National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

This is VAERS ID 390640

History of Changes from the VAERS Wayback Machine

First Appeared on 7/31/2010

390640
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC D98669 / 1 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Intussusception, Surgery, Vomiting, Ultrasound abdomen abnormal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 8/31/2010

390640 Before After
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH D98669 / 1 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Intussusception, Surgery, Vomiting, Ultrasound abdomen abnormal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 4/13/2011

390640 Before After
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Culture stool negative, Dehydration, Haematocrit normal, Haemoglobin normal, Intussusception, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, Enema administration, Ultrasound abdomen abnormal, Rotavirus test negative

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 5/13/2011

390640 Before After
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Culture stool negative, Dehydration, Haematocrit normal, Haemoglobin normal, Intussusception, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, Enema administration, Ultrasound abdomen abnormal, Rotavirus test negative

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 6/11/2011

390640 Before After
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Culture stool negative, Dehydration, Haematocrit normal, Haemoglobin normal, Intussusception, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, Enema administration, Ultrasound abdomen abnormal, Rotavirus test negative

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 5/13/2013

390640 Before After
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 UN / UN
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Culture stool negative, Dehydration, Haematocrit normal, Haemoglobin normal, Intussusception, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, Enema administration, Ultrasound abdomen abnormal, Rotavirus test negative

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 3/14/2015

390640 Before After
VAERS Form:
Age:0.3
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Culture stool negative, Dehydration, Haematocrit normal, Haemoglobin normal, Intussusception, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased, Enema administration, Ultrasound abdomen abnormal, Rotavirus test negative

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 2/14/2017

390640 Before After
VAERS Form:
Age:0.3 0.33
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 - / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Intussusception, Surgery, Vomiting, Ultrasound abdomen abnormal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


Changed on 9/14/2017

390640 Before After
VAERS Form:(blank) 1
Age:0.33
Gender:Male
Location:Georgia
Vaccinated:2010-03-09
Onset:2010-04-09
Submitted:2010-06-07
Entered:2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3588AA / 1 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D98669 / 1 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB036AA / 1 2 - MO / PO

Administered by: Private      Purchased by: Public
Symptoms: Abdominal pain, Intussusception, Surgery, Vomiting, Ultrasound abdomen abnormal

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit? (V2.0) No
Hospitalized? Yes, days: 2     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had not experienced adverse events following previous vaccinations. The subject''s medical history was negative for alcohol and tobacco use.
Allergies:
Diagnostic Lab Data: 09 April 2010: Abdominal ultrasound was positive for intussusception. Biopsy was not performed.
CDC 'Split Type': A0858584A

Write-up:This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX ;GlaxoSmithKline;oral given when the subject was 2-months-old. On an unspecified date, at 4-months-old, the subject received 2nd dose of ROTARIX (oral). Approximately one month after vaccination with ROTARIX, the subject experienced intussusception. This case was assessed as medically serious by GSK. The subject was treated with surgery. At the time of reporting the outcome of the event was unspecified. Follow-up information received from healthcare professional on 18 May 2010: Previous and/or concurrent vaccination included DTPA-POLIO-HIB (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010; either ENGERIX B or RECOMBIVAX ;manufacturer unspecified given on 12 January 2010 and 9 March 2010; ROTARIX ;GlaxoSmithKline;oral given on 12 January 2010; PREVNAR (non-GSK) ;non-GSK manufacturer given on 12 January 2010 and 9 March 2010. On 9 March 2010 the subject received 2nd dose of ROTARIX (oral). On 9 April 2010, 31 days after vaccination with ROTARIX, the subject experienced intussusception, vomiting and abdominal pain. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). Relevant test results included abdominal ultrasound on 09 April 2010 which revealed intussusception. The subject was treated with surgical repair. On 15 April 2010, the events were resolved. Relationship of the events to vaccination with ROTARIX was not specified, but the healthcare professional identified ROTARIX as the suspect product.


New Search

Link To This Search Result:

http://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=390640&WAYBACKHISTORY=ON


Copyright © 2018 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166