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This is VAERS ID 319394

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 319394
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 1/5/2010

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (UNKNOWN) / GLAXOSMITHKLINE BIOLOGICALS (UNKNOWN) - / 0 UN / UN
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days: 0 (blank)     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 3/2/2010

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (UNKNOWN) / GLAXOSMITHKLINE BIOLOGICALS (UNKNOWN) - / 0 UN / UN
PNC: PNEUMO (PREVNAR) PNEUMO (PREVNAR7) / WYETH PHARMACEUTICALS, INC - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 4/7/2010

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (UNKNOWN) / GLAXOSMITHKLINE BIOLOGICALS (UNKNOWN) - / 0 UN / UN
PNC: PNEUMO (PREVNAR7) PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 8/31/2010

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (UNKNOWN) DTAP+IPV+HEPB+HIB (NO BRAND NAME) / GLAXOSMITHKLINE BIOLOGICALS (UNKNOWN) - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration, Decreased appetite

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 11/3/2010

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) DTAP+IPV+HEPB+HIB (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS (UNKNOWN) - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration, Decreased appetite

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 1/4/2011

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS (UNKNOWN) GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration, Decreased appetite

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 5/13/2013

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 2/14/2017

VAERS ID: 319394 Before After
VAERS Form:
Age:0.2 0.18
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 5/14/2017

VAERS ID: 319394 Before After
VAERS Form:
Age:0.18
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN) DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 9/14/2017

VAERS ID: 319394 Before After
VAERS Form:(blank) 1
Age:0.18
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 0 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 0 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 0 1 - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


Changed on 2/14/2018

VAERS ID: 319394 Before After
VAERS Form:1
Age:0.18
Gender:Female
Location:Foreign
Vaccinated:2008-07-01
Onset:2008-07-03
Submitted:2008-07-16
Entered:2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA571A / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Anorexia, Body temperature increased, Haematochezia, Intussusception, Mucous stools, Pyrexia, Surgery, Ultrasound scan, Enema administration

Life Threatening? No
Birth Defect? No
Died? No
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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: According to the physician, the subject had no intestinal malformation.
Allergies:
Diagnostic Lab Data: Body temperature, 03Jul2008, Abnormal; Echography, 05Jul2008, diagnosis
CDC 'Split Type': B0528882A

Write-up: This case was reported by a physician, via a GSK sales representative and described the occurrence of intussusception of intestine in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), INFANRIX HEXA (GlaxoSmithKline), and PREVENAR (Wyeth labs). According to the physician, the subject had no intestinal malformation. On 01 July 2008, the subject received a 1st dose of ROTARIX (oral, batch number A41CA571A), a 1st dose of INFANRIX HEXA (batch number not available) and a 1st dose of PREVENAR (batch number not available). On 03 July 2008, two days after vaccinations, in the morning, the subject developed fever, which resolved the same day. On 05 July 2008, the subject presented with loss of appetite, followed by blood and mucus in stool. In the evening, the subject was hospitalized. Two echographies were performed and diagnosis of intussusception of intestine on 7 centimeters was made. An enema was performed without efficacy. On 06 July 2008, in the morning, the subject underwent a surgery to reduce intussusception, without resection. At the time of reporting, the outcome of the events was unspecified. The reporter''s causality assessment was unspecified. INFANRIX HEXA and PREVENAR were suspected only for fever and ROTARIX for all the events.


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