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This is VAERS ID 353395

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History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 353395
VAERS Form:
Age:0.3
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC D37015 / - RL / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 3/2/2010

VAERS ID: 353395 Before After
VAERS Form:
Age:0.3
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) PNEUMO (PREVNAR7) / WYETH PHARMACEUTICALS, INC D37015 / - RL / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 4/7/2010

VAERS ID: 353395 Before After
VAERS Form:
Age:0.3
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR7) PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC D37015 / - RL / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 8/31/2010

VAERS ID: 353395 Before After
VAERS Form:
Age:0.3
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH D37015 / - RL / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 5/13/2013

VAERS ID: 353395 Before After
VAERS Form:
Age:0.3
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / - RL / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 8/14/2014

VAERS ID: 353395 Before After
VAERS Form:
Age:0.3
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (NO BRAND NAME) HIB (ACTHIB) / UNKNOWN MANUFACTURER SANOFI PASTEUR UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / - RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 2/14/2017

VAERS ID: 353395 Before After
VAERS Form:
Age:0.3 0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / - RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 4/14/2017

VAERS ID: 353395 Before After
VAERS Form:
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / - LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / - RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Vomiting, Immediate post-injection reaction

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 9/14/2017

VAERS ID: 353395 Before After
VAERS Form:(blank) 1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / - UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / - UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / - UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / - UNK - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 2/14/2018

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 6/14/2018

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 8/14/2018

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 9/14/2018

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 10/14/2018

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 12/24/2020

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 12/30/2020

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 5/7/2021

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.


Changed on 5/21/2021

VAERS ID: 353395 Before After
VAERS Form:1
Age:0.33
Sex:Male
Location:Unknown
Vaccinated:2009-07-15
Onset:2009-07-19
Submitted:2009-08-07
Entered:2009-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B173AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF569AA / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37015 / UNK RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA782A / UNK MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Death

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2009-07-19
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: Unknown
Preexisting Conditions: 10/5/09 Medical records received w/PMH: left clavicle fx at birth.
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0800503A

Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported. 8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots. Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min. ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor. 10/5/09 ER records received for 7/18/09 which had been previously received.

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