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This is VAERS ID 340281

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 340281
VAERS Form:
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Se
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 5/13/2013

VAERS ID: 340281 Before After
VAERS Form:
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Se
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 4/14/2017

VAERS ID: 340281 Before After
VAERS Form:
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Se 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 9/14/2017

VAERS ID: 340281 Before After
VAERS Form:(blank) 1
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 1 - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 2/14/2018

VAERS ID: 340281 Before After
VAERS Form:1
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 6/14/2018

VAERS ID: 340281 Before After
VAERS Form:1
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 8/14/2018

VAERS ID: 340281 Before After
VAERS Form:1
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 9/14/2018

VAERS ID: 340281 Before After
VAERS Form:1
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.


Changed on 10/14/2018

VAERS ID: 340281 Before After
VAERS Form:1
Age:0.2
Sex:Female
Location:Foreign
Vaccinated:2008-10-27
Onset:2008-12-24
Submitted:2009-02-20
Entered:2009-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain, Blood potassium increased, Blood sodium normal, Haematochezia, Haemoglobin normal, Hyperaemia, Intussusception, Irritability, Laparotomy, Lymphadenopathy, Platelet count normal, Prothrombin time normal, Pyrexia, Vomiting, White blood cell count increased, X-ray abnormal, Neutrophil percentage decreased, Abdominal X-ray, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, Dec2006, See text; Hemoglobin, 26Dec2008, 10.2g/dL; Neutrophil percentage, 26Dec2008, 44%; Platelet count, 26Dec2008, 219000/mm3; Potassium, 27Dec2008, 5.6mEq; Potassium, 28Dec2008, 5mEq; Prothrombin time, 26Dec2008, 11.3Seconds; Sodium, 27Dec2008, 135mEq; Sodium, 28Dec2008, 136mEq; White blood cell count, 26Dec2008, 13500/mm3
CDC 'Split Type': B0558773A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject had no concomitant medication. On 27 October 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 24 December 2008, 58 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting, bloody stools, abdominal pain and fever. On 25 December 2008, the subject was admitted at ER; physical exam reported irritability, fever, cervical adenopathy, hyperemic pharynx, abdominal pain and increased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed on 26 December 2008 and showed the following: Hemoglobin: 10.2 g/dL; Platelets: 219000/mm3; Prothrombin time: 11.3 Seconds; Leucocytes: 13500/mm3. Abdominal X-ray was performed and showed distention loops and gas/liquid levels. Intussusception was suspected and confirmed by laparotomy on 26 December 2008; Ileocecal intussusception was found and reduced by taxis without complications. Lab tests were performed on 27 December 2008 and showed the following: Potassium: 5.6 mEq; Sodium: 135. Lab tests were performed on 28 December 2008 and showed the following: Potassium: 5 mEq; Sodium: 136. The subject was treated with AMOXICILLIN, trimethoprim + sulfamethoxazol, Metamizol, Ampicillin, metoclopramide and paracetamol. On 29 December 2008, the events were resolved. The vaccination course with ROTARIX was discontinued because of the intussusception. The physician considered the events were unrelated to vaccination with ROTARIX.

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