Dose regimen was 1 dose (IM). COncomitant medications were not reported. A liver transplatation had been planned. The patietn experienced pneumococcal sepsis and was hospitalized. He died on 8/16/03 from liver failure. The treating pediatrist cannot assess the possibility of drug ineffective as she has no information on the serotypes. Furthermore this report was received over a year post-mortem. Due to this it is not possible to obtain further information.


VAERS ID: 227289 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Male  
Location: Foreign  
Vaccinated:2004-08-19
Onset:2004-08-20
   Days after vaccination:1
Submitted: 2004-10-18
   Days after onset:59
Entered: 2004-10-04
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA031A / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10279 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-20
   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: Poractant alfa; Caffeine; Josamycin; Trimebutine; Phototherapy; Albumin; RBC''s; Hydrocortisone H-succ; Fluid therapy-unspecified; Mechanical ventilation;
Current Illness: UNK
Preexisting Conditions: The subject was born at 28 weeks of amenorrhea, eutrophic, weighing 1090 grams. The subject''s family medical history included asthma in his mother and his maternal grandmother.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0346220A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death in a 5-month old male subject who was vaccinated with Infanrix Quinta for diphtheria, tetanus, poliomyelitis, (acellular) pertussis and haemophilus influenzae type B prophylaxis. Vaccination history included two injections of Pentavac (diphtheria, tetanus, poliomyelitis, (acellular) pertussis and haemophilus influenzae type B vaccine) well tolerated. The subject''s medical history included prematurity. He was born at 28 weeks of gestation. Co-suspect vaccine included Prevnar for pneumococcus prophylaxis. On 08/19/04, the subject received the 3rd dose of Infanrix Quinta and a first injection of Prevnar. 12 to 15 hours later, on 08/20/04 in the morning, the subject died of unknown reason (sudden death). There has been no symptoms preceding the death. An autopsy has not been performed. The reporting physician''s causality assessment was unknown. The second physician considered the event as unrelated to Infanrix Quinta and Prevnar. Follow up on 11/02/04 states: "At the time of vaccination, the subject''s clinical examination was normal. Co-suspect vaccine included Prevnar for pneumococcus prophylaxis. On 08/19/04 at 16:00, the subject received the 3rd dose of Infanrix Quinta (batch reference A20CA031A, expiry date 08/06) and a first injection of Prevnar (batch reference 10279, expiry date: 08/06). 12 to 15 hours later, on 08/20/04, between 4:00 and 7:00AM, the subject was found dead on the back (sudden unexplained death). There has been no symptom preceding the death. An autopsy has not been performed. Causality relationship of the first physician (who vaccination the infant) was unknown. The second physician (hospital physician) considered the event as unrelated to Infanrix Quinta and Prevnar."


VAERS ID: 227412 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2004-08-30
Onset:0000-00-00
Submitted: 2004-10-05
Entered: 2004-10-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489782 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Heart disease congenital.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: DEWYE084404OCT04

Write-up: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a male patient who experienced sudden death, cause unknown. The patient received a dose on 8/30/04. The patient''s concurrent illness includes heart disease congenital (several corrective surgeries). Indication for Prevnar was immunization. Product was administered on 8/30/04. Dose regimen is 1 dose (IM). Additional suspect medication included Infanrix Hexa. Concomitant medications were not reported. The patient experienced sudden death, cause unknown on an unknown date in 2004. The cause of death was questioned as a reaction due to vaccination or severe congenital heart disease. An autopsy was performed, but results were not available yet. No additional information was available at the time of this report.


VAERS ID: 227847 (history)  
Form: Version 1.0  
Age: 0.77  
Sex: Male  
Location: Foreign  
Vaccinated:2004-06-26
Onset:2004-06-27
   Days after vaccination:1
Submitted: 2004-10-13
   Days after onset:108
Entered: 2004-10-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Cardiomyopathy, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-02
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Biopsy: Biopsy of the pt''s heart tissue; results: no conclusion regarding pt''s myocarditis.
CDC Split Type: HQWYE521904OCT04

Write-up: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a pt''s mother regarding her 9 month old son who experienced irritability, cough, and breathlessness and died due to dilated "myocardiopathy''. At 9 months of age, the pt received a dose on 09/26/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 06/26/04. Concomitant medications were not reported. A 9 month old male pt experienced irritability on 06/27/04, cough on 06/30/04 and breathlessness on 07/01/04. On 07/02/04 the pt died due to dilated "myocardiopathy" (congestive cardiomyopathy). Additional information received from the pt''s physician reported myocarditis; however, a heart tissue biopsy was inconclusive regarding the pt''s myocarditis. The physician considered myocarditis to be "not related" to the administration of Prevnar. The cause of death was reported as congestive cardiomyopathy. This report was received from a manufacturer. No additional information was available at the time of this report.


VAERS ID: 228034 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-09-27
Onset:2004-09-28
   Days after vaccination:1
Submitted: 2004-10-19
   Days after onset:21
Entered: 2004-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR Y5114 / UNK RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR Y0382 / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Coma, Cyanosis, Feeling hot, 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 (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (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: Pyrazinamide; INH; Rifampicin
Current Illness:
Preexisting Conditions: Allergy to amoxicillin, ampicillin, ceftriaxone. History of benign febrile convulsion - normal work up. Family: No SIDS among relatives.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403371

Write-up: It was reported through Health care professional that a 2.5 year old child dead after the first booster injection of ActHib (lot number Y03821) reconstituted with DTCOQ multidose (lot number Y5114) performed on 27Sep04 (2:30PM). Prior to vaccination, mother gave one teaspoon of paracetamol (stock preparation was unrecalled). Child given ActHib reconstituted with DTCOQ. Allegedly afebrile and comfortable. On Sept 28, 2004 (11:00AM) Child was noted to be playful but was noted to be warm. Mother administered Paracetamol (5ml) and Mefenamic Acid (5ml). Child was bottle fed with milk and slept. No account of the child''s condition until 5PM. On Sept 28,2004 (5PM). Upon being checked by the care giver child was motionless and cyanotic. Attempts were made to awaken the child but to no avail. Child was immediately rushed to the hospital where CPR was immediately done for about 7 times but to no avail. No milk in the airway was noted. Foul breath was noted by the attending physician (on intubation). Child was pronounced dead after 2 hours of resuscitation. No autopsy performed. Pt''s outcome: Fatal.


VAERS ID: 228259 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2004-09-22
Onset:2004-09-23
   Days after vaccination:1
Submitted: 2004-10-26
   Days after onset:33
Entered: 2004-10-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER Y2000 / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5412A2 / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK GM / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER S127GL / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Coma, Cyanosis, Pallor
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0348405A

Write-up: This case was reported by foreign authorities and described the occurrence of death in a 2 month old male subject who received Poliomyelitis vaccine live oral. Medical history and history of other reaction to drugs was unknown. Co-suspect medication included hepatitis B vaccine. Concurrent medications included haemophilus influenza type B conjugate with tetanus protein and anatoxal diphtheria. The subject was a normal child in breast feeding. On 9/22/04 the subject received a first dose of Poliomyelitis vaccine live oral (batch # S127GL) and a dose (not the first dose) of Engerix B vaccine (batch ENG5412A2). The same day, in the evening he received paracetamol, it is unknown whether it was the first time. On 9/23/04, at 8:30 AM, one day following vaccination the subject was brought to the emergency room and showed no vital signs. The subject presented cyanosis of face and skin paleness. At the time of this report, the cause of death was unknown. It is unknown whether an autopsy was performed. The reporter stated that there was a possible relationship between the adverse reaction and vaccination. Further information has been requested.


VAERS ID: 228457 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-10-14
Onset:2004-10-17
   Days after vaccination:3
Submitted: 2004-10-29
   Days after onset:12
Entered: 2004-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / BSI - / UNK - / -
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER X5424 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Coagulopathy, Dehydration, Diarrhoea, Enzyme abnormality, Malaise, Multi-organ failure, Nausea, Platelet count decreased, Pyrexia, Renal disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-22
   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: unknown
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: (This information was obtained from a press release. On 10/14/04, received vaccines on in preparation for trip abroad. On 10/17/04, had with high fever (40 C)and general malaise. Also had diarrhea and vomiting. She was hospitalized in ICU on 10/21/04. During hospitalization, had nausea, vomiting, coagulation disorders, low platelet count, hepatic enzyme abnormalities, severe dehydration, metabilic acidosis, and renal dysfunction. Was given a provisional diagnosis of multi system organ failure. She died on 10/22/04.


VAERS ID: 228588 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-09-27
Onset:2004-10-02
   Days after vaccination:5
Submitted: 2004-10-28
   Days after onset:26
Entered: 2004-11-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pneumonia, Pyrexia, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-14
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Biofermin; Mg oxide
Current Illness:
Preexisting Conditions: Foreign body aspiration; Spondylosis deformans; Gastrointestinal disorder; Upper respiratory tract infection; Dementia Alzheimer''s type.
Allergies:
Diagnostic Lab Data: Body temp: 39.2 C
CDC Split Type: WAES0410USA03495

Write-up: Information has been received from a physician concerning an 89 year old female with spondylosis deformans, dementia Alzheimer''s type, upper respiratory infection, and gastrointestinal disorder and a history of foreign body aspiration who on 9/27/04 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Mg oxide and Bacillus subtilis (as drug) (+) Lactobacillus acidophilus (as drug) (+) Streptococcus faecalis (as drug). On 3/3/04, the patient was diagnosed with an upper respiratory infection which was subsequently suspected as being pneumonia. On 3/8/04, the patient entered into a nursing home. On 9/27/04, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine for prophylaxis of pneumonia. On 10/2/04, the patient developed a fever of 39.2 degrees C, and on 10/3/04, the patient was transferred to the hospital. On 10/14/04, the patient died of pneumonia. The reporting physician felt that the pneumonia was definitely not related to therapy with pneumococcal 23v polysaccharide vaccine considering the age of the patient. No further information is expected.


VAERS ID: 228896 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-10-13
Onset:2004-10-13
   Days after vaccination:0
Submitted: 2004-11-04
   Days after onset:22
Entered: 2004-11-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR Y9552 / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1336N / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-13
   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: Aspirin; Perindopril; Pravastatin Na; Rabeprazole sodium
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0410USA04392

Write-up: Information has been received from a health authority concerning an 80 year old male patient who on 10/13/04 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot # 648713/1336N; batch # HV24410). Secondary concomitant therapy on 10/13/04 included an IM dose of influenza virus split virion 3v vaccine inactivated (batch # Y9552-1). Concomitant therapy included perindopril, zopiclone, pravastatin Na, aspirin and rabeprazole sodium. On 10/13/04 the patient died a sudden, unexplain death. A post mortem had not been performed and a cause of death had not been established. No further infromation expected. Case is closed. Other business partner numbers include E200403681.


VAERS ID: 229114 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-05-13
Onset:2002-06-26
   Days after vaccination:44
Submitted: 2004-11-10
   Days after onset:868
Entered: 2004-11-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Arthritis, Rheumatoid arthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Congenital torticollis
Allergies:
Diagnostic Lab Data: Rheumatoid factor: seronegative; Biological inflammatory syndrome.
CDC Split Type: B0350920A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of possible rheumatoid arthritis in a 56 year old female subject who received hepatitis B vaccine. On 5/13/02, the subject received a booster dose of Engerix B at 20mcg. On 6/26/02, 38 days after the injection, the subject developed rhizomelic inflammatory pain in scapular and pelvic joints. Biological tests showed a moderate inflammatory syndrome; rheumatoid arthritis serology was negative. A diagnosis of rheumatoid polyarthritis was evoked but not confirmed. A treatment with Cortancyl and Plaquenil was initiated. Within an unspecified delay, the subject died (unknown reason). It was unknown whether an autopsy was performed. The foreign regulatory authority did not assess a causal relationship.


VAERS ID: 229624 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2004-07-26
Onset:2004-08-09
   Days after vaccination:14
Submitted: 2004-11-22
   Days after onset:105
Entered: 2004-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ecchymosis, Irritability
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant patient disease history.
Allergies:
Diagnostic Lab Data: Blood test results was normal.
CDC Split Type: 200403636

Write-up: It was reported through a foreign health authority that a 4 month old infant died on 8/9/04 after the injection IMOVAX POLIO (lot number not reported) and Infanrix (lot number not reported) performed on 7/26/04. One hour after vaccination irritation began and patient visited emergency room with severe ecchymosis. Ecchymosis showed on limbs, chest, and abdomen widely after several hours of vaccination. Blood test result was normal.


VAERS ID: 230016 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Foreign  
Vaccinated:2003-10-06
Onset:2003-10-12
   Days after vaccination:6
Submitted: 2004-12-03
   Days after onset:418
Entered: 2004-12-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Depressed level of consciousness, Drug ineffective, Pneumonia, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-12
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE636707OCT04

Write-up: Follow up information received provided the cause of death. Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 2 month old female patient who developed haemophilus influenzae associated with septicemia and acute bronchopneumonia. The patient received a dose on 10/6/03. The patient also received a dose of haemophilus influenzae type B vaccine, a dose of poliovirus vaccine live oral and a dose of diphtheria toxoid/hepatitis B surface antigen/acellular pertussis toxoid/tetanus toxoid vaccine on 10/6/03. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 10/6/03. Dose regimen was 1 dose. Concomitant medications were not reported. On 10/12/03, the patient could not be aroused from sleep. The infant died. The cause of death reported as haemophilus influenzae associated with septicemia and acute bronchopneumonia. The reporter considered the death possible related to vaccine administration.


VAERS ID: 231187 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2004-12-03
Onset:2004-12-09
   Days after vaccination:6
Submitted: 2004-12-15
   Days after onset:6
Entered: 2004-12-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57558C / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hyperpyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-10
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: ITWYE280814DEC04

Write-up: Information regarding Prevnar was received from a company representative regarding a 13 month old patient who experienced hyperpyrexia and vomiting. The patient received a dose on 12/03/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 12/3/04. Dose regimen was 1 dose 1 time per day (IM). Lot number A57558C corresponds to local lot number 11434. Additional suspect medication included Infanrix. Both Prevnar and Infanrix was administered at the same time on 12/3/04. Concomitant medications were not reported. The patient experienced hyperpyrexia and vomiting on 12/9/04 and was hospitalized. The following day the patient died. See related case ITWYE281314DEC04: the same vaccines were administered to patient''s twin. The twin showed the same clinical symptomatology and was hospitalized for a suspect encephalitis. No additional information was available at the time of this report.


VAERS ID: 231464 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-21
Entered: 2004-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Immunosuppression
Allergies:
Diagnostic Lab Data: Serum S. pneumoniae serotype 19F IgG Ab positive.
CDC Split Type: WAES0412AUS00095

Write-up: It was reported in a published article that a 75 year old immunocompromised patient was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, 1.9 years after the vaccination, the patient died of invasive pneumococcal disease. The pneumococcal serotype was vaccine serotype 19F. The authors regarded the patient''s invasive pneumococcal disease was a vaccine failure. The article also discussed five other elderly patient''s who died of invasive pneumococcal disease having previously been vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0412AUS00097, WAES0412AUS00098, WAES0412AUS00099, WAES0412AUS00100 and WAES0412AUS00101). Additional information is not expected.


VAERS ID: 231465 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-21
Entered: 2004-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: General symptom
Allergies:
Diagnostic Lab Data: Vaccine serotype not determined.
CDC Split Type: WAES0412AUS00097

Write-up: It was reported in a published article that an 84 year old patient with chronic disease was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, 3.9 years after the vaccination, the patient died of invasive pneumococcal disease. The pneumococcal serotype was not determined. The article also discussed five other elderly patient''s who died of invasive pneumococcal disease having previously been vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0412AUS00095, WAES0412AUS00098, WAES0412AUS00099, WAES0412AUS00100 and WAES0412AUS00101). Additional information is not expected.


VAERS ID: 231466 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-21
Entered: 2004-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: General symptom
Allergies:
Diagnostic Lab Data: Serum S. pneumoniae serotype 19F IgG Ab positive.
CDC Split Type: WAES0412AUS00098

Write-up: It was reported in a published article that an 88 year old patient with chronic disease was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, 4.1 years after the vaccination, the patient died of invasive pneumococcal disease. The pneumococcal serotype was vaccine serotype 19F. The authors regarded the patient''s invasive pneumococcal disease was a vaccine failure. The article also discussed five other elderly patient''s who died of invasive pneumococcal disease having previously been vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0412AUS00095, WAES0412AUS00097, WAES0412AUS00099, WAES0412AUS00100 and WAES0412AUS00101). Additional information is not expected.


VAERS ID: 231467 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-21
Entered: 2004-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: General symptom
Allergies:
Diagnostic Lab Data: Vaccine serotype 19A
CDC Split Type: WAES0412AUS00101

Write-up: It was reported in a published article that a 91 year old patient with chronic disease was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, 3.7 years after vaccination, the patient died of invasive pneumococcal disease. The pneumococcal serotype was vaccine serotype 19A. The authors regarded the patient''s invasive pneumococcal disease was a vaccine failure. The article also discussed five other elderly patients who died of invasive pneumococcal disease having previously been vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0412AUS00095, WAES0412AUS00097, WAES0412AUS00098, WAES0412AUS00099, and WAES0412AUS000100). Additional information is not expected.


VAERS ID: 231468 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-21
Entered: 2004-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: General symptom.
Allergies:
Diagnostic Lab Data: Serum S. pneumoniae serotype 14 IgG Ab positive.
CDC Split Type: WAES0412AUS00099

Write-up: It was reported in a published article that an 89 year old patient with chronic disease was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, 2.5 years after the vaccination, the patient died of invasive pneumococcal disease. The pneumococcal serotype was vaccine serotype 14. The authors regarded the patient''s invasive pneumococcal disease was a vaccine failure. The article also discussed five other elderly patient''s who died of invasive pneumococcal disease having previously been vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0412AUS00095, WAES0412AUS00097, WAES0412AUS00098, WAES0412AUS00100 and WAES0412AUS00101). Additional information is not expected.


VAERS ID: 231469 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-12-21
Entered: 2004-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Serum S. Pneumoniae serotype 23F IgG Ab positive.
CDC Split Type: WAES0412AUS00100

Write-up: It was reported in a published article that a 90 year old patient was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, 3.6 years after the vaccination, the patient died of invasive pneumococcal disease. The pneumococcal serotype was vaccine serotype 23F. The authors regarded the patient''s invasive pneumococcal disease was a vaccine failure. The article also discussed five other elderly patient''s who died of invasive pneumococcal 23v polysaccharide vaccine (WAES0412AUS00095, WAES0412AUS00097, WAES0412AUS00098, WAES0412AUS00099, and WAES0412AUS00101). Additional information is not expected.


VAERS ID: 231831 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-10-13
Onset:2004-10-26
   Days after vaccination:13
Submitted: 2004-12-24
   Days after onset:59
Entered: 2005-01-03
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Demyelination, Encephalitis, Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Hypersensitivity (broad), 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: 2004-11-22
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200404797

Write-up: It was reported that an 84 year old female patient was vaccinated with influenza vaccine on 10/13 or 10/14/2004. Soon after the vaccination the patient complained about diffusive pain in thigh, sudden confusion and redness. The patient was hospitalized on 10/26/04. The results of MR scanning showed diffusive changes in white matter of the brain and acute dessiminated demyelinized encephalomyelitis. Investigations of spinal fluid showed normal oligoclonal band. ANA and ANCA were negative. Herpes simplex and varicella zoster were excluded. The patient died on 11/22/04. Further information is required.


VAERS ID: 231902 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2004-12-24
Onset:2004-12-25
   Days after vaccination:1
Submitted: 2005-01-04
   Days after onset:10
Entered: 2005-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 14626D9 / UNK - / IM
RAB: RABIES (IMOVAX) / SANOFI PASTEUR X1187 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0362909A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a male child of unspecified age who had received diphtheria tetanus acellular pertussis injection for prophylaxis. Concurrent medications included rabies vaccine given on 12/24/04. On 12/24/04 this child received a dose of Infanrix (IM) at 0.5ml. It was reported that within 15 hours following vaccination, there had been no adverse event. On 12/25/04, the child was found dead. At the time of this report, the cause of death had not yet been determined, but an autopsy was planned. Additional information has been requested.


VAERS ID: 231966 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2004-12-24
Onset:2004-12-25
   Days after vaccination:1
Submitted: 2005-01-03
   Days after onset:9
Entered: 2005-01-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0263 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ventricular septal defect
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Ventricular Septal Defect
Allergies:
Diagnostic Lab Data: Echoencephalography and echocardiography were performed and ventricular septal defect was diagnosed.
CDC Split Type: 200404014

Write-up: It was reported through a health care professional that a 2 month old male pt dies one day after receiving the Imovax polio and Infanrix vaccines. Case''s history: After receiving Imovax Polio (lot X1187 or W0263) and Infanrix at 12 pm on 24 December, the infant was discovered dead by his mother in the morning on 25 December. Echoencephalography and echocardiography were performed and ventricular septal defect was diagnosed. An autopsy is scheduled. Medical assessment: In the present case, death occurred in a baby presenting with a congenital heart defect (ventricular septal defect). However, this case lacks information such as family history, medical circumstances in the previous days, autopsy results, to be fully assessed.


VAERS ID: 232301 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2000-11-02
Onset:2000-11-02
   Days after vaccination:0
Submitted: 2002-10-10
   Days after onset:706
Entered: 2005-01-14
   Days after submission:827
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / 2 - / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Hypoxia, Pulmonary fibrosis, Respiratory failure
SMQs:, Anaphylactic reaction (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisolone 10mg
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200100359

Write-up: An anonymised single pt print received on 05Nov01 regarding a 80 year old male pt who experienced aggravated pulmonary fibrosis (date not provided) after receiving influenza vaccine (brand unspecified) on 02Nov00.The pt had received Pneumovax II vaccine on the same day. The pt''s medical history included cryogenic pulmonary fibrosis which had been stable for 3 years and concomitant medication included prednisolone. After flu and Pneumovax injections, the pt experienced aggravated lung fibrosis with increasing shortness of breath on exertion and progressive cough. The pt''s oxygen saturation was 60% on exercise. Therapeutic measures taken as a result of the event included prednisolone increased from 10mg daily to 30mg daily. The pt died (date not specified) of respiratory failure with hypoxia


VAERS ID: 232422 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2004-12-21
Onset:2004-12-22
   Days after vaccination:1
Submitted: 2005-01-14
   Days after onset:23
Entered: 2005-01-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Hypotension, Hypothermia
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Accidents and injuries (broad), Tumour lysis syndrome (broad), Dehydration (broad), Hypokalaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: ESWYE337813JAN05

Write-up: Information regarding Prevnar was received from a healthcare professional via a regulatory authority regarding a 3 month old female patient who experienced hypothermia, hypotension, and acidosis and consequently died. The patient received the first dose on 12/21/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 12/21/04. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient experienced hypothermia, hypotension, and acidosis on 12/22/04 and was hospitalized. On 12/24/04 the patient died. The physician considered the events as possibly related to Prevnar. The cause of death was reported as hypotension, hypothermia, and acidosis. No additional information was available at the time of this report.


VAERS ID: 232506 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2004-12-01
Onset:2004-12-01
   Days after vaccination:0
Submitted: 2005-01-18
   Days after onset:48
Entered: 2005-01-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Meningitis, Muscle disorder, Pneumothorax, Pyrexia, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: On 12/21/04 test results were: bacteria fluid identified (results: Streptococcus pneumoniae found in bronchial and gastric fluid); CSF bacteria identified (results: Streptococcus pneumoniae found in CSF); blood culture (results: Positive for Streptococcus pneumoniae. Serotype to be determined.); and chest x-ray (results: revealed pneumothorax).
CDC Split Type: FRWYE327010JAN05

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 2 month old male patient who experienced unspecified muscular tonus disorder, pneumococcal meningitis, blood culture positive for Streptococcus pneumoniae, Streptococcus pneumoniae found in bronchial and gastric fluids, drug ineffective, and pneumothorax. The patient would have received the first dose in December 2004. Relevant medical history was not provided. Indication for Prevnar was immunization. Product would have been administered in December 2004 a few days before the events. Dose regimen was 1 dose 1 time per day. It was unknown if the patient was taking any concomitant medications. The patient experienced unspecified muscular tonus disorder and fever in December 2004, leading to emergency room visit on 12/20/04. Physical examinations was unremarkable. The patient was started on antipyretics. On 12/21/04 the patient was found dead in his bed. Resuscitation was unsuccessful. Post mortem investigations revealed Streptococcus pneumoniae in CSF reported as pneumococcal meningitis, in blood and in bronchial and gastric fluids. Chest x-ray showed pneumothorax. These events were considered fatal, except muscle disorder. However, it was noticed that pneumothorax could be due to resuscitation procedure. Pneumococcal serotype determination was ongoing. It was unknown if autopsy has been performed. No additional information was available at the time of this report.


VAERS ID: 232614 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2004-08-30
Submitted: 2005-01-21
   Days after onset:144
Entered: 2005-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 931 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Delirium, Dyskinesia, HIV infection, Muscle spasms, Pain, Phobia, Pruritus, Salivary hypersecretion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-09-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Suspicion of positive HIV; Attacked by a dog
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20050035

Write-up: A 19 year old girl was bitten on the left ankle by a an attacking dog on 04Jul04. There were 2 wounds of 2 centimeters wide and 3 millimeters depth; bone could be seen. She was vaccinated IM with Rabipur (batch no 931) on day 0,3,7,16, and 30 (exact dates not reported; no rabies immunoglobulin was given). The dog had been vaccinated with rabies in 2004 (no exact date known). The pt developed a pruritis and pain at site of bite, contracted and crimped fingers, pharyngeal spasms, hypersalivation, aerophobia, hydrophobia, hyperonea, delirium (rabies infection) on 30Aug04. The pt died on 01Sep04. HIV was suspected. Death, life threatening, medically significant (OMIC).


VAERS ID: 232762 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2005-01-20
Onset:2005-01-21
   Days after vaccination:1
Submitted: 2005-01-24
   Days after onset:3
Entered: 2005-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14A005BB / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-21
   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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0365199A

Write-up: This case was reported by a physician and described the occurrence of death in a 2 month old girl receiving diphtheria, tetanus and acellular pertussis, Infanrix injection for prophylaxis. On 1/20/05, at 11 AM, the patient received a dose of Infanrix (IM) at 0.5ml. The same day, at 7-8 PM, the girl was admitted at hospital, other than vaccinated hospital. On 1/21/05, the patient died, cause of death is unknown. Further information has been requested.


VAERS ID: 233065 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2004-12-29
Onset:2004-12-30
   Days after vaccination:1
Submitted: 2005-01-28
   Days after onset:29
Entered: 2005-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Aspiration, Cyanosis neonatal, Dysphagia
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hepatitis B immunoglobulin
Current Illness: UNK
Preexisting Conditions: At birth, APGAR score was at 10, subject''s weight was at 3144g, height was at 51cm, and head circumference was at 32cm. Normal pregnancy and full term delivery for the subject''s mother (second pregnancy and second delivery). Subject''s mother: chronic carrier of Streptococcus B and hepatitis B. Positive HBs antigen, negative HBe antigen, negative anti-HBs antibody and positive anti-HBe antibody.
Allergies:
Diagnostic Lab Data: Apgar score: 10
CDC Split Type: B0365421A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of cyanosis in a one day old female subject who was vaccinated with Engerix B at 20mcg for hepatitis B prophylaxis. At birth, APGAR score was at 10, subject''s weight was at 3144g, height was at 51cm, and head circumference was at 32cm. There was a normal pregnancy and a full term delivery (it was the second pregnancy and the second delivery for the subject''s mother). The subject''s mother was a chronic carrier of Streptococcus B and hepatitis B. The mother''s serologic status revealed positive HBs antigen, negative HBe antigen, negative anti-HBs antibody and positive anti-HBe antibody. Co-suspect medication included Immunoglobulin anti-hepatitis B for hepatitis B prophylaxis. The subject was born on 12/29/04. On 12/29/04, the subject received Immunoglobulin anti-hepatitis B (IM). On 12/29 or 12/30/04 (not otherwise specified), the subject received the first dose of Engerix B at 20mcg (IM). On 12/30, at 14:00, the mother breast fed the subject. At this time, the subject''s health status was good. Then the mother put her into bed. 30 minutes later, at 14:30, the subject was found cyanosed by her mother. The subject was dead. The physicians noticed that the subject''s mouth and throat were full of milk (deglutition trouble). It was mentioned that the death was very probable due to aspiration and that the contribution to Engerix B and Immunoglobulin anti-hepatitis B in the occurrence of the events was unlikely. It was not specified if an autopsy was performed. The agency considered the events as unlikely related to Engerix B and Immunoglobulin anti-hepatitis B$g


VAERS ID: 233493 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2005-01-28
Onset:2005-01-28
   Days after vaccination:0
Submitted: 2005-01-28
   Days after onset:0
Entered: 2005-02-08
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: FRWYE395202FEB05

Write-up: Information regarding Prevnar was received from a healthcare professional via a foreign regulatory authority regarding a 2 month old male patient who experienced death. The patient received the first dose on 1/28/05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 1/28/05. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Pentavac. Concomitant medications were not reported. The patient was admitted to ICU on 1/28/05 where he was diagnosed dead. The cause of death was unknown. An autopsy was planned. No additional information was available at the time of this report.


VAERS ID: 233604 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-02-09
Entered: 2005-02-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE081703FEB05

Write-up: Additional information provided the coroner''s evaluation. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2 month old pt who experienced a SIDS like death. The pt received Prevnar and Pentacel vaccines (date not specified). Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Pentacel (diphtheria vaccine/haemophilus influenzae b/acellular pertussis vaccine/ poliomyelitis vaccine inactivated/tetanus vaccine). Concomitant medications were not reported. The pt experienced a SIDS-like (sudden infant death syndrome) in Jan05. The reporter stated that the infant died within 1 to 2 weeks post immunization. The cause of death was reported as "SIDS-like" Per the coroner''s evaluation "it was determined that the vaccines had nothing to do with the death of child". The reporter indicated that another infant experienced death. The reporter indicated that no additional information was available at the time of this report. Related cases: HQWYE081403Feb05 (serious, expedited) and HQWYE076303Feb05 (serious, expedited).


VAERS ID: 233605 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-02-09
Entered: 2005-02-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE081403FEB05

Write-up: Additional information provided the coroner''s evaluation. Information regarding Prevnar was received from a healthcare professional regarding a 2 month old patient who died. The patient received the first dose of Prevnar, along with Pentacel vaccines within three weeks prior to death. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Pentacel. Concomitant medications were not reported. The patient experienced death in January 2005. The reporter stated that the infant died with three weeks post immunization. Per the coroner''s evaluation it was determined that the vaccines had nothing to do with the death of child. No additional information was available at the time of this report. The reporter indicated that more than 1 child experienced this event.


VAERS ID: 233606 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-02-09
Entered: 2005-02-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (DTP + ACTHIB) / SANOFI PASTEUR - / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE076303FEB05

Write-up: Additional information provided the coroner''s evaluation. Information regarding Prevnar was received from a healthcare professional regarding a 2 month old patient who experienced a SIDS-like death. The patient received vaccines within one to two weeks prior to death. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Pentacel. Concomitant medications were not reported. The patient experienced a SIDS-like in January 2005. The reporter stated that the infant died within 1 to 2 weeks post immunization. The cause of death was reported as SIDS-like. Per the coroner''s evaluation, it was determined that the vaccines had nothing to do with the death of child. The reporter indicated that more than 1 child experienced this event. The reporter indicated that no lot number was available; however, the infants received Prevnar from different lot numbers. No additional information was available at the time of this report.


VAERS ID: 234675 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-07
Entered: 2005-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood creatinine increased, CSF test abnormal, Delirium, Guillain-Barre syndrome, Heart rate increased, Hypertension, Hyporeflexia, Hypotonia, Hypoxia, Laboratory test abnormal, Malaise, Muscular weakness, Pain, Paralysis, Pneumonia, Pyrexia, Respiratory disorder, Sepsis, Shock, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Hemodialysis; Folic acid; Atorvastatin calcium; Lercanidipine; Calcium Salt
Current Illness: UNK
Preexisting Conditions: Barrett''s Disease Esophagus; Chronic Renal Failure; Polycystic Kidney Disease
Allergies:
Diagnostic Lab Data: Antinuclear antibody: borderline; Blood pressure 140/90mmHg; Body temperature 37.9 degrees C; CAT scan: kidney cysts; CSF: no cells; CSF protein: 0.83g/l; Chemistry normal; Clostridium difficile toxin not detected; Complement factor C3: 1.1g/l; Complement factor C4: 0.42g/l; Creatinine 529mmol/l; Cytomegalovirus antibody negative; Differential white blood cell normal; Double stranded DNA antibody negative; Epstein Barr virus antibody negative; ESR: 60mm/h; Heart rate: 120min; Hemoglobin 12.2g/dl; Hepatitis B surface antibody 105IU/l; Muscle enzymes normal; Platelet count normal; Respiratory rate 20min; Stool culture negative; Urea 12.6mmol/l; White blood cells 9000mm3; White blood cells stool: no cells.
CDC Split Type: B0373544A

Write-up: This case was reported in a literature article and described the occurrence of Guillain [[name]]e Syndrome in a 52 year old female subject who had received Hep B vaccine (Engerix B) injection for prophylaxis. The pt''s past medical history included [[name]]ett''s disease esophagus, chronic renal failure and polycystic kidney disease. Concurrent medications included Hemodialysis, Folic acid, Atorvastatin, Larcanidipine and Calcium. She had also been treated with Helicobacter pylori for [[name]]ett''s esophagus one year earlier. Approx 10 [[name]] after receiving the 2nd dose of Hep B vaccine, this subject developed abdominal pain as well as progressive muscle weakness and limb tenderness particularly in her legs. Two [[name]] later, she was admitted to hospital. She denied any infections in the previous ten [[name]]. She had been tested for the level of hep B surface antibody which was 105 IU/ml 3 [[name]] after vaccination. On admission, her temp was 37.9 deg C, blood pressure 140/90 mmHg, pulse 120/min and resp rate 20/min. She appeared ill. She presented no rash, lymphadenopathy or icterus. An ear, nose and throat examination was interpreted as normal. Heart and breathing sounds were normal. An abdominal examination disclosed diffuse sensitivity without hepatosplenomegaly. Pelvic examination revealed no abnormalities. The arms and legs were unremarkable. There was no neck rigidity and the cranial nerve examination was interpreted as normal. The limbs showed a generalized hypotonia with grade 2-3/5 power in most muscle groups in the arms and 1.2/5 in most muscle groups in the legs. Normal sensation to light touch and pain was found. Biceps and triceps reflexes were diminished with absent knee and ankle reflexes. All the muscle groups were tender. The white blood cell count was 9000/mm3 with a normal differential count. Hemoglobin, platelets and biochemistry were within normal ranges except for creatinine with 529 mmol/l and urea 12.6 mmol/l. Muscle enzyme essays were normal and excluded myopathy. The cerebrospinal fluid was acellular with elevated total protein (0.83g/l) compatible with the diagnosis of Guillain [[name]]e Syndrome. Stool culture for Salmonella, Shigella and Campylobacter as well as serologies for cytomegalovirus, Epstein [[name]] virus and [[name]] Nile fever were all negative. An abdominal and pelvic computed tomography scan revealed renal and liver cysts (non events) compatible with polycystic kidney disease. One day after admission, her legs were sore and she was confined to bed. The pt was treated with 2 courses of 5 days each of normal immunoglobulin. Four days after admission, the weakness progressed and a neurological examination revealed symmetrical areflexic paralysis in the four limbs. Her respiratory function deteriorated and she was mechanically ventilated. Electromyogram and nerve conduction test were not performed because of her deteriorating condition. Seven [[name]] later, there was only minor improvement in the cranial nerves and mechanical ventilation was continued via tracheotomy, a[[name]] with hemodialysis and supportive therapy. Five months after admission, acinobacter pneumonia developed followed by septic shock and she died. A neuro-pathologic examination revealed an inflammation cell infiltrate in the [[name]] matter especially in the anterior [[name]] of the spinal cord, and [[name]] foci of macrophages in the [[name]] tracts. Most of the cells appeared around blood vessels, but there were also found in the parenchyma, close to nerve cells. This report was received from the literature. No further information is available.


VAERS ID: 235376 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-22
Entered: 2005-03-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Meningitis
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: FRWYE509216MAR05

Write-up: Information regarding Prevenar was received from a HCP regarding a pt who experienced pneumococcal meningitis and drug ineffective. The pt received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Prevenar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The pt experienced pneumococcal meningitis. The pt was hospitalized and died from pneumococcal meningitis. Pneumococcal serotype was not known. No additional information was available at the time of this report.


VAERS ID: 235417 (history)  
Form: Version 1.0  
Age: 0.65  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-22
Onset:2005-03-23
   Days after vaccination:1
Submitted: 2005-03-25
   Days after onset:2
Entered: 2005-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA077A / UNK LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA077A / UNK LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA077A / UNK LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0046229A

Write-up: A physician reported via a sales representative the occurrence of sudden death in an 8 month old male subject who was vaccinated with a diphtheria-tetanus-pertussis(a)-poliomyelitis/haemophilus influenzae B vaccine for prophylaxis. Two previous vaccinations with diphtheria-tetanus-pertussis(a)-poliomyelitis/haemophilus influenzae B vaccine were well tolerated. On 3/22/05 at 10 in the morning, the subject received the third dose of diphtheria-tetanus-pertussis(a)-poliomyelitis/haemophilus influenzae B vaccine, injected IM into the left thigh. The following day, on 3/23/05, at 7 in the morning the subject was found dead. The neighbors had heard the child crying before, but the mother, who was sleeping in an adjacent room, had not. When found dead, the subject was lying beneath the bed cover. Death occurred approximately 21 hours after vaccination with diphtheria-tetanus-pertussis(a)-poliomyelitis/haemophilus influenzae B vaccine. The reporting physician didn''t assess a relationship between the event and vaccination with diphtheria-tetanus-pertussis(a)-poliomyelitis/haemophilus influenzae B vaccine. He stated that the cause of death following the vaccination was unknown.


VAERS ID: 235799 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-03
Onset:2005-03-03
   Days after vaccination:0
Submitted: 2005-04-05
   Days after onset:32
Entered: 2005-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3468A2 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Asthma
Preexisting Conditions: Persistent hyperplasia of thymus; Possible congential heart disease.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0375886A

Write-up: This case was reported by a research institute for standardization and control of medicinal and immunobiological products and described the occurrence of a fatal bilateral pneumonia in a 1 month old male subject who received hepatitis B vaccine injection for prophylaxis. The patient''s past medical history included persistent hyperplasia of thymus and possible congenital heart disease. Concurrent medications included an unknown medication used to treat asthma. The first dose of Engerix B vaccine given on 1/23/05 was well tolerated. On 3/3/05 in the morning, the boy received the second dose of Engerix B. The same day, in the evening, the subject was hospitalized. A diagnosis of bilateral pneumonia, acute respiratory failure, multiple organ failure and intranatal infection was made. The subject died on 3/4/05. At the time of the this report, the cause of death was unknown. An autopsy was performed, but as of 3/9/05, the autopsy report was not available. Further information has been requested.


VAERS ID: 236265 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-01
Onset:2005-03-02
   Days after vaccination:1
Submitted: 2005-04-18
   Days after onset:46
Entered: 2005-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AZOCA061B / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS AZOCA061B / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER AZOCA061B / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Epilepsy, Laboratory test abnormal, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-03
   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: Paracetamol; Clobazam; Valproic acid; Stiripentol
Current Illness: UNK
Preexisting Conditions: Asthma; Myoclonic epilepsy
Allergies:
Diagnostic Lab Data: Adenovirus serology negative; Autopsy: no lesion; Chlamydia serology negative; Cytomegalovirus serology negative; Epstein Barr virus serology negative; Herpes simplex serology negative; Influenza serology negative; Mycoplasma serology negative; RSV negative; Rotavirus test negative; Scan brain normal; Spinal fluid culture negative; Stool culture negative; Virus NOS blood no organisms negative; In March 2005: Nasopharyngeal culture: negative; Lung ultrasound: no hemorrhage; Varicella virus serology: negative.
CDC Split Type: B0377627A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of sudden death during sleeping in a 23 month old male subject who was vaccinated with Infanrix Quinta for diphtheria, tetanus, pertussis, poliomyelitis, and haemophilus influenzae B prophylaxis. Concomitant medical conditions included myoclonic epilepsy (Dravet''s Syndrome) and asthma. Co-suspect drugs included paracetamol, clobazam, valproic acid and stiripentol. On 10/1/03, a treatment with valproic acid, at a daily dose of 275mg, for myoclonic epilepsy was initiated. On 11/1/03, a treatment with Urbanyl, at a daily dose of 10mg, for myoclonic epilepsy was initiated. On 2/1/04, a treatment with stiripentol, at a daily dose of 575mg, for myoclonic epilepsy was initiated. On 3/1/05, at 15:00 PM, the subject took paracetamol orally for fever prophylaxis. One hour later, he received an injection of Infanrix Quinta (batch reference: AZOCA061B), in IM. On the same time, he took a second dose of Doliprane, orally for fever prophylaxis. The day after the vaccination, on 3/2/05, he developed a fever syndrome with a body temperature at 38 degrees C in the morning and at 37.9 during the afternoon. In the afternoon of 3/2/05, the subject presented with asthenia and somnolence. At 20:00, he received a third dose of Doliprane. On 3/3/05, at 0:00, the mother saw the baby and he was well. On 3/3/05, between 04:00 to 05:00, the subject died. An autopsy was performed and revealed no lesion relating to the death. Several investigations were performed and were negative: Blood serology, spinal fluid culture, nasopharyngeal culture and stools culture were negative. Brain scan revealed no hemorrhage and no abnormality. Pulmonary ultrasound was normal without inhalation sign. Valproate sodium dosage was at 64mcg/ml. Antimycoplasm and antichlamydia serologies were negative. Viral serologies (influenza, RSV, rotavirus, adenovirus, astrovirus, Epstein Barr virus, Herpes, Cytomegalovirus and varicella) were negative. According to the reporter, the events were dubiously related with Infanrix Quinta vaccine and with co-suspect drugs.


VAERS ID: 236384 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-04-18
Entered: 2005-04-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Arthralgia, Cardiovascular disorder, Cyanosis, Injection site fibrosis, Laboratory test abnormal, Musculoskeletal stiffness, Myalgia, Necrosis, Polyarteritis nodosa, Skin ulcer, Vaccine positive rechallenge, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Interstitial lung disease (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Ventricular fibrillation; Myocardial infarction
Allergies:
Diagnostic Lab Data: Arteriography: arterial occlusion of upper limbs; stenosis of digital arteries. Diagnostic lab test: serum immune complexes slightly elevated, latex fixation test weakly positive, skin biopsy medium sized vessels with concentric fibrosis of muscle wall accompanied by infiltrating inflammator, slightly raised concentrations of immune complexes, skin biopsy polyarteritis nodosa. CSF AGP negative, serum ANA 1:40, serum ANA weakly positive (anti DNA and anti ENA antibodies absent, serum ANCA homogenous 1:64, serum ANCA fluorescence (confirmed by anti proteinase 3 ELISA) positive, serum C-reactive protein elevated 2.3mg, serum hep B core IgG and IgM Ab negative, serum hep B core IgM ab test negative, serum hep B surface ab negative, serum hep B surface Ab negative, serum hep B surface antigen test negative, direct antiglobulin test positive, serum hep B surface antigen test negative, erythrocyte sedimentation rate elevated 31mm/hr.
CDC Split Type: WAES97110879

Write-up: It has been reported in a published article, and a literature article authored by an agency, titled as stated above, that a 45 year old male pt with a history of ventricular fibrillation at the age of 41 (probably related to a limited cardiac infarction) was vaccinated with the second dose (also reported as the first dose) of hep B vaccine recombinant (manf unk). Subsequently, he developed polyarthralgia. Shortly after, the pt developed an ulcer on the left lower limb, together with sharply delineated necrosis of the distal phalanx (right hand) and ischemic discoloration of the distal second and third digit of the left hand. It was reported that 2.1 weeks post vaccination, the pt developed myalgia, arthralgia, morning stiffness, a leg ulcer, and digital ischemia. ANCA was 1:64 (homogenous), ANA was 1:40, and serum immune complexes were slightly elevated. A skin biopsy revealed medium sized vessels with concentric fibrosis of the muscle wall accomanied by infiltrating inflammatory cells. A humeral artery angiogram showed vasculitis. Diagnostic studies included an arteriography of the upper limbs which revealed arterial occlusion and filiform stenosis of digital arteries, compatible with vasculitis. Two months after the last dose, anti HBs, HBsAg, and anti HBc were negative. The pt was hospitalized and out of work for 6 months. The pt was then diagnosed with polyarteritis nodosa and received systemic treatment with high dose cortisone. Subsequently, the pt''s left hand lesions healed, but the distal phalanx of the right hand needed surgical amputation. Three years afterwards, the pt was still symptomatic. Follow up information received from a literature article indicated that the pt was vaccinated with 2 doses of hep B virus vaccine rHBsAg (yeast) (Engerix B) (lot number, site, and date of administration not reported). The pt was not taking regular medication at that time. Two weeks after the first vaccination (date not reported), the pt experienced myalgia, arthralgia, and morning stiffness. The second dose of hep B virus vaccine rHBsAg (yeast) (Engerix B) was administered one month after the first one. Following this injection (date and latency not reported), the pt suffered from an increase in myalgia and arthralgia. He also developed an ulcer of the left lower limb together with sharply delineated necrosis of the distal phalanx of the right hand (second digit) and distal ischemic discoloration at the second and third digits of the left hand. The pt received systemic treatment with high dose cortisone that lasted for one year. This resulted in healing of the lesions of the left hand. The distal phalanx of the right hand needed surgical amputation 7 months after the initial presentation of necrosis. It was noted that the pt died (date unk) of a cardiovascular cause. Blood tests after the second vaccination included: elevated sedimentation rate= 31mm/hr; elevated CRP= 2.3mg%; direct Coombs test positive; ANCA fluorescence (confirmed by anti proteinase 3 ELISA) positive; Waaler Rose test negative; latex fixation test weakly positive; antinuclear factor weakly positive (anti DNA and anti ENA antibodies absent; and slightly raised concentration of immune complexes. Hep B serology: HBsAg negative; anti HBs and anti HBc antibodies negative. Skin biopsy in the immediate vicinity of the left lower limb ulcer polyarteritis nodosa. Upon internal review, the events were considered to be disabling and other important medical events. No more information was to be obtained. The case is closed. The authors also noted 8 other pt that developed polyarteritis nodosa following vaccination with hep B virus vaccine rHBsAg (yeast) (manf unk) (WAES95121215, WAES97120897, WAES0411USA02601, WAES0411USA02602, WAES0411USA02603, WAES0411USA02605, WAES0411USA02608, and WAES0411USA02609). One article also mentioned an additional pt who had a similar experience (WAES97120898). Follow up information indicated that the pt was being treated with hep B virus vaccine rHBsAg (yeast) (Engerix B) and not hep b vaccine recombinant as previously reported. Therefore, WAES97120897, is being deleted from our files on hep b vaccine recombinant. Copies of the published articles are attached as further documentation of the pt''s experience.


VAERS ID: 236425 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-07
Onset:2005-03-08
   Days after vaccination:1
Submitted: 2005-04-21
   Days after onset:43
Entered: 2005-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cyanosis, Diarrhoea, Hypertonia, Hypothermia, Hypotonia, Laboratory test abnormal, Stupor, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (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), Pseudomembranous colitis (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-22
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Labetalol hydrochloride
Current Illness: drug exposure via breast milk
Preexisting Conditions: drug exposure in utero
Allergies:
Diagnostic Lab Data: Alanine aminotranseranse 112IU/l 8 35, Aspartate aminotransferase 555 IU/l 20 60, Blood Calcium 2.89mmol/l, Blood Glucose 41.6 mmol/l, Blood Phosphorus 4.91mmol/l, Body temperature 35.8 Celsius Degrees, Body temperature 33 Celsius Degrees, C-reactive protein <5mg/l, Co2 total abnormal 7mmol/l, CSF culture Sterile, Cerebrospinal fluid glucose 4mmol/, Cerebrospinal protein 0.86 g/l, Chloride 100mmol/l, Coagulation faction IT level 50%, Coagulation factor V level 46%, Coagulation Faction VII level 71%, Coagulation Factor X level, 47%, Creatinine Kinase 1195IU/l 50 200, Creatinine 57mcmol/l, Eosinophils 0/mm3, Fibrin 0.18g/l, Hematocrit 30.7%, Hemoglobin 9.9g/dl, Kaolin cephalic clotting time 3.83, LDH 1077IU/l, Mean cell volume 91.4 mc3, Monocytes, 864/mm3, Neutrophils 1872/mm3, Platelet count 340000/mm3, Potassium 14mmol/l Protein 53g/l Prothrombin ration 16%, Sodium 3.36x 10 3/mm3, Ultrasound chest normal, ultrasound skull, normal, urea 2.5mml/l, WBC count 14400/mm3, X ray of whole skeleton normal. Abdominal imaging: presence of gas the ileum, no other abnormalities.
CDC Split Type: B0376037B

Write-up: This case was initially reported by a pharmacist then by a physician and described the occurrence of sudden infant death in a 10 week old male neonate subject who was vaccinated with Infanrix Quinta for diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenza type b prophylaxis. Approximately at the end of the pregnancy, the mother received labetalol hydrochloride (trandate) for pre-eclampsia ( drug exposure in utero). On 12/27/2004, at full term delivery, the mother gave birth by a normal vaginal delivery to a male neonate. At the delivery, weight and height were normal and APGAR was at 4-9-10. After the delivery, Trandate was discontinued. From 12/27/2004, the mother breast fed. The neonate was exclusively fed with mother''s milk and did not experience any event. On 03/07/2005, the mother''s condition required reintroduction on Trandate at at daily dose of 100mg while breast feeding (drug exposure via breast milk). From that same day, according to the mother, the neonate presented with liquid stools at a frequency of two stools per day. The outcome of the stools was unspecified. On 03/08/2005, the subject received an injection of Infanrix Quinta which was well tolerated. On 03/22/2005, at 9:45 a.m., the father gave him a bottle of mother''s milk which he drank normally, rather quickly, and after the usual aructatuion, laid him on the parents'' bed in ventral decubitus. The child was put to be in lateral decubitus but sometimes ended up in ventral decubitus. The parents'' bed , on which the child was lying, is covered with a rather thin duvet. There were no pillow close to the child. At exactly 10:13 AM, the father saw his child and did not notice anything abnormal or special. Between 10:30 and 10:45, the mother, upon picking up her child who seemed to be asleep in ventral decubitus, then noticed that he was completely inert and unreactive to stimulation on her part. The complexion was pink, neither pale nor cyanotic, there was no trace of vomiting or regurgitation on the bed or on the clothing. The skin temperature was warm, normal. She immediately performed mouth to mouth insufflation, which however immediately resulted in a burst of milk from the nose, While continuing mouth to mouth insufflation, she attempted cardiac massage and called the SMUR (emergency ambulance service). When the Adult SMUR arrived at an unspecified hour, the child was asystolic, resuscitation was begun by intubation and a intra tracheal injection of adrenalin. The Pediatric SMUR arrived at 11:15 am. There was no cardiac recovery and the resuscitation manoevers were discontinued. Body temperature was at 35.9 degrees Celius. The body was then transferred to the hospital. At the admission at 11:55 AM, central temperature was at 33 degrees Celcius degrees. The subject presented with livid complexion, cyanosis of the lips and extremeties, general hypotonia without cadaveric rigidity and healthly teguments. Abdomen was normal, not distended without hepatoslplenomegaley, nor bladder distention. Testicles were in place. Skeleton was clinically normal and oral cavity was unremarkable. Chest x-ray, frontal and lateral views was normal. Skeletal x ray was normal. It was noticed that the superior femoral ossification centeres wer already visible. Blood chemistry (intra cardiac blood sample taken post mortem) was performed. Blood electrolytes gave a blood sugar level at 41.8mmol/l., Urea at 2.5mmol/l: Creatinine at 57 ? mol/l: Na:137mmol/l: K 14mmol/l. Cl:100mmol/l: Total Co2 7mmol/l, Protein;53 g/l Blood Calcium 2.89 mmol/l, Blood phosphorus: 4.91mmol/l. Tansaminase level gave TGO st 555 IU/l (n 20-5-): TGP at 223 IU/l (n 3-35): LDH at 1077 IU/l (n 290-460) and Creatinine Kinase at 1195 IU/l(n50-200). Complete Blood cell count revelaed a red blood cell count at 3.360.00/ mm3, Hemoglobin at 9.9 g/l: Hematocrit at 30.73/4%. Mean core cell volume at 91.4 ? 3; WBC count at 14,400 um3, neutrophila at 1872/ mm3: eosinophils at 0/mm3: lymphoctyes at 11520/mm3: monocytes at 864/ mm3 and platelets at 340,000/ mm3. Coagulation testes evidenced at Prothrombin time (PT) at 16: Coagulation factor IT mt 501/2, Factor v at 46%, Factor VII at 71%, Factor X at 47%, Kaolin cephalin clotting time at 126/33 (-3.83) and Fibrin at 0.18g/l.Cerebrospinal fluid examination gave a clear aspect with a protien level at 0.86 g/l glucose at 4.00 mcl/l: direct microscopic examnation and cytology not done; culture was sterile. Microbiology tests with blood cultures were perfromed and results were pending. An autopsy was proposed to but was refused the next day. All in all, the conclusion is sudden infant unexplained infant death. The physicians assessment between the events and the Infanrix Quinta vaccine was unspecified according to the physician, the events were dubiously related with trandate.


VAERS ID: 236531 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2005-03-15
Onset:2005-03-19
   Days after vaccination:4
Submitted: 2005-04-22
   Days after onset:33
Entered: 2005-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Dyspnoea, Gastrooesophageal reflux disease, Hypothermia, Hypotonia, Restlessness, Sepsis, Vomiting, White blood cell count increased, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-26
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: WBC 16120mm3
CDC Split Type: B0377859A

Write-up: This case was reported by a physician and described the occurrence of a fatal septicemia in an approximately 10 week old female subject who received Infanrix-polio-HIB injection for prophylaxis. There was no previous vaccination and no concurrent medication. The subject had no relevant medical history. On 15 March 2005, the subject received Infanrix-polio-HIB. On 18 March 2005, three days later, the subject developed hypothermia, hypotonia, anorexia, vomiting and restlessness. On 20 March 2005, the subject went to a private hospital emergency department where a diagnosis of gastroesophageal reflux was made. A treatment with cilitron (Domperidone) and ranitidine hydrochloride (Ranitidine) was given. WBC count was 16120 mm3. The subject went home and the symptoms worsened, with dyspnea appearing. On 26 March 2005, the subject went again to the same ER. The subject died one hour after arrival at the hospital. Post mortem examination revealed signs of septicemia. Further information has been requested.


VAERS ID: 236741 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2005-04-15
Onset:2005-04-16
   Days after vaccination:1
Submitted: 2005-04-28
   Days after onset:12
Entered: 2005-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy pending.
CDC Split Type: B0378717A

Write-up: This case was reported by a pediatrician and described the occurrence of a sudden infant death in a 57 day old male subject who received diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, haemophilus influenzae type B injection for prophylaxis. The subject was previously healthy. On 4/15/05 the boy received the first dose of Infanrix-Polio-HIB (IM). On 4/16/05, one day following vaccination, the subject''s mother found him dead. The subject was transferred to hospital where death was confirmed. On 4/18, an autopsy was performed. The cause of death was unknown, histology results were pending. The reporting physician considered the event was unrelated to vaccination with Infanrix-Polio-HIB. Further information has been requested.


VAERS ID: 237134 (history)  
Form: Version 1.0  
Age: 0.41  
Sex: Male  
Location: Foreign  
Vaccinated:2005-02-28
Onset:2005-03-06
   Days after vaccination:6
Submitted: 2005-05-05
   Days after onset:59
Entered: 2005-05-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Apnoea, Bacterial infection, Cardiac arrest, Crying, Depressed level of consciousness, Drug ineffective, Ear disorder, Hypoxia, Laboratory test abnormal, Meningitis, Mydriasis, Pyrexia, Respiratory arrest, Screaming, Sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-09
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Vesicoureteric reflux
Allergies:
Diagnostic Lab Data: On 3/6/05 test results were: thermometry abnormal (results: 38.6 degrees C); bacteria urine no organism observed (results: normal); culture stool (results: negative); chest x-ray (results: normal); and physical examination (results: normal). CSF culture positive (results: positive for S. pneumoniae) was done on 3/9/05. Culture (results: positive for pneumococcus) was done in April 2005. Thermometry abnormal (results: 39.2 degrees C) was done on 4/6/05. Physical examination normal (results: normal) and blood pressure normal (results: normal) were done on 4/8/05. Physical examination abnormal (results: bad condition with abnormal pupils (with mydriasis and no reaction) was done on 4/9/05. The autopsy cause of death was meningitis pneumococcal.
CDC Split Type: ESWYE613825APR05

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an investigator regarding a 5 and a half month old male participant in a study. Three years after the Prevnar launch, who experienced pneumococcal meningitis and drug ineffective. The participant received the first dose on an unspecified date. The pt has a past history of vesicoureteric reflux. Past therapies included Hep B vaccine, DPT (diphtheria and tetanus toxoids and pertussis), Poliomyelitis vaccine inactivated, Haemophilus Influenzae B, Meningococcal vaccine (meningococcal polysaccharide) and Furantoina (nitrofurantoin). Prenatal diagnosis of renal pelvis dilatation. Indication for Prevnar was immunization. Product was administered on 28Feb05. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The pt experienced pneumococcal meningitis and drug ineffective and died on 09Apr05. The pt came for the first time to the ER on 06Mar05 crying. He had no fever before and no other symptoms but soft stool. The pt had in the ER a rectal temp of 38.6C. He had normal labstix test. An urine culture was performed. A stool culture was negative. The thorax x-ray were normal. He was discharged the same day (06Mar05) but he was brought again crying. He had no fever and the physical examination was normal but he had the right ear a bit congestionated. On 08Apr05 the pt came again with fever since 06Apr06 (axilar temp of 39.2C). He had no other symptomatology. He had normal physical examination and a normal blood pressure. The physicians consulted the urine culture and stool culture made before but they were negative so the pt was discharged. Early in the morning of day 09Apr05, 15 hours later of the discharge, the parents came with the child who had been irritable, had food aversion, fever for three days and consciousness level alterated. The pt had cardiorespiratory arrest with an abnormal physical examination and abnormal pupils (with mydriasis and no reaction). After 30 minutes of cardiopulmonary resuscitation, the heart did not beat and the pt died. The autopsy stated that the pt died due to a purulent meningitis and it was seen that the CSF culture was positive for s. pneumoniae. Serotype results are pending. On 06Mar05 test results were: thermometry abnormal (results: 38.6C); bacteria urine organism observed (results: normal); culture stool negative; chest x-ray normal; and physical examination normal. CSF culture positive for S pneumoniae was done on 09Mar05. Culture (positive for pneumococcus) was done in Apr2005. Thermometry abnormal (39.2C) was done on 06apr05. Physical examination normal and blood pressure normal were done on 08Apr05. Physical examination abnormal (bad condition with abnormal pupils (with mydriasis and no reaction) was done on 09Apr05. The autopsy cause of death was meningitis pneumococcal. The assessments of the investigator and medical monitor for meningitis pneumococcal and drug ineffective were unk. No additional information was available at the time of this report.


VAERS ID: 237190 (history)  
Form: Version 1.0  
Age: 0.66  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-22
Onset:2005-03-25
   Days after vaccination:3
Submitted: 2005-05-10
   Days after onset:45
Entered: 2005-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA025A / UNK - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR A20CA025A / UNK - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A20CA025A / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Irritability, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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)

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: Arterial channel opening, Asthma, bronchiolitis, Trisomy 2A
Current Illness:
Preexisting Conditions: March 2005 Cardiac echography: diameter of channel: 3 mm
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0379883A

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 8 month old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrixquinta) for prophylaxis. Concurrent medical conditions included arterial channel opening, asthma, bronchiolitis and trisomy 21. The subject didn''t have any chronic treatment. The subject had a twin sibling. Previous and/or concurrent vaccination included combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix) given on 14Sep04 and 28Dec04 (injections delayed due to multiple hospital admissions). On 22Mar05 the subject received 3rd dose of Infanrixquinta (IM). On the night following the injection, the subject experienced 38C fever which was treated with Paracetamol (Doliprane). During the two following days, the subject was grumpy and got reduced appetite. On 25Mar05, 3 days after vaccination with Infanrixquinta, the subject was found dead in his bed at 9:00AM. The position of bedtime and the time of death''s discovery were unk. The hypothesis of drug origin was evoked but the non-drug causes were not excluded. The cause of death was not specified. An autopsy was not performed. Sudden death was assessed as unlikely related to vaccine.


VAERS ID: 237389 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-10-01
Onset:2005-04-01
   Days after vaccination:182
Submitted: 2005-05-10
   Days after onset:38
Entered: 2005-05-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Sepsis
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0505USA00454

Write-up: Information has been received from a pharmacist concerning a 50 year old female pt with a history of splenectomy who in approx Oct 2004 (date unspecified), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). The pt was hospitalized on an unspecified date. The pt died of pneumococcal sepsis in April 2005 (date unspecified). The treating physician evoked vaccine failure. Further information is expected. Other business partner numbers include E200501692.


VAERS ID: 237437 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-05-12
Entered: 2005-05-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0505USA00868

Write-up: Information has been received from a published literature article concerning a female ( age not provided) who on an unspecified date was vaccinated with PNEUMOVAX 23 vaccine. Following vaccination, the pt died (details regarding the cause of death are unknown). The literature article also described a case of a male pt who developed renal failure following vaccination with PNEUMOVAX 23 vaccine (ref WAES # 0505USA00823). Additional information has been requested. A copy of the un-translated article is attached for further documentation of the pt''s experience. A copy of the translated article will be forwarded when received.


VAERS ID: 237438 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-05-12
Entered: 2005-05-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0505USA00823

Write-up: Information has been received from a published article concerning a male (age not provided) who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine. Following vaccination, the pt developed renal failure. At the time of this report, the outcome of the event was unk. Upon internal review, the renal failure was considered to be an other important medical event. The literature article also described a case of a female pt who died after vaccination with pneumococcal 23v polysaccharide vaccine (ref WAES0505USA00868). Additional information has been requested. A copy of the untranslated article is attached for further documentation of the pt''s experience. A copy of the translated article will be forwarded when received.


VAERS ID: 237644 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-06-06
Onset:0000-00-00
Submitted: 2005-05-17
Entered: 2005-05-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Cardiac arrest, Drug ineffective, Laboratory test abnormal, Sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Blood culture: blood culture and lung swab isolated strep pneumoniae serotype 3 pathogens.
CDC Split Type: WAES0505AUS00093

Write-up: Information was obtained on request by the company from the agency via a public case form. The pt was a 50 year old female who on 06Jun04 was vaccinated with pneumococcal 23v polysaccharide vaccine, 1 dose, 1 time as a prophylactic vaccination. Subsequently the pt experienced bronchitis pneumococcal, pneumococcal sepsis, sepsis and vaccination failure which caused or prolonged with septicemia and subsequently had cardiac arrest and died on 19Jan05. A blood culture and lung swab isolated strep pneumoniae serotype 3 pathogens. The vaccination failure. The agency felt that the outcome of death, may be drug related and assessed that the bronchitis pneumococcal, pneumococcal sepsis, sepsis and vaccination failure were possibly related to therapy with pneumococcal 23v polysaccharide vaccine. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 237787 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2005-03-31
Onset:2005-04-02
   Days after vaccination:2
Submitted: 2005-04-13
   Days after onset:10
Entered: 2005-05-23
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 616A2 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0070N / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1582 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494033 / 2 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Aspiration, Brain oedema, Cardio-respiratory arrest, Convulsion, Electrolyte imbalance, Haemolytic anaemia, Haemolytic uraemic syndrome, Nephritis, Pulmonary congestion, Pyrexia, Renal failure, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Renovascular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-04
   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: Mefloquine 30mg q wk; Acetaminophen 80mg q 4h prn.
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Anemia, Electrolyte Imbalance
CDC Split Type:

Write-up: Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis. Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.


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