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This is VAERS ID 349618

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 349618
VAERS Form:
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC D37016 / 1 LL / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal tenderness, Crying, Discomfort, Dry skin, Haematochezia, Intussusception, Laparotomy, Large intestinal obstruction reduction, Lip dry, Listless, Restlessness, Screaming, Skin warm, Small intestinal intussusception reduction, Vomiting, X-ray abnormal, Enema administration, Ultrasound abdomen abnormal, Occult blood positive, Hypophagia

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 3/2/2010

VAERS ID: 349618 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) PNEUMO (PREVNAR7) / WYETH PHARMACEUTICALS, INC D37016 / 1 LL / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal tenderness, Crying, Discomfort, Dry skin, Haematochezia, Intussusception, Laparotomy, Large intestinal obstruction reduction, Lip dry, Listless, Restlessness, Screaming, Skin warm, Small intestinal intussusception reduction, Vomiting, X-ray abnormal, Enema administration, Ultrasound abdomen abnormal, Occult blood positive, Hypophagia

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 4/7/2010

VAERS ID: 349618 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 LL / UN
PNC: PNEUMO (PREVNAR7) PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC D37016 / 1 LL / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal tenderness, Crying, Discomfort, Dry skin, Haematochezia, Intussusception, Laparotomy, Large intestinal obstruction reduction, Lip dry, Listless, Restlessness, Screaming, Skin warm, Small intestinal intussusception reduction, Vomiting, X-ray abnormal, Enema administration, Ultrasound abdomen abnormal, Occult blood positive, Hypophagia

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 8/31/2010

VAERS ID: 349618 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH D37016 / 1 LL / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal tenderness, Crying, Discomfort, Dry skin, Haematochezia, Intussusception, Laparotomy, Large intestinal obstruction reduction, Lip dry, Listless, Restlessness, Screaming, Skin warm, Small intestinal intussusception reduction, Vomiting, X-ray abnormal, Enema administration, Ultrasound abdomen abnormal, Occult blood positive, Hypophagia

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 5/13/2013

VAERS ID: 349618 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 1 LL / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal tenderness, Crying, Discomfort, Dry skin, Haematochezia, Intussusception, Laparotomy, Large intestinal obstruction reduction, Lip dry, Listless, Restlessness, Screaming, Skin warm, Small intestinal intussusception reduction, Vomiting, X-ray abnormal, Enema administration, Ultrasound abdomen abnormal, Occult blood positive, Hypophagia

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 4/14/2017

VAERS ID: 349618 Before After
VAERS Form:
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 1 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal tenderness, Crying, Discomfort, Dry skin, Haematochezia, Intussusception, Laparotomy, Large intestinal obstruction reduction, Lip dry, Listless, Restlessness, Screaming, Skin warm, Small intestinal intussusception reduction, Vomiting, X-ray abnormal, Enema administration, Ultrasound abdomen abnormal, Occult blood positive, Hypophagia

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 9/14/2017

VAERS ID: 349618 Before After
VAERS Form:(blank) 1
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 1 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 1 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 1 2 - MO / PO

Administered by: Private      Purchased by: Public
Symptoms: Intussusception

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 2/14/2018

VAERS ID: 349618 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 2 MO / PO

Administered by: Private      Purchased by: Public
Symptoms: Intussusception

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 6/14/2018

VAERS ID: 349618 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 2 MO / PO

Administered by: Private      Purchased by: Public
Symptoms: Intussusception

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 8/14/2018

VAERS ID: 349618 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 2 MO / PO

Administered by: Private      Purchased by: Public
Symptoms: Intussusception

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1


Changed on 9/14/2018

VAERS ID: 349618 Before After
VAERS Form:1
Age:0.4
Gender:Male
Location:Alabama
Vaccinated:2009-05-27
Onset:2009-06-04
Submitted:2009-06-19
Entered:2009-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3230AA / 2 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D37016 / 2 LL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41SA697A / 2 MO / PO

Administered by: Private      Purchased by: Public
Symptoms: Intussusception

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations.
Allergies:
Diagnostic Lab Data: UNK. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. LABS and DIAGNOSTICS: Hemoccult (+). X-ray Chest / Abdomen - multiple dilated loops of bowel. Abdominal Ultrasound - intussusception.
CDC 'Split Type': A0792059A

Write-up: This case was reported by a physician, via a GSK representative and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was completely healthy prior to vaccination. He had not experienced adverse events following prior vaccinations. Concurrent vaccinations included PENTACEL (non-GSK) (Sanofi) given on 27 May 2009; PREVNAR (Wyeth Labs) given on 27 May 2009. On 27 May 2009 the subject received 2nd dose of ROTARIX (1 ml, oral). The lot number was reported as "A41SA697A". On 4 June 2009, 8 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalized for 4 days and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with intravenous fluids and barium enema. On 8 June 2009, the event was resolved. 7/9/09 Hospital records received DOS 6/5/09 to 6/7/09. Assessment: Intussusception. Patient presented with vomiting and has not tolerated any po intake. Prior ER visits. Restless, cries, screams. Appears uncomfortable, listless, abdomen tender to palpation, red stool noted during rectal exam. Dry lips. Skin warm, dry to touch. Air enema reduction of ileocolic intussusception. Subsequent exploratory laparoscopy and reduction of ileoileal intussusception ICD-9 Codes: 560.0 789.00, 789.07, 787.02, 792.1

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