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This is VAERS ID 312939

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

312939
VAERS Form:
Age:
Gender:Unknown
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2008-05-21
Entered:2008-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery, Enema administration, Intestinal resection

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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0520623A

Write-up:This case was reported in a literature article (conference abstract) and described the occurrence of intussusception in an infant (aged between 2 and 5 months) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The study is an investigator-intiated study which is supported by GSK and Merck/CSL. Two rotavirus vaccines, ROTARIX (GSK) and ROTATEQ (Merck) were introduced into the National Immunization Program from July 2007. Whilst these vaccines have been shown to be safe and effective in large clinical trials, post marketing surveillance for intussusception (IS) is essential following the withdrawal of the first rotavirus vaccine (ROTASHIELD) in 1999 due to the documented temporal association between receipt of the vaccine and intussusception. The aim of this study was to estimate the incidence of intussusception, describe treatment used and identify any temporal association with Rotavirus vaccine. Method/Design: Prospective national surveillance of acute intussusception in infants aged less than or equal to 24 months began in May 2007. A monthly report card/e-mail was sent requesting notification of incident IS cases. Questionnaire data were collected to record clinical presentation, diagnosis and management. Results: Of 87 reports to the end of November 2007, 57 (65.5%) completed questionnaires were received and 37 met the case definition criteria. Of the 37 cases, 19 were male, mean age 6 months. Four (11%) children aged between 2 and 5 months had received at least one dose of Rotavirus vaccine 2 weeks prior the development of intussusception. Three of these received ROTATEQ and one received ROTARIX. This case was assessed as medically serious by GSK. In 22 (59.5%) cases intussusception was successfully reduced using air-hydrostatic enema, while 11 (29.7%) required surgical intervention. Of the 11 cases, 8 (72.7%) required partial bowel resection and 7 (63.6%) were found to have a pathological lead point. Conclusions: Concern over the possible association between receipt of rotavirus vaccin


Changed on 5/13/2013

312939 Before After
VAERS Form:
Age:
Gender:Unknown
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2008-05-21
Entered:2008-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery, Enema administration, Intestinal resection

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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0520623A

Write-up:This case was reported in a literature article (conference abstract) and described the occurrence of intussusception in an infant (aged between 2 and 5 months) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The study is an investigator-intiated study which is supported by GSK and Merck/CSL. Two rotavirus vaccines, ROTARIX (GSK) and ROTATEQ (Merck) were introduced into the National Immunization Program from July 2007. Whilst these vaccines have been shown to be safe and effective in large clinical trials, post marketing surveillance for intussusception (IS) is essential following the withdrawal of the first rotavirus vaccine (ROTASHIELD) in 1999 due to the documented temporal association between receipt of the vaccine and intussusception. The aim of this study was to estimate the incidence of intussusception, describe treatment used and identify any temporal association with Rotavirus vaccine. Method/Design: Prospective national surveillance of acute intussusception in infants aged less than or equal to 24 months began in May 2007. A monthly report card/e-mail was sent requesting notification of incident IS cases. Questionnaire data were collected to record clinical presentation, diagnosis and management. Results: Of 87 reports to the end of November 2007, 57 (65.5%) completed questionnaires were received and 37 met the case definition criteria. Of the 37 cases, 19 were male, mean age 6 months. Four (11%) children aged between 2 and 5 months had received at least one dose of Rotavirus vaccine 2 weeks prior the development of intussusception. Three of these received ROTATEQ and one received ROTARIX. This case was assessed as medically serious by GSK. In 22 (59.5%) cases intussusception was successfully reduced using air-hydrostatic enema, while 11 (29.7%) required surgical intervention. Of the 11 cases, 8 (72.7%) required partial bowel resection and 7 (63.6%) were found to have a pathological lead point. Conclusions: Concern over the possible association between receipt of rotavirus vaccin


Changed on 4/14/2017

312939 Before After
VAERS Form:
Age:
Gender:Unknown
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2008-05-21
Entered:2008-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery, Enema administration, Intestinal resection

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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0520623A

Write-up:This case was reported in a literature article (conference abstract) and described the occurrence of intussusception in an infant (aged between 2 and 5 months) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The study is an investigator-intiated study which is supported by GSK and Merck/CSL. Two rotavirus vaccines, ROTARIX (GSK) and ROTATEQ (Merck) were introduced into the National Immunization Program from July 2007. Whilst these vaccines have been shown to be safe and effective in large clinical trials, post marketing surveillance for intussusception (IS) is essential following the withdrawal of the first rotavirus vaccine (ROTASHIELD) in 1999 due to the documented temporal association between receipt of the vaccine and intussusception. The aim of this study was to estimate the incidence of intussusception, describe treatment used and identify any temporal association with Rotavirus vaccine. Method/Design: Prospective national surveillance of acute intussusception in infants aged less than or equal to 24 months began in May 2007. A monthly report card/e-mail was sent requesting notification of incident IS cases. Questionnaire data were collected to record clinical presentation, diagnosis and management. Results: Of 87 reports to the end of November 2007, 57 (65.5%) completed questionnaires were received and 37 met the case definition criteria. Of the 37 cases, 19 were male, mean age 6 months. Four (11%) children aged between 2 and 5 months had received at least one dose of Rotavirus vaccine 2 weeks prior the development of intussusception. Three of these received ROTATEQ and one received ROTARIX. This case was assessed as medically serious by GSK. In 22 (59.5%) cases intussusception was successfully reduced using air-hydrostatic enema, while 11 (29.7%) required surgical intervention. Of the 11 cases, 8 (72.7%) required partial bowel resection and 7 (63.6%) were found to have a pathological lead point. Conclusions: Concern over the possible association between receipt of rotavirus vaccin vaccine and intussusception in 4 of the reported cases. A higher than anticipated rate of surgical intervention for intussusception is concerning and requires further investigation. These preliminary data highlight the need for ongoing surveillance for intussusception. Follow up information received on 16 May 2008: The author has submitted another abstract using similar data which has been accepted as a poster at the International Rotavirus Meeting in June 2008.


Changed on 9/14/2017

312939 Before After
VAERS Form:(blank) 1
Age:
Gender:Unknown
Location:Foreign
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted:2008-05-21
Entered:2008-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UNK - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery, Enema administration, Intestinal resection

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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0520623A

Write-up:This case was reported in a literature article (conference abstract) and described the occurrence of intussusception in an infant (aged between 2 and 5 months) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The study is an investigator-intiated study which is supported by GSK and Merck/CSL. Two rotavirus vaccines, ROTARIX (GSK) and ROTATEQ (Merck) were introduced into the National Immunization Program from July 2007. Whilst these vaccines have been shown to be safe and effective in large clinical trials, post marketing surveillance for intussusception (IS) is essential following the withdrawal of the first rotavirus vaccine (ROTASHIELD) in 1999 due to the documented temporal association between receipt of the vaccine and intussusception. The aim of this study was to estimate the incidence of intussusception, describe treatment used and identify any temporal association with Rotavirus vaccine. Method/Design: Prospective national surveillance of acute intussusception in infants aged less than or equal to 24 months began in May 2007. A monthly report card/e-mail was sent requesting notification of incident IS cases. Questionnaire data were collected to record clinical presentation, diagnosis and management. Results: Of 87 reports to the end of November 2007, 57 (65.5%) completed questionnaires were received and 37 met the case definition criteria. Of the 37 cases, 19 were male, mean age 6 months. Four (11%) children aged between 2 and 5 months had received at least one dose of Rotavirus vaccine 2 weeks prior the development of intussusception. Three of these received ROTATEQ and one received ROTARIX. This case was assessed as medically serious by GSK. In 22 (59.5%) cases intussusception was successfully reduced using air-hydrostatic enema, while 11 (29.7%) required surgical intervention. Of the 11 cases, 8 (72.7%) required partial bowel resection and 7 (63.6%) were found to have a pathological lead point. Conclusions: Concern over the possible association between receipt of rotavirus vaccine and intussusception in 4 of the reported cases. A higher than anticipated rate of surgical intervention for intussusception is concerning and requires further investigation. These preliminary data highlight the need for ongoing surveillance for intussusception. Follow up information received on 16 May 2008: The author has submitted another abstract using similar data which has been accepted as a poster at the International Rotavirus Meeting in June 2008.


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