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Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery

Life Threatening? No
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0522066A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No concomitant medication was reported. On 17 March 2008, the subject received unspecified dose of ROTARIX (oral), lot number not provided. Two days prior to the event onset, the 2 subject''s siblings experienced gastroenteritis. On 18 April 2008, 32 days after vaccination with ROTARIX, the subject experienced intussusception. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with surgery. No structural anomaly was detected. At the time of reporting the event was resolved. The regulatory authority reported that the event was probably related to vaccination with ROTARIX.

Changed on 5/13/2013

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery

Life Threatening? No
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0522066A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No concomitant medication was reported. On 17 March 2008, the subject received unspecified dose of ROTARIX (oral), lot number not provided. Two days prior to the event onset, the 2 subject''s siblings experienced gastroenteritis. On 18 April 2008, 32 days after vaccination with ROTARIX, the subject experienced intussusception. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with surgery. No structural anomaly was detected. At the time of reporting the event was resolved. The regulatory authority reported that the event was probably related to vaccination with ROTARIX.

Changed on 2/14/2017

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery

Life Threatening? No
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0522066A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No concomitant medication was reported. On 17 March 2008, the subject received unspecified dose of ROTARIX (oral), lot number not provided. Two days prior to the event onset, the 2 subject''s siblings experienced gastroenteritis. On 18 April 2008, 32 days after vaccination with ROTARIX, the subject experienced intussusception. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with surgery. No structural anomaly was detected. At the time of reporting the event was resolved. The regulatory authority reported that the event was probably related to vaccination with ROTARIX.

Changed on 9/14/2017

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery

Life Threatening? No
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0522066A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No concomitant medication was reported. On 17 March 2008, the subject received unspecified dose of ROTARIX (oral), lot number not provided. Two days prior to the event onset, the 2 subject''s siblings experienced gastroenteritis. On 18 April 2008, 32 days after vaccination with ROTARIX, the subject experienced intussusception. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with surgery. No structural anomaly was detected. At the time of reporting the event was resolved. The regulatory authority reported that the event was probably related to vaccination with ROTARIX.

Changed on 2/14/2018

Administered by: Other      Purchased by: Other
Symptoms: Intussusception, Surgery

Life Threatening? No
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0522066A

Write-up: This case was reported by a regulatory authority and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No concomitant medication was reported. On 17 March 2008, the subject received unspecified dose of ROTARIX (oral), lot number not provided. Two days prior to the event onset, the 2 subject''s siblings experienced gastroenteritis. On 18 April 2008, 32 days after vaccination with ROTARIX, the subject experienced intussusception. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with surgery. No structural anomaly was detected. At the time of reporting the event was resolved. The regulatory authority reported that the event was probably related to vaccination with ROTARIX.

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