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Found 564 cases where Vaccine is RV1 and Symptom is Intussusception and Appearance Date from '2008-02-01' to '2014-12-31'

Case Details

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VAERS ID: 336622 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-31
Onset:2008-12-12
   Days after vaccination:42
Submitted: 2009-01-06
   Days after onset:25
Entered: 2009-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal mass, Abdominal pain, Blood creatinine decreased, Blood potassium normal, Blood sodium increased, Dehydration, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal perforation, Intussusception, Irritability, Laparotomy, Lymphocyte count increased, Mucous stools, Neutrophil count increased, Pallor, Platelet count normal, Prothrombin time prolonged, Pyrexia, Rectal haemorrhage, White blood cell count increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Creatinine, 13Dec2008, 0.4mg/dl; Hematocrit, 13Dec2008, 39%; Hemoglobin, 13Dec2008, 13.1mg/dl; Leukocyte count NOS, 13Dec2008, 18700IU/dl; Lymphocytes, 13Dec2008, 5500IU/dl; Neutrophil count, 13Dec2008, 11300UI/dl; Partial prothrombin time, 13Dec2008, 36.2sec; Platelet count, 13Dec2008, 36500UI/dl; Potassium, 13Dec2008, 5mEq/l; Prothrombin time, 13Dec2008, 12.3sec; Sodium, 13Dec2008, 145mEq/l
CDC Split Type: B0552338A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-ileal intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 31 October 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 12 December 2008, 42 days after vaccination with ROTARIX, the subject started with fever, bloody stools, irritability and abdominal pain. The patient was admitted at ER on 28 July 2008 and showed at physical exam abdominal sausage shaped mass, currant jelly stool, blood at rectal tact, pallor, dehydration and abdominal distension. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray with loop distension and was confirmed by laparotomy. Laparotomy was performed on 13 December 2008 finding an ileo-ileal intussusception and 2 intestinal perforations, resolved by taxis and suture without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Laboratory tests were performed on 13 December 2008 and showed the following results: Hemoglobin: 13.1mg/dl; Hematocrit: 39 %; Leukocytes: 18700 IU/dl; Neutrophiles: 11300 IU/dl; Lymphocytes: 5500 IU/dl; Platelets: 365000 IU/dl; PT: 12.3 sec; PTT: 36.2 sec; Creatinine: 0.4 mg/dl; Sodium: 145 mEq/l; Potassium: 5 mEq/l. The subject was treated with metronidazole and amikac. On 18 December 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 336623 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-12
Onset:2008-12-13
   Days after vaccination:31
Submitted: 2009-01-06
   Days after onset:24
Entered: 2009-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Anal fissure, Blood calcium, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea increased, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Hyperaemia, Intestinal anastomosis, Intestinal resection, Intussusception, Irritability, Laparotomy, Lymphocyte count decreased, Necrosis, Neutrophil percentage, Pharyngeal erythema, Platelet count increased, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, 14Dec2008, 99 mg/dL; Calcium, 14Dec2008, 9.5 mEq/dL; Creatinine, 14Dec2008, 0.2 mg/dL; Hematocrit, 13Dec2008, 35%; Hemoglobin, 13Dec2008, 11.8 mg/dL; Lymphocyte percentage, 13Dec2008, 20%; Neutrophil percentage, 13Dec2008, 68%; Platelet count, 13Dec2008, 470000 UI/dL; Potassium, 14Dec2008, 5 mEq/dL; Sodium, 14Dec2008, 138 mEq/dL; Urea, 14Dec2008, 22 mg/dL; White blood cell count, 13Dec2008, 13250 UI/dL
CDC Split Type: B0552342A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. The subject was previously healthy. On 12 November 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 13 December 2008, 31 days after vaccination with ROTARIX, the subject experienced bloody stools, vomiting and irritability. The subject was admitted at ER on the same day. Physical exam reported hyperemic pharynx, abdominal pain, bloody stools, dehydration, absent bowel sounds, anal fissure and abdominal distention. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Laboratory tests were performed and showed the following: Hemoglobin: 11.8 mg/dL; Hematocrit: 35%; Leucocytes: 13250 UI/dL; Platelets count: 470000 UI/dL; Lymphocytes: 20%; Neutrophils: 68%; Glucose: 99 mg/dL; Urea: 22 mg/dL; Creatinine: 0.2 mg/dL; Calcium: 9.5 mEq/dL; Sodium: 138 mEq/dL; Potassium: 5 mEq/dL. Abdominal X-ray was performed and was with abnormal gas situation. On 19 December 2008, laparatomy was made; findings were Ileocolic intussusception with term ileon necrosis that required intestinal resection with termo-terminal anastomosis without complications. The subject was treated with Ampicillin, Amikacine, metronidazole, Ranitidine, Ketorolac, and Metamizole. After full recovery the subject was discharged on 19 December 2008 in good clinical conditions. On 19 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 336958 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-11
Onset:2008-12-24
   Days after vaccination:135
Submitted: 2009-01-09
   Days after onset:16
Entered: 2009-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anal haemorrhage, Asthenia, Blood creatinine normal, Blood glucose increased, Blood potassium decreased, Blood sodium normal, Blood urea increased, Breath sounds abnormal, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Laparotomy, Mass, Mucous stools, Neutrophil percentage increased, Pallor, Platelet count normal, Prothrombin time prolonged, Stridor, Vomiting, White blood cell count normal
SMQs:, Acute renal failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, 25Dec2008, 183mg/dL; Creatinine, 25Dec2008, 0.4mg/dL; Hematocrit, 25Dec2008, 31.6%; Hemoglobin, 25Dec2008, 10.5mg/dL; Neutrophil percentage, 25Dec2008, 79%; Platelet count, 25Dec2008, 247000UI; Potassium, 25Dec2008, 3.47mg/dL; Prothrombin time, 25Dec2008, 13.9Seconds; Sodium, 25Dec2008, 134mg/dL; Urea, 25Dec2008, 23.5mg/dL; White blood cells, 25Dec2008, 15.5UI
CDC Split Type: B0552625A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was previously healthy. The subject had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline; oral) given on 12 May 2008. On 11 August 2008, the subject received the 2nd dose of ROTARIX (oral). On 24 December 2008, 4 months after vaccination with the 2nd dose of ROTARIX, the subject experienced vomiting, abdominal pain and current jelly stool. The subject was admitted to ER on the same day. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Physical exam reported pallor, asthenia, adynamia, dehydration, vomiting, sausage mass, decreased bowel sounds, blood in the anal exam, pulmonary stridors and whistles. Lab tests were performed and showed the following: Glucose: 183 mg/dL; Urea: 23.5 mg/dL; Creatinine: 0.4 mg/dL; Potassium: 3.47 mg/dL; Sodium: 134 mg/dL; Hemoglobin: 10.5 mg/dL; Hematocrit: 31.6%; Platelets count: 247000 IU; Neutrophils: 79%; Prothrombin time: 13.9 Sec; Leukocytes: 15.5 UI. An Enema realised on 25 December 2008 did not reduced but intussception was diagnosed. Laparatomy was done on 25 December 2008; ileocecal intussusception was found and reduced by taxis without complications. The subject was treated with Ranitidine, amikacin and Ampicillin. After full recovery, the subject was discharged on 29 December 2008 in good clinical conditions. On 29 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 337350 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-07
Onset:2008-07-23
   Days after vaccination:77
Submitted: 2009-01-14
   Days after onset:175
Entered: 2009-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Appendicectomy, Dehydration, Eyelid oedema, Gastrointestinal hypomotility, Haematochezia, Intussusception, Laparotomy, Lymphadenitis, Mucous stools, Pain, Pallor, Pyrexia, Somnolence, Tachycardia, Tachypnoea, Vomiting, X-ray abnormal
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 25Jul2008, showed dilated small bowel absent air in colon with image of intestinal obstruction.
CDC Split Type: B0553224A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 10 March 2008. On 7 May 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided). On 23 July 2008, 77 days after vaccination with ROTARIX, the subject started with vomiting, fever, abdominal distension and bloody stools. The patient was admitted at ER on 25 July 2008 and showed at physician exam somnolence, distended abdomen with intense pain, bowel peristalsis decreased and rectal tact with expulsion of bloody stool with mucus. The subject was hospitalised. On 25 July 2008, abdominal x-ray was performed and showed dilated small bowel, absent air in colon with image of intestinal obstruction. A laparotomy was done on 25 July 2008 and showed ileocecal intussusception of 15 cm, terminal ileon in the ileocecal valve with mesenteric adenitis, dilated and hypoxemic small bowel without necrosis. Ileocecal intussusception was reduced by taxis with appendectomy. The subject was treated with metoclopramide, paracetamol and ceftriaxone. Post surgical evolution showed dehydration, fever, pallor, tachypnea, tachycardia and palpebral edema. These events slowly improved. On 5 August 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 337447 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-26
Onset:2008-10-07
   Days after vaccination:195
Submitted: 2009-01-15
   Days after onset:100
Entered: 2009-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Activated partial thromboplastin time shortened, Appendix disorder, Blood creatinine increased, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea increased, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Neutrophil percentage increased, Oedema, Platelet count normal, Prothrombin time prolonged, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, 07Oct2008, 127mg/dl; Creatinine, 07Oct2008, 0.5mg/dl; Hemoglobin, 07Oct2008, 12.7mg/dl; Leukocyte count NOS, 07Oct2008, 1960Ul/dl; Neutrophil count, 07Oct2008, 75%; Partial prothrombin time, 07Oct2008, 25.2sec; Platelet count, 07Oct2008, 427000Ul/dl; Potassium, 07Oct20008, 4.6mEq/l; Prothrombin time, 07Oct2008, 14sec; Sodium, 07Oct2008, 142mEq/l; Urea, 07Oct2008, 28mg/dl
CDC Split Type: B0553802A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileo-ceco-colic intussusception in a 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKilne). The subject was on no other medication and had no relevant medical history or allergy. On 26 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 7 October 2008, 6 months after vaccination with ROTARIX, the subject the subject started with abdominal pain, irritability, vomiting and bloody stools. The patient was admitted at ER on 7 October 2008 and showed at physical exam bowel sounds increased, current jelly stool, abdominal sausage shaped mass and blood at rectal tact. Abdominal x-ray did not show abnormal findings. Intussusception was suspected and confirmed by laparotomy on 8 October 2008. Surgery was done on 8 October 2008. Ileo-ceco-colic intussusception was found with an appendix edema, reduced by taxis with without appendectomy complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Tests were performed on 7 October 2008 and showed the following results: Platelets: 427 000 UI/dl; Leukocytes: 19 600 UI/dl; Neutrophiles 75%; Hemoglobin: 12.7mg/dl; PT: 14sec; PTT: 25.2sec; glycemia: 127 mg/dl; Urea: 28 mg/dl; Creatinine: 0.5mg/dl; Sodium: 142 mEq/l; Potassium: 4.6 mEq/l 25.2sec; Glycemia: 127 mg/dl; Urea: 28 mg/dL; Creatinine: 0.5mg/dl: Sodium: 142 mEq/l; Potassium: 4.6 mEq/l. The subject was treated with Trimethoprim sulfamethoxazol, paracetamol and DIPHENIDOL. On 10 October 2008, the events were resolved. The subject was discharged in good clinical conditions. The vaccination course with ROTARIX was discontinued. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


VAERS ID: 337660 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-05
Onset:2009-01-06
   Days after vaccination:1
Submitted: 2009-01-16
   Days after onset:10
Entered: 2009-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA868D / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Appendicitis, Intestinal resection, Intussusception, Necrosis ischaemic, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Perinatal infection NOS
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 08Jan2009, intussuscept
CDC Split Type: B0554195A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history included perinatal infection nos. On 5 January 2009, the subject received 1st dose of ROTARIX (oral). On 6 January 2009, 1 day after vaccination with ROTARIX, the subject started with vomiting and was admitted at hospital. Abdominal ultrasound was performed. Ileocolic intussusception was confirmed with necrosis ischemic and peri-appendicitis. Surgery was done on 8 January 2009 with intestine resection and appendectomy. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 8 January 2009, the events were resolved. The subject had fully recovered. The physician considered the events were possibly related to vaccination with ROTARIX. This case has been reported to a regulatory agency.


VAERS ID: 337662 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-28
Onset:2008-12-01
   Days after vaccination:34
Submitted: 2009-01-16
   Days after onset:46
Entered: 2009-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA267A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Emotional distress, Hypotonia, Intussusception, Screaming
SMQs:, Peripheral neuropathy (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0549445A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). In November 2008, when the subject was 2 month old, he received 1st dose of ROTARIX (oral), lot number not provided. The subject was completely fine after vaccination. In December 2008, 1 month after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised. The subject''s condition settled on its own. At the time of reporting the event was resolved. The physician considered the event was unlikely to be related to vaccination with ROTARIX. Follow-up received on 6 January 2008: Previous to vaccination, the subject was in good health with no known medical history. On 28 October 2008, the subject was vaccinated with ROTARIX. On 1 December 2008, 34 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was transferred to another hospital where the diagnosis of intussusception was made. Surgery was not performed as the subject''s condition settled on its own, prior to treatment. On 1 December 2008, the event was resolved. The 2nd dose of ROTARIX was scheduled for 4 December 2008. The reporter did not feel that ROTARIX was the cause of intussusception. Follow-up received on 14 January 2009: On 1 December 2008, the subject experienced sudden onset of severe crying with a bout where he stopped crying, but he was still distressed and looking limp. Then started increased screaming. He was brought to hospital. The tests performed there were not known. The subject was then transferred, still screaming to another hospital where the diagnosis of intussusception was made. At that hospital, the events settled without treatment.


VAERS ID: 337730 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-12
Onset:2008-05-12
   Days after vaccination:61
Submitted: 2009-01-20
   Days after onset:253
Entered: 2009-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Diarrhoea, Gastrointestinal sounds abnormal, Granulocyte count increased, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal anastomosis, Intestinal resection, Intussusception, Lymphocyte count normal, Monocyte count increased, Mucous stools, Platelet count normal, Pyrexia, Surgery, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 14May2008, Abnormal; Granulocyte count, 14May2008, 14500/mm3; Hematocrit, 14May2008, 30.7%; Hemoglobin, 14May2008, 10.5g/dl; Leukocyte count NOS, 14May2008, 20000/mm3; Lymphocytes, 14May2008, 3800/mm3; Monocytes, 14May2008, 2100/mm3; Platelet count, 14May2008, 421000/mm3; Ultrasound abdomen, 14May2008, Abnormal
CDC Split Type: B0554222A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. On 12 March 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 12 May 2008, 61 days after vaccination with ROTARIX, the subject experienced currant jelly stool with diarrhea, vomiting and fever. On 14 May 2008, the subject was hospitalised. Physical examination showed abdominal distension, absent bowel sounds and hard abdomen. The abdomen X-ray revealed air-fluids levels and abdominal ultrasound showed images which suggested an intussusception. The diagnosis of intussusception was made. On 14 May 2008, a surgery was performed and a twisted mesentery intussusception at ileon and ascending colon was found, leading to bowel resection and ileocolic anastomosis. No complication occurred. The subject was hospitalised for 7 days. On 20 May 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 337731 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-19
Onset:2008-12-27
   Days after vaccination:38
Submitted: 2009-01-20
   Days after onset:24
Entered: 2009-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Activated partial thromboplastin time shortened, Blood calcium decreased, Blood chloride increased, Blood creatinine normal, Blood potassium decreased, Blood sodium normal, Dehydration, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Platelet count increased, Prothrombin time normal, Pyrexia, Vomiting, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 29Dec2008, dilated loops and bad gas distribution; Calcium, 29Dec2008, 8.1mg/dl; Chloride, 29Dec2008, 116meq/dl; Creatinine, 29Dec2008, 0.2mg/dl; Hemoglobin, 29Dec2008, 10mg/dl; Platelet count, 29Dec2008, 498000UI/dl; Potassium, 29Dec2008, 1.6meq/dl; Prothrombin time test, 29Dec2008, 12.2s; Sodium, 29Dec2008, 145meq/dl; Thromboplastin, 29Dec2008, 27.9s
CDC Split Type: B0554040A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Subject''s medical condition included a healthy baby. On 19 November 2008 the subject received 1st dose of ROTARIX (oral). On 27 December 2008, 38 days after vaccination with ROTARIX, the subject experienced irritability, vomiting and bloody stools. Therefore she was admitted at the emergency room. Subject''s physical examination showed dehydration, vomiting and fever. The subject was hospitalized. Relevant test results included abdominal x-ray showing dilated loops and bad gas distribution. On 29 December 2008 intussusception was suspected. The same day Appendical Ileocecocolic intussusception was confirmed by laparotomy. It was reduced by taxis without complications. On 01 January 2008 the subject was discharged in good clinical conditions. The subject was treated with Meclizine, Piridoxine, Dimenhydrinate, Trimebutine, Metronidazole, Gentamicine and Nitazoxanide. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 337732 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-06
Onset:2008-12-29
   Days after vaccination:84
Submitted: 2009-01-20
   Days after onset:22
Entered: 2009-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Anorexia, Blood creatinine increased, Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood urea increased, Crepitations, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Mucous stools, Pharyngeal erythema, Platelet count normal, Prothrombin time shortened, Respiratory distress, Rhinitis, Rhinorrhoea, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Recurrent constipation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 31Dec2008, Abnormal; Abdominal X-ray, 02Jan2009, Normal; Blood glucose, 31Dec2008, 85mg/dl; Creatinine, 31Dec2008, 0.7mg/dl; Hematocrit, 31Dec2008, 31.4%; Hemoglobin, 31Dec2008, 10.1mg/dl; Platelet count, 31Dec2008, 220000/mm3; Potassium, 31Dec2008, 3.9mEq/L; Prothrombin time, 31Dec2008, 10.7sec; Sodium, 31Dec2008, 133mEq/L; Ultrasound abdomen, 31Dec2008, Abnormal; Urea, 31Dec2008, 32mg/dl
CDC Split Type: B0553807A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no allergy. Concurrent medical conditions included recurrent constipation without complication treated with laxans. On 6 October 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 29 December 2008, 84 days after vaccination with ROTARIX, the subject experienced irritability, rhinitis and anorexia. On 30 December 2008, the subject experienced bloody stools and 3 times vomiting. On 31 December 2008, the subject was brought to emergency ward due to respiratory distress. At physical examination, she was irritable with hyperemic pharynx without alteration. A rectal tact led to expulsion of currant jelly stool. The subject was hospitalised for 5 days. Abdominal ultrasound revealed an image of pseudokidney in the left side, suggestive of an intussusception. Abdomen X-ray reported dilated bowel loops with hydroaereus levels and lack of air in the rectal ampulla. The laboratory test showed partial thromboplastine time 27 sec. On 31 December 2008, 2 hours after admission, the subject experienced another episode of bloody stools. The physical examination revealed abdominal mass at palpation, hyaline rhinorrhea, bilateral widespread crackles and hyperemic pharynx again. The pulmonary exploration reported no complication. A Chest X-ray was not performed. On 31 December 2008, a surgery was performed and a 10 cm ileocecocolic intussusception was found and reduced by taxis without complication. The subject was treated with METRONIDAZOL, AMPICILLIN and amikacin. On 2 January 2009, the abdominal X-ray showed dilated intestinal loops with air in the rectal ampulla. On 4 January 2009, the events were resolved and the subject was discharged from hospital in good general health. The physician considered the events were unrelated to vaccination with ROTARIX.


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