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This is VAERS ID 252076

History of Changes from the VAERS Wayback Machine

First Appeared on 12/30/2006

VAERS ID: 252076
VAERS Form:
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / AVENTIS PASTEUR, INC. C1527AA / - UN / -
HIBV: HIB (ACTHIB) / AVENTIS PASTEUR, INC. UE237AA / - UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / - UN / -
PNC: PNEUMO, 7-VALENT (PREVNAR) / LEDERLE LABORATORIES A74399C / - UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 20
Allergies:
Diagnostic Lab Data:
CDC 'Split Type':

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in Comparative post-marketing safety study of DAPTACE"L (Diphtheria and Toxoids and Acellular Pertussis vaccine Adsorbed) administered with other recommended vaccine according to the US standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. Protocol Number P3T08. The subject r


Changed on 12/8/2009

VAERS ID: 252076 Before After
VAERS Form:
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / AVENTIS PASTEUR, INC. AVENTIS PASTEUR C1527AA / - UN / -
HIBV: HIB (ACTHIB) / AVENTIS PASTEUR, INC. AVENTIS PASTEUR UE237AA / - UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / - UN / -
PNC: PNEUMO, 7-VALENT (PREVNAR) PNEUMO (PREVNAR) / LEDERLE LABORATORIES A74399C / - UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 20 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': (blank) 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in Comparative post-marketing safety study of DAPTACE"L DAPTACEL (Diphtheria and Toxoids and Acellular Pertussis vaccine Adsorbed) administered with other recommended vaccine according to the US standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. Protocol Number P3T08. The subject r received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 3/2/2010

VAERS ID: 252076 Before After
VAERS Form:
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / AVENTIS PASTEUR C1527AA / - UN / -
HIBV: HIB (ACTHIB) / AVENTIS PASTEUR UE237AA / - UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / - UN / -
PNC: PNEUMO (PREVNAR) PNEUMO (PREVNAR7) / LEDERLE LABORATORIES A74399C / - UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in Comparative post-marketing safety study of DAPTACEL (Diphtheria and Toxoids and Acellular Pertussis vaccine Adsorbed) administered with other recommended vaccine according to the US standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. Protocol Number P3T08. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 4/7/2010

VAERS ID: 252076 Before After
VAERS Form:
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / AVENTIS PASTEUR C1527AA / - UN / -
HIBV: HIB (ACTHIB) / AVENTIS PASTEUR UE237AA / - UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / - UN / -
PNC: PNEUMO (PREVNAR7) PNEUMO (PREVNAR) / LEDERLE LABORATORIES A74399C / - UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in Comparative post-marketing safety study of DAPTACEL (Diphtheria and Toxoids and Acellular Pertussis vaccine Adsorbed) administered with other recommended vaccine according to the US standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. Protocol Number P3T08. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 2/13/2013

VAERS ID: 252076 Before After
VAERS Form:
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / AVENTIS PASTEUR SANOFI PASTEUR C1527AA / - UN / -
HIBV: HIB (ACTHIB) / AVENTIS PASTEUR SANOFI PASTEUR UE237AA / - UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / - UN / -
PNC: PNEUMO (PREVNAR) / LEDERLE LABORATORIES PFIZER/WYETH A74399C / - UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in Comparative post-marketing safety a study of DAPTACEL (Diphtheria and Toxoids and Acellular Pertussis vaccine Adsorbed) administered with other recommended vaccine according to the US standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. Protocol Number P3T08. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 9/14/2017

VAERS ID: 252076 Before After
VAERS Form:(blank) 1
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / - UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / - UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / - UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / - UNK UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 2/14/2018

VAERS ID: 252076 Before After
VAERS Form:1
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / UNK UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 6/14/2018

VAERS ID: 252076 Before After
VAERS Form:1
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / UNK UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 8/14/2018

VAERS ID: 252076 Before After
VAERS Form:1
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / UNK UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 9/14/2018

VAERS ID: 252076 Before After
VAERS Form:1
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / UNK UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


Changed on 10/14/2018

VAERS ID: 252076 Before After
VAERS Form:1
Age:1.3
Sex:Male
Location:Unknown
Vaccinated:2004-11-03
Onset:2004-11-28
Submitted:2006-01-12
Entered:2006-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / UNK UN / -

Administered by: Unknown      Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2004-11-28
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss

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