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This is VAERS ID 290655

History of Changes from the VAERS Wayback Machine

First Appeared on 12/31/2007

VAERS ID: 290655
VAERS Form:
Age:0.2
Sex:Male
Location:Unknown
Vaccinated:2007-08-30
Onset:2007-09-11
Submitted:2007-09-14
Entered:2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHE: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 0 RL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 0 LL / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type':

Write-up: This is a 7-day report. This case was unblinded, the patient received Prevnar. Information regarding Prevnar was received from an investigator regarding a 2-month-old male participant in a study who experienced death. The participant received the first do"se on 30-AUG-2007. On 11-Sep-2007, the patient was found in the crib at Day Care on his back, unresponsive, blue and not breathing. Day Care workers initiated cardiopulmonary resuscitation and contacted 911 emergency response. Upon emergency medical respo


Changed on 12/8/2009

VAERS ID: 290655 Before After
VAERS Form:
Age:0.2
Sex:Male
Location:Unknown
Vaccinated:2007-08-30
Onset:2007-09-11
Submitted:2007-09-14
Entered:2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHE: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 RL / IM
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 0 RL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 0 LL / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': (blank) HQWYE111312SEP07

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


Changed on 3/2/2010

VAERS ID: 290655 Before After
VAERS Form:
Age:0.2
Sex:Male
Location:Unknown
Vaccinated:2007-08-30
Onset:2007-09-11
Submitted:2007-09-14
Entered:2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 0 RL / IM
PNC: PNEUMO (PREVNAR) PNEUMO (PREVNAR7) / WYETH PHARMACEUTICALS, INC - / 0 LL / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 4/7/2010

VAERS ID: 290655 Before After
VAERS Form:
Age:0.2
Sex:Male
Location:Unknown
Vaccinated:2007-08-30
Onset:2007-09-11
Submitted:2007-09-14
Entered:2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 0 RL / IM
PNC: PNEUMO (PREVNAR7) PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 0 LL / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 8/31/2010

VAERS ID: 290655 Before After
VAERS Form:
Age:0.2
Sex:Male
Location:Unknown
Vaccinated:2007-08-30
Onset:2007-09-11
Submitted:2007-09-14
Entered:2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 0 RL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH - / 0 LL / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 9/14/2017

VAERS ID: 290655 Before After
VAERS Form:(blank) 1
Age:0.2
Sex:Male
Location:Unknown
Vaccinated:2007-08-30
Onset:2007-09-11
Submitted:2007-09-14
Entered:2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B132BA / 0 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF162AA / 0 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 1 LL / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 2/14/2018

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 6/14/2018

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 8/14/2018

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 9/14/2018

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 10/14/2018

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 12/24/2020

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 12/30/2020

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 5/7/2021

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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


Changed on 5/14/2021

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

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Body temperature decreased, Cyanosis, Death, Hypothermia, Pulse absent, Pupil fixed, Resuscitation, Unresponsive to stimuli, Musculoskeletal stiffness

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2007-09-11
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: Family history of atrial fibrillation in the father of the child and allergies in an otherwise healthy 7-year-old sibling.
Allergies:
Diagnostic Lab Data: Body temperature (results: 92.2 deg. F.) was done on 11-Sep-2007.
CDC 'Split Type': HQWYE111312SEP07

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

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